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/Sep/202526/8 Meeting Date - 17/09/2025

Minutes of the Norms Committee–3 Meeting No.NC/3/MEET/Aug/202526/7 dated 17/09/2025 under the Chairmanship of Shri Rakesh Kumar, Addl. DGFT for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of the Foreign Trade Policy, 2023 pertaining to Chemical and Allied products falling under Chapter 29 and 30.

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

Sl. No.	Name & Designation	Department
1	Shri Dinesh Narain Mathur, Technical<br>Expert	Consultant (Pharma)
2	Shri Shaish Kumar, Technical Expert	Consultant (Chemical)
3	Shri Nand Lal, Technical Expert	Consultant (Chemical)
4	Shri Raman Kumar, Deputy DGFT	DGFT (HQ)

Signature Not Verified Signature Not Verified Digitally Signed. Digitally signa, Name: RAMAN KUMAR( Deputy Name: RAMAN KUJAAR( Deputy DGFT ) DGFT Date: 07-Oct-2025 10:34:59 Date: 07-Oct-2) 10:34:59 Reason: ramankumar@nic.in Reason: ramankumar@nic.in Location: DGFT(HQ) Location: DGFTTHQ)

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

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5 Smt. Skina Rani, FTDO DGFT (HQ)

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

    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.

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Case Details and Decision(s):

Case No.	Case No.	1 / NC/3/MEET/Sep/202526/8	1 / NC/3/MEET/Sep/202526/8	1 / NC/3/MEET/Sep/202526/8	1 / NC/3/MEET/Sep/202526/8	1 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		FINE ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00001243AM26
RA File Number		NA
Licence No and<br>Date		NA
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for the same<br>export product/import item in the meeting No.NC/3/MEET/Jan/202425/16 dated 27.01.2025 against<br>DGFT (HQ) File No. HQNORMAPPLY00005602AM25, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Hydrogenated Palm Stearin<br>0.872 kg.<br>MONOGLYCERIDE (PS)<br>1 kg.<br>2<br>Refined Glycerine<br>0.222 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	MONOGLYCERIDE (PS)		1 kg.	1	Hydrogenated Palm Stearin	0.872 kg.
				2	Refined Glycerine	0.222 kg.
				as per above decision of NC.

Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||MONOGLYCERIDE (PS)||1 kg.|1|Hydrogenated Palm Stearin|0.872 kg.| |||||2|Refined Glycerine|0.222 kg.| |||||as per above decision of NC.|||

Case No.	2 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	CYKLO PHARMA CHEM PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM REVIW00003152AM25
RA File Number	032404000318 AM04
Licence No and<br>Date	0310204913/29/05/2003
Norms Committee Decision:<br>The Representative of the firm had attended the Personal Hearing and explained the case. The Committee heard the

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

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explanation of the Representative of the firm, and after due deliberation, the Committee has considered for revision of ad-hoc norms on the basis of information provided by the firm or as applied, whichever is less: -

Export Product	Qty.	Sl.<br>No.	Import Items	Qty.<br>allowed.
Allantoin	1 kg.	1	Glyoxalic Acid 50%	1.05 kg.

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

Import Items**|Qty. allowed.| |---|---|---|---|---| |Allantoin|1 kg.|1|Glyoxalic Acid 50%|1.05 kg.|

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

Case No.	3 / NC/3/MEET/Sep/202526/8	3 / NC/3/MEET/Sep/202526/8	3 / NC/3/MEET/Sep/202526/8	3 / NC/3/MEET/Sep/202526/8	3 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM REVIW00002300AM25
RA File Number	092404000413 AM12
Licence No and<br>Date	0910050238/15/12/2011
Norms Committee Decision:<br>The representative of the firm appeared for the personal hearing and presented submissions before the<br>Committee. The Committee carefully examined the explanation furnished. However, it was observed that<br>the firm failed to provide a satisfactory justification for the proposed enhancement of norms. Accordingly,<br>the Committee decided to fix the norms for the two inputs as under, taking cue from the earlier decision in<br>respect of the same export product in NC3/MEET/Jun/202122/2 dated 02.07.2021 against Authorisation<br>No.

ided to fix the norms for the two inputs as under, taking cue from the earlier decision in respect of the same export product in NC3/MEET/Jun/202122/2 dated 02.07.2021 against Authorisation No. 0910051360 dated 21.02.2021: Export Product Qty Sl No Import items Qty allowed (RS) 4-(2–amino-1-hydroxy ethyl) phenol HCL- CAS No 770-05-8 0.446 kg 4(4-HYDROXY PHENYL )-2- RACTOPAMINE HCL 1 kg 1 0.70 kg|||||| |||Qty|Sl No|Import items|Qty allowed| |||1 kg|1|(RS) 4-(2–amino-1-hydroxy ethyl) phenol HCL- CAS No 770-05-8|0.446 kg| |||||4(4-HYDROXY PHENYL )-2-|0.70 kg|

Case No.	3 / NC/3/MEET/Sep/202526/8	3 / NC/3/MEET/Sep/202526/8	3 / NC/3/MEET/Sep/202526/8	3 / NC/3/MEET/Sep/202526/8	3 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM REVIW00002300AM25
RA File Number	092404000413 AM12
Licence No and<br>Date	0910050238/15/12/2011
Norms Committee Decision:<br>The representative of the firm appeared for the personal hearing and presented submissions before the<br>Committee. The Committee carefully examined the explanation furnished. However, it was observed that<br>the firm failed to provide a satisfactory justification for the proposed enhancement of norms.

Committee. The Committee carefully examined the explanation furnished. However, it was observed that the firm failed to provide a satisfactory justification for the proposed enhancement of norms. Accordingly, the Committee decided to fix the norms for the two inputs as under, taking cue from the earlier decision in respect of the same export product in NC3/MEET/Jun/202122/2 dated 02.07.2021 against Authorisation No. 0910051360 dated 21.02.2021: Export Product Qty Sl No Import items Qty allowed (RS) 4-(2–amino-1-hydroxy ethyl) phenol HCL- CAS No 770-05-8 0.446 kg 4(4-HYDROXY PHENYL )-2- RACTOPAMINE HCL 1 kg 1 0.70 kg|||||| |||Qty|Sl No|Import items|Qty allowed| |||1 kg|1|(RS) 4-(2–amino-1-hydroxy ethyl) phenol HCL- CAS No 770-05-8|0.446 kg| |||||4(4-HYDROXY PHENYL )-2-|0.70 kg|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

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BUTANONE -CAS 5471-51-2

It was further noted that the firm had sought authorisation for 11 inputs, but failed to provide adequate justification for 9 of them. This constitutes a prima facie case of misdeclaration on the part of the firm.

In view of the above, the Committee directed the concerned RA to initiate appropriate enforcement action against the firm for misdeclaration and to furnish a detailed action-taken report to Headquarters. A copy of the decision be sent to PC-4 for appropriate action.

iate appropriate enforcement action against the firm for misdeclaration and to furnish a detailed action-taken report to Headquarters. A copy of the decision be sent to PC-4 for appropriate action.

Case No.	4 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	WEXFORD LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM REVIW00003782AM25
RA File Number	072404000120 AM18
Licence No and<br>Date	0710111992/09/08/2017
Norms Committee Decision:<br>The firm was called for Personal Hearing on 17/09/2025through Video Conference, but the firm could not<br>appear before Norms Committee. It was decided to grant one more opportunity to the firm for Personal<br>Hearingwith relevant documents/information.

Case No.	5 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	ORGANIC INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM REVIW00005762AM25
RA File Number	06AA04003603 AM22
Licence No and<br>Date	0611000533/02/07/2021
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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

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be transferred to Norms Committee-6 for revision of ad-hoc norms.

Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

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be transferred to Norms Committee-6 for revision of ad-hoc norms.

Case No.	6 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	ALTA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM REVIW00005721AM25
RA File Number	03AX04000822 AM23
Licence No and<br>Date	0311014992/25/05/2022
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Chemical reaction indicating molecular weight of both reactant and the products with yield of the<br>reaction.<br>1.<br>Stoichiometric material balance on a molar basis and to give value of by product Methanol obtained<br>during the reaction.<br>2.<br>Concentration of the ammonia and aqueous solution and accordingly, calculation of requirement of<br>both the chemical.<br>3.<br>Copy of Bill of Entry.<br>4.

ined during the reaction. 2. Concentration of the ammonia and aqueous solution and accordingly, calculation of requirement of both the chemical. 3. Copy of Bill of Entry. 4.||

Case No.	7 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM REVIW00004127AM25
RA File Number	03AX04002151 AM23
Licence No and<br>Date	0311016241/11/07/2022
Norms Committee Decision:<br>The firm was called for Personal Hearing on 17.09.2025 through Video Conference. The firm vide e-mail<br>dated 16.09.2025 has informed that their technical expert is not available and requested to postpone the<br>Personal Hearing. The Committee has decided to grant one more opportunity to the firm for Personal<br>Hearingwith relevant documents/information.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Hearingwith relevant documents/information.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

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Case No.	Case No.	8 / NC/3/MEET/Sep/202526/8	8 / NC/3/MEET/Sep/202526/8	8 / NC/3/MEET/Sep/202526/8	8 / NC/3/MEET/Sep/202526/8	8 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00001993AM23
RA File Number		34AX04000353 AM23
Licence No and<br>Date		3411002522/12/07/2022
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for same<br>export product/import item in meeting No.NC/3/MEET/Aug/202526/7 dated22/08/2025 against advance<br>authorization No.3411003278 dated 24/01/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Doxycycline Monohydrate USP<br>82.26 mg<br>2<br>Microcrystalline Cellulose (Avicel<br>PH 301)<br>88.874 mg.<br>3<br>Sodium Starch Glycolate (Type A)<br>(EXPLOTAB)<br>12.75 mg.<br>4<br>Povidone (Kollidon30 LP)<br>6.00 mg.<br>5<br>Microcrystalline Cellulose (Avicel<br>PH 200 LM)<br>15.00 mg.<br>6<br>Colloidal Silicon Dioxide (Aerosil<br>200 Pharma)<br>1.088 mg.<br>Doxycycline Caps.

Povidone (Kollidon30 LP) 6.00 mg. 5 Microcrystalline Cellulose (Avicel PH 200 LM) 15.00 mg. 6 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 1.088 mg. Doxycycline Caps. USP 75 mg. 1 Number 7 Magnesium Stearate (Vegetable Source) 2.25 mg. 8 Doxycycline Monohydrate USP 109.68 mg. Doxycycline Caps. USP 100 mg 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Doxycycline Caps. USP 75 mg.||1 Number|1|Doxycycline Monohydrate USP|82.26 mg| |||||2|Microcrystalline Cellulose (Avicel PH 301)|88.874 mg.| |||||3|Sodium Starch Glycolate (Type A) (EXPLOTAB)|12.75 mg.| |||||4|Povidone (Kollidon30 LP)|6.00 mg.| |||||5|Microcrystalline Cellulose (Avicel PH 200 LM)|15.00 mg.| |||||6|Colloidal Silicon Dioxide (Aerosil 200 Pharma)|1.088 mg.| |||||7|Magnesium Stearate (Vegetable Source)|2.25 mg.| ||Doxycycline Caps. USP 100 mg||1 Number|8|Doxycycline Monohydrate USP|109.68 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

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mber|8|Doxycycline Monohydrate USP|109.68 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

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

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

|Colloidal Silicon Dioxide (Aerosil 200 Pharma)|1.45 mg.| ||||14|Magnesium Stearate (Vegetable Source)|3.00 mg.|

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

Case No.	9 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	ALTA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM REVIW00005722AM25
RA File Number	03AX04002261 AM23
Licence No and<br>Date	0311016368/15/07/2022
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Chemical reaction indicating molecular weight of both reactant and the products with yield of the<br>reaction.<br>I.<br>Stoichiometric material balance on a molar basis and to give value of by product Methanol obtained<br>during the reaction.<br>II.<br>Concentration of the ammonia and aqueous solution and accordingly, calculation of requirement of<br>both the chemical.<br>III.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

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IV. Copy of Bill of Entry.

emical. III.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

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IV. Copy of Bill of Entry.

Case No.	Case No.	10 / NC/3/MEET/Sep/202526/8	10 / NC/3/MEET/Sep/202526/8	10 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00002358AM23
RA File Number		34AX04000398 AM23
Licence No and<br>Date		3411002586/29/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Doxepin Hydrochloride<br>11.353 mg.<br>2<br>Microcrystalline cellulose (Avicel<br>PH 302)<br>44.971 mg.<br>3<br>Sodium Lauryl Sulfate (Kolliphor<br>SLS Fine)<br>0.080 mg.<br>4<br>Pregelatinized Starch (Starch 1500<br>Partially Pregelatinized Maize<br>Starch)<br>7.332 mg.<br>5<br>Colloidal silicon dioxide (Aerosil<br>200 Pharma)<br>1.32 mg.<br>Doxepin HCL Capsules 10<br>mg (net content of active<br>ingredients = 28.00 kgs)<br>1 Number<br>6<br>Magnesium Stearate<br>0.496 mg.<br>7<br>Doxepin Hydrochloride<br>28.384 mg.<br>Doxepin HCL Capsules 25 1 Number
	Export Product		Qty.	Sl.

ctive ingredients = 28.00 kgs) 1 Number 6 Magnesium Stearate 0.496 mg. 7 Doxepin Hydrochloride 28.384 mg. Doxepin HCL Capsules 25 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Doxepin HCL Capsules 10 mg (net content of active ingredients = 28.00 kgs)|| 1 Number|1|Doxepin Hydrochloride|11.353 mg.| |||||2|Microcrystalline cellulose (Avicel PH 302)|44.971 mg.| |||||3|Sodium Lauryl Sulfate (Kolliphor SLS Fine)|0.080 mg.| |||||4|Pregelatinized Starch (Starch 1500 Partially Pregelatinized Maize Starch)| 7.332 mg.| |||||5|Colloidal silicon dioxide (Aerosil 200 Pharma)|1.32 mg.| |||||6|Magnesium Stearate|0.496 mg.| ||Doxepin HCL Capsules 25||1 Number|7|Doxepin Hydrochloride|28.384 mg.|

Case No.	Case No.	10 / NC/3/MEET/Sep/202526/8	10 / NC/3/MEET/Sep/202526/8	10 / NC/3/MEET/Sep/202526/8	10 / NC/3/MEET/Sep/202526/8	10 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00002358AM23
RA File Number		34AX04000398 AM23
Licence No and<br>Date		3411002586/29/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.

