IN FORCE Advance Authorisation

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Government of India / भारत सरकार

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

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

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

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Feb/202526/13 DATED: 20/02/2026

Minutes of the Norms Committee–3 Meeting NC/3/MEET/Feb/202526/13 dated 20/02/2026 (actually held on 10.03.2026) under the Chairmanship of Shri Rakesh Kumar, Addl. DGFT for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of the Foreign Trade Policy, 2023 pertaining to Chemical and Allied products falling under Chapter 29 and 30.

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

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

    The Norms Committee has taken decisions only with respect to technical

Signature Not Verified Signature Not Verified Digitally Digitally Signed. signa, Name: RAMAN KUMAR( Deputy Name: RAMAN KUJAMAR( Deputy DGFT )Date: 21-Apr-2026 10:31:34 DGFTDate: )21-Apr-2! 10:31:34 Reason: ramankumar@nic.in Reason: ramankymar@nic.in Location: DGFT(HQ) Location: DGFTTHQ)

This document has been digitally signed by Raman Kumar, Deputy DGFT,DGFT(HQ) on 21-Apr-2026.

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

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

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

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

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

Case No.	1 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00000125AM26
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>As per the advice of the technical authority, the firm was asked to attend a personal hearing through video<br>conference to explain its case. However, the personal hearing could not be conducted due to technical issues<br>beyond control. In view of this, the Committee decided to provide another opportunity to the firm by<br>conducting the personal hearing through video conference in the ensuing meeting.

Case No.	2 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001052AM26
RA File Number	NA

Signature Not Verified

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of<br>Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee<br>decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as<br>applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No. Import Item<br>Qty. allowed<br>1<br>MESALAMINE USP<br>1030.00 mg.<br>2<br>HARDFAT NF<br>2060 .30 mg.<br>3<br>PRT 100 PVC 30 PE 58<br>MM MESALAMINE<br>SUPPOSITORIES 1000<br>MG<br>200.00 mg.<br>MESALAMINE SUPPOSITORIES<br>1000 MG ((ACTIVE INGREDIENT:<br>MESALAMINE USP - NET WT.<br>14758.020 KGS))<br>1 Number<br>4<br>PRT 100 PVC 30 PE 60<br>MM MESALAMINE<br>SUPPOSITORIES 1000<br>MG<br>205.00 mg.<br>RA concerned may take further necessary action as per above decision of NC.

Licence No and Date

Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms to facilitate the issuance of Advance Authorization by the concerned Regional Authority. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm,whichever is less, as per the details indicated below.:- Export Product Qty. Sl. No. Import Item Qty. allowed 1 MESALAMINE USP 1030.00 mg. 2 HARDFAT NF 2060 .30 mg. 3 PRT 100 PVC 30 PE 58 MM MESALAMINE SUPPOSITORIES 1000 MG 200.00 mg. MESALAMINE SUPPOSITORIES 1000 MG ((ACTIVE INGREDIENT: MESALAMINE USP - NET WT. 14758.020 KGS)) 1 Number 4 PRT 100 PVC 30 PE 60 MM MESALAMINE SUPPOSITORIES 1000 MG 205.00 mg. RA concerned may take further necessary action as per above decision of NC.

14758.020 KGS)) 1 Number 4 PRT 100 PVC 30 PE 60 MM MESALAMINE SUPPOSITORIES 1000 MG 205.00 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	3 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	HEMA DYECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00002356AM26
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

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The Committee examined the request for fixation of a new SION and noted that production and consumption data for the same purpose have also been submitted by another manufacturer. Accordingly, the Technical Expert is requested to examine the data submitted by both parties and provide recommendations.

data for the same purpose have also been submitted by another manufacturer. Accordingly, the Technical Expert is requested to examine the data submitted by both parties and provide recommendations.

Case No.	4 / NC/3/MEET/Feb/202526/13
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00002105AM26
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the firm’s request for review of the ad-hoc norms. However, it was observed that<br>Norms for Active Pharmacopia Ingrediant (API) is given as per composition given in Drug Manufacturing<br>Licence, therefore, the Committee did not find any merit in the request and decided to reject the case,<br>thereby maintaining the status quo.

The Committee considered the firm’s request for review of the ad-hoc norms. However, it was observed that Norms for Active Pharmacopia Ingrediant (API) is given as per composition given in Drug Manufacturing Licence, therefore, the Committee did not find any merit in the request and decided to reject the case, thereby maintaining the status quo.

) is given as per composition given in Drug Manufacturing Licence, therefore, the Committee did not find any merit in the request and decided to reject the case, thereby maintaining the status quo.

Case No.	5 / NC/3/MEET/Feb/202526/13
Case Status	Case Rejected
Party Name	ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00005281AM26
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the firm’s request for review of the ad-hoc norms. However, it was observed that<br>the firm had not furnished any technical justification or supporting information for the proposed<br>enhancement. Accordingly, the Committee did not find any merit in the request and decided to reject the<br>case, thereby maintaining the status quo.

The Committee considered the firm’s request for review of the ad-hoc norms. However, it was observed that the firm had not furnished any technical justification or supporting information for the proposed enhancement. Accordingly, the Committee did not find any merit in the request and decided to reject the case, thereby maintaining the status quo.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

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t the case, thereby maintaining the status quo.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Case No.	6 / NC/3/MEET/Feb/202526/13
Case Status	Case Rejected
Party Name	VIJAYASRI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	018305000961AM12
RA File Number	092404000478 AM12
Licence No and<br>Date	0910051240/13/02/2012
Norms Committee Decision:<br>The firm vide letter dated 27.01.2026 has informed that they have surrender their above license. In view of<br>letter of firm, the Committee decided towithdrawthe application of the firm.

Case No.	Case No.	7 / NC/3/MEET/Feb/202526/13	7 / NC/3/MEET/Feb/202526/13	7 / NC/3/MEET/Feb/202526/13	7 / NC/3/MEET/Feb/202526/13	7 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		GLOBE TROTTERS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM REVIW00004519AM25
RA File Number		039404000124 AM16
Licence No and<br>Date		0310796194/26/05/2015
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms .

|RA File Number||039404000124 AM16||||| |Licence No and Date||0310796194/26/05/2015||||| |Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms . After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm,whichever is less, as per the details indicated below.:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Ampicllin Trihydrate (ATH) 5500 kg. 2 Acetonitirlle (CAN) 3 Methylene chloride 4 Sodium Thiocynate AMPICILLIN SODIUM BP ( STERILE ) 5000 kg. Not required and not imported by the firm.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||AMPICILLIN SODIUM BP ( STERILE )|| 5000 kg.|1|Ampicllin Trihydrate (ATH)|5500 kg.| |||||2|Acetonitirlle (CAN)|Not required and not imported by the firm.| |||||3|Methylene chloride|| |||||4|Sodium Thiocynate||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

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	5	Acetone
	6	Triethylamine
	7	Ethyl Acetate
	8	Pivaloyl Chloride
	9	Potassium Carbonate

Note: The above norms are for regularisation and closure purposes only.

The committee noted that the firm has sought additional input items beyond those originally declared and admitted to the same in the personal hearing held on 14.11.25. This constitutes a case of misdeclaration.

noted that the firm has sought additional input items beyond those originally declared and admitted to the same in the personal hearing held on 14.11.25. This constitutes a case of misdeclaration.

Accordingly, the Norms Committee advised the Regional Authority to initiate action against the firm under the FTDR Act for such misdeclaration.

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

Case No.	8 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	BELOORBAYIR BIOTECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00007896AM24
RA File Number	072404000347 AM16
Licence No and<br>Date	0710109255/12/01/2016
Norms Committee Decision:<br>As per the advice of the technical authority, the firm was asked to attend a personal hearing through video<br>conference to explain its case. However, the personal hearing could not be conducted due to technical issues<br>beyond control. In view of this, the Committee decided to provide another opportunity to the firm by<br>conducting the personal hearing through video conference in the ensuing meeting.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

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ugh video conference in the ensuing meeting.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Case No.	Case No.	9 / NC/3/MEET/Feb/202526/13	9 / NC/3/MEET/Feb/202526/13	9 / NC/3/MEET/Feb/202526/13	9 / NC/3/MEET/Feb/202526/13	9 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		CIPLA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM REVIW00003806AM25
RA File Number		039404000247 AM17
Licence No and<br>Date		0310805843/30/06/2016
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/202324/19 dated 05/01/2024 against advance<br>authorization No.0311013222 dated 22/03/2022, 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.

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 Telmisartan Granules 68.034 mg Telmisartan and Amlodipine Tablets 40/10 mg Each uncoated tablets contains : Telmisartan 40 mg (Telmisartan 40 mg equivalent to Telmisartan granules 67.36 mg Amlodipine Besilate equivalent to Amlodipine USP 10 mg) 1 Number 5 Amlodipine Besilate 10.20 mg. 2 Telmisartan Granules 136.07 mg. Telmisartan and Amlodipine Tablets 80/10 mg Each uncoated tablets contains : Telmisartan 80 mg (Telmisartan 80 mg equivalent to Telmisartan granules 134.72mg Amlodipine Besilate equivalent to Amlodipine USP 10mg) 1 Number 6 Amlodipine Besilate 10.20 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Telmisartan and Amlodipine Tablets 40/10 mg Each uncoated tablets contains : Telmisartan 40 mg (Telmisartan 40 mg equivalent to Telmisartan granules 67.36 mg Amlodipine Besilate equivalent to Amlodipine USP 10 mg)|| 1 Number|1|Telmisartan Granules|68.034 mg| |||||5|Amlodipine Besilate|10.20 mg.|

br>Telmisartan granules 67.36 mg Amlodipine Besilate equivalent to Amlodipine USP 10 mg)|| 1 Number|1|Telmisartan Granules|68.034 mg| |||||5|Amlodipine Besilate|10.20 mg.| ||Telmisartan and Amlodipine Tablets 80/10 mg Each uncoated tablets contains : Telmisartan 80 mg (Telmisartan 80 mg equivalent to Telmisartan granules 134.72mg Amlodipine Besilate equivalent to Amlodipine USP 10mg)|| 1 Number|2|Telmisartan Granules|136.07 mg.| |||||6|Amlodipine Besilate|10.20 mg.|

Case No.	Case No.	9 / NC/3/MEET/Feb/202526/13	9 / NC/3/MEET/Feb/202526/13	9 / NC/3/MEET/Feb/202526/13	9 / NC/3/MEET/Feb/202526/13	9 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		CIPLA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM REVIW00003806AM25
RA File Number		039404000247 AM17
Licence No and<br>Date		0310805843/30/06/2016
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/202324/19 dated 05/01/2024 against advance<br>authorization No.0311013222 dated 22/03/2022, 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.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

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|3 Telmisartan Granules 68.034 mg. Telmisartan and Amlodipine Tablets 40/5mg Each uncoated tablets contains : Telmisartan 40 mg (Telmisartan 40 mg equivalent to Telmisartan granules 67.36 mg Amlodipine Besilate equivalent to Amlodipine USP 5mg) 1 Number 7 Amlodipine Besilate 5.10 mg. 4 Telmisartan Granules 136.07 mg. Telmisartan and Amlodipine Tablets 80/5mg Each uncoated tablets contains : Telmisartan 80 mg (Telmisartan 80 mg equivalent to Telmisartan granules 134.72 mg Amlodipine Besilate equivalent to Amlodipine USP 5mg) 1 Number 8 Amlodipine Besilate 5.10 mg. RA concerned may take further necessary action as per above decision of NC.|Telmisartan and Amlodipine Tablets 40/5mg Each uncoated tablets contains : Telmisartan 40 mg (Telmisartan 40 mg equivalent t

Telmisartan and Amlodipine<br>Tablets 40/5mg Each uncoated<br>tablets contains : Telmisartan<br>40 mg (Telmisartan 40 mg<br>equivalent<br>to<br>Telmisartan<br>granules 67.36 mg Amlodipine<br>Besilate<br>equivalent<br>to<br>Amlodipine USP 5mg)	<br> <br> <br>1 Number	3	Telmisartan Granules	68.034 mg.
		7	Amlodipine Besilate	5.10 mg.
Telmisartan and Amlodipine<br>Tablets 80/5mg Each uncoated<br>tablets contains : Telmisartan<br>80 mg (Telmisartan 80 mg<br>equivalent<br>to<br>Telmisartan<br>granules<br>134.72<br>mg<br>Amlodipine Besilate equivalent<br>to Amlodipine USP 5mg)	<br> <br> <br>1 Number	4	Telmisartan Granules	136.07 mg.
		8	Amlodipine Besilate	5.10 mg.

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

Case No.	Case No.	10 / NC/3/MEET/Feb/202526/13	10 / NC/3/MEET/Feb/202526/13	10 / NC/3/MEET/Feb/202526/13	10 / NC/3/MEET/Feb/202526/13	10 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		CIPLA LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM REVIW00000262AM24
RA File Number		039404000295 AM18
Licence No and Date		0310814908/31/07/2017
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms .

|| |RA File Number||039404000295 AM18||||| |Licence No and Date||0310814908/31/07/2017||||| |Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms . After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm,whichever is less, as per the details indicated below.:- 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: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

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1	Salmeterol	0.003 gm.
36	63 mcl Aerosol Valves	Relevant, as per<br>Packing Policy and<br>General Notes.
47	14 ml Aluminium Can	Relevant, as per<br>Packing Policy and<br>General Notes.
68	0.42 mm OD Actuators<br>With Dust Covers / Caps	Relevant, as per<br>Packing Policy and<br>General Notes.
88	1,1,1,2,Tetrafluoroethane<br>(HFA 134A Propellant )	9.405 gm.
110	ETHANOL	0.195 gm.

2 mm OD Actuators With Dust Covers / Caps|Relevant, as per Packing Policy and General Notes.| ||||88|1,1,1,2,Tetrafluoroethane (HFA 134A Propellant )|9.405 gm.| ||||110|ETHANOL|0.195 gm.| ||Foratec Inhaler (CFC Free) (120 MD) / FOROTEL Inhaler (120MD) Formoterol 12mcg Inhaler (CFC Free) (120MD)(with 40 mcl Aerosol Valve, 10 ml Aluminium Can with 0.48 mm Actuator 134A HFA 7.84 gms, Ethanol 0.16 gms)| 1 Number|22|40 mcl Aerosol Valves|Relevant, as per Packing Policy and General Notes.| ||||44|10 ml Aluminium Can|Relevant, as per Packing Policy and General Notes.| ||||69|0.48 mm OD Actuators With Dose Counter|Relevant, as per Packing Policy and General Notes.| ||||89|1,1,1,2,Tetrafluoroethane ( HFA 134A Propellant )|5.88 gm.| ||||111|ETHANOL|0.120 gm.| ||Airflusal 25/250 mcg Inhaler (120 MD) / Fluticort Plus – 250 mcg HFA Inhaler (120MD) Seroflo 25/250 mcg|1 Number|2|Salmetero|0.003 gm.| ||||5|Fluticasone Propionate|0.03 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

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03 gm.| ||||5|Fluticasone Propionate|0.03 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Inhaler (120 MD) / (Seroflo 250 mcg<br>Inhaler (120 MD) Salmeterol 25 mcg<br>& Fluticasone Propionate 250 mcg<br>Inhaler (120MD) with 61mcl Aerosol<br>Valve, 14 ml Aluminium Can with<br>0.48 mm Actuator 134A HFA 12.50<br>gms)		31	61 mcl Aerosol Valves	Relevant, as per<br>Packing Policy and<br>General Notes.
		48	14 ml Aluminium Can	Relevant, as per<br>Packing Policy and<br>General Notes.
		70	0.48 mm OD Actuators<br>With Dose Counter	Relevant, as per<br>Packing Policy and<br>General Notes.
		90	1,1,1,2,Tetrafluoroethane<br>( HFA 134A Propellant )	8.98 gm.
Airflusal 25/125 mcg Inhaler (120<br>MD) / Fluticort Plus 125 mcg HFA<br>Inhaler (120MD) Seroflo 25/125 mcg<br>Inhaler (120 MD) /(Seroflo 125 mcg<br>Inhaler (120 MD) Salmeterol 25 mcg<br>& Fluticasone Propionate 125 mcg<br>Inhaler (120MD) with 61mcl Aerosol<br>Valve, 14 ml Aluminium Can with<br>0.48 mm Actuator 134A HFA 12.50<br>gms)	1 Number	3	Salmeterol	0.003 gm.
		6	Fluticasone Propionate	0.015 gm.
		32	61 mcl Aerosol Valves	Relevant, as per<br>Packing Policy and<br>General Notes.
		49	14 ml Aluminium Can	Relevant, as per<br>Packing Policy and<br>General Notes.
		71	0.48 mm OD Actuators<br>With Dose Counter	Relevant, as per<br>Packing Policy and<br>General Notes.
		91	1,1,1,2,Tetrafluoroethane<br>( HFA 134A Propellant)	8.98 gm.

