IN FORCE Advance Authorisation

DGFT Minutes

Reliability

In force — no superseding record on file.

Document text

UDIN00584001AM25

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/Jan/202425/15 DATED: 28/01/2025

Please Note

I. For information of exporters, Norms Committee - III handles all cases pertaining to fixation/ratification of norms for Export Products falling under ITC (HS) Chapter 29, 30 .Communications in respect of cases/pertaining to NC- III may be sent to email address: nc3.dgft@nic.in
II. The Norms Committee has taken decision only with respect to technical aspect/wastage norms. While redeeming the applications, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure including those in Policy Circulars issued from time to time or any other provisions under FTP/HBP for EODC.
III. Wherever the Committee has fixed Norms, the concerned RA may ensure that AA is issued on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less.

Meeting No. NC/3/MEET/Jan/202425/15 dated 28/01/2025 of Norms Committee - III for the year 2024-25 was held on 28/01/2025 under the Chairmanship of Shri Rakesh Kumar,Additional DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2023.

The following members were present in the meeting:-

plications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2023.

The following members were present in the meeting:-

S.No.	Name and Designation of Representatives	Department
1	Shri Rakesh Kumar, Addl. DGFT	DGFT(HQ)
2	Shri Raman Kumar,Deputy DGFT	DGFT(HQ)
3	Shri NAND Lal,Technical Consultant	Consultant (Chemical)
4	Shri SHAISH KUMAR,Technical Consultant	Consultant (Chemical)
5	Shri DINESHNARAIN MATHUR,Technical	Consultant (Pharma)

1 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-02-2025 11:52:09.

UDIN00584001AM25

Consultant

2 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-02-2025 11:52:09.

UDIN00584001AM25

Case Details and Decision(s):

Case No.		1 / NC/3/MEET/Jan/202425/15
Case Status		Case Deferred
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00003389AM23
RA File Number		08AX04001054 AM23
Licence No and<br>Date		0811006114/26/09/2022
Norms Committee	Decision:
The committee	considered the request of firm for fixation of ad-hoc norms and as per the advice of the
TE, it was decided to call for following information/documents from the firm:-
Certificate of Analysis (CoA) of import item from Foreign Supplier.

Case No.<br>2 / NC/3/MEET/Jan/202425/15	Case No.<br>2 / NC/3/MEET/Jan/202425/15
Case Status<br>Case Approved
Party Name<br>ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202425/ 15	and 28/01/2025
HQ File Number<br>HQRNORM APPLY 00003395AM23
RA File Number<br>34AX04000620 AM23
Licence No and<br>Date<br>3411002830/27/09/2022
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.

x 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.|| |Cream(Clobetasol Propionate Cream USP|| 60000|1|Clobetasol Propionate|459.0 gm.|| |0.05% 15 gm ( net content of active|| Numbers||USP (Micronized)||| |ingredients 450.00 gm. ))||||||| |Cream(Clobetasol Propionate Cream USP|| 30000|2|Clobetasol Propionate|459.0 gm.|| |0.05% 30 gm ( net content of active|| Numbers||USP (Micronized)||| |ingredients 450.00 gm. ))||||||| |Cream(Clobetasol Propionate Cream USP||35000|3|Clobetasol Propionate|803.25 gm.||

This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-02-2025 11:52:09.

UDIN00584001AM25

0.05% 45 gm ( net content of active<br>ingredients 787.50 gm. ))	<br>Numbers		USP (Micronized)
Cream(Clobetasol Propionate Cream USP<br>0.05% 60 gm ( net content of active<br>ingredients 1200.00 gm. ))	<br> <br>40000<br>Numbers	4	Clobetasol Propionate<br>USP (Micronized)	1224.0 gm.
Solution(Clobetasol<br>Propionate<br>Topical<br>Solution USP 0.05% 25ml ( net content of<br>active ingredients 500.00 gm. ))	<br> <br>40000<br>Numbers	5	Clobetasol Propionate<br>USP (Micronized)	510.0 gm.
Solution(Clobetasol<br>Propionate<br>Topical<br>Solution USP 0.05% 50 ml ( net content of<br>active ingredients 375.00 gm.

br>40000 Numbers|5|Clobetasol Propionate USP (Micronized)|510.0 gm.| ||Solution(Clobetasol Propionate Topical Solution USP 0.05% 50 ml ( net content of active ingredients 375.00 gm. ))| 15000 Numbers|6|Clobetasol Propionate USP (Micronized)|382.50 gm.| ||Shampoo(Clobetasol Propionate Shampoo, 0.05% 118 ml ( net content of active ingredients 2360.00 gm.))| 40000 Numbers|7|Clobetasol Propionate USP (Micronized)|2407.2 gm.| ||Spray(Clobetasol Propionate Spray, 0.05% - 59 ml ( net content of active ingredients 295.00 gm.))| 10000 Numbers|8|Clobetasol Propionate USP (Micronized)|300.90 gm.| ||Spray(Clobetasol Propionate Spray, 0.05% - 125 ml ( net content of active ingredients 500.00 gm.))| 8000 Numbers|9|Clobetasol Propionate USP (Micronized)|510.0 gm.| ||Ointment(Clobetasol Propionate Ointment USP 0.05% 15 gm ( net content of active ingredients 375.00 gm. ))| 50000 Numbers|10|Clobetasol Propionate USP (Micronized)|382.50 gm.| ||Ointment(Clobetasol Propionate Ointment USP 0.05% 30 gm ( net content of active ingredients 525.00 gm. ))| 35000 Numbers|11|Clobetasol Propionate USP (Micronized)|535.50 gm.| ||Ointment(Clobetasol Propionate Ointment USP 0.05% 45 gm ( net content of active ingredients 450.00 gm. ))| 20000 Numbers|12|Clobetasol Propionate USP (Micronized)|459.0 gm.| ||Ointment(Clobetasol Propionate Ointment USP 0.05% 60 gm ( net content of active ingredients 750.00 gm.

gm. ))| 20000 Numbers|12|Clobetasol Propionate USP (Micronized)|459.0 gm.| ||Ointment(Clobetasol Propionate Ointment USP 0.05% 60 gm ( net content of active ingredients 750.00 gm. ))| 25000 Numbers|13|Clobetasol Propionate USP (Micronized)|765.0 gm.|

UDIN00584001AM25

Foam(Clobetasol Propionate Foam USP	<br>30000	14	Clobetasol Propionate	765.0 gm.
0.05% 50gm. ( net content of active	<br>Numbers		USP (Micronized)
ingredients 750.00 gm. ))
Foam(Clobetasol Propionate Foam USP	<br>20000	15	Clobetasol Propionate	1020.0 gm.
0.05% 100 gm. ( net content of active	<br>Numbers		USP (Micronized)
ingredients 1000.00 gm. ))

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


Foam(Clobetasol Propionate Foam USP<br>0.05% 50gm. ( net content of active<br>ingredients 750.00 gm. ))<br>30000<br>Numbers<br>14<br>Clobetasol Propionate<br>USP (Micronized)<br>765.0 gm.<br>Foam(Clobetasol Propionate Foam USP<br>0.05% 100 gm. ( net content of active<br>ingredients 1000.00 gm. ))<br>20000<br>Numbers<br>15<br>Clobetasol Propionate<br>USP (Micronized)<br>1020.0 gm.<br>RA concerned may take further necessary action as per above decision of NC.		Foam(Clobetasol Propionate Foam USP<br>0.05% 50gm. ( net content of active<br>ingredients 750.00 gm.

zed) 1020.0 gm. RA concerned may take further necessary action as per above decision of NC.||Foam(Clobetasol Propionate Foam USP 0.05% 50gm. ( net content of active ingredients 750.00 gm. ))|||||| 30000 Numbers|||14||Clobetasol Propionate USP (Micronized)|||765.0 gm.||| |||Foam(Clobetasol Propionate Foam USP 0.05% 100 gm. ( net content of active|||||| 20000 Numbers|||15||Clobetasol Propionate USP (Micronized)|||1020.0 gm.||| ||ingredients 1000.00 gm. ))|ingredients 1000.00 gm. ))||||||||||||||||| |||||||||||||||||||| ||A concerned may take further neces||||||sary acti||on as pe|r above decision of NC.||||||||| |||||||||||||||||||| |||||||||||||||||||| |Case No.||||||3 / NC/3/MEET/Jan/202425/15||||||||||||| |Case Status||||||Case Approved||||||||||||| |Party Name||||||AMNEAL INJECTABLES PRIVATE LIMITED||||||||||||| |Meeting Number and Date||||||NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025||||||||||||| |||||||||||||||||||| |HQ File Number||||||HQRNORM APPLY 00003479AM23||||||||||||| |RA File Number||||||08AX04000835 AM23||||||||||||| |Licence No and Date||||||0811006153/30/09/2022||||||||||||| |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.

rms 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:-||||||||||||||| |||||||||||||||||||| |||Exort Prod||uct||||||||Qt||Sl|Imort Items|||Qt| |||p||||||||||y.||. No.|p|||y. allowed.| |||||||||||||||||||| |||Dexmedetomi ||dine Hydrochloride in 0.9% Sodium Chloride ||||||||1 ||1|Dexmedetomidine |||210 mg.| |||Injection 200 mcg per 50 mL (4 mcg/mL) NET CONTENTS 12.58GM(Dexmedetomidine Hydrochloridein 0.9% Sodium Chloride Injection 200mcg per 50mL (4mcg/mL) NETCONTENTS_12.58GM)||||||||||Number|||import under PC 9 CONDITION|||| |||Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection 400 mcg per 100 mL (4 mcg/mL) NET CONTENTS ||||||||||1 Number||2|Dexmedetomidine import under PC 9 |||420 mg.| |||200 G Chlorid CONT|M (Dexmedetomidine Hydrochloride in 0.9% Sodium e Injection 400 mcg per 100 mL (4 mcg/mL) NET ENTS 200 GM)||||||||||||CONDITION|||| |||||||||||||||||||| |||Dexme Injectio|detomidine Hydrochloride in 0.9% Sodium Chloride n 200 mcg/50 mL (4 mcg/mL) NET CONTENTS|||||||||1 Number||3|Dexmedetomi import under||dine PC 9|210 mg.|

UDIN00584001AM25

ectio|detomidine Hydrochloride in 0.9% Sodium Chloride n 200 mcg/50 mL (4 mcg/mL) NET CONTENTS_|||||||||1 Number||3|Dexmedetomi import under||dine PC 9|210 mg.|

UDIN00584001AM25

7.20GM(Dexmedetomidine Hydrochloride in 0.9% Sodium<br>Chloride Injection 200 mcg/50 mL (4 mcg/mL) NET<br>CONTENTS_ 7.20 GM)			CONDITION
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride<br>Injection 400 mcg/100 mL (4 mcg/mL) NET CONTENTS_5.22<br>GM(Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride<br>Injection 400 mcg/100 mL (4 mcg/mL) NET CONTENTS_ 5.22<br>GM)	1<br>Number	4	Dexmedetomidine<br>import under PC 9<br>CONDITION	420 mg.
Esmolol Hydrochloride in Sodium Chloride Injection 2,500<br>mg/250 mL (10 mg/mL) NET CONTENTS_70 KGS (Esmolol<br>Hydrochloride in Sodium Chloride Injection 2,500 mg/250 mL<br>(10 mg/mL) NET CONTENTS_70 KGS)	1<br>Number	5	ESMOLOL<br>Import under PC 9<br>CONDITION	<br>2625 mg.
Esmolol Hydrochloride in Sodium Chloride Injection [DOUBLE<br>STRENGTH] 2,000 mg/100 mL (20 mg/mL) NET CONTENTS<br>_30 KGS (EsmololHydrochlorideinSodiumChloride<br>Injection[DOUBLESTRENGTH]2,000mg/100mL(20mg/mL)NET<br>CONTENTS_30 KGS)	<br>1<br>Number	6	ESMOLOL<br>Import under PC 9<br>CONDITION	<br>2100 mg.
Ropivacaine HCI Injection, USP 0.5% 500 mg/100 mL (5<br>mg/mL) NET CONTENTS _ 2.55 KGS(Ropivacaine HCI<br>Injection, USP 0.5% 500 mg/100 mL (5 mg/mL) NET<br>CONTENTS_2.55 KGS)	1<br>Number	7	ROPIVACAINE<br>Import under PC 9<br>CONDITION	525 mg.

