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 : dgft@nic.in , Phone Office : 011-23062777

(DES - III SECTION)

Minutes of the Norms Committee–3 Meeting No.NC/3/MEET/Apr/202526/2 dated 08/05/2025, 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.

    The following members were present in the Meeting:-

Sl. No.	Name & Designation	Department
1	Shri Dinesh Narain Mathur, Technical Expert	Consultant (Pharma)
2	Shri Shaish Kumar, Technical Expert	Consultant (Chemical)
3	Shri Nand Lal, Technical Expert	Consultant (Chemical)
In attendance:
1	Shri Raman Kumar, Deputy DGFT	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

1 This document has been digitally signed by Raman Kumar, Deputy DGFT on 09-06-2025 10:25:58.

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Advance Authorization and regularisation of the case.

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

06-2025 10:25:58.

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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 of the provisions of Para 4.12 or the relevant para of the applicable FTP, Para 4.16, Para 4.21,and Para 4.51 or the relevant paras of the applicable HBP shall be made

2 This document has been digitally signed by Raman Kumar, Deputy DGFT on 09-06-2025 10:25:58.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Apr/202526/2
Case Status	Case Rejected
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004156AM25
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Accordingly, committee<br>did not find any merit for enhancement of norms and it was decided torejectthe case, maintaining the<br>status quo.

Case No.	2 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	CYKLO PHARMA CHEM PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00003152AM25
RA File Number	032404000318 AM04
Licence No and<br>Date	0310204913/29/05/2003
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal<br>Hearing<br> before Norms Committee to explain its case along with relevant information / documents from the<br>firm. The Committee also decided to seek the present status of the above authorization from RA as it was<br>issued in the year 2003.

case along with relevant information / documents from the firm. The Committee also decided to seek the present status of the above authorization from RA as it was issued in the year 2003.|||

Case No.	3 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	WEXFORD LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00003784AM25
RA File Number	072404000105 AM15

3 This document has been digitally signed by Raman Kumar, Deputy DGFT on 09-06-2025 10:25:58.

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Licence No and 0710105465/30/06/2014 Date Norms Committee Decision:

The Committee considered the request of firm for fixation of ad-hoc norms 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.
Vancomycin<br>Injection<br>(500MG)	<br>36000<br>Numbers	1	Vancomycin<br>Hydrochloride USP	19.404 kg.
Vancomycin Injection (1GM)	9000<br>Numbers	2	Vancomycin<br>Hydrochloride USP	6.00 kg.

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

Hydrochloride USP|19.404 kg.| |Vancomycin Injection (1GM)|9000 Numbers|2|Vancomycin Hydrochloride USP|6.00 kg.|

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

Case No.	Case No.	4 / NC/3/MEET/Apr/202526/2	4 / NC/3/MEET/Apr/202526/2	4 / NC/3/MEET/Apr/202526/2	4 / NC/3/MEET/Apr/202526/2	4 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		GLOBE TROTTERS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM REVIW00004456AM25
RA File Number		039404000024 AM16
Licence No and<br>Date		0310795429/20/04/2015
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc<br>norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is<br>less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

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

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1<br>Rifampicin BP/IP/USP<br>1177.68 kg.<br>2<br>PG( Propylene glycol<br>IP/BP/USP)<br>11034.45 kg.<br>Rifampicin<br>Syrup/Suspension<br>Each<br>Bottle contains (1) 0.0048 Kgs of<br>Rifampicin BP/IP/USP. (Net Weight is<br>1177.008 Kgs) (+(2) 0.045 kgs. Of PG<br>(Propylene<br>Glycol<br>IP/BP/USP)(Net<br>weight is 11034.450 Kgs) & (3)0.0033<br>Kgs of Sorbitol IP /BP/USP(Net weight<br>is 809.193Kgs)) 120ml bottle.<br>1 kg.<br>3<br>Sorbitol IP/BP/USP<br>809.193 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Rifampicin<br>Syrup/Suspension<br>Each<br>Bottle contains (1) 0.0048 Kgs of<br>Rifampicin BP/IP/USP. (Net Weight is<br>1177.008 Kgs) (+(2) 0.045 kgs. Of PG<br>(Propylene<br>Glycol<br>IP/BP/USP)(Net<br>weight is 11034.450 Kgs) & (3)0.0033<br>Kgs of Sorbitol IP /BP/USP(Net weight<br>is 809.193Kgs)) 120ml bottle.	<br> <br> <br> <br> <br> <br> <br>1 kg.	1	Rifampicin BP/IP/USP	1177.68 kg.
			2	PG( Propylene glycol<br>IP/BP/USP)	11034.45 kg.
			3	Sorbitol IP/BP/USP	809.193 kg.

| 1 kg.|1|Rifampicin BP/IP/USP|1177.68 kg.| |---|---|---|---|---|---| ||||2|PG( Propylene glycol IP/BP/USP)|11034.45 kg.| ||||3|Sorbitol IP/BP/USP|809.193 kg.|

Case No.	5 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	GLOBE TROTTERS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004519AM25
RA File Number	039404000124 AM16
Licence No and<br>Date	0310796194/26/05/2015
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal<br>Hearing<br> before Norms Committee to explain its case along with all relevant details and Shipping Bills and<br>Bill of Entry.

Case No.	6 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	CELOGEN PHARMA PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004916AM25
RA File Number	039404000720 AM16
Licence No and Date	0310801132/16/12/2015
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc

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norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

fixation of ad-hoc norms and it was decided to fix ad-hoc||

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norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl.<br>No.	Import Items	Qty.<br>allowed.
SULPHACHLOROPYRAZINE 30% POWDER<br>(15GM) HiB3(Each gram powder<br>contains:SulfachloropyrazineSodiumMonohydrate<br>337.50mg.(Net<br>content/15Gram=5062.50mg)Total net content<br>50.625kg)	<br>10000<br>Numbers	1	Sulfachloropyrazine<br>Sodium Monohydrate	51.131 kg.

Case No.	7 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	BELOORBAYIR BIOTECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00007896AM24
RA File Number	072404000347 AM16
Licence No and<br>Date	0710109255/12/01/2016
Norms Committee Decision:<br>The Committee considered the case as per agenda and the Committee observed that import item are not as<br>per Drug Manufacturing License/FASSAI certificate, therefore, it was decided to call the firm for attending<br>Personal Hearing<br>before Norms Committee to explain its case along with relevant information /<br>documents, sample, COA of each import items.

Case No.	8 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved

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its case along with relevant information / documents, sample, COA of each import items.||

Case No.	8 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved

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Party Name	CELOGEN PHARMA PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004933AM25
RA File Number	039404000929 AM16
Licence No and Date	0310802331/08/02/2016
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.12/82-ALC4/2018 dated 12.12.2018 against advance authorization<br>No.0310820961 dated 14.05.2018, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>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>Sulphachloropyrazine 30%<br>Powder (15gm) HiB3((Each gram<br>powder<br>contains:Sulphachloropyrazine<br>Sodium<br>Monohydrate<br>337.50mg.)(Net<br>content/15Gram=5062.50mg)Total<br>net content 1012.50kg)<br>200000<br>Numbers<br>1<br>Sulphachloropyrazine<br>Sodium Monohydrate<br>1022.625 kg.<br>RA concerned may take further necessary action as per above decision of NC.

l net content 1012.50kg) 200000 Numbers 1 Sulphachloropyrazine Sodium Monohydrate 1022.625 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	9 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	CIPLA LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00000261AM24
RA File Number	039404000617 AM17
Licence No and Date	0310808312/06/10/2016
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

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Export Product	Qty.	Import Items	Qty.<br>allowed.
Tablets / Capsules(REMURES ULTRA<br>( Diosmin<br>450 mg + Hesparidine 50 mg )<br>coated tablets Pack 2 x 15 tablets =<br>30 Tablets in one Pack.(NET<br>CONTENT = 112.50 KGS),TOTAL<br>GROSS CONTENT (MFG<br>OVERAGES 5% + 2% MFG<br>LOSS)=120.375 KGS)	1<br>Number	Diosmin/Hesparidine<br>(90/10)	<br>510 mg.
Tablets/Capsules(REMURESULTRA<br>(Diosmin450mg+<br>Hesparidine50mg)<br>coatedtabletsPack4x15tablets=60Tablets<br>in one Pack.(NET CONTENT = 225.00<br>KGS) ,<br>TOTAL GROSS CONTENT (MFG<br>OVERAGES 5% + 2% MFG LOSS)=<br>240.750 KGS)	1<br>Number	Diosmin/Hesparidine<br>(90/10)	<br>510 mg.

tablets=60Tablets in one Pack.(NET CONTENT = 225.00 KGS) , TOTAL GROSS CONTENT (MFG OVERAGES 5% + 2% MFG LOSS)= 240.750 KGS)|1 Number|Diosmin/Hesparidine (90/10)| 510 mg.|

Case No.	10 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	MEGHMANI INDUSTRIES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00000008AM26
RA File Number	082404000293 AM17
Licence No and Date	0810139050/22/11/2016
Norms Committee Decision:

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Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
BROMOKETAL	1 kg.	1	2,4 DichloroAceteophenone	0.610 kg.
		2	1,2 Pentandiol	0.385 kg.
		3	Cychlohexane	0.0625 kg.

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
BROMOKETAL	1 kg.	1	2,4 DichloroAceteophenone	0.610 kg.
		2	1,2 Pentandiol	0.385 kg.
		3	Cychlohexane	0.0625 kg.

Case No.<br>	11 / NC/3/MEET/Apr/202526/2
Case Status<br>	Case Approved
Party Name<br>	CIPLA LIMITED
Meeting Number and Date<br>	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number<br>	HQRNORM REVIW00000263AM24
RA File Number<br>	039404001181 AM17
Licence No and Date<br>	0310812323/03/04/2017
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<br>HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br>allowed.<br>1 Fluticasone Propionate<br>6.0 mg.<br>15 Salmeterol<br>3.0 mg.<br>Fluticasone Propionate 50mcg<br>and Salmeterol 25mcg Inhaler<br>(120 MD)(with 61mcl<br>1<br>Number

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. 1 Fluticasone Propionate 6.0 mg. 15 Salmeterol 3.0 mg. Fluticasone Propionate 50mcg and Salmeterol 25mcg Inhaler (120 MD)(with 61mcl 1 Number||

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Aerosol Valve, 14ml<br>Aluminium Can, 0.48 mm<br>Actuator with dust cap, Dose<br>indicator 134A HFA 12.500<br>gms)		30	61mcl AEROSOL<br>VALVES	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		45	14ml ALUMINIUM<br>CAN	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		67	0.48 mm OD<br>ACTUATORS WITH<br>DUST COVERS /CAPS	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		75	Dose Indicator	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		90	1,1,1,2,Tetrafluoroethane	8.982<br>gm.
Fluticasone Propionate<br>125mcg and Salmeterol<br>25mcg Inhaler (120 MD)<br>(with 61mcl Aerosol Valve,<br>14ml Aluminium Can,<br>0.48mm<br>Actuator with dust cap, Dose<br>indicator<br>134A HFA 12.500 gms)	1<br>Number	2 <br>	Fluticasone Propionate	15.0<br>mg.
		16	Salmeterol	3.0 mg.
		31	61mcl AEROSOL<br>VALVES	As per<br>packing<br>policy<br>and<br>General<br>Notes.

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Number|2 |Fluticasone Propionate|15.0 mg.|| ||||16|Salmeterol|3.0 mg.|| ||||31|61mcl AEROSOL VALVES|As per packing policy and General Notes.||

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		46	14ml ALUMINIUM<br>CAN	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		68	0.48 mm OD<br>ACTUATORS WITH<br>DUST COVERS /CAPS	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		76	Dose Indicator	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		91	1,1,1,2,<br>Tetrafluoroethane	8.982<br>gm.
Fluticasone Propionate<br>250mcg and<br>Salmeterol 25mcg Inhaler<br>(120 MD)(with 61mcl<br>Aerosol Valve,<br>14ml Aluminium Can,<br>0.48mm<br>Actuator with dust cap,<br>Dose indicator 134A HFA<br>12.500 gms)	1<br>Number	3 <br>	Fluticasone Propionate	30.0<br>mg.
		17	Salmeterol	3.0 mg.
		32	61mcl AEROSOL<br>VALVES	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		47	14ml ALUMINIUM<br>CAN	As per<br>packing<br>policy<br>and<br>General<br>Notes.

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32|61mcl AEROSOL VALVES|As per packing policy and General Notes.|| ||||47|14ml ALUMINIUM CAN|As per packing policy and General Notes.||

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		69	0.48 mm OD<br>ACTUATORS WITH<br>DUST COVERS /CAPS	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		77	Dose Indicator	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		92	1,1,1,2,Tetrafluoroethane	8.98<br>gm.
Seroflo 50 Inhaler(120MD)/<br>Seroflo 25/50 mcg Inhaler<br>(120MD)/Salmeterol25mcg(&<br>Fluticasone Propionate<br>50mcgInhaler (120MD)<br>with 63mcl Aerosol Valve,<br>14ml Aluminium Can,<br>0.48mm Actuator with dust<br>cap,<br>Dose indicator 134A HFA<br>12.217 gms,<br>Alcohol 0.250)	<br>1<br>Number	4 <br>	Fluticasone Propionate	6.0 mg.
		18	Salmeterol	3.0 mg.
		35	63mcl AEROSOL<br>VALVES	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		48	14ml ALUMINIUM<br>CAN	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		70	0.48 mm OD<br>ACTUATORS WITH<br>DUST COVERS /CAPS	As per<br>packing<br>policy<br>and<br>General<br>Notes.

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s per packing policy and General Notes.|| ||||70|0.48 mm OD ACTUATORS WITH DUST COVERS /CAPS|As per packing policy and General Notes.||

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		78	Dose Indicator	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		93	1,1,1,2,Tetrafluoroethane	9.375<br>gm.
		105	ETHANOL	0.26<br>gm.
Seroflo125Inhaler(120MD)/<br>Seroflo25/125mcgInhaler<br>(120MD)<br>Salmeterol25mcg<br>(& Fluticasone<br>Propionate125 mcg Inhaler<br>(120MD) with 63mcl Aerosol<br>Valve,<br>14ml Aluminium Can,<br>0.48mm Actuator with dust<br>cap,<br>Dose indicator 134A HFA<br>12.205 gms,<br>Alcohol 0.250)	1<br>Number	5 <br>	Fluticasone Propionate	15.0<br>mg.
		19	Salmeterol	3.0 mg.
		36	63 mcl Aerosol Valves	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		49	14ml ALUMINIUM<br>CAN	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		71	0.48 mm OD<br>ACTUATORS WITH<br>DUST COVERS /CAPS	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		79	Dose Indicator	As per<br>packing

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al Notes.|| ||||71|0.48 mm OD ACTUATORS WITH DUST COVERS /CAPS|As per packing policy and General Notes.|| ||||79|Dose Indicator|As per packing||

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				policy<br>and<br>General<br>Notes.
		94	1,1,1,2,<br>Tetrafluoroethane	9.375<br>gm.
		106	ETHANOL	0.26<br>gm.
Seroflo250 Inhaler<br>(120MD)/Seroflo25/250 mcg<br>Inhaler (120MD) Salmeterol<br>25mcg &<br>(Fluticasone Propionate<br>250mcg Inhaler (120MD)<br>with 63 mcl Aerosol Valve,<br>14ml Aluminium Can, 0.48<br>mm Actuator with dust cap,<br>Dose indicator 134A HFA<br>12.185 gms, Alcohol 0.250)	1<br>Number	6 <br>	Fluticasone Propionate	30.0<br>mg.
		20	Salmeterol	3.0 mg.
		37	63 mcl AEROSOL<br>VALVES	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		50	14ml ALUMINIUM<br>CAN	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		72	0.48 mm OD<br>ACTUATORS WITH<br>DUST COVERS /CAPS	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		80	Dose Indicator	As per<br>packing<br>policy<br>and

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||72|0.48 mm OD ACTUATORS WITH DUST COVERS /CAPS|As per packing policy and General Notes.|| ||||80|Dose Indicator|As per packing policy and||

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				General<br>Notes.
		95	1,1,1,2,<br>Tetrafluoroethane	9.375<br>gm.
		107	ETHANOL	0.26<br>gm.
Rexair 50 Inhaler (120 MD)<br>Salmeterol 25mcg &<br>Fluticasone Propionate 50mcg<br>Inhaler (120MD) (with 63mcl<br>Aerosol Valve, 14ml<br>Aluminium Can, 0.42mm<br>Actuator with dust cap, Dose<br>indicator 134A HFA 12.530<br>gms, Alcohol 0.256)	<br>1<br>Number	7 <br>	Fluticasone Propionate	6.0 mg.
		21	Salmeterol	3.0 mg.
		38	63 mcl AEROSOL<br>VALVES	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		51	14ml ALUMINIUM<br>CAN	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		60	0.42 mm OD<br>ACTUATORS WITH<br>DUST COVERS /CAPS	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		81	Dose Indicator	As per<br>packing<br>policy<br>and<br>General<br>Notes.

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TUATORS WITH DUST COVERS /CAPS|As per packing policy and General Notes.|| ||||81|Dose Indicator|As per packing policy and General Notes.||

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		96	1,1,1,2,<br>Tetrafluoroethane	9.375<br>gm.
		108	ETHANOL	0.26<br>gm.
Rexair 125 Inhaler (120 MD)<br>Salmeterol 25mcg &<br>Fluticasone Propionate<br>125mcg Inhaler (120MD)<br>(with 63mcl Aerosol Valve,<br>14 ml Aluminium Can,<br>0.42mm Actuator with dust<br>cap, Dose indicator 134A<br>HFA 12.518 gms, Alcohol<br>0.256)	1<br>Number	8 <br>	Fluticasone Propionate	15.0<br>mg.
		22	Salmeterol	3.0 mg.
		39	61mcl AEROSOL<br>VALVES	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		52	14ml ALUMINIUM<br>CAN	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		61	0.42 mm OD<br>ACTUATORS WITH<br>DUST COVERS /CAPS	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		82	Dose Indicator	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		97	1,1,1,2,<br>Tetrafluoroethane	9.375<br>gm.

