IN FORCE Advance Authorisation

DGFT Minutes

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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

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Mar/202425/19 DATED: 27/03/2025

Minutes of the Norms Committee–3 Meeting No. NC/3/MEET/Mar/202425/19 dated 17/03/2025 (actual held on 28/03/2025) under the Chairmanship of Shri Rakesh Kumar, Addl. DGFT for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2023 pertaining to Chemical and Allied products falling under Chapter 29 and 30.

2. 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)
2	Shri Uttam Dey Sarkar, ASO	DGFT (HQ)

1 This document has been digitally signed by Raman Kumar, Deputy DGFT on 21-04-2025 12:26:46.

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

    RAs shall ensure compliance of 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 of FTP, Para 4.16; Para 4.21; and Para 4.51 of HBP shall be made.

2 This document has been digitally signed by Raman Kumar, Deputy DGFT on 21-04-2025 12:26:46.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM REVIW00006341AM25
RA File Number	NA
Licence No and<br>Date	NA
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>Phthalic Anhydride<br>0.700 kg.<br>Di-Ethyl Phthalate (DEP)<br>1 kg.<br>2<br>Denatured Ethyl Alcohol<br>0.435 kg.<br>Note:NC also recommended to amend the import item No.2 in SION A-1294 based on the comments of<br>TE.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	2 / NC/3/MEET/Mar/202425/19
Case Status	Case Deferred
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM REVIW00002300AM25
RA File Number	092404000413 AM12
Licence No and<br>Date	0910050238/15/12/2011
Norms Committee Decision:<br>The firm was called for Personal Hearing through Video Conference, but the firm could not appear before

This document has been digitally signed by Raman Kumar, Deputy DGFT on 21-04-2025 12:26:46.

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sonal Hearing through Video Conference, but the firm could not appear before||

This document has been digitally signed by Raman Kumar, Deputy DGFT on 21-04-2025 12:26:46.

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Norms Committee. It was decided to grant one more opportunity to the firm for Personal Hearing with relevant documents/information.

Case No.	Case No.	3 / NC/3/MEET/Mar/202425/19	3 / NC/3/MEET/Mar/202425/19	3 / NC/3/MEET/Mar/202425/19	3 / NC/3/MEET/Mar/202425/19	3 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		ALPHAMED FORMULATIONS PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM REVIW00002734AM25
RA File Number		092404000091 AM16
Licence No and Date		0910062478/11/08/2015
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.6/82-ALC4/2020 dated 13/11/2020 against advance authorization<br>No.0910067834 dated 25/07/2019, 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.<br>No.<br>Import Items<br>Qty.

decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Glucuronolactone OR D-Glucuronolactone (Synonym) 51.00 mg/Tablet 2 Ascorbic Acid (Crystalline) 306.0 mg /Tablet 3 Caffeine Anhydrous 51.00 mg/Tablet 4 Sodium Polyphosphate 50.00 mg/Tablet 5 Sodium Hydrogen Carbonate OR Sodium Bicarbonate (Synonym) 950.00 mg/Tablet 6 Gin Fizz Micron Flavour 30.00 mg/Tablet GURONSAN C EFFERVESCENT TABLETS ((Each tablet contains Glucuronolactone Ph..Eur -50 Mg, Ascorbic Acid Ph,Eur- 300 Mg and Caffeine Ph.Eur- 50 Mg )) 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||GURONSAN C EFFERVESCENT TABLETS ((Each tablet contains Glucuronolactone Ph..Eur -50 Mg, Ascorbic Acid Ph,Eur- 300 Mg and Caffeine Ph.Eur- 50 Mg ))|| 1 Number|1|Glucuronolactone OR D-Glucuronolactone (Synonym)|51.00 mg/Tablet| |||||2|Ascorbic Acid (Crystalline)|306.0 mg /Tablet| |||||3|Caffeine Anhydrous|51.00 mg/Tablet| |||||4|Sodium Polyphosphate|50.00 mg/Tablet| |||||5|Sodium Hydrogen Carbonate OR Sodium Bicarbonate (Synonym)|950.00 mg/Tablet| |||||6|Gin Fizz Micron Flavour|30.00 mg/Tablet|

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==> picture [464 x 189] intentionally omitted <==

Carbonate OR Sodium Bicarbonate (Synonym)|950.00 mg/Tablet| |||||6|Gin Fizz Micron Flavour|30.00 mg/Tablet|

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==> picture [464 x 189] intentionally omitted <==

----- Start of picture text ----- 7 Macrogol 6000 135.00 mg/Tablet 8 Monosodium Fumarate 2000.00 mg/Tablet 9 Printed Tube for Guronsan As per packing C Eff Tabs policy and General Notes. 10 Cap with Drier - Tamper As per packing policy Evident and General Notes. ----- End of picture text -----

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

Case No.	Case No.	4 / NC/3/MEET/Mar/202425/19	4 / NC/3/MEET/Mar/202425/19	4 / NC/3/MEET/Mar/202425/19	4 / NC/3/MEET/Mar/202425/19	4 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		AMI ORGANICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM REVIW00002446AM25
RA File Number		522404000068 AM19
Licence No and<br>Date		5210042870/18/12/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Feb/202425/17 dated 25/02/2025 against advance<br>authorization No.5210043424 dated 08/06/2020, it was decided to revise 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.

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. 1 Acetyl Salicylic Acid (For Industrial Use) 1.85 kg. 4-HYDROXY COUMARIN (by Acetyl Salicylic Acid route) 1 kg. 2 Ethyl Aceto Acetate 1.60 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||4-HYDROXY COUMARIN (by Acetyl Salicylic Acid route)||1 kg.|1|Acetyl Salicylic Acid (For Industrial Use)|1.85 kg.| |||||2|Ethyl Aceto Acetate|1.60 kg.|

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Note: The above ad-hoc norms fixed for one time basis.

Case No.	Case No.	5 / NC/3/MEET/Mar/202425/19	5 / NC/3/MEET/Mar/202425/19	5 / NC/3/MEET/Mar/202425/19	5 / NC/3/MEET/Mar/202425/19	5 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM REVIW00002314AM25
RA File Number		318304000051 AM20
Licence No and<br>Date		3110067490/02/08/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to revise ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

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 OCP 50 1.100 kg. 2 Methanol 1.00 kg. 3 Catalyst (Katalco 715) 0.004 kg. DNOVO BP818 (Tetra Methyl Bisphenol F) 1 kg. 4 Paraformaldehyde 0.141 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||DNOVO BP818 (Tetra Methyl Bisphenol F)||1 kg.|1|OCP 50|1.100 kg.| |||||2|Methanol|1.00 kg.| |||||3|Catalyst (Katalco 715)|0.004 kg.| |||||4|Paraformaldehyde|0.141 kg.| |||||per above decision of NC.|||

Case No.	6 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM REVIW00002361AM25

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RA File Number	092404000540 AM20
Licence No and<br>Date	0910068421/28/01/2020
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for same<br>export product/import item in meeting No.NC/3/MEET/Dec/202425/13 dated 07/01/2025 against<br>advance authorization No.0910068991 dated 22/07/2020, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>(1R,2R)-2-amino-6-(4-nitrophenyl)-1-<br>phenylhex-5-yn-1-ol hydrochloride<br>1 kg.<br>1<br>CDX-034 LYOPHILIZED<br>ENZYME POWDER<br>0.0154 kg.<br>RA concerned may take further necessary action as per above decision of NC.

RA File Number

092404000540 AM20

Licence No and Date

0910068421/28/01/2020

Norms Committee Decision: The Committee considered the case as per the agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Dec/202425/13 dated 07/01/2025 against advance authorization No.0910068991 dated 22/07/2020, 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. (1R,2R)-2-amino-6-(4-nitrophenyl)-1- phenylhex-5-yn-1-ol hydrochloride 1 kg. 1 CDX-034 LYOPHILIZED ENZYME POWDER 0.0154 kg. RA concerned may take further necessary action as per above decision of NC.

phenyl)-1- phenylhex-5-yn-1-ol hydrochloride 1 kg. 1 CDX-034 LYOPHILIZED ENZYME POWDER 0.0154 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	7 / NC/3/MEET/Mar/202425/19
Case Status	Case Rejected
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM REVIW00002322AM25
RA File Number	522404000007 AM21
Licence No and<br>Date	5210043401/22/05/2020
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, it was decided toreject<br>the case maintaining the status quo.

Case No.	8 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	OPTRIX LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM REVIW00002780AM25

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RA File Number	092404000047 AM21
Licence No and<br>Date	0910069097/25/08/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Jul/202425/7 dated 06/08/2024 against DGFT HQ File<br>No.HQRNORMAPPLY00000350AM25, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.<br>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>FAVIPIRAVIR<br>1 kg.<br>1<br>6-fluoro-3-hydroxypyrazine-2-carbonitrile<br>dicyclohexylamine salt<br>1.282 kg.<br>RA concerned may take further necessary action as per above decision of NC.

RA File Number

092404000047 AM21

Licence No and Date

0910069097/25/08/2020

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/202425/7 dated 06/08/2024 against DGFT HQ File No.HQRNORMAPPLY00000350AM25, 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. FAVIPIRAVIR 1 kg. 1 6-fluoro-3-hydroxypyrazine-2-carbonitrile dicyclohexylamine salt 1.282 kg. RA concerned may take further necessary action as per above decision of NC.

d. FAVIPIRAVIR 1 kg. 1 6-fluoro-3-hydroxypyrazine-2-carbonitrile dicyclohexylamine salt 1.282 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	9 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	OPTRIX LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM REVIW00002781AM25
RA File Number	092404000042 AM21
Licence No and<br>Date	0910069098/25/08/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Jul/202425/7 dated 06/08/2024 against DGFT HQ File<br>No.HQRNORMAPPLY00000350AM25, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.<br>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>FAVIPIRAVIR<br>1 kg.<br>1<br>6-fluoro-3-hydroxypyrazine-2-carbonitrile<br>dicyclohexylamine salt<br>1.282 kg.<br>RA concerned may take further necessary action as per above decision of NC.

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g. 1 6-fluoro-3-hydroxypyrazine-2-carbonitrile dicyclohexylamine salt 1.282 kg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	10 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM REVIW00002351AM25
RA File Number	09AA04003656 AM21
Licence No and<br>Date	0911000173/11/01/2021
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.0910068991 dated 22/07/2020, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>(1R,2R)-2-amino-6-(4-nitrophenyl)-1-<br>phenylhex-5-yn-1-ol hydrochloride<br>1 kg.<br>1<br>CDX-034 LYOPHILIZED<br>ENZYME POWDER<br>0.0154 kg.<br>RA concerned may take further necessary action as per above decision of NC.

phenyl)-1- phenylhex-5-yn-1-ol hydrochloride 1 kg. 1 CDX-034 LYOPHILIZED ENZYME POWDER 0.0154 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	11 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM REVIW00002558AM25
RA File Number	03AA04019330 AM22
Licence No and<br>Date	0311004745/19/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

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Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>MEROPENEM NONSTERILE<br>MEROPENEM TRIHYDRATE<br>NONSTERILE<br>0.8968 kg.<br>MEROPENEM FOR INJECTION<br>(MEROPENEM BUFFERED<br>STERILE)<br>(Containing NLT 84% Sterile<br>Meropenem)<br>1 kg.<br>2<br>PACKING MATERIAL<br>Relevant, as per<br>Packing Policy<br>and General<br>Notes.<br>RA concerned may take further necessary action as per above decision of NC	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	MEROPENEM FOR INJECTION<br>(MEROPENEM BUFFERED<br>STERILE)<br>(Containing NLT 84% Sterile<br>Meropenem)	1 kg.	1	MEROPENEM NONSTERILE<br>MEROPENEM TRIHYDRATE<br>NONSTERILE	0.8968 kg.
			2	PACKING MATERIAL	Relevant, as per<br>Packing Policy<br>and General<br>Notes.

ing NLT 84% Sterile Meropenem)|1 kg.|1|MEROPENEM NONSTERILE MEROPENEM TRIHYDRATE NONSTERILE|0.8968 kg.| ||||2|PACKING MATERIAL|Relevant, as per Packing Policy and General Notes.|

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

Case No.	12 / NC/3/MEET/Mar/202425/19
Case Status	Case Rejected
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM REVIW00002563AM25
RA File Number	03AA04019330 AM22
Licence No and<br>Date	0311004745/19/06/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, it was decided toreject<br>the case maintaining the status quo.

Case No.	13 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM REVIW00002556AM25
RA File Number	03AX04000308 AM22
Licence No and<br>Date	0311009920/30/12/2021

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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.
MEROPENEM FOR INJECTION<br>(MEROPENEM BUFFERED<br>STERILE)<br>(Containing NLT 84% Sterile<br>Meropenem)	1 kg.	1	MEROPENEM NONSTERILE<br>MEROPENEM TRIHYDRATE<br>NONSTERILE	0.8968 kg.
		2	PACKING MATERIAL	Relevant, as per<br>Packing Policy<br>and General<br>Notes.

Case No.	Case No.	14 / NC/3/MEET/Mar/202425/19	14 / NC/3/MEET/Mar/202425/19	14 / NC/3/MEET/Mar/202425/19	14 / NC/3/MEET/Mar/202425/19	14 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		AMI ORGANICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM REVIW00002448AM25
RA File Number		52AX04000101 AM22
Licence No and<br>Date		5211002273/30/03/2022
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/Feb/202425/17 dated 25/02/2025 against advance<br>authorization No.5210043424 dated 08/06/2020, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<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. 4-HYDROXY COUMARIN Acetyl Salicylic Acid 1 kg. 1 1.85 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||4-HYDROXY COUMARIN||1 kg.|1|Acetyl Salicylic Acid|1.85 kg.|

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(by Acetyl Salicylic Acid route)			(For Industrial Use)
		2	Ethyl Aceto Acetate	1.60 kg.

Note: The above ad-hoc norms fixed for one time basis.

Case No.	15 / NC/3/MEET/Mar/202425/19
Case Status	Case Rejected
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM REVIW00002559AM25
RA File Number	03AX04002208 AM23
Licence No and<br>Date	0311016558/25/07/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, it was decided toreject<br>the case maintaining the status quo.

norms and it was observed that the firm has not provided any technical justification / information for enhancement. Hence, it was decided toreject the case maintaining the status quo**.**||

Case No.	16 / NC/3/MEET/Mar/202425/19
Case Status	Case Rejected
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM REVIW00002557AM25
RA File Number	03AX04003060 AM23
Licence No and<br>Date	0311018071/22/09/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm<br>has not provided any technical justification / information for enhancement. Hence, it was decided toreject<br>the case maintaining the status quo.

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Case No.	Case No.	17 / NC/3/MEET/Mar/202425/19	17 / NC/3/MEET/Mar/202425/19	17 / NC/3/MEET/Mar/202425/19	17 / NC/3/MEET/Mar/202425/19	17 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM REVIW00006507AM25
RA File Number		03AX04002988 AM23
Licence No and Date		0311018145/25/09/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<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. 1 Tetrahydrofuran 1.137 kg. 2 Lithium Metal 0.137 kg. 3 n-Heptane 1.808 kg. 4 Ethyl Isobutyrate 0.686 kg. 5 1 Bromo-5-chloropentane 1.10 kg. 6 Methyl-ethyl-ketone 1.038 kg. 7 N, N Dimethylacetamide 1.678 kg. 8 Sodium t-pentoxide 0.567 kg. 9 Iodine 0.823 kg. diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate 1 kg. 10 Tosmic 0.512 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate||1 kg.|1|Tetrahydrofuran|1.137 kg.| |||||2|Lithium Metal|0.137 kg.| |||||3|n-Heptane|1.808 kg.| |||||4|Ethyl Isobutyrate|0.686 kg.| |||||5|1 Bromo-5-chloropentane|1.10 kg.| |||||6|Methyl-ethyl-ketone|1.038 kg.| |||||7|N, N Dimethylacetamide|1.678 kg.| |||||8|Sodium t-pentoxide|0.567 kg.| |||||9|Iodine|0.823 kg.| |||||10|Tosmic|0.512 kg.|

UDIN00036287AM26

g.| |||||6|Methyl-ethyl-ketone|1.038 kg.| |||||7|N, N Dimethylacetamide|1.678 kg.| |||||8|Sodium t-pentoxide|0.567 kg.| |||||9|Iodine|0.823 kg.| |||||10|Tosmic|0.512 kg.|

UDIN00036287AM26

Case No.	18 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00006284AM25
RA File Number	NA
Licence No and<br>Date	0311018393/06/10/2022
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/202425/5 dated 14/06/2024 against advance<br>authorization No.0311009117 dated 02/12/2021, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Acetic Acid<br>0.95 kg.<br>N-Butylacetoacetate Ester<br>1 kg.<br>2<br>N-Butanol<br>0.50 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	19 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00000289AM25
RA File Number	NA
Licence No and<br>Date	0511017371/17/02/2023

UDIN00036287AM26

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.
Terpenyl Acetate<br>(Mixture of alpha, beta, gamma<br>isomers)	1 kg.	1	Gum Terpentine Oil<br>containing Alpha Pinene<br>82.5%	1.64 kg.

Case No.	Case No.	20 / NC/3/MEET/Mar/202425/19	20 / NC/3/MEET/Mar/202425/19	20 / NC/3/MEET/Mar/202425/19	20 / NC/3/MEET/Mar/202425/19	20 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM REVIW00006508AM25
RA File Number		03AX04005861 AM23
Licence No and Date		0311021934/06/03/2023
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 under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Tetrahydrofuran<br>1.137 kg.<br>2<br>N-Heptane<br>1.808 kg.<br>3<br>Ethyl Isobutyrate<br>0.686 kg.<br>4<br>1 Bromo-5-chloropentane<br>1.10 kg.<br>5<br>N, N Dimethylacetamide<br>1.678 kg.<br>1,15 diethyl 2,2,14,14-tetramethyl-8-<br>oxopentadecanedioate<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

chloropentane 1.10 kg. 5 N, N Dimethylacetamide 1.678 kg. 1,15 diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||1,15 diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate||1 kg.|1|Tetrahydrofuran|1.137 kg.| |||||2|N-Heptane|1.808 kg.| |||||3|Ethyl Isobutyrate|0.686 kg.| |||||4|1 Bromo-5-chloropentane|1.10 kg.| |||||5|N, N Dimethylacetamide|1.678 kg.|

UDIN00036287AM26

6<br>Sodium t-pentoxide<br>0.567 kg.<br>7<br>Tosmic<br>0.512 kg.<br>RA concerned may take further necessary action as per above decision of NC.			6	Sodium t-pentoxide	0.567 kg.
			7	Tosmic	0.512 kg.