0 mL (5 mg/mL) NET CONTENTS _ 2.55 KGS(Ropivacaine HCI Injection, USP 0.5% 500 mg/100 mL (5 mg/mL) NET CONTENTS_2.55 KGS)|1 Number|7|ROPIVACAINE Import under PC 9 CONDITION|525 mg.| ||Ropivacaine HCI Injection, USP 0.5% 1,000 mg/200 mL (5 mg/mL) NET CONTENTS_2.315 KGS (Ropivacaine HCI Injection, USP 0.5% 1,000 mg/200 mL (5 mg/mL) NET CONTENTS_2.315 KGS)|1 Number|8|ROPIVACAINE Import under PC 9 CONDITION|1000 mg.| ||Ropivacaine HCI Injection, USP 0.2% 200 mg/100 mL (2 mg/mL) NET CONTENTS _11.4 KGS (Ropivacaine HCI Injection, USP 0.2% 200 mg/100 mL (2 mg/mL) NET CONTENTS_11.4 KGS)|1 Number|9|ROPIVACAINE Import under PC 9 CONDITION|200 mg.| ||Ropivacaine HCI Injection, USP 0.2% 400 mg/200 mL (2 mg/mL) NET CONTENTS_19.24 KGS (Ropivacaine HCI Injection, USP 0.2% 400 mg/200 mL (2 mg/mL) NET CONTENTS_19.24 KGS)|1 Number|10|ROPIVACAINE Import under PC 9 CONDITION|420 mg.|

UDIN00584001AM25

UDIN00584001AM25

Case No.	4 / NC/3/MEET/Jan/202425/15
Case Status	Case Rejected
Party Name	PRIVI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00003514AM23
RA File Number	03AX04003421 AM23
Licence No and<br>Date	0311018336/03/10/2022
Norms Committee Decision:
The Committee considered the request of the firm for fixation of ad-hoc norms and on the basis of
information provided by the firm and it has been observed by the committee that input Galaxmusk Pure
(Perfumery Compound) as applied by the firm appears to fall under para 4.11(b) of FTP, 2023, and the said
para states that “For export of perfumes, perfumery compounds and various feed ingredients containing
vitamins, no authorisation shall be issued by Regional Authority under para 4.07 of HBP. The applicant
firm is requested to clarify how this application comes under Para 4.07 of HBP and the RA concerned is
directed to provide its comments.

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

Case No.<br>5 / NC/3/MEET/Jan/202425/15
Case Status<br>Case Approved
Party Name<br>CORAL DRUGS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number<br>HQRNORM APPLY 00003543AM23
RA File Number<br>05AX04001818 AM23
Licence No and<br>Date<br>0511015160/06/10/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07
of HBP Vol. I as per details given below or as applied by	the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty. allowed.
Fluticasone Propionate (EP/BP/USP/IP)<br>1 kg.	1	8 DM	1.73 mg.
RA concerned may take further necessary action as per above decision		of NC.

UDIN00584001AM25

ems**|Qty. allowed.|| |Fluticasone Propionate (EP/BP/USP/IP) 1 kg.|1|8 DM|1.73 mg.|| |RA concerned may take further necessary action as per above decision||of NC.|||

UDIN00584001AM25

Case No.	Case No.	6 / NC/3/MEET/Jan/202425/15	6 / NC/3/MEET/Jan/202425/15	6 / NC/3/MEET/Jan/202425/15	6 / NC/3/MEET/Jan/202425/15	6 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00003610AM23
RA File Number		34AX04000652 AM23
Licence No and<br>Date		3411002874/10/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

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 Midodrine Hydrochloride USP (Micronized) 2.55 mg. 2 Microcrystalline Cellulose (Avicel PH 102) 74.5 mg. 3 Crospovidone (Type-A) (Polyplasdone) XL 8.00 mg. 4 Hydroxypropyl cellulose(KLUCEL LF PHARM) 1.50 mg. 5 Colloidal Silicon dioxide (Aerosil 200 Pharma) 2.00 mg. Midodrine HCL Tabs USP 2.5 mg 1 Number 6 Magnesium Stearate 1.50 mg. 7 Midodrine Hydrochloride USP (Micronized) 5.10 mg. 8 Microcrystalline Cellulose (Avicel PH 102) 149.0 mg. Midodrine HCL Tabs USP 5 mg 1 Number||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Midodrine HCL Tabs USP 2.5 mg||1 Number|1|Midodrine Hydrochloride USP (Micronized)|2.55 mg.| |||||2|Microcrystalline Cellulose (Avicel PH 102)|74.5 mg.| |||||3|Crospovidone (Type-A) (Polyplasdone) XL|8.00 mg.| |||||4|Hydroxypropyl cellulose(KLUCEL LF PHARM)|1.50 mg.| |||||5|Colloidal Silicon dioxide (Aerosil 200 Pharma)|2.00 mg.| |||||6|Magnesium Stearate|1.50 mg.| ||Midodrine HCL Tabs USP 5 mg||1 Number|7|Midodrine Hydrochloride USP (Micronized)|5.10 mg.| |||||8|Microcrystalline Cellulose (Avicel PH 102)|149.0 mg.|

UDIN00584001AM25

te|1.50 mg.| ||Midodrine HCL Tabs USP 5 mg||1 Number|7|Midodrine Hydrochloride USP (Micronized)|5.10 mg.| |||||8|Microcrystalline Cellulose (Avicel PH 102)|149.0 mg.|

UDIN00584001AM25

		9	Crospovidone (Type-A)<br>(Polyplasdone) XL	16.0 mg.
		10	Hydroxypropyl cellulose(KLUCEL<br>LF PHARM)	3.0 mg.
		11	Colloidal Silicon dioxide (Aerosil<br>200 Pharma)	4.0 mg.
		12	Magnesium Stearate	3.0 mg.
Midodrine HCL Tabs USP 10 mg	1 Number	13	Midodrine Hydrochloride USP<br>(Micronized)	10.20 mg.
		14	Microcrystalline Cellulose (Avicel<br>PH 102)	298.0 mg.
		15	Crospovidone (Type-A)<br>(Polyplasdone) XL	32.0 mg.
		16	Hydroxypropyl cellulose(KLUCEL<br>LF PHARM)	6.00 mg.
		17	Colloidal Silicon dioxide (Aerosil<br>200 Pharma)	8.00 mg.
		18	Magnesium Stearate	6.00 mg.

(Polyplasdone) XL|32.0 mg.| ||||16|Hydroxypropyl cellulose(KLUCEL LF PHARM)|6.00 mg.| ||||17|Colloidal Silicon dioxide (Aerosil 200 Pharma)|8.00 mg.| ||||18|Magnesium Stearate|6.00 mg.|

Case No.	7 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	LIVEALTH BIOPHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00003619AM23
RA File Number	03AX04003335 AM23

UDIN00584001AM25

Licence No and<br>Date	0311018491/11/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.<br>SUCCIMER CAPSULES 100 MG<br>SUXIMER<br>(200 packs of 10 x 10 Capsules)<br>1 Number<br>1<br>SUCCIMER DMSA<br>(2,3-Dimercapto Succinic<br>acid)<br>100.00 mg.<br>RA concerned may take further necessary action as per above decision of NC.

Licence No and Date

0311018491/11/10/2022

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. SUCCIMER CAPSULES 100 MG SUXIMER (200 packs of 10 x 10 Capsules) 1 Number 1 SUCCIMER DMSA (2,3-Dimercapto Succinic acid) 100.00 mg. RA concerned may take further necessary action as per above decision of NC.

200 packs of 10 x 10 Capsules) 1 Number 1 SUCCIMER DMSA (2,3-Dimercapto Succinic acid) 100.00 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	8 / NC/3/MEET/Jan/202425/15	8 / NC/3/MEET/Jan/202425/15	8 / NC/3/MEET/Jan/202425/15	8 / NC/3/MEET/Jan/202425/15	8 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00003629AM23
RA File Number		34AX04000662 AM23
Licence No and<br>Date		3411002884/11/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Guanfacine Hydrochloride<br>1.171 mg.<br>Methacrylic Acid and Ethyl<br>Guanfacine Extended-Release Tablets<br>USP 1 mg (Net content of active<br>ingredients 3.900 kgs )<br>1 Number<br>2<br>55.00 mg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Guanfacine Extended-Release Tablets<br>USP 1 mg (Net content of active<br>ingredients 3.900 kgs )		<br>1 Number	1	Guanfacine Hydrochloride	1.171 mg.
				2	Methacrylic Acid and Ethyl	55.00 mg.

UDIN00584001AM25

ease 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|55.00 mg.|

UDIN00584001AM25

			Acrylate Copolymer (Eudragit L<br>100-55)
		3	Hypromellose (Methocel K15M<br>Premium CR Grade)	55.00 mg.
		4	Microcrystalline Cellulose (Avicel<br>PH 102)	10.00 mg.
		5	Lactose Monohydrate (Flowlac 100)	46.35 mg.
		6	Magnesium stearate	1.00 mg.
Guanfacine Extended-Release Tablets<br>USP 2 mg (Net content of active<br>ingredients 7.800 kgs )	<br>1 Number	7	Guanfacine Hydrochloride	2.342 mg.
		8	Methacrylic Acid and Ethyl<br>Acrylate Copolymer (Eudragit L<br>100-55)	55.00 mg.
		9	Hypromellose (Methocel K15M<br>Premium CR Grade)	55.00 mg.
		10	Microcrystalline Cellulose (Avicel<br>PH 102)	10.00 mg.
		11	Lactose Monohydrate (Flowlac 100)	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.

UDIN00584001AM25

olymer (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.|

UDIN00584001AM25

		17	Lactose Monohydrate (Flowlac 100)	43.56 mg.
		18	Magnesium stearate	1.00 mg.
Guanfacine Extended-Release Tablets<br>USP 4 mg (Net content of active<br>ingredients 9.60 kgs )	<br>1 Number	19	Guanfacine Hydrochloride	4.684 mg.
		20	Methacrylic Acid and Ethyl<br>Acrylate Copolymer (Eudragit L<br>100-55)	55.00 mg.
		21	Hypromellose (Methocel K15M<br>Premium CR Grade)	55.00 mg.
		22	Microcrystalline Cellulose (Avicel<br>PH 102)	10.00 mg.
		23	Lactose Monohydrate (Flowlac 100)	42.40 mg.
		24	Magnesium stearate	1.00 mg.

thocel K15M Premium CR Grade)|55.00 mg.| ||||22|Microcrystalline Cellulose (Avicel PH 102)|10.00 mg.| ||||23|Lactose Monohydrate (Flowlac 100)|42.40 mg.| ||||24|Magnesium stearate|1.00 mg.|

Case No.	9 / NC/3/MEET/Jan/202425/15
Case Status	Case Rejected
Party Name	VINEET LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00003691AM23
RA File Number	09AX04000567 AM23
Licence No and<br>Date	0911003791/13/10/2022
Norms Committee Decision:<br>The firm vide letter dated 09/06/2023 has informed that they have surrendered their above license to RA.<br>Therefore, the Committee decided toclosethe application of the firm.

UDIN00584001AM25

Case No.	Case No.	10 / NC/3/MEET/Jan/202425/15	10 / NC/3/MEET/Jan/202425/15	10 / NC/3/MEET/Jan/202425/15	10 / NC/3/MEET/Jan/202425/15	10 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00003897AM23
RA File Number		07AX04001077 AM23
Licence No and<br>Date		0711005539/21/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

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 CITRIC ACID-ANY GRADE 0.477 kg. 2 DL-MALIC ACID 0.499 kg. CALCIUM CITRATE MALATE USP 1 kg. 3 CALCIUM CARBONATE 0.712 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||CALCIUM CITRATE MALATE USP||1 kg.|1|CITRIC ACID-ANY GRADE|0.477 kg.| |||||2|DL-MALIC ACID|0.499 kg.| |||||3|CALCIUM CARBONATE|0.712 kg.| |||||above decision of NC.|||

Case No.	11 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00003925AM23
RA File Number	09AX04000647 AM23
Licence No and Date	0911003881/27/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export

UDIN00584001AM25

product/import item in meeting No.NC/3/MEET/Dec/202425/13 dated 07/01/2025 against advance authorization No.0911003541 dated 26/08/2022 , 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:-

advance authorization No.0911003541 dated 26/08/2022 , 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.<br>No.	Import Items	Qty.<br>allowed.
2butyl16dihydro-<br>NN,4trimethyl6oxo1[[2[1(triphenylmethyl)-<br>1H-tetrazol-5-<br>yl][1,1biphenyl]4yl]methyl]5-<br>Pyrimidineacetamide (Drug Intermediate)	1 kg.	1	Chloroform	1.90 kg.
		2	Toluene	2.06 kg.
		3	5-(4-(Bromomethyl)biphenyl-<br>2-yl)-2-trityl-2H-Tetrazole (N-<br>(Triphenylmethyl)	1.02 kg.
		4	Dimethyl Sulfoxide	0.46 kg.
		5	Lithium hydride	0.0166 kg.

Case No.	12 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	NECTAR LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00003987AM23
RA File Number	302404000100 AM20
Licence No and<br>Date	3011002766/01/11/2022
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

UDIN00584001AM25

100 AM20| |Licence No and Date|3011002766/01/11/2022| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

UDIN00584001AM25

Case No.	13 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM REVIW00006136AM24
RA File Number	52AX04001711 AM23
Licence No and<br>Date	5211003710/07/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Personal Hearing<br>before Norms Committee to explain its case along with following information /<br>documents from the firm:<br>To indicate stepwise yield of the reaction and whether trhe overall yield of the reaction is<br>67.18% as shown and accordingly, to calculate the requirement of raw materials.<br>1.<br>Justification of low yield of the reaction giving the details of losses during the process and the<br>value of by-product/s of the reaction generated during the process.<br>2.<br>Current production/consumption data duly certified by Chartered Accountant.<br>3.

To indicate stepwise yield of the reaction and whether trhe overall yield of the reaction is 67.18% as shown and accordingly, to calculate the requirement of raw materials.

ant.** 3.||

To indicate stepwise yield of the reaction and whether trhe overall yield of the reaction is 67.18% as shown and accordingly, to calculate the requirement of raw materials.
Justification of low yield of the reaction giving the details of losses during the process and the value of by-product/s of the reaction generated during the process.