UDIN00137349AM26

br>policy and General Notes.|| ||||82|Dose Indicator|As per packing policy and General Notes.|| ||||97|1,1,1,2, Tetrafluoroethane|9.375 gm.||

UDIN00137349AM26

		109	ETHANOL	0.26<br>gm.
Rexair 250 Inhaler (120 MD)<br>Salmeterol 25mcg &<br>Fluticasone Propionate<br>250mcg Inhaler (120MD)<br>(with 63mcl Aerosol Valve,<br>14ml Aluminium Can,<br>0.42mm Actuator with dust<br>cap, Dose indicator 134A<br>HFA 12.498 gms, Alcohol<br>0.256)	1<br>Number	9 <br>	Fluticasone Propionate	30.0<br>mg.
		23	Salmeterol	3.0 mg.
		40	63 mcl AEROSOL<br>VALVES	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		53	14ml ALUMINIUM<br>CAN	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		62	0.42 mm OD<br>ACTUATORS WITH<br>DUST COVERS /CAPS	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		83	Dose Indicator	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		98	1,1,1,2,Tetrafluoroethane	9.375<br>gm.
		110	ETHANOL	0.26<br>gm.

UDIN00137349AM26

l Notes.|| ||||83|Dose Indicator|As per packing policy and General Notes.|| ||||98|1,1,1,2,Tetrafluoroethane|9.375 gm.|| ||||110|ETHANOL|0.26 gm.||

UDIN00137349AM26

Meterol Inhaler (120 MD)<br>Salmeterol 25mcg Inhaler<br>(120 MD)(with 63mcl<br>Aerosol Valve, 14ml<br>Aluminium Can, 0.42mm<br>Actuator with dust cap, Dose<br>indicator 134A HFA 12.537<br>gms, Alcohol 0.256)	<br> <br>1<br>Number	24 <br>	Salmeterol	3.0 mg.
		41	63 mcl AEROSOL<br>VALVES	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		54	14ml ALUMINIUM<br>CAN	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		63	0.42 mm OD<br>ACTUATORS WITH<br>DUST COVERS /CAPS	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		84	Dose Indicator	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		99	1,1,1,2,<br>Tetrafluoroethane	9.375<br>gm.
		111	ETHANOL	0.26<br>gm.
Floair 50 Inhaler (120 MD)<br>Salmeterol 25mcg &<br>Fluticasone Propionate 50mcg<br>Inhaler (120MD) (with 63mcl<br>Aerosol Valve, 14ml<br>Aluminium Can, 0.42mm	<br>1<br>Number	10 <br>	Fluticasone Propionate	6.0 mg.
		25	Salmeterol	3.0 mg.
		42	63 mcl AEROSOL	As per

UDIN00137349AM26

h 63mcl Aerosol Valve, 14ml Aluminium Can, 0.42mm| 1 Number|10 |Fluticasone Propionate|6.0 mg.|| ||||25|Salmeterol|3.0 mg.|| ||||42|63 mcl AEROSOL|As per||

UDIN00137349AM26

Actuator with dust cap, Dose<br>indicator 134A HFA 12.530<br>gms, Alcohol 0.256)			VALVES	packing<br>policy<br>and<br>General<br>Notes.
		55	14ml ALUMINIUM<br>CAN	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		64	0.42 mm OD<br>ACTUATORS WITH<br>DUST COVERS /CAPS	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		85	Dose Indicator	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		100	1,1,1,2,<br>Tetrafluoroethane	9.375<br>gm.
		112	ETHANOL	0.26<br>gm.
Floair 125 Inhaler (120 MD)<br>Salmeterol 25mcg &<br>Fluticasone Propionate<br>125mcg Inhaler (120MD)<br>(with 63mcl Aerosol Valve,<br>14ml Aluminium Can,<br>0.42mm Actuator with dust<br>cap, Dose indicator 134A<br>HFA 12.518 gms, Alcohol	1<br>Number	11 <br>	Fluticasone Propionate	15.0<br>mg.
		26	Salmeterol	3.0 mg.
		43	63 mcl AEROSOL<br>VALVES	As per<br>packing<br>policy

UDIN00137349AM26

HFA 12.518 gms, Alcohol|1 Number|11 |Fluticasone Propionate|15.0 mg.|| ||||26|Salmeterol|3.0 mg.|| ||||43|63 mcl AEROSOL VALVES|As per packing policy||

UDIN00137349AM26

0.256)				and<br>General<br>Notes.
		56	14ml ALUMINIUM<br>CAN	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		65	0.42 mm OD<br>ACTUATORS WITH<br>DUST COVERS /CAPS	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		86	Dose Indicator	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		101	1,1,1,2,<br>Tetrafluoroethane	9.375<br>gm.
		113	ETHANOL	0.26<br>gm.
Floair 250 Inhaler (120 MD)<br>Salmeterol 25mcg &<br>Fluticasone Propionate<br>250mcg Inhaler (120MD)<br>(with 63mcl Aerosol Valve,<br>14ml Aluminium Can,<br>0.42mm Actuator with dust<br>cap, Dose indicator 134A<br>HFA 12.498 gms, Alcohol<br>0.256)	1<br>Number	12 <br>	Fluticasone Propionate	30.0<br>mg.
		27	Salmeterol	3.0 mg.
		44	63 mcl AEROSOL<br>VALVES	As per<br>packing<br>policy<br>and<br>General

UDIN00137349AM26

0.256)|1 Number|12 |Fluticasone Propionate|30.0 mg.|| ||||27|Salmeterol|3.0 mg.|| ||||44|63 mcl AEROSOL VALVES|As per packing policy and General||

UDIN00137349AM26

				Notes.
		57	14ml ALUMINIUM<br>CAN	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		66	0.42 mm OD<br>ACTUATORS WITH<br>DUST COVERS /CAPS	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		87	Dose Indicator	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		102	1,1,1,2,<br>Tetrafluoroethane	9.375<br>gm.
		114	ETHANOL	0.26<br>gm.
Airflusal 25/125 mcg Inhaler<br>(120 MD) Salmeterol 25mcg<br>&<br>(Fluticasone Propionate<br>125mcg Inhaler (120MD)<br>with 61mcl Aerosol Valve,<br>14ml Aluminium Can,<br>0.48mm Actuator with dust<br>cap, Dose indicator 134A<br>HFA 12.500 gms)	1<br>Number	13 <br>	Fluticasone Propionate	15.0<br>mg.
		28	Salmeterol	3.0 mg.
		33	61mcl AEROSOL<br>VALVES	As per<br>packing<br>policy<br>and<br>General<br>Notes.

UDIN00137349AM26

br>Number|13 |Fluticasone Propionate|15.0 mg.|| ||||28|Salmeterol|3.0 mg.|| ||||33|61mcl AEROSOL VALVES|As per packing policy and General Notes.||

UDIN00137349AM26

		58	14ml ALUMINIUM<br>CAN	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		73	0.48 mm OD<br>ACTUATORS WITH<br>DUST COVERS /CAPS	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		88	Dose Indicator	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		103	1,1,1,2,<br>Tetrafluoroethane	8.982<br>gm.
Airflusal 25/250 mcg Inhaler<br>(120 MD) Salmeterol 25mcg<br>& Fluticasone Propionate 250<br>mcg Inhaler (120MD)<br>(with 61 mcl Aerosol Valve,<br>14ml Aluminium Can,<br>0.48mm Actuator with dust<br>cap, Dose indicator 134A<br>HFA 12.500 gms)	1<br>Number	14 <br>	Fluticasone Propionate	30.0<br>mg.
		29	Salmeterol	3.0 mg.
		34	61mcl AEROSOL<br>VALVES	As per<br>packing<br>policy<br>and<br>General<br>Notes.
		59	14ml ALUMINIUM<br>CAN	As per<br>packing<br>policy<br>and<br>General<br>Notes.

UDIN00137349AM26

==> picture [352 x 267] intentionally omitted <==

----- Start of picture text ----- 74 0.48 mm OD As per ACTUATORS WITH packing DUST COVERS /CAPS policy and General Notes. 89 Dose Indicator As per packing policy and General Notes. 104 1,1,1,2, 8.968 Tetrafluoroethane gm. ----- End of picture text -----

and General Notes. 89 Dose Indicator As per packing policy and General Notes. 104 1,1,1,2, 8.968 Tetrafluoroethane gm. ----- End of picture text -----

Case No.	Case No.	12 / NC/3/MEET/Apr/202526/2	12 / NC/3/MEET/Apr/202526/2	12 / NC/3/MEET/Apr/202526/2	12 / NC/3/MEET/Apr/202526/2	12 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		ALPHAMED FORMULATIONS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM REVIW00005062AM25
RA File Number		092404000670 AM17
Licence No and<br>Date		0910064868/06/04/2017
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.7/82-ALC4/2020 dated 04/12/2020against advance authorization<br>No.0910066310 dated08/06/2018, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00137349AM26

plied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

UDIN00137349AM26

Magnesia De Phillips Chewable<br>Tablets (Mint Flavour)	<br>10494300<br>Numbers	1	Magnesium Hydroxide	1636.58 kg.
		3	GalaenIQ 720 (Isomalt)	3105.89 kg.
		5	Povidone	1049.43 kg.
		7	Mannitol	1787.59 kg.
		9	Aspartame	283.34 kg.
		11	Mint Flavour	125.93 kg.
Magnesia De Phillips Chewable<br>Tablets (Strawberry Flavour)	<br>6996200<br>Numbers	2	Magnesium Hydroxide	1091.05 kg.
		4	GalaenIQ 720 (Isomalt)	2070.59 kg.
		6	Povidone	699.62 kg.
		8	Mannitol	1191.73 kg.
		10	Aspartame	188.89 kg.
		12	Strawberry Flavour	181.90 kg.

agnesium Hydroxide|1091.05 kg.| ||||4|GalaenIQ 720 (Isomalt)|2070.59 kg.| ||||6|Povidone|699.62 kg.| ||||8|Mannitol|1191.73 kg.| ||||10|Aspartame|188.89 kg.| ||||12|Strawberry Flavour|181.90 kg.|

Case No.	13 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00003138AM25
RA File Number	092404000040 AM18
Licence No and Date	0910065196/22/06/2017

UDIN00137349AM26

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Mar/202425/18 dated 17/03/2025 against advance authorization No.0910065113 dated 31/05/2017, 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.
GCLE(7-PHENYL<br>ACETAMIDEO-3-<br>CHLOROMETHYL<br>CEPHALOSPORANIC ACID<br>PARA-METHOXY<br>BENZYL ESTER)	<br>1 kg.	1	PENICILLIN G-POTASSIUM<br>FIRST CRYSTAL	1.375 kg.
		2	ACETONE	1.971 kg.
		3	ISOPROPYL ALCOHOL	0.66 kg.
		4	METHYLENE CHLORIDE(MDC)	3.29 kg.
		5	2 MERCAPTO BENZO<br>THIAZOLE(MBT)	0.511 kg.
		6	METHANOL	1.971 kg.

Case No.	14 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00003372AM25
RA File Number	092404000078 AM18
Licence No and Date	0910065210/23/06/2017
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export

UDIN00137349AM26

No and Date|0910065210/23/06/2017| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export||

UDIN00137349AM26

product/import item in meeting No.NC/3/MEET/Mar/202425/18 dated 17/03/2025 against advance authorization No.0910065113 dated 31/05/2017, 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.
GCLE(7-PHENYL<br>ACETAMIDEO-3-<br>CHLOROMETHYL<br>CEPHALOSPORANIC ACID<br>PARA-METHOXY<br>BENZYL ESTER)	<br>1 kg.	1	PENICILLIN G-POTASSIUM<br>FIRST CRYSTAL	1.375 kg.
		2	ACETONE	1.971 kg.
		3	ISOPROPYL ALCOHOL	0.66 kg.
		4	METHYLENE<br>CHLORIDE(MDC)	3.29 kg.
		5	2 MERCAPTO BENZO<br>THIAZOLE(MBT)	0.511 kg.
		6	METHANOL	1.971 kg.

Case No.	15 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00000262AM24
RA File Number	039404000295 AM18
Licence No and<br>Date	0310814908/31/07/2017
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

UDIN00137349AM26

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

UDIN00137349AM26

Case No.	16 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00003369AM25
RA File Number	092404000205 AM18
Licence No and Date	0910065611/27/10/2017
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Mar/202425/18 dated 17/03/2025 against advance<br>authorization No.0910065113 dated 31/05/2017, 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>PENICILLIN G-<br>POTASSIUM FIRST<br>CRYSTAL<br>1.375 kg.<br>2<br>ACETONE<br>1.971 kg.<br>3<br>ISOPROPYL<br>ALCOHOL<br>0.66 kg.<br>4<br>METHYLENE<br>CHLORIDE(MDC)<br>3.29 kg.<br>5<br>2 MERCAPTO BENZO<br>THIAZOLE(MBT)<br>0.511 kg.<br>GCLE(7-PHENYL<br>ACETAMIDEO-3-<br>CHLOROMETHYL<br>CEPHALOSPORANIC ACID<br>PARA-METHOXY<br>BENZYL ESTER)<br>1 kg.<br>6<br>METHANOL<br>1.971 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00137349AM26

PHALOSPORANIC ACID PARA-METHOXY BENZYL ESTER) 1 kg. 6 METHANOL 1.971 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00137349AM26

Case No.	17 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00003370AM25
RA File Number	092404000371 AM18
Licence No and Date	0910065770/20/12/2017
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Mar/202425/18 dated 17/03/2025 against advance<br>authorization No.0910065113 dated 31/05/2017, 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>PENICILLIN G-<br>POTASSIUM FIRST<br>CRYSTAL<br>1.375 kg.<br>2<br>ACETONE<br>1.971 kg.<br>3<br>ISOPROPYL<br>ALCOHOL<br>0.66 kg.<br>4<br>METHYLENE<br>CHLORIDE(MDC)<br>3.29 kg.<br>5<br>2 MERCAPTO BENZO<br>THIAZOLE(MBT)<br>0.511 kg.<br>GCLE(7-PHENYL<br>ACETAMIDEO-3-<br>CHLOROMETHYL<br>CEPHALOSPORANIC ACID<br>PARA-METHOXY<br>BENZYL ESTER)<br>1 kg.<br>6<br>METHANOL<br>1.971 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00137349AM26

PHALOSPORANIC ACID PARA-METHOXY BENZYL ESTER) 1 kg. 6 METHANOL 1.971 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00137349AM26

Case No.	18 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00003371AM25
RA File Number	092404000436 AM18
Licence No and Date	0910065771/20/12/2017
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Mar/202425/18 dated 17/03/2025 against advance<br>authorization No.0910065113 dated 31/05/2017, 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>PENICILLIN G-<br>POTASSIUM FIRST<br>CRYSTAL<br>1.375 kg.<br>2<br>ACETONE<br>1.971 kg.<br>3<br>ISOPROPYL<br>ALCOHOL<br>0.66 kg.<br>4<br>METHYLENE<br>CHLORIDE(MDC)<br>3.29 kg.<br>5<br>2 MERCAPTO BENZO<br>THIAZOLE(MBT)<br>0.511 kg.<br>GCLE(7-PHENYL<br>ACETAMIDEO-3-<br>CHLOROMETHYL<br>CEPHALOSPORANIC ACID<br>PARA-METHOXY<br>BENZYL ESTER)<br>1 kg.<br>6<br>METHANOL<br>1.971 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00137349AM26

PHALOSPORANIC ACID PARA-METHOXY BENZYL ESTER) 1 kg. 6 METHANOL 1.971 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00137349AM26

Case No.	Case No.	19 / NC/3/MEET/Apr/202526/2	19 / NC/3/MEET/Apr/202526/2	19 / NC/3/MEET/Apr/202526/2	19 / NC/3/MEET/Apr/202526/2	19 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		CIPLA LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM REVIW00000265AM24
RA File Number		039404000822 AM18
Licence No and Date		0310818765/30/01/2018
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<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>58 mcl AEROSOL<br>VALVES<br>As per packing<br>policy and<br>General Notes.<br>5<br>19ml ALUMINIUM<br>CAN<br>As per packing<br>policy and<br>General Notes.<br>9<br>0.48 mm OD<br>ACTUATORS WITH<br>DOSE COUNTER<br>As per packing<br>policy and<br>General Notes.<br>Budesonide Inhaler 200mcg<br>(200MD) / BUDEFLAM<br>200mcg Inhaler (200MD)<br>Budespray / Budecort /<br>Budemar<br>/(Aerovial<br>Inhaler<br>200mcg<br>(200MD) with 58mcl Aerosol<br>Valve, 19ml Aluminium Can,<br>0.48<br>Actuator<br>134A<br>HFA<br>18.20 gms)<br>1 Number<br>13<br>1,1,1,2,Tetrafluoroethane<br>( HFA 134A Propellant )<br>15.20 gm.<br>2<br>58 mcl AEROSOL<br>VAL

osol Valve, 19ml Aluminium Can, 0.48 Actuator 134A HFA 18.20 gms) 1 Number 13 1,1,1,2,Tetrafluoroethane ( HFA 134A Propellant ) 15.20 gm. 2 58 mcl AEROSOL VALVES As per packing policy and General Notes. Foracort 100 Inhaler (120MD) / Formoterol Fumarate and Budesonide Inhaler 6/100 mcg (120MD)(with 58mcl Aerosol Valve, 19ml Aluminium Can, 0.48 Actuator 134A HFA As per packing policy and 1 Number 6 19ml ALUMINIUM CAN||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Budesonide Inhaler 200mcg (200MD) / BUDEFLAM 200mcg Inhaler (200MD) Budespray / Budecort / Budemar /(Aerovial Inhaler 200mcg (200MD) with 58mcl Aerosol Valve, 19ml Aluminium Can, 0.48 Actuator 134A HFA 18.20 gms)|| 1 Number|1|58 mcl AEROSOL VALVES|As per packing policy and General Notes.| |||||5|19ml ALUMINIUM CAN|As per packing policy and General Notes.| |||||9|0.48 mm OD ACTUATORS WITH DOSE COUNTER|As per packing policy and General Notes.| |||||13|1,1,1,2,Tetrafluoroethane ( HFA 134A Propellant )| 15.20 gm.| ||Foracort 100 Inhaler (120MD) / Formoterol Fumarate and Budesonide Inhaler 6/100 mcg (120MD)(with 58mcl Aerosol Valve, 19ml Aluminium Can, 0.48 Actuator 134A HFA|| 1 Number|2|58 mcl AEROSOL VALVES|As per packing policy and General Notes.| |||||6|19ml ALUMINIUM CAN|As per packing policy and|

UDIN00137349AM26

tor 134A HFA|| 1 Number|2|58 mcl AEROSOL VALVES|As per packing policy and General Notes.| |||||6|19ml ALUMINIUM CAN|As per packing policy and|

UDIN00137349AM26

14.50 gms)	14.50 gms)				General Notes.
			10	0.48 mm OD	As per packing
				<br>ACTUATORS WITH	<br>policy and
				DOSE COUNTER	<br>General Notes.