it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Doxepin Hydrochloride 11.353 mg. 2 Microcrystalline cellulose (Avicel PH 302) 44.971 mg. 3 Sodium Lauryl Sulfate (Kolliphor SLS Fine) 0.080 mg. 4 Pregelatinized Starch (Starch 1500 Partially Pregelatinized Maize Starch) 7.332 mg. 5 Colloidal silicon dioxide (Aerosil 200 Pharma) 1.32 mg. Doxepin HCL Capsules 10 mg (net content of active ingredients = 28.00 kgs) 1 Number 6 Magnesium Stearate 0.496 mg. 7 Doxepin Hydrochloride 28.384 mg. Doxepin HCL Capsules 25 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Doxepin HCL Capsules 10 mg (net content of active ingredients = 28.00 kgs)|| 1 Number|1|Doxepin Hydrochloride|11.353 mg.| |||||2|Microcrystalline cellulose (Avicel PH 302)|44.971 mg.| |||||3|Sodium Lauryl Sulfate (Kolliphor SLS Fine)|0.080 mg.| |||||4|Pregelatinized Starch (Starch 1500 Partially Pregelatinized Maize Starch)| 7.332 mg.| |||||5|Colloidal silicon dioxide (Aerosil 200 Pharma)|1.32 mg.| |||||6|Magnesium Stearate|0.496 mg.| ||Doxepin HCL Capsules 25||1 Number|7|Doxepin Hydrochloride|28.384 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

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||1 Number|7|Doxepin Hydrochloride|28.384 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

mg (net content of active<br>ingredients = 70.00 kgs)		8	Microcrystalline cellulose (Avicel<br>PH 302)	112.427 mg.
		9	Sodium Lauryl Sulfate (Kolliphor<br>SLS Fine)	0.200 mg.
		10	Pregelatinized Starch (Starch 1500<br>Partially Pregelatinized Maize<br>Starch	<br>18.33 mg.
		11	Colloidal silicon dioxide (Aerosil<br>200 Pharma)	3.30 mg.
		12	Magnesium Stearate(Magnesium<br>Stearate )	1.24 mg.
Doxepin HCL Capsules 50<br>mg (net content of active<br>ingredients = 140.00 kgs)	<br> <br>1 Number	13	Doxepin Hydrochloride	56.766 mg.
		14	Microcrystalline cellulose (Avicel<br>PH 302)	91.592 mg
		15	Sodium Lauryl Sulfate (Kolliphor<br>SLS Fine)	1.313 mg.
		16	Pregelatinized Starch (Starch 1500<br>Partially Pregelatinized Maize<br>Starch)	<br>19.445 mg.
		17	Colloidal silicon dioxide (Aerosil<br>200 Pharma)	3.50 mg.
		18	Magnesium Stearate	1.312 mg.
Doxepin HCL Capsules 75<br>mg (net content of active<br>ingredients = 90.00 kgs)	<br> <br>1 Number	19	Doxepin Hydrochloride	85.152 mg.
		20	Microcrystalline cellulose (Avicel<br>PH 302)	137.388 mg.
		21	Sodium Lauryl Sulfate (Kolliphor	1.969 mg.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

1|Sodium Lauryl Sulfate (Kolliphor|1.969 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

			SLS Fine)
		22	Pregelatinized Starch (Starch 1500<br>Partially Pregelatinized Maize<br>Starch)	<br>29.168 mg.
		23	Colloidal silicon dioxide (Aerosil<br>200 Pharma)	5.25 mg.
		24	Magnesium Stearate	1.969 mg.
Doxepin HCL Capsules 100<br>mg (net content of active<br>ingredients = 120.00 kgs)	<br> <br>1 Number	25	Doxepin Hydrochloride	113.538 mg.
		26	Microcrystalline cellulose (Avicel<br>PH 302)	183.185 mg.
		27	Sodium Lauryl Sulfate (Kolliphor<br>SLS Fine)	2.625 mg.

= 120.00 kgs)| 1 Number|25|Doxepin Hydrochloride|113.538 mg.| ||||26|Microcrystalline cellulose (Avicel PH 302)|183.185 mg.| ||||27|Sodium Lauryl Sulfate (Kolliphor SLS Fine)|2.625 mg.| ||||28|Pregelatinized Starch (Starch 1500 Partially Pregelatinized Maize Starch)| 38.890 mg.| ||||29|Colloidal silicon dioxide (Aerosil 200 Pharma)|7.00 mg.| ||||30|Magnesium Stearate|2.625 mg.|

Case No.	11 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00003251AM23
RA File Number	34AX04000590 AM23

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Licence No and<br>Date	Licence No and<br>Date	3411002800/21/09/2022	3411002800/21/09/2022	3411002800/21/09/2022	3411002800/21/09/2022	3411002800/21/09/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.

it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Doxepin Hydrochloride 11.353 mg. 2 Microcrystalline cellulose (Avicel PH 302) 44.971 mg. 3 Sodium Lauryl Sulfate (Kolliphor SLS Fine) 0.080 mg. 4 Pregelatinized Starch (Starch 1500 Partially Pregelatinized Maize Starch) 7.332 mg. 5 Colloidal silicon dioxide (Aerosil 200 Pharma) 1.32 mg. Doxepin HCL Capsules 10 mg (net content of active ingredients = 28.00 kgs) 1 Number 6 Magnesium Stearate 0.496 mg. 7 Doxepin Hydrochloride 28.384 mg. 8 Microcrystalline cellulose (Avicel PH 302) 112.427 mg. 9 Sodium Lauryl Sulfate (Kolliphor SLS Fine) 0.200 mg. 10 Pregelatinized Starch (Starch 1500 Partially Pregelatinized Maize Starch 18.33 mg. 11 Colloidal silicon dioxide (Aerosil 200 Pharma) 3.30 mg. Doxepin HCL Capsules 25 mg (net content of active ingredients = 70.00 kgs) 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.

con dioxide (Aerosil 200 Pharma) 3.30 mg. Doxepin HCL Capsules 25 mg (net content of active ingredients = 70.00 kgs) 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Doxepin HCL Capsules 10 mg (net content of active ingredients = 28.00 kgs)|| 1 Number|1|Doxepin Hydrochloride|11.353 mg.| |||||2|Microcrystalline cellulose (Avicel PH 302)|44.971 mg.| |||||3|Sodium Lauryl Sulfate (Kolliphor SLS Fine)|0.080 mg.| |||||4|Pregelatinized Starch (Starch 1500 Partially Pregelatinized Maize Starch)| 7.332 mg.| |||||5|Colloidal silicon dioxide (Aerosil 200 Pharma)|1.32 mg.| |||||6|Magnesium Stearate|0.496 mg.| ||Doxepin HCL Capsules 25 mg (net content of active ingredients = 70.00 kgs)|| 1 Number|7|Doxepin Hydrochloride|28.384 mg.| |||||8|Microcrystalline cellulose (Avicel PH 302)|112.427 mg.| |||||9|Sodium Lauryl Sulfate (Kolliphor SLS Fine)|0.200 mg.| |||||10|Pregelatinized Starch (Starch 1500 Partially Pregelatinized Maize Starch| 18.33 mg.| |||||11|Colloidal silicon dioxide (Aerosil 200 Pharma)|3.30 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

con dioxide (Aerosil 200 Pharma)|3.30 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

		12	Magnesium Stearate(Magnesium<br>Stearate )	1.24 mg.
Doxepin HCL Capsules 50<br>mg (net content of active<br>ingredients = 140.00 kgs)	<br> <br>1 Number	13	Doxepin Hydrochloride	56.766 mg.
		14	Microcrystalline cellulose (Avicel<br>PH 302)	91.592 mg
		15	Sodium Lauryl Sulfate (Kolliphor<br>SLS Fine)	1.313 mg.
		16	Pregelatinized Starch (Starch 1500<br>Partially Pregelatinized Maize<br>Starch)	<br>19.445 mg.
		17	Colloidal silicon dioxide (Aerosil<br>200 Pharma)	3.50 mg.
		18	Magnesium Stearate	1.312 mg.
Doxepin HCL Capsules 75<br>mg (net content of active<br>ingredients = 90.00 kgs)	<br> <br>1 Number	19	Doxepin Hydrochloride	85.152 mg.
		20	Microcrystalline cellulose (Avicel<br>PH 302)	137.388 mg.
		21	Sodium Lauryl Sulfate (Kolliphor<br>SLS Fine)	1.969 mg.
		22	Pregelatinized Starch (Starch 1500<br>Partially Pregelatinized Maize<br>Starch)	<br>29.168 mg.
		23	Colloidal silicon dioxide (Aerosil<br>200 Pharma)	5.25 mg.
		24	Magnesium Stearate	1.969 mg.
Doxepin HCL Capsules 100	1 Number	25	Doxepin Hydrochloride	113.538 mg.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Number|25|Doxepin Hydrochloride|113.538 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

26	Microcrystalline cellulose (Avicel<br>PH 302)	183.185 mg.
27	Sodium Lauryl Sulfate (Kolliphor<br>SLS Fine)	2.625 mg.
28	Pregelatinized Starch (Starch 1500<br>Partially Pregelatinized Maize<br>Starch)	<br>38.890 mg.
29	Colloidal silicon dioxide (Aerosil<br>200 Pharma)	7.00 mg.
30	Magnesium Stearate	2.625 mg.

elatinized Starch (Starch 1500 Partially Pregelatinized Maize Starch)| 38.890 mg.| ||||29|Colloidal silicon dioxide (Aerosil 200 Pharma)|7.00 mg.| ||||30|Magnesium Stearate|2.625 mg.|

Case No.	12 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	RADHA KRISHNA IMPEX PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00003806AM23
RA File Number	02AX04000380 AM23
Licence No and<br>Date	0211003213/18/10/2022
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 to Norms Committee-6 for revision of ad-hoc norms.

Case No.	13 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	YELLOWSTONE FINE CHEMICALS PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

r|NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

and Date
HQ File Number	HQRNORM APPLY 00008613AM24
RA File Number	03AX04005249 AM24
Licence No and<br>Date	0311031269/16/02/2024
Norms Committee Decision:<br>The Committee considered the case as per the agenda and observed that the reply to the Deficiency Letter<br>has been submitted in the name ofM/s Laxmi Organic Industriesinstead ofM/s Yellowstone Fine<br>Chemicals Private Limited. In view of this discrepancy, the Committee decided to call upon the firm to<br>clarify whether a change of name has taken place from_M/s Yellowstone Fine Chemicals Private Limited_to<br>_M/s Laxmi Organic Industries_and, if so, to furnish duly authenticated documentary evidence in support of<br>the same.

Case No.	14 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM REVIW00006320AM25
RA File Number	03AX04005442 AM24
Licence No and<br>Date	0311031542/27/02/2024
Norms Committee Decision:<br>The Committee considered the case as per the agenda and noted that the firm has furnished the Weighted<br>Average of Potency/Assay as sought by the Committee in its meeting held on 24.06.2025.

on: The Committee considered the case as per the agenda and noted that the firm has furnished the Weighted Average of Potency/Assay as sought by the Committee in its meeting held on 24.06.2025. However, the firm has not submitted the certified copy of the Customs test report or the Certificate of Analysis (CoA). Accordingly, the Committee decided to call upon the firm to furnish the aforesaid documents for further examination of the case..||

Case No.	15 / NC/3/MEET/Sep/202526/8
Case Status	Case Rejected
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM REVIW00004130AM25
RA File Number	03AX04000436 AM25
Licence No and<br>Date	0311033409/29/04/2024

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

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 rejectthe case maintaining the status quo.

Case No.	16 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	INNOVARE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00000484AM25
RA File Number	09AX04001160 AM24
Licence No and<br>Date	0911007159/30/04/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	17 / NC/3/MEET/Sep/202526/8
Case Status	Case Rejected
Party Name	PRIGIV SPECIALTIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00000698AM25
RA File Number	03AX04000618 AM25
Licence No and<br>Date	0311033818/14/05/2024
Norms Committee Decision:<br>The firm was initially granted an Advance Authorisation for the export product<br>_“LuzernyIsobutyrate”_under Para 4.07 of the Handbook of Procedures (HBP).

/14/05/2024| |Norms Committee Decision: The firm was initially granted an Advance Authorisation for the export product _“LuzernyIsobutyrate”_under Para 4.07 of the Handbook of Procedures (HBP). However, as per Para 4.11(b) of the Foreign Trade Policy (FTP) 2023, products falling under the category of perfume or perfumery compounds are ineligible for authorisation under Para 4.07 and are mandatorily required to be processed under Para 4.06 of the HBP. It was observed that the firm obtained the authorisation bymisdeclaring that its application was covered under the provisions of Para 4.07, and has not furnished any technical justification/information for the export product. Accordingly, the Committee found no merit in||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

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.

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.	18 / NC/3/MEET/Sep/202526/8
Case Status	Case Rejected
Party Name	PRIGIV SPECIALTIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00000797AM25
RA File Number	03AX04000605 AM25
Licence No and<br>Date	0311033967/17/05/2024
Norms Committee Decision:<br>The firm was initially granted an Advance Authorisation for the export product_“Luzerny_<br>_Benzoate”_under Para 4.07 of the Handbook of Procedures (HBP). However, as per Para 4.11(b)<br>of the Foreign Trade Policy (FTP) 2023, products falling under the category of perfume or<br>perfumery compounds are ineligible for authorisation under Para 4.07 and are mandatorily<br>required to be processed under Para 4.06 of the HBP.<br>It was observed that the firm obtained the authorisation bymisdeclaring that its application<br>was covered under the provisions of Para 4.07, and has not furnished any technical<br>justification/information for the export product. Accordingly, the Committee found no merit in<br>fixing the norms and decided to reject the application.<br>The RA shall ensure that the said authorisation is regularised by recovery of applicable Customs<br>duty along with interest.

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Case No.	19 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	MELOG SPECIALITY CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00000920AM25
RA File Number	03AX04000829 AM25
Licence No and<br>Date	0311034133/27/05/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Apr/202526/2 dated 08/05/2025 against advance<br>authorization No.0311037677 dated 05/10/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl.

ed 05/10/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 2,6-DI-TERT-BUTYL PHENOL 1.129 kg. 4,4-BIPHENOL 1 kg. 2 METHANOL 0.30 kg. RA concerned may take further necessary action as per above decision of NC||

Case No.	20 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM REVIW00001502AM26
RA File Number	03AX04001280 AM25
Licence No and<br>Date	0311034602/13/06/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26


Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Assurity Plus SPOT ON (For Small Cat )<br>(Pack size 0.4ml x 6 pipettes),(Each ml<br>contains: Imidacloprid EP 100mg<br>andMoxidectin BP 10mg (Imidacloprid EP<br>Net Weight = 240.00 gms& Moxidectin<br>BP Net weight = 24.00 gms))	<br>1000<br>Numbers	1	Imidacloprid EP	244.8 gm.
		25	Moxidectin BP	24.48 gm.
Assurity Plus SPOT ON (For Large Cat)<br>(Pack size 0.8ml x 6 pipettes),(Each ml<br>contains: Imidacloprid EP 100mg<br>andMoxidectin BP 10 mg, (Imidacloprid<br>EP Net Weight = 480.00 gms&<br>Moxidectin BP Net weight = 48.00 gms))	1000<br>Numbers	2	Imidacloprid EP	489.6 gm.
		26	Moxidectin BP	48.96 gm.
Assurity Plus SPOT ON (For Small Dog)<br>(Pack size 0.4ml x 6 Pipettes),(Each ml<br>contains: Imidacloprid EP 100mg<br>andMoxidectin BP 25 mg, ( Imidacloprid<br>EP Net Weight = 240.00 gms&<br>Moxidectin BP Net weight = 60.00 gms))	1000<br>Numbers	3	Imidacloprid EP	244.8 gm.
		27	Moxidectin BP	61.2 gm.
Assurity Plus SPOT ON (For Medium<br>Dog) (Pack size 1ml x 6 Pipettes),(Each<br>ml contains: Imidacloprid EP 100mg<br>andMoxidectin BP 25 mg, (Imidacloprid<br>EP Net Weight = 600.00 gms&<br>Moxidectin BP Net weight = 150.00gms))	1000<br>Numbers	4	Imidacloprid EP	612.0 gm.
		28	Moxidectin BP	153.0 gm.