Case No.	21 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	ALKALOIDS PVT LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00000398AM24
RA File Number	02AX04000047 AM24
Licence No and<br>Date	0211004284/25/04/2023
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>Reserpine BP/USP(Powder)<br>1 kg.<br>1<br>Rauwolfia Vomitoria Root Bark Dried<br>138.42 kg.<br>RA concerned may take further necessary action as per above decision of NC.

ems Qty. allowed. Reserpine BP/USP(Powder) 1 kg. 1 Rauwolfia Vomitoria Root Bark Dried 138.42 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	22 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	NEULAND LABORATORIES LTD.
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM REVIW00003641AM25
RA File Number	09AX04000226 AM24
Licence No and Date	0911005228/19/06/2023
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

UDIN00036287AM26

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.
Benzyl<br>(1S,2R,3R,4aR,6aS,7R,8R,10aR,10bR,12aR)-3-<br>hydrazineyl-2-hydroxy-1,6a,8,10a-tetramethyl-8-<br>((R)-3-methylbutan.(-2-yl)-<br>1,3,4,6,6a,7,8,9,10,10a,10b,11,12,12a-<br>tetradecahydro-2H-1,4a-<br>(methanooxymethano)chrysene-7-carboxylate(Drug<br>Intermediate of IbrexafungerpCitrate))	<br>1 kg.	1	ENFUMAFUNGIN	2.086 kg.

r>1,3,4,6,6a,7,8,9,10,10a,10b,11,12,12a- tetradecahydro-2H-1,4a- (methanooxymethano)chrysene-7-carboxylate(Drug Intermediate of IbrexafungerpCitrate))| 1 kg.|1|ENFUMAFUNGIN|2.086 kg.|

Case No.	Case No.	23 / NC/3/MEET/Mar/202425/19	23 / NC/3/MEET/Mar/202425/19	23 / NC/3/MEET/Mar/202425/19	23 / NC/3/MEET/Mar/202425/19	23 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		NEULAND LABORATORIES LTD.
Meeting Number and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM REVIW00003643AM25
RA File Number		09AX04000257 AM24
Licence No and Date		0911005276/27/06/2023
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.<br>No.<br>Import Items<br>Qty. allowed.<br>Benzyl<br>(1S,2R,3R,4aR,6aS,7R,8R,10aR,10bR,12aR)-3-<br>hydrazineyl-2-hydroxy-1,6a,8,10a-tetramethyl-8-<br>((R)-3-methylbutan.(-2-yl)-<br>1,3,4,6,6a,7,8,9,10,10a,10b,11,12,12a-<br>tetradecahydro-2H-1,4a-<br>(methanooxymethano)chrysene-7-carboxylate(Drug<br>1 kg.<br>1<br>ENFUMAFUNGIN<br>2.086 kg.
	Export Product		Qty.	Sl.<br>No.	Import Items	Qty.

0,10a,10b,11,12,12a- tetradecahydro-2H-1,4a- (methanooxymethano)chrysene-7-carboxylate(Drug 1 kg. 1 ENFUMAFUNGIN 2.086 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Benzyl (1S,2R,3R,4aR,6aS,7R,8R,10aR,10bR,12aR)-3- hydrazineyl-2-hydroxy-1,6a,8,10a-tetramethyl-8- ((R)-3-methylbutan.(-2-yl)- 1,3,4,6,6a,7,8,9,10,10a,10b,11,12,12a- tetradecahydro-2H-1,4a- (methanooxymethano)chrysene-7-carboxylate(Drug|| 1 kg.|1|ENFUMAFUNGIN|2.086 kg.|

Case No.	Case No.	23 / NC/3/MEET/Mar/202425/19	23 / NC/3/MEET/Mar/202425/19	23 / NC/3/MEET/Mar/202425/19	23 / NC/3/MEET/Mar/202425/19	23 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		NEULAND LABORATORIES LTD.
Meeting Number and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM REVIW00003643AM25
RA File Number		09AX04000257 AM24
Licence No and Date		0911005276/27/06/2023
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.<br>No.<br>Import Items<br>Qty.

decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Benzyl (1S,2R,3R,4aR,6aS,7R,8R,10aR,10bR,12aR)-3- hydrazineyl-2-hydroxy-1,6a,8,10a-tetramethyl-8- ((R)-3-methylbutan.(-2-yl)- 1,3,4,6,6a,7,8,9,10,10a,10b,11,12,12a- tetradecahydro-2H-1,4a- (methanooxymethano)chrysene-7-carboxylate(Drug 1 kg. 1 ENFUMAFUNGIN 2.086 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Benzyl (1S,2R,3R,4aR,6aS,7R,8R,10aR,10bR,12aR)-3- hydrazineyl-2-hydroxy-1,6a,8,10a-tetramethyl-8- ((R)-3-methylbutan.(-2-yl)- 1,3,4,6,6a,7,8,9,10,10a,10b,11,12,12a- tetradecahydro-2H-1,4a- (methanooxymethano)chrysene-7-carboxylate(Drug|| 1 kg.|1|ENFUMAFUNGIN|2.086 kg.|

UDIN00036287AM26

Intermediate of IbrexafungerpCitrate))

Case No.	24 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	NEULAND LABORATORIES LTD.
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM REVIW00003644AM25
RA File Number	09AX04000270 AM24
Licence No and Date	0911005295/28/06/2023
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.<br>No.<br>Import Items<br>Qty.

decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Benzyl (1S,2R,3R,4aR,6aS,7R,8R,10aR,10bR,12aR)-3- hydrazineyl-2-hydroxy-1,6a,8,10a-tetramethyl-8- ((R)-3-methylbutan.(-2-yl)- 1,3,4,6,6a,7,8,9,10,10a,10b,11,12,12a- tetradecahydro-2H-1,4a- (methanooxymethano)chrysene-7-carboxylate(Drug Intermediate of IbrexafungerpCitrate)) 1 kg. 1 ENFUMAFUNGIN 2.086 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	25 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM REVIW00006509AM25

UDIN00036287AM26

RA File Number	03AX04004237 AM24
Licence No and Date	0311029470/19/12/2023
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 under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

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. 1 Tetrahydrofuran 1.137 kg. 2 Lithium Metal 0.137 kg. 3 n-Heptane 1.808 kg. 4 Ethyl Isobutyrate 0.686 kg. 5 1 Bromo-5-chloropentane 1.10 kg. 6 Methyl-ethyl-ketone 1.038 kg. 7 N, N Dimethylacetamide 1.678 kg. 8 Sodium t-pentoxide 0.567 kg. 9 Iodine 0.823 kg. 1,15 diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate (CION-4) 1 kg. 10 Tosmic 0.512 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	26 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00007772AM24

UDIN00036287AM26

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RA File Number	09AX04000883 AM24
Licence No and<br>Date	0911006495/05/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Feb/202425/17 dated 25/02/2025 against advance<br>authorization No.0911005327 dated 06/07/2023, 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.<br>Import Items<br>Qty. allowed.<br>1<br>2,3,4,5-Tetra fluoro benzoyl Chloride<br>2.60 kg.<br>2<br>Ethyl 3-(N,N-dimethyl amino) acrylate<br>2.11 kg.<br>3<br>Toluene<br>9.21 kg.<br>4<br>N-Methyl Piperazine<br>1.03 kg.<br>MARBOFLOXACIN<br>(PHARMACEUTICAL<br>PRODUCT)<br>1 kg.<br>5<br>Dimethyl Sulfoxide<br>1.33 kg.<br>RA concerned may take further necessary action as per above decision of NC.

RA File Number

09AX04000883 AM24

Licence No and Date

0911006495/05/01/2024

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/Feb/202425/17 dated 25/02/2025 against advance authorization No.0911005327 dated 06/07/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 2,3,4,5-Tetra fluoro benzoyl Chloride 2.60 kg. 2 Ethyl 3-(N,N-dimethyl amino) acrylate 2.11 kg. 3 Toluene 9.21 kg. 4 N-Methyl Piperazine 1.03 kg. MARBOFLOXACIN (PHARMACEUTICAL PRODUCT) 1 kg. 5 Dimethyl Sulfoxide 1.33 kg. RA concerned may take further necessary action as per above decision of NC.

erazine 1.03 kg. MARBOFLOXACIN (PHARMACEUTICAL PRODUCT) 1 kg. 5 Dimethyl Sulfoxide 1.33 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	27 / NC/3/MEET/Mar/202425/19
Case Status	Case Deferred
Party Name	NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00007813AM24
RA File Number	03AX04004498 AM24
Licence No and<br>Date	0311029998/08/01/2024
Norms Committee Decision:<br>The committee considered the firm's request for the fixation of ad-hoc norms and observed that the firm<br>has not furnished the specific reply of DL. Therefore, it was decided to call for following<br>information/documents from the firm:-<br>Commercial value of 30% Isomerized Bromo Compounds obtained during manufacturing.<br>1.

UDIN00036287AM26

Case No.	Case No.	28 / NC/3/MEET/Mar/202425/19	28 / NC/3/MEET/Mar/202425/19	28 / NC/3/MEET/Mar/202425/19	28 / NC/3/MEET/Mar/202425/19	28 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number and<br>Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00007828AM24
RA File Number		08AX04001867 AM24
Licence No and Date		0811010468/09/01/2024

and Date||NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025||||| |HQ File Number||HQRNORM APPLY 00007828AM24||||| |RA File Number||08AX04001867 AM24||||| |Licence No and Date||0811010468/09/01/2024||||| |Norms Committee Decision: The Committee considered the case as per the agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Dec/202425/12 dated 10/12/2024, against advance authorization No. 0811011943 dated 26/06/2024**,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. ISOSORBIDE MONONITRATE EXTENDED RELEASE TABLETS USP 60 MG(EACH FILM COATED EXTENDEDRELEASE TABLETS CONTAINS: DILUTED ISOSORBIDE MONONITRATE (50% DILUTED WITH LACTOSE MONOHYDRATE) USPEQUIVALENT TO ISOSORBIDE MONONITRATE 60MG 1 Number 1 Isosorbide Mononitrate 50 percent Assay. Diluted ISMN (50% diluted with lactose monohydrate) USP 122.40 mg. ISOSORBIDE MONONITRATE EXTENDED RELEASE TABLETS USP 120 MG(EACH FILM COATED EXTENDEDRELEASE TABLETS CONTAINS: DILUTED ISOSORBIDE MONONITRATE (50% DILUTED WITH LACTOSE MONOHYDRATE) USPEQUIVALENT TO ISOSORBIDE MONONITRATE 120MG 1 Number 2 Isosorbide Mononitrate 50 percent Assay.Diluted ISMN (50% diluted with lactose monohydrate) USP 244.80 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.

br>1 Number 2 Isosorbide Mononitrate 50 percent Assay.Diluted ISMN (50% diluted with lactose monohydrate) USP 244.80 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||ISOSORBIDE MONONITRATE EXTENDED RELEASE TABLETS USP 60 MG(EACH FILM COATED EXTENDEDRELEASE TABLETS CONTAINS: DILUTED ISOSORBIDE MONONITRATE (50% DILUTED WITH LACTOSE MONOHYDRATE) USPEQUIVALENT TO ISOSORBIDE MONONITRATE 60MG||1 Number|1|Isosorbide Mononitrate 50 percent Assay. Diluted ISMN (50% diluted with lactose monohydrate) USP| 122.40 mg.| ||ISOSORBIDE MONONITRATE EXTENDED RELEASE TABLETS USP 120 MG(EACH FILM COATED EXTENDEDRELEASE TABLETS CONTAINS: DILUTED ISOSORBIDE MONONITRATE (50% DILUTED WITH LACTOSE MONOHYDRATE) USPEQUIVALENT TO ISOSORBIDE MONONITRATE 120MG|| 1 Number|2|Isosorbide Mononitrate 50 percent Assay.Diluted ISMN (50% diluted with lactose monohydrate) USP|244.80 mg|

UDIN00036287AM26

ISOSORBIDE MONONITRATE 120MG|| 1 Number|2|Isosorbide Mononitrate 50 percent Assay.Diluted ISMN (50% diluted with lactose monohydrate) USP|244.80 mg|

UDIN00036287AM26

Case No.	29 / NC/3/MEET/Mar/202425/19
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00007862AM24
RA File Number	07AX04001619 AM24
Licence No and<br>Date	0711010173/10/01/2024
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>Firm has given two steps reaction whereas the yields claimed for three step.<br>I.<br>Provide complete chemistry as the chemistry given is incomplete.<br>II.<br>Firm may be advised to furnish balanced chemical reactions for the entire process with molecular<br>weight and percentage yield on molar basis.<br>III.

III. Firm may be advised to furnish balanced chemical reactions for the entire process with molecular weight and percentage yield on molar basis.

nd percentage yield on molar basis. III.||

III. Firm may be advised to furnish balanced chemical reactions for the entire process with molecular weight and percentage yield on molar basis.

Case No.	30 / NC/3/MEET/Mar/202425/19
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00007864AM24
RA File Number	07AX04001614 AM24
Licence No and<br>Date	0711010175/10/01/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Firm has not giving chemistry of 3rdstage for preparation of export item.<br>1.<br>Recovering of solvents.<br>2.

22 This document has been digitally signed by Raman Kumar, Deputy DGFT on 21-04-2025 12:26:46.

UDIN00036287AM26

dstage for preparation of export item. 1. Recovering of solvents. 2.||

22 This document has been digitally signed by Raman Kumar, Deputy DGFT on 21-04-2025 12:26:46.

UDIN00036287AM26

Case No.	Case No.	31 / NC/3/MEET/Mar/202425/19	31 / NC/3/MEET/Mar/202425/19	31 / NC/3/MEET/Mar/202425/19	31 / NC/3/MEET/Mar/202425/19	31 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00007865AM24
RA File Number		07AX04001617 AM24
Licence No and<br>Date		0711010176/10/01/2024
Norms Committee Decision:<br>The Committee considered the case as per the 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.<br>Import Items<br>Qty. allowed.<br>1<br>1 BROMO 3 CHLORO PROPANE<br>1.12 kg.<br>2<br>TETRA HYDRO FURAN<br>0.68 kg.<br>3<br>METHANOL<br>Not required.<br>4<br>TOLUENE<br>Not required<br>DOXEPIN HYDROCHLORIDE<br>(BP/EP/USP)<br>1 kg.<br>5<br>ACETONE<br>Not required.<br>RA concerned may take further necessary action as per above decision of NC.				agenda and it was decided to fix ad-hoc norms under Para<br>or as applied by the firm, whichever is less:-
	Export Product		Qty.	Sl. No.	Import Items	Qty.

y action as per above decision of NC.||||agenda and it was decided to fix ad-hoc norms under Para or as applied by the firm, whichever is less:-||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||DOXEPIN HYDROCHLORIDE (BP/EP/USP)||1 kg.|1|1 BROMO 3 CHLORO PROPANE|1.12 kg.| |||||2|TETRA HYDRO FURAN|0.68 kg.| |||||3|METHANOL|Not required.| |||||4|TOLUENE|Not required| |||||5|ACETONE|Not required.|

Case No.	32 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00007866AM24
RA File Number	07AX04001599 AM24
Licence No and<br>Date	0711010178/10/01/2024

UDIN00036287AM26

|N R T|orms Committee Decision: The Committee considered the case as per the 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:-|orms Committee Decision: The Committee considered the case as per the 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:-|orms Committee Decision: The Committee considered the case as per the agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

ow or as applied by the firm, whichever is less:-|orms Committee Decision: The Committee considered the case as per the 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:-|orms Committee Decision: The Committee considered the case as per the 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:-|orms Committee Decision: The Committee considered the case as per the agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.| ||DOXYCYCLINE 100MG DISPERSIBLE TABLETS (Eq toanhydrous Doxycycline 100mg) (400.00kgs)| 1 Number|1|DOXYCYCLINE MONOHYDRATE U.S.P/B.P|106.13 mg/100 mg. Tablet| ||A concerned may take further necessary action as per above decision of NC. he Committee also recommended to make a new SION for the above item.|||||

Norms Committee Decision:

The Committee considered the case as per the 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:-

RA concerned may take further necessary action as per above decision of NC. The Committee also recommended to make a new SION for the above item.

Case No.	Case No.	33 / NC/3/MEET/Mar/202425/19	33 / NC/3/MEET/Mar/202425/19	33 / NC/3/MEET/Mar/202425/19	33 / NC/3/MEET/Mar/202425/19	33 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		FDC LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00007890AM24
RA File Number		03AX04004630 AM24
Licence No and Date		0311030104/11/01/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>CHLORAMPHENICOL EYE<br>DROPS 10 ML (CLORAH EYE<br>DROPS 10 ML AND<br>OPTIPHEN OPHTHALMIC<br>SOLUTIONS 5 mg/ml<br>10ML)((EACH VIAL<br>CONTAINS<br>CHLORAMPHENICOL<br>MICRONIZED 0.050GM NET<br>590000<br>Vials<br>1<br>CHLORAMPHENICOL<br>MICRONIZED<br>30.086 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

0ML)((EACH VIAL CONTAINS CHLORAMPHENICOL MICRONIZED 0.050GM NET 590000 Vials 1 CHLORAMPHENICOL MICRONIZED 30.086 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||CHLORAMPHENICOL EYE DROPS 10 ML (CLORAH EYE DROPS 10 ML AND OPTIPHEN OPHTHALMIC SOLUTIONS 5 mg/ml 10ML)((EACH VIAL CONTAINS CHLORAMPHENICOL MICRONIZED 0.050GM NET||590000 Vials|1|CHLORAMPHENICOL MICRONIZED|30.086 kg.|

Case No.	Case No.	33 / NC/3/MEET/Mar/202425/19	33 / NC/3/MEET/Mar/202425/19	33 / NC/3/MEET/Mar/202425/19	33 / NC/3/MEET/Mar/202425/19	33 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		FDC LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00007890AM24
RA File Number		03AX04004630 AM24
Licence No and Date		0311030104/11/01/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>CHLORAMPHENICOL EYE<br>DROPS 10 ML (CLORAH EYE<br>DROPS 10 ML AND<br>OPTIPHEN OPHTHALMIC<br>SOLUTIONS 5 mg/ml<br>10ML)((EACH VIAL<br>CONTAINS<br>CHLORAMPHENICOL<br>MICRONIZED 0.050GM NET<br>590000<br>Vials<br>1<br>CHLORAMPHENICOL<br>MICRONIZED<br>30.086 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

UDIN00036287AM26

WT OF BULK DRUG IS 29.500 KGS))

Case No.	34 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	UNIMAX LABORATORIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00007901AM24
RA File Number	05AX04003229 AM24
Licence No and<br>Date	0511023203/11/01/2024
Norms Committee Decision:<br>The Committee considered the case as per the 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.<br>Import Items<br>Qty. allowed.<br>Spiramycin Tablets 3.0 MIU<br>(Each tablet contains Spiramycin EP 3.0<br>MIU)<br>1 Number<br>1<br>Spiramycin EP<br>670.00 mg.<br>RA concerned may take further necessary action as per above decision of NC.

Tablets 3.0 MIU (Each tablet contains Spiramycin EP 3.0 MIU) 1 Number 1 Spiramycin EP 670.00 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	35 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	AVIK PHARMACEUTICAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00007926AM24
RA File Number	52AX04000307 AM24
Licence No and<br>Date	5211007035/12/01/2024

UDIN00036287AM26

Norms Committee Decision:

The Committee considered the case as per the agenda and it was decided to fix ad-hoc norms as per newly fixed SION A3682 or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
CLOBETASOL PROPIONATE	1 kg.	1	BETAMETHASONE	0.95 kg.