			14	1,1,1,2,Tetrafluoroethane<br>	<br>9.12 gm.
				( HFA 134A Propellant )


Foracort 200<br>/ Formoterol	Inhaler (120MD)<br>Fumarate and	1 Number	3	58 mcl AEROSOL<br>VALVES	As per packing<br>policy and
Budesonide Inhaler 6/200 mcg<br>(120MD)(with 58mcl Aerosol<br>Valve, 19ml Aluminium Can,<br>0.48<br>Actuator<br>134A<br>HFA<br>12.20 gms)		<br>			<br>General Notes.
			7	19ml ALUMINIUM<br>CAN	As per packing<br>policy and<br>General Notes.
			11	048 mm OD	As per packing
				.<br>ACTUATORS WITH<br>DOSE COUNTER	<br>policy and<br>General Notes.

			15	1,1,1,2,Tetrafluoroethane	<br>9.12 gm.
				( HFA 134A Propellant )
Aerogold Inhaler 100mcg<br>(200MD) Salbutamol 100		1 Number	4	58 mcl AEROSOL<br>VALVES	As per packing<br>policy and
<br>Pressurised Inhalation (200<br>MD)(with 58mcl Aerosol<br>Valve, 19ml					<br>General Notes.
			8	19ml ALUMINIUM<br>	As per packing<br>
Aluminium C<br>	an, 0.48 Actuator<br>			CAN	policy and<br>
134A HFA 1	8.20 gms)				General Notes.


			12	0.48 mm OD<br>ACTUATORS WITH	As per packing<br>policy and

||Aluminium C |an, 0.48 Actuator |||||CAN|policy and | ||134A HFA 1|8.20 gms)||||||General Notes.| |||||||||| |||||||||| ||||||12||0.48 mm OD ACTUATORS WITH|As per packing policy and| ||||||||DOSE COUNTER| General Notes.| |||||||||| ||||||16||1,1,1,2,Tetrafluoroethane | 15.20 gm.| |( HFA 134A Propellant )|||||||( HFA 134A Propellant )|| ||||||||||

UDIN00137349AM26

Case No.	20 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	BALAJI AMINES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004550AM25
RA File Number	318304000020 AM19
Licence No and Date	3110067057/21/05/2018
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was decided to revise ad-<br>hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is<br>less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>GAMMA<br>BUTYROLACTONE<br>0.810 kg.<br>N-ETHYL-2-PYRROLIDONE 1 kg.<br>2<br>MONOETHYLAMINE<br>70% SOLUTION<br>0.610 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	21 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	SMILAX LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00003518AM25
RA File Number	092404000128 AM19

UDIN00137349AM26

UDIN00137349AM26

Licence No and 0910066351/19/06/2018 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Jul/202425/7dated 06/08/2024 against advance authorization No.0910066351dated 19/06/2018, it was decided to revise 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.
PANTOPRAZOLE BASE	1 kg.	1	MALTOL	0.80 kg.

Case No.<br>22 / NC/3/MEET/Apr/202526/2	Case No.<br>22 / NC/3/MEET/Apr/202526/2
Case Status<br>Case Approved
Party Name<br>STERLING AUXILIARIES PVT LTD
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number<br>HQRNORM REVIW00004999AM25
RA File Number<br>039504000332 AM19
Licence No and<br>Date<br>0310822247/11/07/2018
Norms Committee Decision:
The Committee considered the request of firm for fixation of ad-hoc norms 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.

ecided 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.|| |STERO MDEA -PIP (SP)| 200000 kg.|1||METHYL DI|110000 kg.|| |(Blends of Piperazine &||||ETHANOL AMINE||| |Methyl Di Ethanol Amine)||||(MDEA)|||

Case No.<br>22 / NC/3/MEET/Apr/202526/2	Case No.<br>22 / NC/3/MEET/Apr/202526/2
Case Status<br>Case Approved
Party Name<br>STERLING AUXILIARIES PVT LTD
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number<br>HQRNORM REVIW00004999AM25
RA File Number<br>039504000332 AM19
Licence No and<br>Date<br>0310822247/11/07/2018
Norms Committee Decision:
The Committee considered the request of firm for fixation of ad-hoc norms 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.
STERO MDEA -PIP (SP)	<br>200000 kg.	1		METHYL DI	110000 kg.
(Blends<br>of<br>Piperazine<br>&				ETHANOL AMINE
Methyl Di Ethanol Amine)				(MDEA)

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Qty. allowed.|| |STERO MDEA -PIP (SP)| 200000 kg.|1||METHYL DI|110000 kg.|| |(Blends of Piperazine &||||ETHANOL AMINE||| |Methyl Di Ethanol Amine)||||(MDEA)|||

UDIN00137349AM26

		2	PIPERAZINE 68%	110000 kg.
STERO NMMO 50 ( N-<br>Methyl Morpholine Oxide)	<br>150000 kg.	3	MORPHOLINE	73500 kg.
		4	FORMALDEHYDE<br>37%	57150 kg.
		5	FORMIC ACID 85%	38100 kg.
		6	HYDROGEN<br>PEROXIDE	27750 kg.

Case No.	Case No.	23 / NC/3/MEET/Apr/202526/2	23 / NC/3/MEET/Apr/202526/2	23 / NC/3/MEET/Apr/202526/2	23 / NC/3/MEET/Apr/202526/2	23 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		VINS BIOPRODUCTS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM REVIW00003479AM25
RA File Number		092404000363 AM19
Licence No and Date		0910066851/14/11/2018
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl.

ee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. allowed. Tetanus Antitoxin IHS/BP 1000IU / 1500IU - PFS / VIALS/ Ampoules 100000 Vials 1 Tetanus Antitoxin 3000IU/ML 57.5 Liter||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Tetanus Antitoxin IHS/BP 1000IU / 1500IU - PFS / VIALS/ Ampoules||100000 Vials|1|Tetanus Antitoxin 3000IU/ML|57.5 Liter|

UDIN00137349AM26

Case No.	24 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	GLOBE TROTTERS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004505AM25
RA File Number	039404000713 AM19
Licence No and<br>Date	0310825212/26/11/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Hearing<br>before Norms Committee to explain its case along with all relevant details and Shipping<br>Bill of Entry.		Personal<br>Bills and

da and it was decided to call the firm for attending Hearing before Norms Committee to explain its case along with all relevant details and Shipping Bill of Entry.||Personal Bills and|

Case No.	Case No.	25 / NC/3/MEET/Apr/202526/2	25 / NC/3/MEET/Apr/202526/2	25 / NC/3/MEET/Apr/202526/2	25 / NC/3/MEET/Apr/202526/2	25 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		BALAJI AMINES LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM REVIW00004549AM25
RA File Number		318304000149 AM19
Licence No and Date		3110067274/31/12/2018
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc<br>norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is<br>less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>GAMMA BUTYROLACTONE 0.810 kg.<br>N-ETHYL-2-PYRROLIDONE<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	N-ETHYL-2-PYRROLIDONE		1 kg.	1	GAMMA BUTYROLACTONE	0.810 kg.

UDIN00137349AM26

	2	MONOETHYLAMINE	70%	0.610	kg.
		SOLUTION

Import Items|Qty. allowed.| ||N-ETHYL-2-PYRROLIDONE||1 kg.|1|GAMMA BUTYROLACTONE|0.810 kg.|

UDIN00137349AM26

	2	MONOETHYLAMINE	70%	0.610	kg.
		SOLUTION

Case No.	26 / NC/3/MEET/Apr/202526/2
Case Status	Case Rejected
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00007594AM24
RA File Number	039404001019 AM19
Licence No and<br>Date	0310827414/01/03/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, it was decided to<br>rejectthe case maintaining thestatus quo.

Case No.	Case No.	27 / NC/3/MEET/Apr/202526/2	27 / NC/3/MEET/Apr/202526/2	27 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		SRF LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM REVIW00004742AM25
RA File Number		052404000296 AM20
Licence No and<br>Date		0510411778/06/09/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl.

basis of information provided by the firm, it was decided to revise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

UDIN00137349AM26

1<br>HYPE<br>0.978 kg.<br>TESA-1-(3-<br>CHLOROPYRIDIN-2YL)-3-<br>[5-(TRIFLUOROMETHYL)-<br>2H TETRAZOL-<br>2YLMETHYL-1H-<br>PYRAZOLE-5-CARBOXYLIC<br>ACID<br>1 kg.<br>2<br>TFMT-NA<br>1.91 kg.<br>RA concerned may take further necessary action as per above decision of NC.	TESA-1-(3-<br>CHLOROPYRIDIN-2YL)-3-<br>[5-(TRIFLUOROMETHYL)-<br>2H TETRAZOL-<br>2YLMETHYL-1H-<br>PYRAZOLE-5-CARBOXYLIC<br>ACID	<br>1 kg.	1	HYPE	0.978 kg.
			2	TFMT-NA	1.91 kg.

Case No.	28 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00000048AM25
RA File Number	318304000087 AM20
Licence No and<br>Date	3110067548/30/09/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing<br>before Norms Committee to explain its case alongwith relevant information / documents from the firm.

the case as per agenda and it was decided to call the firm for attendingPersonal Hearing before Norms Committee to explain its case alongwith relevant information / documents from the firm.|||

Case No.	29 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	VINS BIOPRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00003485AM25
RA File Number	092404000410 AM20
Licence No and<br>Date	0910068189/15/11/2019
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc

UDIN00137349AM26

norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Tetanus<br>Antitoxin<br>HIS/BP<br>1500 IU, Plus [overage of 150<br>IU in addition] in PFS / vials /<br>Ampoule	<br> <br> <br>100,000<br>Vials	1	Tetanus Antitoxin<br>2500IU/ML<br>(Condition:- Import is<br>allowed as per Form 10<br>No.	69.3 Liter

Case No.	Case No.	30 / NC/3/MEET/Apr/202526/2	30 / NC/3/MEET/Apr/202526/2	30 / NC/3/MEET/Apr/202526/2	30 / NC/3/MEET/Apr/202526/2	30 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		BALAJI AMINES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM REVIW00004548AM25
RA File Number		318304000117 AM20
Licence No and<br>Date		3110067616/02/12/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was decided to revise ad-<br>hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever<br>is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Methanol<br>0.37 kg<br>2<br>Ammonia Anhydrous<br>0.16 kg<br>N-Methyl-2-Pyrrolidone<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	N-Methyl-2-Pyrrolidone		1 kg.	1	Methanol	0.37 kg
				2	Ammonia Anhydrous	0.16 kg

UDIN00137349AM26

3 Gamma Butyrolactone 0.9 kg

ort Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||N-Methyl-2-Pyrrolidone||1 kg.|1|Methanol|0.37 kg| |||||2|Ammonia Anhydrous|0.16 kg|

UDIN00137349AM26

3 Gamma Butyrolactone 0.9 kg

3<br>Gamma Butyrolactone<br>0.9 kg					3	Gamma Butyrolactone	Gamma Butyrolactone

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






Case No.			31 / NC/3/MEET/Apr/202526/2
Case Status			Case Approved

Party Name			WEXFORD LABORATORIES PRIVATE LIMITED
Meeting Number and<br>Date			NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number			HQRNORM REVIW00003752AM25
RA	File Number		072404000302 AM20

Lic	ence No and Date		0710116263/16/0	3/2020
Nor<br>Th<br>pr<br>N<br>de	ms Committee Decision:
	e Committee considered the case as<br>oduct/import item in meeting N<br>o.0710115236dated01/08/2019, it w			per agenda<br>o. 6/82-aLC<br>as decided to	and takin<br>4/2020d<br>fix ad-h	g cue from the earlier d<br>ated 13/11/202against<br>oc norms under Para 4.0	ecision for same export<br>advance authorization<br>7 of HBP Vol.

LC as decided to||||and takin 4/2020d fix ad-h||g cue from the earlier d ated 13/11/202against oc norms under Para 4.0|ecision for same export advance authorization 7 of HBP Vol. I as per|||| ||tails given below or as applied by the firm, whichever is less:-|||||||||||||||||| |||||||||||||||||||| ||Export Product||||||Qty.||||Sl. No.|||Import Items||Qty. allowed.||| |||||||||||||||||||| ||CEFADROXIL CA|||PSULES|||1 Number||||1|||CEFADROXIL||510 mg/500 mg||| ||USP 500MG (46 KG|||)||||||||||MONOHYDRATE USP||Capsule||| |||||||||||||||||||| |||||||||||||||||||| ||CEFADROXIL CA|||SULES|||1 Number||||2|||CEFADROXIL||510 mg/500 mg||| || USP 500MG (46 KG||| )|||||||||| MONOHYDRATE USP|| Capsule||| |||||||||||||||||||| |||||||||||||||||||| ||CEFADROXIL CAPSULES USP 500MG (46 KG)||||||1 Number||||3|||CEFADROXIL MONOHYDRATE USP||510 mg/500 mg Capsule||| ||CEFADROXIL CAPSULES USP 500MG - CETRALON (92KG)|||||| 1 Number||||4|||CEFADROXIL MONOHYDRATE USP||510 mg/500 mg Capsule||| |||||||||||||||||||| ||CEFADROXIL FOR||||ORAL|| 1 Num||ber||5|||CEFADROXIL||5.2||48 gm/Bottle| ||||||||||||||||||||

UDIN00137349AM26

SUSPENSION	USP			MONOHYDRATE USP
250MG/5ML -	CETRALON,
100 ML (46 KG)

5|||CEFADROXIL||5.2||48 gm/Bottle| ||||||||||||||||||||

UDIN00137349AM26

SUSPENSION	USP			MONOHYDRATE USP
250MG/5ML -	CETRALON,
100 ML (46 KG)

Case No.	32 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	ALPHAMED FORMULATIONS PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00005185AM25
RA File Number	092404000160 AM21
Licence No and Date	0910068998/28/07/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc<br>norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is<br>less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>NACOL 18-98 P (Stearl<br>Alcohol)<br>2160 kg.<br>PLENISH-K<br>600<br>SR<br>TABLETS((Each<br>Tablet<br>Contains<br>-<br>600<br>Mg<br>of<br>Potassium Chloride))<br>36000000Numbers<br>2<br>Ethanol Absolute (Ethanol<br>Anhydrous) Suitable for<br>use as excipient<br>2502 Ltr.<br>The above norms is given alongwith condition mentioned in the authorization.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 33 / NC/3/MEET/Apr/202526/2

UDIN00137349AM26

alongwith condition mentioned in the authorization. RA concerned may take further necessary action as per above decision of NC.||

Case No. 33 / NC/3/MEET/Apr/202526/2

UDIN00137349AM26

Case Status	Case Approved
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004949AM25
RA File Number	052404000258 AM21
Licence No and<br>Date	0510415088/02/09/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>HYPE<br>0.978 kg.<br>TESA-1-(3-<br>CHLOROPYRIDIN-2YL)-3-<br>[5-(TRIFLUOROMETHYL)-<br>2H TETRAZOL-<br>2YLMETHYL-1H-<br>PYRAZOLE-5-CARBOXYLIC<br>ACID<br>1 kg.<br>2<br>TFMT-NA<br>1.91 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	34 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	CIPLA LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00000254AM24
RA File Number	03AA04011698 AM21
Licence No and Date	0311000235/21/12/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and<br>it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per

UDIN00137349AM26

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

ation of ad-hoc norms and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per||

UDIN00137349AM26

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

|details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Efavirenz 612 mg. 2 Lamivudine 306 mg. 3 Tenofovir Disoproxil Fumarate 306 mg. 4 Croscarmellose Sodium (AC- DI-SOL) NF 123 mg. 5 Microcrystalline Cellulose NF (Avicel PH 101) 297.6 mg. 6 Magnesium Stearate NF (Vegetable Grade) 17 mg. 7 Hydroxy Propyl Cellulose NF (KlucelLF) 38.4 mg. 8 Lactose for DC (Tablettose 80/Super Tab) BP/PH Eur 199.6 mg. As per packing policy and Efavirenz 600mg, Lamivudine 300mg, Tenofovir Disoproxil Fumarate 300mg Tablets(Each Tablet contains: Efavirenz 600mg,Tenofovir Disoproxil Fumarate 300mg,Lamivudine 300mg Tablets) 1 Number 9 Silica Gel bags 3 GM StripaxR/F|details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Efavirenz 612 mg. 2 Lamivudine 306 mg. 3 Tenofovir Disoproxil Fumarate 306 mg. 4 Croscarmellose Sodium (AC- DI-SOL) NF 123 mg. 5 Microcrystalline Cellulose NF (Avicel PH 101) 297.6 mg. 6 Magnesium Stearate NF (Vegetable Grade) 17 mg. 7 Hydroxy Propyl Cellulose NF (KlucelLF) 38.4 mg. 8 Lactos

stalline Cellulose NF (Avicel PH 101) 297.6 mg. 6 Magnesium Stearate NF (Vegetable Grade) 17 mg. 7 Hydroxy Propyl Cellulose NF (KlucelLF) 38.4 mg. 8 Lactose for DC (Tablettose 80/Super Tab) BP/PH Eur 199.6 mg. As per packing policy and Efavirenz 600mg, Lamivudine 300mg, Tenofovir Disoproxil Fumarate 300mg Tablets(Each Tablet contains: Efavirenz 600mg,Tenofovir Disoproxil Fumarate 300mg,Lamivudine 300mg Tablets) 1 Number 9 Silica Gel bags 3 GM StripaxR/F|details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Efavirenz 612 mg. 2 Lamivudine 306 mg. 3 Tenofovir Disoproxil Fumarate 306 mg. 4 Croscarmellose Sodium (AC- DI-SOL) NF 123 mg. 5 Microcrystalline Cellulose NF (Avicel PH 101) 297.6 mg. 6 Magnesium Stearate NF (Vegetable Grade) 17 mg. 7 Hydroxy Propyl Cellulose NF (KlucelLF) 38.4 mg. 8 Lactose for DC (Tablettose 80/Super Tab) BP/PH Eur 199.6 mg. As per packing policy and Efavirenz 600mg, Lamivudine 300mg, Tenofovir Disoproxil Fumarate 300mg Tablets(Each Tablet contains: Efavirenz 600mg,Tenofovir Disoproxil Fumarate 300mg,Lamivudine 300mg Tablets) 1 Number 9 Silica Gel bags 3 GM StripaxR/F|details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Efavirenz 612

ica Gel bags 3 GM StripaxR/F|details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Efavirenz 612 mg. 2 Lamivudine 306 mg. 3 Tenofovir Disoproxil Fumarate 306 mg. 4 Croscarmellose Sodium (AC- DI-SOL) NF 123 mg. 5 Microcrystalline Cellulose NF (Avicel PH 101) 297.6 mg. 6 Magnesium Stearate NF (Vegetable Grade) 17 mg. 7 Hydroxy Propyl Cellulose NF (KlucelLF) 38.4 mg. 8 Lactose for DC (Tablettose 80/Super Tab) BP/PH Eur 199.6 mg. As per packing policy and Efavirenz 600mg, Lamivudine 300mg, Tenofovir Disoproxil Fumarate 300mg Tablets(Each Tablet contains: Efavirenz 600mg,Tenofovir Disoproxil Fumarate 300mg,Lamivudine 300mg Tablets) 1 Number 9 Silica Gel bags 3 GM StripaxR/F|details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Efavirenz 612 mg. 2 Lamivudine 306 mg. 3 Tenofovir Disoproxil Fumarate 306 mg. 4 Croscarmellose Sodium (AC- DI-SOL) NF 123 mg. 5 Microcrystalline Cellulose NF (Avicel PH 101) 297.6 mg. 6 Magnesium Stearate NF (Vegetable Grade) 17 mg. 7 Hydroxy Propyl Cellulose NF (KlucelLF) 38.4 mg. 8 Lactose for DC (Tablettose 80/Super Tab) BP/PH Eur 199.6 mg. As per packing policy and Efavirenz 600mg, Lamivudine 300mg, Tenofovir Disoproxil

ucelLF) 38.4 mg. 8 Lactose for DC (Tablettose 80/Super Tab) BP/PH Eur 199.6 mg. As per packing policy and Efavirenz 600mg, Lamivudine 300mg, Tenofovir Disoproxil Fumarate 300mg Tablets(Each Tablet contains: Efavirenz 600mg,Tenofovir Disoproxil Fumarate 300mg,Lamivudine 300mg Tablets) 1 Number 9 Silica Gel bags 3 GM StripaxR/F|details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Efavirenz 612 mg. 2 Lamivudine 306 mg. 3 Tenofovir Disoproxil Fumarate 306 mg. 4 Croscarmellose Sodium (AC- DI-SOL) NF 123 mg. 5 Microcrystalline Cellulose NF (Avicel PH 101) 297.6 mg. 6 Magnesium Stearate NF (Vegetable Grade) 17 mg. 7 Hydroxy Propyl Cellulose NF (KlucelLF) 38.4 mg. 8 Lactose for DC (Tablettose 80/Super Tab) BP/PH Eur 199.6 mg. As per packing policy and Efavirenz 600mg, Lamivudine 300mg, Tenofovir Disoproxil Fumarate 300mg Tablets(Each Tablet contains: Efavirenz 600mg,Tenofovir Disoproxil Fumarate 300mg,Lamivudine 300mg Tablets) 1 Number 9 Silica Gel bags 3 GM StripaxR/F| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.| ||Efavirenz 600mg, Lamivudine 300mg, Tenofovir Disoproxil Fumarate 300mg Tablets(Each Tablet contains: Efavirenz 600mg,Tenofovir Disoproxil Fumarate 300mg,Lamivudine 300mg Tablets)| 1 Number|1 |Efavirenz|612 mg.|