EP 100mg andMoxidectin BP 25 mg, (Imidacloprid EP Net Weight = 600.00 gms& Moxidectin BP Net weight = 150.00gms))|1000 Numbers|4|Imidacloprid EP|612.0 gm.| ||||28|Moxidectin BP|153.0 gm.| ||Assurity Plus SPOT ON (For Large Dog) (Pack size 2.5ml x 6 Pipettes),(Each ml contains: Imidacloprid EP 100mg andMoxidectin BP 25 mg, (Imidacloprid EP Net Weight = 1500.00gms& Moxidectin BP Net weight = 375.00 gms))BP Net weight = 375.00 gms))|1000 Numbers|5|Imidacloprid EP|1530.0 gm.| ||||29|Moxidectin BP|382.5 gm.| ||Assurity Plus SPOT ON (For Extra Large Dog) (Pack size 4ml x 6 Pipettes),(Each|1500 Numbers|6|Imidacloprid EP|3672.0 gm.| |||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26


ml contains: I<br>	midacloprid EP 100mg<br>		30	Moxidectin BP	918.0 gm.
andMoxidect<br>	in BP 25 mg, (Imidacloprid<br>
EP Net Weig<br>Moxidectin B	ht = 3600.00 gms&<br>P Net weight = 900 gms))


Nugard Spot	On for Puppies and Dogs up	1000	7	Imidacloprid EP	40.8 gm.
<br>to 4kg (Pack<br>Litre contains	<br>size 0.4ml x 1 Pipettes),(Each<br>: Imidacloprid EP 100gms	<br>Numbers

<br>and Moxidectin BP 25 gms, (Imidacloprid<br>EP Net Weight = 40.00 gms& Moxidectin<br>BP Net weight = 10.00 gms))			31	Moxidectin BP	10.2 gm.

midacloprid EP 100gms|| Numbers||||| |||||||||| || and Moxidectin BP 25 gms, (Imidacloprid EP Net Weight = 40.00 gms& Moxidectin BP Net weight = 10.00 gms))||||31||Moxidectin BP|10.2 gm.| ||Nugard Spot On for Puppies and Dogs up to 4kg (Pack size 0.4ml x 3 Pipettes),(Each ||| 1000 Numbers|8||Imidacloprid EP|122.4 gm.| |||||||||| ||Litre contains: Imidacloprid EP 100Gms and Moxidectin BP 25 gms, (Imidacloprid EP Net Weight = 120.00 gms& Moxidectin BP Net weight = 30.00 gms))||||32||Moxidectin BP|30.6 gm.| |||||||||| |||||||||| ||Nugard Spot|On for Puppies and Dogs up||2000|9||Imidacloprid EP|489.6 gm.| ||to 4kg (Pack|size 0.4ml x 6 Pipettes),(Each|| Numbers||||| |||||||||| ||Litre contains and Moxidec|: Imidacloprid EP 100gms tin BP 25 gms, (Imidacloprid|||33||Moxidectin BP|122.4 gm.| ||EP Net Weig|ht = 480.00 gms&||||||| ||Moxidectin B|P Net weight = 120.00 gms))||||||| |||||||||| |||||||||| ||Nugard Spot On for Dogs 4-10kg (Pack size 1ml x 1 Pipettes),(Each Litre contains: Imidacloprid EP 100 gmsandMoxidectin BP 25 gms, (Imidacloprid EP Net Weight = 100.00 gms& Moxidectin BP Net weight = 25.00||| 1000 Numbers|10||Imidacloprid EP|102.0 gm.| ||||||34||Moxidectin BP|25.5 gm.| || gms))|||||||| |||||||||| ||Nugard Spot On for Dogs 4-10kg (Pack size 1ml x 3 Pipettes),(Each Litre contai Imidacloprid EP 100 GmsandMoxidecti BP 25 gms, (Imidacloprid EP Net Weight = 60000|| ns: n| 2000 Numbers|11||Imidacloprid EP|612.0 gm.| ||||||35||Moxidectin BP|153.0 gm.|

contai Imidacloprid EP 100 GmsandMoxidecti BP 25 gms, (Imidacloprid EP Net Weight = 60000|| ns: n| 2000 Numbers|11||Imidacloprid EP|612.0 gm.| ||||||35||Moxidectin BP|153.0 gm.| ||. gms& Moxidectin BP Net weight = 150.00 gms))|||||||| ||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Nugard Spot On for Dogs 4-10 kg (Pack<br>size 1ml x 6 Pipettes),(Each Litre contains:<br>Imidacloprid EP 100 gmsandMoxidectin<br>	Nugard Spot On for Dogs 4-10 kg (Pack<br>size 1ml x 6 Pipettes),(Each Litre contains:<br>Imidacloprid EP 100 gmsandMoxidectin<br>	<br>4000<br>Numbers	12	Imidacloprid EP	2448.0 gm.
			36	Moxidectin BP	612.0 gm.
BP 25 gms, (<br>	Imidacloprid EP Net Weight<br>
= 2400.00 gm<br>	s& Moxidectin BP Net<br>
weight = 600	.00 gms))

Nugard Spot	On for Dogs 10- 25kg (Pack	1000	13	Imidacloprid EP	255.0 gm.
<br>size 2.5ml x	<br>1 Pipettes),(Each Litre	Numbers
<br>contains: Imi	<br>dacloprid EP 100
<br>gmsandMoxi<br>gms,(Imidacl	<br>dectin BP 25<br>oprid EP Net Weight =		37	Moxidectin BP	63.75 gm.
<br>250.00 gms& Moxidectin BP Net weight =<br>62.500 gms))

oprid EP 100|||||||| ||| gmsandMoxi gms,(Imidacl| dectin BP 25 oprid EP Net Weight =||||37|Moxidectin BP|63.75 gm.|| ||| 250.00 gms& Moxidectin BP Net weight = 62.500 gms))||||||||| |||Nugard Spot On for Dogs 10- 25kg (Pack size 2.5ml x 3 Pipettes),(Each Litre contains: Imidacloprid EP 100|||2000 Numbers||14|Imidacloprid EP|1530.0 gm.|| |||||||||||| ||| gmsandMoxidectin BP 25 gms, (Imidacloprid EP Net Weight = 1 gms& Moxidectin BP Net weigh||500.00 t = 375.00|||38|Moxidectin BP||382.5 gm.| |||gms))||||||||| |||Nugard Spot On for Dogs 10- 25||kg (Pack||2000|15|Imidacloprid EP|3|060.0 gm.| |||size 2.5ml x 6 Pipettes),(Each Lit contains: Imidacloprid EP 100 g Moxidectin BP 25 gms, (Imidacl||re msand oprid EP|N|umbers||||| ||||||||39|Moxidectin BP||765.0 gm.| |||Net Weight = 3000.00 gms& Mo BP Net weight = 750.00 gms))||xidectin||||||| |||||||||||| |||Nugard Spot On for Dogs over 25kg (Pack size 4ml x 1 Pipettes),(Each Litre contains: Iidlid EP 100 dMidti||| 1000 Numbers||16|Imidacloprid EP|408.0 gm.|| |||||||||||| |||macopr gmsanoxecn BP 25 gms, (Imidacloprid EP Net Weight = 400.00 gms& Moxidectin BP Net weight = 100.00 gms))|||||40|Moxidectin BP|102.0 gm.|| |||||||||||| |||Nugard Spot |On for Dogs over 25kg (Pack || 2000 ||17|Imidacloprid EP|2448.0 gm.|| |||size 4ml x 3 |Pipettes),(Each Litre contains: || Numbers|||||| |||||||||||| |||Imidacloprid BP 25 gms, ( |EP 100 gmsandMoxidectin Imidacloprid EP Net Weight ||||41|Moxidectin BP|612.0 gm.||

3 |Pipettes),(Each Litre contains: || Numbers|||||| |||||||||||| |||Imidacloprid BP 25 gms, ( |EP 100 gmsandMoxidectin Imidacloprid EP Net Weight ||||41|Moxidectin BP|612.0 gm.|| |||= 2400.00 gm|s& Moxidectin BP Net|||||||| |||||||||||| ||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

weight = 600.00 gms))
Nugard Spot On for Dogs over 25kg (Pack<br>size 4ml x 6 Pipettes),(Each Litre contains:<br>Imidacloprid EP 100 gmsandMoxidectin<br>BP 25 gms, (Imidacloprid EP Net Weight<br>= 7200.00 gms& Moxidectin BP Net<br>weight = 1800.00 gms))	<br> <br>3000<br>Numbers	18	Imidacloprid EP	7344.0 gm.
		42	Moxidectin BP	1836.0 gm.
Nugard Spot On for kittens and cats up to<br>4 kg (Pack size 0.4ml x 1 Pipettes),(Each<br>Litre contains: Imidacloprid EP 100Gms<br>and Moxidectin BP 10 gms, (Imidacloprid<br>EP Net Weight = 40.00 gms&Moxidectin<br>BP Net weight = 4.00 gms))	1000<br>Numbers	19	Imidacloprid EP	40.8 gm.
		43	Moxidectin BP	4.08 gm.
Nugard Spot On for kittens and cats up to<br>4 kg (Pack size 0.4ml x 3 Pipettes),(Each<br>Litre contains: Imidacloprid EP<br>100gmsand Moxidectin BP 10 gms,<br>(Imidacloprid EP Net Weight = 300.00<br>gms& Moxidectin BP Net weight = 30.00<br>gms))	2500<br>Numbers	20	Imidacloprid EP	306.0 gm.
		44	Moxidectin BP	30.6 gm.

100gmsand Moxidectin BP 10 gms, (Imidacloprid EP Net Weight = 300.00 gms& Moxidectin BP Net weight = 30.00 gms))|2500 Numbers|20|Imidacloprid EP|306.0 gm.| ||||44|Moxidectin BP|30.6 gm.| ||Nugard Spot On for kittens and cats up to 4 kg (Pack size 0.4ml x 6 Pipettes),(Each Litre contains: Imidacloprid EP 100gms and Moxidectin BP 10 gms,(Imidacloprid EP Net Weight = 960.00 gms& Moxidectin BP Net weight = 96.00 gms))|4000 Numbers|21|Imidacloprid EP|979.2 gm.| ||||45|Moxidectin BP|97.92 gm.| ||Nugrad Spot On Cats over 4 kg (Pack size 0.8ml x 1 Pipettes),(Each Litre contains: Imidacloprid EP 100 gmsandMoxidectin BP 10 gms, (Imidacloprid EP Net Weight = 80.00 gms& Moxidectin BP Net weight = 8.00 gms))|1000 Numbers|22|Imidacloprid EP|81.6 gm.| ||||46|Moxidectin BP|8.16 gm.| ||Nugrad Spot On Cats over 4 kg (Pack size 0.8ml x 3 Pipettes),(Each Litre contains: Imidacloprid EP 100 gmsandMoxidectin BP 10 gms, (Imidacloprid EP Net Weight|2500 Numbers|23|Imidacloprid EP|612.0 gm.| ||||47|Moxidectin BP|61.2 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

EP|612.0 gm.| ||||47|Moxidectin BP|61.2 gm.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

= 600.00 gms& Moxidectin BP Net weight
= 60.00 gms))
Nugrad Spot On Cats over 4 kg (Pack size	10000	24	Imidacloprid EP	4896.0 gm.
0.8ml x 6 Pipettes),(Each Litre contains:	Numbers
Imidacloprid EP 100 gmsandMoxidectin<br>BP 10 gms, (Imidacloprid EP Net Weight		48	Moxidectin BP	489.6 gm.
= 4800.00 gms& Moxidectin BP Net
weight = 480.00 gms))

Case No.	21 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	ACUTAAS CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00001820AM25
RA File Number	52AX04000089 AM25
Licence No and<br>Date	5211008812/08/07/2024
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal
Hearing<br>before Norms Committee to explain its case along with relevant documents from the firm.

Case No.	22 / NC/3/MEET/Sep/202526/8
Case Status	Case Rejected
Party Name	GLAND PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00002566AM25
RA File Number	09AX04000345 AM25
Licence No and<br>Date	0911007758/19/08/2024
Norms Committee Decision:

3/ MEET/ Sep/ 202526/ 8 and 17/09/2025| |HQ File Number|HQRNORM APPLY 00002566AM25| |RA File Number|09AX04000345 AM25| |Licence No and Date|0911007758/19/08/2024| |Norms Committee Decision:||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

The Committee considered the case as per agenda and it has been observed that the firm vide their e-mail dated 16.09.2025 has informed that they have not utilized the Advance Authorisation and the same has been cancelled by concerned RA. Therefore, it was decided to close the application of the firm.