Case No.	14 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM REVIW00006412AM24
RA File Number	09AX04000649 AM23
Licence No and<br>Date	0911004131/08/12/2022
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 other relevant cases.		Personal

Case No.	15 / NC/3/MEET/Jan/202425/15
Case Status	Case Rejected
Party Name	VINYL PRODUCTS PRIVATE LIMITED

UDIN00584001AM25

long with other relevant cases.||Personal|

Case No.	15 / NC/3/MEET/Jan/202425/15
Case Status	Case Rejected
Party Name	VINYL PRODUCTS PRIVATE LIMITED

UDIN00584001AM25

Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM REVIW00001983AM25
RA File Number	05AX04002721 AM23
Licence No and<br>Date	0511016406/15/12/2022
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 thestatus quo. The exports and imports under this are also similar to SION A-<br>1303 therefore the committee also decided to review the SION A-1303.

Case No.	16 / NC/3/MEET/Jan/202425/15
Case Status	Case Rejected
Party Name	LYRUS LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000961AM24
RA File Number	NA
Licence No and<br>Date	0711006229/19/01/2023
Norms Committee Decision:<br>The Committee considered the request of the firm and observed that the firm has filed dual application on<br>same license, therefore, the committee has decided toclosethe application of the firm.

ommittee considered the request of the firm and observed that the firm has filed dual application on same license, therefore, the committee has decided toclosethe application of the firm.||

Case No.	17 / NC/3/MEET/Jan/202425/15
Case Status	Case Rejected
Party Name	MICROTROL STERILISATION SERVICES PVT.LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00005834AM23
RA File Number	07AX04001525 AM23
Licence No and<br>Date	0711006236/19/01/2023
Norms Committee Decision:<br>The Committee considred the case as per the agenda and the firm has informed during personal hearing that<br>they have surrendered the license to concerned RA. Therefore, the Committee has decided toclosethe

16 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-02-2025 11:52:09.

UDIN00584001AM25

application of the firm.

Case No.	18 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00005935AM23
RA File Number	03AX04005248 AM23
Licence No and<br>Date	0311020993/27/01/2023

|Meeting Number and Date|NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025| |HQ File Number|HQRNORM APPLY 00005935AM23| |RA File Number|03AX04005248 AM23| |Licence No and Date|0311020993/27/01/2023| |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 meetingNo.NC/3/MEET/Nov/202324/16 dated 17/11/2023against advance authorizationNo.0311024614 dated 16/06/2023, 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. 1 Fenofibrate Micronized IH/Ph Eur 147.90 mg. Fenofibrate 145mg tablets) (6,78,60,000Nos) (NetContent:1) 9955.062KGS2) 9878.380KGS3) (Indi):2004.584KGS 4) (Indi):196.115KGS 5) (Indi):681.993KGS 6) (Indi):8864.552KGS 7) (Indi):5778.279KGS 8) (Indi):5067.785KGS 9) (Indi):61.074KGS 10) (Indi): 2015.442KGS ) 1 kg. 2 Sucrose PH.Eur (exepient) 143.575 mg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00584001AM25

KGS 10) (Indi): 2015.442KGS ) 1 kg. 2 Sucrose PH.Eur (exepient) 143.575 mg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00584001AM25

Case No.	19 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00005968AM23
RA File Number	03AX04005323 AM23
Licence No and<br>Date	0311021042/30/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.NC/3/MEET/Sep/202425/9 dated 10/10/2024against advance<br>authorizationNo.0311020797 dated 19/01/2023, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Fenofibrate Micronized IH/Ph.Eur<br>0.3155 kg.<br>2<br>Hypromellose (2910, 3 cps) Ph. Eur<br>0.0625 kg.<br>3<br>Docusate Sodium Ph.Eur<br>0.0062 kg.<br>4<br>Sucrose Ph.Eur<br>0.3124 kg.<br>5<br>Sodium Lauril Sulfate Ph.Eur<br>0.0216 kg.<br>Fenofibrate Bulk Granulate<br>1 kg.<br>6<br>Lactose Monohydrate Ph.Eur<br>0.2804 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	20 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved

UDIN00584001AM25

.2804 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	20 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved

UDIN00584001AM25

Party Name	KRITI NUTRIENTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM REVIW00001038AM25
RA File Number	56AX04000363 AM23
Licence No and<br>Date	5611001525/02/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.NC/3/MEET/Sep/202425/9 dated 10/10/2024against advance<br>authorizationNo.5611000556 dated 12/10/2021, 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.<br>allowed.<br>Soya Lecithin Liquid Food Grade<br>(Non GMO)<br>1 kg.<br>1<br>Soya Lecithin Liquid<br>1.00 kg.<br>RA concerned may take further necessary action as per above decision of NC.

* allowed. Soya Lecithin Liquid Food Grade (Non GMO) 1 kg. 1 Soya Lecithin Liquid 1.00 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	21 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00006103AM23
RA File Number	05AX04003187 AM23
Licence No and<br>Date	0511017188/06/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00584001AM25

|Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Amoxycillin Trihydrate 99.75 kg. Amoxycillin Trihydrate and Clavulanate Potassium + Silicon Dioxide (1:1) Suspension 156.25mg/5ml (100ml Bottle, Each 5 ml contains Amoxycillin Trihydrate equivalent to Amoxycillin 125mg &Clavulanate Potassium + Silicon Dioxide (1:1) equivalent to Clavulanic acid 31.25mg) (Equivalent to 95.000Kg of Amoxycillin Trihydrate &23.750Kg of Clavulan 38000 Numbers 2 Clavulanate Potassium + Silicon Dioxide (1:1) 58.92 kg. 3 Amoxycillin Trihydrate 82.32 kg. Amoxycillin Trihydrate and Clavulanate Potassium + Silicon Dioxide (1:1) Suspension 228.50mg/5ml (70ml Bottle, Each 5 ml contains Amoxycillin

Amoxycillin Trihydrate 82.32 kg. Amoxycillin Trihydrate and Clavulanate Potassium + Silicon Dioxide (1:1) Suspension 228.50mg/5ml (70ml Bottle, Each 5 ml contains Amoxycillin Trihydrate equivalent to Amoxycillin 200mg &Clavulanate Potassium + Silicon Dioxide (1:1) equivalent to Clavulanic acid 28.5mg) (Equivalent to 78.400Kg of Amoxycillin Trihydrate &11.172Kg of Clavulanate 28000 Numbers 4 Clavulanate Potassium + Silicon Dioxide (1:1) 27.72 kg. 5 Amoxycillin Trihydrate 88.2 kg. Amoxycillin Trihydrate and Clavulanate Potassium + Silicon Dioxide (1:1) Suspension 312.5mg/5ml 60ml Bottle, Each 5 ml contains Amoxycillin Trihydrate equivalent to Amoxycillin 250mg &Clavulanate Potassium + Silicon Dioxide (1:1) equivalent to Clavulanic acid 62.5mg) (Equivalent to 84.000Kg of Amoxycillin Trihydrate &21.000Kg of Clavulanat 28000 Numbers 6 Clavulanate Potassium + Silicon Dioxide (1:1) 52.1 kg. 7 Amoxycillin Trihydrate 164.64 kg. Amoxycillin Trihydrate and Clavulanate Potassium + Silicon Dioxide (1:1) Suspension 457.00mg/5ml (70ml Bottle, Each 5 ml contains Amoxycillin Trihydrate equivalent to Amoxycillin 400mg &Clavulanate Potassium + Silicon Dioxide (1:1) equivalent to Clavulanic acid 57mg) (Equivalent to 156.800Kg of Amoxycillin Trihydrate & 22.344Kg of Clavulanate 28000 Numbers 8 Clavulanate Potassium + Silicon Dioxide (1:1) 55.44 kg. RA concerned may take further neces

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Amoxycillin Trihydrate and Clavulanate<br>Potassium<br>+<br>Silicon<br>Dioxide<br>(1:1)<br>Suspension 156.25mg/5ml (100ml Bottle,<br>Each 5 ml contains Amoxycillin Trihydrate<br>equivalent<br>to<br>Amoxycillin<br>125mg<br>&Clavulanate Potassium + Silicon Dioxide<br>(1:1) equivalent to Clavulanic acid 31.25mg)<br>(Equivalent to 95.000Kg of Amoxycillin<br>Trihydrate &23.750Kg of Clavulan	<br> <br> <br> <br> <br> <br> <br> <br>38000<br>Numbers	1	Amoxycillin Trihydrate	99.75 kg.
		2	Clavulanate Potassium +<br>Silicon Dioxide (1:1)	<br>58.92 kg.
Amoxycillin Trihydrate and Clavulanate<br>Potassium<br>+<br>Silicon<br>Dioxide<br>(1:1)<br>Suspension 228.50mg/5ml (70ml Bottle,<br>Each 5 ml contains Amoxycillin Trihydrate<br>equivalent<br>to<br>Amoxycillin<br>200mg<br>&Clavulanate Potassium + Silicon Dioxide<br>(1:1) equivalent to Clavulanic acid 28.5mg)<br>(Equivalent to 78.400Kg of Amoxycillin<br>Trihydrate &11.172Kg of Clavulanate	<br> <br> <br> <br> <br> <br> <br> <br>28000<br>Numbers	3	Amoxycillin Trihydrate	82.32 kg.
		4	Clavulanate Potassium +<br>Silicon Dioxide (1:1)	<br>27.72 kg.

r>Trihydrate &11.172Kg of Clavulanate| 28000 Numbers|3|Amoxycillin Trihydrate|82.32 kg.| ||||4|Clavulanate Potassium + Silicon Dioxide (1:1)| 27.72 kg.| ||Amoxycillin Trihydrate and Clavulanate Potassium + Silicon Dioxide (1:1) Suspension 312.5mg/5ml 60ml Bottle, Each 5 ml contains Amoxycillin Trihydrate equivalent to Amoxycillin 250mg &Clavulanate Potassium + Silicon Dioxide (1:1) equivalent to Clavulanic acid 62.5mg) (Equivalent to 84.000Kg of Amoxycillin Trihydrate &21.000Kg of Clavulanat| 28000 Numbers|5|Amoxycillin Trihydrate|88.2 kg.| ||||6|Clavulanate Potassium + Silicon Dioxide (1:1)| 52.1 kg.| ||Amoxycillin Trihydrate and Clavulanate Potassium + Silicon Dioxide (1:1) Suspension 457.00mg/5ml (70ml Bottle, Each 5 ml contains Amoxycillin Trihydrate equivalent to Amoxycillin 400mg &Clavulanate Potassium + Silicon Dioxide (1:1) equivalent to Clavulanic acid 57mg) (Equivalent to 156.800Kg of Amoxycillin Trihydrate & 22.344Kg of Clavulanate| 28000 Numbers|7|Amoxycillin Trihydrate|164.64 kg.| ||||8|Clavulanate Potassium + Silicon Dioxide (1:1)| 55.44 kg.|

UDIN00584001AM25

ulanate| 28000 Numbers|7|Amoxycillin Trihydrate|164.64 kg.| ||||8|Clavulanate Potassium + Silicon Dioxide (1:1)| 55.44 kg.|

UDIN00584001AM25

Case No.	Case No.	22 / NC/3/MEET/Jan/202425/15	22 / NC/3/MEET/Jan/202425/15	22 / NC/3/MEET/Jan/202425/15	22 / NC/3/MEET/Jan/202425/15	22 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00006153AM23
RA File Number		34AX04001000 AM23
Licence No and<br>Date		3411003357/07/02/2023
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. Import Items<br>Qty. allowed.<br>Cream(Clobetasol Propionate Cream USP<br>0.05% 15 gm ( net content of active<br>ingredients 525.00 gm. ))<br>70000<br>Numbers<br>1<br>Clobetasol Propionate<br>USP (Micronized)<br>535.5 gm.<br>Cream(Clobetasol Propionate Cream USP<br>0.05% 30 gm ( net content of active<br>ingredients 600.00 gm. ))<br>40000 Numbers<br>2<br>Clobetasol Propionate<br>USP (Micronized)<br>612.0 gm.<br>Cream(Clobetasol Propionate Cream USP<br>0.05% 45 gm ( net content of active<br>ingredients 1012.50 gm.

00.00 gm. )) 40000 Numbers 2 Clobetasol Propionate USP (Micronized) 612.0 gm. Cream(Clobetasol Propionate Cream USP 0.05% 45 gm ( net content of active ingredients 1012.50 gm. )) 45000 Numbers 3 Clobetasol Propionate USP (Micronized) 1032.75 gm. Cream(Clobetasol Propionate Cream USP 0.05% 60 gm ( net content of active ingredients 1800.00 gm. )) 60000 Numbers 4 Clobetasol Propionate USP (Micronized) 1836.0 gm. Solution(Clobetasol Propionate Topical Solution USP 0.05% 25ml ( net content of active ingredients 625.00 gm. ) 50000 Numbers 5 Clobetasol Propionate USP (Micronized) 637.5 gm. Solution(Clobetasol Propionate Topical Solution USP 0.05% 50 ml ( net content of active ingredients 500.00 gm. )) 20000 Numbers 6 Clobetasol Propionate USP (Micronized) 510.0 gm.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Cream(Clobetasol Propionate Cream USP 0.05% 15 gm ( net content of active ingredients 525.00 gm. ))|| 70000 Numbers|1|Clobetasol Propionate USP (Micronized)|535.5 gm.| ||Cream(Clobetasol Propionate Cream USP 0.05% 30 gm ( net content of active ingredients 600.00 gm. ))|| 40000 Numbers|2|Clobetasol Propionate USP (Micronized)|612.0 gm.| ||Cream(Clobetasol Propionate Cream USP 0.05% 45 gm ( net content of active ingredients 1012.50 gm.