Case No.	36 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	SAGA LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00008014AM24
RA File Number	08AX04001772 AM24
Licence No and<br>Date	0811010513/17/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>DIOSMIN<br>459.00 mg.<br>Diosmin and Hesperidin Tablets 500 mg<br>(305.14 KGS)<br>1 Number<br>2<br>HESPERIDIN<br>51.00 mg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	37 / NC/3/MEET/Mar/202425/19
Case Status	Case Deferred
Party Name	SANPRAS HEALTHCARE PRIVATE LIMITED

UDIN00036287AM26

sary action as per above decision of NC.||

Case No.	37 / NC/3/MEET/Mar/202425/19
Case Status	Case Deferred
Party Name	SANPRAS HEALTHCARE PRIVATE LIMITED

UDIN00036287AM26

Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00008015AM24
RA File Number	31AX04000283 AM24
Licence No and<br>Date	3111003005/17/01/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>The firm has to indicate export quantity in number of Bottles.<br>1.<br>The committee also recommended to make a new SION for above items after receipt of information from<br>the firm.

Case No.	Case No.	38 / NC/3/MEET/Mar/202425/19	38 / NC/3/MEET/Mar/202425/19	38 / NC/3/MEET/Mar/202425/19	38 / NC/3/MEET/Mar/202425/19	38 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00008039AM24
RA File Number		03AX04004687 AM24
Licence No and<br>Date		0311030266/18/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<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. 1 Fenofibrate Micronized IH/Ph Eur 147.90 mg. Fenofibrate 145mg tablets)(146415000 NOS)(Net Content:1)21442.184 KGS 2)21313.632 KGS 3) (Indi):4325.099 KGS 4) (Indi):423.139KGS 5) (Indi):1471.471KGS 6) (Indi):19126.191KGS 7) (Indi):12467.237KGS 8) (Indi):10934.272KGS 9)(Indi):131.774KGS 10)(Indi): 4348.526KGS) 1Number 2 Sucrose PH.Eur (exepient) 146.45 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Fenofibrate 145mg tablets)(146415000 NOS)(Net Content:1)21442.184 KGS 2)21313.632 KGS 3) (Indi):4325.099 KGS 4) (Indi):423.139KGS 5) (Indi):1471.471KGS 6) (Indi):19126.191KGS 7) (Indi):12467.237KGS 8) (Indi):10934.272KGS 9)(Indi):131.774KGS 10)(Indi): 4348.526KGS)||1Number|1|Fenofibrate Micronized IH/Ph Eur|147.90 mg.| |||||2|Sucrose PH.Eur (exepient)|146.45 mg.|

UDIN00036287AM26

:10934.272KGS 9)(Indi):131.774KGS 10)(Indi): 4348.526KGS)||1Number|1|Fenofibrate Micronized IH/Ph Eur|147.90 mg.| |||||2|Sucrose PH.Eur (exepient)|146.45 mg.|

UDIN00036287AM26

Case No.	39 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	ANNORA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00008068AM24
RA File Number	09AX04000846 AM24
Licence No and<br>Date	0911006469/19/01/2024
Norms Committee Decision:<br>The Committee considered the case as per the 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.<br>Import Items<br>Qty. allowed.<br>Gabapentin Oral Solution 250 mg / 5 Ml<br>470 ML ((Each 5 mL of Oral Solution<br>Contains, Gabapentin USP 250<br>mg))<br>1 Number<br>1<br>GABAPENTIN USP<br>23.97 gm/Bottle<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	40 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM REVIW00006510AM25
RA File Number	03AX04004728 AM24
Licence No and Date	0311030291/19/01/2024
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information

UDIN00036287AM26

No and Date|0311030291/19/01/2024| |Norms Committee Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information||

UDIN00036287AM26

provided by the firm, it was decided to revise ad-hoc norms as under:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
1,15 diethyl 2,2,14,14-tetramethyl-8-<br>oxopentadecanedioate	1 kg.	1	Tetrahydrofuran	1.137 kg.
		2	Lithium Metal	0.137 kg.
		3	n-Heptane	1.808 kg.
		4	Ethyl Isobutyrate	0.686 kg.
		5	1 Bromo-5-chloropentane	1.10 kg.
		6	Methyl-ethyl-ketone	1.038 kg.
		7	N, N Dimethylacetamide	1.678 kg.
		8	Sodium t-pentoxide	0.567 kg.
		9	Iodine	0.823 kg.
		10	Tosmic	0.512 kg.

Case No.	41 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00008094AM24
RA File Number	08AX04001922 AM24
Licence No and<br>Date	0811010550/22/01/2024
Norms Committee Decision:

UDIN00036287AM26

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

AM26

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Pazopanib Tablet 200 MG(Each film<br>coated tablet contains: Pazopanib<br>Hydrochloride 216.70 mg equivalent<br>to Pazopanib 200mg. Net content of<br>active<br>ingredient<br>Pazopanib<br>Hydrochloride should not be less than<br>43.340 kgs in export product.)	<br> <br> <br> <br> <br> <br>200000<br>Numbers	1	Pazopanib Hydrochloride	44.207 kg.

Case No.	42 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00008141AM24
RA File Number	09AX04000959 AM24
Licence No and<br>Date	0911006629/24/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>2-Phenyl phenol<br>0.83 kg.<br>Fendizoic acid(Drug Intermediate)<br>1 kg.<br>2<br>Ethylene dichloride<br>2.80 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00036287AM26

kg. Fendizoic acid(Drug Intermediate) 1 kg. 2 Ethylene dichloride 2.80 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00036287AM26

Case No.	Case No.	43 / NC/3/MEET/Mar/202425/19	43 / NC/3/MEET/Mar/202425/19	43 / NC/3/MEET/Mar/202425/19	43 / NC/3/MEET/Mar/202425/19	43 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00008188AM24
RA File Number		34AX04000814 AM24
Licence No and Date		3411004545/29/01/2024
Norms Committee Decision:<br>The Committee considered the case as per the 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.<br>No.<br>Import Items<br>Qty.

decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 CIPROFLOXACIN HYDROCHLORIDE USP 25.475 mg. CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION USP 0.3% /0.1% -7.5 ML 1 Number 2 DEXAMETHASONE USP 7.65 mg. 3 TOBRAMYCIN USP 7.65 mg. TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SUSPENSION USP 0.3% /0.1% - 2.5 ML 1 Number 4 DEXAMETHASONE USP 2.55 mg. 5 TOBRAMYCIN USP 15.30 mg. TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SUSPENSION USP 0.3% /0.1% - 5 ML 1 Number 6 DEXAMETHASONE USP 5.10 mg. 7 TOBRAMYCIN USP 30.60 mg. TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SUSPENSION USP 0.3% /0.1% - 10 ML 1 Number 8 DEXAMETHASONE USP 10.20 mg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.

10 ML 1 Number 8 DEXAMETHASONE USP 10.20 mg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||CIPROFLOXACIN AND DEXAMETHASONE OTIC SUSPENSION USP 0.3% /0.1% -7.5 ML||1 Number|1|CIPROFLOXACIN HYDROCHLORIDE USP|25.475 mg.| |||||2|DEXAMETHASONE USP|7.65 mg.| ||TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SUSPENSION USP 0.3% /0.1% - 2.5 ML|| 1 Number|3|TOBRAMYCIN USP|7.65 mg.| |||||4|DEXAMETHASONE USP|2.55 mg.| ||TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SUSPENSION USP 0.3% /0.1% - 5 ML|| 1 Number|5|TOBRAMYCIN USP|15.30 mg.| |||||6|DEXAMETHASONE USP|5.10 mg.| ||TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SUSPENSION USP 0.3% /0.1% - 10 ML|| 1 Number|7|TOBRAMYCIN USP|30.60 mg.| |||||8|DEXAMETHASONE USP|10.20 mg.| |||||above decision of NC.|||

UDIN00036287AM26

Case No.	44 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	AMNEAL INJECTABLES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00008190AM24
RA File Number	08AX04001949 AM24
Licence No and Date	0811010589/29/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.

decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection 200 mcg/50 mL (4 mcg/mL) 1 Number 1 DEXMEDETOMIDINE 210.00 mcg. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) 1 Number 2 DEXMEDETOMIDINE 420.00 mcg. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection 200 mcg per 50 mL (4 mcg/mL) 1 Number 3 DEXMEDETOMIDINE 210.00 mcg. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection 400 mcg per 100 mL (4 mcg/mL) 1 Number 4 DEXMEDETOMIDINE 420.00 mcg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	45 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	SUPRIYA LIFESCIENCE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM REVIW00002816AM25
RA File Number	03AX04005187 AM24

UDIN00036287AM26

Licence No and 0311031241/15/02/2024 Date 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 under:-

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 under:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
RIBOFLAVIN SODIUM<br>PHOSPHATE HYDRATE EP<br>11.2	1 kg.	1	Vitamin B2 Or Riboflavin	1.269 kg.
		2	Pyridine	1.20 kg.
		3	Acetonitrile	1.538 kg.
		4	Phosphorus Oxychloride	2.00 kg.

Case No.	Case No.	46 / NC/3/MEET/Mar/202425/19	46 / NC/3/MEET/Mar/202425/19	46 / NC/3/MEET/Mar/202425/19	46 / NC/3/MEET/Mar/202425/19	46 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM REVIW00006511AM25
RA File Number		03AX04000076 AM25
Licence No and Date		0311033249/22/04/2024
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>Tetrahydrofuran<br>1.137 kg.<br>2<br>N-Heptane<br>1.808 kg.<br>1,15 diethyl 2,2,14,14-tetramethyl-8-<br>oxopentadecanedioate<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

rofuran 1.137 kg. 2 N-Heptane 1.808 kg. 1,15 diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||1,15 diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate||1 kg.|1|Tetrahydrofuran|1.137 kg.| |||||2|N-Heptane|1.808 kg.|

Case No.	Case No.	46 / NC/3/MEET/Mar/202425/19	46 / NC/3/MEET/Mar/202425/19	46 / NC/3/MEET/Mar/202425/19	46 / NC/3/MEET/Mar/202425/19	46 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM REVIW00006511AM25
RA File Number		03AX04000076 AM25
Licence No and Date		0311033249/22/04/2024
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>Tetrahydrofuran<br>1.137 kg.<br>2<br>N-Heptane<br>1.808 kg.<br>1,15 diethyl 2,2,14,14-tetramethyl-8-<br>oxopentadecanedioate<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	1,15 diethyl 2,2,14,14-tetramethyl-8-<br>oxopentadecanedioate		1 kg.	1	Tetrahydrofuran	1.137 kg.
				2	N-Heptane	1.808 kg.

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. No.**|Import Items|Qty. allowed.| ||1,15 diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate||1 kg.|1|Tetrahydrofuran|1.137 kg.| |||||2|N-Heptane|1.808 kg.|

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3	Ethyl Isobutyrate	0.686 kg.
4	1 Bromo-5-chloropentane	1.10 kg.
5	N, N Dimethylacetamide	1.678 kg.
6	Sodium t-pentoxide	0.567 kg.
7	Tosmic	0.512 kg.

Case No.	Case No.	47 / NC/3/MEET/Mar/202425/19	47 / NC/3/MEET/Mar/202425/19	47 / NC/3/MEET/Mar/202425/19	47 / NC/3/MEET/Mar/202425/19	47 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM REVIW00006512AM25
RA File Number		03AX04000120 AM25
Licence No and Date		0311033250/22/04/2024
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. Import Items<br>**Qty.

eview 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. 1 Tetrahydrofuran 1.137 kg. 2 N-Heptane 1.808 kg. 3 Ethyl Isobutyrate 0.686 kg. 4 1 Bromo-5-chloropentane 1.10 kg. 5 N, N Dimethylacetamide 1.678 kg. 1,15 diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||1,15 diethyl 2,2,14,14-tetramethyl-8- oxopentadecanedioate||1 kg.|1|Tetrahydrofuran|1.137 kg.| |||||2|N-Heptane|1.808 kg.| |||||3|Ethyl Isobutyrate|0.686 kg.| |||||4|1 Bromo-5-chloropentane|1.10 kg.| |||||5|N, N Dimethylacetamide|1.678 kg.|

Case No.	Case No.	47 / NC/3/MEET/Mar/202425/19	47 / NC/3/MEET/Mar/202425/19	47 / NC/3/MEET/Mar/202425/19	47 / NC/3/MEET/Mar/202425/19	47 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM REVIW00006512AM25
RA File Number		03AX04000120 AM25
Licence No and Date		0311033250/22/04/2024
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. Import Items<br>**Qty.

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6<br>Sodium t-pentoxide<br>0.567 kg.<br>7<br>Tosmic<br>0.512 kg.<br>RA concerned may take further necessary action as per above decision of NC.			6	Sodium t-pentoxide	0.567 kg.
			7	Tosmic	0.512 kg.

kg.<br>7<br>Tosmic<br>0.512 kg.<br>RA concerned may take further necessary action as per above decision of NC.			6	Sodium t-pentoxide	0.567 kg.
			7	Tosmic	0.512 kg.

Case No.	48 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00000410AM25
RA File Number	52AX04000014 AM25
Licence No and Date	5211007960/24/04/2024
Norms Committee Decision:<br>The Committee considered the case as per the agenda and taking cue from the earlier decision for same<br>export product/import item in meeting No.NC/3/MEET/Mar/202425/8 dated 17/03/2025 against advance<br>authorization No. 5211003710 dated 07/12/2022,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.<br>allowed.<br>1<br>2-chloro-4-(1H-pyrazol-3-<br>yl)benzonitrile<br>0.963 kg.<br>2<br>Tert-Butyl((1S)-2-hydroxy-1-<br>methylethyl)carbamate<br>0.826 kg.<br>3<br>Diisopropyl azodicarboxylate<br>1.034 kg.<br>4-{1-[(2S)-2-Aminopropyl]-1-H-<br>Pyrazole-3-yl}-2- Chlorobenzonitrile)<br>1 kg.<br>4<br>TRIPHENYLPHOSPHINE<br>1.237 kg.<br>RA concerned may take further necessary action as per above decision of NC.

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Pyrazole-3-yl}-2- Chlorobenzonitrile) 1 kg. 4 TRIPHENYLPHOSPHINE 1.237 kg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	Case No.	49 / NC/3/MEET/Mar/202425/19	49 / NC/3/MEET/Mar/202425/19	49 / NC/3/MEET/Mar/202425/19	49 / NC/3/MEET/Mar/202425/19	49 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		CONNEX PHARMA PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00000436AM25
RA File Number		26AX04000084 AM24
Licence No and Date		2611001430/25/04/2024
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/Nov/202425/10 dated 22/11/2024 against advance<br>authorization No. 2611000980 dated16/06/2023,it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>METHYL<br>CHLOROFORMATE<br>0.885 kg.<br>CHLOROMETHYL ISOPROPYL<br>CARBONATE<br>1 kg.<br>2<br>ISOPROPYL ALCOHOL<br>0.492 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

PYL CARBONATE 1 kg. 2 ISOPROPYL ALCOHOL 0.492 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||CHLOROMETHYL ISOPROPYL CARBONATE||1 kg.|1|METHYL CHLOROFORMATE|0.885 kg.| |||||2|ISOPROPYL ALCOHOL|0.492 kg.| |||||as per above decision of NC.|||

Case No.	50 / NC/3/MEET/Mar/202425/19
Case Status	Case Deferred
Party Name	INNOVARE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00000484AM25
RA File Number	09AX04001160 AM24
Licence No and<br>Date	0911007159/30/04/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the application of the firm was<br>sent to Deptt. of Bio-Technology (DBT) for comments on 15/10/2024. DBT vide e-mail dated 21/10/2024<br>has informed that the export item mentioned in the application is comes under chemical item and requested

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to seek the comments fromDeptt. of Chemical &Petrochemicals. The application of the firm was sent to Deptt. of C&PC on 06/11/2024 and comments is still awaited. A reminder was also issued.

AM26

to seek the comments fromDeptt. of Chemical &Petrochemicals. The application of the firm was sent to Deptt. of C&PC on 06/11/2024 and comments is still awaited. A reminder was also issued.

Case No.	51 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00000517AM25
RA File Number	08AX04000152 AM25
Licence No and<br>Date	0811011425/02/05/2024
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>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Vasopressin Injection, USP 20 Units per<br>MI<br>572105<br>Vials.<br>1<br>Vasopressin USP<br>20.981 gm.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	52 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	DEEPAK CHEM TECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00000594AM25
RA File Number	34AX04000083 AM25
Licence No and<br>Date	3411004899/08/05/2024
Norms Committee Decision:<br>The Committee considered the case as per the 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:-

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case as per the 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:-||

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Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Benzo Trifluoride<br>1 kg.<br>1<br>BENZO TRICHLORIDE<br>1.402 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	Benzo Trifluoride	1 kg.	1	BENZO TRICHLORIDE	1.402 kg.

Case No.	53 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	DEEPAK CHEM TECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00000595AM25
RA File Number	34AX04000021 AM25
Licence No and<br>Date	3411004900/08/05/2024
Norms Committee Decision:<br>The Committee considered the case as per the 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.<br>Import Items<br>Qty. allowed.<br>Benzo Trifluoride<br>1 kg.<br>1<br>BENZO TRICHLORIDE<br>1.402 kg.<br>RA concerned may take further necessary action as per above decision of NC.

y. Sl. No. Import Items Qty. allowed. Benzo Trifluoride 1 kg. 1 BENZO TRICHLORIDE 1.402 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	54 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00000608AM25
RA File Number	03AX04000430 AM25
Licence No and<br>Date	0311033683/08/05/2024
Norms Committee Decision:

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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/202425/18dated 17/03/2024 against advance authorization No. 0311025742 dated 25/07/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

vance authorization No. 0311025742 dated 25/07/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

|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/202425/18dated 17/03/2024 against advance authorization No. 0311025742 dated 25/07/2023**,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. TYLOSIN BOLUS 200MG (EACH BOLUS CONTAINS TYLOSIN 200MG) 1 Number 1 TYLOSIN TARTRATE 204.00 gm. TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATEEQ. TO TYLOSIN BASE 50MG) 1 Number 2 TYLOSIN TARTRATE 3.056 gm. TYLOSIN INJECTION 5%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ.

0 ML (EACH ML CONTAINS TYLOSIN TARTRATEEQ. TO TYLOSIN BASE 50MG) 1 Number 2 TYLOSIN TARTRATE 3.056 gm. TYLOSIN INJECTION 5%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) 1 Number 3 TYLOSIN TARTRATE 6.111 gm. TYLOSIN TARTRATE INJECTION 20%-50 ML (EACH MLCONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG) 1 Number 4 TYLOSIN TARTRATE 12.222 gm. TYLOSIN TARTRATE INJECTION 20%-100 ML (EACH MLCONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG 1 Number 5 TYLOSIN TARTRATE 24.444 gm. TYLOSIN TARTRATE POWDER 100%-100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 6 TYLOSIN TARTRATE 101 gm. TYLOSIN TARTRATE POWDER 100% -500GM SACHET(EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 7 TYLOSIN TARTRATE 505 gm. TYLOSIN TARTRATE POWDER 100% -1KG JAR (EACH GRAM 1 Number 8 TYLOSIN TARTRATE 1010 gm.|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/202425/18dated 17/03/2024 against advance authorization No. 0311025742 dated 25/07/2023**,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items **Qty.