General Notes.| ||||71|0.48 mm OD Actuators With Dose Counter|Relevant, as per Packing Policy and General Notes.| ||||91|1,1,1,2,Tetrafluoroethane ( HFA 134A Propellant)|8.98 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Beclate / Beclort HFA /<br>Beclometasone Dipropionate / Aircort /<br>Beclometasone Pressurised Inhalation<br>/(Beclocross /<br>Beclocip HFA / BECLOMAR CFC<br>Free 50 MCG Inhaler (200 MD) with<br>63 mcl Aerosol Valve, 19 ml<br>Aluminium Can with 0.48 mm<br>Actuator 134A HFA 17.772 gms,<br>Ethanol 0.456 gms)	<br>1 Number	11	Beclometasone<br>Dipropionate	0.010 gm.
		37	63 mcl Aerosol Valves	Relevant, as per<br>Packing Policy and<br>General Notes
		54	19 ml Aluminium Can	Relevant, as per<br>Packing Policy and<br>General Notes
		72	0.48 mm OD Actuators<br>With Dose Counter	Relevant, as per<br>Packing Policy and<br>General Notes
		92	1,1,1,2,Tetrafluoroethane<br>( HFA 134A Propellant )	14.82 gm.
		112	ETHANOL	0.383 gm.
Beclate / Beclort / Beclometasone<br>Dipropionate / AIRCORT /<br>Beclometasone Pressurised Inhalation<br>/(Beclocross / Beclocip HFA /<br>BECLOMAR CFC Free 100 MCG<br>Inhaler (200MD) with 63mcl Aerosol	1 Number	12	Beclometasone<br>Dipropionate	0.020 gm.
		38	63 mcl Aerosol Valves	Relevant, as per<br>Packing Policy and<br>General Notes

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

rosol Valves|Relevant, as per Packing Policy and General Notes|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Valve, 19 ml Aluminium Can with<br>0.48 mm Actuator 134A HFA 17.304<br>gms, Ethanol 0.912 gms)		55	19 ml Aluminium Can	Relevant, as per<br>Packing Policy and<br>General Notes
		73	0.48 mm OD Actuators<br>With Dose Counter	Relevant, as per<br>Packing Policy and<br>General Notes
		93	1,1,1,2,Tetrafluoroethane<br>( HFA 134A Propellant)	14.44 gm.
		113	ETHANOL	0.760 gm.
Beclate / Beclort / Beclometasone<br>Dipropionate / AIRCORT /<br>Beclometasone Pressurised Inhalation /<br>Beclocross / (Beclocip HFA /<br>BECLOMAR CFC Free 200 MCG<br>Inhaler (200 MD) with 63 mcl Aerosol<br>Valve, 19 ml Aluminium Can with<br>0.48mm Actuator 134A HFA 16.368<br>gms, Ethanol 1.824 gms)	<br>1 Number	13	Beclometasone<br>Dipropionate	0.020 gm.
		39	63 mcl Aerosol Valves	Relevant, as per<br>Packing Policy and<br>General Notes
		56	19 ml Aluminium Can	Relevant, as per<br>Packing Policy and<br>General Notes
		74	0.48 mm OD Actuators<br>With Dose Counter	Relevant, as per<br>Packing Policy and<br>General Notes
		94	1,1,1,2,Tetrafluoroethane<br>(HFA 134A Propellant)	13.68 gm.
		114	ETHANOL	1.52 gm.
Beclate / Beclort / Beclometasone<br>Dipropionate / AIRCORT /<br>Beclometasone Pressurised Inhalation /<br>Beclocross / (Beclocip<br>HFA / BECLOMAR CFC Free 250	<br>1 Number	14	Beclometasone<br>Dipropionate	0.050 gm.

/ Beclometasone Dipropionate / AIRCORT / Beclometasone Pressurised Inhalation / Beclocross / (Beclocip HFA / BECLOMAR CFC Free 250| 1 Number|14|Beclometasone Dipropionate|0.050 gm.| ||||40|63 mcl Aerosol Valves|Relevant, as per Packing Policy and General Notes|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

MCG Inhaler (200MD) with 63 mcl<br>Aerosol Valve, 19 ml Aluminium Can<br>with 0.48 mm Actuator 134A HFA<br>15.900 gms, Ethanol 2.280 gms)		57	19 ml Aluminium Can	Relevant, as per<br>Packing Policy and<br>General Notes
		75	0.48 mm OD Actuators<br>With Dose Counter	Relevant, as per<br>Packing Policy and<br>General Notes
		95	1,1,1,2,Tetrafluoroethane<br>( HFA 134A Propellant)	13.25 gm.
		115	ETHANOL	1.90 gm.
Ciclesonide Inhaler 80 mcg (120 MD)<br>Ciclohale 80 Inhaler (120 MD)<br>Disbronc 80 Inhaler (120 MD) (with<br>50mcl Aerosol Valve, 10ml<br>Aluminium Can, 0.33 Actuator 134A<br>HFA 9.010 gms, Ethanol 0.576 gms)	1 Number	23	50 mcl Aerosol Valves	Relevant, as per<br>Packing Policy and<br>General Notes
		45	10 ml Aluminium Can	Relevant, as per<br>Packing Policy and<br>General Notes
		66	0.33 mm OD Actuators<br>With Dust Covers / Caps	Relevant, as per<br>Packing Policy and<br>General Notes
		96	1,1,1,2,Tetrafluoroethane<br>( HFA 134A Propellant )	6.76 gm.
		116	ETHANOL	0.435 gm.

33 mm OD Actuators With Dust Covers / Caps|Relevant, as per Packing Policy and General Notes| ||||96|1,1,1,2,Tetrafluoroethane ( HFA 134A Propellant )|6.76 gm.| ||||116|ETHANOL|0.435 gm.| ||Ciclesonide Inhaler 160mcg (120 MD) Ciclohale 160 Inhaler (120 MD) Disbronc 160 Inhaler (120 MD) (with 50 mcl Aerosol Valve, 10 ml Aluminium Can, 0.33 Actuator 134A HFA 8.995 gms, Ethanol 0.576 gms)|1 Number|24|50 mcl Aerosol Valves|Relevant, as per Packing Policy and General Notes| ||||46|10 ml Aluminium Can|Relevant, as per Packing Policy and General Notes| ||||67|0.33 mm OD Actuators With Dust Covers / Caps|Relevant, as per Packing Policy and General Notes|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

		97	1,1,1,2,Tetrafluoroethane	6.75 gm.
			( HFA 134A Proellant )
			p
		117	ETHANOL	0.435 gm.

Aerodini 100 mcg Inhaler (200MD) /<br>Bulmol 100 mcg Inhaler (200 MD) /<br>Salcross HFA 100 mcg Inhaler<br>(200MD) / (Asthalin Inhaler (200 MD)<br>/ Salair Inhaler (200 MD) Salbutamol<br>Pressurised Inhalation BP 100 mcg	1 Number	16	Salbutamo	0.002
		25	50 mcl Aerosol Valves	Relevant, as per<br>Packing Policy and<br>General Notes
(200 MD) / SALBUREX 100 mcg<br>Inhaler (200MD) with 50 mcl Aerosol<br>Valve, 19ml Aluminium Can, 0.48<br>Actuator 134A HFA 18.20 gms)
		58	19 ml Aluminium Can	Relevant, as per<br>Packing Policy and<br>General Notes

MD) with 50 mcl Aerosol Valve, 19ml Aluminium Can, 0.48 Actuator 134A HFA 18.20 gms)|||||| |||||58|19 ml Aluminium Can|Relevant, as per Packing Policy and General Notes| |||||||| |||||||| |||||76|0.48 mm OD Actuators|Relevant, as per| ||||||With Dose Counter| Packing Policy and| |||||||General Notes| |||||98|1112Ttflth|1517| ||||||,,,,erauoroeane|. gm.| ||||||( HFA 134A Propellant )|| ||Budespray 200 mcg HFA Inhaler (200 MD) / Budecort 200 mcg Inhaler (200 MD) Budesonide Inhaler 200mcg (200 MD) /(BUDEMAR 200 mcg Inhaler (200 MD) with 58 mcl Aerosol Valve, 19 ml Aluminium Can, 0.48 Actuator 134A HFA 18.20 gms)||1 Number|19|Budesonide|0.040 gm.| |||||27|58 mcl Aerosol Valves|Relevant, as per Packing Policy and General Notes| |||||||| |||||59|19 ml Aluminium Can|Relevant, as per Packing Policy and General Notes| |||||77|048 OD Att|Rlt| ||||||. mm cuaors With Dose Counter|eevan, as per Packing Policy and| ||||||| General Notes| |||||||| |||||||| |||||99|1,1,1,2,Tetrafluoroethane|15.17 gm.| ||||||( HFA 134A Propellant )|| |||||||| |||||||| ||Budespray 100 mcg HFA Inhaler (200||1 Number|20|Budesonide|0.020 gm.| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

0||1 Number|20|Budesonide|0.020 gm.| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

MD) / Budecort 100 mcg Inhaler (200<br>MD) Budesonide Inhaler 100 mcg<br>(200MD) /(BUDEMAR 100 mcg<br>Inhaler (200 MD) with 58 mcl Aerosol<br>Valve, 19 ml Aluminium Can, 0.48<br>Actuator 134A HFA 18.20 gms)		28	58 mcl Aerosol Valves	Relevant, as per<br>Packing Policy and<br>General Notes
		60	19 ml Aluminium Can	Relevant, as per<br>Packing Policy and<br>General Notes
		78	0.48 mm OD Actuators<br>With Dose Counter	Relevant, as per<br>Packing Policy and<br>General Notes
		100	1,1,1,2,Tetrafluoroethane<br>( HFA 134A Propellant )	15.17 gm.
Formoterol Fumarate and Budesonide<br>Inhaler 6/100 mcg (120 MD) / Foracort<br>100 Inhaler (120MD)(with 58mcl<br>Aerosol Valve, 19 ml Aluminium Can,<br>0.48 Actuator 134A HFA 12.20 gms)	<br>1 Number	29	58 mcl Aerosol Valves	Relevant, as per<br>Packing Policy and<br>General Notes
		61	19 ml Aluminium Can	Relevant, as per<br>Packing Policy and<br>General Notes
		79	0.48 mm OD Actuators<br>With Dose Counter	Relevant, as per<br>Packing Policy and<br>General Notes
		101	1,1,1,2,Tetrafluoroethane<br>( HFA 134A Propellant )	9.15 gm.

and General Notes| ||||79|0.48 mm OD Actuators With Dose Counter|Relevant, as per Packing Policy and General Notes| ||||101|1,1,1,2,Tetrafluoroethane ( HFA 134A Propellant )|9.15 gm.| ||Formoterol Fumarate and Budesonide Inhaler 6/200 mcg (120 MD) / Foracort 200 Inhaler (120 MD) (with 58 mcl Aerosol Valve, 19ml Aluminium Can, 0.48 Actuator 134A HFA 12.20 gms)| 1 Number|30|58 mcl Aerosol Valves|Relevant, as per Packing Policy and General Notes| ||||62|19 ml Aluminium Can|Relevant, as per Packing Policy and General Notes| ||||80|0.48 mm OD Actuators With Dose Counter|Relevant, as per Packing Policy and General Notes|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

		102	1,1,1,2,Tetrafluoroethane<br>( HFA 134A Propellant )	9.15 gm.
Beclomethasone Dipropionate 50mcg<br>and Salbutamol 100 mcg Inhaler (200<br>MD) Aerocort HFA Inhaler (200 MD)<br>/(Aeroday Inhaler (200 MD) /<br>Asmabron HFA Inhaler (200 MD)<br>Asthalin B Inhaler (200 MD) with 50<br>mcl Aerosol Valve, 19 ml Aluminium<br>Can, 0.48 Actuator 134A HFA 14.04<br>gms, Ethanol 0.36 gms)	1 Number	15	Beclometasone<br>Dipropionate	0.010 gm
		17	Salbutamol	0.020 gm.
		26	50 mcl Aerosol Valves	Relevant, as per<br>Packing Policy and<br>General Notes
		63	19 ml Aluminium Can	Relevant, as per<br>Packing Policy and<br>General Notes
		81	0.48 mm OD Actuators<br>With Dose Counter	Relevant, as per<br>Packing Policy and<br>General Notes

al Notes| ||||63|19 ml Aluminium Can|Relevant, as per Packing Policy and General Notes| ||||81|0.48 mm OD Actuators With Dose Counter|Relevant, as per Packing Policy and General Notes| ||||103|1,1,1,2,Tetrafluoroethane ( HFA 134A Propellant )|11.70 gm.| ||||118|ETHANOL|0.300 gm.| ||Fluticasone Propionate 50mcg Inhaler (120 MD) / Floair 50 mcg Inhaler (120 MD) Flohale 50 Inhaler (120 MD) /(TRUFLO 50 Inhaler (120 MD) with 61 mcl Aerosol Valve, 14 ml Aluminium Can, 0.48 Actuator 134A HFA 12.50 gms, Ethanol 0.256 gms)|1 Number|7|Fluticasone Propionate|0.006 gm.| ||||33|61 mcl Aerosol Valves|Relevant, as per Packing Policy and General Notes| ||||50|14 ml Aluminium Can|Relevant, as per Packing Policy and General Notes| ||||82|0.48 mm OD Actuators With Dose Counter|Relevant, as per Packing Policy and General Notes| ||||104|1,1,1,2,Tetrafluoroethane|9.38 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

| ||||104|1,1,1,2,Tetrafluoroethane|9.38 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

			( HFA 134A Propellant )
		119	ETHANOL	0.192 gm.
Fluticasone Propionate 125 mcg<br>Inhaler (120MD) Flohale 125 Inhaler<br>(120 MD) / TRUFLO 125 Inhaler (120<br>MD) (with 61mcl Aerosol Valve, 14<br>ml Aluminium Can, 0.48 Actuator<br>134A HFA 12.50 gms, Ethanol 0.256<br>gms)	1 Number	8	Fluticasone Propionate	0.015 gm.
		34	61mcl Aerosol Valves	Relevant, as per<br>Packing Policy and<br>General Notes
		51	14 ml Aluminium Can	Relevant, as per<br>Packing Policy and<br>General Notes
		83	0.48 mm OD Actuators<br>With Dose Counter	Relevant, as per<br>Packing Policy and<br>General Notes
		105	1,1,1,2,Tetrafluoroethane<br>( HFA 134A Propellant )	9.38 gm.
		120	ETHANOL	0.192 gm.
Fluticasone Propionate 250 mcg<br>Inhaler (120 MD) Flohale 250 Inhaler<br>(120 MD) /(TRUFLO 250 Inhaler (120<br>MD) with 61mcl Aerosol Valve, 14ml<br>Aluminium Can, 0.48 Actuator 134A<br>HFA 12.50 gms, Ethanol 0.256 gms)	1 Number	9	Fluticasone Propionate	0.030 gm.
		35	61 mcl Aerosol Valves	Relevant, as per<br>Packing Policy and<br>General Notes
		52	14 ml Aluminium Can	Relevant, as per<br>Packing Policy and<br>General Notes
		84	0.48 mm OD Actuators<br>With Dose Counter	Relevant, as per<br>Packing Policy and<br>General Notes
		106	1,1,1,2,Tetrafluoroethane<br>( HFA 134A Propellant)	9.38 gm.

d General Notes| ||||84|0.48 mm OD Actuators With Dose Counter|Relevant, as per Packing Policy and General Notes| ||||106|1,1,1,2,Tetrafluoroethane ( HFA 134A Propellant)|9.38 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

		121	ETHANOL	0.192
Fluticort Plus – 50 mcg HFA Inhaler<br>(120 MD) / Salmeterol 25 mcg and<br>Fluticasone Propionate 50 mcg Inhaler<br>(120 MD) /(Flunacross S – 50 mcg<br>HFA Inhaler (120 MD) with 63 mcl<br>Aerosol Valve, 14 ml Aluminium Can,<br>0.48 Actuator 134A HFA 12.50 gms,<br>Ethanol 0.256 gms)	1 Number	4	Salmeterol	0.003 gm.
		10	Fluticasone Propionate	0.006 gm.
		41	63 mcl Aerosol Valves	Relevant, as per<br>Packing Policy and<br>General Notes
		53	14 ml Aluminium Can	Relevant, as per<br>Packing Policy and<br>General Notes
		85	0.48 mm OD Actuators<br>With Dose Counter	Relevant, as per<br>Packing Policy and<br>General Notes
		107	1,1,1,2,Tetrafluoroethane<br>( HFA 134A Propellant )	9.38 gm.
		122	ETHANOL	0.192 gm.
Budes N Inhaler 200 mcg (200 MD)<br>Budesonide Inhaler (200 MD) (with 63<br>mcl Aerosol Valve, 19 ml coated<br>Aluminium Can, 0.48 Actuator 134A<br>HFA 15.42 gms, Ethanol 2.730 gms)	1 Number	21	Budesonide	0.040 gm.
		42	63 mcl Aerosol Valves	Relevant, as per<br>Packing Policy and<br>General Notes
		65	19 ml Coated Aluminium<br>Can	Relevant, as per<br>Packing Policy and<br>General Notes

desonide|0.040 gm.| ||||42|63 mcl Aerosol Valves|Relevant, as per Packing Policy and General Notes| ||||65|19 ml Coated Aluminium Can|Relevant, as per Packing Policy and General Notes| ||||86|0.48 mm OD Actuators With Dose Counter|Relevant, as per Packing Policy and General Notes| ||||108|1,1,1,2,Tetrafluoroethane ( HFA 134A Propellant )|12.85 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

123<br>ETHANOL<br>2.275 gm.<br>18<br>Salbutamol<br>0.020 gm.<br>43<br>63 mcl Aerosol Valves<br>Relevant, as per<br>Packing Policy and<br>General Notes<br>64<br>19 ml Aluminium Can<br>Relevant, as per<br>Packing Policy and<br>General Notes<br>87<br>0.48 mm OD Actuators<br>With Dose Counter<br>Relevant, as per<br>Packing Policy and<br>General Notes<br>109<br>1,1,1,2,Tetrafluoroethane<br>( HFA 134A Propellant )<br>14.87 gm.<br>Bropil Inhaler (200 MD) Salbutamol<br>100 Pressurised Inhalation (200 MD)<br>(with 63 mcl Aerosol Valve, 19 ml<br>Aluminium Can, 0.48 Actuator 134A<br>HFA 17.84 gms, Ethanol 0.364 gms)<br>1 Number<br>124<br>ETHANOL<br>0.303 gm.<br>RA concerned may take further necessary action as per above decision of NC.			123	ETHANOL	2.275 gm.
	Bropil Inhaler (200 MD) Salbutamol<br>100 Pressurised Inhalation (200 MD)<br>(with 63 mcl Aerosol Valve, 19 ml<br>Aluminium Can, 0.48 Actuator 134A<br>HFA 17.84 gms, Ethanol 0.364 gms)	1 Number	18	Salbutamol	0.020 gm.