The Committee co<br>	The Committee co<br>	nsidered the case as per agenda and it has been observed that the<br>	nsidered the case as per agenda and it has been observed that the<br>	nsidered the case as per agenda and it has been observed that the<br>	nsidered the case as per agenda and it has been observed that the<br>	firm vide their e-mail dated<br>	firm vide their e-mail dated<br>
16.09.2025 has inf<br>		ormed that they have not utilized the Advance Authorisation an<br>				the same has been cancelled by
concerned RA.

heir e-mail dated | |---|---|---|---|---|---|---|---| |16.09.2025 has inf ||ormed that they have not utilized the Advance Authorisation an ||||the same has been cancelled by|| |concerned RA. Th||erefore, it was decided to close the application of the firm.|||||| ||||||||| ||||||||| ||||||||| |Case No.||23 / NC/3/MEET/Sep/202526/8|||||| |Case Status||Case Approved|||||| |Party Name||DR.REDDY'S LABORATORIES LTD|||||| |Meeting Number and Date||NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025|||||| |HQ File Number||HQRNORM APPLY 00002569AM25|||||| |RA File Number||09AX04000367 AM25|||||| |Licence No and||0911007762/19/08/2024|||||| |Date|||||||| |Norms Committee||Decision:|||||| |The Committee ||considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 |||||| |of|HBP Vol. I as|per details given below or as applied by the firm, whichever is less:-|||||| ||||||||| ||||||||| ||||||||| ||Export Product||Qty.|Sl. No.|Import Items||Qty.

nder 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.| ||Phentermine and Topiramate Extended Release Capsules 3.75/23mg US Pack Size:30s (Consisting of Phentermine 10.13Kgs)||2700000 Numbers|1|Phentermine Hydrochloride USP||12.58 kg.| ||Phentermine and Topiramate Extended Rl Cl 750/46 US Pk||5400000 Nb|2|Phentermine Hdhlid USP||50.38 kg.| ||eease apsues .mg ac Size:30s (Consisting of Phentermine 40.50Kgs)||umers||yrocore||| ||||||||| ||Phentermine|and Topiramate Extended|2640000|3|Phentermine||36.96 kg.| ||Release Caps|ules 11.25/69mg US Pack|Numbers||Hydrochloride USP||| ||Size:30s (Co |nsisting of Phentermine|||||| ||29.70Kgs)||||||| ||||||||| ||Phentermine|and Topiramate Extended|2640000|4|Phentermine||4926 kg| || Release Caps| ules 15/92mg US Pack| Numbers|| Hydrochloride USP||. .| || Size:30s (Co| nsisting of Phentermine 39.60||||||

Topiramate Extended|2640000|4|Phentermine||4926 kg| || Release Caps| ules 15/92mg US Pack| Numbers|| Hydrochloride USP||. .| || Size:30s (Co| nsisting of Phentermine 39.60||||||

The Committee co<br>	The Committee co<br>	nsidered the case as per agenda and it has been observed that the<br>	nsidered the case as per agenda and it has been observed that the<br>	nsidered the case as per agenda and it has been observed that the<br>	nsidered the case as per agenda and it has been observed that the<br>	firm vide their e-mail dated<br>	firm vide their e-mail dated<br>
16.09.2025 has inf<br>		ormed that they have not utilized the Advance Authorisation an<br>				the same has been cancelled by
concerned RA. Th		erefore, it was decided to close the application of the firm.



Case No.		23 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00002569AM25
RA File Number		09AX04000367 AM25
Licence No and		0911007762/19/08/2024
Date
Norms Committee		Decision:
The Committee<br>		considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>
of	HBP Vol. I as	per details given below or as applied by the firm, whichever is less:-



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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Kgs)

r>nsisting of Phentermine 39.60||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Kgs)

Case No.<br>24 / NC/3/MEET/Sep/202526/8
Case Status<br>Case Approved
Party Name<br>MELOG SPECIALITY CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number<br>HQRNORM APPLY 00002583AM25
RA File Number<br>03AX04002187 AM25
Licence No and<br>Date<br>0311036462/20/08/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import item in meeting No.NC/3/MEET/Apr/202526/2 dated 08/05/2025		against advance
authorization No.0311037677 dated 05/10/2024, it was decided to fix ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty.
		allowed.
1<br>4,4-BIPHENOL<br>1 kg.	2,6-DI-TERT-BUTYL	1.129 kg.
	PHENOL
2	METHANOL	0.30 kg.
RA concerned may take further necessary action as per above decision of NC

Case No.	25 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025

se No.	25 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

HQ File Number	HQRNORM APPLY 00002619AM25
RA File Number	31AX04000169 AM25
Licence No and<br>Date	3111003807/21/08/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>DNOVO CP388 (Tetra Methyl Bisphenol-A)<br>1 kg.<br>1<br>2,6 xylenol<br>1.19 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	26 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	RUBICON RESEARCH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00002727AM25
RA File Number	03AX04002597 AM25
Licence No and<br>Date	0311036698/28/08/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Copy of Master-Batch Formula for each export item showing net content of import item in the export.

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

Case No.	27 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	CLARIANT INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00002789AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

RA File Number	03AX04002663 AM25
Licence No and<br>Date	0311036805/02/09/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/May/202526/3 dated 04/06/2025 against advance<br>authorization No.0311034385 dated 05/06/2024, 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. Import Items<br>Qty. allowed.<br>1<br>Dimethyl Acrylic Acid Ester<br>0.770 kg<br>2<br>Hydroxyl ammonium sulfate<br>1.628 kg<br>3<br>Isononyl Acid Chloride<br>1.515 kg<br>Piroctone Olamine or Vipirox<br>(OctopiroxPlus)<br>1 kg<br>4<br>Mono Ethanol Amine<br>0.372 kg<br>RA concerned may take further necessary action as per above decision of NC.

RA File Number

03AX04002663 AM25

Licence No and Date

0311036805/02/09/2024

Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/May/202526/3 dated 04/06/2025 against advance authorization No.0311034385 dated 05/06/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Dimethyl Acrylic Acid Ester 0.770 kg 2 Hydroxyl ammonium sulfate 1.628 kg 3 Isononyl Acid Chloride 1.515 kg Piroctone Olamine or Vipirox (OctopiroxPlus) 1 kg 4 Mono Ethanol Amine 0.372 kg RA concerned may take further necessary action as per above decision of NC.

oride 1.515 kg Piroctone Olamine or Vipirox (OctopiroxPlus) 1 kg 4 Mono Ethanol Amine 0.372 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	28 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00002874AM25
RA File Number	09AX04000408 AM25
Licence No and Date	0911007869/05/09/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import item in meeting No.NC/3/MEET/Jul/202526/6dated 31/07/2025against advance<br>authorization No.0911008698dated24/12/2024, 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:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

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

-3-yl]-3-[(2-|||(FMP)|| |fluoro-6-methoxy-4-pyridyl)||||| |amino]pyrazole-4-carboxamide (L- 005251026-Form-I))||2|4,5-bis(Diphenylphosphino)- 9,9-dimethylxanthane|0.125 kg| ||||(Xantphos)||

Case No.	29 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00003039AM25
RA File Number	09AX04000248 AM25
Licence No and<br>Date	0911007949/13/09/2024
Norms Committee Decision:
The firm was called for Personal Hearing on 17/09/2025 through Video Conference, but the firm could not
appear before Norms Committee. It was decided to grant one last opportunity to the firm for Personal
Hearingwith relevant documents/information.

Case No.	30 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	AVIK PHARMACEUTICAL LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00003481AM25
RA File Number	52AX04000198 AM25
Licence No and Date	5211010153/04/10/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

e from the earlier decision for same export||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

product/import product in meeting No.NC/3/MEET/May/202425/4dated 06/06/2024 against advance authorization No. 5211007605 dated 07/03/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.<br>allowed.
TRIAMICINOLONE IP/EP/BP/USP	1 kg.	1<br><br> <br>	3,20-DIOXOPREGNA-<br>1,4,9(11),16 - TETRAEN - 21-<br>YLACETATE (3 TR)	1.00 kg.

Case No.	31 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	SAGA LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00003526AM25
RA File Number	08AX04001122 AM25
Licence No and<br>Date	0811012864/08/10/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. 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. Diosmin + Hesperidin 1000 mg Suspension (75.52 KGS) 75517 Numbers 1 Diosmin and Hesperidin 9:1(DIOSMIN + HESPERIDIN 9:1 (ASSAY NMT 93% AND WATER CONTENT NLT 2.9%) 79.293 kg. RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Case No.	32 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	PI INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00003572AM25
RA File Number	13AX04000225 AM25
Licence No and<br>Date	1311003391/09/10/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Percentage yield on molar basis for each step of manufacturing process with justification.

the advice of the TE, it was decided to call for following information/documents from the firm:- Percentage yield on molar basis for each step of manufacturing process with justification.||

Case No.	33 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00003598AM25
RA File Number	09AX04000471 AM25
Licence No and<br>Date	0911008128/10/10/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending Personal<br>Hearing before Norms Committee to explain its case along with relevant information / documents from the<br>firm.

Case No.	34 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00003600AM25
RA File Number	09AX04000467 AM25
Licence No and<br>Date	0911008130/10/10/2024

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Norms Committee Decision:

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

Case No.	35 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00003633AM25
RA File Number	03AX04003448 AM25
Licence No and<br>Date	0311037925/15/10/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Complete chemistry, chemical reaction, Stoichiometric balance on molar basis with molecular weight and<br>percentage yield for each step of reaction.

Case No.	36 / NC/3/MEET/Sep/202526/8
Case Status	Case Rejected
Party Name	BVC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00003646AM25
RA File Number	34AX04000564 AM25
Licence No and<br>Date	3411005540/15/10/2024
Norms Committee Decision:<br>The firm was initially granted an Advance Authorisation for the export product_“Anisole”_under<br>Para 4.07 of the Handbook of Procedures (HBP).

e|3411005540/15/10/2024| |Norms Committee Decision: The firm was initially granted an Advance Authorisation for the export product_“Anisole”_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.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

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

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.	37 / NC/3/MEET/Sep/202526/8
Case Status	Case Rejected
Party Name	BVC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00003672AM25
RA File Number	34AX04000597 AM25
Licence No and<br>Date	3411005544/16/10/2024
Norms Committee Decision:<br>The firm was initially granted an Advance Authorisation for the export product_“Anisole”_under<br>Para 4.07 of the Handbook of Procedures (HBP). However, as per Para 4.11(b) of the Foreign<br>Trade Policy (FTP) 2023, products falling under the category of perfume or perfumery<br>compounds are ineligible for authorisation under Para 4.07 and are mandatorily required to be<br>processed under Para 4.06 of the HBP.<br>It was observed that the firm obtained the authorisation bymisdeclaring that its application<br>was covered under the provisions of Para 4.07, and has not furnished any technical<br>justification/information for the export product. Accordingly, the Committee found no merit in<br>fixing the norms and decided to reject the application.<br>The RA shall ensure that the said authorisation is regularised by recovery of applicable Customs<br>duty along with interest.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Committee.

Case No.	38 / NC/3/MEET/Sep/202526/8
Case Status	Case Rejected
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00003724AM25
RA File Number	03AX04003565 AM25
Licence No and<br>Date	0311038045/18/10/2024
Norms Committee Decision:<br>The firm was initially granted an Advance Authorisation for the export product_“Alpha Hexyl_<br>_Cinnamaldehyde and or Hexyl Cinnamic Aldehyde”_under Para 4.07 of the Handbook of<br>Procedures (HBP). However, as per Para 4.11(b) of the Foreign Trade Policy (FTP) 2023,<br>products falling under the category of perfume or perfumery compounds are ineligible for<br>authorisation under Para 4.07 and are mandatorily required to be processed under Para 4.06 of the<br>HBP.<br>It was observed that the firm obtained the authorisation bymisdeclaring that its application<br>was covered under the provisions of Para 4.07, and has not furnished any technical<br>justification/information for the export product. Accordingly, the Committee found no merit in<br>fixing the norms and decided to reject the application.<br>The RA shall ensure that the said authorisation is regularised by recovery of applicable Customs<br>duty along with interest.

Case No.	39 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	MEDICARE HYGIENE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

HQ File Number	HQRNORM APPLY 00003843AM25
RA File Number	08AX04001190 AM25
Licence No and<br>Date	0811013002/24/10/2024
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-5, therefore, it has been decided that the application of the firm may<br>be transferred to Norms Committee-5 for the fixation of ad-hoc norms.

applied by the firm pertains to Norms Committee-5, therefore, it has been decided that the application of the firm may be transferred to Norms Committee-5 for the fixation of ad-hoc norms.||

Case No.	40 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	PRACHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00003845AM25
RA File Number	08AX04001204 AM25
Licence No and<br>Date	0811013007/24/10/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending Personal<br>Hearingbefore Norms Committee to explain its case along with following information / documents from<br>the firm:<br>Copy of Drug Manufacturing Licence (DML).<br>1.<br>Whether export in BP/USP/EP grade, if so, get the grade endorsed in the Advance Authorisation<br>from concerned RA.<br>2.

Case No.	41 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	ACUTAAS CHEMICALS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00003846AM25
RA File Number	52AX04000212 AM25
Licence No and Date	5211010462/24/10/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

decided to fix ad-hoc norms under Para 4.07||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
4-{1-[(2S)-2-Aminopropyl]-1-H-<br>Pyrazole-3-yl}-2- Chlorobenzonitrile)	1 kg.	1	2-chloro-4-(1H-pyrazol-3-yl)<br>benzonitrile	0.963 kg.
		2	Tert-Butyl ((1S)-2-hydroxy-1-<br>methylethyl) carbamate	0.826 kg.
		3	Diisopropyl azodicarboxylate	1.034 kg.
		4	Triphenylphosphine	1.237 kg.

Case No.	Case No.	42 / NC/3/MEET/Sep/202526/8	42 / NC/3/MEET/Sep/202526/8	42 / NC/3/MEET/Sep/202526/8	42 / NC/3/MEET/Sep/202526/8	42 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		LAZERHEAD LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00003851AM25
RA File Number		09AX04000499 AM25
Licence No and<br>Date		0911008210/24/10/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. 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. Ovaplant 250 mcg ((Salmon Gonadotropin Releasing Hormone Analogue Implant)) 1 Number 1 Salmon Gonadorelin 255.00 mcg. Ovaplant 150 mcg ((Salmon 1 Number 2 Salmon Gonadorelin 153.00 mcg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Ovaplant 250 mcg ((Salmon Gonadotropin Releasing Hormone Analogue Implant))||1 Number|1|Salmon Gonadorelin|255.00 mcg.| ||Ovaplant 150 mcg ((Salmon||1 Number|2|Salmon Gonadorelin|153.00 mcg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Gonadotropin Releasing Hormone<br>Analogue Implant))<br>Ovaplant 75 mcg ((Salmon<br>Gonadotropin Releasing Hormone<br>Analogue Implant))<br>1 Number<br>3<br>Salmon Gonadorelin<br>76.50 mcg.<br>RA concerned may take further necessary action as per above decision of NC.	Gonadotropin Releasing Hormone<br>Analogue Implant))
	Ovaplant 75 mcg ((Salmon<br>Gonadotropin Releasing Hormone<br>Analogue Implant))	1 Number	3	Salmon Gonadorelin	76.50 mcg.