600.00 gm. ))|| 40000 Numbers|2|Clobetasol Propionate USP (Micronized)|612.0 gm.| ||Cream(Clobetasol Propionate Cream USP 0.05% 45 gm ( net content of active ingredients 1012.50 gm. ))|| 45000 Numbers|3|Clobetasol Propionate USP (Micronized)|1032.75 gm.| ||Cream(Clobetasol Propionate Cream USP 0.05% 60 gm ( net content of active ingredients 1800.00 gm. ))|| 60000 Numbers|4|Clobetasol Propionate USP (Micronized)|1836.0 gm.| ||Solution(Clobetasol Propionate Topical Solution USP 0.05% 25ml ( net content of active ingredients 625.00 gm. )|| 50000 Numbers|5|Clobetasol Propionate USP (Micronized)|637.5 gm.| ||Solution(Clobetasol Propionate Topical Solution USP 0.05% 50 ml ( net content of active ingredients 500.00 gm. ))|| 20000 Numbers|6|Clobetasol Propionate USP (Micronized)|510.0 gm.|

UDIN00584001AM25

		Shampoo(Clob	etasol Propionate Shampoo,	etasol Propionate Shampoo,	<br>50000 Numbers	<br>50000 Numbers	7	7	Clobetasol Propionate	Clobetasol Propionate	3009.0 gm.
		0.05% 118 ml ( net content of active<br>ingredients 2950.00 gm.))							USP (Micronized)
		Spray(Clobetasol Propionate Spray, 0.05% -<br>59 ml ( net content of active ingredients<br>442.50 gm.))			<br> <br>15000 Numbers		8		Clobetasol Propionate<br>USP (Micronized)		451.35 gm.

ized)||| |||Spray(Clobetasol Propionate Spray, 0.05% - 59 ml ( net content of active ingredients 442.50 gm.))||| 15000 Numbers||8||Clobetasol Propionate USP (Micronized)||451.35 gm.| |||Spray(Clobetasol Propionate Spray, 0.05% - 125 ml ( net content of active ingredients 625.00 gm.))||| 10000 Numbers||9||Clobetasol Propionate USP (Micronized)||637.50 gm.| ||||||||||||| |||Ointment(Clobetasol Propionate Ointment USP 0.05% 15 gm ( net content of active ingredients 450.00 gm. ))||| 60000 Numbers||10||Clobetasol Propionate USP (Micronized)||459.0 gm.| ||||||||||||| ||||||||||||| |||Ointment(Clob|etasol Propionate Ointment|| 45000 Numbers||11||Clobetasol Propionate||688.50 gm.| |||USP 0.05% 3 |0 gm ( net content of active ||||||USP (Micronized)||| |||ingredients 67|5.00 gm. ))||||||||| ||||||||||||| |||Ointment(Clob|etasol Propionate Ointment|| 30000 Numbers||12||Clobetasol Propionate||688.50 gm.| ||| USP 0.05% 4| 5 gm ( net content of active|| |||| USP (Micronized)||| |||ingredients 67|5.00 gm. ))||||||||| |Ointment(Clobetasol Propionate Ointment USP 0.05% 60 gm ( net content of active ingredients 1800.00 gm. )) 60000 Numbers 13 Clobetasol Propionate USP (Micronized) 1836.0 gm. Foam(Clobetasol Propionate Foam USP 0.05% 50gm. ( net content of active ingredients 1000.00 gm. )) 40000 Numbers 14 Clobetasol Propionate USP (Micronized) 1020.0 gm. Foam(Clobetasol Propionate Foam USP 0.05% 100 gm.

net content of active ingredients 1000.00 gm. )) 40000 Numbers 14 Clobetasol Propionate USP (Micronized) 1020.0 gm. Foam(Clobetasol Propionate Foam USP 0.05% 100 gm. ( net content of active ingredients 1500.00 gm. )) 30000 Numbers 15 Clobetasol Propionate USP (Micronized) 1530.0 gm. RA concerned may take further necessary action as per above decision of NC.||Ointment(Clobetasol Propionate Ointment USP 0.05% 60 gm ( net content of active ingredients 1800.00 gm. ))||| 60000 Numbers||13||Clobetasol Propionate USP (Micronized)||1836.0 gm.| |||Foam(Clobetasol Propionate Foam USP ||| 40000|Numbers|14||Clobetasol Propionate ||1020.0 gm.| |||0.05% 50gm. ( net content of a ingredients 1000.00 gm. ))||ctive|||||USP (Micronized)||| ||Foam(Clobetasol Propionate Foam 0.05% 100 gm. ( net content of a ingredients 1500.00 gm. )) A concerned may take further necessary act|Foam(Clobetasol Propionate Foam 0.05% 100 gm. ( net content of a ingredients 1500.00 gm. ))||USP ctive| 30000|Numbers||15|Clobetasol Propiona USP (Micronized)|te|1530.0 gm.| ||||||||||||| |||||ion as per a|||||||| |||||||bove decisio||n of NC.|||| ||||||||||||| ||||||||||||| ||||||||||||| ||N||23 / NC/3/MEET/J/202|25/15|||||||| |ase o.|||an|||||||||

Case No. 23 / NC/3/MEET/Jan/202425/15

UDIN00584001AM25

bove decisio||n of NC.|||| ||||||||||||| ||||||||||||| ||||||||||||| ||N||23 / NC/3/MEET/J/202|25/15|||||||| |ase o.|||an|||||||||

Case No. 23 / NC/3/MEET/Jan/202425/15

UDIN00584001AM25

Case Status<br>Case Approved
Party Name<br>ALTA LABORATORIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number<br>HQRNORM APPLY 00006165AM23
RA File Number<br>03AX04005445 AM23
Licence No and<br>Date<br>0311021243/08/02/2023
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 meetingNo.NC/3/MEET/Mar/202324/25 dated 11/03/2024		against advance
authorizationNo.0311029142 dated 06/12/2023, it was decided to fix ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
1<br>PROPYL PARABEN<br>1 kg.	PARAHYDROXY BENZOIC ACID	0.80 kg.
2	N PROPANOL	0.347 kg.
RA concerned may take further necessary action as per above decision of NC.

s**|Qty. allowed.|| |1 PROPYL PARABEN 1 kg.|PARAHYDROXY BENZOIC ACID|0.80 kg.|| |2|N PROPANOL|0.347 kg.|| |RA concerned may take further necessary action as per above decision of NC.||||

Case No.	24 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	DEEPAK NITRITE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00006212AM23
RA File Number	34AX04001024 AM23
Licence No and<br>Date	3411003367/09/02/2023
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:-

UDIN00584001AM25


	Export Prod	uct	Qty.	Sl. No.	Import Items	Qty. allowed.


	ORTHO NIT	RO TOLUENE	1 kg.	1	NITRIC ACID 68%	0.675 kg.

				2	TOLUENE	0.661 kg.

				3	SULPHURIC ACID 98%	Deleted rocured from
RA						p<br>Indigenous source
				4	SODA ASH	Deleted procured from<br>Indigenous source
	concerned may take further necessary action as per above decision of NC.

ocured from| |RA||||||p Indigenous source| |||||4|SODA ASH|Deleted procured from Indigenous source| ||concerned may take further necessary action as per above decision of NC.|||||| ||||||||

Case No.	Case No.	Case No.	25 / NC/3/MEET/Jan/202425/15	25 / NC/3/MEET/Jan/202425/15	25 / NC/3/MEET/Jan/202425/15	25 / NC/3/MEET/Jan/202425/15	25 / NC/3/MEET/Jan/202425/15
Case Status			Case Approved
Party Name			GLENMARK PHARMACEUTICALS LIMITED
Meeting Number
and Date			NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number			HQRNORM APPLY 00006186AM23
RA File Number			03AX04005398 AM23
Licence No and
Date			0311021275/09/02/2023
Norms Committee<br>			Decision:<br>
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Clindamycin Phosphate<br>USP<br>262.50 mg/pack<br>Clindamycin & Benzoyl Peroxide<br>Gel 1%/5% ( Pack Size 25gm )<br>((Net Wt. of Import Item Sr. No. 1<br>is 8.75 Kgs. &Sr.<br>1 Number Pack<br><br> <br>
	Export Product			Qty.	Sl. No.	Import Items	Qty. allowed.

	Clindam<br>Gel 1%<br>((Net W<br>is 8.75	ycin & Benzoyl Peroxide<br>/5% ( Pack Size 25gm )<br>t. of Import Item Sr. No. 1<br>Kgs.

ty.**|**Sl. No. **|Import Items|Qty. allowed.|| ||||||||||| |||Clindam Gel 1% ((Net W is 8.75|ycin & Benzoyl Peroxide /5% ( Pack Size 25gm ) t. of Import Item Sr. No. 1 Kgs. &Sr.||1 Number Pack|1|Clindamycin Phosphate USP|262.5|0 mg/pack| ||||||||||| |||No. 2 is 43.75 Kgs.))||||2|HYDROUS BENZOYL PEROXIDE USP|1312.50 mg/pack||

UDIN00584001AM25

Clinda<br>Peroxi<br>Size 3	mycin & Benzoyl<br>de Gel 1%/5% ( Pack<br>5gm ) ((Net Wt of	1 Number Pack	3<br>	HYDROUS BENZOYL<br>PEROXIDE USP	367.5	0 mg/pack
<br>Import<br>Kgs. &<br>Kgs.))	.<br>Item Sr. No. 1 is 17.50<br>Sr. No. 2 is 87.50		4	Clindamycin Phosphate<br>USP	1837.	50 mg/pack

Clinda<br>Peroxi	mycin & Benzoyl<br>de Gel 1%/5% ( Pack	1 Number Pack	5<br>	Clindamycin Phosphate<br>USP	525.0	0 mg/pack
<br>Size 5<br>Import<br>Kgs. &	<br>0gm )((Net Wt. of<br>Item Sr. No. 1 is 17.50<br>Sr. No. 2 is 87.50
			6	HYDROUS BENZOYL<br>PEROXIDE USP	2625.	00 mg/pack
Kgs.))
CLIND	AMYCIN	1 Number Pack	<br>7	Clindamycin Phosphate	306.0	0 mg/pack
PHOS<br>Size<br>Import<br>	PHATE GEL 1% (Pack<br>30gm ) (Net Wt. of<br>Item Sr. No. 2 is 10.50	<br> <br>		USP
Kgs.)
CLIND	AMYCIN	1 Number Pack	<br>8	Clindamycin Phosphate	612.0	0 mg/pack
PHOS<br>Size<br>Import<br>	PHATE GEL 1% (Pack<br>60gm ) (Net Wt. of<br>Item Sr. No.

|| ||USP||| |||Kgs.)|||||||| |||CLIND|AMYCIN||1 Number Pack| 8|Clindamycin Phosphate|612.0|0 mg/pack| |||PHOS Size Import |PHATE GEL 1% (Pack 60gm ) (Net Wt. of Item Sr. No. 2 is || ||USP||| |||210.00|Kgs.)||||||| |||Adapa |lene & Benzoyl || 1 Number Pack| 9|HYDROUS BENZOYL |1181.|25 mg/pack| |||Peroxi Pack S Import 112.50|de Gel 0.1%/2.5% ( ize 45gm ) (Net Wt. of Item Sr. No. 2 is Kgs.)|| ||PEROXIDE USP||| ||A concer||||||||| ||||ned may take further necessary action as per above decision of NC.||||||| ||||||||||| |Case No.||||26 / NC/3/MEET/Jan/202425/15|||||| |Case Status||||Case Approved|||||| ||||||||||| |Party Name||||AURORE LIFE SCIENCES PRIVATE LIMITED|||||| |Meeting Number||||NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025||||||

Case No.	26 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025

UDIN00584001AM25

/3/MEET/Jan/202425/15| |---|---| |Case Status|Case Approved| |Party Name|AURORE LIFE SCIENCES PRIVATE LIMITED| |Meeting Number|NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025|

UDIN00584001AM25

and Date
HQ File Number	HQRNORM APPLY 00006267AM23
RA File Number	09AX04000893 AM23
Licence No and<br>Date	0911004453/13/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.NC/3/MEET/Dec/202424/25 dated 07/01/2025against advance<br>authorizationNo.0911003340 dated 13/07/2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Guanine<br>0.80 kg.<br>2<br>Dioxolane Diacetate<br>1.30 kg.<br>3<br>Acetone<br>0.69 kg.<br>4<br>Aqueous Dimethyl Amine<br>1.64 kg.<br>5<br>Acetic Acid<br>0.47 kg.<br>6<br>CBZ - L - Valine<br>1.112 kg.<br>7<br>N,N-Dicyclohexyl carbodimide<br>1.14 kg.<br>8<br>Dimethylaminopyridine<br>0.028 kg.<br>9<br>Dimethyl formamide<br>1.92 kg.<br>10<br>methanol<br>4.82 kg.<br>Valaciclovir HCl<br>1 kg.<br>11<br>Isopropanol<br>2.55 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00584001AM25

r>10 methanol 4.82 kg. Valaciclovir HCl 1 kg. 11 Isopropanol 2.55 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00584001AM25

Case No.	27 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	ARCH PROTECTION CHEMICALS PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00007396AM24
RA File Number	NA
Licence No and Date	0311021465/15/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Jan/202324/21 dated 24/01/2024<br>against advance authorizationNo.0311021465 dated 15/02/2023, it was decided to fix ad-hoc<br>norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>1<br>2- CHLOROBENZ<br>ONITRILE<br>0.968 kg.<br>BIT 84 PERCENTAGE 400KG<br>BB IN 1-2 Benzisothiazoline-3-<br>One and Various Pack sizes (25<br>Kg, 250 Kg and 400Kg etc.)<br>import (Net Content in export<br>product as follows Sr No 1 and 2<br>with qty 0.98 Kg, & Mtr 2.525 Kg<br>per Kg.)<br>1 kg.<br>2<br>SODIUM METHYL<br>MERCAPTIDE 20%<br>2.418 kg.<br>RA concerned may take further necessary action as per above decision of NC.

and 2 with qty 0.98 Kg, & Mtr 2.525 Kg per Kg.) 1 kg. 2 SODIUM METHYL MERCAPTIDE 20% 2.418 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	28 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025

UDIN00584001AM25

and Date
HQ File Number	HQRNORM APPLY 00006441AM23
RA File Number	03AX04005543 AM23
Licence No and<br>Date	0311021564/20/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.NC/3/MEET/Dec/202424/25 dated 07/01/2025against advance<br>authorizationNo.0311035363 dated 10/07/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Fenofibrate Micronized IH/Ph Eur<br>48.96 mg.<br>Fenofibrate 48mg tablets<br>1 Number<br>2<br>Sucrose PH.Eur (exepient)<br>145.57 mg.<br>RA concerned may take further necessary action as per above decision of NC.

ized IH/Ph Eur 48.96 mg. Fenofibrate 48mg tablets 1 Number 2 Sucrose PH.Eur (exepient) 145.57 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	29 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	SAURAV CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00006594AM23
RA File Number	30AX04000547 AM23
Licence No and<br>Date	3011003202/24/02/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Advance Authorisation shows 4 inputs whereas in Annexure to Appendix-4E, only 3 inputs are<br>shown. Please give justification and whether 4th item (Ethyl Acetate) is to be deleted from<br>import.<br>1.<br>In case Ethyl Acetate is required, furnish complete chemistry, molecular weight and percentage<br>2.