Tenofovir Disoproxil Fumarate 300mg Tablets(Each Tablet contains: Efavirenz 600mg,Tenofovir Disoproxil Fumarate 300mg,Lamivudine 300mg Tablets)| 1 Number|1 |Efavirenz|612 mg.| ||||2|Lamivudine|306 mg.| ||||3|Tenofovir Disoproxil Fumarate|306 mg.| ||||4|Croscarmellose Sodium (AC- DI-SOL) NF|123 mg.| ||||5|Microcrystalline Cellulose NF (Avicel PH 101)| 297.6 mg.| ||||6|Magnesium Stearate NF (Vegetable Grade)|17 mg.| ||||7|Hydroxy Propyl Cellulose NF (KlucelLF)| 38.4 mg.| ||||8|Lactose for DC (Tablettose 80/Super Tab) BP/PH Eur|199.6 mg.| ||||9|Silica Gel bags 3 GM StripaxR/F|As per packing policy and|

UDIN00137349AM26

==> picture [482 x 462] intentionally omitted <==

----- Start of picture text ----- General Notes. DOLUTEGRAVIR (AS SODIUM) + LAMIVUDINE + 1 10 Lamivudine 306 mg. TENOFOVIR DISOPROXIL FUMARATE TABLETS 50mg / Number 300mg/300mg(Eachtabletscontains:DolutegravirSodiumEquivalentto 11 Tenofovir 306 mg. Dolutegravir50mg, Disoproxil LamivudineUSP300mg, Fumarate TenofovirDisproxilFumarate 300 mg, Equivalent to Tenofovir Disoproxil 245 mg) 12 Dolutegravir 51 mg. VIRADAY / ODIMUNE TABLETS (Each tablet contains: 1 13 Efavirenz 612 mg. Tenofovir Disproxil Fumarate IP 300 mg, Emtricitabine IP 200 Number mg, Efavirenz IP 600 mg) 14 Tenofovir 306 mg. Disoproxil Fumarate 15 Emtricitabine 204 mg. TENOMUNE TABLETS (Each tablet contains: 1 16 Efavirenz 612 mg. Tenofovir Disproxil Fumarate 300 mg Efav

z IP 600 mg) 14 Tenofovir 306 mg. Disoproxil Fumarate 15 Emtricitabine 204 mg. TENOMUNE TABLETS (Each tablet contains: 1 16 Efavirenz 612 mg. Tenofovir Disproxil Fumarate 300 mg Efavirenz Number USP 600 mg, Emtricitabine 17 Tenofovir 306 mg. 200 mg) Disoproxil Fumarate 18 Emtricitabine 204 mg. ----- End of picture text -----

Case No.	35 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	WEXFORD LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00003780AM25

UDIN00137349AM26

R	A File Number	A File Number	07AA04006165 AM21	07AA04006165 AM21	07AA04006165 AM21	07AA04006165 AM21	07AA04006165 AM21	07AA04006165 AM21	07AA04006165 AM21
L<br>D	icence No and<br>ate		0711000260/12/01/2021
N<br> <br> <br> <br> <br>R	orms 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.6/82-ALC4/2020 dated 13/11/2020against advance authorization No.<br>0710115236dated 01/08/2019, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-


		Export Pr		oduct	Qty.	Sl. No.	Import	tems	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 Pr||oduct||Qty.|Sl. No.|Import|tems|Qty. allowed.| |||||||||||| |||CEFADROXI CAPSULES||500MG||1 Number|1|PURID COMP CEFAD|ROX ACTED ROXIL|510 mg/500 mg Capsules| |||||||||||| |||CEFADROXI||L 500MG||1 Number|2|PURID|ROX|510 mg/500 mg| |||CAPSULES||||||COMPACTED CEFADROXIL||Capsules| |||CEFADROXIL 500MG CAPSULES-FADROXIDEL|||| 1 Number|3|PURIDROX COMPACTED ||510 mg/500 mg Capsules| |||||||||CEFAD|ROXIL|| |||||||||||| ||A concerned may take||||further necessary action as per above decision o||||f NC.|| |||||||||||| |||||||||||| |||||||||||| |C||||||||||| ||ase No.||36 / NC/3/MEET/Apr/202526/2|||||||| |C|ase Status||Case Approved|||||||| |P|arty Name||INDORAMA VENTURES OXIDES ANKLESHWAR PRIVATE LIMITED|||||||| |M a|eeting Number nd Date||NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025|||||||| |H|Q File Number||HQRNORM REVIW00004289AM25|||||||| |R|A File Number||03AA04||018728 AM22|||||| |L D|icence No and ate||0311004||668/16/06/2021|||||| |||||||||||| |N|orms Committee Decision||||:|||||| ||||||||||||

Case No.	36 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	INDORAMA VENTURES OXIDES ANKLESHWAR PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004289AM25
RA File Number	03AA04018728 AM22
Licence No and<br>Date	0311004668/16/06/2021
Norms Committee Decision:

MEET/ Apr/ 202526/ 2 and 08/05/2025| |HQ File Number|HQRNORM REVIW00004289AM25| |RA File Number|03AA04018728 AM22| |Licence No and Date|0311004668/16/06/2021| |Norms Committee Decision:||

UDIN00137349AM26

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Methyldiethanolamine	1 kg.	1	Ethylene Oxide	0.7 kg.

Case No.	37 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	VACHICHEM INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004907AM25
RA File Number	07AA04028991 AM22
Licence No and<br>Date	0711002024/30/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal<br>Hearing<br>before Norms Committee to explain its case along with relevant information / documents from the<br>firm.

Case No.	38 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	PANACEA BIOTEC PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00005946AM24
RA File Number	05AX04000321 AM22
Licence No and<br>Date	0511007823/11/01/2022

UDIN00137349AM26

Norms Committee Decision:

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

Case No.	39 / NC/3/MEET/Apr/202526/2
Case Status	Case Rejected
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004726AM25
RA File Number	07AX04000477 AM22
Licence No and<br>Date	0711003428/15/03/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, there is no merit in<br>the case for review of norms and it was decided torejectthe case maintaining thestatus quo.

Case No.	40 / NC/3/MEET/Apr/202526/2
Case Status	Case Rejected
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004698AM25
RA File Number	07AX04000034 AM23
Licence No and<br>Date	0711003861/26/04/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, there is no merit in<br>the case for review of norms and it was decided torejectthe case maintaining thestatus quo.

Case No.	41 / NC/3/MEET/Apr/202526/2
Case Status	Case Rejected

UDIN00137349AM26

r review of norms and it was decided torejectthe case maintaining thestatus quo.||

Case No.	41 / NC/3/MEET/Apr/202526/2
Case Status	Case Rejected

UDIN00137349AM26

Party Name		ACUTAAS CHEMICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM REVIW00004697AM25
RA File Number		52AX04000039 AM23
Licence No and<br>Date		5211002485/13/05/2022
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, there is no merit in
the case for review of norms and it was decided torejectthe case maintaining thestatus quo.

Case No.		42 / NC/3/MEET/Apr/202526/2
Case Status		Case Rejected
Party Name		MICRO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM REVIW00004701AM25
RA File Number		07AX04000113 AM23
Licence No and<br>Date		0711004050/23/05/2022
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, there is no merit in
the case for review of norms and it was decided torejectthe case maintaining thestatus quo.

any technical justification / information for enhancement. Hence, there is no merit in||| |the case for review of norms and it was decided torejectthe case maintaining thestatus quo.|||

Case No.	43 / NC/3/MEET/Apr/202526/2
Case Status	Case Rejected
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004707AM25
RA File Number	07AX04000159 AM23
Licence No and<br>Date	0711004100/26/05/2022
Norms Committee Decision:

47 This document has been digitally signed by Raman Kumar, Deputy DGFT on 09-06-2025 10:25:58.

UDIN00137349AM26

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, there is no merit in the case for review of norms and it was decided to reject the case maintaining the status quo.

vided any technical justification / information for enhancement. Hence, there is no merit in the case for review of norms and it was decided to reject the case maintaining the status quo.

Case No.	44 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	ZENFOLD SUSTAINABLE TECHNOLOGIES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00001090AM23
RA File Number	09AX04000132 AM23
Licence No and Date	0911003083/31/05/2022
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<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>DIETHYLTHIOGLYCOLATE<br>4.0 kg.<br>2<br>1,2-BUTANEDIOL<br>4.0 kg.<br>2-Ethyl-2,3-dihydrothieno[3,4-<br>b][1,4] dioxine<br>1 kg.<br>3<br>ELECTROLYTIC COPPER<br>POWDER<br>0.02 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	45 / NC/3/MEET/Apr/202526/2
Case Status	Case Rejected
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00001347AM23

UDIN00137349AM26

UDIN00137349AM26

RA File Number	05AX04000669 AM23
Licence No and<br>Date	0511013173/13/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm vide letter dated<br>11/04/2025 has informed that they had already been redeemed the Advance Authorisation and requested to<br>withdraw the application of the firm. It was decided to close the application of the firm.

Case No.	46 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004127AM25
RA File Number	03AX04002151 AM23
Licence No and<br>Date	0311016241/11/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal<br>Hearing<br>before Norms Committee to explain its case along with relevant information / documents from the<br>firm:

se as per agenda and it was decided to call the firm for attendingPersonal Hearing before Norms Committee to explain its case along with relevant information / documents from the firm:|||

Case No.	47 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
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 case is under consideration and TE was requested to expedite his comments.

49 This document has been digitally signed by Raman Kumar, Deputy DGFT on 09-06-2025 10:25:58.

UDIN00137349AM26

Case No.	48 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
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 case is under consideration and TE was requested to expedite his comments.

|RA File Number|34AX04000398 AM23| |Licence No and Date|3411002586/29/07/2022| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	Case No.	49 / NC/3/MEET/Apr/202526/2	49 / NC/3/MEET/Apr/202526/2	49 / NC/3/MEET/Apr/202526/2	49 / NC/3/MEET/Apr/202526/2	49 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00002645AM23
RA File Number		03AX04002727 AM23
Licence No and<br>Date		0311017254/16/08/2022
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<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>Olopatadine<br>Hydrochloride USP<br>14688 gm.<br>Olopatadine Hydrochloride and<br>Mometasone Furoate Nasal<br>Spray 600mcg/25mcg<br>(RYALTRIS) 240 MD((Net<br>Wt. of<br>Olopatadine HCL is 14400<br>Grams<br>and<br>Mometasone<br>Furoate mono. is 600 Grams))<br>100000<br>Numbers<br>2<br>Mometasone Furoate<br>Monohydrate<br>612 gm.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Olopatadine Hydrochloride and<br>Mometasone Furoate Nasal<br>Spray 600mcg/25mcg<br>(RYALTRIS) 240 MD((Net<br>Wt. of<br>Olopatadine HCL is 14400<br>Grams<br>and<br>Mometasone<br>Furoate mono.

owed.| ||Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 240 MD((Net Wt. of Olopatadine HCL is 14400 Grams and Mometasone Furoate mono. is 600 Grams))|| 100000 Numbers|1|Olopatadine Hydrochloride USP|14688 gm.| |||||2|Mometasone Furoate Monohydrate|612 gm.|

UDIN00137349AM26

|3 Olopatadine Hydrochloride USP 7344 gm. Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 120 MD((Net Wt. of Olopatadine HCL is 7200 Grams and Mometasone Furoate mono. is 300 Grams)) 100000 Numbers 4 Mometasone Furoate Monohydrate 306 gm. 5 Olopatadine Hydrochloride USP 3427 gm. Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 56 MD((Net Wt. of Olopatadine HCL is 3360 Grams and Mometasone Furoate mono. is 140 Grams)) 100000 Numbers 6 Mometasone Furoate Monohydrate 142.8 gm. RA concerned may take further necessary action as per above decision of NC.|Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 120 MD((Net Wt. of Olopatadine HCL is 7200 Grams and Mometasone Furoate mono.

|Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 120 MD((Net Wt. of Olopatadine HCL is 7200 Grams and Mometasone Furoate mono. is 300 Grams))| 100000 Numbers|3|Olopatadine Hydrochloride USP|7344 gm.| |---|---|---|---|---|---| ||||4|Mometasone Furoate Monohydrate|306 gm.| ||Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 56 MD((Net Wt. of Olopatadine HCL is 3360 Grams and Mometasone Furoate mono. is 140 Grams))| 100000 Numbers|5|Olopatadine Hydrochloride USP|3427 gm.| ||||6|Mometasone Furoate Monohydrate|142.8 gm.|

Case No.	Case No.	50 / NC/3/MEET/Apr/202526/2	50 / NC/3/MEET/Apr/202526/2	50 / NC/3/MEET/Apr/202526/2	50 / NC/3/MEET/Apr/202526/2	50 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00002919AM23
RA File Number		34AX04000543 AM23
Licence No and<br>Date		3411002729/02/09/2022
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<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.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00137349AM26

plied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

UDIN00137349AM26

Nadolol Tablets USP 20mg	1 Number	1	Nadolol USP	20.4 mg.
		2	Povidone K-30	4.14 mg.
		3	Corn Starch (5%)	31.91 mg.
		4	Microcrystalline cellulose<br>(Avicel PH 101)	50.0 mg.
		5	Citric acid monohydrate<br>(Powder Emprove)	5.75 mg.
		6	Magnesium stearate	1.75 mg.
Nadolol Tablets USP 40mg	1 Number	7	Nadolol USP	40.8 mg.
		8	Povidone K-30	7.14 mg.
		9	Corn Starch (5%)	75.0 mg.
		10	Microcrystalline cellulose<br>(Avicel PH 101)	91.0 mg.
		11	Citric acid monohydrate<br>(Powder Emprove)	11.50 mg.
		12	Magnesium stearate	3.50 mg.
Nadolol Tablets USP 80mg	1 Number	13	Nadolol USP	81.60 mg.
		14	Povidone K-30	12.00 mg.
		15	Corn Starch (5%)	150.0 mg.
		16	Microcrystalline cellulose<br>(Avicel PH 101)	185.0 mg.

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	17	Citric acid monohydrate	23.00 mg.
		(Powder Emprove)
	18	Magnesium stearate	7.00 mg.

rocrystalline cellulose (Avicel PH 101)|185.0 mg.|

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	17	Citric acid monohydrate	23.00 mg.
		(Powder Emprove)
	18	Magnesium stearate	7.00 mg.

Case No.	51 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	INTIGREAT CONSULTING SERVICES LLP
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00003056AM23
RA File Number	03AX04002543 AM23
Licence No and Date	0311017790/12/09/2022
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<br>HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br>allowed.<br>Tablets / Capsules(REMURES ULTRA<br>( Diosmin 450 mg + Hesparidine 50 mg<br>)<br>coated tablets Pack 2 x 15 tablets = 30<br>Tablets in one Pack.(NET CONTENT =<br>112.50 KGS),<br>TOTAL GROSS CONTENT (MFG<br>OVERAGES<br>5%<br>+<br>2%<br>MFG<br>LOSS)=120.375 KGS)<br>1<br>Number<br>1<br>Diosmin/<br>Hesparidine(90/10)<br>510 mg.<br>Tablets/Capsules(REMURESULTRA<br>(Diosmin450mg+Hesparidine50mg)<br>1<br>Number<br>2<br>Diosmin/<br>Hesparidine(90/10)<br>510 mg.