Releasing Hormone Analogue Implant))||||| |---|---|---|---|---|---| ||Ovaplant 75 mcg ((Salmon Gonadotropin Releasing Hormone Analogue Implant))|1 Number|3|Salmon Gonadorelin|76.50 mcg.|

Case No.	43 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00003868AM25
RA File Number	08AX04001241 AM25
Licence No and<br>Date	0811013030/25/10/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Nicardipine Hydrochloride Injection<br>USP, 2.5 mg/mL<br>(10 mL)<br>1 Number<br>Vial<br>1<br>Nicardipine<br>Hydrochloride USP<br>26.25 mg/10 ml. Vial<br>Nicardipine Hydrochloride in 0.9 %<br>Sodium Chloride Injection, 0.2<br>mg/mL (40 mg/200 mL)<br>1 Number<br>Vial<br>2<br>Nicardipine<br>Hydrochloride USP<br>42.00 mg/200 ml Vial<br>Nicardipine Hydrochloride in 0.9 %<br>Sodium Chloride Injection, 0.1<br>mg/mL (20 mg/200 mL)<br>1 Number<br>Vial<br>3<br>Nicardipine<br>Hydrochloride USP<br>21.00 mg/200 ml.Vial<br>RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

cessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Case No.	44 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00003943AM25
RA File Number	09AX04000560 AM25
Licence No and<br>Date	0911008287/29/10/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Apr/202526/1dated 25/04/2025 against advance<br>authorization No. 0911005577 dated 04/08/2023, 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. Import Items<br>Qty. allowed.<br>Diluted Everolimus 5%<br>1 kg.<br>1<br>Everolimus (Spec-1)<br>0.051 kg.<br>RA concerned may take further necessary action as per above decision of NC.

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

Case No.	45 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	PARADISE HEALTHCARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00003965AM25
RA File Number	34AX04000658 AM25
Licence No and<br>Date	3411005628/30/10/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Percentage yield on molar basis for each step of manufacturing process supported by technical literature.

7-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Percentage yield on molar basis for each step of manufacturing process supported by technical literature.

Case No.	46 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005355AM25
RA File Number	03AX04005058 AM25
Licence No and<br>Date	0311040130/02/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>M-DEA<br>1 kg.<br>1<br>2,6-DIETHYL ANILINE (DEA)<br>1.20 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	47 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005684AM25
RA File Number	08AX04001751 AM25
Licence No and<br>Date	0811013820/16/01/2025
Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Sevelamer Carbonate For Oral<br>Suspension 2.4 g (Sevelamer<br>Carbonate 2.4 g Powder ForOral<br>Suspension Sachets/Packets)(Each<br>Packets/ Sachets Contains : Sevelamer<br>Carbonate For Oral Suspension 2.4<br>gram Net Content Of Sevelamer<br>Carbonate Should Not Be Less Than<br>40.800 kg In Export Item)	<br>17000<br>Numbers	1	Sevelamer Carbonate	42.84 kg.

Case No.	Case No.	48 / NC/3/MEET/Sep/202526/8	48 / NC/3/MEET/Sep/202526/8	48 / NC/3/MEET/Sep/202526/8	48 / NC/3/MEET/Sep/202526/8	48 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		ABHILASH LIFE SCIENCES LLP
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00005689AM25
RA File Number		32AX04000688 AM25
Licence No and<br>Date		3211008262/16/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Valsartan 40 mg Capsules 1 Number 1 Valsartan 40.8 mg/Capsule||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Valsartan 40 mg Capsules||1 Number|1|Valsartan|40.8 mg/Capsule|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Valsartan	80 mg Capsules	1 Number	2	Valsartan	81.6 mg/Capsule
Valsartan	160 mg Capsules	1 Number	3	Valsartan	163.2 mg/Capsule

Case No.	Case No.	49 / NC/3/MEET/Sep/202526/8	49 / NC/3/MEET/Sep/202526/8	49 / NC/3/MEET/Sep/202526/8	49 / NC/3/MEET/Sep/202526/8	49 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		S KANT HEALTHCARE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00005704AM25
RA File Number		03AX04005307 AM25
Licence No and<br>Date		0311040532/17/01/2025
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/Aug/202526/7dated 22/08/2025 against advance<br>authorization No. 0311029247dated 11/12/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol.

/import product in meeting No.NC/3/MEET/Aug/202526/7dated 22/08/2025 against advance authorization No. 0311029247dated 11/12/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- (A) Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Artemether 20.4 mg. Artemether 20 mg & Lumefantrine 120 mg Tablets 1 Number Tablet 2 Lumefantrine 122.4 mg. 1 Artemether 20.4 mg. Artemether 20 mg & Lumefantrine 120 mg Dispersible Tablets 1 Number Tablet 2 Lumefantrine 122.4 mg. 1 Artemether 40.8 mg. Artemether 40 mg & Lumefantrine 240 mg 1 Number Tablet 2 Lumefantrine 244.8 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Artemether 20 mg & Lumefantrine 120 mg Tablets|| 1 Number Tablet|1|Artemether|20.4 mg.| |||||2|Lumefantrine|122.4 mg.| ||Artemether 20 mg & Lumefantrine 120 mg Dispersible Tablets|| 1 Number Tablet|1|Artemether|20.4 mg.| |||||2|Lumefantrine|122.4 mg.| ||Artemether 40 mg & Lumefantrine 240 mg||1 Number Tablet|1|Artemether|40.8 mg.| |||||2|Lumefantrine|244.8 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Artemether	80	mg & Lumefantrine	480	mg	<br>1	Number Tablet	1	Artemether	81.6 mg.
Tablets
							2	Lumefantrine	489.6 mg.

(B)

)
Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Artemether	1 kg.	1	Artemisinin	1.04 kg.
		2	Sodium Borohydride	0.188 kg.
		3	Trimethyl Ortho Acetate 99% Min	0.50 kg.

(C)

)
Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Lumefantrine	1 kg.	1	2, 7 Dichloro A Dibutylamino Methyl 9<br>Hfluorene-4-Methanol DBA 99% Min	0.86896 kg.
		2	4 - Chlorobenzaldehyde	0.3476 kg.

Case No.	50 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	UMALAXMI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005705AM25
RA File Number	13AX04000328 AM25
Licence No and<br>Date	1311003622/17/01/2025
Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

The Committee considered the case as per agenda and it has been observed that export product applied by the firm pertains to Norms Committee-6, therefore, it has been decided that the application of the firm may be transferred to Norms Committee-6 for the fixation of ad-hoc norms.

Case No.	51 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	DCM NOUVELLE SPECIALTY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005711AM25
RA File Number	05AX04003667 AM25
Licence No and<br>Date	0511030378/17/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Benzylamine<br>1 kg.<br>1<br>Benzonitrile<br>1.07 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	52 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	CLARIANT INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005757AM25
RA File Number	03AX04005387 AM25
Licence No and<br>Date	0311040605/21/01/2025
Norms Committee Decision:

3/ MEET/ Sep/ 202526/ 8 and 17/09/2025| |HQ File Number|HQRNORM APPLY 00005757AM25| |RA File Number|03AX04005387 AM25| |Licence No and Date|0311040605/21/01/2025| |Norms Committee Decision:||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/May/202526/3 dated 04/06/2025 against advance authorization No.0311034385 dated 05/06/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Piroctone Olamine or Vipirox<br>(OctopiroxPlus)	<br>1 kg	1	Dimethyl Acrylic Acid Ester	0.770 kg
		2	Hydroxyl ammonium sulfate	1.628 kg
		3	Isononyl Acid Chloride	1.515 kg
		4	Mono Ethanol Amine	0.372 kg

ine or Vipirox (OctopiroxPlus)| 1 kg|1|Dimethyl Acrylic Acid Ester|0.770 kg| |||2|Hydroxyl ammonium sulfate|1.628 kg| |||3|Isononyl Acid Chloride|1.515 kg| |||4|Mono Ethanol Amine|0.372 kg|

Case No.	53 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	KALPSUTRA GUJARAT
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005770AM25
RA File Number	34AX04000913 AM25
Licence No and<br>Date	3411005984/21/01/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>End use of export product.<br>1.<br>Certificate of Analysis (CoA) of export item indicating percentage purity.<br>2.<br>Wastages at each stage of manufacturing.<br>3.<br>Justification of low yield.<br>4.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Commercial value of low and high boiler.

Case No.	54 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	RUBICON RESEARCH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005775AM25
RA File Number	03AX04005395 AM25
Licence No and<br>Date	0311040632/21/01/2025
Norms Committee Decision:<br>The committee considered the case as per agenda and it was decided to fix ad-hoc norms as perSION A-<br>412.

|Licence No and Date|0311040632/21/01/2025| |Norms Committee Decision: The committee considered the case as per agenda and it was decided to fix ad-hoc norms as perSION A- 412.||

Case No.	55 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005789AM25
RA File Number	09AX04000881 AM25
Licence No and<br>Date	0911008880/22/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending Personal<br>Hearingbefore Norms Committee to explain its case along with relevant information / documents from the<br>firm.

Case No.	56 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	ALCHYMARS ICM SM PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

r|NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

and Date
HQ File Number	HQRNORM APPLY 00005800AM25
RA File Number	04AX04001008 AM25
Licence No and<br>Date	0411008933/22/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending Personal<br>Hearing before Norms Committee to explain its case along with following information / documents from<br>the firm:<br>Improvement in the conversioin yield in the last 10 years with batch-log sheet for recent 10 batches.<br>1.<br>Past production/consumption data for the year 2022-23, 2023-24 and 2024-25 duly certified by CA.<br>2.<br>Batch log sheet for import made in recent three licences.<br>3.

Case No.	Case No.	57 / NC/3/MEET/Sep/202526/8	57 / NC/3/MEET/Sep/202526/8	57 / NC/3/MEET/Sep/202526/8	57 / NC/3/MEET/Sep/202526/8	57 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		SPAR PHARMA LLP
Meeting Number and<br>Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00005802AM25
RA File Number		09AX04000901 AM25
Licence No and Date		0911008883/22/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol.

|| |Licence No and Date||0911008883/22/01/2025||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Aniline Oil (Liquid) 0.47 kg. 2 Fluorobenzene (Liquid) 0.52 kg. 3 Acetone (Liquid) 0.50 kg. 4 Methyl Aceto Acetate (Liquid) 1.06 kg. 4-Fluoro-alpha-[2-methyl-1- oxopropyl]-gamma-oxo-N- beta-diphenyl benzene butanamide(SOLID) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||4-Fluoro-alpha-[2-methyl-1- oxopropyl]-gamma-oxo-N- beta-diphenyl benzene butanamide(SOLID)||1 kg.|1|Aniline Oil (Liquid)|0.47 kg.| |||||2|Fluorobenzene (Liquid)|0.52 kg.| |||||3|Acetone (Liquid)|0.50 kg.| |||||4|Methyl Aceto Acetate (Liquid)|1.06 kg.|

Case No.	Case No.	57 / NC/3/MEET/Sep/202526/8	57 / NC/3/MEET/Sep/202526/8	57 / NC/3/MEET/Sep/202526/8	57 / NC/3/MEET/Sep/202526/8	57 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		SPAR PHARMA LLP
Meeting Number and<br>Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00005802AM25
RA File Number		09AX04000901 AM25
Licence No and Date		0911008883/22/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

5<br>Iso Butyryl Chloride (Liquid)<br>0.97 kg.<br>6<br>Iso Propyl Alcohol (IPA) (Liquid) Not showing in the<br>past consumption<br>data<br>RA concerned may take further necessary action as per above decision of NC.			5	Iso Butyryl Chloride (Liquid)	0.97 kg.
			6	Iso Propyl Alcohol (IPA) (Liquid)	Not showing in the<br>past consumption<br>data

y action as per above decision of NC.			5	Iso Butyryl Chloride (Liquid)	0.97 kg.
			6	Iso Propyl Alcohol (IPA) (Liquid)	Not showing in the<br>past consumption<br>data

Case No.	58 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005808AM25
RA File Number	09AX04000882 AM25
Licence No and<br>Date	0911008886/22/01/2025
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attending Personal
Hearingbefore Norms Committee to explain its case along with relevant information / documents from the
firm:

Case No.	59 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005811AM25
RA File Number	08AX04001768 AM25
Licence No and<br>Date	0811013886/23/01/2025
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import	item in meeting No.NC/3/MEET/Jul/202526/3 dated 31/07/2025 against advance

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

ul/202526/3 dated 31/07/2025 against advance|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

authorization No.0811013728 dated 07/01/2025, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.<br>allowed.
Magnesium Sulfate In Water for<br>Injection (0.325 mEq Mg++/mL) 40<br>mg/mL 2g Total	<br> <br>1 Number	1	Magnesium Sulfate<br>Heptahydrate PhEur, USP,<br>Injectable grade	2.00 gm
Magnesium Sulfate In Water for<br>Injection (0.325 mEq Mg++/mL) 40<br>mg/mL 4g Total	<br> <br>1 Number	2	Magnesium Sulfate<br>Heptahydrate PhEur, USP,<br>Injectable grade	4.00 gm.

Case No.	60 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	BIOMATRIX HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005847AM25
RA File Number	08AX04001762 AM25
Licence No and<br>Date	0811013905/24/01/2025
Norms Committee Decision:<br>The Committee has decided to defer the case for next meeting.

Case No.	61 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	FLAGSHIP BIOTECH INTERNATIONAL PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005855AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

RA File Number

03AX04005459 AM25

Licence No and Date

0311040715/24/01/2025

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. OKSIMAKS SPRAY((Oxytetracycline Hydrochloride 25mg,Florfenicol 25 mg, Gentian Violet 5mg Spray Solution,),1 x 200ml) 1 Number Bottle 1 Florfenicol 5.10 gm. RA concerned may take further necessary action as per above decision of NC.

l 25 mg, Gentian Violet 5mg Spray Solution,),1 x 200ml) 1 Number Bottle 1 Florfenicol 5.10 gm. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	62 / NC/3/MEET/Sep/202526/8	62 / NC/3/MEET/Sep/202526/8	62 / NC/3/MEET/Sep/202526/8	62 / NC/3/MEET/Sep/202526/8	62 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00005860AM25
RA File Number		05AX04003696 AM25
Licence No and<br>Date		0511030545/24/01/2025
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/Nov/202223/12 dated 18/11/2022 against advance<br>authorization No.0511011543 dated 31/03/2022, 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. Import Items<br>Qty.<br>allowed.<br>Vancomycin<br>VANCOMYCIN<br>HYDROCHLORIDE (STERILE)<br>1 kg.<br>1<br>1.01 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.<br>allowed.
	VANCOMYCIN<br>HYDROCHLORIDE (STERILE)		1 kg.	1	Vancomycin	1.01 kg.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

(Non Sterile)

1 kg.|1|Vancomycin|1.01 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

(Non Sterile)

Case No.	63 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005910AM25
RA File Number	03AX04005472 AM25
Licence No and<br>Date	0311040840/29/01/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Ciclesonide inhalation aerosol 100 mcg<br>120MD / Ciclesonide inhalation aerosol<br>100 mcg/actuation (ex-valve)((Net Wt.<br>of Ciclesonide Ph. Eur. Is Qty. 840 Grams))<br>70000<br>Numbers<br>1<br>Ciclesonide Ph.<br>Eur.<br>856.8 gm.<br>Ciclesonide inhalation aerosol 200 mcg<br>120MD / Ciclesonide inhalation aerosol<br>200 mcg/actuation (ex-valve)((Net Wt.<br>of Ciclesonide Ph. Eur. Is Qty. 2880<br>Grams))<br>120000<br>Numbers<br>2<br>Ciclesonide Ph.<br>Eur.<br>2937.6 gm.<br>RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

cessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Case No.	64 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	RUBICON RESEARCH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005920AM25
RA File Number	03AX04005299 AM25
Licence No and<br>Date	0311040876/29/01/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Copy of Master-Batch Formula for each export in showing net content of each ingredient in the export.