MD) Salbutamol 100 Pressurised Inhalation (200 MD) (with 63 mcl Aerosol Valve, 19 ml Aluminium Can, 0.48 Actuator 134A HFA 17.84 gms, Ethanol 0.364 gms)|1 Number|18|Salbutamol|0.020 gm.| ||||43|63 mcl Aerosol Valves|Relevant, as per Packing Policy and General Notes| ||||64|19 ml Aluminium Can|Relevant, as per Packing Policy and General Notes| ||||87|0.48 mm OD Actuators With Dose Counter|Relevant, as per Packing Policy and General Notes| ||||109|1,1,1,2,Tetrafluoroethane ( HFA 134A Propellant )|14.87 gm.| ||||124|ETHANOL|0.303 gm.|

Case No.	11 / NC/3/MEET/Feb/202526/13
Case Status	Case Rejected
Party Name	WEXFORD LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00003782AM25
RA File Number	072404000120 AM18
Licence No and<br>Date	0710111992/09/08/2017
Norms Committee Decision:<br>The Committee examined all documents submitted by the firm and noted that no clear specification<br>was provided regarding whether the exported quantity was 500 mg or 1 mg. Despite repeated<br>requests, the authorisation holder failed to furnish the required product specifications. Accordingly,

The Committee examined all documents submitted by the firm and noted that no clear specification was provided regarding whether the exported quantity was 500 mg or 1 mg. Despite repeated requests, the authorisation holder failed to furnish the required product specifications. Accordingly,

ion was provided regarding whether the exported quantity was 500 mg or 1 mg. Despite repeated requests, the authorisation holder failed to furnish the required product specifications. Accordingly,

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

the Committee has decided to reject the case.

Case No.	12 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	SHREE BANKEY BEHARI LAL FLAVORS
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00006890AM24
RA File Number	052404000067 AM19
Licence No and<br>Date	0510406412/10/05/2018
Norms Committee Decision:<br>The Committee noted that CLA Delhi has now submitted its report. It was decided to examine the case<br>based on the report furnished by the RA. Accordingly, the matter has been deferred to the next meeting.

Case No.	Case No.	13 / NC/3/MEET/Feb/202526/13	13 / NC/3/MEET/Feb/202526/13	13 / NC/3/MEET/Feb/202526/13	13 / NC/3/MEET/Feb/202526/13	13 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		GLOBE TROTTERS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM REVIW00004505AM25
RA File Number		039404000713 AM19
Licence No and<br>Date		0310825212/26/11/2018
Norms Committee Decision:<br>The Committee examined the request of the firm for the fixation of ad-hoc norms . After due deliberation,<br>the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical<br>Authority or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

inputs received from the Technical Authority or as applied for by the firm,whichever is less, as per the details indicated below.:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 AMPICILLIN TRIHYDRATE IP/BP/USP 9.390 kg. AMPICILLIN SODIUM STERILE BP 10000 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||AMPICILLIN SODIUM STERILE BP|| 10000 kg.|1 |AMPICILLIN TRIHYDRATE IP/BP/USP|9.390 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

==> picture [464 x 146] intentionally omitted <==

----- Start of picture text ----- 2 ACETONITRILE (ACN) Not required. 3 METHYLENE CHLORIDE 4 TRIETHYLAMINE 5 ETHYL ACETATE ----- End of picture text -----

Note: The above norms are for regularization and closure purposes only.

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

----- End of picture text -----**

Note: The above norms are for regularization and closure purposes only.

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

Case No.	Case No.	14 / NC/3/MEET/Feb/202526/13	14 / NC/3/MEET/Feb/202526/13	14 / NC/3/MEET/Feb/202526/13	14 / NC/3/MEET/Feb/202526/13	14 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		CIPLA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM REVIW00001465AM26
RA File Number		039404001019 AM19
Licence No and<br>Date		0310827414/01/03/2019
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in meeting No.NC/3/MEET/Apr/202526/2 dated 08/05/2025 against advance<br>authorization No.0311000235 dated 21/12/2020, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Efavirenz<br>612 mg.<br>2<br>Lamivudine<br>306 mg.<br>Efavirenz<br>600<br>mg,<br>Lamivudine<br>300<br>mg,<br>Tenofovir<br>Disoproxil<br>1 Number
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Efavirenz<br>600<br>mg,<br>Lamivudine<br>300<br>mg,<br>Tenofovir<br>Disoproxil		<br> <br> <br>1 Number	1	Efavirenz	612 mg.
				2	Lamivudine	306 mg.

||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Efavirenz 600 mg, Lamivudine 300 mg, Tenofovir Disoproxil|| 1 Number|1|Efavirenz|612 mg.| |||||2|Lamivudine|306 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

3	Tenofovir Disoproxil Fumarate	306 mg.
4	Croscarmellose Sodium<br>(AC-DI-SOL) NF	123 mg.
5	Microcrystalline Cellulose NF<br>(Avicel PH 101)	297.6 mg.
6	Magnesium Stearate NF<br>(Vegetable Grade)	17 mg.
7	Hydroxy Propyl Cellulose NF<br>(KlucelLF)	38.4 mg.

I-SOL) NF|123 mg.| ||||5|Microcrystalline Cellulose NF (Avicel PH 101)|297.6 mg.| ||||6|Magnesium Stearate NF (Vegetable Grade)|17 mg.| ||||7|Hydroxy Propyl Cellulose NF (KlucelLF)|38.4 mg.| ||||8|Lactose for DC (Tablettose 80/Super Tab) BP/PH Eur|199.6 mg.| ||||9|Silica Gel bags 3 GM StripaxR/F|As per packing policy and General Notes.|

Case No.	15 / NC/3/MEET/Feb/202526/13
Case Status	Case Rejected
Party Name	DIPS BIOSCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00001257AM26
RA File Number	039404000788 AM20
Licence No and<br>Date	0310833754/27/12/2019
Norms Committee Decision:<br>The Committee considered the request of the 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 didn’t<br>find any merit to review the norms, and it was decided to reject the case, maintaining the status quo.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

eject the case, maintaining the status quo.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Case No.	16 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00001603AM26
RA File Number	039404000340 AM21
Licence No and<br>Date	0310838214/11/09/2020
Norms Committee Decision:<br>The committee considered the case as per the agenda and after examination, it was observed that the firm has not<br>furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in<br>view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the<br>following documents:<br>1. Copy of amended Advance Authorisation showing all six export items and additional import items.

ical Authority, the Committee decided to ask the firm to furnish the following documents: 1. Copy of amended Advance Authorisation showing all six export items and additional import items.||

Case No.	Case No.	17 / NC/3/MEET/Feb/202526/13	17 / NC/3/MEET/Feb/202526/13	17 / NC/3/MEET/Feb/202526/13	17 / NC/3/MEET/Feb/202526/13	17 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		ANANTA MEDICARE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM REVIW00000878AM26
RA File Number		05AA040108247 AM22
Licence No and<br>Date		0511006681/07/12/2021
Norms Committee Decision:<br>The Committee examined the request of the firm for the fixation of ad-hoc norms. After due deliberation,<br>the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical<br>Authority or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

CEFEPIME POWDER FOR<br>SOLUTION FOR<br>INJECTION, WEIGHT 1<br>GMS /VIAL(CEFEPIME<br>HCL+LARGININE STERILE<br>USP)<br>1 Number<br>1<br>Cefepime HCL+L-Arginine<br>Sterile USP<br>1.04 gm/vial<br>CEFEPIME POWDER FOR<br>SOLUTION FOR<br>INJECTION, WEIGHT 2<br>GMS /VIAL(CEFEPIME<br>HCL+LARGININE<br>STERILE USP)<br>1 Number<br>2<br>Cefepime HCL+L-Arginine<br>Sterile USP<br>2.08 gm/vial<br>RA concerned may take further necessary action as per above decision of NC.	CEFEPIME POWDER FOR<br>SOLUTION FOR<br>INJECTION, WEIGHT 1<br>GMS /VIAL(CEFEPIME<br>HCL+LARGININE STERILE<br>USP)	1 Number	1	Cefepime HCL+L-Arginine<br>Sterile USP	1.04 gm/vial
	CEFEPIME POWDER FOR<br>SOLUTION FOR<br>INJECTION, WEIGHT 2<br>GMS /VIAL(CEFEPIME<br>HCL+LARGININE<br>STERILE USP)	1 Number	2	Cefepime HCL+L-Arginine<br>Sterile USP	2.08 gm/vial

--|---|---|---| ||CEFEPIME POWDER FOR SOLUTION FOR INJECTION, WEIGHT 2 GMS /VIAL(CEFEPIME HCL+LARGININE STERILE USP)|1 Number|2|Cefepime HCL+L-Arginine Sterile USP|2.08 gm/vial|

Case No.	Case No.	18 / NC/3/MEET/Feb/202526/13	18 / NC/3/MEET/Feb/202526/13	18 / NC/3/MEET/Feb/202526/13	18 / NC/3/MEET/Feb/202526/13	18 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		ANANTA MEDICARE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM REVIW00000879AM26
RA File Number		05AX04000189 AM22
Licence No and<br>Date		0511007079/21/12/2021
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms . After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>CEFEPIME POWDER FOR<br>Cefepime HCL+L-Arginine<br>1 Number<br>1<br>1.04 gm/vial
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	CEFEPIME POWDER FOR		1 Number	1	Cefepime HCL+L-Arginine	1.04 gm/vial

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

umber|1|Cefepime HCL+L-Arginine|1.04 gm/vial|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

SOLUTION FOR<br>INJECTION, WEIGHT 1<br>GMS /VIAL(CEFEPIME<br>HCL+LARGININE STERILE<br>USP)<br>Sterile USP<br>CEFEPIME POWDER FOR<br>SOLUTION FOR<br>INJECTION,WEIGHT 2 GMS<br>/VIAL(CEFEPIME<br>HCL+LARGININE<br>STERILE USP)<br>1 Number<br>2<br>Cefepime HCL+L-Arginine<br>Sterile USP<br>2.08 gm/vial<br>RA concerned may take further necessary action as per above decision of NC.	SOLUTION FOR<br>INJECTION, WEIGHT 1<br>GMS /VIAL(CEFEPIME<br>HCL+LARGININE STERILE<br>USP)			Sterile USP
	CEFEPIME POWDER FOR<br>SOLUTION FOR<br>INJECTION,WEIGHT 2 GMS<br>/VIAL(CEFEPIME<br>HCL+LARGININE<br>STERILE USP)	1 Number	2	Cefepime HCL+L-Arginine<br>Sterile USP	2.08 gm/vial

Case No.	19 / NC/3/MEET/Feb/202526/13
Case Status	Case Rejected
Party Name	PRIVI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00000613AM26
RA File Number	03AX04003421 AM23
Licence No and<br>Date	0311018336/03/10/2022
Norms Committee Decision:<br>The firm was initially granted an Advance Authorisation for the export product_“Galaxmusk Pure”_under<br>Para 4.07 of the Handbook of Procedures (HBP).

336/03/10/2022| |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 and are mandatorily required to be processed under Para 4.06 of the HBP. It was observed that the firm obtained the authorisation bymisdeclaring that its application was covered under the provisions of Para 4.07, and has not furnished any technical justification/information for the export product. Accordingly, the Committee found no merit in fixing the norms and decided to reject the application. The RA shall ensure that the said authorisation is regularised by recovery of applicable Customs duty along with interest. Further, the RA should also submit a report on how this authorisation was issued||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

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

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

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

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

Case No.	20 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	VASISTA LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00004049AM23
RA File Number	09AX04000675 AM23
Licence No and<br>Date	0911003903/03/11/2022
Norms Committee Decision:<br>The committee considered the case as per the agenda and after examination, it was observed that the firm has not<br>furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in<br>view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the<br>following documents:<br>1. Net content of THF is not given in Certificate of Analysis (CoA) of export items

s of the Technical Authority, the Committee decided to ask the firm to furnish the following documents: 1. Net content of THF is not given in Certificate of Analysis (CoA) of export items||

Case No.	21 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	BOTANIC HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00001486AM26
RA File Number	09AX04000641 AM23
Licence No and<br>Date	0911003939/10/11/2022
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms . After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
L-Glutathone Reduced	1 kg.	1	L - Glutathione	1.007 kg.

nkumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
L-Glutathone Reduced	1 kg.	1	L - Glutathione	1.007 kg.

Case No.	Case No.	22 / NC/3/MEET/Feb/202526/13	22 / NC/3/MEET/Feb/202526/13	22 / NC/3/MEET/Feb/202526/13	22 / NC/3/MEET/Feb/202526/13	22 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		ACUTAAS CHEMICALS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM REVIW00001070AM26
RA File Number		52AX04001711 AM23
Licence No and Date		5211003710/07/12/2022
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Triphenylphosphine<br>2.54 kg.<br>2<br>Tert-Butyl((1S)-2-hydroxy-1-<br>methylethyl)carbamate<br>(DARO-IV)<br>1.70 kg.<br>3<br>(S)-4-(1-(2-aminopropyl)-1H-<br>pyrazol-3-yl)-2-chlorobenzonitrile<br>(DARO-V)<br>0.001 kg.<br>4<br>2-chloro-4-(1H-pyrazol-3-<br>yl)benzonitrile (DARO-III)<br>0.963 kg.<br>4-{1-[(2S)-2-Aminopropyl]-1-H-<br>Pyrazole-3-yl}-2-<br>Chlorobenzonitrile<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

yl)benzonitrile (DARO-III) 0.963 kg. 4-{1-[(2S)-2-Aminopropyl]-1-H- Pyrazole-3-yl}-2- Chlorobenzonitrile 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||4-{1-[(2S)-2-Aminopropyl]-1-H- Pyrazole-3-yl}-2- Chlorobenzonitrile||1 kg.|1|Triphenylphosphine|2.54 kg.| |||||2|Tert-Butyl((1S)-2-hydroxy-1- methylethyl)carbamate (DARO-IV)|1.70 kg.| |||||3|(S)-4-(1-(2-aminopropyl)-1H- pyrazol-3-yl)-2-chlorobenzonitrile (DARO-V)|0.001 kg.| |||||4|2-chloro-4-(1H-pyrazol-3- yl)benzonitrile (DARO-III)|0.963 kg.|

Case No.	Case No.	22 / NC/3/MEET/Feb/202526/13	22 / NC/3/MEET/Feb/202526/13	22 / NC/3/MEET/Feb/202526/13	22 / NC/3/MEET/Feb/202526/13	22 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		ACUTAAS CHEMICALS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM REVIW00001070AM26
RA File Number		52AX04001711 AM23
Licence No and Date		5211003710/07/12/2022
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

ived from the Technical Authority or as applied for by the firm,whichever is less, as per the details indicated below.:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Triphenylphosphine 2.54 kg. 2 Tert-Butyl((1S)-2-hydroxy-1- methylethyl)carbamate (DARO-IV) 1.70 kg. 3 (S)-4-(1-(2-aminopropyl)-1H- pyrazol-3-yl)-2-chlorobenzonitrile (DARO-V) 0.001 kg. 4 2-chloro-4-(1H-pyrazol-3- yl)benzonitrile (DARO-III) 0.963 kg. 4-{1-[(2S)-2-Aminopropyl]-1-H- Pyrazole-3-yl}-2- Chlorobenzonitrile 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||4-{1-[(2S)-2-Aminopropyl]-1-H- Pyrazole-3-yl}-2- Chlorobenzonitrile||1 kg.|1|Triphenylphosphine|2.54 kg.| |||||2|Tert-Butyl((1S)-2-hydroxy-1- methylethyl)carbamate (DARO-IV)|1.70 kg.| |||||3|(S)-4-(1-(2-aminopropyl)-1H- pyrazol-3-yl)-2-chlorobenzonitrile (DARO-V)|0.001 kg.| |||||4|2-chloro-4-(1H-pyrazol-3- yl)benzonitrile (DARO-III)|0.963 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

	5	Diisopropyl azodicarboxylate	1.96	kg.
		(DIAD)

MAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

	5	Diisopropyl azodicarboxylate	1.96	kg.
		(DIAD)

Case No.	23 / NC/3/MEET/Feb/202526/13
Case Status	Case Rejected
Party Name	NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00000820AM26
RA File Number	03AX04000048 AM24
Licence No and<br>Date	0311022711/11/04/2023
Norms Committee Decision:<br>The Committee considered the firm’s request for review of the ad-hoc norms. However, it was observed that<br>the firm had not furnished any technical justification or supporting information for the proposed<br>enhancement. Accordingly, the Committee did not find any merit in the request and decided to reject the<br>case, thereby maintaining the status quo.

fication or supporting information for the proposed enhancement. Accordingly, the Committee did not find any merit in the request and decided to reject the case, thereby maintaining the status quo.

Case No.	24 / NC/3/MEET/Feb/202526/13
Case Status	Case Rejected
Party Name	MOREPEN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00000817AM26
RA File Number	05AX04000110 AM24
Licence No and<br>Date	0511018340/17/04/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, the committee didn’t<br>find any merit to review the norms and it was decided to reject the case maintaining the status quo.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

reject the case maintaining the status quo.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Case No.	25 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	HIKAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00001916AM26
RA File Number	03AX04000161 AM24
Licence No and<br>Date	0311022971/20/04/2023
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>2-Acetyl Butyro Lactone<br>1.250 kg.<br>2<br>2-Chloro Benzyl Chloride<br>1.050 kg.<br>3<br>Sodium Thiocyanate<br>0.652 kg.<br>4<br>Tetrahydrofuran (THF)<br>0.150 kg.<br>5<br>Hydrazine Hydrate 64%<br>1.265 kg.<br>Prothioconazole (HPP-723)<br>1 kg.<br>6<br>Magnesium Rasping<br>0.300 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 26 / NC/3/MEET/Feb/202526/13

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

NC.||

Case No. 26 / NC/3/MEET/Feb/202526/13

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Case Status	Case Deferred
Party Name	SARAL CHEMTECH LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00000865AM24
RA File Number	33AX04000105 AM23
Licence No and<br>Date	3311001206/16/05/2023
Norms Committee Decision:<br>As per the advice of the technical authority, the firm was asked to attend a personal hearing through video<br>conference to explain its case. However, the personal hearing could not be conducted due to technical issues<br>beyond control. In view of this, the Committee decided to provide another opportunity to the firm by<br>conducting the personal hearing through video conference in the ensuing meeting.