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coatedtabletsPack4x15tablets=60Tablets in one Pack. (NET CONTENT = 225.00 KGS) , TOTAL GROSS CONTENT (MFG OVERAGES 5% + 2% MFG LOSS)= 240.750 KGS)

e(90/10) 510 mg.||

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coatedtabletsPack4x15tablets=60Tablets in one Pack. (NET CONTENT = 225.00 KGS) , TOTAL GROSS CONTENT (MFG OVERAGES 5% + 2% MFG LOSS)= 240.750 KGS)

Case No.	Case No.	52 / NC/3/MEET/Apr/202526/2	52 / NC/3/MEET/Apr/202526/2	52 / NC/3/MEET/Apr/202526/2	52 / NC/3/MEET/Apr/202526/2	52 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00003118AM23
RA File Number		09AX04000498 AM23
Licence No and Date		0911003623/14/09/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Dec/202425/13 dated 07/01/2025 against advance<br>authorization No.0911003340 dated 13/07/2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Guanine<br>0.80 kg.<br>2<br>Dioxolane Diacetate<br>1.30 kg.<br>3<br>Acetic anhydride<br>2.30 kg.<br>4<br>Acetone<br>0.69 kg.<br>Valaciclovir<br>Hydrochloride(Pharmaceuticals<br>product)<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

1.30 kg. 3 Acetic anhydride 2.30 kg. 4 Acetone 0.69 kg. Valaciclovir Hydrochloride(Pharmaceuticals product) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Valaciclovir Hydrochloride(Pharmaceuticals product)||1 kg.|1|Guanine|0.80 kg.| |||||2|Dioxolane Diacetate|1.30 kg.| |||||3|Acetic anhydride|2.30 kg.| |||||4|Acetone|0.69 kg.|

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5	Aqueous Dimethyl<br>Amine	1.64 kg.
6	Acetic Acid	0.47 kg.
7	CBZ - L - Valine	1.112 kg.
8	Dimethyl carbonyl<br>chloride	0.98 kg.
9	Dimethylaminopyridine	0.028 kg.
10	Dimethyl formamide	1.92 kg.
11	methanol	4.82 kg.
12	Isopropanol	2.55 kg.

Case No.	53 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00003251AM23
RA File Number	34AX04000590 AM23
Licence No and<br>Date	3411002800/21/09/2022
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

UDIN00137349AM26

590 AM23| |Licence No and Date|3411002800/21/09/2022| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

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Case No.	54 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	LASENOR INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00002957AM25
RA File Number	50AX04000050 AM23
Licence No and<br>Date	5011000587/22/09/2022
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/Jun/202425/6 dated 01/07/2024against advance<br>authorization No.5011000972 dated 31/07/2023, 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.<br>allowed.<br>Sunflower Lecithin (Powder)<br>1 MT<br>1<br>Sunflower Lecithin (Crude)<br>1.40 MT<br>RA concerned may take further necessary action as per above decision of NC.

** Qty. allowed. Sunflower Lecithin (Powder) 1 MT 1 Sunflower Lecithin (Crude) 1.40 MT RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	55 / NC/3/MEET/Apr/202526/2
Case Status<br>	Case Rejected
Party Name<br>	OPES HEALTH CARE PRIVATE LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number<br>	HQRNORM REVIW00006256AM24
RA File Number<br>	08AX04000971 AM23
Licence No and<br>Date<br>	0811006083/22/09/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence the committee<br>didn’t find any merit to review the case and it was decided torejectthe case maintaining thestatus quo.

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Case No.	56 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00002982AM25
RA File Number	05AX04001819 AM23
Licence No and<br>Date	0511014976/23/09/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as per details given below or as applied by the<br>firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

r>provided by the firm, it was decided to revise ad-hoc norms as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Tobramycin Inhalation Solution, USP, 300mg/ 4ml(Having net conent of 25.20 kg of Bulk drug) 1 Number Pack 1 TobramycinUSP 315 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	57 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	ALIVUS LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00003339AM23
RA File Number	03AX04003267 AM23
Licence No and<br>Date	0311018114/24/09/2022
Norms Committee Decision:

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

Th	e case is under consideratio	e case is under consideratio	n and TE	n and TE	n and TE	was reques	was reques	was reques	ted to expedite his comments.	ted to expedite his comments.	ted to expedite his comments.

Case No.		58 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		LASENOR INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM REVIW00002955AM25
RA File Number		50AX04000062 AM23

D|||||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025|||||||||||| |HQ File Number||HQRNORM REVIW00002955AM25|||||||||||| |RA File Number||50AX04000062 AM23|||||||||||| |Licence No and ||5011000669/04/11/2022|||||||||||| |Date|||||||||||||| |Norms Committee||Decision:|||||||||||| |The Committee||onsidered the case as er aenda and takin cue from the earlier decision for same exort|||||||||||| | roduct/imort||p g g p item in meetin NoNC/3/MEET/Jun/202425/6 dated 01/07/2024aainst advance|||||||||||| |pp authorization N HBP Vl I||g . g o.5011000972 dated 31/07/2023, it was decided to fix ad-hoc norms under Para 4.07 of dtil i bl lid b th fi hih i l|||||||||||| | RA|o. as per eas gven eow or as appe y e rm, wcever s ess:-||||||||||||| ||Export Product||||Qty.|||**Sl. No. **|||Import Items||Qty.| |||||||||||||| allowed.| ||Sunflower Lecithin (Powder)||||1 MT|||1|||Sunflower Lecithin (Crude)||1.40 MT| ||||||||||||||| ||concerned may take further necessar|||y action as|||||||||| ||||||||per abov|||e decision of NC.|||| |||||||||||||||

Case No.	59 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	VACHICHEM INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004906AM25
RA File Number	07AX04001122 AM23
Licence No and<br>Date	0711005637/09/11/2022

UDIN00137349AM26

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.	60 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	PANACEA BIOTEC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00003221AM25
RA File Number	05AX04002301 AM23
Licence No and<br>Date	0511015737/10/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case to Deptt. of Bio-<br>Technology for obtaining their comments.

Case No.	61 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	VACHICHEM INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004908AM25
RA File Number	07AX04001398 AM23
Licence No and<br>Date	0711006018/26/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal<br>Hearing<br>before Norms Committee to explain its case along with relevant information / documents from the<br>firm.

Case No. 62 / NC/3/MEET/Apr/202526/2

59 This document has been digitally signed by Raman Kumar, Deputy DGFT on 09-06-2025 10:25:58.

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rmation / documents from the firm.|||

Case No. 62 / NC/3/MEET/Apr/202526/2

59 This document has been digitally signed by Raman Kumar, Deputy DGFT on 09-06-2025 10:25:58.

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Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00002981AM25
RA File Number	05AX04002919 AM23
Licence No and<br>Date	0511016690/03/01/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as per details given below or as applied by the<br>firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Tobramycin<br>Inhalation<br>Solution,<br>USP,<br>300mg/<br>4ml(Having<br>net<br>conent<br>of<br>23.10 kg of Bulk drug)<br>1 Number Pack<br>1<br>TOBRAMYCIN USP<br>315 mg./Pack<br>RA concerned may take further necessary action as per above decision of NC.

4ml(Having net conent of 23.10 kg of Bulk drug) 1 Number Pack 1 TOBRAMYCIN USP 315 mg./Pack RA concerned may take further necessary action as per above decision of NC.||

Case No.	63 / NC/3/MEET/Apr/202526/2
Case Status	Case Rejected
Party Name	ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004761AM25
RA File Number	03AX04005159 AM23
Licence No and<br>Date	0311020797/19/01/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, the committee didn’t<br>find any merit to review the norms and it was decided torejectthe case maintaining thestatus quo.

UDIN00137349AM26

Case No.	64 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	SYNERGIA SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00006312AM23
RA File Number	03AX04005369 AM23
Licence No and<br>Date	0311021429/14/02/2023
Norms Committee Decision:<br>The committee considered the request of the firm for 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>Yield of 50.4% not given. Please furnish the details.<br>1.

ion of ad-hoc norms, and as per the advice of the TE, it was decided to call for following information/documents from the firm:- Yield of 50.4% not given. Please furnish the details. 1.||

Case No.	65 / NC/3/MEET/Apr/202526/2
Case Status	Case Rejected
Party Name	SAVA HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004372AM25
RA File Number	31AX04000353 AM23
Licence No and<br>Date	3111002045/23/02/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, the committee didn’t<br>find any merit to review the norms and it was decided torejectthe case maintaining thestatus quo.

Case No.	66 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	NAVIN FLUORINE ADVANCED SCIENCES LIMITED

61 This document has been digitally signed by Raman Kumar, Deputy DGFT on 09-06-2025 10:25:58.

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61 This document has been digitally signed by Raman Kumar, Deputy DGFT on 09-06-2025 10:25:58.

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Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00006353AM25
RA File Number	03AX04005808 AM23
Licence No and Date	0311021816/01/03/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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>ACETALDOXIME<br>713.48 MT<br>3 TRIFLUORO METHYL<br>ACETOPHENONE<br>355.13 MT.<br>2<br>META AMINO<br>BENZOTRIFLUORIDE<br>Not imported<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	67 / NC/3/MEET/Apr/202526/2	67 / NC/3/MEET/Apr/202526/2	67 / NC/3/MEET/Apr/202526/2	67 / NC/3/MEET/Apr/202526/2	67 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		MANKIND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM REVIW00004161AM25
RA File Number		05AX04003575 AM23
Licence No and<br>Date		0511017985/24/03/2023

r>and Date||NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025||||| |HQ File Number||HQRNORM REVIW00004161AM25||||| |RA File Number||05AX04003575 AM23||||| |Licence No and Date||0511017985/24/03/2023||||| |Norms Committee Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as 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.|

UDIN00137349AM26

Tobramycin		Inhalation
Solution,	USP,	<br>300mg/
5ml(Having	net	conent<br>of
100.440 kg of	Bulk	drug)

Case No.	68 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00006354AM25
RA File Number	03AX04006341 AM23
Licence No and<br>Date	0311022753/12/04/2023
Norms Committee Decision:<br>The committee considered the request of the firm for fixation of ad-hoc norms, and as per the advice of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Copy of Shipping Bill and Bill of Entries.<br>1.

for fixation of ad-hoc norms, and as per the advice of the TE, it was decided to call for following information/documents from the firm:- Copy of Shipping Bill and Bill of Entries. 1.||

Case No.	69 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	AZAKEM LABS PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00000910AM24
RA File Number	09AX04000127 AM24
Licence No and Date	0911005042/17/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00137349AM26

Export Product	Qty.	Sl. No.	Import Items	Qty.<br>allowed.
((4-Fluoro Phenyl)-6-Iso Propyl?2?(N-<br>Methyl -N-Methyl Sulfonamide)<br>Pyrimidin -5-yl) Tri<br>Phenyl?Phosphonium Bromide	1 kg.	1	N-(4-(4-Fluorophenyl)-5-<br>(Hydroxymethyl)-6-<br>Isopropylpyrimidin-2-Yl)-<br>Nmethylmethanesulfonamide	0.399 kg.

thyl Sulfonamide) Pyrimidin -5-yl) Tri Phenyl?Phosphonium Bromide|1 kg.|1|N-(4-(4-Fluorophenyl)-5- (Hydroxymethyl)-6- Isopropylpyrimidin-2-Yl)- Nmethylmethanesulfonamide|0.399 kg.|

Case No.	70 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	VASISTA PHARMA CHEM PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00001152AM24
RA File Number	26AX04000028 AM24
Licence No and Date	2611000961/26/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Pyrazole<br>0.952 kg.<br>1-(Difluoromethyl)-4-<br>Nitro-1h-Pyrazole<br>1 kg.<br>2<br>Sodium Chlorodifluoroacetate<br>1.33 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00137349AM26

omethyl)-4- Nitro-1h-Pyrazole 1 kg. 2 Sodium Chlorodifluoroacetate 1.33 kg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	71 / NC/3/MEET/Apr/202526/2
Case Status	Case Rejected
Party Name	PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00003575AM25
RA File Number	05AX04000851 AM24
Licence No and<br>Date	0511019523/26/06/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, the committee<br>didn’t find any merit to review the norms and it was decided torejectthe case maintaining thestatus quo.<br>The Committee also decided to revise the SION A-1303.

Case No.	72 / NC/3/MEET/Apr/202526/2
Case Status	Case Rejected
Party Name	SPAR PHARMA LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00003504AM25
RA File Number	09AX04000344 AM24
Licence No and<br>Date	0911005672/23/08/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, the committee<br>didn’t find any merit to review the norms and it was decided torejectthe case maintaining thestatus quo.

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

Case No.	73 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	USV PRIVATE LIMITED
Meeting Number and	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025

UDIN00137349AM26

Date
HQ File Number	HQRNORM REVIW00003559AM25
RA File Number	03AX04004322 AM24
Licence No and Date	0311029676/27/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Propafenone HCL ER Capsules USP<br>225 MG 60' s us (Ris((13,998 Bottles<br>X 60 Capsules Per Bottles = 8,39,880<br>Capsules) (Total Weight of Export<br>Product = 188.97 Kgs) (Net Content<br>weight of Import Product = 207.87<br>kgs))<br>1 Number<br>Capsule<br>1<br>Propafenone<br>Hydrochloride<br>229.5 mg./Capsule<br>Propafenone HCL ER Capsules USP<br>325 MG 60' s us (Ris((40,838 Bottles<br>X 60 Capsules Per Bottles =<br>24,50,280Capsules ) (Total Weight of<br>Export Product = 796.34 Kgs) (Net<br>Content weight of Import Product =<br>875.98 kgs))<br>1 Number<br>Capsule<br>2<br>Propafenone<br>Hydrochloride<br>331.5 mg./ Capsule<br>RA concerned may take further necessary action as per above decision of NC.

Import Product = 875.98 kgs)) 1 Number Capsule 2 Propafenone Hydrochloride 331.5 mg./ Capsule RA concerned may take further necessary action as per above decision of NC.||

Case No.	74 / NC/3/MEET/Apr/202526/2
Case Status	Case Rejected
Party Name	USV PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00003558AM25
RA File Number	03AX04004600 AM24
Licence No and<br>Date	0311030078/10/01/2024

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Norms Committee Decision:

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

Case No.	75 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	GALAXY SURFACTANTS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004387AM25
RA File Number	03AX04006008 AM24
Licence No and<br>Date	0311032549/27/03/2024
Norms Committee Decision:<br>The committee considered the request of the firm for 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>To indicate the active content of “Lauric monoethanolamide (Galaxy 200)” and to submit Certificate<br>of Analysis (CoA) report of the export product.<br>1.<br>Calculation of the requirement of raw materials base on active content of export product in CoA<br>report.<br>2.

o submit Certificate of Analysis (CoA) report of the export product. 1. Calculation of the requirement of raw materials base on active content of export product in CoA report. 2.||

Case No.	76 / NC/3/MEET/Apr/202526/2
Case Status	Case Rejected
Party Name	ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004758AM25
RA File Number	03AX04006123 AM24
Licence No and<br>Date	0311033283/23/04/2024
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the<br>firm has not provided any technical justification / information for enhancement. Hence, the committee

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didn’t find any merit to review the norms and it was decided to reject the case maintaining the status quo.

signed by Raman Kumar, Deputy DGFT on 09-06-2025 10:25:58.

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didn’t find any merit to review the norms and it was decided to reject the case maintaining the status quo.

Case No.	77 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	UMEDICA LABORATORIES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00000408AM25
RA File Number	03AX04000290 AM25
Licence No and Date	0311033317/24/04/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<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>Rosuvastatin Tablet BP /<br>USP 40 MG.((Each Tablet<br>contains Rosuvastatin<br>Calcium 41.600 mg) Eq. to<br>Rosuvastatin 40 mg. (Net wt<br>of import material is 492.960<br>kg.))<br>1 Number<br>1<br>Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-<br>fluorophenyl)-6-isopropyl-2-(N-<br>methylmethylsulfonamido)pyrimidin-<br>5-yl)vinyl)-2,2-dimethyl-1,3-dioxan-<br>4-yl)acetate<br>42.432 mg/<br>Tablet<br>RA concerned may take further necessary action as per above decision of NC.

methylmethylsulfonamido)pyrimidin- 5-yl)vinyl)-2,2-dimethyl-1,3-dioxan- 4-yl)acetate 42.432 mg/ Tablet RA concerned may take further necessary action as per above decision of NC.||

Case No.	78 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	UMEDICA LABORATORIES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00000437AM25
RA File Number	03AX04000385 AM25
Licence No and Date	0311033377/26/04/2024

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Norms Committee Decision:

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

Export Product	Qty.	Sl.<br>No.	Import Items	Qty. allowed.
Rosuvastatin Tablet BP /<br>USP 5 MG.((Each Tablet<br>contains Rosuvastatin<br>Calcium 5.200 mg) Eq. to<br>Rosuvastatin 5 mg. (Net wt<br>of<br>import<br>material<br>is<br>494.000 kg.))	<br> <br>1 Number	1	Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-<br>fluorophenyl)-6-isopropyl-2-(N-<br>methylmethylsulfonamido)pyrimidin-<br>5-yl)vinyl)-2,2-dimethyl-1,3-dioxan-<br>4-yl)acetate	5.304 mg./<br>Tablet

Case No.	79 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004130AM25
RA File Number	03AX04000436 AM25
Licence No and<br>Date	0311033409/29/04/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal<br>Hearing<br>before Norms Committee to explain its case along with relevant information / documents from the<br>firm:

Case No.	80 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred

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mittee to explain its case along with relevant information / documents from the firm:|||

Case No.	80 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred

UDIN00137349AM26

Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM REVIW00004138AM25
RA File Number	03AX04000426 AM25
Licence No and<br>Date	0311033410/29/04/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal<br>Hearing<br>before Norms Committee to explain its case along with relevant information / documents from the<br>firm:

Case No.	Case No.	81 / NC/3/MEET/Apr/202526/2	81 / NC/3/MEET/Apr/202526/2	81 / NC/3/MEET/Apr/202526/2	81 / NC/3/MEET/Apr/202526/2	81 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00001312AM25
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:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Imidacloprid EP 244.8 gm. Assurity Plus SPOT ON (For Small Cat ) (Pack size 0.4ml x 6 pipettes),(Each ml contains: Imidacloprid EP 100mg andMoxidectin BP 10mg ( Imidacloprid EP Net Weight = 240.00 gms& Moxidectin BP Net weight = 24.00 gms)) 1000 Numbers 25 Moxidectin BP 24.48 gm. 2 Imidacloprid EP 489.6 gm. Assurity Plus SPOT ON (For Large Cat) (Pack size 0.8ml x 1000 Numbers||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Assurity Plus SPOT ON (For Small Cat ) (Pack size 0.4ml x 6 pipettes),(Each ml contains: Imidacloprid EP 100mg andMoxidectin BP 10mg ( Imidacloprid EP Net Weight = 240.00 gms& Moxidectin BP Net weight = 24.00 gms))|| 1000 Numbers|1|Imidacloprid EP|244.8 gm.| |||||25|Moxidectin BP|24.48 gm.| ||Assurity Plus SPOT ON (For Large Cat) (Pack size 0.8ml x||1000 Numbers|2|Imidacloprid EP|489.6 gm.| ||||||||

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rge Cat) (Pack size 0.8ml x||1000 Numbers|2|Imidacloprid EP|489.6 gm.| ||||||||