In case Ethyl Acetate is required, furnish complete chemistry, molecular weight and percentage

UDIN00584001AM25

yield on molar basis.

Requirement and recov ery of solvent at each step.
Material balance for each step.
Production/Conduction data for the last three years duly certified by Chartered Accountant.

Requirement and recov ery of solvent at each step.

Material balance for each step.
Production/Conduction data for the last three years duly certified by Chartered Accountant.

Case No.	30 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	MAHARASHTRA ALDEHYDES AND CHEMICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00006735AM23
RA File Number	03AX04004601 AM23
Licence No and<br>Date	0311021876/03/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it has been observed the<br>firm has not furnished the complete reply of DL as sought by the Committee during the meeting held on<br>08.06.2023. Hence it was decided to call for following information/documents from the firm:-<br>Step wise manufacturing process.<br>1.<br>Complete chemical reactions with molecular and structural formula and molecular weights<br>along with stage wise percentage yields on molar basis.<br>2.<br>Complete technical details as per Annexture to Appendix-4E for chemical products.<br>3.<br>Stoichiometric balance between import and export on molar basis.<br>4.<br>Details of indigenous input with quantity.<br>5.

per Annexture to Appendix-4E for chemical products.** 3. Stoichiometric balance between import and export on molar basis. 4. Details of indigenous input with quantity. 5.||

Case No.	31 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	AARTI PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00006751AM23
RA File Number	03AX04005685 AM23
Licence No and<br>Date	0311021895/04/03/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07

29 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-02-2025 11:52:09.

UDIN00584001AM25

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
DI ETHYL SULPHATE	1 kg.	1	ETHANOL	0.746 kg.
		2	SO3	1.29 kg.
		3	SODIUM SULPHATE	0.114 kg.
		4	UREA	0.19 kg.

Qty.|Sl. No.|Import Items|Qty. allowed.| |---|---|---|---|---| |DI ETHYL SULPHATE|1 kg.|1|ETHANOL|0.746 kg.| |||2|SO3|1.29 kg.| |||3|SODIUM SULPHATE|0.114 kg.| |||4|UREA|0.19 kg.|

Case No.	32 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	MEDREICH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00006767AM23
RA File Number	07AX04001781 AM23
Licence No and<br>Date	0711006639/06/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Copy of Master Batch Formula showing net content of import item no.2.<br>1.<br>Justification for quantity of packing material with samples.<br>2.

Case No.	33 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved

UDIN00584001AM25

no.2.** 1. Justification for quantity of packing material with samples. 2.||

Case No.	33 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved

UDIN00584001AM25

Party Name	Party Name	ZYDUS LIFESCIENCES LIMITED	ZYDUS LIFESCIENCES LIMITED	ZYDUS LIFESCIENCES LIMITED	ZYDUS LIFESCIENCES LIMITED	ZYDUS LIFESCIENCES LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00006898AM23
RA File Number		08AX04002105 AM23
Licence No and Date		0811007519/10/03/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>CHLORPROMAZINE<br>HYDROCHLORIDE USP<br>10.2 mg<br>2<br>LACTOSE MONOHYDRATE<br>NF/PH.E<br>5.57 mg.<br>3<br>MICROCRYSTALLINE<br>CELLULOSE NF/IP/PH.E/BP<br>(AVICEL PH102)<br>36.0 mg.<br>4<br>CALCIUM SULPHATE<br>DIHYDRATE NF<br>3.60 mg.<br>5<br>SODIUM STARCH<br>GLYCOLATE NF/JP<br>2.43 mg.<br>6<br>CROSCARMELLOSE<br>SODIUM NF<br>2.71 mg.<br>7<br>MAGNESIUM STEARATE<br>PH.E/NF/JP<br>1.00 mg.<br>CHLORPROMAZINE HYDROCHLORIDE<br>TABLETS USP 10 MG((ACTIVE<br>INGREDIENT: CHLORPROMAZINE<br>HYDROCHLORIDE USP - 37.482 KGS))<br>1 Number<br>8<br>METHYL ALCOHOL NF<br>24.49 mg.<br>9<br>CHLORPROMAZINE<br>HYDROCHLORIDE USP<br>25.50 mg.<br>LACTOSE MONOHYDRATE<br>CHLORPROMAZINE HYDROCHLORIDE<br>

HYDROCHLORIDE USP - 37.482 KGS)) 1 Number 8 METHYL ALCOHOL NF 24.49 mg. 9 CHLORPROMAZINE HYDROCHLORIDE USP 25.50 mg. LACTOSE MONOHYDRATE CHLORPROMAZINE HYDROCHLORIDE TABLETS USP 25 MG((ACTIVE INGREDIENT: CHLORPROMAZINE HYDROCHLORIDE USP - 104.965 KGS)) 1 Number 10 13.925 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||CHLORPROMAZINE HYDROCHLORIDE TABLETS USP 10 MG((ACTIVE INGREDIENT: CHLORPROMAZINE HYDROCHLORIDE USP - 37.482 KGS))||1 Number|1|CHLORPROMAZINE HYDROCHLORIDE USP|10.2 mg| |||||2|LACTOSE MONOHYDRATE NF/PH.E| 5.57 mg.| |||||3|MICROCRYSTALLINE CELLULOSE NF/IP/PH.E/BP (AVICEL PH102)|36.0 mg.| |||||4|CALCIUM SULPHATE DIHYDRATE NF|3.60 mg.| |||||5|SODIUM STARCH GLYCOLATE NF/JP|2.43 mg.| |||||6|CROSCARMELLOSE SODIUM NF|2.71 mg.| |||||7|MAGNESIUM STEARATE PH.E/NF/JP|1.00 mg.| |||||8|METHYL ALCOHOL NF|24.49 mg.| ||CHLORPROMAZINE HYDROCHLORIDE TABLETS USP 25 MG((ACTIVE INGREDIENT: CHLORPROMAZINE HYDROCHLORIDE USP - 104.965 KGS))||1 Number|9|CHLORPROMAZINE HYDROCHLORIDE USP|25.50 mg.| |||||10|LACTOSE MONOHYDRATE| 13.925 mg.|

UDIN00584001AM25

E INGREDIENT: CHLORPROMAZINE HYDROCHLORIDE USP - 104.965 KGS))||1 Number|9|CHLORPROMAZINE HYDROCHLORIDE USP|25.50 mg.| |||||10|LACTOSE MONOHYDRATE| 13.925 mg.|

UDIN00584001AM25

			NF/PH.E
		11	MICROCRYSTALLINE<br>CELLULOSE NF/IP/PH.E/BP<br>(AVICEL PH102)	29.67 mg.
		12	CALCIUM SULPHATE<br>DIHYDRATE NF	11.175 mg.
		13	SODIUM STARCH<br>GLYCOLATE NF/JP	6.075 mg.
		14	CROSCARMELLOSE<br>SODIUM NF	6.775 mg.
		15	MAGNESIUM STEARATE<br>PH.E/NF/JP	1.40 mg.
		16	METHYL ALCOHOL NF	61.22 mg.
CHLORPROMAZINE HYDROCHLORIDE<br>TABLETS USP 50 MG((ACTIVE<br>INGREDIENT: CHLORPROMAZINE<br>HYDROCHLORIDE USP - 479.890 KGS))	1 Number	17	CHLORPROMAZINE<br>HYDROCHLORIDE USP	51.00 mg.
		18	LACTOSE MONOHYDRATE<br>NF/PH.E	<br>18.30 mg.
		19	MICROCRYSTALLINE<br>CELLULOSE NF/IP/PH.E/BP<br>(AVICEL PH102)	38.95 mg.
		20	CALCIUM SULPHATE<br>DIHYDRATE NF	18.75 mg.
		21	SODIUM STARCH<br>GLYCOLATE NF/JP	10.50 mg.
		22	CROSCARMELLOSE<br>SODIUM NF	10.50 mg.
		23	MAGNESIUM STEARATE<br>PH.E/NF/JP	2.25 mg.

UDIN00584001AM25

DIHYDRATE NF|18.75 mg.| ||||21|SODIUM STARCH GLYCOLATE NF/JP|10.50 mg.| ||||22|CROSCARMELLOSE SODIUM NF|10.50 mg.| ||||23|MAGNESIUM STEARATE PH.E/NF/JP|2.25 mg.|

UDIN00584001AM25

		24	METHYL ALCOHOL NF	122.45 mg.
CHLORPROMAZINE HYDROCHLORIDE<br>TABLETS USP 100 MG((ACTIVE<br>INGREDIENT: CHLORPROMAZINE<br>HYDROCHLORIDE USP - 519.880 KGS))	1 Number	25	CHLORPROMAZINE<br>HYDROCHLORIDE USP	102.00 mg.
		26	LACTOSE MONOHYDRATE<br>NF/PH.E	<br>36.60 mg.
		27	MICROCRYSTALLINE<br>CELLULOSE NF/IP/PH.E/BP<br>(AVICEL PH102)	77.90 mg.
		28	CALCIUM SULPHATE<br>DIHYDRATE NF	37.50 mg.
		29	SODIUM STARCH<br>GLYCOLATE NF/JP	21.00 mg.
		30	CROSCARMELLOSE<br>SODIUM NF	21.00 mg.
		31	MAGNESIUM STEARATE<br>PH.E/NF/JP	4.50 mg.
		32	METHYL ALCOHOL NF	244.90 mg.
CHLORPROMAZINE HYDROCHLORIDE<br>TABLETS USP 200 MG((ACTIVE<br>INGREDIENT: CHLORPROMAZINE<br>HYDROCHLORIDE USP - 799.600 KGS))	1 Number	33	CHLORPROMAZINE<br>HYDROCHLORIDE USP	204.00 mg.
		34	LACTOSE MONOHYDRATE<br>NF/PH.E	<br>73.20 mg.
		35	MICROCRYSTALLINE<br>CELLULOSE NF/IP/PH.E/BP<br>(AVICEL PH102)	155.80 mg.
		36	CALCIUM SULPHATE<br>DIHYDRATE NF	75.00 mg.
		37	SODIUM STARCH<br>GLYCOLATE NF/JP	42.00 mg.

UDIN00584001AM25

OCRYSTALLINE CELLULOSE NF/IP/PH.E/BP (AVICEL PH102)|155.80 mg.| ||||36|CALCIUM SULPHATE DIHYDRATE NF|75.00 mg.| ||||37|SODIUM STARCH GLYCOLATE NF/JP|42.00 mg.|

UDIN00584001AM25

38<br>CROSCARMELLOSE<br>SODIUM NF<br>42.00 mg.<br>39<br>MAGNESIUM STEARATE<br>PH.E/NF/JP<br>9.00 mg.<br>40<br>METHYL ALCOHOL NF<br>489.8 mg.<br>RA concerned may take further necessary action as per above decision of NC.			38	CROSCARMELLOSE<br>SODIUM NF	42.00 mg.
			39	MAGNESIUM STEARATE<br>PH.E/NF/JP	9.00 mg.
			40	METHYL ALCOHOL NF	489.8 mg.

Case No.	34 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM REVIW00006563AM24
RA File Number	08AX04001977 AM23
Licence No and<br>Date	0811007532/10/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Balance Chemical reaction between Aniline and formaldehyde and accordingly calculations of<br>the requirement of Aniline based on 100% yield, as mentioned.<br>1.<br>Composition of Formulated Aromatic Amine, indicating three components of Basic Amine.<br>2.<br>The commercial value of By-product/s during reaction and indigenous item/s used in the<br>process<br>3.