Case No.	27 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00000787AM26
RA File Number	07AX04000371 AM24
Licence No and<br>Date	0711008304/19/06/2023
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No.

c norms on the basis of inputs received from the Technical Authority or as applied for by the firm,whichever is less, as per the details indicated below.:- Export Product Qty. Sl. No. Import Items Qty. allowed. Tranexamic Acid Injection Solution 1000 mg./10 ml. 1 Number 1 Tranexamic Acid USP 1100 mg. RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Case No.<br>28 / NC/3/MEET/Feb/202526/13
Case Status<br>Case Approved
Party Name<br>MICRO LABS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number<br>HQRNORM REVIW00001463AM26
RA File Number<br>07AX04000371 AM24
Licence No and<br>Date<br>0711008304/19/06/2023
Norms Committee Decision:
The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the
Committee decided to fix the ad-hoc norms on the basis of		inputs received from the Technical Authority
or as applied for by the firm,whichever is less, as per the details indicated below.:-
Export Product<br>Qty.	Sl.	No.	Import Items	Qty. allowed.
Tranexamic Acid Injection Solution<br>1 Number		1	Tranexamic Acid USP	1100 mg.
1000 mg./10 ml.
RA concerned may take further necessary action as per above		decision of NC.

owed.**|| |Tranexamic Acid Injection Solution 1 Number||1|Tranexamic Acid USP|1100 mg.|| |1000 mg./10 ml.|||||| |RA concerned may take further necessary action as per above||decision of NC.||||

Case No.	29 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	VINEET LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00000583AM26
RA File Number	09AX04000203 AM24
Licence No and<br>Date	0911005339/06/07/2023
Norms Committee Decision:
The Committee examined the request of the firm for fixation of ad-hoc norms . After due deliberation, the
Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority
or as applied for	by the firm,whichever is less, as per the details indicated below.:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
N Butyl Lithium 30% w/w in Hexane Solution	1 kg.	1	N-Butyl Chloride	0.6 kg.
		2	Lithium Metal	0.09 kg.
		3	n-Hexane	0.84 kg.

No.**|Import Items|Qty. allowed.| |---|---|---|---|---| |N Butyl Lithium 30% w/w in Hexane Solution|1 kg.|1|N-Butyl Chloride|0.6 kg.| |||2|Lithium Metal|0.09 kg.| |||3|n-Hexane|0.84 kg.|

Case No.	30 / NC/3/MEET/Feb/202526/13
Case Status	Case Rejected
Party Name	PIL PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00001725AM26
RA File Number	05AX04001384 AM24
Licence No and<br>Date	0511020419/16/08/2023
Norms Committee Decision:<br>The Committee considered the firm’s request for review of the ad-hoc norms. However, it was observed that<br>the firm had not furnished any technical justification or supporting information for the proposed<br>enhancement. Accordingly, the Committee did not find any merit in the request and decided to reject the<br>case, thereby maintaining the status quo.

Case No.	31 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00005955AM24
RA File Number	34AX04000512 AM24

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Licence No and 3411004188/29/09/2023 Date Norms Committee Decision:

The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less , as per the details indicated below.:-

Licence No and<br>Date	Licence No and<br>Date	3411004188/29/09/2023	3411004188/29/09/2023	3411004188/29/09/2023	3411004188/29/09/2023	3411004188/29/09/2023
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

inputs received from the Technical Authority or as applied for by the firm,whichever is less, as per the details indicated below.:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Doxycycline Hyclate USP 58.86 mg. Doxycycline Hyclate Capsules USP 50 mg (Net content of active ingredients 15.000 kgs) 1 Number 2 Microcrystalline cellulose (Avicel PH112) 128.295 mg. 3 Doxycycline Hyclate USP 117.72 mg. Doxycycline Hyclate Capsules USP 100 mg (Net content of active ingredients 30.00 kgs) 1 Number 4 Microcrystalline cellulose (Avicel PH112) 256.59 mg. 5 Doxycycline Hyclate USP 23.46 mg. 6 Microcrystalline cellulose (Avicel PH112) 114.0 mg. Doxycycline Hyclate Tablets USP 20 mg (Net content of active ingredients 20.000 kgs) 1 Number 7 Crosscarmellose sodium (Ac -Di -Sol) 6.00 mg. 8 Doxycycline Hyclate USP 58.86 mg. 9 Microcrystalline cellulose (Avicel PH112) 50.55 mg. Doxycycline Hyclate Tablets USP 50 mg (Net content of active ingredients 35.00 kgs) 1 Number 10 Crosscarmellose sodium (Ac -Di -Sol) 2.50 mg. 11 Doxycycline Hyclate USP 88.29 mg. Doxycycline Hyclate Tablets 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.

br>Crosscarmellose sodium (Ac -Di -Sol) 2.50 mg. 11 Doxycycline Hyclate USP 88.29 mg. Doxycycline Hyclate Tablets 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Doxycycline Hyclate Capsules USP 50 mg (Net content of active ingredients 15.000 kgs)|| 1 Number|1|Doxycycline Hyclate USP|58.86 mg.| |||||2|Microcrystalline cellulose (Avicel PH112)|128.295 mg.| ||Doxycycline Hyclate Capsules USP 100 mg (Net content of active ingredients 30.00 kgs)||1 Number|3|Doxycycline Hyclate USP|117.72 mg.| |||||4|Microcrystalline cellulose (Avicel PH112)|256.59 mg.| ||Doxycycline Hyclate Tablets USP 20 mg (Net content of active ingredients 20.000 kgs)|| 1 Number|5|Doxycycline Hyclate USP|23.46 mg.| |||||6|Microcrystalline cellulose (Avicel PH112)|114.0 mg.| |||||7|Crosscarmellose sodium (Ac -Di -Sol)|6.00 mg.| ||Doxycycline Hyclate Tablets USP 50 mg (Net content of active ingredients 35.00 kgs)|| 1 Number|8|Doxycycline Hyclate USP|58.86 mg.| |||||9|Microcrystalline cellulose (Avicel PH112)|50.55 mg.| |||||10|Crosscarmellose sodium (Ac -Di -Sol)|2.50 mg.| ||Doxycycline Hyclate Tablets||1 Number|11|Doxycycline Hyclate USP|88.29 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Number|11|Doxycycline Hyclate USP|88.29 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

USP 75 mg (Net content of active<br>ingredients 30.000 kgs)	USP 75 mg (Net content of active<br>ingredients 30.000 kgs)		12	Microcrystalline Cellulose<br>(Avicel PH112)	33.191 mg.
			13	Microcystalline cellulose	3300 mg
				<br>(Avicel PH 101)	. .
			14	Crosscarmellose sodium	0.375 mg.

				(Ac -Di -Sol)


Doxycycline H<br>USP 150 mg (	yclate Tablets<br>Net content of	1 Number	15	Doxycycline Hyclate USP	176.58 mg.
active ingredie	nts 90.00 kgs)
			16	Microcrystalline Cellulose	66.383 mg.
				(Avicel PH 112)
			17	Microcystalline cellulose<br>(Avicel PH 101	66.00 mg.
			18	Crosscarmellose sodium	0.75 mg.
				(Ac -Di -Sol)
Doxycycline Hyclate Delayed-<br>Release Tablets, USP 75 mg		1 Number	19	Doxycycline Hyclate USP	70.63 mg.
	i idi		20	Lt Mhdt	1875
(Net content o<br>5250 ks)	actve ngreents			acose onoyrae	. mg.
. g				(Granulac 200)

			21	Mitlli Clll (Ail	1875
				crocrysane euose vce<br>PH 101)	. mg.

			22	Cross Carmellose Sodium	5.625 mg.
				(Ac di Sol)
Doxycycline Hyclate Delayed-<br>Release Tablets, USP 100mg<br>(Net content of active ingredients<br>90.00 kgs)		1 Number	23	Doxycycline Hyclate USP	94.175 mg.
			24	Lactose Monohydrate	25.00 mg.
				(Granulac 200)

d- Release Tablets, USP 100mg (Net content of active ingredients 90.00 kgs)||1 Number|23|Doxycycline Hyclate USP|94.175 mg.| |||||24|Lactose Monohydrate|25.00 mg.| ||||||(Granulac 200)||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

25<br>Microcrystalline Cellulose (Avicel<br>PH 101)<br>25.00 mg.<br>26<br>Cross Carmellose Sodium<br>(Ac di Sol)<br>7.50 mg.<br>27<br>Doxycycline Hyclate USP<br>141.26 mg.<br>28<br>Lactose Monohydrate (Granulac<br>200)<br>37.50 mg.<br>29<br>Microcrystalline Cellulose (Avicel<br>PH 101)<br>37.50 mg.<br>Doxycycline Hyclate Delayed-<br>Release Tablets, USP 150 mg<br>(Net content of active ingredients<br>90.00 kgs)<br>1 Number<br>30<br>Cross Carmellose Sodium<br>(Ac di Sol)<br>11.25 mg.<br>31<br>Doxycycline Hyclate USP<br>188.35 mg.<br>32<br>Lactose Monohydrate<br>(Granulac 200)<br>50.00 mg.<br>33<br>Microcrystalline Cellulose (Avicel<br>PH 101)<br>50.00 mg.<br>Doxycycline Hyclate Delayed-<br>Release Tablets, USP 200mg<br>(Net content of active ingredients<br>80.00 kgs)<br>1 Number<br>34<br>Cross Carmellose Sodium<br>(Ac di Sol)<br>15.00 mg.<br>RA concerned may take further necessary action as per above decision of NC.			25	Microcrystalline Cellulose (Avicel<br>PH 101)	25.00 mg.
			26	Cross Carmellose Sodium<br>(Ac di Sol)	7.50 mg.
	Doxycycline Hyclate Delayed-<br>Release Tablets, USP 150 mg<br>(Net content of active ingredients<br>90.00 kgs)	1 Number	27	Doxycycline Hyclate USP	141.26 mg.

llose Sodium (Ac di Sol)|7.50 mg.| ||Doxycycline Hyclate Delayed- Release Tablets, USP 150 mg (Net content of active ingredients 90.00 kgs)|1 Number|27|Doxycycline Hyclate USP|141.26 mg.| ||||28|Lactose Monohydrate (Granulac 200)|37.50 mg.| ||||29|Microcrystalline Cellulose (Avicel PH 101)|37.50 mg.| ||||30|Cross Carmellose Sodium (Ac di Sol)|11.25 mg.| ||Doxycycline Hyclate Delayed- Release Tablets, USP 200mg (Net content of active ingredients 80.00 kgs)|1 Number|31|Doxycycline Hyclate USP|188.35 mg.| ||||32|Lactose Monohydrate (Granulac 200)|50.00 mg.| ||||33|Microcrystalline Cellulose (Avicel PH 101)|50.00 mg.| ||||34|Cross Carmellose Sodium (Ac di Sol)|15.00 mg.|

Case No.	32 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	HIKAL LIMITED
Meeting Number	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

|NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

and Date
HQ File Number	HQRNORM APPLY 00005992AM24
RA File Number	03AX04002781 AM24
Licence No and<br>Date	0311027528/03/10/2023
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>2-Acetyl Butyro Lactone<br>1.250 kg.<br>2<br>2-Chloro Benzyl Chloride<br>1.050 kg.<br>3<br>Sodium Thiocyanate<br>0.652 kg.<br>4<br>Tetrahydrofuran (THF)<br>1.50 kg.<br>5<br>Hydrazine Hydrate 100%<br>Delete<br>6<br>Hydrazine Hydrate 80%<br>1.012 kg.<br>Prothioconazole (HPP-723)<br>1 kg.<br>7<br>Magnesium Rasping<br>0.300 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	33 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	USV PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00008930AM24
RA File Number	03AX04003005 AM24

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

08930AM24| |RA File Number|03AX04003005 AM24|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Licence No and 0311027533/03/10/2023 Date Norms Committee Decision: As per the advice of the technical authority, the firm was asked to attend a personal hearing through video conference to explain its case. However, the personal hearing could not be conducted due to technical issues beyond control. In view of this, the Committee decided to provide another opportunity to the firm by conducting the personal hearing through video conference in the ensuing meeting.

Case No.	34 / NC/3/MEET/Feb/202526/13
Case Status	Case Rejected
Party Name	VIDACARE MEDICA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00000929AM26
RA File Number	03AX04003293 AM24
Licence No and<br>Date	0311028015/18/10/2023
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm
has not provided any technical justification / information for enhancement. Hence, the committee didn’t
find any merit to	review the norms and it was decided to reject the case maintaining the status quo.

ded 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.		35 / NC/3/MEET/Feb/202526/13

Case Status		Case Approved

Party Name		RUMIT LIFE CARE

Meeting Number an<br>Date	d	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026

HQ File Number		HQRNORM APPLY 00006397AM24
RA File Number		03AX04002697 AM24
Licence No and Date		0311028091/20/10/2023
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority
or as applied for by the firm,whichever is less, as per the details indicated below.:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
DIFLUCORTOLONE VALERATE BP	1 kg.	1	FLUMETHASONE	0.925 kg.

DGFT(HQ)

UDIN00043607AM27

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
DIFLUCORTOLONE VALERATE BP	1 kg.	1	FLUMETHASONE	0.925 kg.

Case No.	Case No.	36 / NC/3/MEET/Feb/202526/13	36 / NC/3/MEET/Feb/202526/13	36 / NC/3/MEET/Feb/202526/13	36 / NC/3/MEET/Feb/202526/13	36 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		RALLIS INDIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM APPLY 00006775AM24
RA File Number		03AX04003377 AM24
Licence No and<br>Date		0311028623/09/11/2023
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Dimethyl Sulfoxide (DMSO)<br>0.6013 kg.<br>2<br>Trimethyl Ortho Formate (TMOF)<br>0.01 kg.<br>3<br>Methanol (MeOH)<br>0.2460 kg.<br>4<br>Toluene<br>0.05 kg.<br>Trimethylsulfoxonium Bromide<br>(TMSOB)<br>1 kg.<br>5<br>Bromine (Liquid Bromine)<br>0.462 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

r>4 Toluene 0.05 kg. Trimethylsulfoxonium Bromide (TMSOB) 1 kg. 5 Bromine (Liquid Bromine) 0.462 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Trimethylsulfoxonium Bromide (TMSOB)||1 kg.|1|Dimethyl Sulfoxide (DMSO)|0.6013 kg.| |||||2|Trimethyl Ortho Formate (TMOF)|0.01 kg.| |||||3|Methanol (MeOH)|0.2460 kg.| |||||4|Toluene|0.05 kg.| |||||5|Bromine (Liquid Bromine)|0.462 kg.| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Case No.	37 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00007173AM24
RA File Number	05AX04002730 AM24
Licence No and<br>Date	0511022438/04/12/2023
Norms Committee Decision:<br>As per the advice of the technical authority, the firm was asked to attend a personal hearing through video<br>conference to explain its case. However, the personal hearing could not be conducted due to technical issues<br>beyond control. In view of this, the Committee decided to provide another opportunity to the firm by<br>conducting the personal hearing through video conference in the ensuing meeting.

issues beyond control. In view of this, the Committee decided to provide another opportunity to the firm by conducting the personal hearing through video conference in the ensuing meeting.||

Case No.	38 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00007728AM24
RA File Number	09AX04000875 AM24
Licence No and<br>Date	0911006481/03/01/2024
Norms Committee Decision:<br>As per the advice of the technical authority, the firm was asked to attend a personal hearing through video<br>conference to explain its case. However, the personal hearing could not be conducted due to technical issues<br>beyond control. In view of this, the Committee decided to provide another opportunity to the firm by<br>conducting the personal hearing through video conference in the ensuing meeting.

Case No. 39 / NC/3/MEET/Feb/202526/13

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

ng.||

Case No. 39 / NC/3/MEET/Feb/202526/13

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Case Status	Case Deferred
Party Name	ACUTAAS CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00008367AM24
RA File Number	52AX04000336 AM24
Licence No and<br>Date	5211007280/06/02/2024
Norms Committee Decision:<br>As per the advice of the technical authority, the firm was asked to attend a personal hearing through video<br>conference to explain its case. However, the personal hearing could not be conducted due to technical issues<br>beyond control. In view of this, the Committee decided to provide another opportunity to the firm by<br>conducting the personal hearing through video conference in the ensuing meeting.

Case No.	Case No.	40 / NC/3/MEET/Feb/202526/13	40 / NC/3/MEET/Feb/202526/13	40 / NC/3/MEET/Feb/202526/13	40 / NC/3/MEET/Feb/202526/13	40 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		ELPPE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM APPLY 00008471AM24
RA File Number		03AX04004959 AM24
Licence No and<br>Date		0311031032/09/02/2024
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms.

|RA File Number||03AX04004959 AM24||||| |Licence No and Date||0311031032/09/02/2024||||| |Norms Committee Decision: The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm,whichever is less, as per the details indicated below.:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 5 Methoxy-2-Tetralone 0.92 kg. 2 Pyridoxal-5-Fosfat (PLP) 0.0075 kg. (S)-5-Methoxi-2-Aminotetraline HCL 1 kg. 3 IE AT32P (Enzymes) 0.045 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||(S)-5-Methoxi-2-Aminotetraline HCL||1 kg.|1|5 Methoxy-2-Tetralone|0.92 kg.| |||||2|Pyridoxal-5-Fosfat (PLP)|0.0075 kg.| |||||3|IE AT32P (Enzymes)|0.045 kg.| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

||||3|IE AT32P (Enzymes)|0.045 kg.| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Case No.	41 / NC/3/MEET/Feb/202526/13
Case Status	Case Rejected
Party Name	VIDACARE MEDICA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00000935AM26
RA File Number	03AX04005005 AM24
Licence No and<br>Date	0311031320/19/02/2024
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, the committee didn’t<br>find any merit to review the norms and it was decided to reject the case maintaining the status quo

Case No.	42 / NC/3/MEET/Feb/202526/13
Case Status	Case Rejected
Party Name	EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00000986AM26
RA File Number	05AX04003663 AM24
Licence No and<br>Date	0511023926/26/02/2024
Norms Committee Decision:<br>The Committee considered the firm’s request for review of the ad-hoc norms. However, it was observed<br>that the firm had not furnished any technical justification or supporting information for the proposed<br>enhancement. Accordingly, the Committee did not find any merit in the request and decided to reject the<br>case, thereby maintaining the status quo.

or supporting information for the proposed enhancement. Accordingly, the Committee did not find any merit in the request and decided to reject the case, thereby maintaining the status quo.||

Case No.	43 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Party Name	SRI KRISHNA PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00008937AM24
RA File Number	09AX04001083 AM24
Licence No and<br>Date	0911006881/06/03/2024
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>PARA AMINO PHENOL<br>0.727 kg.<br>PARACETAMOL GRANULES DC<br>GRADE 90%<br>1 kg<br>2<br>ACETIC ANHYDRIDE<br>0.682 kg.<br>RA concerned may take further necessary action as per above decision of NC.