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6 pipettes),(Each ml contains:<br>Imidacloprid EP 100mg<br>andMoxidectin BP 10mg, (<br>Imidacloprid EP Net Weight =<br>480.00 gms& Moxidectin BP<br>Net weight = 48.00 gms))		26	Moxidectin BP	48.96 gm.
Assurity Plus SPOT ON (For<br>Small Dog) (Pack size 0.4ml x<br>6 Pipettes),(Each ml contains:<br>Imidacloprid EP 100mg<br>andMoxidectin BP 25 mg, (<br>Imidacloprid EP Net Weight =<br>240.00 gms& Moxidectin BP<br>Net weight = 60.00 gms))	<br> <br>1000 Numbers	3	Imidacloprid EP	244.8 gm.
		27	Moxidectin BP	61.2 gm.
Assurity Plus SPOT ON (For<br>Medium Dog) (Pack size 1ml<br>x 6 Pipettes),(Each ml<br>contains: Imidacloprid EP<br>100mg andMoxidectin BP 25<br>mg, ( Imidacloprid EP Net<br>Weight = 600.00 gms&<br>Moxidectin BP Net weight =<br>150.00gms))	1000 Numbers	4	Imidacloprid EP	612.0 gm.
		28	Moxidectin BP	153.0 gm.
Assurity Plus SPOT ON (For<br>Large Dog) (Pack size 2.5ml x<br>6 Pipettes),(Each ml contains:<br>Imidacloprid EP 100mg<br>andMoxidectin BP 25 mg, (<br>Imidacloprid EP Net Weight =<br>1500.00gms & Moxidectin BP<br>Net weight = 375.00 gms))BP<br>Net weight = 375.00 gms))	<br> <br> <br>1000 Numbers	5	Imidacloprid EP	1530.0 gm.
		29	Moxidectin BP	382.5 gm.

prid 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 ml contains: Imidacloprid EP 100mg andMoxidectin BP 25 mg, ( Imidacloprid EP Net Weight = 3600.00 gms&|1500 Numbers|6|Imidacloprid EP|3672.0 gm.| ||||30|Moxidectin BP|918.0 gm.|

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Moxidectin BP Net weight =<br>900 gms))
Nugard Spot On for Puppies<br>and Dogs up to 4kg (Pack size<br>0.4ml x 1 Pipettes),(Each Litre<br>contains: Imidacloprid EP<br>100Gms and Moxidectin BP<br>25 Gms, ( Imidacloprid EP<br>Net Weight = 40.00 gms&<br>Moxidectin BP Net weight =<br>10.00 gms))	<br>1000 Numbers	7	Imidacloprid EP	40.8 gm.
		31	Moxidectin BP	10.2 gm.
Nugard Spot On for Puppies<br>and Dogs up to 4kg (Pack size<br>0.4ml x 3 Pipettes),(Each Litre<br>contains: Imidacloprid EP<br>100Gms and Moxidectin BP<br>25 Gms, ( Imidacloprid EP<br>Net Weight = 120.00 gms&<br>Moxidectin BP Net weight =<br>30.00 gms))	<br>1000 Numbers	8	Imidacloprid EP	122.4 gm.
		32	Moxidectin BP	30.6 gm.
Nugard Spot On for Puppies<br>and Dogs up to 4kg (Pack size<br>0.4ml x 6 Pipettes),(Each Litre<br>contains: Imidacloprid EP<br>100Gms and Moxidectin BP<br>25 Gms, ( Imidacloprid EP<br>Net Weight = 480.00 gms&<br>Moxidectin BP Net weight =<br>120.00 gms))	<br>2000 Numbers	9	Imidacloprid EP	489.6 gm.
		33	Moxidectin BP	122.4

0Gms and Moxidectin BP 25 Gms, ( Imidacloprid EP Net Weight = 480.00 gms& Moxidectin BP Net weight = 120.00 gms))| 2000 Numbers|9|Imidacloprid EP|489.6 gm.| ||||33|Moxidectin BP|122.4| ||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 gms))|1000 Numbers|10|Imidacloprid EP|102.0 gm.| ||||34|Moxidectin BP|25.5 gm.|

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Nugard Spot On for Dogs 4-<br>10kg (Pack size 1ml x 3<br>Pipettes),(Each Litre contains:<br>Imidacloprid EP 100<br>GmsandMoxidectin BP 25<br>Gms, ( Imidacloprid EP Net<br>Weight = 600.00 gms&<br>Moxidectin BP Net weight =<br>150.00 gms))	2000 Numbers	11	Imidacloprid EP	612.0 gm.
		35	Moxidectin BP	153.0 gm.
Nugard Spot On for Dogs 4-10<br>kg (Pack size 1ml x 6<br>Pipettes),(Each Litre contains:<br>Imidacloprid EP 100<br>GmsandMoxidectin BP 25<br>Gms, ( Imidacloprid EP Net<br>Weight = 2400.00 gms&<br>Moxidectin BP Net weight =<br>600.00 gms))	<br>4000 Numbers	12	Imidacloprid EP	2448.0 gm.
		36	Moxidectin BP	612.0 gm.
Nugard Spot On for Dogs 10-<br>25kg (Pack size 2.5ml x 1<br>Pipettes),(Each Litre contains:<br>Imidacloprid EP 100<br>GmsandMoxidectin BP 25<br>Gms, ( Imidacloprid EP Net<br>Weight = 250.00 gms&<br>Moxidectin BP Net weight =<br>62.500 gms))	1000 Numbers	13	Imidacloprid EP	255.0 gm.
		37	Moxidectin BP	63.75 gm.

r>GmsandMoxidectin BP 25 Gms, ( Imidacloprid EP Net Weight = 250.00 gms& Moxidectin BP Net weight = 62.500 gms))|1000 Numbers|13|Imidacloprid EP|255.0 gm.| ||||37|Moxidectin BP|63.75 gm.| ||Nugard Spot On for Dogs 10- 25kg (Pack size 2.5ml x 3 Pipettes),(Each Litre contains: Imidacloprid EP 100 GmsandMoxidectin BP 25 Gms, ( Imidacloprid EP Net Weight = 1500.00 gms& Moxidectin BP Net weight = 375.00 gms))|2000 Numbers|14|Imidacloprid EP|1530.0 gm.| ||||38|Moxidectin BP|382.5| ||Nugard Spot On for Dogs 10- 25kg (Pack size 2.5ml x 6 Pipettes),(Each Litre contains:|2000 Numbers|15|Imidacloprid EP|3060.0 gm.| ||||39|Moxidectin BP|765.0|

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Imidacloprid EP 100 Gmsand<br>Moxidectin BP 25 Gms, (<br>Imidacloprid EP Net Weight =<br>3000.00 gms& Moxidectin BP<br>Net weight = 750.00 gms))	<br>
Nugard Spot On for Dogs over<br>25kg (Pack size 4ml x 1<br>Pipettes),(Each Litre contains:<br>Imidacloprid EP 100<br>GmsandMoxidectin BP 25<br>Gms, ( Imidacloprid EP Net<br>Weight = 400.00 gms&<br>Moxidectin BP Net weight =<br>100.00 gms))	<br>1000 Numbers	16	Imidacloprid EP	408.0 gm.
		40	Moxidectin BP	102.0 gm.
Nugard Spot On for Dogs over<br>25kg (Pack size 4ml x 3<br>Pipettes),(Each Litre contains:<br>Imidacloprid EP 100<br>GmsandMoxidectin BP 25<br>Gms, ( Imidacloprid EP Net<br>Weight = 2400.00 gms&<br>Moxidectin BP Net weight =<br>600.00 gms))	<br>2000 Numbers	17	Imidacloprid EP	2448.0 gm.
		41	Moxidectin BP	612.0 gm.

ndMoxidectin BP 25 Gms, ( Imidacloprid EP Net Weight = 2400.00 gms& Moxidectin BP Net weight = 600.00 gms))| 2000 Numbers|17|Imidacloprid EP|2448.0 gm.| ||||41|Moxidectin BP|612.0 gm.| ||Nugard Spot On for Dogs over 25kg (Pack size 4ml x 6 Pipettes),(Each Litre contains: Imidacloprid EP 100 GmsandMoxidectin BP 25 Gms, ( Imidacloprid EP Net Weight = 7200.00 gms& Moxidectin BP Net weight = 1800.00 gms))| 3000 Numbers|18|Imidacloprid EP|7344.0 gm.| ||||42|Moxidectin BP|1836.0 gm.| ||Nugard Spot On for kittens and cats up to 4 kg (Pack size 0.4ml x 1 Pipettes),(Each Litre contains: Imidacloprid EP 100Gms and Moxidectin BP 10 Gms, ( Imidacloprid EP Net Weight = 40.00 gms&| 1000 Numbers|19|Imidacloprid EP|40.8 gm.| ||||43|Moxidectin BP|4.08 gm.|

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Moxidectin BP Net weight =<br>4.00 gms))
Nugard Spot On for kittens<br>and cats up to 4 kg (Pack size<br>0.4ml x 3 Pipettes),(Each Litre<br>contains: Imidacloprid EP<br>100Gms and Moxidectin BP<br>10 Gms, ( Imidacloprid EP<br>Net Weight = 300.00 gms&<br>Moxidectin BP Net weight =<br>30.00 gms))	<br>2500 Numbers	20	Imidacloprid EP	306.0 gm.
		44	Moxidectin BP	30.6 gm.
Nugard Spot On for kittens<br>and cats up to 4 kg (Pack size<br>0.4ml x 6 Pipettes),(Each Litre<br>contains: Imidacloprid EP<br>100Gms and Moxidectin BP<br>10 Gms, ( Imidacloprid EP<br>Net Weight = 960.00 gms&<br>Moxidectin BP Net weight =<br>96.00 gms))	<br>4000 Numbers	21	Imidacloprid EP	979.2 gm.
		45	Moxidectin BP	97.92 gm.

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 = 600.00 gms& Moxidectin BP Net weight = 60.00 gms))|2500 Numbers|23|Imidacloprid EP|612.0 gm.| ||||47|Moxidectin BP|61.2 gm.|

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24<br>Imidacloprid EP<br>4896.0 gm.<br>Nugrad Spot On Cats over 4<br>kg (Pack size 0.8ml x 6<br>Pipettes),(Each Litre contains:<br>Imidacloprid EP 100<br>GmsandMoxidectin BP 10<br>Gms, ( Imidacloprid EP Net<br>Weight = 4800.00 gms&<br>Moxidectin BP Net weight =<br>480.00 gms))<br>10000<br>Numbers<br>48<br>Moxidectin BP<br>489.6 gm.<br>RA concerned may take further necessary action as per above decision of NC.	Nugrad Spot On Cats over 4<br>kg (Pack size 0.8ml x 6<br>Pipettes),(Each Litre contains:<br>Imidacloprid EP 100<br>GmsandMoxidectin BP 10<br>Gms, ( Imidacloprid EP Net<br>Weight = 4800.00 gms&<br>Moxidectin BP Net weight =<br>480.00 gms))	10000<br>Numbers	24	Imidacloprid EP	4896.0 gm.

r>GmsandMoxidectin BP 10 Gms, ( Imidacloprid EP Net Weight = 4800.00 gms& Moxidectin BP Net weight = 480.00 gms))|10000 Numbers|24|Imidacloprid EP|4896.0 gm.| |---|---|---|---|---|---| ||||48|Moxidectin BP|489.6 gm.|

Case No.	82 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	DINAKARA LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00001982AM25
RA File Number	09AX04000270 AM25
Licence No and<br>Date	0911007602/18/07/2024
Norms Committee Decision:<br>The committee considered the request of the firm for 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>The molecular weight of export product and in the reaction the end product is mentioned as<br>‘Complex’ without giving name.<br>1.<br>The commercial value of by-products Acetone, Mineral oil spent etc.<br>2.<br>Current production/consumption data duly certified by Chartered Accountant.<br>3.

Case No.	83 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	AVIK PHARMACEUTICAL LIMITED
Meeting Number and	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025

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83 / NC/3/MEET/Apr/202526/2| |---|---| |Case Status|Case Approved| |Party Name|AVIK PHARMACEUTICAL LIMITED| |Meeting Number and|NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025|

UDIN00137349AM26

Date
HQ File Number	HQRNORM APPLY 00002537AM25
RA File Number	52AX04000141 AM25
Licence No and Date	5211009406/14/08/2024
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.<br>No.<br>Import Items<br>Qty. allowed.<br>Betamethasone Valerate EP/BP/USP<br>1 kg.<br>1<br>Betamethasone<br>0.915 kg.<br>RA concerned may take further necessary action as per above decision of NC.<br>The Committee also decided to make a new SION for above export item.

Case No.	Case No.	84 / NC/3/MEET/Apr/202526/2	84 / NC/3/MEET/Apr/202526/2	84 / NC/3/MEET/Apr/202526/2	84 / NC/3/MEET/Apr/202526/2	84 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		FDC LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00003072AM25
RA File Number		03AX04002949 AM25
Licence No and Date		0311037176/16/09/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<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.

e case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Azelastine Eye Drops 8ML (AZELASTINE 0.05% W/V 8 ml Vial 1 AZELASTINE HYDROCHLORIDE 4.08 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Azelastine Eye Drops 8ML (AZELASTINE 0.05% W/V||8 ml Vial|1|AZELASTINE HYDROCHLORIDE|4.08 mg|

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EYE DROPS 8ML )((NET CONTAINS AZELASTINE HYDROCHLODRIDE 0.004 GM PER VIAL OF 8 ML NET WT OF BULK DRUG IS 192 GRAMS))

Case No.	Case No.	Case No.	85 / NC/3/MEET/Apr/202526/2	85 / NC/3/MEET/Apr/202526/2	85 / NC/3/MEET/Apr/202526/2
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number			HQRNORM APPLY 00003336AM25
RA File Number			03AX04003196 AM25
Licence No and<br>Date			0311037481/27/09/2024
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of<br>information provided by the firm, it was decided to fix ad-hoc norms as under:-<br>Sl. No<br>Export Product<br>Quantity<br>1<br>Medical Creams & Ointments (Halcinonide Topical Solution, USP 0.1% 120ML,<br>Net Wt. 3000Kgs (Hal 3Kgs, OvalBo 25000Nos, Screw cap 25000Nos, LDPE<br>Dropper 25000Nos))<br>1 Number<br>**S.

y** 1 Medical Creams & Ointments (Halcinonide Topical Solution, USP 0.1% 120ML, Net Wt. 3000Kgs (Hal 3Kgs, OvalBo 25000Nos, Screw cap 25000Nos, LDPE Dropper 25000Nos)) 1 Number S. No Import Product Quantity allowed. 1 Relevant Bulk Drugs Net content in the export product plus 2% wastage.|||||| ||Sl. No|Export Product |||Quantity| ||1|Medical Creams & Ointments (Halcinonide Topical Solution, USP 0.1% 120ML, Net Wt. 3000Kgs (Hal 3Kgs, OvalBo 25000Nos, Screw cap 25000Nos, LDPE Dropper 25000Nos)) |||1 Number| ||||||| ||S. No|Import Product||Quantity allowed.|| ||1|Relevant Bulk Drugs||Net content in the export product plus 2% wastage.||

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2	Relevant Excipients	Net content in the export product plus 2% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy & General Notes.

Note:

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

vant as per Packing Policy & General Notes.|

Note:

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

Case No.	Case No.	86 / NC/3/MEET/Apr/202526/2	86 / NC/3/MEET/Apr/202526/2	86 / NC/3/MEET/Apr/202526/2	86 / NC/3/MEET/Apr/202526/2	86 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		RUBICON RESEARCH LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00003338AM25
RA File Number		03AX04003176 AM25
Licence No and Date		0311037482/27/09/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of<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>1<br>Actuator_Asm<br>2<br>Cont_Holder-<br>PP-White<br>3<br>Rub Sto CB<br>5mm 2177<br>NaloxonHclNasalSpray4mg/Spray125ml(Packingmaterial-<br>Actuator_Asm,Cont_Holder-PP-<br>White,RubStoCB5mm2177,Via G(Naloxone Hcl Nasal<br>Spray 4mg/Spray 125 ml (Packing material -<br>Actuator_Asm,Cont_Holder-PP-White,RubSto CB 5mm<br>2177,Via Glass Clear 0.4mL Type I as per export qty))<br>1000000<br>Numbers<br>Relevant as<br>per Packing<br>Policy &<br>General Notes<br>with<br>accountability.
	Export Product		Qty.	Sl.<br>No.	Import Items	Qty.

0.4mL Type I as per export qty)) 1000000 Numbers Relevant as per Packing Policy & General Notes with accountability.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||NaloxonHclNasalSpray4mg/Spray125ml(Packingmaterial- Actuator_Asm,Cont_Holder-PP- White,RubStoCB5mm2177,Via G(Naloxone Hcl Nasal Spray 4mg/Spray 125 ml (Packing material - Actuator_Asm,Cont_Holder-PP-White,RubSto CB 5mm 2177,Via Glass Clear 0.4mL Type I as per export qty))||1000000 Numbers|1|Actuator_Asm|Relevant as per Packing Policy & General Notes with accountability.| |||||2|Cont_Holder- PP-White|| |||||3|Rub Sto CB 5mm 2177||

UDIN00137349AM26

R			4	Via Glass<br>Clear 0.4mL<br>Type I
	A concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	87 / NC/3/MEET/Apr/202526/2	87 / NC/3/MEET/Apr/202526/2	87 / NC/3/MEET/Apr/202526/2	87 / NC/3/MEET/Apr/202526/2	87 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		ZENTIVA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00003386AM25
RA File Number		03AX04003250 AM25
Licence No and<br>Date		0311037559/01/10/2024

and Date||NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025||||| |HQ File Number||HQRNORM APPLY 00003386AM25||||| |RA File Number||03AX04003250 AM25||||| |Licence No and Date||0311037559/01/10/2024||||| |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/Aug/202425/8 dated 28/08/2024 against advance authorization No.0311032228 dated 15/03/2024, 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. Co-codamol 8/500 tablets (Codeine Phosphate Hemihydrate 8mg and Paracetamol 500mg)(Each Tablet contains Codeine Phosphate Hemihydrate 8mg and Paracetamol 500mg (Net Wt.Codeine Phosphate Hemihydrate 768.00 KGS)) 1 Number 1 Codeine Phosphate Hemihydrate 8.16 mg. Co-codamol 15/500 tablets Codeine Phosphate 1 Number 2 15.30 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Co-codamol 8/500 tablets (Codeine Phosphate Hemihydrate 8mg and Paracetamol 500mg)(Each Tablet contains Codeine Phosphate Hemihydrate 8mg and Paracetamol 500mg (Net Wt.Codeine Phosphate Hemihydrate 768.00 KGS))|| 1 Number|1|Codeine Phosphate Hemihydrate|8.16 mg.| ||Co-codamol 15/500 tablets||1 Number|2|Codeine Phosphate|15.30 mg.|

UDIN00137349AM26

phate Hemihydrate 768.00 KGS))|| 1 Number|1|Codeine Phosphate Hemihydrate|8.16 mg.| ||Co-codamol 15/500 tablets||1 Number|2|Codeine Phosphate|15.30 mg.|

UDIN00137349AM26

(Codeine Phosphate<br>Hemihydrate 15mg and<br>Paracetamol 500mg)(Each<br>Tablet containsCodeine<br>Phosphate Hemihydrate 15mg<br>and Paracetamol 500mg (Net<br>Wt.Codeine Phosphate<br>Hemihydrate 1353.60 KGS))<br>Hemihydrate<br>Co-codamol 30/500 tablets<br>(Codeine Phosphate<br>Hemihydrate 30mg and<br>Paracetamol 500mg)(Each<br>Tablet containsCodeine<br>Phosphate Hemihydrate 30mg<br>and Paracetamol 500mg (Net<br>Wt.Codeine Phosphate<br>Hemihydrate 2707.20 KGS))<br>1 Number<br>3<br>Codeine Phosphate<br>Hemihydrate<br>30.60 mg.<br>RA concerned may take further necessary action as per above decision of NC.	(Codeine Phosphate<br>Hemihydrate 15mg and<br>Paracetamol 500mg)(Each<br>Tablet containsCodeine<br>Phosphate Hemihydrate 15mg<br>and Paracetamol 500mg (Net<br>Wt.Codeine Phosphate<br>Hemihydrate 1353.60 KGS))			Hemihydrate
	Co-codamol 30/500 tablets<br>(Codeine Phosphate<br>Hemihydrate 30mg and<br>Paracetamol 500mg)(Each<br>Tablet containsCodeine<br>Phosphate Hemihydrate 30mg<br>and Paracetamol 500mg (Net<br>Wt.Codeine Phosphate<br>Hemihydrate 2707.20 KGS))	1 Number	3	Codeine Phosphate<br>Hemihydrate	30.60 mg.