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. TYLOSIN BOLUS 200MG (EACH BOLUS CONTAINS TYLOSIN 200MG) 1 Number 1 TYLOSIN TARTRATE 204.00 gm. TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATEEQ. TO TYLOSIN BASE 50MG) 1 Number 2 TYLOSIN TARTRATE 3.056 gm. TYLOSIN INJECTION 5%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) 1 Number 3 TYLOSIN TARTRATE 6.111 gm. TYLOSIN TARTRATE INJECTION 20%-50 ML (EACH MLCONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG) 1 Number 4 TYLOSIN TARTRATE 12.222 gm. TYLOSIN TARTRATE INJECTION 20%-100 ML (EACH MLCONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG 1 Number 5 TYLOSIN TARTRATE 24.444 gm. TYLOSIN TARTRATE POWDER 100%-100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 6 TYLOSIN TARTRATE 101 gm. TYLOSIN TARTRATE POWDER 100% -500GM SACHET(EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 7 TYLOSIN TARTRATE 505 gm. TYLOSIN TARTRATE POWDER 100% -1KG JAR (EACH GRAM 1 Number 8 TYLOSIN TARTRATE 1010 gm.|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/202425/18dated 17/03/2024 against advance

he 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/202425/18dated 17/03/2024 against advance authorization No. 0311025742 dated 25/07/2023**,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. TYLOSIN BOLUS 200MG (EACH BOLUS CONTAINS TYLOSIN 200MG) 1 Number 1 TYLOSIN TARTRATE 204.00 gm. TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATEEQ. TO TYLOSIN BASE 50MG) 1 Number 2 TYLOSIN TARTRATE 3.056 gm. TYLOSIN INJECTION 5%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG) 1 Number 3 TYLOSIN TARTRATE 6.111 gm. TYLOSIN TARTRATE INJECTION 20%-50 ML (EACH MLCONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG) 1 Number 4 TYLOSIN TARTRATE 12.222 gm. TYLOSIN TARTRATE INJECTION 20%-100 ML (EACH MLCONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG 1 Number 5 TYLOSIN TARTRATE 24.444 gm. TYLOSIN TARTRATE POWDER 100%-100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 6 TYLOSIN TARTRATE 101 gm. TYLOSIN TARTRATE POWDER 100% -500GM SACHET(EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 7 TYLOSIN TARTRATE 505 gm. TYLOSIN TARTRATE POWDER 100

TYLOSIN TARTRATE POWDER 100% -500GM SACHET(EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 7 TYLOSIN TARTRATE 505 gm. TYLOSIN TARTRATE POWDER 100% -1KG JAR (EACH GRAM 1 Number 8 TYLOSIN TARTRATE 1010 gm.|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/202425/18dated 17/03/2024 against advance authorization No. 0311025742 dated 25/07/2023**,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. TYLOSIN BOLUS 200MG (EACH BOLUS CONTAINS TYLOSIN 200MG) 1 Number 1 TYLOSIN TARTRATE 204.00 gm. TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATEEQ. TO TYLOSIN BASE 50MG) 1 Number 2 TYLOSIN TARTRATE 3.056 gm. TYLOSIN INJECTION 5%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ.

TYLOSIN TARTRATE POWDER 100% -500GM SACHET(EACH GRAM CONTAINS TYLOSIN TARTRATE 100%) 1 Number 7 TYLOSIN TARTRATE 505 gm. TYLOSIN TARTRATE POWDER 100% -1KG JAR (EACH GRAM 1 Number 8 TYLOSIN TARTRATE 1010 gm.| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.| ||TYLOSIN BOLUS 200MG (EACH BOLUS CONTAINS TYLOSIN 200MG)| 1 Number|1|TYLOSIN TARTRATE|204.00 gm.| ||TYLOSIN INJECTION 5%-50 ML (EACH ML CONTAINS TYLOSIN TARTRATEEQ. TO TYLOSIN BASE 50MG)| 1 Number|2|TYLOSIN TARTRATE|3.056 gm.| ||TYLOSIN INJECTION 5%-100 ML (EACH ML CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN BASE 50MG)| 1 Number|3|TYLOSIN TARTRATE|6.111 gm.| ||TYLOSIN TARTRATE INJECTION 20%-50 ML (EACH MLCONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG)| 1 Number|4|TYLOSIN TARTRATE|12.222 gm.| ||TYLOSIN TARTRATE INJECTION 20%-100 ML (EACH MLCONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 200MG| 1 Number|5|TYLOSIN TARTRATE|24.444 gm.| ||TYLOSIN TARTRATE POWDER 100%-100GM SACHET (EACH GRAM CONTAINS TYLOSIN TARTRATE 100%)| 1 Number|6|TYLOSIN TARTRATE|101 gm.| ||TYLOSIN TARTRATE POWDER 100% -500GM SACHET(EACH GRAM CONTAINS TYLOSIN TARTRATE 100%)| 1 Number|7|TYLOSIN TARTRATE|505 gm.| ||TYLOSIN TARTRATE POWDER 100% -1KG JAR (EACH GRAM| 1 Number|8|TYLOSIN TARTRATE|1010 gm.|

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TARTRATE 100%)| 1 Number|7|TYLOSIN TARTRATE|505 gm.| ||TYLOSIN TARTRATE POWDER 100% -1KG JAR (EACH GRAM| 1 Number|8|TYLOSIN TARTRATE|1010 gm.|

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|CONTAINS TYLOSIN TARTRATE 100%) TYLOSIN TARTRATE POWDER 20%-5GM (EACH GRAM CONTAINSTYLOSIN TARTRATE EQ. TO TYLOSIN 20%) 1 Number 9 TYLOSIN TARTRATE 1.1756 gm. TYLOSIN TARTRATE POWDER 20% -100GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) 1 Number 10 TYLOSIN TARTRATE 23.513 gm. TYLOSIN TARTRATE POWDER 20% -500GM (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) 1 Number 11 TYLOSIN TARTRATE 117.564 gm. TYLOSIN TARTRATE POWDER 20% -1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE EQ. TO TYLOSIN 20%) 1 Number 12 TYLOSIN TARTRATE 235.128 gm. TYLOSIN TARTRATE POWDER 99% -100GM SACHET(EACH GRAM CONTAINS TYLOSIN TARTRATE 99%) 1 Number 13 TYLOSIN TARTRATE 100 gm. TYLOSIN TARTRATE POWDER 99% -500GM SACHET(EACH GRAM CONTAINS TYLOSIN TARTRATE 99%) 1 Number 14 TYLOSIN TARTRATE 500 gm. TYLOSIN TARTRATE POWDER 99% -1KG JAR (EACH GRAM CONTAINS TYLOSIN TARTRATE 99%) 1 Number 15 TYLOSIN TARTRATE 1000 gm. TYLOSIN TARTRATE BOLUS 600MG(EACH BOLUS CONTAINSTYLOSIN TARTRATE 600MG) 1 Number 16 TYLOSIN TARTRATE 612.00 mg. RA concerned may take further necessary action as per above decision

CONTAINS TYLOSIN TARTRATE<br>100%)
TYLOSIN<br>TARTRATE<br>POWDER<br>20%-5GM<br>(EACH<br>GRAM<br>CONTAINSTYLOSIN<br>TARTRATE<br>EQ. TO TYLOSIN 20%)	<br> <br> <br>1 Number	9	TYLOSIN TARTRATE	1.1756 gm.
TYLOSIN<br>TARTRATE<br>POWDER<br>20%<br>-100GM<br>(EACH<br>GRAM<br>CONTAINS TYLOSIN TARTRATE<br>EQ. TO TYLOSIN 20%)	<br> <br>1 Number	10	TYLOSIN TARTRATE	23.513 gm.
TYLOSIN<br>TARTRATE<br>POWDER<br>20%<br>-500GM<br>(EACH<br>GRAM<br>CONTAINS TYLOSIN TARTRATE<br>EQ. TO TYLOSIN 20%)	<br> <br>1 Number	11	TYLOSIN TARTRATE	117.564 gm.
TYLOSIN<br>TARTRATE<br>POWDER<br>20% -1KG JAR (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE<br>EQ. TO TYLOSIN 20%)	<br> <br>1 Number	12	TYLOSIN TARTRATE	235.128 gm.
TYLOSIN<br>TARTRATE<br>POWDER<br>99%<br>-100GM<br>SACHET(EACH<br>GRAM<br>CONTAINS<br>TYLOSIN<br>TARTRATE 99%)	<br> <br> <br>1 Number	13	TYLOSIN TARTRATE	100 gm.
TYLOSIN<br>TARTRATE<br>POWDER<br>99%<br>-500GM<br>SACHET(EACH<br>GRAM<br>CONTAINS<br>TYLOSIN<br>TARTRATE 99%)	<br> <br> <br>1 Number	14	TYLOSIN TARTRATE	500 gm.
TYLOSIN<br>TARTRATE<br>POWDER<br>99% -1KG JAR (EACH GRAM<br>CONTAINS TYLOSIN TARTRATE<br>99%)	<br> <br>1 Number	15	TYLOSIN TARTRATE	1000 gm.
TYLOSIN<br>TARTRATE<br>BOLUS<br>600MG(EACH<br>BOLUS<br>CONTAINSTYLOSIN<br>TARTRATE<br>600MG)	<br> <br> <br>1 Number	16	TYLOSIN TARTRATE	612.00 mg.

UDIN00036287AM26

N TARTRATE|1000 gm.| ||TYLOSIN TARTRATE BOLUS 600MG(EACH BOLUS CONTAINSTYLOSIN TARTRATE 600MG)| 1 Number|16|TYLOSIN TARTRATE|612.00 mg.|

UDIN00036287AM26

Case No.	55 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	K.P.MANISH GLOBAL INGREDIENTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00000654AM25
RA File Number	04AX04000110 AM25
Licence No and<br>Date	0411007398/10/05/2024
Norms Committee Decision:<br>The Committee considered the case as per the 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. allowed.<br>MUPIROCIN USP/EP (Assay<br>(by HPLC) (Not less than 990μg/mg)<br>1 kg.<br>1<br>CARBOXYLIC ACID-S-<br>ACPE 9-[(E) -4-[(2S,3R,5S)-<br>3,4-dihydroxy-5-[[(2S,3S)-3-<br>[(2S,3S)-3-hydroxybutan-2-<br>yl]oxiran-2-yl]methyl]oxan-2-<br>yl]-3-methylbut-2-enoyl]<br>(Crude) (Assy not more than<br>92.1%<br>1.07 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	56 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	NECTAR LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00000693AM25
RA File Number	30AX04000069 AM25
Licence No and<br>Date	3011005168/13/05/2024
Norms Committee Decision:

UDIN00036287AM26

and 27/03/2025| |HQ File Number|HQRNORM APPLY 00000693AM25| |RA File Number|30AX04000069 AM25| |Licence No and Date|3011005168/13/05/2024| |Norms Committee Decision:||

UDIN00036287AM26

The Committee considered the case as per the 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.
Ceftibuten Hydrate<br>(62/0-Ceftibuten Hydrate)	1 kg.	1	GHYH	2.977 kg.
		2	Ethyl-4-chloroacetoacetate	1.82 kg.
		3	Methylene Chloride	85.60 kg.
		4	Triethylamine	3.214 kg
		5	Isopropyl acetate	7.99 kg.
		6	DL Malic acid	7.18 kg.
		7	Methanol	52.50 kg.
		8	Prenol (Prenyl alcohol)	3.114 kg.
		9	Methyl 3-methoxyacrylate	1.62 kg.
		10	Dimethylformamide (DMF)	4.82 kg.
		11	Toluene	0.38 kg.
		12	Acetone	2.13 kg.

Case No.	57 / NC/3/MEET/Mar/202425/19
Case Status	Case Deferred
Party Name	PRIGIV SPECIALTIES PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025

UDIN00036287AM26

NC/3/MEET/Mar/202425/19| |---|---| |Case Status|Case Deferred| |Party Name|PRIGIV SPECIALTIES PRIVATE LIMITED| |Meeting Number|NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025|

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and Date
HQ File Number	HQRNORM APPLY 00000698AM25
RA File Number	03AX04000618 AM25
Licence No and<br>Date	0311033818/14/05/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>As per details furnished by firm 0.21 kg of white oil is added per kg of export product, hence, the<br>percentatage of purity of export is required.

Case No.	58 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00000703AM25
RA File Number	05AX04000448 AM25
Licence No and<br>Date	0511025482/14/05/2024
Norms Committee Decision:<br>The Committee considered the case as per the 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.<br>Import Items<br>Qty. allowed.<br>1<br>ADIPIC ACID<br>0.925 kg.<br>2<br>METHANOL<br>0.423 kg.<br>DIMETHYL ADIPATE (DMA)<br>(PACKED IN 426 NOS. OF HM-HDPE<br>DRUMS MADE<br>OF HDPE GRANULES (3,621.000<br>KGS.

Items Qty. allowed. 1 ADIPIC ACID 0.925 kg. 2 METHANOL 0.423 kg. DIMETHYL ADIPATE (DMA) (PACKED IN 426 NOS. OF HM-HDPE DRUMS MADE OF HDPE GRANULES (3,621.000 KGS. WITHOUT WASTAGE)) (EACH DRUM SHALL WEIGHT 8.5 KG AND STORAGE CAPACITY 235.000 KGS.)) 1 kg. 3 HDPE GRANULES (TOTAL WEIGHT = 3,802.050 KGS.) Relevant, as per Packing Policy and General Notes. RA concerned may take further necessary action as per above decision of NC.||

UDIN00036287AM26

Case No.	Case No.	59 / NC/3/MEET/Mar/202425/19	59 / NC/3/MEET/Mar/202425/19	59 / NC/3/MEET/Mar/202425/19	59 / NC/3/MEET/Mar/202425/19	59 / NC/3/MEET/Mar/202425/19	59 / NC/3/MEET/Mar/202425/19	59 / NC/3/MEET/Mar/202425/19	59 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		S KANT HEALTHCARE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00000712AM25
RA File Number		03AX04000705 AM25
Licence No and Date		0311033849/14/05/2024
Norms Committee Decision:<br>The Committee considered the case as per the 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 Item<br>Qty<br>S.No.<br>Import item<br>Qty.

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 Item Qty S.No. Import item Qty. allowed 1 ARTEMETHER 20.4 mg/Tablet ARTEMETHER 20 MG & LUMEFANTRINE 120 MG TABLETS 1 Number Tablet 2 LUMEFANTRINE 122.4 mg/Tablet 1 ARTEMETHER 20.4 mg/Tablet ARTEMETHER 20 MG & LUMEFANTRINE 120 MG DISPERSIBLE TABLETS 1 Number Tablet 2 LUMEFANTRINE 122.4 mg/Tablet 1 ARTEMETHER 40.8 mg/Tablet ARTEMETHER 40 MG & LUMEFANTRINE 240 MG TABLETS 1 Number Tablet 2 LUMEFANTRINE 244.8 mg/Tablet 1 ARTEMETHER 81.6 mg./Tablet ARTEMETHER 80 MG & LUMEFANTRINE 480 MG TABLETS 1 Number Tablet 2 LUMEFANTRINE 489.60 mg./Tablet Norms Proposed for 1 kg of ARTEMETHER Export Item Qty S.No. Import item Qty. allowed|||||||||| ||Export Item|||Qty||S.No.||Import item|Qty.

LUMEFANTRINE 489.60 mg./Tablet Norms Proposed for 1 kg of ARTEMETHER Export Item Qty S.No. Import item Qty. allowed|||||||||| ||Export Item|||Qty||S.No.||Import item|Qty. allowed| ||ARTEMETHER 20 MG & LUMEFANTRINE 120 MG TABLETS|||1 Number Tablet||1||ARTEMETHER|20.4 mg/Tablet| |||||||2||LUMEFANTRINE|122.4 mg/Tablet| ||ARTEMETHER 20 MG & LUMEFANTRINE 120 MG DISPERSIBLE TABLETS|||1 Number Tablet||1||ARTEMETHER|20.4 mg/Tablet| |||||||2||LUMEFANTRINE|122.4 mg/Tablet| ||ARTEMETHER 40 MG & LUMEFANTRINE 240 MG TABLETS|||1 Number Tablet||1||ARTEMETHER|40.8 mg/Tablet| |||||||2||LUMEFANTRINE|244.8 mg/Tablet| ||ARTEMETHER 80 MG & LUMEFANTRINE 480 MG TABLETS|||1 Number Tablet||1||ARTEMETHER|81.6 mg./Tablet| |||||||2||LUMEFANTRINE|489.60 mg./Tablet| ||||||||||| ||Norms Proposed for 1 kg of ARTEMETHER||||||||| ||Export Item||Qty||S.No.||Import item||Qty. allowed|

Case No.	Case No.	59 / NC/3/MEET/Mar/202425/19	59 / NC/3/MEET/Mar/202425/19	59 / NC/3/MEET/Mar/202425/19	59 / NC/3/MEET/Mar/202425/19	59 / NC/3/MEET/Mar/202425/19	59 / NC/3/MEET/Mar/202425/19	59 / NC/3/MEET/Mar/202425/19	59 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		S KANT HEALTHCARE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00000712AM25
RA File Number		03AX04000705 AM25
Licence No and Date		0311033849/14/05/2024

|NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025|||||||| |HQ File Number||HQRNORM APPLY 00000712AM25|||||||| |RA File Number||03AX04000705 AM25|||||||| |Licence No and Date||0311033849/14/05/2024|||||||| |Norms Committee Decision: The Committee considered the case as per the 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 Item Qty S.No. Import item Qty. allowed 1 ARTEMETHER 20.4 mg/Tablet ARTEMETHER 20 MG & LUMEFANTRINE 120 MG TABLETS 1 Number Tablet 2 LUMEFANTRINE 122.4 mg/Tablet 1 ARTEMETHER 20.4 mg/Tablet ARTEMETHER 20 MG & LUMEFANTRINE 120 MG DISPERSIBLE TABLETS 1 Number Tablet 2 LUMEFANTRINE 122.4 mg/Tablet 1 ARTEMETHER 40.8 mg/Tablet ARTEMETHER 40 MG & LUMEFANTRINE 240 MG TABLETS 1 Number Tablet 2 LUMEFANTRINE 244.8 mg/Tablet 1 ARTEMETHER 81.6 mg./Tablet ARTEMETHER 80 MG & LUMEFANTRINE 480 MG TABLETS 1 Number Tablet 2 LUMEFANTRINE 489.60 mg./Tablet Norms Proposed for 1 kg of ARTEMETHER Export Item Qty S.No. Import item Qty. allowed|||||||||| ||Export Item|||Qty||S.No.||Import item|Qty.

44 This document has been digitally signed by Raman Kumar, Deputy DGFT on 21-04-2025 12:26:46.

UDIN00036287AM26

1	Artemisinin	1.04 Kg
2	Sodium Borohydride	0.188 Kg
3	Trimethyl Ortho Acetate	0.50 Kg.
	99% MIN

GFT on 21-04-2025 12:26:46.