Case No.	Case No.	65 / NC/3/MEET/Sep/202526/8	65 / NC/3/MEET/Sep/202526/8	65 / NC/3/MEET/Sep/202526/8	65 / NC/3/MEET/Sep/202526/8	65 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00005922AM25
RA File Number		05AX04003756 AM25
Licence No and<br>Date		0511030623/29/01/2025

and Date||NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025||||| |HQ File Number||HQRNORM APPLY 00005922AM25||||| |RA File Number||05AX04003756 AM25||||| |Licence No and Date||0511030623/29/01/2025||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Apr/202526/1 dated 25/04/2025 against advance authorization No.0511027808 dated 18/03/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Ceftriaxone Sodium Sterile 1 kg. 1 Ceftriaxone Sodium (Non Sterile) 1.04 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Ceftriaxone Sodium Sterile||1 kg.|1|Ceftriaxone Sodium (Non Sterile)|1.04 kg.| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

xone Sodium (Non Sterile)|1.04 kg.| ||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Case No.	Case No.	66 / NC/3/MEET/Sep/202526/8	66 / NC/3/MEET/Sep/202526/8	66 / NC/3/MEET/Sep/202526/8	66 / NC/3/MEET/Sep/202526/8	66 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00005925AM25
RA File Number		31AX04000397 AM25
Licence No and<br>Date		3111004376/29/01/2025
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 meetingNo.NC/3/MEET/Mar/202324/25 dated 11/03/2024 against advance<br>authorizationNo.0311028861 dated 23/11/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Sodium Lactate (PurasalSP/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% wastage. 4 Sodium Chloride (SANAL) (EP) Net content in export + 2% wastage. SF9-11 195/140 (PLASTIC FILM Net content in Sodium Lactate (Hartmann's) 1000 ml 1 Number 5||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Sodium Lactate (Hartmann's) 1000 ml|| 1 Number|1|Sodium Lactate (PurasalSP/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% wastage.| |||||4|Sodium Chloride (SANAL) (EP)|Net content in export + 2% wastage.| |||||5|SF9-11 195/140 (PLASTIC FILM|Net content in|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

|SF9-11 195/140 (PLASTIC FILM|Net content in|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

	(NON-PVC) FOR PRIMARY<br>PACKING) (0369631)	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.

N-PVC) FOR SECONDARY PACKING (0369661)| Net content in export + 1% wastage.| ||||8|SSC Infusion Port (0434181)|Net content in export + 1% wastage.| ||||9|SSC 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.|

Case No.	67 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005926AM25
RA File Number	31AX04000396 AM25
Licence No and<br>Date	3111004377/29/01/2025
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|31AX04000396 AM25| |Licence No and Date|3111004377/29/01/2025| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	68 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	VARTIKA CHEMICALS AND PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005931AM25
RA File Number	13AX04000347 AM25
Licence No and<br>Date	1311003649/30/01/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Composition of export item showing percentage content of API in the export supported by Certificate of<br>Analysis (CoA) of export item and Master-Batch Formula.

Case No.	69 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005934AM25
RA File Number	03AX04005533 AM25
Licence No and<br>Date	0311040887/30/01/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

f ad-hoc norms and as per the advice of the||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

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

Certificate of Analysis (CoA) of import item from Foreign Suplier.
Weighted Average of Potency/Assay of the API imported.

Case No.	Case No.	70 / NC/3/MEET/Sep/202526/8	70 / NC/3/MEET/Sep/202526/8	70 / NC/3/MEET/Sep/202526/8	70 / NC/3/MEET/Sep/202526/8	70 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		USV PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00005959AM25
RA File Number		03AX04005511 AM25
Licence No and<br>Date		0311040909/30/01/2025
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 meetingNo.NC/3/MEET/Jun/202025/5 dated 30/06/2025 against advance<br>authorizationNo.0311039799 dated 20/12/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>**Qty.

norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Doxycycline Tablets, USP 75 MG 100 S((2,200 Bottles X 100 Per Bottles = 2,20,000 Tablets) (Total Weight of Export Product = 16.500 Kgs) (Exempts imported input/material weight inclusive of wastage = 17.772 Kgs)) 1 Number 2 Doxycycline USP (Monohydrate) 79.600 mg. Doxycycline Tablets, USP 100 MG 500 S((9,800 Bottles X 500 Per Bottles = 49.00.000 Tablets) (Total Weight of ExportProduct = 490.000 Kgs) (Exempts imported input/material weight inclusive of 1 Number 3 Doxycycline USP (Monohydrate) 106.13 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Doxycycline Tablets, USP 75 MG 100 S((2,200 Bottles X 100 Per Bottles = 2,20,000 Tablets) (Total Weight of Export Product = 16.500 Kgs) (Exempts imported input/material weight inclusive of wastage = 17.772 Kgs))||1 Number|2|Doxycycline USP (Monohydrate)|79.600 mg.| ||Doxycycline Tablets, USP 100 MG 500 S((9,800 Bottles X 500 Per Bottles = 49.00.000 Tablets) (Total Weight of ExportProduct = 490.000 Kgs) (Exempts imported input/material weight inclusive of|| 1 Number|3|Doxycycline USP (Monohydrate)|106.13 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

|Doxycycline USP (Monohydrate)|106.13 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

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

Case No.	71 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005962AM25
RA File Number	07AX04001802 AM25
Licence No and<br>Date	0711013517/30/01/2025

| |Meeting Number and Date|NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025| |HQ File Number|HQRNORM APPLY 00005962AM25| |RA File Number|07AX04001802 AM25| |Licence No and Date|0711013517/30/01/2025| |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/Jun/202425/19 dated 27/03/2025 against advance authorization No.**0711012089 dated 14/08/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Ramelteon 8 mg Tablets 1 Number Tablet 1 Ramelteon 8.16 mg/Tablet RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

cessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Case No.	72 / NC/3/MEET/Sep/202526/8	72 / NC/3/MEET/Sep/202526/8	72 / NC/3/MEET/Sep/202526/8	72 / NC/3/MEET/Sep/202526/8	72 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	MEDREICH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005963AM25
RA File Number	07AX04001809 AM25
Licence No and<br>Date	0711013518/30/01/2025
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 meetingNo.NC/3/MEET/Jul/202526/6 dated 31/07/2025 against advance<br>authorization No.0711013347 dated 15/01/2025, 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:-
Export Product<br>Clindamycin Hydrochloride 300 mg<br>Capsules [1628.900 KG] [Each<br>Capsule contains Clindamycin<br>Hydrochloride 325.78 mg equivalent<br>to Clindamycin 300 mg])		Qty.	Sl.<br>No.	Import Items	Qty. allowed.
		1 Number	1	Clindamycin Hydrochloride<br>Ph.Eur	<br>332.29 mg.
RA concerned may take further necessary action as per above decision of NC.

No.|Import Items|Qty. allowed.| |||1 Number|1|Clindamycin Hydrochloride Ph.Eur| 332.29 mg.| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	73 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	PANACEA BIOTEC PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005970AM25
RA File Number	05AX04003703 AM25
Licence No and<br>Date	0511030649/31/01/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Norms Committee Decision:

The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Paclitaxel (Protein-Bound<br>Particles for Injectable<br>Suspension 100 mg) Pacliall	19853 Vials	1	Albumin Human USP<br>(25%) Solution	72.9 Liter

Case No.	74 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00005984AM25
RA File Number	03AX04005605 AM25
Licence No and<br>Date	0311040984/01/02/2025
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advice of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Composition of export items do not match with composition given in Drug Manufacturing Licence (DML).<br>Please justify the reason and get the licence amended in line with DML.

Case No.	75 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

r|NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

and Date
HQ File Number	HQRNORM APPLY 00005993AM25
RA File Number	31AX04000415 AM25
Licence No and<br>Date	3111004396/03/02/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>2,6 xylenol<br>1.19 kg.<br>2<br>Toluene<br>0.283 kg.<br>DNOVO BP838<br>(Tetra Methyl Bisphenol-A)<br>1 kg.<br>3<br>Acetone<br>0.231 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	76 / NC/3/MEET/Sep/202526/8	76 / NC/3/MEET/Sep/202526/8	76 / NC/3/MEET/Sep/202526/8	76 / NC/3/MEET/Sep/202526/8	76 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00006000AM25
RA File Number		03AX04005208 AM25
Licence No and<br>Date		0311041035/04/02/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol.

|Licence No and Date||0311041035/04/02/2025||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

1	Levofloxacin Q-Acid	0.856 kg.
2	N, Methyl Piperazine	0.432 kg.
3	Methanol	0.366 kg.
4	Caustic Soda Flakes	0.190 kg.

1	Levofloxacin Q-Acid	0.856 kg.
2	N, Methyl Piperazine	0.432 kg.
3	Methanol	0.366 kg.
4	Caustic Soda Flakes	0.190 kg.

Case No.	Case No.	77 / NC/3/MEET/Sep/202526/8	77 / NC/3/MEET/Sep/202526/8	77 / NC/3/MEET/Sep/202526/8	77 / NC/3/MEET/Sep/202526/8	77 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00006001AM25
RA File Number		03AX04005544 AM25
Licence No and Date		0311041038/04/02/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Tetrahydrofuran<br>1.125 kg.<br>2<br>n-Heptane<br>1.787 kg.<br>3<br>Ethyl Isobutyrate<br>0.686 kg.<br>4<br>1 Bromo-5-chloropentane<br>1.10 kg.<br>1,15 diethyl 2,2,14,14-tetramethyl-8-<br>oxopentadecanedioate<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	1,15 diethyl 2,2,14,14-tetramethyl-8-<br>oxopentadecanedioate		1 kg.	1	Tetrahydrofuran	1.125 kg.
				2	n-Heptane	1.787 kg.
				3	Ethyl Isobutyrate	0.686 kg.
				4	1 Bromo-5-chloropentane	1.10 kg.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

|Ethyl Isobutyrate|0.686 kg.| |||||4|1 Bromo-5-chloropentane|1.10 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

5	N, N Dimethylacetamide	1.675 kg.
6	Sodium t-pentoxide	0.567 kg.
7	Tosmic	0.512 kg.
8	N-butyl lithium<br>(25% in N-Heptane)	1.826 kg.

Case No.	Case No.	78 / NC/3/MEET/Sep/202526/8	78 / NC/3/MEET/Sep/202526/8	78 / NC/3/MEET/Sep/202526/8	78 / NC/3/MEET/Sep/202526/8	78 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		MICRO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00006003AM25
RA File Number		07AX04001828 AM25
Licence No and<br>Date		0711013540/04/02/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.

it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Lisinopril Dihydrate Ph.Eur 5.10 mg. Lisinopril 5mg + Amlodipine 5 mgTablets(21.00Kgs) 1 Number Tablet 2 Amlodipine Besilate BP 5.10 mg. 3 Lisinopril Dihydrate Ph.Eur 10.2 mg. 1 Number Lisinopril 10 mg + Amlodipine 5mg Tablets(40.50kgs)||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Lisinopril 5mg + Amlodipine 5 mgTablets(21.00Kgs)||1 Number Tablet|1|Lisinopril Dihydrate Ph.Eur|5.10 mg.| |||||2|Amlodipine Besilate BP|5.10 mg.| ||Lisinopril 10 mg + Amlodipine 5mg Tablets(40.50kgs)||1 Number|3|Lisinopril Dihydrate Ph.Eur|10.2 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Tablet 4 Amlodipine Besilate BP 5.10 mg.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Tablet 4 Amlodipine Besilate BP 5.10 mg.

Case No.	79 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00006004AM25
RA File Number	07AX04001834 AM25
Licence No and<br>Date	0711013545/04/02/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Doxycycline 100 mg Dispersible Tablets<br>(Eq. To Anhydrous Doxycycline 100 mg)<br>1 Number<br>Tablet<br>1<br>Doxycycline<br>Monohydrate USP/BP<br>106.13 mg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	80 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00006007AM25
RA File Number	07AX04001830 AM25

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Licence No and 0711013550/04/02/2025 Date Norms Committee Decision:

me: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Licence No and 0711013550/04/02/2025 Date Norms Committee Decision:

The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Tranexamic Acid Injection Solution 1000<br>mg / 10ml (Net Contents 22.50kg)	22500<br>Numbers	1	Tranexamic Acid<br>BP/EP/IP/USP	24.75 kg.

Case No.	Case No.	81 / NC/3/MEET/Sep/202526/8	81 / NC/3/MEET/Sep/202526/8	81 / NC/3/MEET/Sep/202526/8	81 / NC/3/MEET/Sep/202526/8	81 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		LEGENCY REMEDIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00006011AM25
RA File Number		30AX04000637 AM25
Licence No and<br>Date		3011006460/04/02/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.

it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Sterilised Water for Injections BP 10 ml 1 Number 1 Low Density Polyethylene Medical Grade :BB 120 /150 1.03 kg/kg content in the export product. Dextrose Injection USP 40% Low Density 1.03 kg/kg content in the 1 Number 2||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Sterilised Water for Injections BP 10 ml||1 Number|1|Low Density Polyethylene Medical Grade :BB 120 /150|1.03 kg/kg content in the export product.| ||Dextrose Injection USP 40%||1 Number|2|Low Density|1.03 kg/kg content in the|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

W/v 20 ml			Polyethylene Medical	export product.
			Grade :BB 120 /150
Salbutamol 2.5 mg/2.5ml	1 Number	3	Low Density	1.03 kg/kg content in the
			Polyethylene Medical	export product. .
			Grade :BB 120 /150

Note: (i) The firm will declare net content of import item in each export in the Shipping Bill.

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

de :BB 120 /150||

Note: (i) The firm will declare net content of import item in each export in the Shipping Bill.

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

Case No.	82 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	RUBICON RESEARCH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00006027AM25
RA File Number	03AX04005587 AM25
Licence No and<br>Date	0311041065/05/02/2025
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Copy of Master-Batch Formula for each export item.