Case No.	Case No.	88 / NC/3/MEET/Apr/202526/2	88 / NC/3/MEET/Apr/202526/2	88 / NC/3/MEET/Apr/202526/2	88 / NC/3/MEET/Apr/202526/2	88 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		USV PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00003391AM25
RA File Number		03AX04003178 AM25
Licence No and<br>Date		0311037564/01/10/2024
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.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.|

Case No.	Case No.	88 / NC/3/MEET/Apr/202526/2	88 / NC/3/MEET/Apr/202526/2	88 / NC/3/MEET/Apr/202526/2	88 / NC/3/MEET/Apr/202526/2	88 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		USV PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00003391AM25
RA File Number		03AX04003178 AM25
Licence No and<br>Date		0311037564/01/10/2024
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.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00137349AM26

- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.|

UDIN00137349AM26

Doxycycline Tablets, USP 50 MG 100<br>S((21,600 Bottles X 100 Per Bottles =<br>21,60,000<br>Tablets)<br>(Total<br>Weight<br>of<br>ExportProduct<br>=<br>108.000<br>Kgs)<br>(Net<br>Content weight of Import Product =<br>116.327 kgs))<br>1 Number<br>1<br>Doxycycline USP<br>(Monohydrate)<br>53.066 mg<br>Doxycycline Tablets, USP 100 MG 500<br>S((5,600 Bottles X 500 Per Bottles =<br>28,00,000<br>Tablets)<br>(Total<br>Weight<br>of<br>ExportProduct<br>=<br>280.000<br>Kgs)<br>(Net<br>Content weight of Import Product =<br>301.588 kgs))<br>1 Number<br>2<br>Doxycycline USP<br>(Monohydrate)<br>106.13 mg.<br>Doxycycline Tablets, USP 100 MG 50<br>S((56,000 Bottles X 50 Per Bottles =<br>28,00,000<br>Tablets)<br>(Total<br>Weight<br>of<br>ExportProduct<br>=<br>280.000<br>Kgs)<br>(Net<br>Content weight of Import Product =<br>301.588 kgs))<br>1 Number<br>3<br>Doxycycline USP<br>(Monohydrate)<br>106.13 mg.<br>RA concerned may take further necessary action as per above decision of NC.	Doxycycline Tablets, USP 50 MG 100<br>S((21,600 Bottles X 100 Per Bottles =<br>21,60,000<br>Tablets)<br>(Total<br>Weight<br>of<br>ExportProduct<br>=<br>108.000<br>Kgs)<br>(Net<br>Content weight of Import Product =<br>116.327 kgs))	<br> <br> <br> <br> <br>1 Number	1	Doxycycline USP<br>(Monohydrate)	53.066 mg

Product = 108.000 Kgs) (Net Content weight of Import Product = 116.327 kgs))| 1 Number|1|Doxycycline USP (Monohydrate)|53.066 mg| |---|---|---|---|---|---| ||Doxycycline Tablets, USP 100 MG 500 S((5,600 Bottles X 500 Per Bottles = 28,00,000 Tablets) (Total Weight of ExportProduct = 280.000 Kgs) (Net Content weight of Import Product = 301.588 kgs))| 1 Number|2|Doxycycline USP (Monohydrate)|106.13 mg.| ||Doxycycline Tablets, USP 100 MG 50 S((56,000 Bottles X 50 Per Bottles = 28,00,000 Tablets) (Total Weight of ExportProduct = 280.000 Kgs) (Net Content weight of Import Product = 301.588 kgs))| 1 Number|3|Doxycycline USP (Monohydrate)|106.13 mg.|

Case No.	89 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00003403AM25
RA File Number	34AX04000535 AM25
Licence No and<br>Date	3411005481/01/10/2024
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 item in meeting No.NC/3/MEET/Dec/202324/17 dated 20/12/2023 against advance<br>authorization No.3411002799dated 20/09/2022, 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:-

UDIN00137349AM26

3411002799dated 20/09/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||

UDIN00137349AM26

Export	Product				Qty.	Sl. No.	Import Items	Qty.
								allowed.
Dimethyl	Benzyl	Carbinyl	Butyrate(((1-	1	kg.	1	N Butyric Anhydride	0.80 kg.
Cyclohexyl-2-methylpropan-2-yl			butanoate)))
						2	Magnesium Turning	0.17 kg.

Case No.	90 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	PRIGIV SPECIALTIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00003427AM25
RA File Number	03AX04003148 AM25
Licence No and<br>Date	0311037588/03/10/2024
Norms Committee Decision:<br>The Committee considered the request of the firm for fixation of ad-hoc norms and on the basis of<br>information provided by the firm and it has been observed by the committee that export product“Alpha<br>Rosacone”(Perfumery Compound) as applied by the firm appears to fall under para 4.11(b) of FTP, 2023,<br>and the said para states that “For export of perfumes, perfumery compounds and various feeding redients<br>containing vitamins, no authorisation shall be issued by Regional Authority under para 4.07 of HBP. The<br>applicant firm is requested to clarify how this application comes under Para 4.07 of HBP and the RA<br>concerned is also directed to provide its comments on the same

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

Case No.	91 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	BVC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025

UDIN00137349AM26

HQ File Number	HQRNORM APPLY 00003432AM25
RA File Number	34AX04000497 AM25
Licence No and<br>Date	3411005487/03/10/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	92 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	BVC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00003433AM25
RA File Number	34AX04000550 AM25
Licence No and<br>Date	3411005489/03/10/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|34AX04000550 AM25| |Licence No and Date|3411005489/03/10/2024| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	Case No.	93 / NC/3/MEET/Apr/202526/2	93 / NC/3/MEET/Apr/202526/2	93 / NC/3/MEET/Apr/202526/2	93 / NC/3/MEET/Apr/202526/2	93 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00003434AM25
RA File Number		08AX04001068 AM25
Licence No and<br>Date		0811012792/03/10/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

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

Case No.	Case No.	93 / NC/3/MEET/Apr/202526/2	93 / NC/3/MEET/Apr/202526/2	93 / NC/3/MEET/Apr/202526/2	93 / NC/3/MEET/Apr/202526/2	93 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00003434AM25
RA File Number		08AX04001068 AM25
Licence No and<br>Date		0811012792/03/10/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00137349AM26

ed by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

UDIN00137349AM26

Propofol Injectable Emulsion, USP 200<br>mg per 20 mL (10 mg per mL)(Propofol<br>Injectable Emulsion, USP 200 mg per20<br>mL (10 mg per mL))<br>1 Number<br>1<br>Propofol<br>210 mg./pack<br>Propofol Injectable Emulsion, USP 500<br>mg per 50 mL (10 mg per mL)(Propofol<br>Injectable Emulsion, USP 500 mg per50<br>mL (10 mg per mL))<br>1 Number<br>2<br>Propofol<br>525 mg./pack<br>Propofol Injectable Emulsion, USP<br>1,000 mg per 100 mL (10 mg per<br>mL)(Propofol Injectable Emulsion, USP<br>1,000mg per 100 mL (10 mg per mL))<br>1 Number<br>3<br>Propofol<br>1050 mg./pack<br>RA concerned may take further necessary action as per above decision of NC.	Propofol Injectable Emulsion, USP 200<br>mg per 20 mL (10 mg per mL)(Propofol<br>Injectable Emulsion, USP 200 mg per20<br>mL (10 mg per mL))	<br> <br>1 Number	1	Propofol	210 mg./pack
	Propofol Injectable Emulsion, USP 500<br>mg per 50 mL (10 mg per mL)(Propofol<br>Injectable Emulsion, USP 500 mg per50<br>mL (10 mg per mL))	<br> <br>1 Number	2	Propofol	525 mg./pack
	Propofol Injectable Emulsion, USP<br>1,000 mg per 100 mL (10 mg per<br>mL)(Propofol Injectable Emulsion, USP<br>1,000mg per 100 mL (10 mg per mL))	<br>1 Number	3	Propofol	1050 mg./pack

./pack| ||Propofol Injectable Emulsion, USP 1,000 mg per 100 mL (10 mg per mL)(Propofol Injectable Emulsion, USP 1,000mg per 100 mL (10 mg per mL))| 1 Number|3|Propofol|1050 mg./pack|

Case No.	94 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00003450AM25
RA File Number	05AX04001783 AM25
Licence No and<br>Date	0511028112/03/10/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	95 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	FDC LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00003453AM25

UDIN00137349AM26

RA File Number	03AX04003287 AM25
Licence No and Date	0311037616/03/10/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Chloramphenicol Eye Drops 10 Ml (Clorah Eye Drops 10 Ml , Venmycetin Eye Drops 10 Ml, Clorogen Eye Drops 10 Ml)((Each Vial Contains Chloramphenicol Micronized 0.050 Gm Net Wt Of Bulk Drug Is 33 Kgs)) 660000 Vials 1 Chloramphenicol Micronized 33.655 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	96 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	NIXI LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00003472AM25
RA File Number	03AX04003192 AM25
Licence No and<br>Date	0311037637/04/10/2024
Norms Committee Decision:<br>The committee considered the request of the firm for 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>Specify the actual items of import.<br>1.<br>How can be 7 API used in one export item.<br>2.

UDIN00137349AM26

Copy of Master Batch Formula.
Copy of Drug ManufacturingLicence.

Specify the actual items of import. 1. How can be 7 API used in one export item. 2.||

UDIN00137349AM26

Copy of Master Batch Formula.
Copy of Drug ManufacturingLicence.

Case No.	97 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	AVIK PHARMACEUTICAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00003481AM25
RA File Number	52AX04000198 AM25
Licence No and<br>Date	5211010153/04/10/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	98 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	BROOKS STERISCIENCE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00003492AM25
RA File Number	34AX04000554 AM25
Licence No and<br>Date	3411005493/04/10/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	99 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	MELOG SPECIALITY CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00003510AM25

87 This document has been digitally signed by Raman Kumar, Deputy DGFT on 09-06-2025 10:25:58.

UDIN00137349AM26

EET/ Apr/ 202526/ 2 and 08/05/2025| |HQ File Number|HQRNORM APPLY 00003510AM25|

87 This document has been digitally signed by Raman Kumar, Deputy DGFT on 09-06-2025 10:25:58.

UDIN00137349AM26

RA File Number

03AX04002822 AM25

Licence No and Date

0311037677/05/10/2024

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.3/82-ALC4/2019 dated 05.07.2019 against advance authorization No.0310824922 dated 06.11.2018, 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(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.	100 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	ENALTEC LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00003514AM25
RA File Number	03AX04003311 AM25
Licence No and<br>Date	0311037686/07/10/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	101 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved

UDIN00137349AM26

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

Case No.	101 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved

UDIN00137349AM26

Party Name	VINDHYA ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00003515AM25
RA File Number	09AX04000456 AM25
Licence No and<br>Date	0911008093/07/10/2024
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/Mar/202425/18 dated17/03/2025 against Hqr. File<br>No. HQRNORMAPPLY00002820AM25, 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>2-Azabicyclo (2.2.1)Hept-5-En-<br>3-One ( Vincelactam)<br>1.75 kg.<br>2<br>N-(2-Amino-4, 6-Dichloro-5-<br>Pyrimidinyl) Formamide<br>1.07 kg.<br>3<br>Sodium Borohydride Powder<br>0.44 kg.<br>4<br>D(-) Tartaric Acid<br>0.088 kg.<br>5<br>L + Tartaric Acid<br>1.54 kg.<br>6<br>Iso Propyl Alcohol<br>2.24 kg.<br>(1S,4R)-4-(2-Amino-6-Chloro-9H-<br>Purin-Yl)-2-Cyclopentane-1-<br>Methanol(AFC-2FB) (or) Abacavir<br>Sulfate (ABC) I (SA)<br>1 kg.<br>7<br>Triethyl Orthoformate (TEOF)<br>1.16 kg.<br>RA concerned may take further necessary action as per above decision of NC.

r>Methanol(AFC-2FB) (or) Abacavir Sulfate (ABC) I (SA) 1 kg. 7 Triethyl Orthoformate (TEOF) 1.16 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	102 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved

UDIN00137349AM26

Party Name	DR. DALAVAI'S LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00003521AM25
RA File Number	07AX04001012 AM25
Licence No and<br>Date	0711012501/07/10/2024
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 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>Minoxidil Intermediate<br>(2,4-Diamino-6-Chlro Pyrimidine)<br>1 kg.<br>1<br>Barbituric Acid<br>1.00 kg.<br>RA concerned may take further necessary action as per above decision of NC.

allowed. Minoxidil Intermediate (2,4-Diamino-6-Chlro Pyrimidine) 1 kg. 1 Barbituric Acid 1.00 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	103 / NC/3/MEET/Apr/202526/2	103 / NC/3/MEET/Apr/202526/2	103 / NC/3/MEET/Apr/202526/2	103 / NC/3/MEET/Apr/202526/2	103 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		HETERO LABS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00003523AM25
RA File Number		09AX04000510 AM25
Licence No and Date		0911008104/07/10/2024
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.<br>allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty.<br>allowed.

UDIN00137349AM26

by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

UDIN00137349AM26

1<br>N-(1-Tert-Butyloxycarbonyl)-<br>N-[-4-(Pyridine-2-<br>Yl)Benzylidene] Hydrazine<br>0.576 kg.<br>1-[4-(Pyridine-2-Yl)Phenyl]-5(S)-2,5-<br>Bis[(Tert-Butoxy-Carbonyl)-Amino]-<br>4(S)-Hydroxy-6-<br>Phenyl-2-Azahexane)(Hetero<br>Cyclic<br>Compounds With Nitrogen Hetero-<br>Atom(S) Only )<br>1 kg.<br>2<br>(2r,3s)-N-Boc-3-Amino-1,2-<br>Epoxy-4-Phenyl Butane<br>0.562 kg.<br>RA concerned may take further necessary action as per above decision of NC.	1-[4-(Pyridine-2-Yl)Phenyl]-5(S)-2,5-<br>Bis[(Tert-Butoxy-Carbonyl)-Amino]-<br>4(S)-Hydroxy-6-<br>Phenyl-2-Azahexane)(Hetero<br>Cyclic<br>Compounds With Nitrogen Hetero-<br>Atom(S) Only )	<br>1 kg.	1	N-(1-Tert-Butyloxycarbonyl)-<br>N-[-4-(Pyridine-2-<br>Yl)Benzylidene] Hydrazine	0.576 kg.
			2	(2r,3s)-N-Boc-3-Amino-1,2-<br>Epoxy-4-Phenyl Butane	0.562 kg.

r>1 kg.|1|N-(1-Tert-Butyloxycarbonyl)- N-[-4-(Pyridine-2- Yl)Benzylidene] Hydrazine|0.576 kg.| |---|---|---|---|---|---| ||||2|(2r,3s)-N-Boc-3-Amino-1,2- Epoxy-4-Phenyl Butane|0.562 kg.|

Case No.	Case No.	104 / NC/3/MEET/Apr/202526/2	104 / NC/3/MEET/Apr/202526/2	104 / NC/3/MEET/Apr/202526/2	104 / NC/3/MEET/Apr/202526/2	104 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		INDOCO REMEDIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00003531AM25
RA File Number		03AX04003284 AM25
Licence No and<br>Date		0311037738/08/10/2024
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/Dec/202425/13 dated07/01/2025 against advance<br>authorization No. 0311035673 dated 22/07/202, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Timolol Maleate 25.50 mg. 2 BOTTLE Relevant, as per Packing Policy & General Notes. 3 CAP Relevant, as per Packing Policy & General Notes. Brimonidine Tartrate /Timolol ophthalmic solution 0.2%/0.5% (5 ml Bottle) ((Each ml Contains : Brimonidine Tartrate 2mgand Timolol Maleate 6.8 mg equivalent to Timolol 5mg) (Each 5 ml Bottle Contains :Brimonidine Tartrate 10mg and Timolol Maleate 34 mg ) 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Brimonidine Tartrate /Timolol ophthalmic solution 0.2%/0.5% (5 ml Bottle) ((Each ml Contains : Brimonidine Tartrate 2mgand Timolol Maleate 6.8 mg equivalent to Timolol 5mg) (Each 5 ml Bottle Contains :Brimonidine Tartrate 10mg and Timolol Maleate 34 mg )||1 Number|1|Timolol Maleate|25.50 mg.| |||||2|BOTTLE|Relevant, as per Packing Policy & General Notes.| |||||3|CAP|Relevant, as per Packing Policy & General Notes.|

l Maleate 34 mg )||1 Number|1|Timolol Maleate|25.50 mg.| |||||2|BOTTLE|Relevant, as per Packing Policy & General Notes.| |||||3|CAP|Relevant, as per Packing Policy & General Notes.|

Case No.	Case No.	104 / NC/3/MEET/Apr/202526/2	104 / NC/3/MEET/Apr/202526/2	104 / NC/3/MEET/Apr/202526/2	104 / NC/3/MEET/Apr/202526/2	104 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		INDOCO REMEDIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00003531AM25
RA File Number		03AX04003284 AM25
Licence No and<br>Date		0311037738/08/10/2024
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/Dec/202425/13 dated07/01/2025 against advance<br>authorization No. 0311035673 dated 22/07/202, 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.