ARA AMINO PHENOL 0.727 kg. PARACETAMOL GRANULES DC GRADE 90% 1 kg 2 ACETIC ANHYDRIDE 0.682 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	44 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	SYNERGIA SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00000333AM25
RA File Number	03AX04000023 AM25
Licence No and<br>Date	0311033222/19/04/2024
Norms Committee Decision:<br>As per the advice of the technical authority, the firm was asked to attend a personal hearing through video<br>conference to explain its case. However, the personal hearing could not be conducted due to technical issues<br>beyond control. In view of this, the Committee decided to provide another opportunity to the firm by<br>conducting the personal hearing through video conference in the ensuing meeting.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

gh video conference in the ensuing meeting.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Case No.<br>45 / NC/3/MEET/Feb/202526/13
Case Status<br>Case Deferred
Party Name<br>APTRA SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number<br>HQRNORM APPLY 00000952AM25
RA File Number<br>26AX04000006 AM25
Licence No and<br>Date<br>2611001464/28/05/2024
Norms Committee Decision:
As per the advice of the technical authority, the firm was asked to attend a personal hearing through video
conference to explain its case. However, the personal hearing could not be conducted due to technical issues
beyond control. In view of this, the Committee decided to provide another opportunity to the firm by
conducting the personal hearing through video conference in the ensuing meeting.

al issues| |beyond control. In view of this, the Committee decided to provide another opportunity to the firm by| |conducting the personal hearing through video conference in the ensuing meeting.|

Case No.	46 / NC/3/MEET/Feb/202526/13
Case Status	Case Rejected
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00000644AM26
RA File Number	03AX04000876 AM25
Licence No and<br>Date	0311034159/28/05/2024
Norms Committee Decision:
The Committee considered the firm’s request for review of the ad-hoc norms. However, it was observed that
the norms given are in line with Batch Manufactured Record with 10% wastage as per SION. Accordingly,
the Committee did not find any merit in the request and decided to reject the case, thereby maintaining the
status quo.

The Committee considered the firm’s request for review of the ad-hoc norms. However, it was observed that the norms given are in line with Batch Manufactured Record with 10% wastage as per SION. Accordingly, the Committee did not find any merit in the request and decided to reject the case, thereby maintaining the status quo.

Case No.	47 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	AARTI PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

|NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

HQ File Number	HQRNORM APPLY 00001028AM25
RA File Number	03AX04000079 AM25
Licence No and<br>Date	0311034279/31/05/2024
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Ethyl Alcohol and Other Spirits Denatured<br>of Any Strenth Denatured Ethyl Alcohol<br>0.703 kg.<br>2<br>SO3<br>0.611 kg.<br>Di Ethyl Sulphate<br>1 kg.<br>3<br>Sodium Sulphate<br>0.09 kg.<br>RA concerned may take further necessary action as per above decision of NC.

hyl Alcohol 0.703 kg. 2 SO3 0.611 kg. Di Ethyl Sulphate 1 kg. 3 Sodium Sulphate 0.09 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	48 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00004316AM26
RA File Number	31AX04000060 AM25
Licence No and<br>Date	3111003614/27/06/2024
Norms Committee Decision:<br>The Committee considered the firm’s request for review of the ad-hoc norms but observed that no technical<br>justification or supporting data was provided for the proposed enhancement. Accordingly, the Committee<br>decided to request the firm to furnish a detailed justification for the enhancement of norms.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

justification for the enhancement of norms.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Case No.	49 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001769AM25
RA File Number	07AX04000561 AM25
Licence No and<br>Date	0711011739/05/07/2024
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Magnesium Orotate<br>1 MT<br>1<br>Orotic Acid (Monohydrate)<br>0.990 MT<br>Calcium Orotate<br>1 MT<br>2<br>Orotic Acid (Monohydrate)<br>0.948 MT<br>Potassium Orotate<br>1 MT<br>3<br>Orotic Acid (Monohydrate)<br>0.944 MT<br>Zinc Orotate<br>1 MT<br>4<br>Orotic Acid (Monohydrate)<br>0.890 MT<br>Ferrous Orotate<br>1 MT<br>5<br>Orotic Acid (Monohydrate)<br>0.872 MT<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	50 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	ACUTAAS CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026

Case No.	50 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	ACUTAAS CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

HQ File Number<br>HQRNORM APPLY 00001820AM25
RA File Number<br>52AX04000089 AM25
Licence No and<br>Date<br>5211008812/08/07/2024
Norms Committee Decision:
As per the advice of the technical authority, the firm was asked to attend a personal hearing through video
conference to explain its case. However, the personal hearing could not be conducted due to technical issues
beyond control. In view of this, the Committee decided to provide another opportunity to the firm by
conducting the personal hearing through video conference in the ensuing meeting.

HQ File Number	HQ File Number	HQRNORM APPLY 00001820AM25	HQRNORM APPLY 00001820AM25	HQRNORM APPLY 00001820AM25	HQRNORM APPLY 00001820AM25	HQRNORM APPLY 00001820AM25	HQRNORM APPLY 00001820AM25	HQRNORM APPLY 00001820AM25	HQRNORM APPLY 00001820AM25	HQRNORM APPLY 00001820AM25
RA File Number		52AX04000089 AM25
Licence No and
Date		5211008812/08/07/2024
Norms Committee Decision:<br>As per the advice of the technical authority, the firm was asked to attend a personal hearing through video<br>conference to explain its case.

8812/08/07/2024||||||||| |Norms Committee Decision: As per the advice of the technical authority, the firm was asked to attend a personal hearing through video conference to explain its case. However, the personal hearing could not be conducted due to technical issues beyond control. In view of this, the Committee decided to provide another opportunity to the firm by conducting the personal hearing through video conference in the ensuing meeting.||||||||||| |||||||||||| |||||||||||| |||||||||||| |Cas|e No.|51 / NC/3/MEET/Feb/||202526/13||||||| |Cas|e Status|Case Approved||||||||| |Par|ty Name|FRESENIUS KABI IN||DIA PRIV||ATE LIMI||TED||| |Me and|eting Number Date|NC/ 3/ MEET/ Feb/ 20||2526/ 13 a||nd 20/02/2||026||| |HQ|File Number|HQRNORM APPLY||00001961A||M25||||| |RA|File Number|03AX04001867 AM2||5||||||| |Lic Dat|ence No and e|0311035566/16/07/20||24||||||| |||||||||||| |Nor Th pr au H|ms Committee Decision: e Committee considered the case oduct/import product in meeting thorization No**.3111004376 date BP Vol. I as per details given belo|||as per age No. NC/ d 29/01/20 w or as app||nda and ta 3/MEET/ 25, it wa lid b||king cue from the earlier decision Sep/202526/8 dated 17/09/2025 s decided to fix ad-hoc norms un fi hih i l||for same export against advance der Para 4.07 of| |||||||e y t||e rm, wcever s ess:-||| |||||||||||| ||Export Product||Qty|.**|Sl.|**No. **|Imp|ort Items|Q|**ty.

i l||for same export against advance der Para 4.07 of| |||||||e y t||e rm, wcever s ess:-||| |||||||||||| ||Export Product||Qty|.|Sl.|**No. **|Imp|ort Items|Q|ty. allowed.| |||||||||||| ||Sodium Lactate (Hartmann's) 1000 ml|| 1 Number||1||Sodium Lactate (Purasal SP/F 50) (EP)||Net content in export + 2% wastage.|| |||||||||||| ||||||2||Potassium Chloride EP||Net content in export + 2% || ||||||||||wastage.|| |||||||||||| |||||||||||| ||||||3||Calcium Chloride EP||Net content in|| ||||||||||export + 2%||

HQ File Number	HQ File Number	HQRNORM APPLY 00001820AM25	HQRNORM APPLY 00001820AM25	HQRNORM APPLY 00001820AM25	HQRNORM APPLY 00001820AM25	HQRNORM APPLY 00001820AM25	HQRNORM APPLY 00001820AM25	HQRNORM APPLY 00001820AM25	HQRNORM APPLY 00001820AM25	HQRNORM APPLY 00001820AM25
RA File Number		52AX04000089 AM25
Licence No and
Date		5211008812/08/07/2024
Norms Committee Decision:<br>As per the advice of the technical authority, the firm was asked to attend a personal hearing through video<br>conference to explain its case. However, the personal hearing could not be conducted due to technical issues<br>beyond control.

ity, the firm was asked to attend a personal hearing through video conference to explain its case. However, the personal hearing could not be conducted due to technical issues beyond control. In view of this, the Committee decided to provide another opportunity to the firm by conducting the personal hearing through video conference in the ensuing meeting.||||||||||| |||||||||||| |||||||||||| |||||||||||| |Cas|e No.|51 / NC/3/MEET/Feb/||202526/13||||||| |Cas|e Status|Case Approved||||||||| |Par|ty Name|FRESENIUS KABI IN||DIA PRIV||ATE LIMI||TED||| |Me and|eting Number Date|NC/ 3/ MEET/ Feb/ 20||2526/ 13 a||nd 20/02/2||026||| |HQ|File Number|HQRNORM APPLY||00001961A||M25||||| |RA|File Number|03AX04001867 AM2||5||||||| |Lic Dat|ence No and e|0311035566/16/07/20||24||||||| |||||||||||| |Nor Th pr au H|ms Committee Decision: e Committee considered the case oduct/import product in meeting thorization No**.3111004376 date BP Vol. I as per details given belo|||as per age No. NC/ d 29/01/20 w or as app||nda and ta 3/MEET/ 25, it wa lid b||king cue from the earlier decision Sep/202526/8 dated 17/09/2025 s decided to fix ad-hoc norms un fi hih i l||for same export against advance der Para 4.07 of| |||||||e y t||e rm, wcever s ess:-||| |||||||||||| ||Export Product||Qty|.**|Sl.|**No. **|Imp|ort Items|Q|**ty.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

		wastage.
4	Sodium Chloride (SANAL) (EP)	Net content in<br>export + 2%<br>wastage.
5	SF9-11 195/140 (PLASTIC FILM<br>(NON-PVC) FOR PRIMARY<br>PACKING) (0369631)	Net content in<br>export + 1%<br>wastage.
6	OFR2-11 120/524<br>PHTALATFREE (PLASTIC FILM<br>(NON-PVC) FOR SECONDARY<br>PACKING (0369681)	<br>Net content in<br>export + 1%<br>wastage.
7	UFR2-11 150/524<br>PHTALATFREE (PLASTIC FILM<br>(NON-PVC) FOR SECONDARY<br>PACKING (0369661)	<br>Net content in<br>export + 1%<br>wastage.
8	SSC Infusion Port (0434181)	Net content in<br>export + 1%<br>wastage.
9	SSC Injection Port<br>(Art. 0434371)	Net content in<br>export + 1%<br>wastage.
10	BOP Infusion Port<br>(Art.No 0434171)	Net content in<br>export + 1%<br>wastage.
11	BOP Injection Port<br>(Art.

Injection Port (Art. 0434371)|Net content in export + 1% wastage.| ||||10|BOP Infusion Port (Art.No 0434171)|Net content in export + 1% wastage.| ||||11|BOP Injection Port (Art. 0434481)|Net content in export + 1% wastage.| ||||12|Hot Stamping foil (Art. 0368991)|Net content in export + 1% wastage.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Case No.	52 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001994AM25
RA File Number	03AX04001885 AM25
Licence No and<br>Date	0311035597/18/07/2024
Norms Committee Decision:<br>As per the advice of the technical authority, the firm was asked to attend a personal hearing through video<br>conference to explain its case. However, the personal hearing could not be conducted due to technical issues<br>beyond control. In view of this, the Committee decided to provide another opportunity to the firm by<br>conducting the personal hearing through video conference in the ensuing meeting.

issues beyond control. In view of this, the Committee decided to provide another opportunity to the firm by conducting the personal hearing through video conference in the ensuing meeting.||

Case No.	Case No.	53 / NC/3/MEET/Feb/202526/13	53 / NC/3/MEET/Feb/202526/13	53 / NC/3/MEET/Feb/202526/13	53 / NC/3/MEET/Feb/202526/13	53 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		STYRAX LIFE SCIENCES PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM APPLY 00002025AM25
RA File Number		09AX04000240 AM25
Licence No and Date		0911007615/19/07/2024
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty.<br>allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

**|Import Items|Qty. allowed.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

1	GLYOXALIC ACID 50 PCT	0.68 kg.
2	2,5-DIHYDROXY-1, 4-DIATHINE	0.28 kg.
3	5-FLUORO CYTOSINE	0.44 kg.
4	SODIUM BOROHYDRIDE (SBH)	0.28 kg.
5	HEXA METHYL DISILAZANE<br>(HMDS)	0.53 kg.
6	METHYLENE DI CHLORIDE<br>(MDC)	3.00 kg.
7	L-MENTHOL	0.70 kg.
8	ISO PROPYL ALCOHOL (IPA)	1.00 kg.

DIUM BOROHYDRIDE (SBH)|0.28 kg.| ||||5|HEXA METHYL DISILAZANE (HMDS)|0.53 kg.| ||||6|METHYLENE DI CHLORIDE (MDC)|3.00 kg.| ||||7|L-MENTHOL|0.70 kg.| ||||8|ISO PROPYL ALCOHOL (IPA)|1.00 kg.|

Case No.	54 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	STYRAX LIFE SCIENCES PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00002026AM25
RA File Number	09AX04000239 AM25
Licence No and Date	0911007616/19/07/2024
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms . After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

ss**, as per the details indicated below.:-||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
4-AMINO-5-FLUORO-1-[(2R,5S)-2-<br>(HYDROXYMENTHYL) - 1,2-<br>OXATHIOLAN-5-YL] PYRIMIDIN-2<br>(1H)-ONE OR EMO-1	1 kg.	1	(FCE [(2R,5S)-5-(4-Amino-5-<br>fluoro-2-oxo-2H-pyrimidin-1-<br>yl)-[1,3]-oxathiolane-2-<br>carboxylic acid,2S-isopropyl-<br>5R-methyl-1R-cyclohexyl<br>ester])	1.726 kg.
		2	Dipotassiium Hydrogen Ortho<br>Phosphate	<br>1.38 kg.
		3	Sodium Borohydride	0.46 kg.
		4	Ortho Phosphoric Acid	0.40 kg.
		5	Iso Propyl Alcohol (IPA)	1.00 kg.
		6	Toluene	0.50 kg.

|2|Dipotassiium Hydrogen Ortho Phosphate| 1.38 kg.| ||||3|Sodium Borohydride|0.46 kg.| ||||4|Ortho Phosphoric Acid|0.40 kg.| ||||5|Iso Propyl Alcohol (IPA)|1.00 kg.| ||||6|Toluene|0.50 kg.|

Case No.	55 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00002051AM25
RA File Number	34AX04000849 AM24
Licence No and<br>Date	3411005190/22/07/2024
Norms Committee Decision:<br>As per the advice of the technical authority, the firm was asked to attend a personal hearing through video<br>conference to explain its case. However, the personal hearing could not be conducted due to technical issues<br>beyond control. In view of this, the Committee decided to provide another opportunity to the firm by

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

conducting the personal hearing through video conference in the ensuing meeting.

AR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

conducting the personal hearing through video conference in the ensuing meeting.

Case No.	56 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	USV PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM REVIW00000518AM26
RA File Number	03AX04002550 AM25
Licence No and<br>Date	0311036761/29/08/2024
Norms Committee Decision:<br>The Committee considered the firm’s request for review of the ad-hoc norms. However, it was observed that<br>the firm had not furnished any technical justification or supporting information for the proposed<br>enhancement. Accordingly, the Committee did not find any merit in the request and decided to reject the<br>case, thereby maintaining the status quo.

fication or supporting information for the proposed enhancement. Accordingly, the Committee did not find any merit in the request and decided to reject the case, thereby maintaining the status quo.