Case No.	83 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	PUNJAB CHEMICALS AND CROP PROTECTION LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00006042AM25
RA File Number	03AX04005681 AM25
Licence No and	0311041097/06/02/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Date

Norms Committee Decision:

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

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

Dat	e
Nor<br>Th<br>TE<br>Co<br>pe	ms Committee Decision:<br>e committee considered the<br>, it was decided to call for fo<br>mplete chemistry, chemical<br>rcentage yield for each step o		request of fi<br>llowing info<br>reaction, Sto<br>f reaction.	rm for fix	ation of ad-hoc norms and as per th	e advice of the
				<br>rmation/do<br>ichiometri	<br>cuments from the firm:-<br>c balance on molar basis with molec	<br>ular weight and




Cas	e No.	84 / NC/3/MEET	/Sep/202526/	8
Cas	e Status	Case Approved

Par	ty Name	PLASTIBLEND	S INDIA LIM	ITED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ S	ep/ 202526/ 8	and 17/09/	2025

HQ	File Number	HQRNORM AP	PLY 0000604	5AM25
RA	File Number	03AX04005636	AM25
Lic<br>Dat	ence No and<br>e	0311041109/06/	02/2025

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

se as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Relevant polymer such as Hydrocarb on Resin 152955 kg. 2 Additive namely Antioxidant 305.91 kg. Addtive Masterbatch (Net Content:1)Relevant polymer such as Hydrocarbon Resin: 1,48,500 kgs. 2) Additive namely Antioxidant: 297.000 kgs 3) Relevant polymers such as BOPP:1,48,203.00 KGS) 297000 kg. 3 Relevant polymers such as BOPP 152649 kg. RA concerned may take further necessary action as per above decision of NC.||ms Committee Decision: e Committee considered the HBP Vol. I as per details giv||case as per a en below or||||||| ||||||genda and as applied|it was decided to fix ad-hoc norms by the firm, whichever is less:-|||under Para 4.07|| |||||||||||| ||E|xport Product||||||||| ||||||Qty.||Sl. No.|Import Items||Qty. allowed.| || C 3 B|Addtive Masterbatch (Net ontent:1)Relevant polymer s Hydrocarbon Resin: 1,48,500 Additive namely Antioxidant: ) Relevant polymers such as OPP:1,48,203.00 KGS)||uch as kgs. 2) 297.000 kgs ||||||| ||||||297000|kg.|1|Relevant polymer such as Hydrocarb on Resin||152955 kg.| |||||||||||| ||||||||2|Additive namely Antioxidant||305.91 kg.| |||||||||||| ||||||||3|Relevant polymers suc as BOPP|h|152649 kg.| |||||||||||| |||||||||||| ||||||||||||

Resin||152955 kg.| |||||||||||| ||||||||2|Additive namely Antioxidant||305.91 kg.| |||||||||||| ||||||||3|Relevant polymers suc as BOPP|h|152649 kg.| |||||||||||| |||||||||||| ||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Case No.<br>85 / NC/3/MEET/Sep/202526/8
Case Status<br>Case Approved
Party Name<br>CUCKOS PHARMACEUTICAL PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number<br>HQRNORM APPLY 00006049AM25
RA File Number<br>05AX04003457 AM25
Licence No and<br>Date<br>0511030734/06/02/2025
Norms Committee Decision:
The Committee considered the case as per agenda and	it was decided to fix ad-hoc norms under Para 4.07
of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty. allowed.
Oclacitnib Maleate Tablets 5.4 mg<br>1 Number	1	Oclacitinib Maleate	7.588 mg.
Oclacitnib Maleate Tablets 16 mg<br>1 Number	2	Oclacitinib Maleate	22.48 mg.
RA concerned may take further necessary action as per	above decision of NC.

r|1|Oclacitinib Maleate|7.588 mg.|| |Oclacitnib Maleate Tablets 16 mg 1 Number|2|Oclacitinib Maleate|22.48 mg.|| |RA concerned may take further necessary action as per|above decision of NC.||||

Case No.	86 / NC/3/MEET/Sep/202526/8
Case Status	Case Rejected
Party Name	BVC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00006056AM25
RA File Number	34AX04000966 AM25
Licence No and<br>Date	3411006053/06/02/2025
Norms Committee Decision:
The firm was initially granted an Advance Authorisation for the export product_“Allyl Caproate”_
under Para 4.07 of the Handbook of Procedures (HBP). However, as per Para 4.11(b) of the

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

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.

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

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

Case No.	87 / NC/3/MEET/Sep/202526/8
Case Status	Case Rejected
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00006069AM25
RA File Number	34AX04000969 AM25
Licence No and<br>Date	3411006055/07/02/2025
Norms Committee Decision:<br>The firm was initially granted an Advance Authorisation for the export product_“Ozonal”_under<br>Para 4.07 of the Handbook of Procedures (HBP).

te|3411006055/07/02/2025| |Norms Committee Decision: The firm was initially granted an Advance Authorisation for the export product_“Ozonal”_under Para 4.07 of the Handbook of Procedures (HBP). However, as per Para 4.11(b) of the Foreign Trade Policy (FTP) 2023, products falling under the category of perfume or perfumery compounds are ineligible for authorisation under Para 4.07 and are mandatorily required to be processed under Para 4.06 of the HBP. It was observed that the firm obtained the authorisation bymisdeclaring that its application was covered under the provisions of Para 4.07, and has not furnished any technical justification/information for the export product. Accordingly, the Committee found no merit in fixing the norms and decided to reject the application. The RA shall ensure that the said authorisation is regularised by recovery of applicable Customs||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

duty along with interest. Further, the RA should also submit a report on how this authorisation was issued under Para 4.07 of HBP, to the Chairperson of the Norms Committee and to PC-4 Section, DGFT Headquarters.

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

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

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

Case No.	Case No.	Case No.	88 / NC/3/MEET/Sep/202526/8	88 / NC/3/MEET/Sep/202526/8	88 / NC/3/MEET/Sep/202526/8	88 / NC/3/MEET/Sep/202526/8	88 / NC/3/MEET/Sep/202526/8	88 / NC/3/MEET/Sep/202526/8
Case Status			Case Approved
Party Name			LEBEN LABORATORIES PRIVATE LIMITED
Meeting Number an<br>		d	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
Date

HQ File Number			HQRNORM APPLY 00006079AM25
RA File Number			03AX04005625 AM25
Licence No and Da		te	0311041044/07/02/2025
Norms Committee		Decision:
The Committee<br>f HBP Vl I		considered the case as per agenda and it was decided to fix ad-hoc norms under<br>dil i bl lid b h fi hih i l						Para 4.07
o o. as per etas gven eow or as appe y te rm, wcever s ess:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.
	Export Product			Qty.	Sl. No.	Import Items	Qty.	allowed.

	MOXILEB -CV -375 TABLET USP.

s appe y te rm, wcever s ess:- Export Product Qty. Sl. No. Import Items Qty.||||||||| ||Export Product|||Qty.|Sl. No.|Import Items|Qty.|allowed.| |||||||||| ||MOXILEB -CV -375 TABLET USP. ( AMOXICILLIN & CLAVULANATE POTASSIUM TABLETS USP |||1 Number|1|AMOXICILLIN TRIHYDRATE USP COMPACTED|292.639 mg.|| ||375MG)|||||||| ||(((EACH TAB|LET CONTAINING||||||| ||AMOXICILLI|N TRIHYDRATE||||||| ||EQUIVALEN AMOXICILLI|T TO 250MG OF N) NET CONTENT||||||| || OFIMPORT/E| XEMPT MATERIAL||||||| ||USED IN EXP|ORT PRODUCT 1)||||||| ||AMOXICILLI (COMPACTE|N TRIHYDRATE USP D) EXTRADRY -||||||| ||49.709KG (EXCL 2% WASTAGE))|||||||| ||MOXILEB -CV -625 TABLET USP.|||1 Number|2|AMOXICILLIN|585.28 mg.|| ||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

	(AMOXICILLIN & CLAVULANATE<br>POTASSIUM TABLETS<br>USP625MG).(((EACH TABLET<br>CONTAINING AMOXICILLIN<br>TRIHYDRATE EQUIAVLENT TO<br>500MG OF AMOXICILLIN). NET<br>CONTENT OF IMPORT/EXEMPT<br>MATERIAL USED IN EXPORT<br>PRODUCT 1) AMOXICILLIN<br>TRIHYDRATE USP COMPACTED)<br>EXTRA DRY - 128.117KG (EXCL<br>2% WASTAGE))			TRIHYDRATE USP<br>COMPACTED
	MOXILEB -CV -1000TABLET USP.<br>(AMOXICILLIN & CLAVULANATE<br>POTASSIUM TABLETS USP<br>1000MG) (((EACH TABLET<br>CONTAINING AMOXICILLIN<br>TRIHYDRATE EQUIVALENT TO<br>875MG OF AMOXICILLIN ).

-|---| ||MOXILEB -CV -1000TABLET USP. (AMOXICILLIN & CLAVULANATE POTASSIUM TABLETS USP 1000MG) (((EACH TABLET CONTAINING AMOXICILLIN TRIHYDRATE EQUIVALENT TO 875MG OF AMOXICILLIN ). NET CONTENT OFIMPORT/EXEMPT MATERIAL USED IN EXPORT PRODUCT 1) AMOXICILLIN TRIHYDRATE USP (COMPACTED ) EXTRA DRY -238.359KG (EXCL 2% WASTAGE)| 1 Number|3|AMOXICILLIN TRIHYDRATE USP COMPACTED|892.511 mg.| ||MOXILEB -CV -156.25 DRY SYRUP USP. (AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORALSUSPENSION USP 156.25MG/5ML)((EACH 5ML CONTAINS AMOXICILLIN TRIHYDRATE EQUIVALENT TO 125MG OFAMOXICILLIN). NET CONTENT OF IMPORT/EXEMPT MATERIAL USED IN EXPORT PRODUCT 1AMOXICILLIN TRIHYDRATEUSP (COMPACTED) EXTRA DRY -44.083KG (EXCL 2% WASTAGE)) 60 ml Bottle.|1 Number|4|AMOXICILLIN TRIHYDRATE USP COMPACTED|1575.0 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

IN TRIHYDRATE USP COMPACTED|1575.0 mg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

|MOXILEB -CV -228.5 DRY SYRUP USP. (AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORALSUSPENSION USP 228.5 MG/5ML)(( EACH 5ML CONTAINS AMOXICILLIN TRIHYDRATE EQUIVALENT TO 200MG OFAMOXICILLIN) . NET CONTENT OF IMPORT /EXEMPT MATERIAL USED IN EXPORT PRODUCT 1) AMOXICILLIN TRIHYDRATEUSP (COMPACTED) EXTRA DRY - 87.202KG (EACL 2% WASTAGE) 60 ml. Bottle. 1 Number 5 AMOXICILLIN TRIHYDRATE USP COMPACTED 2520.0 mg. MOXILEB -CV -457 DRY SYRUP USP. (AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORALSUSPENSION USP 457MG/5ML)((EACH 5ML CONTIANS AMOXICILLIN TRIHYDRATE EQUIVALENT TO 400MG OF AMOXICILLIN). NET CONTENT OF IMPORT/EXEMPT MATERIAL USED IN EXPORT PRODUCT 1) AMOXICILLIN TRIHYDRATE USP(COMPACTED) EXTRA DRY - 187.825KG (EXCL 2% WASTAGE) 70 ml. Bottle. 1 Number 6 AMOXICILLIN TRIHYDRATE USP COMPACTED 5880.0 mg. RA concerned may take further necessary action as per above decision of NC.|MOXILEB -CV -228.5 DRY SYRUP USP. (AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORALSUSPENSION USP 228.5 MG/5ML)(( EACH 5ML CONTAINS AMOXICILLIN TRIHYDRATE EQUIVALENT TO 200MG OFAMOXICILLIN) . NET CONTENT OF IMPORT /EXEMPT MATERIAL USED IN EXPORT PRODUCT 1) AMOXICILLIN TRIHYDRATEUSP (COMPACTED) EXTRA DRY - 87.202KG (EACL 2% WASTAGE) 60 ml.

ENT TO 200MG OFAMOXICILLIN) . NET CONTENT OF IMPORT /EXEMPT MATERIAL USED IN EXPORT PRODUCT 1) AMOXICILLIN TRIHYDRATEUSP (COMPACTED) EXTRA DRY - 87.202KG (EACL 2% WASTAGE) 60 ml. Bottle.| 1 Number|5|AMOXICILLIN TRIHYDRATE USP COMPACTED|2520.0 mg.| |---|---|---|---|---|---| ||MOXILEB -CV -457 DRY SYRUP USP. (AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORALSUSPENSION USP 457MG/5ML)((EACH 5ML CONTIANS AMOXICILLIN TRIHYDRATE EQUIVALENT TO 400MG OF AMOXICILLIN). NET CONTENT OF IMPORT/EXEMPT MATERIAL USED IN EXPORT PRODUCT 1) AMOXICILLIN TRIHYDRATE USP(COMPACTED) EXTRA DRY - 187.825KG (EXCL 2% WASTAGE) 70 ml. Bottle.|1 Number|6|AMOXICILLIN TRIHYDRATE USP COMPACTED|5880.0 mg.|

Case No.	89 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	USV PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00006087AM25
RA File Number	03AX04005733 AM25
Licence No and	0311041178/10/02/2025

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Date 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/May/202526/3 dated 04/06/2025 against advance authorization No . 0311032405 dated 21/03/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl.	Import Items	Qty. allowed.
		No.
Doxycycline Hyclate DR Tablets USP	<br>1 Number	1	Doxycycline Hyclate USP	115.40 mg.
100 mg.

Case No.		90 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		ENALTEC LABS PRIVATE LIMITED
Meeting Number an	d Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00006117AM25
RA File Number		03AX04005751 AM25
Licence No and Da	te	0311041201/10/02/2025
Norms Committee<br>	Decision:<br>
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol.