UDIN00036287AM26

1	Artemisinin	1.04 Kg
2	Sodium Borohydride	0.188 Kg
3	Trimethyl Ortho Acetate	0.50 Kg.
	99% MIN

Norms Proposed for 1 kg of LUMEFANTRINE	Norms Proposed for 1 kg of LUMEFANTRINE	Norms Proposed for 1 kg of LUMEFANTRINE	Norms Proposed for 1 kg of LUMEFANTRINE	Norms Proposed for 1 kg of LUMEFANTRINE
Export Item	Qty	S.No.	Import item	Qty. allowed
LUMEFANTRINE	1Kg	1	2, 7 DICHLORO A<br>DIBUTYLAMINO METHYL<br>9 HFLUORENE-4-<br>METHANOL DBA 99<br>PERCENT MIN	0.86896 kg
		2	4-chlorobenzaldehide	0.3476 Kg

Case No.	60 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00000731AM25
RA File Number	03AX04000559 AM25
Licence No and<br>Date	0311033874/15/05/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Mar/202425/18dated 17/03/2024 against advance

45 This document has been digitally signed by Raman Kumar, Deputy DGFT on 21-04-2025 12:26:46.

UDIN00036287AM26

authorization No. 0311025665dated24/07/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

87AM26

authorization No. 0311025665dated24/07/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

|authorization No. 0311025665dated24/07/2023**,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 50ml vial 1 Number 1 PROPYLENE GLYCOL 39.52 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 100ml vial 1 Number 2 PROPYLENE GLYCOL 79.04 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 250ml vial 1 Number 3 PROPYLENE GLYCOL 197.60 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 500ml vial 1 Number 4 PROPYLENE GLYCOL 395.20 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 50ml vial 1 Number 5 PROPYLENE GLYCOL 35.256 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 100ml vial 1 Number 6 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 250ml vial 1 Number 7 PROPYLENE GLYCOL 176.28 gm/Vial PAN Ashoxy 3% (Oxytetracycline Injection 30mg) 100ml vial 1 Number 8 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eqOxytetracycline 200mg) 50ml vial 1 Number 9 PROPYLENE

on 30mg) 100ml vial 1 Number 8 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eqOxytetracycline 200mg) 50ml vial 1 Number 9 PROPYLENE GLYCOL 9.00 gm/Vial Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eq Oxytetracycline 200mg) 100ml vial 1 Number 10 PROPYLENE GLYCOL 18.00 gm/Vial Ashoxy 20% LA (Oxytetracycline 1 Number 11 PROPYLENE GLYCOL 45.00 gm/Vial|authorization No. 0311025665dated24/07/2023**,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 50ml vial 1 Number 1 PROPYLENE GLYCOL 39.52 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 100ml vial 1 Number 2 PROPYLENE GLYCOL 79.04 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 250ml vial 1 Number 3 PROPYLENE GLYCOL 197.60 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 500ml vial 1 Number 4 PROPYLENE GLYCOL 395.20 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 50ml vial 1 Number 5 PROPYLENE GLYCOL 35.256 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 100ml vial 1 Number 6 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 250ml vial 1 Number 7 PROPYLENE GLYCOL

Oxytetracycline Injection 100mg) 100ml vial 1 Number 6 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 250ml vial 1 Number 7 PROPYLENE GLYCOL 176.28 gm/Vial PAN Ashoxy 3% (Oxytetracycline Injection 30mg) 100ml vial 1 Number 8 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eqOxytetracycline 200mg) 50ml vial 1 Number 9 PROPYLENE GLYCOL 9.00 gm/Vial Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eq Oxytetracycline 200mg) 100ml vial 1 Number 10 PROPYLENE GLYCOL 18.00 gm/Vial Ashoxy 20% LA (Oxytetracycline 1 Number 11 PROPYLENE GLYCOL 45.00 gm/Vial|authorization No. 0311025665dated24/07/2023**,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items **Qty.

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. Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 50ml vial 1 Number 1 PROPYLENE GLYCOL 39.52 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 100ml vial 1 Number 2 PROPYLENE GLYCOL 79.04 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 250ml vial 1 Number 3 PROPYLENE GLYCOL 197.60 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 500ml vial 1 Number 4 PROPYLENE GLYCOL 395.20 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 50ml vial 1 Number 5 PROPYLENE GLYCOL 35.256 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 100ml vial 1 Number 6 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 250ml vial 1 Number 7 PROPYLENE GLYCOL 176.28 gm/Vial PAN Ashoxy 3% (Oxytetracycline Injection 30mg) 100ml vial 1 Number 8 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eqOxytetracycline 200mg) 50ml vial 1 Number 9 PROPYLENE GLYCOL 9.00 gm/Vial Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eq Oxytetracycline 200mg) 100ml vial 1 Number 10 PROPYLENE GLYCOL 18.00 gm/Vial Ashoxy 20% LA (Oxytetracycline 1 Number 11 PROPYLENE GLYCOL 45.00 gm/Vial|author

Injection eq Oxytetracycline 200mg) 100ml vial 1 Number 10 PROPYLENE GLYCOL 18.00 gm/Vial Ashoxy 20% LA (Oxytetracycline 1 Number 11 PROPYLENE GLYCOL 45.00 gm/Vial|authorization No. 0311025665dated24/07/2023**,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 50ml vial 1 Number 1 PROPYLENE GLYCOL 39.52 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 100ml vial 1 Number 2 PROPYLENE GLYCOL 79.04 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 250ml vial 1 Number 3 PROPYLENE GLYCOL 197.60 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 500ml vial 1 Number 4 PROPYLENE GLYCOL 395.20 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 50ml vial 1 Number 5 PROPYLENE GLYCOL 35.256 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 100ml vial 1 Number 6 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 250ml vial 1 Number 7 PROPYLENE GLYCOL 176.28 gm/Vial PAN Ashoxy 3% (Oxytetracycline Injection 30mg) 100ml vial 1 Number 8 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eqOxytetracycline 200mg) 50ml vial 1 Number 9 PROPYLENE GLYCOL<

) 100ml vial 1 Number 8 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eqOxytetracycline 200mg) 50ml vial 1 Number 9 PROPYLENE GLYCOL 9.00 gm/Vial Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eq Oxytetracycline 200mg) 100ml vial 1 Number 10 PROPYLENE GLYCOL 18.00 gm/Vial Ashoxy 20% LA (Oxytetracycline 1 Number 11 PROPYLENE GLYCOL 45.00 gm/Vial|authorization No. 0311025665dated24/07/2023**,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 50ml vial 1 Number 1 PROPYLENE GLYCOL 39.52 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 100ml vial 1 Number 2 PROPYLENE GLYCOL 79.04 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 250ml vial 1 Number 3 PROPYLENE GLYCOL 197.60 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 500ml vial 1 Number 4 PROPYLENE GLYCOL 395.20 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 50ml vial 1 Number 5 PROPYLENE GLYCOL 35.256 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 100ml vial 1 Number 6 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 250ml vial 1 Number 7 PROPYLENE GLYCOL 176

acycline Injection 100mg) 100ml vial 1 Number 6 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 250ml vial 1 Number 7 PROPYLENE GLYCOL 176.28 gm/Vial PAN Ashoxy 3% (Oxytetracycline Injection 30mg) 100ml vial 1 Number 8 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eqOxytetracycline 200mg) 50ml vial 1 Number 9 PROPYLENE GLYCOL 9.00 gm/Vial Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eq Oxytetracycline 200mg) 100ml vial 1 Number 10 PROPYLENE GLYCOL 18.00 gm/Vial Ashoxy 20% LA (Oxytetracycline 1 Number 11 PROPYLENE GLYCOL 45.00 gm/Vial|authorization No. 0311025665dated24/07/2023**,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items **Qty.

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. Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 50ml vial 1 Number 1 PROPYLENE GLYCOL 39.52 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 100ml vial 1 Number 2 PROPYLENE GLYCOL 79.04 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 250ml vial 1 Number 3 PROPYLENE GLYCOL 197.60 gm/Vial Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 500ml vial 1 Number 4 PROPYLENE GLYCOL 395.20 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 50ml vial 1 Number 5 PROPYLENE GLYCOL 35.256 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 100ml vial 1 Number 6 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 10% (Oxytetracycline Injection 100mg) 250ml vial 1 Number 7 PROPYLENE GLYCOL 176.28 gm/Vial PAN Ashoxy 3% (Oxytetracycline Injection 30mg) 100ml vial 1 Number 8 PROPYLENE GLYCOL 70.512 gm/Vial Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eqOxytetracycline 200mg) 50ml vial 1 Number 9 PROPYLENE GLYCOL 9.00 gm/Vial Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eq Oxytetracycline 200mg) 100ml vial 1 Number 10 PROPYLENE GLYCOL 18.00 gm/Vial Ashoxy 20% LA (Oxytetracycline 1 Number 11 PROPYLENE GLYCOL 45.00 gm/Vial|

rate Injection eq Oxytetracycline 200mg) 100ml vial 1 Number 10 PROPYLENE GLYCOL 18.00 gm/Vial Ashoxy 20% LA (Oxytetracycline 1 Number 11 PROPYLENE GLYCOL 45.00 gm/Vial| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 50ml vial|1 Number|1|PROPYLENE GLYCOL|39.52 gm/Vial| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 100ml vial| 1 Number|2|PROPYLENE GLYCOL|79.04 gm/Vial| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 250ml vial| 1 Number|3|PROPYLENE GLYCOL|197.60 gm/Vial| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 500ml vial| 1 Number|4|PROPYLENE GLYCOL|395.20 gm/Vial| ||Ashoxy 10% (Oxytetracycline Injection 100mg) 50ml vial|1 Number|5|PROPYLENE GLYCOL|35.256 gm/Vial| ||Ashoxy 10% (Oxytetracycline Injection 100mg) 100ml vial|1 Number|6|PROPYLENE GLYCOL|70.512 gm/Vial| ||Ashoxy 10% (Oxytetracycline Injection 100mg) 250ml vial|1 Number|7|PROPYLENE GLYCOL|176.28 gm/Vial| ||PAN Ashoxy 3% (Oxytetracycline Injection 30mg) 100ml vial|1 Number|8|PROPYLENE GLYCOL|70.512 gm/Vial| ||Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eqOxytetracycline 200mg) 50ml vial| 1 Number|9|PROPYLENE GLYCOL|9.00 gm/Vial| ||Ashoxy 20% LA (Oxytetracycline Dihydrate Injection eq Oxytetracycline 200mg) 100ml vial|1 Number|10|PROPYLENE GLYCOL|18.00 gm/Vial| ||Ashoxy 20% LA (Oxytetracycline|1 Number|11|PROPYLENE GLYCOL|45.00 gm/Vial|

UDIN00036287AM26

Injection eq Oxytetracycline 200mg) 100ml vial|1 Number|10|PROPYLENE GLYCOL|18.00 gm/Vial| ||Ashoxy 20% LA (Oxytetracycline|1 Number|11|PROPYLENE GLYCOL|45.00 gm/Vial|

UDIN00036287AM26

Dihydrate Injection eq<br>Oxytetracycline 200mg) 250ml vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 10ml viaL	1 Number	12	PROPYLENE GLYCOL	10.40 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 50ml vial	1 Number	13	PROPYLENE GLYCOL	52.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 100ml vial	1 Number	14	PROPYLENE GLYCOL	104.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 250ml vial	1 Number	15	PROPYLENE GLYCOL	260.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg<br>Injection) 500ml vial	1 Number	16	PROPYLENE GLYCOL	520.00 gm/Vial
Ashiver Forte (Ivermectin 10mg and<br>Clorsulon 100mg Injection) 50ml viaL	1 Number	17	PROPYLENE GLYCOL	50.96 gm/Vial
Ashiver Forte (Ivermectin 10mg and<br>Clorsulon 100mg Injection) 100ml<br>vial	1 Number	18	PROPYLENE GLYCOL	101.92 gm/Vial
Ashienro 10% (Enrofloxacin Injection<br>100mg) 50ml vial	<br>1 Number	19	PROPYLENE GLYCOL	5.20 gm/Vial
Ashienro 10% (Enrofloxacin Injection<br>100mg) 100ml vial	<br>1 Number	20	PROPYLENE GLYCOL	10.40 gm/Vial
Ashienro 10% (Enrofloxacin Injection<br>100mg) 250ml vial	<br>1 Number	21	PROPYLENE GLYCOL	26.00 gm/Vial
Ashityl 20% (Tylosin Tartrate<br>injection eq to Tylosin 200mg) 50ml<br>vial	1 Number	22	PROPYLENE GLYCOL	10.40 gm/Vial

jection 100mg) 250ml vial| 1 Number|21|PROPYLENE GLYCOL|26.00 gm/Vial| ||Ashityl 20% (Tylosin Tartrate injection eq to Tylosin 200mg) 50ml vial|1 Number|22|PROPYLENE GLYCOL|10.40 gm/Vial| ||Ashityl 20% (Tylosin Tartrate injection eq to Tylosin 200mg) 100ml vial| 1 Number|23|PROPYLENE GLYCOL|20.80 gm/Vial|

UDIN00036287AM26

Ashityl 20% (Tylosin Tartrate<br>injection eq to Tylosin 200mg) 250ml<br>vial<br>1 Number<br>24<br>PROPYLENE GLYCOL<br>52.00 gm/Vial<br>Ashityl 5% (Tylosin Tartrate injection<br>eq to Tylosin 50mg) 50ml vial<br>1 Number<br>25<br>PROPYLENE GLYCOL<br>10.40 gm/Vial<br>Ashital 10% (Closantel 10% Inj)<br>100ml vial<br>1 Number<br>26<br>PROPYLENE GLYCOL<br>55.12 gm/Vial<br>RA concerned may take further necessary action as per above decision of NC.	Ashityl 20% (Tylosin Tartrate<br>injection eq to Tylosin 200mg) 250ml<br>vial	<br>1 Number	24	PROPYLENE GLYCOL	52.00 gm/Vial
	Ashityl 5% (Tylosin Tartrate injection<br>eq to Tylosin 50mg) 50ml vial	<br>1 Number	25	PROPYLENE GLYCOL	10.40 gm/Vial
	Ashital 10% (Closantel 10% Inj)<br>100ml vial	1 Number	26	PROPYLENE GLYCOL	55.12 gm/Vial

sin Tartrate injection eq to Tylosin 50mg) 50ml vial| 1 Number|25|PROPYLENE GLYCOL|10.40 gm/Vial| ||Ashital 10% (Closantel 10% Inj) 100ml vial|1 Number|26|PROPYLENE GLYCOL|55.12 gm/Vial|

Case No.	61 / NC/3/MEET/Mar/202425/19	61 / NC/3/MEET/Mar/202425/19	61 / NC/3/MEET/Mar/202425/19	61 / NC/3/MEET/Mar/202425/19	61 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	S KANT HEALTHCARE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00000736AM25
RA File Number	03AX04000697 AM25
Licence No and Date	0311033882/15/05/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Item<br>Qty<br>S.No.<br>Import item<br>Qty. allowed<br>1<br>ARTEMETHER<br>20.4 mg/Tablet<br>ARTEMETHER 20 MG &<br>LUMEFANTRINE 120 MG<br>TABLETS<br>1 Number<br>Tablet<br>2<br>LUMEFANTRINE<br>122.4 mg/Tablet<br>1<br>ARTEMETHER<br>20.4 mg/Tablet<br>ARTEMETHER 20 MG &<br>LUMEFANTRINE 120 MG<br>DISPERSIBLE TABLETS<br>1 Number<br>Tablet<br>2<br>LUMEFANTRINE<br>122.4 mg/Tablet<br>1<br>ARTEMETHER<br>40.8 mg/Tablet<br>ARTEMETHER 40 MG &<br>LUMEFANTRINE 240 MG<br>TABLETS<br>1 Number<br>Tablet<br>2<br>LUMEFANTRINE<br>244.8 mg/Tablet
		Qty	S.No.	Import item	Qty.

g/Tablet 1 ARTEMETHER 40.8 mg/Tablet ARTEMETHER 40 MG & LUMEFANTRINE 240 MG TABLETS 1 Number Tablet 2 LUMEFANTRINE 244.8 mg/Tablet|||||| |||Qty|S.No.|Import item|Qty. allowed| |||1 Number Tablet|1|ARTEMETHER|20.4 mg/Tablet| ||||2|LUMEFANTRINE|122.4 mg/Tablet| |||1 Number Tablet|1|ARTEMETHER|20.4 mg/Tablet| ||||2|LUMEFANTRINE|122.4 mg/Tablet| |||1 Number Tablet|1|ARTEMETHER|40.8 mg/Tablet| ||||2|LUMEFANTRINE|244.8 mg/Tablet|

UDIN00036287AM26

ARTEMETHER 80 MG &	1 Number	1	ARTEMETHER	81.6 mg./Tablet
LUMEFANTRINE 480 MG	Tablet
TABLETS		2	LUMEFANTRINE	489.60 mg./Tablet

Norms Proposed for 1 kg of ARTEMETHER	Norms Proposed for 1 kg of ARTEMETHER	Norms Proposed for 1 kg of ARTEMETHER	Norms Proposed for 1 kg of ARTEMETHER	Norms Proposed for 1 kg of ARTEMETHER
Export Item	Qty	S.No.	Import item	Qty. allowed
ARTEMETHER	1Kg	1	Artemisinin	1.04 Kg
		2	Sodium Borohydride	0.188 Kg
		3	Trimethyl Ortho Acetate<br>99% MIN.	0.50 Kg.

Norms Proposed for 1 kg of LUMEFANTRINE	Norms Proposed for 1 kg of LUMEFANTRINE	Norms Proposed for 1 kg of LUMEFANTRINE	Norms Proposed for 1 kg of LUMEFANTRINE	Norms Proposed for 1 kg of LUMEFANTRINE
Export Item	Qty	S.No.	Import item	Qty. allowed
LUMEFANTRINE	1Kg	1	2, 7 DICHLORO A<br>DIBUTYLAMINO METHYL<br>9 HFLUORENE-4-<br>METHANOL DBA 99<br>PERCENT MIN	0.86896 kg
		2	4-chlorobenzaldehide	0.3476 Kg

UDIN00036287AM26

allowed| |LUMEFANTRINE|1Kg|1|2, 7 DICHLORO A DIBUTYLAMINO METHYL 9 HFLUORENE-4- METHANOL DBA 99 PERCENT MIN|0.86896 kg| |||2|4-chlorobenzaldehide|0.3476 Kg|

UDIN00036287AM26

Case No.	62 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	VINS BIOPRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00000776AM25
RA File Number	09AX04000030 AM25
Licence No and<br>Date	0911007243/17/05/2024
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 ffix ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Tetanus Antitoxin I.H.S B.P 1500<br>IU, Plus [overage of 150 IU in<br>addition] in PFS/Vials/Ampoule<br>100000<br>Vials<br>1<br>Tetanus Antitoxin 2500<br>I.U/ml<br>69.3 Liter<br>RA concerned may take further necessary action as per above decision of NC.

0 IU in addition] in PFS/Vials/Ampoule 100000 Vials 1 Tetanus Antitoxin 2500 I.U/ml 69.3 Liter RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	Case No.<br>	63 / NC/3/MEET/Mar/202425/19	63 / NC/3/MEET/Mar/202425/19	63 / NC/3/MEET/Mar/202425/19	63 / NC/3/MEET/Mar/202425/19	63 / NC/3/MEET/Mar/202425/19
Case Status<br>		Case Approved
Party Name<br>		KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date<br>		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number<br>		HQRNORM APPLY 00000784AM25
RA File Number<br>		05AX04000474 AM25
Licence No and<br>Date<br>		0511025589/17/05/2024
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 revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>MALEIC ANHYDRIDE<br>0.67 kg.<br>DI-ETHYL MALEATE (DEM)<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	DI-ETHYL MALEATE (DEM)		1 kg.	1	MALEIC ANHYDRIDE	0.67 kg.