Formulated Aromatic Amine, indicating three components of Basic Amine.** 2. The commercial value of By-product/s during reaction and indigenous item/s used in the process 3.||

Balance Chemical reaction between Aniline and formaldehyde and accordingly calculations of the requirement of Aniline based on 100% yield, as mentioned.
The commercial value of By-product/s during reaction and indigenous item/s used in the process

Case No.	35 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	MAHIMA LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00006908AM23

UDIN00584001AM25

RA File Number	RA File Number	05AX04003427 AM23	05AX04003427 AM23	05AX04003427 AM23	05AX04003427 AM23	05AX04003427 AM23
Licence No and<br>Date		0511017696/10/03/2023

Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.NC/3/MEET/Apr/202424/2 dated 30/04/2024against advance
authorizationN		o.0311021914 dated 06/03/2023, it was decided to fix ad-hoc norms under Para 4.07 of
HBP Vol. I as p		er details given below or as applied by the firm, whichever is less:-



	Export Prod	uct	Qty.	Sl. No.	Import Items	**Qty.

of||||| |HBP Vol. I as p||er details given below or as applied by the firm, whichever is less:-||||| |||||||| |||||||| |||||||| ||Export Prod|uct|Qty.|**Sl. No. **|Import Items|Qty. allowed.| |||||||| |||||||| ||DEFLAZAC|ORT|1 kg.|1|11B, 16 B) 11-HYDROXY - 2 - METHYL - 5 H- PREGNA- 14-|1.00 kg.| |, DIENO (17, 16-D) OXAZOLE - 3, 20- DIONE (D5) RA concerned may take further necessary action as per above decision of NC.|||||, DIENO (17, 16-D) OXAZOLE - 3, 20- DIONE (D5)|| ||||||||

Case No.	Case No.	36 / NC/3/MEET/Jan/202425/15

Case Status		Case Approved

Party Name		J B CHEMICALS AND PHARMACEUTICALS LIMITED

Meeting Number an	d Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025

HQ File Number		HQRNORM APPLY 00006981AM23
RA File Number		03AX04006011 AM23
Licence No and Da	te	0311022155/15/03/2023
Norms Committee	Decision:
The Committee<br>product/import ite	considered the case as per agenda and taking cue from the earlier decision for same export<br>m in meetingNo.NC/3/MEET/Apr/202424/2dated 30/04/2024against advance authorization
<br>No.0311024276 dated 06/06/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

in meetingNo.NC/3/MEET/Apr/202424/2dated 30/04/2024against advance authorization||||||| | No.0311024276 dated 06/06/2023, 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.| ||||||||||||

UDIN00584001AM25

|||Carbam mg.(Ea Cellulo Eastma 10 NF (iii) 39.|azepine Extended-Release Tablets USP 100 ch tablet contains (i) Carbamazepine 100 mg. (ii) seAcetate(CA-320S)- n35.04mg.(iii)Eastman(TMCelluloseAcetate(CA398- / EP)- 5.28 mg Net content (i) 750 Kg (ii)262.80 Kg 60 Kg.)|azepine Extended-Release Tablets USP 100 ch tablet contains (i) Carbamazepine 100 mg. (ii) seAcetate(CA-320S)- n35.04mg.(iii)Eastman(TMCelluloseAcetate(CA398- / EP)- 5.28 mg Net content (i) 750 Kg (ii)262.80 Kg 60 Kg.)|azepine Extended-Release Tablets USP 100 ch tablet contains (i) Carbamazepine 100 mg. (ii) seAcetate(CA-320S)- n35.04mg.(iii)Eastman(TMCelluloseAcetate(CA398- / EP)- 5.28 mg Net content (i) 750 Kg (ii)262.80 Kg 60 Kg.)|azepine Extended-Release Tablets USP 100 ch tablet contains (i) Carbamazepine 100 mg.

.04mg.(iii)Eastman(TMCelluloseAcetate(CA398- / EP)- 5.28 mg Net content (i) 750 Kg (ii)262.80 Kg 60 Kg.)|azepine Extended-Release Tablets USP 100 ch tablet contains (i) Carbamazepine 100 mg. (ii) seAcetate(CA-320S)- n35.04mg.(iii)Eastman(TMCelluloseAcetate(CA398- / EP)- 5.28 mg Net content (i) 750 Kg (ii)262.80 Kg 60 Kg.)|azepine Extended-Release Tablets USP 100 ch tablet contains (i) Carbamazepine 100 mg. (ii) seAcetate(CA-320S)- n35.04mg.(iii)Eastman(TMCelluloseAcetate(CA398- / EP)- 5.28 mg Net content (i) 750 Kg (ii)262.80 Kg 60 Kg.)|azepine Extended-Release Tablets USP 100 ch tablet contains (i) Carbamazepine 100 mg. (ii) seAcetate(CA-320S)- n35.04mg.(iii)Eastman(TMCelluloseAcetate(CA398- / EP)- 5.28 mg Net content (i) 750 Kg (ii)262.80 Kg 60 Kg.)|azepine Extended-Release Tablets USP 100 ch tablet contains (i) Carbamazepine 100 mg. (ii) seAcetate(CA-320S)- n35.04mg.(iii)Eastman(TMCelluloseAcetate(CA398- / EP)- 5.28 mg Net content (i) 750 Kg (ii)262.80 Kg 60 Kg.)|1 Number|1|Carbamazepine|Carbamazepine||102.00 mg.| |---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---| ||||||||||||2|Cellulose Acetate (CA-320S) Eastma||n|29.20 mg.| ||||||||||||||||| ||||||||||||3|EASTMAN (TM) CELLULOSE ACETATE (CA 398-|||4.40 mg.| |||||||||||||10NF/EP)|||| ||||||||||||||||| |||Carbamazep mg.(Each ta Cellulose Ac||ine Extended-Release Tablets USP 200 blet contains (i) Carbamazepine 200 mg. ( etate (CA-320S) -Eastman 35.04 mg.

|||10NF/EP)|||| ||||||||||||||||| |||Carbamazep mg.(Each ta Cellulose Ac||ine Extended-Release Tablets USP 200 blet contains (i) Carbamazepine 200 mg. ( etate (CA-320S) -Eastman 35.04 mg. (iii)||||ii) ||1 Number|4|Carbamazepine|||204.00 mg.| ||||||||||||||||| ||| Eastman (T mg Net cont|| M Cellulose Acetate (CA 398-10NF/EP)- ent (i) 550 kg (ii) 96.36 Kg (iii) 14.52 Kg.|||| 5.28 )|||5|Cellulose Acetate (CA-320S) Eastman|||29.20 mg.| ||||||||||||6|EASTMAN (TM) CELLULOSE ACETATE (CA 398- 10NF/EP)|||4.40 mg.| |||Carbamazepine Extended-Release Tablets USP 400 mg.(Each tablet contains (i) Carbamazepine 400 mg. (ii) Cellulose Acetate (CA-320S) -Eastman 26.28 mg. (iii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 3.96||||||||1 Number|7|Carbamazepine|||4408.00 mg.| ||||||||||||||||| ||| mg Net conten||| t (i) 666 Kg. (ii) 43.76 Kg (ii) 6.59 Kg. )||||||8|Cellulose Acetate |||29.20 mg.| |||||||||||||(CA-320S) Eastman|||| ||||||||||||||||| ||||||||||||||||| ||||||||||||9|EASTMAN (TM) CELLULOSE|||4.40 mg.| |||||||||||||ACETATE (CA 398-|||| |||||||||||||10NF/EP)|||| ||||||||||||||||| ||||||||||||||||| |RA concerned may take further necessary action as per above decision of NC.|||||||||||||||| ||||||||||||||||| ||||||||||||||||| |C|ase No.||||37 / NC/3/MEET/Jan/|202425/15|||||||||| |C|ase Status||||Case Approved||||||||||| ||||||||||||||||| |P|arty Name||||VENUS REMEDIES|LIMITED|||||||||| |M |eeting Number ||||NC/ 3/ MEET/ Jan/ 20|2425/ 15 a|nd 28/01/2||025||||||| |a|nd Date|||||||||||||||

Approved||||||||||| ||||||||||||||||| |P|arty Name||||VENUS REMEDIES|LIMITED|||||||||| |M |eeting Number ||||NC/ 3/ MEET/ Jan/ 20|2425/ 15 a|nd 28/01/2||025||||||| |a|nd Date|||||||||||||||

Case No.	37 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	VENUS REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025

UDIN00584001AM25

H	Q File Number	Q File Number	HQRNORM APPLY	00007009A	M23
R	A File Number		30AX04000578 AM2	3
L<br>D	icence No and<br>ate		3011003279/16/03/20	23
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:-

		Export Product			Qty.	**Sl. No.

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.| ||||||||||||||||| ||||||||||||||||| |||VINORELB |NE SOLUTION FOR |||||||1 Number||1|VINORELBINE ||69.00 mg.| |||INJECTION SOLUTION |(50MG/5ML) (1 ML OF CONTAINS: VINORELBINE ||||||||||TARTRATE||| |||TARTRATE |, EQUIVALENT TO ||||||||||||| |||VINORELB TARTARIC|NE 10 MG EXCIPIENTS: ACID ATER FOR||||||||||||| ||| INJECTION|, W )||||||||||||| |VINORELBINE SOLUTION FOR INJECTION (10MG/ML) (1 ML OF SOLUTION CONTAINS: VINORELBINE TARTRATE , EQUIVALENT TO VINORELBINE 10 MG EXCIPIENTS: TARTARIC ACID, WATER FOR INJECTION) 1 Number 2 VINORELBINE TARTRATE 13.80 mg. RA concerned may take further necessary action as per above decision of NC.|||||||||||||||| |||VINORELBINE SOLUTION FOR INJECTION (10MG/ML) (1 ML OF SOLUTION CONTAINS: VINORELBINE TARTRATE , EQUIVALENT TO VINORELBINE 10 MG EXCIPIENTS:||||||||1 Number||2|VINORELBINE TARTRATE||13.80 mg.| |||TARTARIC ACID, WA INJECTION)|||TER FOR||||||||||| ||A concerned may take furt||||||||||||||| ||||||her necess||ary action||as per above decision of NC.||||||| ||||||||||||||||| ||||||||||||||||| ||||||||||||||||| |C|ase No.|||38 / N|C/3/MEE||T/Jan/20242||5/15||||||| |C|ase Status|||Case|Approved||||||||||| ||||||||||||||||| |P|arty Name|||GLO|BAL CAL||CIUM PRIV||ATE LIMITED|||||||

|||||||||| ||||||||||||||||| |C|ase No.|||38 / N|C/3/MEE||T/Jan/20242||5/15||||||| |C|ase Status|||Case|Approved||||||||||| ||||||||||||||||| |P|arty Name|||GLO|BAL CAL||CIUM PRIV||ATE LIMITED||||||| |M D|eeting Number and ate|||NC/ 3|/ MEET/ J||||||||||| ||||||||an/ 202425/||15 and 28/01/2025||||||| |H|Q File Number|||HQR|NORM AP||PLY 00007||011AM23||||||| |R|A File Number|||07AX|04001891||||||||||| ||||||||AM23||||||||| |L|icence No and Date|||07110|06773/16/||03/2023||||||||| |N|orms Committee Decision:|||||||||||||||

Case No.	38 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00007011AM23
RA File Number	07AX04001891 AM23
Licence No and Date	0711006773/16/03/2023
Norms Committee Decision:

UDIN00584001AM25

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.
Calcium Dobesilate Monohydrate BP/	1 kg.	1	HYDROQUINONE	0.631 kg.
Calcium Dobesilate Monohydrate Eur.Ph
/ Calcium Dobesilate(Calcium Dobesilate
Monohydrate BP/ Calcium Dobesilate
Monohydrate Eur.Ph / Calcium
Dobesilate)
Etamsylate / Etamsylate EP	1 kg.	2	HYDROQUINONE	0.527 kg.

alcium Dobesilate(Calcium Dobesilate||||| |Monohydrate BP/ Calcium Dobesilate||||| |Monohydrate Eur.Ph / Calcium||||| |Dobesilate)||||| |Etamsylate / Etamsylate EP|1 kg.|2|HYDROQUINONE|0.527 kg.|

Case No.	39 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM REVIW00006561AM24
RA File Number	04AX04001126 AM23
Licence No and<br>Date	0411005084/21/03/2023
Norms Committee Decision:
Decision:The Committee considered the request of firm for a review of ad-hoc norms and on the basis of
information provided by the firm, it was decided to check from RA about the change in the description of
items in the Authorisation. The case is deferred for the next meeting.