UDIN00137349AM26

umber|1|Timolol Maleate|25.50 mg.| |||||2|BOTTLE|Relevant, as per Packing Policy & General Notes.| |||||3|CAP|Relevant, as per Packing Policy & General Notes.|

UDIN00137349AM26

		4	DROPPER	Relevant, as per<br>Packing Policy &<br>General Notes.
Brimonidine Tartrate /Timolol ophthalmic<br>solution 0.2%/0.5% (10mlBottle) ((Each ml<br>Contains:Brimonidine<br>Tartrate<br>2mg<br>and<br>Timolol Maleate 6.8mg equivalent to Timolol<br>5mg)<br>(Each<br>10<br>ml<br>Bottle<br>Contains<br>:Brimonidine Tartrate 20mg and Timolol<br>Maleate 68 mg )	<br> <br> <br> <br> <br> <br>1 Number	5	Timolol Maleate	51.00 mg.
		6	BOTTLE	Relevant, as per<br>Packing Policy &<br>General Notes.
		7	CAP	Relevant, as per<br>Packing Policy &<br>General Notes.
		8	DROPPER	Relevant, as per<br>Packing Policy &<br>General Notes.
Brimonidine Tartrate /Timolol ophthalmic<br>solution 0.2%/0.5% (15 ml Bottle )((Each ml<br>Contains : Brimonidine Tartrate 2mg and<br>Timolol Maleate 6.8mg equivalent to Timolol<br>5mg) (Each 15 ml Contains :Brimonidine<br>Tartrate 30mg and Timolol Maleate 102 mg )	<br>1 Number	9	Timolol Maleate	76.50 mg.
		10	BOTTLE	Relevant, as per<br>Packing Policy &<br>General Notes.
		11	CAP	Relevant, as per<br>Packing Policy &<br>General Notes.
		12	DROPPER	Relevant, as per<br>Packing Policy &<br>General Notes.

OTTLE|Relevant, as per Packing Policy & General Notes.| ||||11|CAP|Relevant, as per Packing Policy & General Notes.| ||||12|DROPPER|Relevant, as per Packing Policy & General Notes.| ||Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution USP (5mlBottle) ((Each ml Contains:Dorzolamide Hydrochloride 22.3mg equivalent to Dorzolamide 20mg and Timolol Maleate 6.8mg equivalent to Timolol 5mg) (Each 5ml Contains: Dorzolamide Hydrochloride 111.50mg & Timolol Maleate 34 mg)|1 Number|13|Timolol Maleate|25.50 mg.| ||||14|BOTTLE|Relevant, as per Packing Policy & General Notes.| ||||15|CAP|Relevant, as per Packing Policy & General Notes.|

UDIN00137349AM26

16<br>DROPPER<br>Relevant, as per<br>Packing Policy &<br>General Notes.<br>17<br>Timolol Maleate<br>51.00 mg.<br>18<br>BOTTLE<br>Relevant, as per<br>Packing Policy &<br>General Notes.<br>19<br>CAP<br>Relevant, as per<br>Packing Policy &<br>General Notes.<br>Dorzolamide Hydrochloride-Timolol<br>Maleate Ophthalmic Solution USP<br>(10mlBottle) ((Each ml<br>Contain:Dorzolamide Hydrochloride 22.3mg<br>equivalent to Dorzolamide 20mg and<br>Timolol Maleate 6.8mg equivalent to<br>Timolol 5mg) (Each 10ml Contains:<br>Dorzolamide Hydrochloride 223 mg &<br>Timolol Maleate 68 mg)<br>1 Number<br>20<br>DROPPER<br>Relevant, as per<br>Packing Policy &<br>General Notes.<br>RA concerned may take further necessary action as per above decision of NC.			16	DROPPER	Relevant, as per<br>Packing Policy &<br>General Notes.

		16	DROPPER	Relevant, as per<br>Packing Policy &<br>General Notes.
Dorzolamide Hydrochloride-Timolol<br>Maleate Ophthalmic Solution USP<br>(10mlBottle) ((Each ml<br>Contain:Dorzolamide Hydrochloride 22.3mg<br>equivalent to Dorzolamide 20mg and<br>Timolol Maleate 6.8mg equivalent to<br>Timolol 5mg) (Each 10ml Contains:<br>Dorzolamide Hydrochloride 223 mg &<br>Timolol Maleate 68 mg)	1 Number	17	Timolol Maleate	51.00 mg.
		18	BOTTLE	Relevant, as per<br>Packing Policy &<br>General Notes.
		19	CAP	Relevant, as per<br>Packing Policy &<br>General Notes.
		20	DROPPER	Relevant, as per<br>Packing Policy &<br>General Notes.

Case No.	Case No.	105 / NC/3/MEET/Apr/202526/2	105 / NC/3/MEET/Apr/202526/2	105 / NC/3/MEET/Apr/202526/2	105 / NC/3/MEET/Apr/202526/2	105 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00003534AM25
RA File Number		08AX04001146 AM25
Licence No and Date		0811012874/08/10/2024
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 of<br>HBP Vol.

|| |Licence No and Date||0811012874/08/10/2024||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Doxepin Hydrochloride USP 2.295 gm./ pack Doxepin Hydrochloride Cream 5% , 45g Tube Us (Each Tube Contains : Doxepinhydrochloridecream5%)(Eachcontains:Doxepinhydrochloride, 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Doxepin Hydrochloride Cream 5% , 45g Tube Us (Each Tube Contains : Doxepinhydrochloridecream5%)(Eachcontains:Doxepinhydrochloride,|| 1 Number|1|Doxepin Hydrochloride USP|2.295 gm./ pack|

UDIN00137349AM26

USP,5%(Equivalentto4.4%Doxepin)Net Content Of Should Not Be 2 Printed Relevant, Less Than 99.00 Kgs. In Export Item) Aluminum as per collapsible Packing Tubes and Caps Policy & for Doxepin HCl General Cream Notes. 5%,45g,Tube,US 45 GRS

ent Of Should Not Be 2 Printed Relevant, Less Than 99.00 Kgs. In Export Item) Aluminum as per collapsible Packing Tubes and Caps Policy & for Doxepin HCl General Cream Notes. 5%,45g,Tube,US 45 GRS

Case No.	Case No.	106 / NC/3/MEET/Apr/202526/2	106 / NC/3/MEET/Apr/202526/2	106 / NC/3/MEET/Apr/202526/2	106 / NC/3/MEET/Apr/202526/2	106 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00003550AM25
RA File Number		34AX04000568 AM25
Licence No and<br>Date		3411005503/08/10/2024
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/Feb/202324/23 dated19/02/2024 against advance<br>authorization No.3411004138 dated21/09/2023 , 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>1<br>Duloxetine Hydrochloride Ph,Eur.<br>22.88 mg.<br>2<br>Sugar Spheres (30-35 PHARM-A-<br>SPHERES)<br>20.33 mg.<br>Duloxetine Caps.20 mg<br>(Net<br>content<br>of<br>active<br>ingredients 180.000 kgs )<br>1 Number<br>Capsule<br>3<br>Sucrose (CompressucPS)<br>50.67 mg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

et content of active ingredients 180.000 kgs ) 1 Number Capsule 3 Sucrose (CompressucPS) 50.67 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Duloxetine Caps.20 mg (Net content of active ingredients 180.000 kgs )|| 1 Number Capsule|1|Duloxetine Hydrochloride Ph,Eur.|22.88 mg.| |||||2|Sugar Spheres (30-35 PHARM-A- SPHERES)|20.33 mg.| |||||3|Sucrose (CompressucPS)|50.67 mg.|

UDIN00137349AM26

|4 Duloxetine Hydrochloride Ph,Eur. 34.36 mg. 5 Sugar Spheres (30-35 PHARM-A- SPHERES) 30.50 mg. Duloxetine Caps. 30 mg (Net content of active ingredients 750.00 kgs ) 1 Number Capsule 6 Sucrose (CompressucPS) 23.50 mg 7 Duloxetine Hydrochloride Ph,Eur. 45.76 mg 8 Sugar Spheres (30-35 PHARM-A- SPHERES) 40.67 mg. Duloxetine Caps. 40 mg (Net content of active ingredients 360.000 kgs ) 1 Number Capsule 9 Sucrose (CompressucPS) 31.34 mg. 10 Duloxetine Hydrochloride Ph,Eur. 68.71 mg. 11 Sugar Spheres (30-35 PHARM-A- SPHERES) 61.00 mg. Duloxetine Caps. 60 mg (Net content of active ingredients 1500.00 kgs ) 1 Number Capsule 12 Sucrose (CompressucPS) 47.00 mg. RA concerned may take further necessary action as per above decision of NC.|Duloxetine Caps.

Duloxetine Caps. 30 mg<br>(Net<br>content<br>of<br>active<br>ingredients 750.00 kgs )	<br>1 Number<br>Capsule	4	Duloxetine Hydrochloride Ph,Eur.	34.36 mg.
		5	Sugar Spheres (30-35 PHARM-A-<br>SPHERES)	30.50 mg.
		6	Sucrose (CompressucPS)	23.50 mg
Duloxetine Caps. 40 mg<br>(Net<br>content<br>of<br>active<br>ingredients 360.000 kgs )	<br>1 Number<br>Capsule	7	Duloxetine Hydrochloride Ph,Eur.	45.76 mg
		8	Sugar Spheres (30-35 PHARM-A-<br>SPHERES)	40.67 mg.
		9	Sucrose (CompressucPS)	31.34 mg.
Duloxetine Caps. 60 mg<br>(Net<br>content<br>of<br>active<br>ingredients 1500.00 kgs )	<br>1 Number<br>Capsule	10	Duloxetine Hydrochloride Ph,Eur.	68.71 mg.
		11	Sugar Spheres (30-35 PHARM-A-<br>SPHERES)	61.00 mg.
		12	Sucrose (CompressucPS)	47.00 mg.

Case No.	107 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	ENCEE AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00003551AM25
RA File Number	32AX04000460 AM25
Licence No and<br>Date	3211007682/08/10/2024
Norms Committee Decision:<br>The Committee considered the request of the firm for fixation of ad-hoc norms and on the basis of<br>information provided by the firm and it has been observed by the committee that export product

UDIN00137349AM26

he request of the firm for fixation of ad-hoc norms and on the basis of information provided by the firm and it has been observed by the committee that export product||

UDIN00137349AM26

“Enamber/Kephalis/Tetrambrone (Perfumery Compound) as applied by the firm appears to fall under para 4.11(b) of FTP, 2023, and the said para states that “For export of perfumes, perfumery compounds and various feeding redients containing vitamins, no authorisation shall be issued by Regional Authority under para 4.07 of HBP. The applicant firm is requested to clarify how this application comes under Para 4.07 of HBP and the RA concerned is also directed to provide its comments on the same.

Case No.	108 / NC/3/MEET/Apr/202526/2
Case Status	Case Approved
Party Name	AKUMS DRUGS AND PHARMACEUTICALS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00003556AM25
RA File Number	05AX04002112 AM25
Licence No and Date	0511028203/09/10/2024
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. Progesterone 200MG Capsules(Progesterone USP/IP Net Weight = 400 KGS) 1 Number 1 PROGESTERONE USP MICRONISED IP 204 mg. Progesterone 100MG Capsules(Progesterone USP/IP Net Weight = 88.630 KGS) 1 Number 2 PROGESTERONE USP MICRONISED IP 102 mg. Progesterone - 50MG Injection(Progesterone USP/IP Net Weight = 1.570 KGS) 1 Number 3 PROGESTERONE USP MICRONISED IP 51 mg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00137349AM26

Case No.	109 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
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 case is under consideration and TE was requested to expedite his comments.

|RA File Number|09AX04000471 AM25| |Licence No and Date|0911008128/10/10/2024| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	Case No.	110 / NC/3/MEET/Apr/202526/2	110 / NC/3/MEET/Apr/202526/2	110 / NC/3/MEET/Apr/202526/2	110 / NC/3/MEET/Apr/202526/2	110 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00003599AM25
RA File Number		09AX04000475 AM25
Licence No and<br>Date		0911008129/10/10/2024
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>1<br>Liraglutide<br>19.8 mg.<br>2<br>3.0 mL Pre - Crimped<br>Glass Siliconized<br>Cartridge (Cartridge<br>EZ-Fill Nexa VB 3mL)<br>Relevant, as per<br>packing policy and<br>General Notes.<br>BD Vystra Disposable Relevant, as per<br>Liraglutide Injection 18 mg/3<br>mL(6 mg/mL)((Each 3 Ml<br>contains Liraglutide 18 Mg) Fill<br>Volume-<br>3.3 Ml)<br>1 Number<br>3
	Export Product		Qty.	Sl. No.	Import Items	Qty.

t, as per Liraglutide Injection 18 mg/3 mL(6 mg/mL)((Each 3 Ml contains Liraglutide 18 Mg) Fill Volume- 3.3 Ml) 1 Number 3||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Liraglutide Injection 18 mg/3 mL(6 mg/mL)((Each 3 Ml contains Liraglutide 18 Mg) Fill Volume- 3.3 Ml)||1 Number|1|Liraglutide|19.8 mg.| |||||2|3.0 mL Pre - Crimped Glass Siliconized Cartridge (Cartridge EZ-Fill Nexa VB 3mL)|Relevant, as per packing policy and General Notes.| |||||3|BD Vystra Disposable|Relevant, as per|

Case No.	Case No.	110 / NC/3/MEET/Apr/202526/2	110 / NC/3/MEET/Apr/202526/2	110 / NC/3/MEET/Apr/202526/2	110 / NC/3/MEET/Apr/202526/2	110 / NC/3/MEET/Apr/202526/2
Case Status		Case Approved
Party Name		ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00003599AM25
RA File Number		09AX04000475 AM25
Licence No and<br>Date		0911008129/10/10/2024
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. 1 Liraglutide 19.8 mg. 2 3.0 mL Pre - Crimped Glass Siliconized Cartridge (Cartridge EZ-Fill Nexa VB 3mL) Relevant, as per packing policy and General Notes. BD Vystra Disposable Relevant, as per Liraglutide Injection 18 mg/3 mL(6 mg/mL)((Each 3 Ml contains Liraglutide 18 Mg) Fill Volume- 3.3 Ml) 1 Number 3||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Liraglutide Injection 18 mg/3 mL(6 mg/mL)((Each 3 Ml contains Liraglutide 18 Mg) Fill Volume- 3.3 Ml)||1 Number|1|Liraglutide|19.8 mg.| |||||2|3.0 mL Pre - Crimped Glass Siliconized Cartridge (Cartridge EZ-Fill Nexa VB 3mL)|Relevant, as per packing policy and General Notes.| |||||3|BD Vystra Disposable|Relevant, as per|

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r>Glass Siliconized Cartridge (Cartridge EZ-Fill Nexa VB 3mL)|Relevant, as per packing policy and General Notes.| |||||3|BD Vystra Disposable|Relevant, as per|

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Pen Body Subassembly<br>with Purple Colour<br>Dose Button (VYSTRA<br>BSA FR PL 284C BTN<br>2685C<br>50IU)<br>packing policy and<br>General Notes.<br>4<br>"BD Vystra Disposable<br>Pen Printed Cartridge<br>Holder (VYSTRA<br>CARTRIDGE<br>HOLDER PRINTED<br>0.6-15)"<br>Relevant, as per<br>packing policy and<br>General Notes.<br>5<br>BD Vystra Disposable<br>Pen Cap (VYSTRA<br>CAP PL MODERN<br>284C)<br>Relevant, as per<br>packing policy and<br>General Notes.<br>RA concerned may take further necessary action as per above decision of NC.				Pen Body Subassembly<br>with Purple Colour<br>Dose Button (VYSTRA<br>BSA FR PL 284C BTN<br>2685C<br>50IU)	<br>packing policy and<br>General Notes.
			4	"BD Vystra Disposable<br>Pen Printed Cartridge<br>Holder (VYSTRA<br>CARTRIDGE<br>HOLDER PRINTED<br>0.6-15)"	Relevant, as per<br>packing policy and<br>General Notes.
			5	BD Vystra Disposable<br>Pen Cap (VYSTRA<br>CAP PL MODERN<br>284C)	Relevant, as per<br>packing policy and<br>General Notes.

.6-15)"|Relevant, as per packing policy and General Notes.| ||||5|BD Vystra Disposable Pen Cap (VYSTRA CAP PL MODERN 284C)|Relevant, as per packing policy and General Notes.|

Case No.	111 / NC/3/MEET/Apr/202526/2
Case Status	Case Deferred
Party Name	ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number	HQRNORM APPLY 00003600AM25
RA File Number	09AX04000467 AM25
Licence No and<br>Date	0911008130/10/10/2024
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No. 112 / NC/3/MEET/Apr/202526/2

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Case Status	Case Status	Case Approved	Case Approved	Case Approved	Case Approved	Case Approved
Party Name		VITAL LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202526/ 2 and 08/05/2025
HQ File Number		HQRNORM APPLY 00004985AM25
RA File Number		03AX04004733 AM25
Licence No and<br>Date		0311039829/23/12/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<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. 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 9 H Fluorene 0.814 kg. 2 Para ChloroBenzaldehyde 0.336 kg. 3 Methanol 3.305 kg. 4 Methylene Dichloride (MDC) 1.83 kg. 5 Isopropyl Alcohol (IPA) 0.110 kg. 6 Dimethyl Formamide (DMF) 0.555 kg. 7 Chloro Acetyl Chloride 0.380 kg. 8 sodium borohydride powder 0.040 kg. 9 Dibutyl Amine 0.390 kg. 10 N-Butanol 0.20 kg. Lumefantrine PH .I 1 kg. 11 Ethyl Acetate 0.88 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Lumefantrine PH .I||1 kg.|1|9 H Fluorene|0.814 kg.| |||||2|Para ChloroBenzaldehyde|0.336 kg.| |||||3|Methanol|3.305 kg.| |||||4|Methylene Dichloride (MDC)|1.83 kg.| |||||5|Isopropyl Alcohol (IPA)|0.110 kg.| |||||6|Dimethyl Formamide (DMF)|0.555 kg.| |||||7|Chloro Acetyl Chloride|0.380 kg.| |||||8|sodium borohydride powder|0.040 kg.| |||||9|Dibutyl Amine|0.390 kg.| |||||10|N-Butanol|0.20 kg.| |||||11|Ethyl Acetate|0.88 kg.| ||||||||

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