UDIN00036287AM26

0.67 kg. DI-ETHYL MALEATE (DEM) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||DI-ETHYL MALEATE (DEM)||1 kg.|1|MALEIC ANHYDRIDE|0.67 kg.|

UDIN00036287AM26

2<br>DENATURED ETHYL<br>ALCOHOL<br>0.65 kg.<br>(PACKED IN 852 NOS. OF HM-<br>HDPE DRUMS MADEOF HDPE<br>GRANULES (7,242.000 KGS.<br>WITHOUT WASTAGE)) (EACH<br>DRUM SHALL WEIGHT 8.5 KG<br>AND STORAGE CAPACITY<br>235.000 KGS.))<br>3<br>HDPE GRANULES<br>(TOTAL WEIGHT =<br>7,604.100 KGS.)<br>Relevant, as per<br>Packing Policy<br>& General<br>Notes.<br>RA concerned may take further necessary action as per above decision of NC.	(PACKED IN 852 NOS. OF HM-<br>HDPE DRUMS MADEOF HDPE<br>GRANULES (7,242.000 KGS.<br>WITHOUT WASTAGE)) (EACH<br>DRUM SHALL WEIGHT 8.5 KG<br>AND STORAGE CAPACITY<br>235.000 KGS.))		2	DENATURED ETHYL<br>ALCOHOL	0.65 kg.
			3	HDPE GRANULES<br>(TOTAL WEIGHT =<br>7,604.100 KGS.)	Relevant, as per<br>Packing Policy<br>& General<br>Notes.

llowed.| ||Aztreonam for Injection USP 1 Gram||1 Number|1|Aztreonam and Arginine|1.10 gm.|

UDIN00036287AM26

Aztreonam for Injection USP 500 mg 1 Number 2 Aztreonam and Arginine 0.55 gm.

Case No.	85 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002334AM25
RA File Number	07AX04000751 AM25
Licence No and Date	0711012019/06/08/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>DOXYCYCLINE 100MG<br>DISPERSIBLE<br>TABLETS(DOXYCYCLINE<br>100MG DISPERSIBLE TABLETS<br>(Eq to ANHYDROUS<br>DOXYCYCLINE 100MG)<br>(400KGS))<br>1 Number<br>1<br>DOXYCYCLINE<br>MONOHYDRATE USP/BP<br>106.13 mg.<br>RA concerned may take further necessary action as per above decision of NC

Case No.	86 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002335AM25
RA File Number	07AX04000750 AM25
Licence No and	0711012020/06/08/2024

UDIN00036287AM26

Date

Norms Committee Decision:

UDIN00036287AM26

Date

Norms Committee Decision:

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
INDORAMIN 20MG TABLETS<br>(INDORAMIN 20MG TABLETS<br>(10KGS))	1 Number	1	INDORAMIN<br>HYDROCHLORIDE	22.54 mg.

Case No.	Case No.	87 / NC/3/MEET/Mar/202425/19	87 / NC/3/MEET/Mar/202425/19	87 / NC/3/MEET/Mar/202425/19	87 / NC/3/MEET/Mar/202425/19	87 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00002346AM25
RA File Number		03AX04002200 AM25
Licence No and<br>Date		0311036131/06/08/2024
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.

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 MEROPENEM NONSTERILE MEROPENEM TRIHYDRATE NONSTERILE 0.8968 kg. MEROPENEM FOR INJECTION (MEROPENEM BUFFERED STERILE) (Containing NLT 84% Sterile Meropenem) 1 kg. 2 PACKING MATERIAL Relevant, as per Packing Policy and General Notes.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||MEROPENEM FOR INJECTION (MEROPENEM BUFFERED STERILE) (Containing NLT 84% Sterile Meropenem)||1 kg.|1|MEROPENEM NONSTERILE MEROPENEM TRIHYDRATE NONSTERILE|0.8968 kg.| |||||2|PACKING MATERIAL|Relevant, as per Packing Policy and General Notes.|

UDIN00036287AM26

Case No.	Case No.	88 / NC/3/MEET/Mar/202425/19	88 / NC/3/MEET/Mar/202425/19	88 / NC/3/MEET/Mar/202425/19	88 / NC/3/MEET/Mar/202425/19	88 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00002366AM25
RA File Number		34AX04000972 AM24
Licence No and<br>Date		3411005275/07/08/2024

and Date||NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025||||| |HQ File Number||HQRNORM APPLY 00002366AM25||||| |RA File Number||34AX04000972 AM24||||| |Licence No and Date||3411005275/07/08/2024||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Jan/202425/15 dated 28/01/2025 against advance authorization No.3411002884 dated 11/10/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Guanfacine Hydrochloride 1.171 mg. 2 Methacrylic Acid and Ethyl Acrylate Copolymer (Eudragit L 100-55) 55.00 mg. 3 Hypromellose (Methocel K15M Premium CR Grade) 55.00 mg. 4 Microcrystalline Cellulose (Avicel PH 102) 10.00 mg. 5 Lactose Monohydrate (Flowlac100) 46.35 mg. Guanfacine Extended-Release Tablets USP 1 mg (Net content of active ingredients 3.900 kgs ) 1 Number 6 Magnesium stearate 1.00 mg. 7 Guanfacine Hydrochloride 2.342 mg. Methacrylic Acid and Ethyl Guanfacine Extended-Release Tablets USP 2 mg (Net content of active ingredients 7.800 kgs ) 1 Number 8 55.00 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.

id and Ethyl Guanfacine Extended-Release Tablets USP 2 mg (Net content of active ingredients 7.800 kgs ) 1 Number 8 55.00 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Guanfacine Extended-Release Tablets USP 1 mg (Net content of active ingredients 3.900 kgs )|| 1 Number|1|Guanfacine Hydrochloride|1.171 mg.| |||||2|Methacrylic Acid and Ethyl Acrylate Copolymer (Eudragit L 100-55)|55.00 mg.| |||||3|Hypromellose (Methocel K15M Premium CR Grade)|55.00 mg.| |||||4|Microcrystalline Cellulose (Avicel PH 102)|10.00 mg.| |||||5|Lactose Monohydrate (Flowlac100)|46.35 mg.| |||||6|Magnesium stearate|1.00 mg.| ||Guanfacine Extended-Release Tablets USP 2 mg (Net content of active ingredients 7.800 kgs )|| 1 Number|7|Guanfacine Hydrochloride|2.342 mg.| |||||8|Methacrylic Acid and Ethyl|55.00 mg.|

UDIN00036287AM26

			Acrylate Copolymer (Eudragit L<br>100-55)
		9	Hypromellose (Methocel K15M<br>Premium CR Grade)	55.00 mg.
		10	Microcrystalline Cellulose (Avicel<br>PH 102)	10.00 mg.
		11	Lactose Monohydrate (Flowlac100)	45.20 mg.
		12	Magnesium stearate	1.00 mg.
Guanfacine Extended-Release Tablets<br>USP 3 mg (Net content of active<br>ingredients 7.50 kgs )	<br>1 Number	13	Guanfacine Hydrochloride	3.513 mg.
		14	Methacrylic Acid and Ethyl<br>Acrylate Copolymer (Eudragit L<br>100-55)	55.00 mg.
		15	Hypromellose (Methocel K15M<br>Premium CR Grade)	55.00 mg.
		16	Microcrystalline Cellulose (Avicel<br>PH 102)	10.00 mg.

id and Ethyl Acrylate Copolymer (Eudragit L 100-55)|55.00 mg.| ||||15|Hypromellose (Methocel K15M Premium CR Grade)|55.00 mg.| ||||16|Microcrystalline Cellulose (Avicel PH 102)|10.00 mg.| ||||17|Lactose Monohydrate (Flowlac100)|43.56 mg.| ||||18|Magnesium stearate|1.00 mg.| ||Guanfacine Extended-Release Tablets USP 4 mg (Net content of active ingredients 9.60 kgs )| 1 Number|19|Guanfacine Hydrochloride|4.684 mg.| ||||20|Methacrylic Acid and Ethyl Acrylate Copolymer (Eudragit L 100-55)|55.00 mg.| ||||21|Hypromellose (Methocel K15M Premium CR Grade)|55.00 mg.| ||||22|Microcrystalline Cellulose (Avicel PH 102)|10.00 mg.|

UDIN00036287AM26

23<br>Lactose Monohydrate (Flowlac100)<br>42.40 mg.<br>24<br>Magnesium stearate<br>1.00 mg.<br>RA concerned may take further necessary action as per above decision of NC.			23	Lactose Monohydrate (Flowlac100)	42.40 mg.
			24	Magnesium stearate	1.00 mg.

0 mg.<br>RA concerned may take further necessary action as per above decision of NC.			23	Lactose Monohydrate (Flowlac100)	42.40 mg.
			24	Magnesium stearate	1.00 mg.

Case No.	Case No.	89 / NC/3/MEET/Mar/202425/19	89 / NC/3/MEET/Mar/202425/19	89 / NC/3/MEET/Mar/202425/19	89 / NC/3/MEET/Mar/202425/19	89 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00002396AM25
RA File Number		03AX04002271 AM25
Licence No and<br>Date		0311036187/08/08/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Clobetasol Propionate Foam 0.05percent<br>50gm(( Net. wt. of Net. wt. of Clobetasol<br>Propionate USP (Micronized) is1.00 Kgs.))<br>40000<br>Numbers<br>1<br>Clobetasol<br>Propionate<br>Foam<br>0.05percent<br>100gm((Net. wt.

am 0.05percent 50gm(( Net. wt. of Net. wt. of Clobetasol Propionate USP (Micronized) is1.00 Kgs.)) 40000 Numbers 1 Clobetasol Propionate Foam 0.05percent 100gm((Net. wt. of Clobetasol Propionate USP (Micronized) is 2.00 Kgs.)) 40000 Numbers 2 Clobetasol Propionate Cream USP 0.05percent (Pack Size 15gm)((Net Weight of Clobetasol Propionate USP(Micronized) 0.300 Kgs)) 40000 Numbers 3 Clobetasol Propionate Cream USP 0.05percent (Pack size 30gm)((Net Weight of Clobetasol Propionate USP(Micronized) 0.600 Kgs)) 40000 Numbers 4 Clobetasol Propionate Cream USP 0.05percent 40000 5 CLOBETASOL PROPIONATE USP (MICRONIZED) 19.93 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Clobetasol Propionate Foam 0.05percent 50gm(( Net. wt. of Net. wt. of Clobetasol Propionate USP (Micronized) is1.00 Kgs.))||40000 Numbers|1|CLOBETASOL PROPIONATE USP (MICRONIZED)|19.93 kg.| ||Clobetasol Propionate Foam 0.05percent 100gm((Net. wt. of Clobetasol Propionate USP (Micronized) is 2.00 Kgs.))|| 40000 Numbers|2||| ||Clobetasol Propionate Cream USP 0.05percent (Pack Size 15gm)((Net Weight of Clobetasol Propionate USP(Micronized) 0.300 Kgs))||40000 Numbers|3||| ||Clobetasol Propionate Cream USP 0.05percent (Pack size 30gm)((Net Weight of Clobetasol Propionate USP(Micronized) 0.600 Kgs))||40000 Numbers|4||| ||Clobetasol Propionate Cream USP 0.05percent||40000|5|||

UDIN00036287AM26

nt (Pack size 30gm)((Net Weight of Clobetasol Propionate USP(Micronized) 0.600 Kgs))||40000 Numbers|4||| ||Clobetasol Propionate Cream USP 0.05percent||40000|5|||

UDIN00036287AM26

(Pack size 45 gm)((Net Weight of Clobetasol<br>Propionate USP(Micronized) 0.900 Kgs))	Numbers
Clobetasol Propionate Cream USP 0.05percent<br>(Pack size 60gm)((Net Weight of Clobetasol<br>Propionate USP(Micronized) 1.200 Kgs))	40000<br>Numbers	6
Clobetasol Propionate Ointment USP<br>0.05percent (Pack size 15gm)((Net Weight of<br>Clobetasol Propionate USP(Micronized) 0.300<br>Kgs))	40000<br>Numbers	7
Clobetasol Propionate Ointment USP<br>0.05percent (Pack size 30gm)((Net Weight of<br>Clobetasol Propionate USP(Micronized) 0.600<br>Kgs))	40000<br>Numbers	8
Clobetasol Propionate Ointment USP<br>0.05percent (Pack size 45gm)((Net Weight of<br>Clobetasol Propionate USP(Micronized) 0.900<br>Kgs))	40000<br>Numbers	9
Clobetasol Propionate Ointment USP<br>0.05percent (Pack size 60gm)((Net Weight of<br>Clobetasol Propionate USP(Micronized) 1.200<br>Kgs))	40000<br>Numbers	10
Clobetasol Propionate Spray 0.05percent (Pack<br>size 59ml)((Net Weight of Clobetasol<br>Propionate USP (Micronized)1.180 Kgs))	40000<br>Numbers	11
Clobetasol Propionate Spray 0.05percent (Pack<br>size 125ml)((Net Weight of Clobetasol<br>Propionate USP (Micronized)2.500 Kgs))	40000<br>Numbers	12
Clobetasol Prop. Top Sol USP, 0.05percent<br>25ml((Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.500Kgs))	40000<br>Numbers	13
Clobetasol Prop.

ed)2.500 Kgs))|40000 Numbers|12||| ||Clobetasol Prop. Top Sol USP, 0.05percent 25ml((Net Weight of Clobetasol Propionate USP (Micronized) 0.500Kgs))|40000 Numbers|13||| ||Clobetasol Prop. Top Sol USP, 0.05percent 50ml((Net Weight of Clobetasol Propionate USP (Micronized) 1.000Kgs))|40000 Numbers|14|||

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Clobetasol<br>Pro<br>Shampoo,<br>0.05<br>percent<br>118ml((Net Weight of Clobetasol Propionate<br>USP (Micronized) 2.360 Kgs))<br>40000<br>Numbers<br>15<br>Clobetasol Propionate Foam 0.05percent<br>100gm (Emulsion Formulation)(( Net. wt. of<br>Clobetasol Propionate USP(Micronized) is<br>2.000 Kgs.))<br>40000<br>Numbers<br>16<br>Clobetasol Propionate Foam 0.05percent 50gm<br>(Emulsion Formulation)((Net. wt. of<br>Clobetasol Propionate USP(Micronized) is<br>1.000 Kgs.))<br>40000<br>Numbers<br>17<br>RA concerned may take further necessary action as per above decision of NC	Clobetasol<br>Pro<br>Shampoo,<br>0.05<br>percent<br>118ml((Net Weight of Clobetasol Propionate<br>USP (Micronized) 2.360 Kgs))	<br> <br>40000<br>Numbers	15
	Clobetasol Propionate Foam 0.05percent<br>100gm (Emulsion Formulation)(( Net. wt. of<br>Clobetasol Propionate USP(Micronized) is<br>2.000 Kgs.))	40000<br>Numbers	16
	Clobetasol Propionate Foam 0.05percent 50gm<br>(Emulsion Formulation)((Net. wt. of<br>Clobetasol Propionate USP(Micronized) is<br>1.000 Kgs.))	40000<br>Numbers	17

s.))|40000 Numbers|16||| ||Clobetasol Propionate Foam 0.05percent 50gm (Emulsion Formulation)((Net. wt. of Clobetasol Propionate USP(Micronized) is 1.000 Kgs.))|40000 Numbers|17|||

Case No.	Case No.	90 / NC/3/MEET/Mar/202425/19	90 / NC/3/MEET/Mar/202425/19	90 / NC/3/MEET/Mar/202425/19	90 / NC/3/MEET/Mar/202425/19	90 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		MEDREICH LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00002405AM25
RA File Number		07AX04000768 AM25
Licence No and<br>Date		0711012041/08/08/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Aug/202425/8 dated 28/08/2024 against advance<br>authorization No. 0711010859 dated 21/03/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>REBAMIPIDE JP<br>102.00 mg.<br>Ethyl Alcohol 200<br>Proof<br>REBAMIPIDE 100MG TABLETS<br>1 Number<br>Tablet<br>2<br>0.19 ml.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	REBAMIPIDE 100MG TABLETS		1 Number<br>Tablet	1	REBAMIPIDE JP	102.00 mg.
				2	Ethyl Alcohol 200<br>Proof	0.19 ml.

UDIN00036287AM26

.**|Sl. No.|Import Items|Qty. allowed.| ||REBAMIPIDE 100MG TABLETS||1 Number Tablet|1|REBAMIPIDE JP|102.00 mg.| |||||2|Ethyl Alcohol 200 Proof|0.19 ml.|

UDIN00036287AM26

Case No.	91 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	DIVI'S LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002430AM25
RA File Number	09AX04000389 AM25
Licence No and<br>Date	0911007722/09/08/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>ATIPA DI CHLORIDE<br>1.27 kg.<br>2<br>DIMETHYL FORMAMIDE<br>0.68 kg.<br>3<br>N N DIMETHYL ACETAMIDE<br>1.46 kg.<br>4<br>NITRO METHANE<br>0.48 kg.<br>IOPAMIDOL (POWDER)<br>1 kg.<br>5<br>L LACTIC ACID<br>0.67 kg.<br>RA concerned may take further necessary action as per above decision of NC

Case No.	92 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD

UDIN00036287AM26

er necessary action as per above decision of NC||

Case No.	92 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD

UDIN00036287AM26

Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00002458AM25
RA File Number		08AX04000712 AM25
Licence No and<br>Date		0811012363/12/08/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Dec/202425/12 dated 10/12/2024 against advance<br>authorization No. 0811011943 dated 26/06/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>ISOSORBIDE MONONITRATE<br>EXTENDED RELEASE<br>TABLETS USP 60 MG(EACH<br>FILM COATED<br>EXTENDEDRELEASE<br>TABLETS CONTAINS:<br>DILUTED ISOSORBIDE<br>MONONITRATE (50%<br>DILUTED WITH LACTOSE<br>MONOHYDRATE) USP<br>EQUIVALENT TO ISOSORBIDE<br>MONONITRATE 60MG, NET<br>CONTENT OF ACTIVE<br>INGREDIENT ISMN SHOULD<br>NOT BE LESS THAN1815.264<br>KGS.)<br>1 Number<br>1<br>Isosorbide Mononitrate 50<br>percent Assay.

r>EQUIVALENT TO ISOSORBIDE MONONITRATE 60MG, NET CONTENT OF ACTIVE INGREDIENT ISMN SHOULD NOT BE LESS THAN1815.264 KGS.) 1 Number 1 Isosorbide Mononitrate 50 percent Assay. Diluted ISMN (50% diluted with lactose monohydrate) USP 122.40 mg. ISOSORBIDE MONONITRATE EXTENDED RELEASE TABLETS USP 120 MG(EACH FILM COATED EXTENDEDRELEASE TABLETS CONTAINS: DILUTED ISOSORBIDE MONONITRATE (50% DILUTED WITH LACTOSE MONOHYDRATE) USP EQUIVALENT TO ISOSORBIDE MONONITRATE 120MG, NET 1 Number 2 Isosorbide Mononitrate 50 percent Assay.Diluted ISMN (50% diluted with lactose monohydrate) USP 244.80 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||ISOSORBIDE MONONITRATE EXTENDED RELEASE TABLETS USP 60 MG(EACH FILM COATED EXTENDEDRELEASE TABLETS CONTAINS: DILUTED ISOSORBIDE MONONITRATE (50% DILUTED WITH LACTOSE MONOHYDRATE) USP EQUIVALENT TO ISOSORBIDE MONONITRATE 60MG, NET CONTENT OF ACTIVE INGREDIENT ISMN SHOULD NOT BE LESS THAN1815.264 KGS.)|| 1 Number|1|Isosorbide Mononitrate 50 percent Assay.