Case No.	40 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
PartyName	SOHAN HEALTHCARE PRIVATE LIMITED

UDIN00584001AM25

The case is deferred for the next meeting.||

Case No.	40 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
PartyName	SOHAN HEALTHCARE PRIVATE LIMITED

UDIN00584001AM25

Meeting Number and<br>Date	Meeting Number and<br>Date	Meeting Number and<br>Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number			HQRNORM APPLY 00007173AM23
RA File Number			31AX04000352 AM23
Licence No and Da		te	3111002109/24/03/2023
Norms Committee		Decision:
Th Cmmitt		nidrd th r nd nd tkin frm th rlir diin fr m rt
e oee<br>product/import<br>hiiN		osee e case as pe agea a ag cue o e eae ecso o sae expo<br>item in meetingNo.NC/3/MEET/Sep/202424/9 dated 10/10/2024against advance<br>3111001838dd 24/11/2022i didd fi dh d P 407 f
autorzaton<br>HBP Vl I		. ate, t was ece to x a-oc norms uner ara . o<br>dtil i bl lid b th fi hih i l
	o. as p	r eas gven eow or as appe y e rm, wcever s ess:-

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

til i bl lid b th fi hih i l|||||||| |||o. as p|||r eas gven eow or as appe y e rm, wcever s ess:-|||||||| |||||||||||||| |RA||Export Product|||||Qty.||**Sl. No. **|Import Items|Qty. allowed.|| |||METFORMIN HYDROCHLORIDE DIRECT COMPRESSIBLE |||||1 kg.||1|DICYANDIAMIDE ( DCDA) WHITE|0.484 kg.|| |||GRAN GRAN|ULES 86.66% W/W WHITE ULES POWDER||||||| POWDER||| ||||||||||2|SODIUM STARCH ||0.034 kg.| ||A|||||||||GLYCOLATE WHITE POWDER||| |||concer|ned may take further necessary action as per above decision of NC.|||||||||| |||||||||||||| |||||||||||||| |||||||||||||| |C|as|e No.|||41 / NC/3/MEET/Jan/202425/15|||||||| |C|as|e Status|||Case Deferred|||||||| |P|ar|||||||||||| |||y Name|||VINS BIOPRODUCTS LIMITED|||||||| |M a|e nd|eting Number Date|||NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/0|||1/2025||||| |H|Q|File Number|||HQRNORM APPLY 00000068AM24|||||||| |RA File Number|||||09AX04001155 AM23|||||||| |Licence No and Date|||||0911004801/10/04/2023|||||||| |Norms Committee Decision:||||||||||||| |The Committee considered the cases as per the agenda. The representatives of the firm attended the|||||||||||||

Date|||||0911004801/10/04/2023|||||||| |Norms Committee Decision:||||||||||||| |The Committee considered the cases as per the agenda. The representatives of the firm attended the|||||||||||||

Case No.	41 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	VINS BIOPRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000068AM24
RA File Number	09AX04001155 AM23
Licence No and<br>Date	0911004801/10/04/2023
Norms Committee Decision:
The Committee considered the cases as per the agenda. The representatives of the firm attended the

UDIN00584001AM25

Personal Hearing through Video Conference wherein Technical Expert of the Department of BioTechnology was also present through VC. The representative of the firm explained the reason for the enhancement of ad-hoc norms in respect of the above Advance Authorisations as well as other AA No. 0910066851 dated 14/11/2018, No. 0910068189 dated 15/11/2019 & No. 0911003795 dated 13/10/2022 for same export/import items.

The Committee heard the explanation of the firm and after due deliberation with the Technical Expert of Deptt. of Bio-Technology decided to enhance the wastage norms to 5%. Accordingly, DBT will send their comments on above said applications.

and after due deliberation with the Technical Expert of Deptt. of Bio-Technology decided to enhance the wastage norms to 5%. Accordingly, DBT will send their comments on above said applications.

Case No.	Case No.	Case No.	42 / NC/3/MEET/Jan/202425/15	42 / NC/3/MEET/Jan/202425/15	42 / NC/3/MEET/Jan/202425/15	42 / NC/3/MEET/Jan/202425/15	42 / NC/3/MEET/Jan/202425/15	42 / NC/3/MEET/Jan/202425/15	42 / NC/3/MEET/Jan/202425/15	42 / NC/3/MEET/Jan/202425/15
Case Status			Case Approved
Party Name			GLENMARK PHARMACEUTICALS LIMITED
Meeting Number			NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
and Date
HQ File Number			HQRNORM APPLY 00000059AM24
RA File Number			03AX04006327 AM23
Licence No and			0311022677/10/04/2023
Date
Norms Committee			Decision:
The Committee<br>idd b h			considered the request of firm for review of ad-hoc norms and on the basis of information<br>i i didd i dh d
prove y te rm, t was ece to revse a-oc norms as uner:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>**Qty.

n the basis of information i i didd i dh d|||||||| |prove y te rm, t was ece to revse a-oc norms as uner:- Export Product Qty. Sl. No. Import Items Qty. allowed. Diazepam Rectal Gel 2.5mg/ 0.5 ml and Lubricating Jelly (Combo Pack) ((Each Pack having 2.5mg twin pack with 2 packets of 3gm lubricating jelly ( Net Wt. of Diazepam USP is 150.00 Grams)) 1 Number Combo Pack 1 Diazepam USP 0.0051 gm. Diazepam Rectal Gel 10 mg/ 2 ml and Lubricating Jelly (Combo Pack) ((Each Pack having 10 mg Delivery system twin k ih 2 k f lbii 1 Number Combo Pack 2 Diazepam USP 0.0204 gm.||||||||||| |||Export Product|||Qty.||Sl. No.|Import Items||Qty. allowed.| |||Diazepam Rectal Gel 2.5mg/ 0.5 ml and|||1 Number||1|Diazepam USP||0.0051 gm.| ||| Lubricating Jelly (Combo Pack) ( Pack having 2.5mg twin pack wit || (Each h 2 |Combo Pa|ck||||| |||packets of 3gm lubricating jelly ( of Diazepam USP is 150.00 Gram||Net Wt. s))||||||| |||Diazepam Rectal Gel 10 mg/ 2 ml and Lubricating Jelly (Combo Pack) ((Each Pack having 10 mg Delivery system twin k ih 2 k f lbii|||1 Number Combo Pack||2|Diazepam USP||0.0204 gm.| |||pac wt pacets o 3gm urcatng jelly) ( Net Wt. of Diazepam USP is|||||||||

UDIN00584001AM25

ivery system twin k ih 2 k f lbii|||1 Number Combo Pack||2|Diazepam USP||0.0204 gm.| |||pac wt pacets o 3gm urcatng jelly) ( Net Wt. of Diazepam USP is|||||||||

UDIN00584001AM25

2000.00 Grams))<br>Diazepam Rectal Gel 20 mg/ 4 ml and<br>Lubricating Jelly (Combo Pack) ((Each<br>Pack having 20 mg Delivery system twin<br>pack with 2 packets of 3gm lubricating<br>jelly) ( Net Wt. of Diazepam USP is<br>2000.00 Grams))<br>1 Number<br>Combo Pack<br>3<br>Diazepam USP<br>0.0408 gm.<br>RA concerned may take further necessary action as per above decision of NC.	2000.00 Grams))
	Diazepam Rectal Gel 20 mg/ 4 ml and<br>Lubricating Jelly (Combo Pack) ((Each<br>Pack having 20 mg Delivery system twin<br>pack with 2 packets of 3gm lubricating<br>jelly) ( Net Wt. of Diazepam USP is<br>2000.00 Grams))	1 Number<br>Combo Pack	3	Diazepam USP	0.0408 gm.

Case No.	Case No.	43 / NC/3/MEET/Jan/202425/15	43 / NC/3/MEET/Jan/202425/15	43 / NC/3/MEET/Jan/202425/15	43 / NC/3/MEET/Jan/202425/15	43 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00000075AM24
RA File Number		08AX04002209 AM23
Licence No and Date		0811007825/10/04/2023

er and Date||NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025||||| |HQ File Number||HQRNORM APPLY 00000075AM24||||| |RA File Number||08AX04002209 AM23||||| |Licence No and Date||0811007825/10/04/2023||||| |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 meetingNo.NC/3/MEET/Nov/202324/16 dated 17/11/2023against advance authorizationNo.0811002393 dated 25/08/2021, 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. VINORELBINE CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML, 1ML VIAL(EACH ML CONTAINS: VINORELBINE TARTRATE PH.EUR EQ. TO VINORELBINE 10 MG) 1 Number 1 VINORELBINE TARTRATE EP / BP / IP / USP / PH. EUR (Water content 2.3%) 14.33 mg. VINORELBINE CONCENTRATE VINORELBINE 1 Number 2 71.66 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||VINORELBINE CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML, 1ML VIAL(EACH ML CONTAINS: VINORELBINE TARTRATE PH.EUR EQ. TO VINORELBINE 10 MG)||1 Number|1|VINORELBINE TARTRATE EP / BP / IP / USP / PH. EUR (Water content 2.3%)|14.33 mg.| ||VINORELBINE CONCENTRATE||1 Number|2|VINORELBINE|71.66 mg.|

UDIN00584001AM25

10 MG)||1 Number|1|VINORELBINE TARTRATE EP / BP / IP / USP / PH. EUR (Water content 2.3%)|14.33 mg.| ||VINORELBINE CONCENTRATE||1 Number|2|VINORELBINE|71.66 mg.|

UDIN00584001AM25

FOR SOLUTION FOR INFUSION TARTRATE EP / BP / 10MG/ML, 5ML VIAL(EACH ML IP / USP / PH. EUR CONTAINS:VINORELBINE (Water content 2.3%) TARTRATE PH.EUR EQ. TO VINORELBINE 10 MG [IN WHICH ACTIVE INGREDIENT VINORELBINE TARTRATE USED IS 606.000 GRAMS])

Case No.	Case No.	44 / NC/3/MEET/Jan/202425/15	44 / NC/3/MEET/Jan/202425/15	44 / NC/3/MEET/Jan/202425/15	44 / NC/3/MEET/Jan/202425/15	44 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		LITMUS ORGANICS PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00000097AM24
RA File Number		03AX04006355 AM23
Licence No and Date		0311022717/11/04/2023
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>CYANOACETIC ACID 70%<br>0.91 kg.<br>2-ETHOXYETHYL<br>CYANOACETATE(2EOECA)<br>1 kg.<br>2<br>ETHYLENE GLYCOL<br>MONOETHYL ETHER EGME<br>0.714 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

NE GLYCOL MONOETHYL ETHER EGME 0.714 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||2-ETHOXYETHYL CYANOACETATE(2EOECA)||1 kg.|1|CYANOACETIC ACID 70%|0.91 kg.| |||||2|ETHYLENE GLYCOL MONOETHYL ETHER EGME|0.714 kg.| |||||as per above decision of NC.|||

UDIN00584001AM25

Case No.	45 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	GENERIC HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000102AM24
RA File Number	31AX04000374 AM23
Licence No and<br>Date	3111002194/11/04/2023
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>MEQUI-GH 2,5MG/5ML SP F/60ML<br>76058<br>Numbers<br>1<br>Mequitazine<br>2.3 kg.<br>RA concerned may take further necessary action as per above decision of NC.

ort Items** Qty. allowed. MEQUI-GH 2,5MG/5ML SP F/60ML 76058 Numbers 1 Mequitazine 2.3 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	46 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000136AM24
RA File Number	03AX04006098 AM23
Licence No and<br>Date	0311022771/12/04/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.NC/3/MEET/Nov/202425/10 dated 22/11/2024against advance<br>authorizationNo.0511023876 dated 09/02/2024, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00584001AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
2- ACETOACETOXY ETHYL<br>METHACRYLATE	1 kg.	1<br>	Acetic Acid	0.755 kg.
		2<br>	2-Hydroxyethyl Methacrylate	0.640 kg.

*|**Sl. No. **|Import Items|Qty. allowed.| |---|---|---|---|---| |2- ACETOACETOXY ETHYL METHACRYLATE|1 kg.|1 |Acetic Acid|0.755 kg.| |||2 |2-Hydroxyethyl Methacrylate|0.640 kg.|

Case No.	Case No.	47 / NC/3/MEET/Jan/202425/15	47 / NC/3/MEET/Jan/202425/15	47 / NC/3/MEET/Jan/202425/15	47 / NC/3/MEET/Jan/202425/15	47 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00000156AM24
RA File Number		08AX04000016 AM24
Licence No and<br>Date		0811007856/12/04/2023
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.<br>No.<br>Import Items<br>Qty. allowed.<br>Nystatin Cream USP, 100000 units/gm,<br>15gm (15gm Tube)(Each gram<br>Contains: 100,000 USP Nystatin Units<br>in an aqueous, cream base. Net content<br>of Nystatin should not be less than<br>108.347 Kg in export item)<br>1 Number<br>1<br>Nystatin (Nystatin<br>Micronized)<br>245.586 mg/<br>Tablet<br>Nystatin Cream USP, 100000 units/gm,<br>Nystatin (Nystatin 491.172 mg/<br>1 Number<br>2
	Export Product		Qty.	Sl.<br>No.	Import Items	**Qty.

d) 245.586 mg/ Tablet Nystatin Cream USP, 100000 units/gm, Nystatin (Nystatin 491.172 mg/ 1 Number 2||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Nystatin Cream USP, 100000 units/gm, 15gm (15gm Tube)(Each gram Contains: 100,000 USP Nystatin Units in an aqueous, cream base. Net content of Nystatin should not be less than 108.347 Kg in export item)||1 Number|1|Nystatin (Nystatin Micronized)|245.586 mg/ Tablet| ||Nystatin Cream USP, 100000 units/gm,||1 Number|2|Nystatin (Nystatin|491.172 mg/|

Case No.	Case No.	47 / NC/3/MEET/Jan/202425/15	47 / NC/3/MEET/Jan/202425/15	47 / NC/3/MEET/Jan/202425/15	47 / NC/3/MEET/Jan/202425/15	47 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00000156AM24
RA File Number		08AX04000016 AM24
Licence No and<br>Date		0811007856/12/04/2023
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.<br>No.<br>Import Items<br>Qty. allowed.<br>Nystatin Cream USP, 100000 units/gm,<br>15gm (15gm Tube)(Each gram<br>Contains: 100,000 USP Nystatin Units<br>in an aqueous, cream base.