Case No.	Case No.	57 / NC/3/MEET/Feb/202526/13	57 / NC/3/MEET/Feb/202526/13	57 / NC/3/MEET/Feb/202526/13	57 / NC/3/MEET/Feb/202526/13	57 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		REYAANSH HEALTHCARE
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM REVIW00001207AM26
RA File Number		03AX04002796 AM25
Licence No and<br>Date		0311037050/10/09/2024
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>SELAMECTIN 6% SPOT ON 0.25 ML<br>90912<br>1<br>SELAMECTIN<br>1.39 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	SELAMECTIN 6% SPOT ON 0.25 ML		<br>90912	1	SELAMECTIN	1.39 kg.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

ON 0.25 ML|| 90912|1|SELAMECTIN|1.39 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

TUBE(Each ml Contains Selamectin 60 mg<br>Brand Name : Catch One. Net Quantity of<br>Selamectin Consumed Including Wastages &<br>Overages : 1.500 Kgs. (Net Content of<br>Selamectin is 1.3637 kg))	TUBE(Each ml Contains Selamectin 60 mg<br>Brand Name : Catch One. Net Quantity of<br>Selamectin Consumed Including Wastages &<br>Overages : 1.500 Kgs. (Net Content of<br>Selamectin is 1.3637 kg))	<br> <br> <br> <br>Numbers
SELAMECTIN 6% SPOT ON 0.50 ML<br>TUBEEh l Ci Sli 60		<br> <br>181836	2	SELAMECTIN	5.56 kg.
(ac m ontans eamectn mg<br>Brand Name : Catch One. Net Quantity of<br>Selamectin Consumed Including Wastages &<br>Overages : 6.000 Kgs.(Net Content of<br>Selamectin is 54551 kg))		<br> <br> <br> <br>Numbers
	.
		<br>
SELAMECT<br>	IN 6% SPOT ON 0.75 ML<br>	<br> <br>232326	3	SELAMECTIN	10.66 kg.
TUBE(Each<br>Brand Name<br>	ml Contains Selamectin 60 mg<br>: Catch One. Net Quantity of<br>	<br> <br> <br>Numbers
Selamectin C<br>	onsumed Including Wastages &<br>	<br>
Overages :<br>	11.500 Kgs. (Net Content of<br>
Selamectin is	10.4547 kg))

SELAMECTIN 6% SPOT ON 1 ML<br>TUBE(Each ml Contains Selamectin 60 mg<br>Brand Name : Catch One. Net Quantity<br>of Selamectin Consumed Including Wastages<br>& Overages : 7.500 Kgs.

))||||| |||||||| ||SELAMECTIN 6% SPOT ON 1 ML TUBE(Each ml Contains Selamectin 60 mg Brand Name : Catch One. Net Quantity of Selamectin Consumed Including Wastages & Overages : 7.500 Kgs. (Net Content of Selamectin is 6.8184 kg))|| 113640 Numbers|4|SELAMECTIN|6.95 kg.| ||SELAMECTIN 6% SPOT ON 2 ML TUBE(Each ml Contains Selamectin 60 mg Brand Name : Catch One. Net Quantity of Selamectin Consumed Includin Wastaes|| 60609 Numbers|5|SELAMECTIN|7.41 kg.| ||g g & Overages : 8.000 Kgs.(Net Content of Selamectin is 7.2731 kg))|| |||| |||| |||| ||SELAMECT |IN 6% SPOT ON 4 ML | 18942 |6|SELAMECTIN|4.63 kg.| ||TUBE(Each |ml Contains Selamectin 60 mg | Numbers|||| ||Brand Name|: Catch One. Net Quantity||||| ||of Selamecti & Overaes|n Consumed Including Wastages : 5000 Ks (Net Content of| |||| ||g Selamectin is|. g 45461 kg))||||| |||.||||| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

is|. g 45461 kg))||||| |||.||||| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Case No.	58 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00003178AM25
RA File Number	05AX04001863 AM25
Licence No and<br>Date	0511027857/20/09/2024
Norms Committee Decision:<br>As per the advice of the technical authority, the firm was asked to attend a personal hearing through video<br>conference to explain its case. However, the personal hearing could not be conducted due to technical issues<br>beyond control. In view of this, the Committee decided to provide another opportunity to the firm by<br>conducting the personal hearing through video conference in the ensuing meeting.

issues beyond control. In view of this, the Committee decided to provide another opportunity to the firm by conducting the personal hearing through video conference in the ensuing meeting.||

Case No.	Case No.	59 / NC/3/MEET/Feb/202526/13	59 / NC/3/MEET/Feb/202526/13	59 / NC/3/MEET/Feb/202526/13	59 / NC/3/MEET/Feb/202526/13	59 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		CADCHEM LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM APPLY 00003280AM25
RA File Number		30AX04000313 AM25
Licence No and<br>Date		3011005810/25/09/2024
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or<br>as applied for by the firm,whichever is less, as per the details indicated below.:-<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: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Citicoline Sodium USP	1	kg.	1	Cytidine Diphosphate Choline	1.082 kg.
				Hydrochloride

31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Citicoline Sodium USP	1	kg.	1	Cytidine Diphosphate Choline	1.082 kg.
				Hydrochloride

Case No.	60 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00003321AM25
RA File Number	05AX04002052 AM25
Licence No and<br>Date	0511028003/27/09/2024
Norms Committee Decision:<br>As per the advice of the technical authority, the firm was asked to attend a personal hearing through video<br>conference to explain its case. However, the personal hearing could not be conducted due to technical issues<br>beyond control. In view of this, the Committee decided to provide another opportunity to the firm by<br>conducting the personal hearing through video conference in the ensuing meeting.

issues beyond control. In view of this, the Committee decided to provide another opportunity to the firm by conducting the personal hearing through video conference in the ensuing meeting.||

Case No.	61 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00003450AM25
RA File Number	05AX04001783 AM25
Licence No and<br>Date	0511028112/03/10/2024
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms . After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

ss**, as per the details indicated below.:-||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.<br>CEFEPIME POWDER FOR<br>SOLUTION FOR INJECTION,<br>WEIGHT 1 GMS / VIAL<br>(CEFEPIME HCL+LARGININE<br>STERILE USP)<br>1 Number<br>1<br>Cefepime HCL+L-Arginine<br>Sterile USP<br>1.04 gm/vial<br>CEFEPIME POWDER FOR<br>SOLUTION FOR INJECTION ,<br>WEIGHT 2 GMS / VIAL<br>(CEFEPIME HCL+LARGININE<br>STERILE USP)<br>1 Number<br>2<br>Cefepime HCL+L-Arginine<br>Sterile USP<br>2.08 gm/vial<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl.<br>No.	Import Items	Qty. allowed.
	CEFEPIME POWDER FOR<br>SOLUTION FOR INJECTION,<br>WEIGHT 1 GMS / VIAL<br>(CEFEPIME HCL+LARGININE<br>STERILE USP)	1 Number	1	Cefepime HCL+L-Arginine<br>Sterile USP	1.04 gm/vial
	CEFEPIME POWDER FOR<br>SOLUTION FOR INJECTION ,<br>WEIGHT 2 GMS / VIAL<br>(CEFEPIME HCL+LARGININE<br>STERILE USP)	1 Number	2	Cefepime HCL+L-Arginine<br>Sterile USP	2.08 gm/vial

|1.04 gm/vial| ||CEFEPIME POWDER FOR SOLUTION FOR INJECTION , WEIGHT 2 GMS / VIAL (CEFEPIME HCL+LARGININE STERILE USP)|1 Number|2|Cefepime HCL+L-Arginine Sterile USP|2.08 gm/vial|

Case No.	Case No.	62 / NC/3/MEET/Feb/202526/13	62 / NC/3/MEET/Feb/202526/13	62 / NC/3/MEET/Feb/202526/13	62 / NC/3/MEET/Feb/202526/13	62 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
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 Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Clobetasol Propionate Cream USP<br>10000<br>Clobetasol Propionate<br>1<br>76.50 gm.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Clobetasol Propionate Cream USP		10000	1	Clobetasol Propionate	76.50 gm.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

ss**, as per the details indicated below.:-||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Paricalcitol Injection USP, 2 mcg / ml.<br>(1 ml.)	110367<br>Vials	1	Paricalcito	242.807 mg.
Paricalcitol Injection USP, 5 mcg / ml.<br>(1 ml.)	110360<br>Vials	2	Paricalcito	606.98 mg.
Paricalcitol Injection, USP 10 mcg / 2 ml.<br>(5 mcg / ml.) (2 ml.) MDV	66363 Vials	3	Paricalcito	381.59 mg.

Case No.	83 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	ADCOCK INGRAM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00000875AM26
RA File Number	07AX04000262 AM26
Licence No and<br>Date	0711014466/16/05/2025
Norms Committee Decision:<br>The committee considered the case as per the agenda and after examination, it was observed that the firm has not<br>furnished the requisite technical details as prescribed in Annexure to Appendix-4E. After detailed deliberations and in<br>view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the<br>following documents:<br>1. Certificate of Analysis (CoA) of import item No. (i) and (5) from Foreign Supplier showing content of<br>active ingredient in the import

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

ntent of active ingredient in the import||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Case No.	84 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	ADCOCK INGRAM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00000876AM26
RA File Number	07AX04000253 AM26
Licence No and<br>Date	0711014468/16/05/2025
Norms Committee Decision:<br>The committee considered the case as per the agenda and after examination, it was observed that the firm has not<br>furnished the requisite technical details as prescribed in Annexure to Appendix-4E. After detailed deliberations and in<br>view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the<br>following documents:<br>1. Certificate of Analysis (CoA) of import item No. (i) and (5) from Foreign Supplier showing content of<br>active ingredient in the import.

sk the firm to furnish the following documents: 1. Certificate of Analysis (CoA) of import item No. (i) and (5) from Foreign Supplier showing content of active ingredient in the import.||

Case No.	85 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	KADAMBA INTRAC PVT.LTD,
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00000877AM26
RA File Number	07AX04000227 AM26
Licence No and<br>Date	0711014477/16/05/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed that export product applied by<br>the firm pertains to Norms Committee-6, therefore, it has been decided that the application of the firm may<br>be transferred toNorms Committee-6for fixation of ad-hoc norms.

Case No.	86 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
PartyName	AMNEAL PHARMACEUTICALS PRIVATE LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

yName|AMNEAL PHARMACEUTICALS PRIVATE LIMITED|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number<br>HQRNORM APPLY 00000880AM26
RA File Number<br>08AX04000296 AM26
Licence No and<br>Date<br>0811015041/17/05/2025
Norms Committee Decision:
The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the
Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority
or as applied for by the firm,whichever is less, as per the details indicated below.:-
Export Product<br>Qty.<br>Sl. No. Import Items	Qty. allowed.
Leuprolide Acetate Injection<br>1 Number<br>1<br>0.5 ml. Sterile Disposable	Relevant, as per
14 mg / 2.8 mL (1 mg /0.2<br>Syringe with Permanently	Packing Policy
ml)<br>Attached Needle (0.36 MM	with
X 13 MM) 28GX1/2" (0.5	Accountibility
ml. 28 G*1/2)
RA concerned may take further necessary action as per above decision of NC.

|Packing Policy|| |ml) Attached Needle (0.36 MM|with|| |X 13 MM) 28GX1/2" (0.5|Accountibility|| |ml. 28 G*1/2)||| |RA concerned may take further necessary action as per above decision of NC.|||

Case No.	87 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00000882AM26
RA File Number	03AX04000661 AM26
Licence No and<br>Date	0311043940/17/05/2025
Norms Committee Decision:
The committee considered the case as per the agenda and after examination, it was observed that the firm has not
furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in
view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the
following documents:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Wastage at each stage of manufacture to justify the wastage claimed.
Source of imported raw material whether it is waste of some chemical plant.

ocation: DGFT(HQ)

UDIN00043607AM27

Wastage at each stage of manufacture to justify the wastage claimed.
Source of imported raw material whether it is waste of some chemical plant.

Case No.	Case No.	88 / NC/3/MEET/Feb/202526/13	88 / NC/3/MEET/Feb/202526/13	88 / NC/3/MEET/Feb/202526/13	88 / NC/3/MEET/Feb/202526/13	88 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM APPLY 00000894AM26
RA File Number		34AX04000135 AM26
Licence No and<br>Date		3411006455/19/05/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Apr/202526/1 dated 25/04/2025 against advance<br>authorization No. 3411004561 dated 30/01/2024, 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.

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. Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 15 gm Tube 1 Number 1 Nystatin USP 238.65 mg. Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 30 gm tube 1 Number 2 Nystatin USP 477.30 mg. Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 60 gm tube 1 Number 3 Nystatin USP 954.61 mg. Nystatin and Triamcinolone Acetonide Cream USP, 1,00,000 UNITS / GM; 0.1% - 15 gm tube 1 Number 4 Nystatin USP 238.65 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 15 gm Tube||1 Number|1|Nystatin USP|238.65 mg.| ||Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 30 gm tube||1 Number|2|Nystatin USP|477.30 mg.| ||Nystatin and Triamcinolone Acetonide Ointment USP, 1,00,000 UNITS / GM; 0.1% - 60 gm tube||1 Number|3|Nystatin USP|954.61 mg.| ||Nystatin and Triamcinolone Acetonide Cream USP, 1,00,000 UNITS / GM; 0.1% - 15 gm tube||1 Number|4|Nystatin USP|238.65 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

gm tube||1 Number|4|Nystatin USP|238.65 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Nystatin and Triamcinolone Acetonide<br>Cream USP, 1,00,000 UNITS / GM;<br>0.1% - 30 gm tube<br>1 Number<br>5<br>Nystatin USP<br>477.30 mg.<br>Nystatin and Triamcinolone Acetonide<br>Cream USP, 1,00,000 UNITS / GM;<br>0.1% - 60 gm tube<br>1 Number<br>6<br>Nystatin USP<br>954.61 mg.<br>RA concerned may take further necessary action as per above decision of NC.	Nystatin and Triamcinolone Acetonide<br>Cream USP, 1,00,000 UNITS / GM;<br>0.1% - 30 gm tube	1 Number	5	Nystatin USP	477.30 mg.
	Nystatin and Triamcinolone Acetonide<br>Cream USP, 1,00,000 UNITS / GM;<br>0.1% - 60 gm tube	1 Number	6	Nystatin USP	954.61 mg.

Case No.	89 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	OM TITANATES
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00000913AM26
RA File Number	03AX04006607 AM25
Licence No and<br>Date	0311043988/20/05/2025
Norms Committee Decision:<br>The committee considered the case as per the agenda and after examination, it was observed that the firm has not<br>furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in<br>view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the<br>following documents:<br>1.

exure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents: 1. Complete chemistry, chemical reaction, and stichometric balance on molar basis with molecular weight and percentage yield for each step of reaction.||

Case No.	90 / NC/3/MEET/Feb/202526/13
Case Status	Case Rejected
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00000931AM26

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

RA File Number	03AX04000780 AM26
Licence No and<br>Date	0311044012/20/05/2025
Norms Committee Decision:
The firm was initially granted an Advance Authorisation for the export product_“_Methyl - 3 - Oxo - 2 -
Pentyl - 1 - Cyclopentane Acetate_”_under Para 4.07 of the Handbook of Procedures (HBP). However, as
per Para 4.11(b) of the Foreign Trade Policy (FTP) 2023, products falling under the category of perfume
or perfumery compounds are ineligible for authorisation under Para 4.07 and are mandatorily required to
be processed under Para 4.06 of the HBP.
It was observed that the firm obtained the authorisation bymisdeclaring that its application was
covered under the provisions of Para 4.07, and has not furnished any technical justification/information
for the export product.

he authorisation bymisdeclaring that its application was|| |covered under the provisions of Para 4.07, and has not furnished any technical justification/information|| |for the export product. Accordingly, the Committee found no merit in fixing the norms and decided to|| |reject the application.|| |The RA shall ensure that the said authorisation is regularised by recovery of applicable Customs duty|| |along with interest. Further, the RA should also submit a report on how this authorisation was issued|| |under Para 4.07 of HBP, to the Chairperson of the Norms Committee and to PC-4 Section, DGFT|| |Headquarters.|| |The RA concerned may take further necessary action in line with the above decision of the Committee.||

Case No.<br>91 / NC/3/MEET/Feb/202526/13
Case Status<br>Case Approved
Party Name<br>TITAN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number<br>HQRNORM APPLY 00000962AM26
RA File Number<br>03AX04000867 AM26
Licence No and<br>Date<br>0311044043/21/05/2025
Norms Committee Decision:
The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the
Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority
or as applied for by the firm,whichever is less, as per the details indicated below.:-
Export Product<br>Qty.	Sl. No.	Import Items	**Qty.

from the Technical Authority||||| |or as applied for by the firm,whichever is less, as per the details indicated below.:-||||| |Export Product Qty.|Sl. No.|Import Items|Qty. allowed.|| |Dexlansoprazole Dual Release Pellets 1 kg.|1|Dexlansoprazole|0.202 kg.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

20.0 % w/w

Case No.	92 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00000983AM26
RA File Number	05AX04000642 AM26
Licence No and<br>Date	0511032775/22/05/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No. NC/3/MEET/Sep/202324/14 dated 27/09/2023 against advance<br>authorization No. 0511020475 dated 18/08/2023,it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Ciprofloxacin<br>24.374 kg<br>Ciprofloxacin and<br>Dexamethasone Sterile Otic<br>Suspension 7.5 ml ((Each ml<br>contains Ciprofloxacin 3mg.