Da||te|0311041201/10/02/2025||||||| |Norms Committee ||Decision: |||||||| |The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Sitagliptin Phosphate Monohydrate 1 kg. 1 3R)-3-AMINO-1-[3-TRIFLUOROMETHYL)- 5,6,7,8- TETRAHYDRO-12,4TRIAZOLO [4,3- a]PYRAZIN-7-YL]-4-(2,4,5- TRIFLUOROPHENYL)BUTAN) 0.816 kg.|||||||||| ||||||||||| ||xport Product|||Qty.|Sl. No.|Import Items|||Qty. allowed.| ||||||||||| ||itagliptin Phosphate Monohydrate|||1 kg.|1|3R)-3-AMINO-1-[ 5,6,7,8- TETRAH|3-TRIF YDRO-|LUOROMETHYL)- 12,4TRIAZOLO [4,3-|0.816 kg.| ||||||| a]PYRAZIN-7-YL TRIFLUOROPHE| ]-4-(2,4 NYL)B| ,5- UTAN)||

Case No.		90 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		ENALTEC LABS PRIVATE LIMITED
Meeting Number an	d Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00006117AM25
RA File Number		03AX04005751 AM25
Licence No and Da	te	0311041201/10/02/2025
Norms Committee<br>	Decision:<br>

5||||||| |HQ File Number|||HQRNORM APPLY 00006117AM25||||||| |RA File Number|||03AX04005751 AM25||||||| |Licence No and Da||te|0311041201/10/02/2025||||||| |Norms Committee ||Decision: |||||||| |The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Sitagliptin Phosphate Monohydrate 1 kg. 1 3R)-3-AMINO-1-[3-TRIFLUOROMETHYL)- 5,6,7,8- TETRAHYDRO-12,4TRIAZOLO [4,3- a]PYRAZIN-7-YL]-4-(2,4,5- TRIFLUOROPHENYL)BUTAN) 0.816 kg.|||||||||| ||||||||||| ||xport Product|||Qty.|Sl. No.|Import Items|||Qty. allowed.| ||||||||||| ||itagliptin Phosphate Monohydrate|||1 kg.|1|3R)-3-AMINO-1-[ 5,6,7,8- TETRAH|3-TRIF YDRO-|LUOROMETHYL)- 12,4TRIAZOLO [4,3-|0.816 kg.| ||||||| a]PYRAZIN-7-YL TRIFLUOROPHE| ]-4-(2,4 NYL)B| ,5- UTAN)||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

PHE| ]-4-(2,4 NYL)B| ,5- UTAN)||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Case No.	91 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	ENALTEC LABS PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00006118AM25
RA File Number	03AX04005750 AM25
Licence No and Date	0311041202/10/02/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>Sitagliptin Phosphate<br>Monohydrate<br>1 kg.<br>1<br>3R)-3-AMINO-1-[3-TRIFLUOROMETHYL)-<br>5,6,7,8- TETRAHYDRO-12,4TRIAZOLO [4,3-<br>a]PYRAZIN-7-YL]-4-(2,4,5-<br>TRIFLUOROPHENYL)BUTAN)<br>0.816 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	92 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	SHUKRA PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00006129AM25
RA File Number	08AX04001931 AM25
Licence No and	0811014061/11/02/2025

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Date

Norms Committee Decision:

1/02/2025|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Date

Norms Committee Decision:

The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Methyldopa Tablets 250 mg	1 Number	1	Methyldopa API	255 mg/Tablet

Case No.	93 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	RUBICON RESEARCH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00006136AM25
RA File Number	03AX04005786 AM25
Licence No and<br>Date	0311041215/11/02/2025
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	94 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	CORAL DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00006181AM25
RA File Number	05AX04003803 AM25
Licence No and<br>Date	0511030866/12/02/2025
Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Fluticasone Propionate	1 kg.	1	8 DM	1.30 kg.
(EP or BP or USP or IP)

Case No.	95 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00006182AM25
RA File Number	07AX04001888 AM25
Licence No and<br>Date	0711013638/12/02/2025
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 meetingNo.NC/3/MEET/Jul/202526/6 dated 31/07/2025 against advance<br>authorization No.0711013126 dated 24/12/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.<br>Bromocriptine Tablets 2.5 mg<br>1 Number<br>1<br>Bromocriptine<br>Mesilate<br>BP/EP/IP/USP<br>2.927 mg/Tablet

uct** Qty. Sl. No. Import Items Qty. allowed. Bromocriptine Tablets 2.5 mg 1 Number 1 Bromocriptine Mesilate BP/EP/IP/USP 2.927 mg/Tablet||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

NC also recommended to make a new SION for this export product.

Case No.	96 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	LEE PHARMA LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00006185AM25
RA File Number	09AX04001050 AM25
Licence No and Date	0911009037/12/02/2025
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 meetingNo.NC/3/MEET/Jun/202526/5 dated 30.06.2025 against advance authorizationNo.<br>0911008676 dated 20/12/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given<br>below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Rosuvastatin Calcium 1 kg. 1 Tert.Butyl-( E )-(6[-[4-(4-fluorophenyl)-6- isopropyl-2-(N-methyl Sulfonyl) amino] pyrimidin-5-yl]vinyl] (4R,6S)-2,2-Dimethy (tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4- fluorophenyl)-6-isopropyl-2-(N- methylmethylsulfonamido) pyrimidin-5-yl) vinyl) -2,2-dimethyl-1,3-dioxan-4-yl) acetate) 1.30 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	97 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ S	ep/ 202526/ 8	and 17/0
HQ	File Number	HQRNORM AP	PLY 0000618	9AM25

RA	File Number	08AX04001924	AM25
Lic<br>Dat	ence No and<br>e	0811014088/12/	02/2025

Norms Committee Decision:<br>The Committee considered the case as per a<br>of HBP Vol.

||File Number|08AX04001924|AM25||||||| |Lic Dat||ence No and e|0811014088/12/|02/2025||||||| |||||||||||| |Norms Committee Decision: The Committee considered the case as per a of HBP Vol. I as per details given below or Export Product Phenylephrine Hydrochloride in 0.9 % Sodium Chloride Injection, 0.08 mg/m (20 mg/250 mL) Phenylephrine Hydrochloride in 0.9 % Sodium Chloride Injection, 0.16 mg/m (40 mg/250 mL) Phenylephrine Hydrochloride in 0.9 % Sodium Chloride Injection, 0.4 mg/m (100 mg/250 mL) Phenylephrine Hydrochloride Injectio USP, 10 mg/mL (10 mL) Phenylephrine Hydrochloride Injectio USP, 10 mg/mL (5 mL)||ms Committee Decision: e Committee considered the HBP Vol. I as per details giv||case as per a en below or||||||| ||||||genda a as applie|nd it was decided to fix ad-hoc norms un d by the firm, whichever is less:-||||der Para 4.07| |||||||||||| ||E|xport Product||||||||| ||||||Qt|y.|Sl. No.|Import Items|Q|ty.

|||genda a as applie|nd it was decided to fix ad-hoc norms un d by the firm, whichever is less:-||||der Para 4.07| |||||||||||| ||E|xport Product||||||||| ||||||Qt|y.|Sl. No.|Import Items|Q|ty. allowed.| ||P S (|henylephrine Hydrochlorid odium Chloride Injection,||e in 0.9 % 0.08 mg/m||||||| |||||| L 1 Nu|mber|1|Phenylephrine HCl USP/Ph.Eur||21.00 mg.| |||20 mg/250 mL)||||||||| ||P S (|henylephrine Hydrochlorid odium Chloride Injection, 40 mg/250 mL)||e in 0.9 % 0.16 mg/m||||||| |||||| L 1 Nu|mber|2|Phenylephrine HCl USP/Ph.Eur||42.00 mg.| |||||||||||| ||P S (|henylephrine Hydrochlorid odium Chloride Injection, 100 mg/250 mL)||e in 0.9 % 0.4 mg/m| ||| | || |||||| L 1 Nu|mber|3|Phenylephrine HCl USP/Ph.Eur| |105.00 mg.| |||||||||||| ||P |henylephrine Hydrochlori USP, 10 mg/mL (10 mL)||de Injectio| 1 Nu|ber|4|Phenlehrine HCl| |11000 m| |||||| |||yp USP/Ph.Eur| |. g.| ||Phenylephrine Hydrochloride Injectio USP, 10 mg/mL (5 mL)|||||||||| ||||||n 1 Number||5|Phenylephrine HCl USP/Ph.Eur| 55.00 mg.|| |||||||||||| ||Phenylephrine Hydrochloride Injectio USP, 10 mg/mL (1 mL)||||n 1 Number||6|Phenylephrine HCl USP/Ph.Eur| 11.00 mg.|| |||||||||||| |||||||||||| |RA concerned m|||ay take further necessary action as per above decision of NC.|||||||| |||||||||||| |||||||||||| |||||||||||| |||||||||||| ||||||||||||

| 11.00 mg.|| |||||||||||| |||||||||||| |RA concerned m|||ay take further necessary action as per above decision of NC.|||||||| |||||||||||| |||||||||||| |||||||||||| |||||||||||| ||||||||||||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Case No.	98 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00006194AM25
RA File Number	05AX04003930 AM25
Licence No and<br>Date	0511030876/13/02/2025
Norms Committee Decision:<br>The committee considered the request of firm for rfixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Separate Molecular required for Diethylene Glycol (DEG) and Dipropylene Glycol (DPG) in reaction<br>details.<br>1.

Separate Molecular required for Diethylene Glycol (DEG) and Dipropylene Glycol (DPG) in reaction details.

Diethylene Glycol (DEG) and Dipropylene Glycol (DPG) in reaction details. 1.||

Separate Molecular required for Diethylene Glycol (DEG) and Dipropylene Glycol (DPG) in reaction details.

Case No.<br>	Case No.<br>	99 / NC/3/MEET/Sep/202526/8	99 / NC/3/MEET/Sep/202526/8	99 / NC/3/MEET/Sep/202526/8	99 / NC/3/MEET/Sep/202526/8	99 / NC/3/MEET/Sep/202526/8
Case Status<br>		Case Approved
Party Name<br>		KAWAKEN STERLING SURFACTANTS PRIVATE LIMITED
Meeting Number<br>and Date<br>		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number<br>		HQRNORM APPLY 00006208AM25
RA File Number<br>		03AX04000593 AM25
Licence No and<br>Date<br>		0311041317/13/02/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Fatty Acid<br>(Kortacid CG)/(C1218HK)<br>200502 kg.<br>STEROCARE CMEA<br>(Coco Mono Ethanol Amide)<br>235000 kg.<br>2<br>Mono Ethanol Amine (MEA)<br>55601 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	STEROCARE CMEA<br>(Coco Mono Ethanol Amide)		235000 kg.	1	Fatty Acid<br>(Kortacid CG)/(C1218HK)	200502 kg.
				2	Mono Ethanol Amine (MEA)	55601 kg.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

| |||||2|Mono Ethanol Amine (MEA)|55601 kg.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Case No.	100 / NC/3/MEET/Sep/202526/8
Case Status	Case Deferred
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00006210AM25
RA File Number	05AX04003649 AM25
Licence No and<br>Date	0511030885/13/02/2025
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending Personal<br>Hearing before Norms Committee to explain its case along with relevant information / documents from the<br>firm.

Case No.	Case No.	101 / NC/3/MEET/Sep/202526/8	101 / NC/3/MEET/Sep/202526/8	101 / NC/3/MEET/Sep/202526/8	101 / NC/3/MEET/Sep/202526/8	101 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		PANACEA BIOTEC PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00006212AM25
RA File Number		05AX04003935 AM25
Licence No and<br>Date		0511030888/13/02/2025

and Date||NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025||||| |HQ File Number||HQRNORM APPLY 00006212AM25||||| |RA File Number||05AX04003935 AM25||||| |Licence No and Date||0511030888/13/02/2025||||| |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/Feb/202425/17 dated 25/02/2025 against advance authorization No.**0511021399 dated09/10/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Alphadol Capsules (Each Soft Gelatin	1 Number	1	Alfacalcidol	0.255 mcg.
Capsule Contains: Alfacalcidol0.25 mcg.)
Alphadol-CA Capsules((Each Soft Gelatin	1 Number	2	Alfacalcidol	0.255 mcg.
Capsule Contains: Alfacalcidol 0.25
mcg.&Calcium Carbonate 500 mg.
equivalent to Elemental Calcium 200 mg.))
Alphadol 1 mg (Each Soft Glatin Capsule	1 Number	3	Alfacalcidol	1.02 mcg.
Contains: Alfacalcidol 1.00 mcg.)

&Calcium Carbonate 500 mg.||||| |equivalent to Elemental Calcium 200 mg.))||||| |Alphadol 1 mg (Each Soft Glatin Capsule|1 Number|3|Alfacalcidol|1.02 mcg.| |Contains: Alfacalcidol 1.00 mcg.)|||||

Case No.	Case No.	102 / NC/3/MEET/Sep/202526/8	102 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		PRACHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00006216AM25
RA File Number		08AX04001958 AM25
Licence No and<br>Date		0811014102/13/02/2025
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07
of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
	Export Product<br>Qty.		Sl. No.	Import Items	Qty. allowed.
	Triamcinolone	Acetonide<br>1 kg.	1	9,11B-Epoxide Triamcinolone	1.00 kg.
				(5TR)
RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

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

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Case No.	103 / NC/3/MEET/Sep/202526/8
Case Status	Case Approved
Party Name	VENUS REMEDIES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number	HQRNORM APPLY 00006218AM25
RA File Number	30AX04000658 AM25
Licence No and Date	3011006529/13/02/2025
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 meetingNo.NC/3/MEET/Mar/202425/19 dated 27/03/2025 against advance<br>authorization No.3011005627 dated 22/08/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

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. METHOTREXATE INJECTION USP (50 MG/2ML)(EACH ML CONTAINS: METHOTREXATE USP...25 MG, WATER FOR INJECTION USP...Q.S) 1 Number 1 Methotrexate 55.00 mg. METHOTREXATE INJECTION USP (500 MG/5 ML)(EACH ML CONTAINS METHOTREXATE USP...100 MG, WATER FOR INJECTION USP...Q.S) 1 Number 2 Methotrexate 550.00 mg. METHOTREXATE INJECTION USP (1000mg/10ml)(EACH ML CONTAINS: METHOTREXATE USP...100 MG, WATER FOR INJECTION USP...Q.S) 1 Number 3 Methotrexate 1100.00 mg. RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

cessary action as per above decision of NC.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Case No.		104 / NC/3/MEET/Sep/202526/8
Case Status		Case Deferred
Party Name		DECCAN NUTRACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00006568AM25
RA File Number		02AX04000733 AM25
Licence No and<br>Date		0211008274/05/03/2025
Norms Committee	Decision:
The committee	considered the request of firm for fixation of ad-hoc norms and as per the advice of the
TE, it was decided to call for following information/documents from the firm:-
Complete chemistry with molecular weight and percentage yield on molar basis.

Case No.	Case No.	105 / NC/3/MEET/Sep/202526/8
Case Status		Case Approved
Party Name		FINE ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Sep/ 202526/ 8 and 17/09/2025
HQ File Number		HQRNORM APPLY 00001553AM26
RA File Number		03AX04001307 AM26
Licence No and<br>Date		0311044903/18/06/2025
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07
of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
	Export Product<br>Qty.<br>Sl. No.		Import Items	Qty.

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 Neutralized Amide Ester 1 kg.||Stearic Acid|0.95 kg.|| |||2|Mono Ethanol Amine|0.056 kg.||

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

UDIN00341461AM26

Signature Not Verified

Digitally Signed. Name: RAMAN KUMAR( Deputy DGFT ) Date: 07-Oct-2025 10:34:59 Reason: ramankumar@nic.in Location: DGFT(HQ)

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