SP EQUIVALENT TO ISOSORBIDE MONONITRATE 60MG, NET CONTENT OF ACTIVE INGREDIENT ISMN SHOULD NOT BE LESS THAN1815.264 KGS.)|| 1 Number|1|Isosorbide Mononitrate 50 percent Assay. Diluted ISMN (50% diluted with lactose monohydrate) USP|122.40 mg.| ||ISOSORBIDE MONONITRATE EXTENDED RELEASE TABLETS USP 120 MG(EACH FILM COATED EXTENDEDRELEASE TABLETS CONTAINS: DILUTED ISOSORBIDE MONONITRATE (50% DILUTED WITH LACTOSE MONOHYDRATE) USP EQUIVALENT TO ISOSORBIDE MONONITRATE 120MG, NET|| 1 Number|2|Isosorbide Mononitrate 50 percent Assay.Diluted ISMN (50% diluted with lactose monohydrate) USP| 244.80 mg.|

UDIN00036287AM26

CONTENT OF ACTIVE INGREDIENT ISMN SHOULD NOT BE LESSTHAN 113.454 KGS)

Case No.	Case No.	93 / NC/3/MEET/Mar/202425/19	93 / NC/3/MEET/Mar/202425/19	93 / NC/3/MEET/Mar/202425/19	93 / NC/3/MEET/Mar/202425/19	93 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		USV PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00002468AM25
RA File Number		03AX04002293 AM25
Licence No and<br>Date		0311036279/12/08/2024
Norms Committee Decision:<br>The Committee considered the case as per the 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.<br>No.<br>Import Items<br>Qty.

decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Doxycycline Tablets, USP 50 MG 100 S((21,600 Bottles X 100 Per Bottles = 21,60,000 Tablets) (Total Weight of ExportProduct = 108.000 Kgs) (Net Content weight of Import Product = 116.327 kgs)) 1 Number 1 Doxycycline USP (Monohydrate) 53.066 mg./50 mg. Tablet Doxycycline Tablets, USP 100 MG 500 S((2,800 Bottles X 500 Per Bottles = 14,00,000 Tablets) (Total Weight of ExportProduct = 140.000 Kgs) (Net Content weight of Import Product = 150.794 kgs)) 1 Number 2 Doxycycline USP (Monohydrate) 106.13 mg./100 mg. Tablet||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Doxycycline Tablets, USP 50 MG 100 S((21,600 Bottles X 100 Per Bottles = 21,60,000 Tablets) (Total Weight of ExportProduct = 108.000 Kgs) (Net Content weight of Import Product = 116.327 kgs))|| 1 Number|1|Doxycycline USP (Monohydrate)|53.066 mg./50 mg. Tablet| ||Doxycycline Tablets, USP 100 MG 500 S((2,800 Bottles X 500 Per Bottles = 14,00,000 Tablets) (Total Weight of ExportProduct = 140.000 Kgs) (Net Content weight of Import Product = 150.794 kgs))||1 Number|2|Doxycycline USP (Monohydrate)|106.13 mg./100 mg. Tablet|

UDIN00036287AM26

ght of ExportProduct = 140.000 Kgs) (Net Content weight of Import Product = 150.794 kgs))||1 Number|2|Doxycycline USP (Monohydrate)|106.13 mg./100 mg. Tablet|

UDIN00036287AM26

Case No.	Case No.	94 / NC/3/MEET/Mar/202425/19	94 / NC/3/MEET/Mar/202425/19	94 / NC/3/MEET/Mar/202425/19	94 / NC/3/MEET/Mar/202425/19	94 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		BULI CHEMICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00002482AM25
RA File Number		03AX04002360 AM25
Licence No and<br>Date		0311036306/13/08/2024
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/Feb/202425/17 dated 25/02/2025 against advance<br>authorization No. 0311026225 dated 10/08/2023,it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

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 LITHIUM METAL 0.0406 kg. 2 BUTYL CHLORIDE 0.270 kg. N-BUTYL LITHIUM IN HEXANE (n-butyl Lithium) 15% 1 kg. 3 HEXANE 1.760 kg. 1 LITHIUM METAL 0.0650 kg. 2 BUTYL CHLORIDE 0.432 kg. N-BUTYL LITHIUM IN HEXANE (n-butyl Lithium) 24% 1 kg. 3 HEXANE 1.574 kg. 1 LITHIUM METAL 0.0812 kg. 2 BUTYL CHLORIDE 0.540 kg. N-BUTYL LITHIUM IN HEXANE (n-butyl Lithium) 30% 1 kg. 3 HEXANE 1.450 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||N-BUTYL LITHIUM IN HEXANE (n-butyl Lithium) 15%||1 kg.|1|LITHIUM METAL|0.0406 kg.| |||||2|BUTYL CHLORIDE|0.270 kg.| |||||3|HEXANE|1.760 kg.| ||N-BUTYL LITHIUM IN HEXANE (n-butyl Lithium) 24%||1 kg.|1|LITHIUM METAL|0.0650 kg.| |||||2|BUTYL CHLORIDE|0.432 kg.| |||||3|HEXANE|1.574 kg.| ||N-BUTYL LITHIUM IN HEXANE (n-butyl Lithium) 30%||1 kg.|1|LITHIUM METAL|0.0812 kg.| |||||2|BUTYL CHLORIDE|0.540 kg.| |||||3|HEXANE|1.450 kg.|

UDIN00036287AM26

|||||3|HEXANE|1.574 kg.| ||N-BUTYL LITHIUM IN HEXANE (n-butyl Lithium) 30%||1 kg.|1|LITHIUM METAL|0.0812 kg.| |||||2|BUTYL CHLORIDE|0.540 kg.| |||||3|HEXANE|1.450 kg.|

UDIN00036287AM26

Case No.	95 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	COVALENT LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002508AM25
RA File Number	09AX04000392 AM25
Licence No and<br>Date	0911007730/13/08/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>7-Phenylacetamideo-3-<br>Chloromethyl<br>Cephalosporonic Acid<br>Para Methoxybenzyl Ester<br>(GCLE)<br>2.672 kg.<br>2<br>Acetone<br>8.85 kg.<br>3<br>Methylene Chloride<br>5.70 kg.<br>4<br>Methanol<br>5.70 kg.<br>5<br>Activated Carbon<br>0.100 kg.<br>7-AMINO-3-VINYL-3- CEPHEM-4-<br>CARBOXYLIC ACID (7-AVCA)(API)<br>1 kg.<br>6<br>Triphenyl Phosphine<br>1.26 kg.<br>RA concerned may take further necessary action as per above decision of NC

UDIN00036287AM26

CEPHEM-4- CARBOXYLIC ACID (7-AVCA)(API) 1 kg. 6 Triphenyl Phosphine 1.26 kg. RA concerned may take further necessary action as per above decision of NC||

UDIN00036287AM26

Case No.	96 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002521AM25
RA File Number	52AX04000126 AM25
Licence No and Date	5211009387/14/08/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Mar/202425/8 dated 17/03/2025 against advance<br>authorization No. 5211003710 dated 07/12/2022,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.<br>allowed.<br>1<br>Tert-Butyl((1S)-2-hydroxy-1-<br>methylethyl)carbamate<br>0.826 kg.<br>2<br>Diisopropyl azodicarboxylate<br>1.034 kg.<br>4-{1- [(2S)-2-Aminopropyl]-1-H-<br>Pyrazole-3-yl}-2- Chlorobenzonitrile)<br>1 kg.<br>3<br>TRIPHENYLPHOSPHINE<br>1.237 kg.<br>RA concerned may take further necessary action as per above decision of NC.

[(2S)-2-Aminopropyl]-1-H- Pyrazole-3-yl}-2- Chlorobenzonitrile) 1 kg. 3 TRIPHENYLPHOSPHINE 1.237 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	97 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002528AM25
RA File Number	07AX04000784 AM25
Licence No and Date	0711012089/14/08/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Dec/202425/13 dated 07/01/2025 against advance

UDIN00036287AM26

authorization No.0711006347 dated 02/02/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
RAMELTEON 8MG TABLETS	1 NumberTablet	1	RAMELTEON	8.16 mg/Tablet

he firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
RAMELTEON 8MG TABLETS	1 NumberTablet	1	RAMELTEON	8.16 mg/Tablet

Case No.	98 / NC/3/MEET/Mar/202425/19
Case Status	Case Deferred
Party Name	CHROMO LABORATORIES INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002535AM25
RA File Number	09AX04000325 AM25
Licence No and<br>Date	0911007740/14/08/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>A balanced chemical reaction indicating molecular weight of both reactants and products with yield<br>of the reaction.<br>1.<br>Current production/consumption data, duly certified by Chartered Accountant.<br>2.<br>To indicate the item of inputs, act as reactant, catalyst, consumable etc., as the case may be.<br>3.<br>End use of export item.<br>4.

Case No.	99 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002541AM25
RA File Number	09AX04000362 AM25
Licence No and<br>Date	0911007744/16/08/2024

UDIN00036287AM26

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.
Aspirin and Extended-Release<br>Dipyridamole Capsules 25 mg/200 mg<br>Pack Size : 60s (Consist of 960 Kgs of<br>DipyridamoleUSP)	<br> <br>1 Number	1	Dipyridamole USP	204.0 mg/Capsule

Case No.	Case No.	100 / NC/3/MEET/Mar/202425/19	100 / NC/3/MEET/Mar/202425/19	100 / NC/3/MEET/Mar/202425/19	100 / NC/3/MEET/Mar/202425/19	100 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		DR.REDDY'S LABORATORIES LTD
Meeting Number and<br>Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00002542AM25
RA File Number		09AX04000364 AM25
Licence No and Date		0911007745/16/08/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

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. Dipyridamole modified release and Acetyl Salicyclic Acid Capsules 200mg+25mg - Brand Name : (Orisantin 200mg/25mg depotkapseli, kova/kapsel med modifieradfrisattning, hard) Pack Size : 100s (Consist of 960.00 Kgs of Dipyridamole - Ph Eur ) 1 Number 1 Dipyridamole 204 mg/Capsule Dipyridamole modified release and Acetyl Salicyclic Acid Capsules 200mg+25mg - Brand Name : (Diprasorin 200mg/25 mg 1 Number 2 Dipyridamole 204 mg/Capsule||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Dipyridamole modified release and Acetyl Salicyclic Acid Capsules 200mg+25mg - Brand Name : (Orisantin 200mg/25mg depotkapseli, kova/kapsel med modifieradfrisattning, hard) Pack Size : 100s (Consist of 960.00 Kgs of Dipyridamole - Ph Eur )|| 1 Number|1|Dipyridamole|204 mg/Capsule| ||Dipyridamole modified release and Acetyl Salicyclic Acid Capsules 200mg+25mg - Brand Name : (Diprasorin 200mg/25 mg||1 Number|2|Dipyridamole|204 mg/Capsule|

UDIN00036287AM26

psule| ||Dipyridamole modified release and Acetyl Salicyclic Acid Capsules 200mg+25mg - Brand Name : (Diprasorin 200mg/25 mg||1 Number|2|Dipyridamole|204 mg/Capsule|

UDIN00036287AM26

hardkapsel med modifieradfrisattning/<br>hardkapsel med modifisertfr) Pack Size :<br>100s (Consist of 800.00 Kgs of<br>Dipyridamole - Ph Eur )<br>Dipyridamole Modified Release capsules<br>200 mg Pack Size : 60s Consist of 319.97<br>Kgs of Dipyridamole - Ph Eur )<br>1 Number<br>3<br>Dipyridamole<br>204 mg/Capsule<br>RA concerned may take further necessary action as per above decision of NC	hardkapsel med modifieradfrisattning/<br>hardkapsel med modifisertfr) Pack Size :<br>100s (Consist of 800.00 Kgs of<br>Dipyridamole - Ph Eur )
	Dipyridamole Modified Release capsules<br>200 mg Pack Size : 60s Consist of 319.97<br>Kgs of Dipyridamole - Ph Eur )	1 Number	3	Dipyridamole	204 mg/Capsule

Case No.	Case No.	101 / NC/3/MEET/Mar/202425/19	101 / NC/3/MEET/Mar/202425/19	101 / NC/3/MEET/Mar/202425/19	101 / NC/3/MEET/Mar/202425/19	101 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00002543AM25
RA File Number		09AX04000378 AM25
Licence No and<br>Date		0911007746/16/08/2024
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 of HBP<br>Vol.

|Licence No and Date||0911007746/16/08/2024||||| |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. Amlodipine and Benazepril Hydrochloride Capsules USP 2.5 mg/ 10 mg (Pack size:100s) (Consists of 08 Kgs of Benazepril Hydrochloride USP) 1 Number 1 Benazepril Hydrochloride USP 10.2 mg. Amlodipine and Benazepril Hydrochloride Capsules USP 5 mg/ 10 mg (Pack size:100s) (Consists of 63 Kgs of Benazepril Hydrochloride USP) 1 Number 2 Benazepril Hydrochloride USP 10.2 mg. Amlodipine and Benazepril Hydrochloride Capsules USP 5 mg/ 10 mg (Pack size:500s) (Consists of 21 Kgs 1 Number 3 Benazepril Hydrochloride USP 10.2 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Amlodipine and Benazepril Hydrochloride Capsules USP 2.5 mg/ 10 mg (Pack size:100s) (Consists of 08 Kgs of Benazepril Hydrochloride USP)||1 Number|1|Benazepril Hydrochloride USP|10.2 mg.| ||Amlodipine and Benazepril Hydrochloride Capsules USP 5 mg/ 10 mg (Pack size:100s) (Consists of 63 Kgs of Benazepril Hydrochloride USP)||1 Number|2|Benazepril Hydrochloride USP|10.2 mg.| ||Amlodipine and Benazepril Hydrochloride Capsules USP 5 mg/ 10 mg (Pack size:500s) (Consists of 21 Kgs||1 Number|3|Benazepril Hydrochloride USP|10.2 mg|

UDIN00036287AM26

P|10.2 mg.| ||Amlodipine and Benazepril Hydrochloride Capsules USP 5 mg/ 10 mg (Pack size:500s) (Consists of 21 Kgs||1 Number|3|Benazepril Hydrochloride USP|10.2 mg|

UDIN00036287AM26

|of Benazepril Hydrochloride USP) Amlodipine and Benazepril Hydrochloride Capsules USP 5 mg/ 20 mg (Pack size:100s) (Consists of 140 Kgs of Benazepril Hydrochloride USP) 1 Number 4 Benazepril Hydrochloride USP 20.4 mg. Amlodipine and Benazepril Hydrochloride Capsules USP 5 mg/ 20 mg (Pack size:500s) (Consists of 84 Kgs of Benazepril Hydrochloride USP) 1 Number 5 Benazepril Hydrochloride USP 20.4 mg. Amlodipine and Benazepril Hydrochloride Capsules USP 10 mg/ 20 mg (Pack size:100s) (Consists of 140 Kgs of Benazepril Hydrochloride USP) 1 Number 6 Benazepril Hydrochloride USP 20.4 mg. Amlodipine and Benazepril Hydrochloride Capsules USP 10 mg/ 20 mg (Pack size:500s) (Consists of 56 Kgs of Benazepril Hydrochloride USP) 1 Number 7 Benazepril Hydrochloride USP 20.4 mg. Amlodipine and Benazepril Hydrochloride Capsules USP 5 mg/ 40 mg (Pack size:100s) (Consists of 252 Kgs of Benazepril Hydrochloride USP)) 1 Number 8 Benazepril Hydrochloride USP 40.8 mg. Amlodipine and Benazepril Hydrochloride Capsules USP 10 mg/ 40 mg (Pack size:100s) (Consists of 336 Kgs of Benazepril Hydrochloride USP) 1 Number 9 Benazepril Hydrochloride USP 40.8 mg. RA concerned may take further necessary action as per above decision of NC|of Benazepril Hydrochloride USP)

of Benazepril Hydrochloride USP)
Amlodipine and Benazepril<br>Hydrochloride Capsules USP 5 mg/ 20<br>mg (Pack size:100s) (Consists of 140 Kgs<br>of Benazepril Hydrochloride USP)	1 Number	4	Benazepril Hydrochloride USP	20.4 mg.
Amlodipine and Benazepril<br>Hydrochloride Capsules USP 5 mg/ 20<br>mg (Pack size:500s) (Consists of 84 Kgs<br>of Benazepril Hydrochloride USP)	1 Number	5	Benazepril Hydrochloride USP	20.4 mg.
Amlodipine and Benazepril<br>Hydrochloride Capsules USP 10 mg/ 20<br>mg (Pack size:100s) (Consists of 140 Kgs<br>of Benazepril Hydrochloride USP)	1 Number	6	Benazepril Hydrochloride USP	20.4 mg.
Amlodipine and Benazepril<br>Hydrochloride Capsules USP 10 mg/ 20<br>mg (Pack size:500s) (Consists of 56 Kgs<br>of Benazepril Hydrochloride USP)	1 Number	7	Benazepril Hydrochloride USP	20.4 mg.
Amlodipine and Benazepril<br>Hydrochloride Capsules USP 5 mg/ 40<br>mg (Pack size:100s) (Consists of 252 Kgs<br>of Benazepril Hydrochloride USP))	1 Number	8	Benazepril Hydrochloride USP	40.8 mg.
Amlodipine and Benazepril<br>Hydrochloride Capsules USP 10 mg/ 40<br>mg (Pack size:100s) (Consists of 336 Kgs<br>of Benazepril Hydrochloride USP)	1 Number	9	Benazepril Hydrochloride USP	40.8 mg.

Case No.	102 / NC/3/MEET/Mar/202425/19
Case Status	Case Deferred
Party Name	GLAND PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025

UDIN00036287AM26

HQ File Number	HQRNORM APPLY 00002566AM25
RA File Number	09AX04000345 AM25
Licence No and<br>Date	0911007758/19/08/2024
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 relevant information / documents<br>firm.		Personal<br>from the

Case No.	103 / NC/3/MEET/Mar/202425/19
Case Status	Case Deferred
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002569AM25
RA File Number	09AX04000367 AM25
Licence No and<br>Date	0911007762/19/08/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Copy of Drug Manufacturing Licence (DML) showing approved composition for each export item.

the advice of the TE, it was decided to call for following information/documents from the firm:- Copy of Drug Manufacturing Licence (DML) showing approved composition for each export item.||

Case No.	104 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002574AM25
RA File Number	03AX04002287 AM25
Licence No and<br>Date	0311036455/19/08/2024
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

82 This document has been digitally signed by Raman Kumar, Deputy DGFT on 21-04-2025 12:26:46.

UDIN00036287AM26

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.
TENOFOVIR DISOPROXILE<br>OROTATE(TDO)	1 kg.	1	PMPA [(R)-9-(2-Phosphonyl<br>Methoxy Propyl) Adenine]	0.689 kg.

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
TENOFOVIR DISOPROXILE<br>OROTATE(TDO)	1 kg.	1	PMPA [(R)-9-(2-Phosphonyl<br>Methoxy Propyl) Adenine]	0.689 kg.

Case No.	105 / NC/3/MEET/Mar/202425/19
Case Status	Case Deferred
Party Name	MELOG SPECIALITY CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002583AM25
RA File Number	03AX04002187 AM25
Licence No and<br>Date	0311036462/20/08/2024
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advice of<br>the TE, it was decided to call for following information/documents from the firm:-<br>Quantity and value of products (Iso Butylene, PTBP, High Polymer Butylated Hydrocarbon) not<br>given.<br>1.<br>Recovery of Methanol in kg.<br>2.