Product Qty. Sl. No. Import Items Qty. 1 Ciprofloxacin 24.374 kg Ciprofloxacin and Dexamethasone Sterile Otic Suspension 7.5 ml ((Each ml contains Ciprofloxacin 3mg. & Dexamethasone 1 mg (Equivalent to 14625.00 gm. Ciprofloxacin and 4875.00 gm. Dexamethasone Bulk Drug)) 942000 Numbers 2 Dexamethasone (Micronised) 7.418 kg RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Case No.	Case No.	93 / NC/3/MEET/Feb/202526/13	93 / NC/3/MEET/Feb/202526/13	93 / NC/3/MEET/Feb/202526/13	93 / NC/3/MEET/Feb/202526/13	93 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		USV PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM APPLY 00000993AM26
RA File Number		03AX04000781 AM26
Licence No and<br>Date		0311044098/22/05/2025
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

om the Technical Authority or as applied for by the firm,whichever is less, as per the details indicated below.:- Export Product Qty. Sl. No. Import Items Qty. allowed. Doxycycline Tablets, USP 50 MG 100 S((32,400 Bottles X 100 Per Bottles = 32,40,000 Tablets) (Total Weight of Export Product = 162.000 Kgs) (Exempts imported input/material weight inclusive of wastage = 175.219 Kgs)) 1 Number 1 Doxycycline USP (Monohydrate) 53.066 mg./Tablet Doxycycline Tablets, USP 100 MG 50 S((1,12,000 Bottles X 50 Per Bottles = 56,00,000 Tablets) (Total Weight of Export Product = 560.000 Kgs) (Exempts imported input/material weight inclusive of wastage = 605.696 Kgs)) 1 Number 2 Doxycycline USP (Monohydrate) 106.13 mg./Tablet Doxycycline Tablets, USP 100 MG 500 S((11,200 Bottles X 500 Per Bottles = 56,00,000 Tablets) (Total Weight of Export Product = 560.000 Kgs) (Exempts imported input/material weight inclusive of wastage = 605.696 Kgs)) 1 Number 3 Doxycycline USP (Monohydrate) 106.13 mg./Tablet||||||| ||Export Product||Qty.|Sl. No.|Import Items|**Qty.

l weight inclusive of wastage = 605.696 Kgs)) 1 Number 3 Doxycycline USP (Monohydrate) 106.13 mg./Tablet||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Doxycycline Tablets, USP 50 MG 100 S((32,400 Bottles X 100 Per Bottles = 32,40,000 Tablets) (Total Weight of Export Product = 162.000 Kgs) (Exempts imported input/material weight inclusive of wastage = 175.219 Kgs))|| 1 Number|1|Doxycycline USP (Monohydrate)| 53.066 mg./Tablet| ||Doxycycline Tablets, USP 100 MG 50 S((1,12,000 Bottles X 50 Per Bottles = 56,00,000 Tablets) (Total Weight of Export Product = 560.000 Kgs) (Exempts imported input/material weight inclusive of wastage = 605.696 Kgs))|| 1 Number|2|Doxycycline USP (Monohydrate)| 106.13 mg./Tablet| ||Doxycycline Tablets, USP 100 MG 500 S((11,200 Bottles X 500 Per Bottles = 56,00,000 Tablets) (Total Weight of Export Product = 560.000 Kgs) (Exempts imported input/material weight inclusive of wastage = 605.696 Kgs))|| 1 Number|3|Doxycycline USP (Monohydrate)| 106.13 mg./Tablet|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

r>USP (Monohydrate)| 106.13 mg./Tablet|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Doxycycline Tablets, USP 150 MG	1 Number	4	Doxycycline	USP	<br>159.2 mg/Tablet
30 S((5,000 Bottles X 30 Per Bottles			(Monohydrate)
= 1,50,000 Tablets) (Total Weight of
Export Product = 22.500 Kgs)
(Exempts imported input/material
weight inclusive of wastage =
24.336 Kgs))

	Doxycycline Tablets, USP 150 MG<br>30 S((5,000 Bottles X 30 Per Bottles<br>= 1,50,000 Tablets) (Total Weight of<br>	Doxycycline Tablets, USP 150 MG<br>30 S((5,000 Bottles X 30 Per Bottles<br>= 1,50,000 Tablets) (Total Weight of<br>
	Export Product<br>	= 22.500 Kgs)<br>
	(Exempts impo<br>	rted input/material<br>
	weight inclusiv<br>	e of wastage =
24.336 Kgs))	24.336 Kgs))

empts impo ||rted input/material ||||||||||||| ||weight inclusiv ||e of wastage =||||||||||||| |24.336 Kgs))|24.336 Kgs))||||||||||||||| ||||||||||||||||| ||||||||||||||||| ||||||||||||||||| |RA concerned m|||ay take further necessary action as per above decision of NC.||||||||||||| ||||||||||||||||| ||||||||||||||||| |Cas||e No.|94 / NC/3/MEET/Feb/202526/13||||||||||||| |Cas||e Status|Case Approved||||||||||||| |Par||ty Name|USV PRIVATE LIMITED||||||||||||| |Me and||eting Number Date|NC/ 3/ MEET|/ Feb/ 202526/||13 and 20/02/2|||026||||||| |HQ||File Number|HQRNORM|PPLY 00000||994AM26|||||||||| ||||||||||||||||| |RA||File Number|03AX0400078|2 AM26|||||||||||| |Lic Dat||ence No and e|0311044099/2|2/05/2025|||||||||||| ||||||||||||||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Dec/202425/12 dated 10/12/2024 against advance authorization No. 0311034851 dated 24/06/2024**,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||ms Committee Decision:|||||||||||||| ||||||||||||||||| |||Export Product|||||Qty.|||Sl. No.||Import Items|||Qty.| ||||||||||||||||| ||||||||||||||||| |||Id 150|Tblt 28 S Ibt||||1 Nb|||1||Ibt Ph E|||153| |||ezar m Tablets 150|g aes (resaran 28 S ) ((15175 Boxes X||||umer|||||resaran .

mport Items|||Qty.| ||||||||||||||||| ||||||||||||||||| |||Id 150|Tblt 28 S Ibt||||1 Nb|||1||Ibt Ph E|||153| |||ezar m Tablets 150|g aes (resaran 28 S ) ((15175 Boxes X||||umer|||||resaran . ur|||mg.| ||| 28 Tablets pe Tl Wih|g , r Boxes = 4,24,900 Tablets) f E Pd||||||||||||| |||(ota eg 63735 K)|t o xport rouct = Et itd||||||||||||| |||. gs inut/materia|xemps mpore l weiht inclusive of||||||||||||| |||p wastage = 66|g .813 Kgs))||||||||||||| ||||||||||||||||| ||||||||||||||||| |||Idezar 300 MG Tablets 28 S (Irbesartan|||||1 Number|||2||Irbesartan Ph. Eur|||306 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Tablets 300 Mg 28 S ) ((14,500 Boxes X 28 Tablets per Boxes = 4,06,000 Tablets) (Total Weight of Export Product = 121.800 Kgs) (Exempts imported input/material weight inclusive of wastage = 127.683 Kgs))

300 Mg 28 S ) ((14,500 Boxes X 28 Tablets per Boxes = 4,06,000 Tablets) (Total Weight of Export Product = 121.800 Kgs) (Exempts imported input/material weight inclusive of wastage = 127.683 Kgs))

Case No.	95 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00000999AM26
RA File Number	03AX04000802 AM26
Licence No and<br>Date	0311044107/22/05/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No. NC/3/MEET/Jan/202526/12 dated 15/01/2026 against advance<br>authorization No. 0311034851 dated 24/06/2024,it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Acetaldoxime<br>2.01 kg.<br>3 Trifluoro Methyl Acetophenone<br>1 kg.<br>2<br>Meta Amino Benzotrifluoride<br>1.96 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

cessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

|Case No.|96 / NC/3/MEET/Feb/202526/13|
|---|---|
|Case Status|Case Approved|
|Party Name|ATUL LIMITED|
|Meeting Number and<br>Date|NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026|
|HQ File Number|HQRNORM APPLY 00001010AM26|
|RA File Number|08AX04000262 AM26|
|Licence No and Date|0811015090/22/05/2025|
|Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Aug/202526/7  dated 22/08/2025 against advance<br>authorization No.0811009108 dated 16/08/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Isophorone Diamine |<br>(Vestamine IPD | Baxxodur EC<br>201| Wanamine IPDA)<br>0.520 kg.<br>2<br>Bisphenol-A<br>0.090 kg.<br>Cycloaliphatic<br>Amine<br>Adduct<br>1 kg.<br>3<br>Epichlorohydrin<br>0.072 kg.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No.	97 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	MANGALAM ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001021AM26
RA File Number	03AX04000601 AM26

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Licence No and Date

0311044153/23/05/2025

Norms Committee Decision: The committee considered the case as per the agenda and after examination, it was observed that the firm has not furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the following documents: Indicate the Alpha Pinene content in Gum Terpantine Oil with Certificate of Analysis (CoA). 1. Copy of Bill of Entry indicating Alpha Pinene content in it. 2.

br>following documents: Indicate the Alpha Pinene content in Gum Terpantine Oil with Certificate of Analysis (CoA). 1. Copy of Bill of Entry indicating Alpha Pinene content in it. 2.||

Case No.	98 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001030AM26
RA File Number	05AX04000638 AM26
Licence No and<br>Date	0511032819/23/05/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Sep/202526/8 dated 17/09/2025 against advance<br>authorization No.0511030623 dated 29/01/2025, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br>allowed.<br>Ceftriaxone Sodium Sterile<br>1 kg.<br>1<br>Ceftriaxone Sodium (Non Sterile) IP<br>1.04 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 99 / NC/3/MEET/Feb/202526/13

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

NC.||

Case No. 99 / NC/3/MEET/Feb/202526/13

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Case Status	Case Status	Case Approved	Case Approved	Case Approved	Case Approved
Party Name		USV PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM APPLY 00001033AM26
RA File Number
	File Number	03AX04000820 AM26
Lic<br>Dat	ence No and<br>e	0311044159/23/05/202	5
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Griseofulvin Tablets USP 500 mg<br> <br>1 Number<br>1<br>Griseofulvin USP<br>510 mg./Tablet	ms Committee Decision:<br>he Committee examined the reques<br>ommittee decided to fix the ad-hoc<br>as applied for by the firm,whiche		t of the f<br>norms o<br>ver is les	irm for	fixation of ad-hoc norms.

cision: he Committee examined the reques ommittee decided to fix the ad-hoc as applied for by the firm,whiche||t of the f norms o ver is les||irm for||fixation of ad-hoc norms. After due|||deliberation, the| ||||||| n the ba s, as per|| sis of inputs received from the Tech the details indicated below.:-||| nical Authority| ||||||||||||| ||Export Product|Export Product|||Qt|y.||Sl. No.|Import Items|Q|ty. allowed.| ||||||||||||| ||Griseofulvin Tablets USP 500 mg ||||1 Number||1||Griseofulvin USP|510 mg./Tablet|| ||100s((6,450 Bottles X 100 Per Bottles = 6,45,000 Tablets) (Total Weight of Export Product = 322.500 Kgs) (Exempts imported ||||||||||| ||input/material 4||weight inclusive of 2||||||||| ||wastage = 33.||37 Kgs))||||||||| ||||||||||||| ||||||||||||| ||Ultramicrosize USP 125 mg 1||Griseofulvin Tablets, 00s((2,800 Bottles X||1 Number||2||Griseofulvin USP|127.5 mg./Tablet|| ||100 Per Bottles||= 2,80,000 Tablets)||||||||| ||(Total Weight||of Export Product =||||||||| ||35.000 Kgs) (E input/material||xempts imported weight inclusive of||||||||| ||wastage = 37.251 Kgs))||||||||||| ||Ultramicrosize Griseofulvin Tablets, USP 250 mg 100s((4,200 Bottles X 100 Per Bottles = 4,20,000 Tablets)||||1 Number||3||Griseofulvin USP|255.0 mg/Tablet|| ||(Total Weight of Export Product = 105.000 Kgs) (Exempts imported input/material weight inclusive of wastage = 111.752 Kgs))||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| |||||||||||||

(Total Weight of Export Product = 105.000 Kgs) (Exempts imported input/material weight inclusive of wastage = 111.752 Kgs))||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| |RA concerned m|||ay take further necessary action as per above decision of NC.||||||||| |||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27




Case No.		100 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		DR.REDDY'S LABORATORIES LTD
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ	File Number	HQRNORM APPLY 00001037AM26
RA	File Number	09AX04000133 AM26

Lic<br>Dat	ence No and<br>e	091100969	0/23/05/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Jan/202526/12 dated 15/01/2026 against advance<br>authorization No.0911008629 dated 17/12/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-	ms Committee Decision:<br>e Committee considered		the case as p	er agenda and t		aking cue from the earlier decisi		on for same export

	Export Product				Qty.		Sl.

hever is less:-|ms Committee Decision: e Committee considered|||the case as p|er agenda and t||aking cue from the earlier decisi|||on for same export|| ||||||||||||| ||Export Product|||||Qty.||Sl. No.|Import Items||Qty. allowed.| ||||||||||||| ||Liraglutide s|olution for injection 6 mg/ml||||1 Number ||1|Liraglutide||19.8 mg.| ||(18 m / 3 m|) (Each re-filled en contains|||| Injection|||||| ||g 3 mL solut|p p ion of Liralutide injection|||| |||||| || which is equ (Pk Si|g ivalent to Liraglutide 18 mg) ))|||| |||||| ||ac ze :|s|||||||||| ||||||||||||| |RA d||k fh i b dii f NC|||||||||| |concerne may tae urter necessary acton as per aove ecson o .|||||||||||| ||||||||||||| |Case No.|||101 / NC/3/MEET/Feb/202526/13||||||||| |Case Status|||Case Approved||||||||| |Party Name|||LAURUS SYNTHESIS PRIVATE LIMITED||||||||| |Meeting Number and Date|||NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026||||||||| |HQ File Number|||HQRNORM APPLY 00001043AM26||||||||| |RA File Number|||09AX04000174 AM26||||||||| |Licence No and Date|||0911009701/23/05/2025||||||||| |Norms Committee||Decision:||||||||||

Case No.	101 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001043AM26
RA File Number	09AX04000174 AM26
Licence No and Date	0911009701/23/05/2025
Norms Committee Decision:

C/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026| |HQ File Number|HQRNORM APPLY 00001043AM26| |RA File Number|09AX04000174 AM26| |Licence No and Date|0911009701/23/05/2025| |Norms Committee Decision:||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Sep/202526/8 dated 17/09/2025 against advance authorization No.0911007869 dated 05/09/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Atinvicitinib(1-[(3R,4S)-4-<br>Cyanotetrahydropyran-3-yl]-3-[(2-<br>fluoro-6-methoxy-4-pyridyl)<br>amino]pyrazole-4-carboxamide (L-<br>005251026-Form-I))	1 kg.	1	2-Fluoro-6-methoxy pyridine<br>(FMP)	1.975 kg.
		2	4,5-bis(Diphenylphosphino)-<br>9,9-dimethylxanthane<br>(Xantphos)	0.125 kg.

br>amino]pyrazole-4-carboxamide (L- 005251026-Form-I))|1 kg.|1|2-Fluoro-6-methoxy pyridine (FMP)|1.975 kg.| |||2|4,5-bis(Diphenylphosphino)- 9,9-dimethylxanthane (Xantphos)|0.125 kg.|

Case No.	Case No.	102 / NC/3/MEET/Feb/202526/13	102 / NC/3/MEET/Feb/202526/13	102 / NC/3/MEET/Feb/202526/13	102 / NC/3/MEET/Feb/202526/13	102 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM APPLY 00001057AM26
RA File Number		09AX04000188 AM26
Licence No and<br>Date		0911009705/26/05/2025
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Quetiapine Fumarate Tabs 25 mg (Pack<br>size:30s) (Consist of 160 Kgs of<br>Quetiapine Fumarate ) Brand Name :<br>6400020<br>Numbers<br>1<br>Quetiapine Fumarate<br>184.19 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Quetiapine Fumarate Tabs 25 mg (Pack<br>size:30s) (Consist of 160 Kgs of<br>Quetiapine Fumarate ) Brand Name :		<br>6400020<br>Numbers	1	Quetiapine Fumarate	184.19 kg.

ort Items|Qty. allowed.| ||Quetiapine Fumarate Tabs 25 mg (Pack size:30s) (Consist of 160 Kgs of Quetiapine Fumarate ) Brand Name :|| 6400020 Numbers|1|Quetiapine Fumarate|184.19 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Dopaquel 25 mg<br>Quetiapine Fumarate Tabs 100 mg<br>(Pack size:30s) (Consist of 320 Kgs of<br>Quetiapine Fumarate ) Brand Name :<br>Dopaquel 100 mg<br>3200010<br>Numbers<br>2<br>Quetiapine Fumarate<br>368.42 kg.<br>Quetiapine Fumarate Tabs 200 mg<br>(Pack size:30s) (Consist of 320 Kgs of<br>Quetiapine Fumarate ) Brand Name :<br>Dopaquel 200 mg<br>1600020<br>Numbers<br>3<br>Quetiapine Fumarate<br>368.31 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Dopaquel 25 mg
	Quetiapine Fumarate Tabs 100 mg<br>(Pack size:30s) (Consist of 320 Kgs of<br>Quetiapine Fumarate ) Brand Name :<br>Dopaquel 100 mg	3200010<br>Numbers	2	Quetiapine Fumarate	368.42 kg.
	Quetiapine Fumarate Tabs 200 mg<br>(Pack size:30s) (Consist of 320 Kgs of<br>Quetiapine Fumarate ) Brand Name :<br>Dopaquel 200 mg	1600020<br>Numbers	3	Quetiapine Fumarate	368.31 kg.

8.42 kg.| ||Quetiapine Fumarate Tabs 200 mg (Pack size:30s) (Consist of 320 Kgs of Quetiapine Fumarate ) Brand Name : Dopaquel 200 mg|1600020 Numbers|3|Quetiapine Fumarate|368.31 kg.|

Case No.	103 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	ROSSARI BIOTECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001059AM26
RA File Number	03AX04000929 AM26
Licence No and<br>Date	0311044189/26/05/2025
Norms Committee Decision:<br>The committee considered the case as per the agenda and after examination, it was observed that the firm has not<br>furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in<br>view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the<br>following documents:<br>1. Complete chemistry, chemical reaction, and stichometric balance on molar basis with Molecular weight<br>and percentage yield for each step of reaction.

Case No.	104 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

526/13| |---|---| |Case Status|Case Approved|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Party Name	GOPINATH CHEM-TECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001061AM26
RA File Number	08AX04000183 AM26
Licence No and<br>Date	0811015133/26/05/2025
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Sulpho Gamma Acid (7-Amino-1-<br>Naphthol-3,6-Disulfonic Acid)<br>1 kg.<br>1<br>K ACID<br>1.371 kg.<br>RA concerned may take further necessary action as per above decision of NC.

. allowed.** Sulpho Gamma Acid (7-Amino-1- Naphthol-3,6-Disulfonic Acid) 1 kg. 1 K ACID 1.371 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	105 / NC/3/MEET/Feb/202526/13	105 / NC/3/MEET/Feb/202526/13	105 / NC/3/MEET/Feb/202526/13	105 / NC/3/MEET/Feb/202526/13	105 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM APPLY 00001063AM26
RA File Number		31AX04000070 AM26
Licence No and<br>Date		3111004839/26/05/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Aug/202526/7 dated 22/08/2025 against advance<br>authorization No.0311035506 dated 15/07/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Aminowel	5% Infusion	250	ml	310000	1	Glycine EP	284.81	kg.
				Numbers

:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Aminowel	5% Infusion	250	ml	310000	1	Glycine EP	284.81	kg.
				Numbers

Case No.	Case No.	106 / NC/3/MEET/Feb/202526/13	106 / NC/3/MEET/Feb/202526/13	106 / NC/3/MEET/Feb/202526/13	106 / NC/3/MEET/Feb/202526/13	106 / NC/3/MEET/Feb/202526/13
Case Status		Case Approved
Party Name		VENUS REMEDIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number		HQRNORM APPLY 00001079AM26
RA File Number		30AX04000122 AM26
Licence No and<br>Date		3011007033/27/05/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Jan/202526/12 dated 15/01/2026 against Advance<br>Authorization No.3011006926 dated 08/05/2025 , it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.

it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Ceftriaxone powder for solution for injection 500 mg (Each vial contains: Ceftriaxone Sodium equivalent to ceftriaxone...500 mg) 1 Number 1 Ceftriaxone Sodium Sterile 580 mg. Ceftriaxone powder for solution for injection1000 mg (Each vial contains: Ceftriaxone sodium Equivalent to ceftriaxone..1000 mg) 1 Number 2 Ceftriaxone Sodium Sterile 1.16 gm. Ceftriaxone powder for solution for injection 2000 mg (Each vial contains: 1 Number 3 Ceftriaxone Sodium Sterile 2.32 gm.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Ceftriaxone powder for solution for injection 500 mg (Each vial contains: Ceftriaxone Sodium equivalent to ceftriaxone...500 mg)||1 Number|1|Ceftriaxone Sodium Sterile|580 mg.| ||Ceftriaxone powder for solution for injection1000 mg (Each vial contains: Ceftriaxone sodium Equivalent to ceftriaxone..1000 mg)||1 Number|2|Ceftriaxone Sodium Sterile|1.16 gm.| ||Ceftriaxone powder for solution for injection 2000 mg (Each vial contains:||1 Number|3|Ceftriaxone Sodium Sterile|2.32 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Ceftriaxone sodium equivalent to ceftriaxone..2000 mg)

y Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Ceftriaxone sodium equivalent to ceftriaxone..2000 mg)

Case No.	107 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	MANGALAM ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001097AM26
RA File Number	03AX04000374 AM26
Licence No and<br>Date	0311044240/28/05/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Feb/202223/20 dated 24/02/2023 against Advance<br>Authorization No.0311006375 dated 23/08/2021 , 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>Dipentene<br>(Mixture of Monocyclic Terpenes)<br>1 kg.<br>1<br>Gum Turpentine Oil<br>1.03 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	108 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	USV PRIVATE LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

se Approved| |Party Name|USV PRIVATE LIMITED|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001101AM26
RA File Number	03AX04000973 AM26
Licence No and<br>Date	0311044251/28/05/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Jul/202526/6 dated 31/07/2025 against advance<br>authorization No. 0311040406 dated 14/01/2025, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Propafenone HCL ER Capsules USP<br>225 MG 60 s us (Ris ((6,999 Bottles<br>X 60 Capsules Per Bottles = 4,19940<br>Capsules ) (Total Weight of Export<br>Product = 94.487 Kgs)<br>1 Number<br>Capsule<br>1<br>Propafenone<br>Hydrochloride<br>229.5 mg/Capsule<br>RA concerned may take further necessary action as per above decision of NC.

of Export Product = 94.487 Kgs) 1 Number Capsule 1 Propafenone Hydrochloride 229.5 mg/Capsule RA concerned may take further necessary action as per above decision of NC.||

Case No.	109 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	VENUS REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001102AM26
RA File Number	30AX04000129 AM26
Licence No and<br>Date	3011007048/28/05/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Jan/202526/6 dated 15/01/2026 against advance<br>authorization No. 3011006063 dated 21/11/2024, 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: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

==> picture [464 x 431] intentionally omitted <==

ally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

==> picture [464 x 431] intentionally omitted <==

----- Start of picture text ----- Export Product Qty. Sl. No. Import Items Qty. allowed. Docetaxel Injection Concentrate (20 1 Number 1 Docetaxel Anhydrous 23.468 mg. mg / 0.5 ml) (Each 0.5 ml Contains: Docetaxel Trihydrate Eqv. To Anhydrous Docetaxel...20 mg, Polysorbate-80 USP...Q.S. Containing 990.040 gm of Docetaxel Trihydrate) Docetaxel Injection Concentrate (80 1 Number 2 Docetaxel Anhydrous 93.873 mg. mg /2.0 ml) (Each 0.5 Ml Contains: Docetaxel Trihydrate Eqv. To Anhydrous Docetaxel...20 mg, Polysorbate-80 USP...Q.S Containing 2650.039 gm of Docetaxel Trihydrate) Docetaxel Injection Concentrate (120 1 Number 3 Docetaxel Anhydrous 140.81 mg. mg /3.0 Ml) (Each 0.5 Ml Contains: Docetaxel Trihydrate Eqv. To Anhydrous Docetaxel...20 mg, Polysorbate-80 USP...Q.S Containing 3360 gm of Docetaxel Trihydrate) ----- End of picture text -----

Case No.	110 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001122AM26

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

| |HQ File Number|HQRNORM APPLY 00001122AM26|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

RA File Number

31AX04000081 AM26

Licence No and Date

3111004847/28/05/2025

Norms Committee Decision: As per the advice of the technical authority, the firm was asked to attend a personal hearing through video conference to explain its case. However, the personal hearing could not be conducted due to technical issues beyond control. In view of this, the Committee decided to provide another opportunity to the firm by conducting the personal hearing through video conference in the ensuing meeting.

Case No.	111 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001124AM26
RA File Number	05AX04000719 AM26
Licence No and<br>Date	0511032963/28/05/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Apr/202526/1 dated 25/04/2025 against advance<br>authorization No. 0511027690 dated 12/09/2024, 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. Import Items<br>Qty.

it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Brinex / Brinex-M / Brinarga / Brinera (Brinzolamide Opthalmic Suspension 1%)- 5ml (Each ml contains 10 mg of Brinzolamide)) 1 Vial 1 Brinzolamide Micronized Sterile 51.00 mg/Vial RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Case No.	112 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001125AM26
RA File Number	05AX04000723 AM26
Licence No and<br>Date	0511032964/28/05/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No. NC/3/MEET/Jul/202526/6 dated 31/07/2025 against advance<br>authorization No. 0511030286 dated 13/01/2025, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.

it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Visallergol Eye Drops 0.2%, 2.5 ml (Visallergol Eye Drops 0.2%, 2.5 ml) 1 Number 1 Olopatadine HCL 5.61 mg. Oftahist (Olopatadine Eye Solution 0.1 Percent in 5ml Vial)(Oftahist (Olopatadine Eye Solution 0.1 Percent in 5ml Vial)) 1 Number 2 Olopatadine HCL 5.61 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	113 / NC/3/MEET/Feb/202526/13
Case Status<br>	Case Approved
Party Name<br>	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number<br>	HQRNORM APPLY 00001126AM26
RA File Number<br>	05AX04000695 AM26
Licence No and<br>Date<br>	0511032965/28/05/2025
Norms Committee Decision:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

e Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm, whichever is less , as per the details indicated below.:-

Export Product	Qty.	Sl. No.	Import Items	Qty.
				allowed.
Difluprednate Ophthalmic Emulsion,	1 Number	1	Difluprednate (Micronized)	1.53 mg.
0.05% w/v Sterile Eye Drops,
3ml((Each ml contains Difluprednate
0.5 mg (Equivalent to 9.000 Gram of
Bulk Drug))
Difluprednate Ophthalmic Emulsion,	1 Number	2	Difluprednate (Micronized)	2.55 mg.
0.05% w/v Sterile Eye Drops,
5ml((Each ml contains Difluprednate
0.5 mg (Equivalent to 167.590 Gram
of Bulk Drug))
Difluprednate Ophthalmic Emulsion,	1 Number	3	Difluprednate (Micronized)	5.10 mg.
0.05% w/v Sterile Eye Drops,
10ml((Each ml contains
Difluprednate 0.5 mg (Equivalent to
30.000 Gram of Bulk Drug))

Case No.	114 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001127AM26
RA File Number	05AX04000722 AM26
Licence No and<br>Date	0511032966/28/05/2025
Norms Committee Decision:

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

2966/28/05/2025| |Norms Committee Decision:||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Apr/202324/1 dated 28/04/2023 against advance authorization No.0511016292 dated 12/12/2022, it was decided to ratify 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.
Mydrimax Eye Drops 5 ml Vials (Each<br>ml contains Tropicamide 0.8% )	1 Number	1	Tropicamide	40.8 mg / 5 ml vial


Case No		115 / NC/3/MEET/Feb/202526/13
.
Case Status		Case Approved

Party Name		GLENMARK PHARMACEUTICALS LIMITED

Meeting Number<br>and Date		NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026

HQ File Number		HQRNORM APPLY 00001128AM26

RA File Number		03AX04000994 AM26

Licence No and<br>Date		0311044297/28/05/2025

Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-
	Export Product		Qty.	Sl.

-hoc norms on the basis of inputs received from the Technical Authority or as applied for by the firm,whichever is less, as per the details indicated below.:-||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||PHELISANS (Phenazone & Lidocaine||300000|1|Phenazone|195.84 kg.| ||Hydrochlorid|e Ear Drops 4 % + 1 % /|Numbers|||| ||(Phenazone a|nd Lidocaine Hydrochloride Ear||||| ||Drops 40 mg|/gm + 10 mg/gm) (Pack Size 16||||| ||gms) ( Net w|t. of Phenazone is 192.00 Kgs))|||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27



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

Case No.	116 / NC/3/MEET/Feb/202526/13
Case Status	Case Approv	ed
Party Name	ADCOCK IN	GRAM LI	MITED
Meeting Number<br>and Date
	NC/ 3/ MEE	T/ Feb/ 2025	26/ 13 an	d 20/02/2026
HQ File Number	HQRNORM	APPLY 000	01129AM	26
RA File Number	07AX04000	304 AM26

Licence No and<br>Date	0711014563/28/05/2025

Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Apr/202324/1 dated 28/04/2023 against advance<br>authorization No.0511016292 dated 12/12/2022, it was decided to ratify ad-hoc norms under Para 4.07 of
<br>HBP Vol.

in meeting No.NC/3/MEET/Apr/202324/1 dated 28/04/2023 against advance authorization No.0511016292 dated 12/12/2022, it was decided to ratify ad-hoc norms under Para 4.07 of|||||||||| | HBP Vol. I as p|| er details given below or as applied by the firm, whichever is less: -|||||||| ||||||||||| ||||||||||| ||||||||||| ||Export P|roduct||Qty.||Sl. No.|Import Items||Qty. allowed.| ||||||||||| ||||||||||| ||IBUPROFEN CODEINE P |200 mg + HOSPHATE || 1 Number||1|Ibuprofen BP/USP/EP||204.00 mg.| ||||||||||| ||12.8mg Tablets (IBUPROFEN 200 mg + CODEINE PHOSPHATE 13.169mg Tablets (IBU- 600.00+COD-39.507 KGS, No||| ||2|Codeine Phosphate BP/EP/USP/ PH.EUR||13.056 mg.| ||of Tabs 3000000) BP/US||P/EP)||||||| ||||||||||| ||CO-CODAMOL 15 mg / mg TABLETS (CO- CODAMOL 15.432 mg /||500 500|1 N|umber|3|Codeine Phosphate BP/USP/EP/ PH.EUR||15.30 mg.| ||mg TABLETS (PARA 500 mg + CODEINE||||||||| ||PHOSPHATE 15.432 mg) (PARA-15000+COD-462.960|||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

KGS (No of Tabs 30000000) BP/EP/USP/ PH.EUR)

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

KGS (No of Tabs 30000000) BP/EP/USP/ PH.EUR)

Case No.	117 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	HINDYS LAB PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001141AM26
RA File Number	09AX04000095 AM26
Licence No and Date	0911009733/29/05/2025
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>N-(4-(4-<br>Fluorophenyl)-5-<br>(hydroxymethyl)-6-<br>isopropylpyrimidin-2-yl)-N-<br>methylmethane sulfonamide<br>(FMS) )<br>0.927 kg.<br>Tert-Butyl-2-((4R,6S)-6-((E)-2-(4-(4-<br>Flurophenyl)-6-Isopropyl-2-(N-<br>Methylmethanesulfonamido)Pyrimidin-<br>5-Yl)vinyl)-2,2-Dimethyl-<br>1,3-Dioxane-4-Yl-) Acetate (TIN))<br>1 kg.<br>2<br>Tert-butyl 2-((4R,6S)-2,2-<br>dimethyl-6-(((5-methyl-1,3,4-<br>thiadiazol-2-yl) sulfonyl)<br>methyl)-1,3-dioxan-4-yl)<br>acetate (TTD)<br>0.984 kg.<br>RA concerned may take further necessary action as per above decision of NC.

ethyl-6-(((5-methyl-1,3,4- thiadiazol-2-yl) sulfonyl) methyl)-1,3-dioxan-4-yl) acetate (TTD) 0.984 kg. RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Case No.	118 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	NOVA INTERCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001143AM26
RA File Number	08AX04000299 AM26
Licence No and<br>Date	0811015144/29/05/2025
Norms Committee Decision:<br>The committee considered the case as per the agenda and after examination, it was observed that the firm has not<br>furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in<br>view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the<br>following documents:<br>1. Complete chemistry, chemical reaction, and stichometric balance on molar basis with Molecular weight<br>and percentage yield for each step of reaction.

furnish the following documents: 1. Complete chemistry, chemical reaction, and stichometric balance on molar basis with Molecular weight and percentage yield for each step of reaction.||

Case No.	119 / NC/3/MEET/Feb/202526/13
Case Status	Case Deferred
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001144AM26
RA File Number	08AX04000362 AM26
Licence No and<br>Date	0811015145/29/05/2025
Norms Committee Decision:<br>The committee considered the case as per the agenda and after examination, it was observed that the firm has not<br>furnished the requisite technical details as prescribed in Annexure to Appendix 4E. After detailed deliberations and in<br>view of the recommendations of the Technical Authority, the Committee decided to ask the firm to furnish the<br>following documents:<br>A balanced chemical reaction indicating molecular weight of reactants and products with yield of the<br>reaction.<br>1.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Technical details with calculation of requirement of raw materials, indicating wastage of raw materials.

Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

Technical details with calculation of requirement of raw materials, indicating wastage of raw materials.

Case No.	120 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026
HQ File Number	HQRNORM APPLY 00001145AM26
RA File Number	08AX04000350 AM26
Licence No and<br>Date	0811015149/29/05/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Jul/202122/4 dated 15/07/2021 against advance<br>authorization No.081100725 dated 19/02/2021, 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>Epichlorohydrin<br>0.626 kg.<br>Cresyl Glycidyl Ether<br>1500000 kg.<br>2<br>Ortho Cresol<br>0.725 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	121 / NC/3/MEET/Feb/202526/13
Case Status	Case Approved
Party Name	ARESKO LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

|NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 21-Apr-2026 10:31:34 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00043607AM27

HQ File Number	HQ File Number	HQRNORM APPLY 00001151AM26	HQRNORM APPLY 00001151AM26	HQRNORM APPLY 00001151AM26	HQRNORM APPLY 00001151AM26	HQRNORM APPLY 00001151AM26
RA File Number		05AX04000384 AM26
Licence No and<br>Date		0511032974/29/05/2025
Norms Committee Decision:<br>The Committee examined the request of the firm for fixation of ad-hoc norms. After due deliberation, the<br>Committee decided to fix the ad-hoc norms on the basis of inputs received from the Technical Authority<br>or as applied for by the firm,whichever is less, as per the details indicated below.:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Nandrolone decanoate<br>(Non-Micronized)<br>1 kg.<br>1<br>19-Norandrostenedione<br>0.982 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

Sl. No. Import Items Qty. allowed. Nandrolone decanoate (Non-Micronized) 1 kg. 1 19-Norandrostenedione 0.982 kg.|||||||||| |||Export Product|||Qty.|Sl. No.|Import Items||Qty. allowed.| |||Nandrolone decanoate (Non-Micronized)|||1 kg.|1|19-Norandrostenedione||0.982 kg.| ||||||||||| |||Norethisterone Enanthate|||1 kg.|2|19-Norandrostenedione||0.950 kg.| |||Norethisterone|||1 kg.|3|19-Norandrostenedione||1.066 kg.| |(Micronized/Non-Micronized) Norethisterone Acetate (USP) 1 kg. 4 19-Norandrostenedione 1.038 kg. Norethisterone (Micronized/Non-Micronized) 1 kg. 5 19-Norandrostenedione 1.066 kg. RA concerned may take further necessary action as per above decision of NC.||(Micronized/Non-Micronized)|||||||| |||Norethisterone Acetate (USP)|||1 kg.|4|19-Norandrostenedione||1.038 kg.| |||Norethisterone Miid/NMiid|||1 kg.|5|19-Norandrostenedione||1.066 kg.| |||(cron|eon-cronze)||||||| ||||||||||| ||A concerne||d may take further necessary action as per above decisi|||||on of NC.|| ||||||||||| ||||||||||| |C|ase No.|||122 / NC/3/MEET/Feb/202526/13|||||| |Case Status||||Case Approved|||||| |Party Name||||INDIA GLYCOLS LIMITED|||||| |Meeting Number and Date||||NC/ 3/ MEET/ Feb/ 202526/ 13 and 20/02/2026|||||| |HQ File Number||||HQRNORM APPLY 00001171AM26|||||| |RA File Number||||05AX04000324 AM26|||||| |Licence No and||||05110330

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