Case No.	106 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	UMEDICA LABORATORIES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002587AM25
RA File Number	03AX04002398 AM25
Licence No and Date	0311036465/20/08/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export

UDIN00036287AM26

No and Date|0311036465/20/08/2024| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export||

UDIN00036287AM26

product/import item in meeting No.NC/3/MEET/Dec/202425/12 dated 10/12/2024 against advance authorization No. 0311034440 dated 07/06/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
ROSUVASTATIN<br>TABLET BP / USP 10<br>MG.((Each Tablet contains<br>Rosuvastatin Calcium<br>10.400 mg) Eq.<br>toRosuvastatin 10 mg.	1 Number	1	Tert-butyl 2-((4R,6S)-6-((E)-2-(4-<br>(4-fluorophenyl)-6-isopropyl-2-(N-<br>methylmethylsulfonamido)<br>pyrimidin-5-yl)vinyl)-2,2-dimethyl-<br>1,3-dioxan-4-yl)acetate	13.79 mg/10 mg<br>Tablet

Case No.	107 / NC/3/MEET/Mar/202425/19
Case Status	Case Deferred
Party Name	LINCOLN PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002591AM25
RA File Number	08AX04000799 AM25
Licence No and<br>Date	0811012437/20/08/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Copy of Certificate of Analysis (CoA) of import item from Foreign Supplier.

Case No.	108 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved

rmation/documents from the firm:- Copy of Certificate of Analysis (CoA) of import item from Foreign Supplier.||

Case No.	108 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved

UDIN00036287AM26

Party Name	MANKIND PHARMA LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002603AM25
RA File Number	05AX04001571 AM25
Licence No and Date	0511027226/20/08/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/May/202425/4 dated 06/06/2024 against advance<br>authorization No.0511019054 dated 29/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Cynacobalamin Injection USP,<br>1000mcg/ml,<br>1325000<br>Numbers<br>1<br>CYANOCOBALAMIN USP<br>1457.5 gm.<br>Cynacobalamin Injection USP,<br>10000mcg/10ml (1000mcg/ml),<br>35000<br>Numbers<br>2<br>CYANOCOBALAMIN USP<br>378.77 gm.<br>RA concerned may take further necessary action as per above decision of NC.

obalamin Injection USP, 10000mcg/10ml (1000mcg/ml), 35000 Numbers 2 CYANOCOBALAMIN USP 378.77 gm. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	109 / NC/3/MEET/Mar/202425/19	109 / NC/3/MEET/Mar/202425/19	109 / NC/3/MEET/Mar/202425/19	109 / NC/3/MEET/Mar/202425/19	109 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM REVIW00006514AM25
RA File Number		03AX04002439 AM25
Licence No and Date		0311036466/20/08/2024
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. No.	Import Items	Qty. allowed.

y 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.|

Case No.	Case No.	109 / NC/3/MEET/Mar/202425/19	109 / NC/3/MEET/Mar/202425/19	109 / NC/3/MEET/Mar/202425/19	109 / NC/3/MEET/Mar/202425/19	109 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		BLUE JET HEALTHCARE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM REVIW00006514AM25
RA File Number		03AX04002439 AM25
Licence No and Date		0311036466/20/08/2024
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. No.	Import Items	Qty. allowed.

UDIN00036287AM26

d 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.|

UDIN00036287AM26

1	Tetrahydrofuran	1.137 kg.
2	N-Heptane	1.808 kg.
3	Ethyl Isobutyrate	0.686 kg.
4	1 Bromo-5-chloropentane	1.10 kg.
5	N, N Dimethylacetamide	1.678 kg.
6	Sodium t-pentoxide	0.567 kg.
7	Tosmic	0.512 kg.

Case No.	Case No.	110 / NC/3/MEET/Mar/202425/19	110 / NC/3/MEET/Mar/202425/19	110 / NC/3/MEET/Mar/202425/19	110 / NC/3/MEET/Mar/202425/19	110 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		UMEDICA LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00002605AM25
RA File Number		03AX04002286 AM25
Licence No and<br>Date		0311036494/21/08/2024

and Date||NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025||||| |HQ File Number||HQRNORM APPLY 00002605AM25||||| |RA File Number||03AX04002286 AM25||||| |Licence No and Date||0311036494/21/08/2024||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Jan/202425/15 dated 28/01/2025 against advance authorization No.0311024147 dated 02/06/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

UDIN00036287AM26

1<br>Ortho Chloro Phenyl Diphenyl<br>Chloromethane<br>1.03 kg.<br>Clotrimazole USP / BP / EP / IH<br>1 kg.<br>2<br>Imidazole<br>0.310 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Clotrimazole USP / BP / EP / IH	1 kg.	1	Ortho Chloro Phenyl Diphenyl<br>Chloromethane	<br>1.03 kg.
			2	Imidazole	0.310 kg.

essary action as per above decision of NC.	Clotrimazole USP / BP / EP / IH	1 kg.	1	Ortho Chloro Phenyl Diphenyl<br>Chloromethane	<br>1.03 kg.
			2	Imidazole	0.310 kg.

Case No.	111 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	UMEDICA LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002606AM25
RA File Number	03AX04002289 AM25
Licence No and<br>Date	0311036495/21/08/2024
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/Jan/202425/15 dated 28/01/2025 against advance<br>authorization No.0311024147 dated 02/06/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Ortho Chloro Phenyl Diphenyl<br>Chloromethane<br>1.03 kg.<br>Clotrimazole USP / BP / EP / IH<br>1 kg.<br>2<br>Imidazole<br>0.310 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	112 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved

UDIN00036287AM26

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

Case No.	112 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved

UDIN00036287AM26

Par	ty Name	UNIMAX LABORATORIES	UNIMAX LABORATORIES	UNIMAX LABORATORIES	UNIMAX LABORATORIES	UNIMAX LABORATORIES
Me<br>Dat	eting Number and<br>e	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ	File Number	HQRNORM APPLY 00002613AM25
RA	File Number	05AX04001529 AM25
Lic	ence No and Date	0511027267/21/08/2024
No<br>Th<br>pr<br>au<br>H<br>R	rms Committee Decision:<br>e Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>oduct/import item in meeting No.NC/3/MEET/Jan/202425/15 dated 28/01/2025 against advance<br>thorization No.0511019298 dated 12/06/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>BP Vol. I as per details given below or as applied by the firm, whichever is less:-
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Spiramycin<br>Tablets<br>1.5<br>MIU(Each<br>tablet<br>contains<br>Spiramycin EP)		<br> <br>1 Number	1	Spiramycin EP	373.02 mg.
	Spiramycin<br>Tablets<br>3.0<br>MIU(Each<br>tablet<br>contains<br>Spiramycin EP)		<br> <br>1 Number	2	Spiramycin EP	Does not match with<br>DML
	Azithromycin Tablets 250 mg<br>USP(Each tablet contains<br>Azithromycin USP (As<br>Dihydrate) Eq.

tablet contains Spiramycin EP)|| 1 Number|2|Spiramycin EP|Does not match with DML| ||Azithromycin Tablets 250 mg USP(Each tablet contains Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin)||1 Number|3|Azithromycin Dihydrate USP|267.27 mg.| ||Azithromycin Tablets 500 mg USP(Each tablet contains Azithromycin USP (As Dihydrate) Eq. to AnhydrousAzithromycin)||1 Number|4|Azithromycin Dihydrate USP|534.54 mg.| ||A concerned may take further necessary action as per above decision of NC.||||||

Par	ty Name	UNIMAX LABORATORIES	UNIMAX LABORATORIES	UNIMAX LABORATORIES	UNIMAX LABORATORIES	UNIMAX LABORATORIES
Me<br>Dat	eting Number and<br>e	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ	File Number	HQRNORM APPLY 00002613AM25
RA	File Number	05AX04001529 AM25
Lic	ence No and Date	0511027267/21/08/2024
No<br>Th<br>pr<br>au<br>H<br>R	rms Committee Decision:<br>e Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>oduct/import item in meeting No.NC/3/MEET/Jan/202425/15 dated 28/01/2025 against advance<br>thorization No.0511019298 dated 12/06/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>BP Vol. I as per details given below or as applied by the firm, whichever is less:-
	Export Product		Qty.	Sl. No.	Import Items	Qty.

23, it was decided to fix ad-hoc norms under Para 4.07 of BP Vol. I as per details given below or as applied by the firm, whichever is less:-|||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Spiramycin Tablets 1.5 MIU(Each tablet contains Spiramycin EP)|| 1 Number|1|Spiramycin EP|373.02 mg.| ||Spiramycin Tablets 3.0 MIU(Each tablet contains Spiramycin EP)|| 1 Number|2|Spiramycin EP|Does not match with DML| ||Azithromycin Tablets 250 mg USP(Each tablet contains Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin)||1 Number|3|Azithromycin Dihydrate USP|267.27 mg.| ||Azithromycin Tablets 500 mg USP(Each tablet contains Azithromycin USP (As Dihydrate) Eq. to AnhydrousAzithromycin)||1 Number|4|Azithromycin Dihydrate USP|534.54 mg.| ||A concerned may take further necessary action as per above decision of NC.||||||

Case No.	113 / NC/3/MEET/Mar/202425/19
Case Status	Case Deferred

UDIN00036287AM26

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

Case No.	113 / NC/3/MEET/Mar/202425/19
Case Status	Case Deferred

UDIN00036287AM26

Party Name	DR.ACHARYA LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002617AM25
RA File Number	03AX04002498 AM25
Licence No and<br>Date	0311036513/21/08/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>The function of Tetrahydrofuraninin the reaction and yield of the reaction.<br>1.<br>The Stoichiometric material balance on a molar basis.<br>2.<br>The current production/consumption data duly certified by Chartered Accountant.<br>3.

Case No.	114 / NC/3/MEET/Mar/202425/19
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002619AM25
RA File Number	31AX04000169 AM25
Licence No and<br>Date	3111003807/21/08/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>1. Chemical Name of DNOVO CP388.<br>2.

equest of firm for fixation of ad-hoc norms and as per the advice of the TE, it was decided to call for following information/documents from the firm:- 1. Chemical Name of DNOVO CP388. 2. Calculation for the requirement of Raw materials for the manufacture of Export item, giving justification for the yield of the reaction. 3. Production/Consumption data for the current year duly certified by Chartered Accountant.||

Case No. 115 / NC/3/MEET/Mar/202425/19

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Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002625AM25
RA File Number	05AX04001393 AM25
Licence No and<br>Date	0511027293/21/08/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was<br>decided to call for following information/documents from the firm:-<br>Complete technical details as per Annexure to Appendix-4E.<br>1.<br>Wastage applied for Tablets from API.<br>2.

decided to call for following information/documents from the firm:- Complete technical details as per Annexure to Appendix-4E. 1. Wastage applied for Tablets from API. 2.||

Case No.	116 / NC/3/MEET/Mar/202425/19
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002626AM25
RA File Number	05AX04001408 AM25
Licence No and<br>Date	0511027294/21/08/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Complete technical details as per Annexure to Appendix-4E.<br>1.

Case No.	117 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025

90 This document has been digitally signed by Raman Kumar, Deputy DGFT on 21-04-2025 12:26:46.

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MITED| |Meeting Number and Date|NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025|

90 This document has been digitally signed by Raman Kumar, Deputy DGFT on 21-04-2025 12:26:46.

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HQ File Number	HQRNORM APPLY 00002628AM25
RA File Number	05AX04001578 AM25
Licence No and<br>Date	0511027297/22/08/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meeting No.NC/3/MEET/Apr/202425/2 dated 30/04/2024 against advance<br>authorization No.0511019178 dated 05/06/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Budesonide Suspension For Inhalation ,<br>0.125 mg / ml (2 ml Ampoule)<br>12195000<br>Numbers<br>1<br>Budesonide<br>3.201 kg.<br>Budesonide Suspension For Inhalation ,<br>0.25 mg / ml (2 ml Ampoule)<br>11700000<br>Numbers<br>2<br>Budesonide<br>6.1425 kg.<br>Budesonide Suspension For Inhalation ,<br>0.5 mg / ml (2 ml Ampoule)<br>3600000<br>Numbers<br>3<br>Budesonide<br>3.78 kg.<br>RA concerned may take further necessary action as per above decision of NC.

nide Suspension For Inhalation , 0.5 mg / ml (2 ml Ampoule) 3600000 Numbers 3 Budesonide 3.78 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	118 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	UMEDICA LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002629AM25
RA File Number	03AX04002320 AM25
Licence No and<br>Date	0311036536/22/08/2024
Norms Committee Decision:

UDIN00036287AM26

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/Jan/202425/15 dated 28/01/2025 against advance authorization No.0311024147 dated 02/06/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Clotrimazole USP / BP / EP / IH	1 kg.	1	Ortho Chloro Phenyl Diphenyl<br>Chloromethane	<br>1.03 kg.
		2	Imidazole	0.310 kg.

oduct	Qty.	Sl. No.	Import Items	Qty. allowed.
Clotrimazole USP / BP / EP / IH	1 kg.	1	Ortho Chloro Phenyl Diphenyl<br>Chloromethane	<br>1.03 kg.
		2	Imidazole	0.310 kg.

Case No.	Case No.	119 / NC/3/MEET/Mar/202425/19	119 / NC/3/MEET/Mar/202425/19	119 / NC/3/MEET/Mar/202425/19	119 / NC/3/MEET/Mar/202425/19	119 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		VENUS REMEDIES LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00002632AM25
RA File Number		30AX04000255 AM25
Licence No and Date		3011005627/22/08/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>METHOTREXATE INJECTION USP<br>(15 MG/ML)(EACH ML CONTAINS:<br>METHOTREXATE USP...15 MG,<br>WATER FOR INJECTION USP...Q.S<br>CONTAINING 0.103 KG OF<br>METHOTREXATE )<br>1 Number<br>1<br>METHOTREXATE<br>16.50 mg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	METHOTREXATE INJECTION USP<br>(15 MG/ML)(EACH ML CONTAINS:<br>METHOTREXATE USP...15 MG,<br>WATER FOR INJECTION USP...Q.S<br>CONTAINING 0.103 KG OF<br>METHOTREXATE )		1 Number	1	METHOTREXATE	16.50 mg.

OTREXATE INJECTION USP (15 MG/ML)(EACH ML CONTAINS: METHOTREXATE USP...15 MG, WATER FOR INJECTION USP...Q.S CONTAINING 0.103 KG OF METHOTREXATE )||1 Number|1|METHOTREXATE|16.50 mg.|

Case No.	Case No.	119 / NC/3/MEET/Mar/202425/19	119 / NC/3/MEET/Mar/202425/19	119 / NC/3/MEET/Mar/202425/19	119 / NC/3/MEET/Mar/202425/19	119 / NC/3/MEET/Mar/202425/19
Case Status		Case Approved
Party Name		VENUS REMEDIES LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number		HQRNORM APPLY 00002632AM25
RA File Number		30AX04000255 AM25
Licence No and Date		3011005627/22/08/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>METHOTREXATE INJECTION USP<br>(15 MG/ML)(EACH ML CONTAINS:<br>METHOTREXATE USP...15 MG,<br>WATER FOR INJECTION USP...Q.S<br>CONTAINING 0.103 KG OF<br>METHOTREXATE )<br>1 Number<br>1<br>METHOTREXATE<br>16.50 mg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	METHOTREXATE INJECTION USP<br>(15 MG/ML)(EACH ML CONTAINS:<br>METHOTREXATE USP...15 MG,<br>WATER FOR INJECTION USP...Q.S<br>CONTAINING 0.103 KG OF<br>METHOTREXATE )		1 Number	1	METHOTREXATE	16.50 mg.

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(15 MG/ML)(EACH ML CONTAINS: METHOTREXATE USP...15 MG, WATER FOR INJECTION USP...Q.S CONTAINING 0.103 KG OF METHOTREXATE )||1 Number|1|METHOTREXATE|16.50 mg.|

UDIN00036287AM26

METHOTREXATE INJECTION USP<br>(50 MG/2ML)(EACH ML CONTAINS:<br>METHOTREXATE USP...25 MG,<br>WATER FOR INJECTION USP...Q.S<br>CONTAINING 13.447 KG OF<br>METHOTREXATE)<br>1 Number<br>2<br>METHOTREXATE<br>55.00 mg.<br>METHOTREXATE INJECTION USP<br>(500 MG/5 ML)( EACH ML<br>CONTAINS METHOTREXATE<br>USP...100 MG, WATER FOR<br>INJECTION USP...Q.SCONTAINING<br>10.000 KG OF METHOTREXATE)<br>1 Number<br>3<br>METHOTREXATE<br>550.00 mg.<br>METHOTREXATE INJECTION USP<br>(1000mg/10ml)(EACH ML<br>CONTAINS: METHOTREXATE<br>USP...100 MG,WATER FOR<br>INJECTION USP...Q.S CONTAINING<br>6.456 KG OF METHOTREXATE)<br>1 Number<br>4<br>METHOTREXATE<br>1100.00 mg.<br>RA concerned may take further necessary action as per above decision of NC.	METHOTREXATE INJECTION USP<br>(50 MG/2ML)(EACH ML CONTAINS:<br>METHOTREXATE USP...25 MG,<br>WATER FOR INJECTION USP...Q.S<br>CONTAINING 13.447 KG OF<br>METHOTREXATE)	1 Number	2	METHOTREXATE	55.00 mg.
	METHOTREXATE INJECTION USP<br>(500 MG/5 ML)( EACH ML<br>CONTAINS METHOTREXATE<br>USP...100 MG, WATER FOR<br>INJECTION USP...Q.SCONTAINING<br>10.000 KG OF METHOTREXATE)	1 Number	3	METHOTREXATE	550.00 mg.
	METHOTREXATE INJECTION USP<br>(1000mg/10ml)(EACH ML<br>CONTAINS: METHOTREXATE<br>USP...100 MG,WATER FOR<br>INJECTION USP...Q.S CONTAINING<br>6.456 KG OF METHOTREXATE)	1 Number	4	METHOTREXATE	1100.00 mg.

Case No.	120 / NC/3/MEET/Mar/202425/19
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202425/ 19 and 27/03/2025
HQ File Number	HQRNORM APPLY 00002640AM25
RA File Number	03AX04002521 AM25
Licence No and Date	0311036548/22/08/2024
Norms Committee Decision:<br>The Committee considered the request of firm in details and also discussed report of factory visit. The<br>committee found that in the above mention case export product is in form of Gel not a cream/Ointments<br>and accordingly decided to fix the ad-hoc norms as under :-

UDIN00036287AM26

Sl.	Export Product	Quantity
No
(i)	Medical Cream and Ointments(Glycerine Vaseline and Paraffin Cream 250gm	1 Number
	[Total Wt. 800000Kgs(NetCont:Gly120000Kgs,Vase64000Kgs,ParaLiq
	16000Kgs,Ste50% 16800Kgs,Ste95% 7200 Kgs,Cyclo20000Kgs,Sili4000
	Kgs,Mac40000Kgs,Trie4000 Kgs)])

Sl. No.	Import Items	Quantity allowed.
1	Relevant Bulk Drugs	Net content in the export product plus 2% wastage.
2	Relevant Excipients	Net content in the export product plus 2% wastage.
3	Relevant Packaging Material

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