Sl. No. Import Items Qty. allowed. Nystatin Cream USP, 100000 units/gm, 15gm (15gm Tube)(Each gram Contains: 100,000 USP Nystatin Units in an aqueous, cream base. Net content of Nystatin should not be less than 108.347 Kg in export item) 1 Number 1 Nystatin (Nystatin Micronized) 245.586 mg/ Tablet Nystatin Cream USP, 100000 units/gm, Nystatin (Nystatin 491.172 mg/ 1 Number 2||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Nystatin Cream USP, 100000 units/gm, 15gm (15gm Tube)(Each gram Contains: 100,000 USP Nystatin Units in an aqueous, cream base. Net content of Nystatin should not be less than 108.347 Kg in export item)||1 Number|1|Nystatin (Nystatin Micronized)|245.586 mg/ Tablet| ||Nystatin Cream USP, 100000 units/gm,||1 Number|2|Nystatin (Nystatin|491.172 mg/|

UDIN00584001AM25

30gm (30gm Tube)(Each gram<br>Contains: 100,000 USP Nystatin Units<br>in anaqueous, cream base. Net content<br>of Nystatin should not be less than<br>231.140 Kg in export item)<br>Micronized)<br>Tablet<br>RA concerned may take further necessary action as per above decision of NC.	30gm (30gm Tube)(Each gram<br>Contains: 100,000 USP Nystatin Units<br>in anaqueous, cream base. Net content<br>of Nystatin should not be less than<br>231.140 Kg in export item)			Micronized)	Tablet

Contains: 100,000 USP Nystatin Units in anaqueous, cream base. Net content of Nystatin should not be less than 231.140 Kg in export item)|||Micronized)|Tablet| |---|---|---|---|---|---|

Case No.	48 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000159AM24
RA File Number	03AX04000117 AM24
Licence No and<br>Date	0311022786/13/04/2023
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>Acetic Acid<br>0.90 kg.<br>DIMETHYL ACETOACETAMIDE<br>1 kg.<br>2<br>Dimethyl Amine<br>0.45 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 49 / NC/3/MEET/Jan/202425/15

UDIN00584001AM25

TAMIDE 1 kg. 2 Dimethyl Amine 0.45 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No. 49 / NC/3/MEET/Jan/202425/15

UDIN00584001AM25

Case Status	Case Deferred
Party Name	S KANT CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000218AM24
RA File Number	03AX04000033 AM24
Licence No and<br>Date	0311022832/17/04/2023
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>Complete technical details as per Annexure to Appendix-4E.

Case No.	Case No.	50 / NC/3/MEET/Jan/202425/15	50 / NC/3/MEET/Jan/202425/15	50 / NC/3/MEET/Jan/202425/15	50 / NC/3/MEET/Jan/202425/15	50 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		MOREPEN LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00000238AM24
RA File Number		05AX04000110 AM24
Licence No and<br>Date		0511018340/17/04/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and 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 (4R-Cis)-1,1-Dimethylethyl-6- cyanomethyl-2,2-dimethyl-1,3-dioxane - 4-Acetate 0.6259 kg. 2 4-Fluoro-α-[2-methyl-1-oxopropyl]-γ- oxo-N-β-diphenyl benzene butanamide 0.994 kg. 3 Methanol 4.285 kg. ATORVASTATIN CALCIUM 1 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||ATORVASTATIN CALCIUM||1 kg.|1|(4R-Cis)-1,1-Dimethylethyl-6- cyanomethyl-2,2-dimethyl-1,3-dioxane - 4-Acetate|0.6259 kg.| |||||2|4-Fluoro-α-[2-methyl-1-oxopropyl]-γ- oxo-N-β-diphenyl benzene butanamide|0.994 kg.| |||||3|Methanol|4.285 kg.|

UDIN00584001AM25

4	Methyl tert-butyl ether (M201)	1.145 kg.
5	Tetrahydrofuran	0.542 kg.
6	Methylene chloride	1.414 kg.
7	Diisopropyl ether	0.754 kg.

4	Methyl tert-butyl ether (M201)	1.145 kg.
5	Tetrahydrofuran	0.542 kg.
6	Methylene chloride	1.414 kg.
7	Diisopropyl ether	0.754 kg.

Case No.	Case No.	51 / NC/3/MEET/Jan/202425/15	51 / NC/3/MEET/Jan/202425/15	51 / NC/3/MEET/Jan/202425/15	51 / NC/3/MEET/Jan/202425/15	51 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		ZYDUS LIFESCIENCES LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00000266AM24
RA File Number		08AX04002260 AM23
Licence No and Date		0811007905/18/04/2023
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. Import Items<br>Qty. allowed.<br>1<br>SPIRONOLACTONE USP<br>25.50 mg.<br>2<br>CORN STARCH NF<br>17.50 mg.<br>3<br>CROSCARMELLOSE<br>SODIUM NF<br>9.00 mg.<br>POVIDONE USP<br>SPIRONOLACTONE TABLETS USP<br>25 MG ((ACTIVE INGREDIENT:<br>SPIRONOLACTONE USP - NET WT.<br>6982.100 KGS))<br>1 Number<br>4<br>7.50 mg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

ONE TABLETS USP 25 MG ((ACTIVE INGREDIENT: SPIRONOLACTONE USP - NET WT. 6982.100 KGS)) 1 Number 4 7.50 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||SPIRONOLACTONE TABLETS USP 25 MG ((ACTIVE INGREDIENT: SPIRONOLACTONE USP - NET WT. 6982.100 KGS))||1 Number|1|SPIRONOLACTONE USP|25.50 mg.| |||||2|CORN STARCH NF|17.50 mg.| |||||3|CROSCARMELLOSE SODIUM NF|9.00 mg.| |||||4|POVIDONE USP|7.50 mg.|

Case No.	Case No.	51 / NC/3/MEET/Jan/202425/15	51 / NC/3/MEET/Jan/202425/15	51 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		ZYDUS LIFESCIENCES LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00000266AM24
RA File Number		08AX04002260 AM23
Licence No and Date		0811007905/18/04/2023
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. Import Items<br>Qty. allowed.<br>1<br>SPIRONOLACTONE USP<br>25.50 mg.<br>2<br>CORN STARCH NF<br>17.50 mg.<br>3<br>CROSCARMELLOSE<br>SODIUM NF<br>9.00 mg.<br>POVIDONE USP<br>SPIRONOLACTONE TABLETS USP<br>25 MG ((ACTIVE INGREDIENT:<br>SPIRONOLACTONE USP - NET WT.<br>6982.100 KGS))<br>1 Number<br>4<br>7.50 mg.
	Export Product		Qty.	**Sl. No.

POVIDONE USP SPIRONOLACTONE TABLETS USP 25 MG ((ACTIVE INGREDIENT: SPIRONOLACTONE USP - NET WT. 6982.100 KGS)) 1 Number 4 7.50 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||SPIRONOLACTONE TABLETS USP 25 MG ((ACTIVE INGREDIENT: SPIRONOLACTONE USP - NET WT. 6982.100 KGS))||1 Number|1|SPIRONOLACTONE USP|25.50 mg.| |||||2|CORN STARCH NF|17.50 mg.| |||||3|CROSCARMELLOSE SODIUM NF|9.00 mg.| |||||4|POVIDONE USP|7.50 mg.|

UDIN00584001AM25

			(K-29/32)
		5	MICROCRYSTALLINE<br>CELLULOSE NF 102	4.50 mg.
		6	MAGNESIUM STEARATE PH<br>EUR/NF	<br>1.125 mg.
		7	CALCIUM<br>SULPHATE<br>DIHYDRATE NF	<br>86.375 mg.
SPIRONOLACTONE TABLETS USP<br>50 MG(ACTIVE INGREDIENT:<br>SPIRONOLACTONE USP - NET WT.<br>7717.200 KGS))	1 Number	8	SPIRONOLACTONE USP	51.00 mg.
		9	CORN STARCH NF	35.00 mg.
		10	CROSCARMELLOSE<br>SODIUM NF	18.00 mg.
		11	POVIDONE USP (K-29/32)	15.00 mg.
		12	MICROCRYSTALLINE<br>CELLULOSE NF 102	9.00 mg.
		13	MAGNESIUM STEARATE PH<br>EUR/NF	<br>2.25 mg.
		14	CALCIUM<br>SULPHATE<br>DIHYDRATE NF	<br>172.75 mg.
SPIRONOLACTONE TABLETS USP<br>100 MG (ACTIVE INGREDIENT:<br>SPIRONOLACTONE USP - NET<br>WT.8189.400 KGS))	1 Number	15	SPIRONOLACTONE USP	102.00 mg.
		16	CORN STARCH NF	70.00 mg.
		17	CROSCARMELLOSE<br>SODIUM NF	36.00 mg.
		18	POVIDONE USP (K-29/32)	30.00 mg.
		19	MICROCRYSTALLINE<br>CELLULOSE NF 102	18.00 mg.

UDIN00584001AM25

|16|CORN STARCH NF|70.00 mg.| ||||17|CROSCARMELLOSE SODIUM NF|36.00 mg.| ||||18|POVIDONE USP (K-29/32)|30.00 mg.| ||||19|MICROCRYSTALLINE CELLULOSE NF 102|18.00 mg.|

UDIN00584001AM25

20<br>MAGNESIUM STEARATE PH<br>EUR/NF<br>4.50 mg.<br>21<br>CALCIUM<br>SULPHATE<br>DIHYDRATE NF<br>345.50 mg.<br>RA concerned may take further necessary action as per above decision of NC.			20	MAGNESIUM STEARATE PH<br>EUR/NF	<br>4.50 mg.
			21	CALCIUM<br>SULPHATE<br>DIHYDRATE NF	<br>345.50 mg.

Case No.	52 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000292AM24
RA File Number	03AX04000045 AM24
Licence No and<br>Date	0311022935/19/04/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	53 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000325AM24
RA File Number	03AX04000169 AM24
Licence No and<br>Date	0311022998/21/04/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

UDIN00584001AM25

169 AM24| |Licence No and Date|0311022998/21/04/2023| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

UDIN00584001AM25

Case No.	Case No.	54 / NC/3/MEET/Jan/202425/15	54 / NC/3/MEET/Jan/202425/15	54 / NC/3/MEET/Jan/202425/15	54 / NC/3/MEET/Jan/202425/15	54 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00000357AM24
RA File Number		03AX04000234 AM24
Licence No and<br>Date		0311023026/24/04/2023
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. Import Items<br>Qty. allowed.<br>Olopatadine Hydrochloride and<br>Mometasone Furoate Nasal Spray<br>600mcg/25mcg (RYALTRIS) 240<br>MD((Net Wt. of Mometasone Furoate<br>mono. is 4200 Grams))<br>700000 Numbers<br>1<br>Mometasone Furoate<br>Monohydrate<br>4284.00 gm.<br>Olopatadine Hydrochloride and<br>Mometasone Furoate Nasal Spray<br>600mcg/25mcg (RYALTRIS) 240<br>MD((Net Wt. of Mometasone Furoate<br>mono. is 2100 Grams))<br>350000 Numbers<br>2<br>Mometasone Furoate<br>Monohydrate<br>2142.00 gm.<br>Olopatadine Hydrochloride and<br>Mometasone Furoate Nasal Spray<br>600mcg/25mcg (RYALTRIS) 120<br>MD((Net Wt.

100 Grams)) 350000 Numbers 2 Mometasone Furoate Monohydrate 2142.00 gm. Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 120 MD((Net Wt. of Mometasone Furoate mono. is 2100 Grams)) 700000 Numbers 3 Mometasone Furoate Monohydrate 2142.00 gm. Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 120 MD((Net Wt of Mometasone Furoate mono. is 1050 Grams)) 350000 Numbers 4 Mometasone Furoate Monohydrate 1071.00 gm. Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 400000 Numbers 5 Mometasone Furoate Monohydrate 571.20 gm.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 240 MD((Net Wt. of Mometasone Furoate mono. is 4200 Grams))||700000 Numbers|1|Mometasone Furoate Monohydrate|4284.00 gm.| ||Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 240 MD((Net Wt. of Mometasone Furoate mono. is 2100 Grams))||350000 Numbers|2|Mometasone Furoate Monohydrate|2142.00 gm.| ||Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 120 MD((Net Wt. of Mometasone Furoate mono. is 2100 Grams))||700000 Numbers|3|Mometasone Furoate Monohydrate|2142.00 gm.| ||Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 120 MD((Net Wt of Mometasone Furoate mono.

Numbers|3|Mometasone Furoate Monohydrate|2142.00 gm.| ||Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 120 MD((Net Wt of Mometasone Furoate mono. is 1050 Grams))||350000 Numbers|4|Mometasone Furoate Monohydrate|1071.00 gm.| ||Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray||400000 Numbers|5|Mometasone Furoate Monohydrate|571.20 gm.|

Case No.	Case No.	54 / NC/3/MEET/Jan/202425/15	54 / NC/3/MEET/Jan/202425/15	54 / NC/3/MEET/Jan/202425/15	54 / NC/3/MEET/Jan/202425/15	54 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00000357AM24
RA File Number		03AX04000234 AM24
Licence No and<br>Date		0311023026/24/04/2023
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. Import Items<br>Qty. allowed.<br>Olopatadine Hydrochloride and<br>Mometasone Furoate Nasal Spray<br>600mcg/25mcg (RYALTRIS) 240<br>MD((Net Wt. of Mometasone Furoate<br>mono. is 4200 Grams))<br>700000 Numbers<br>1<br>Mometasone Furoate<br>Monohydrate<br>4284.00 gm.<br>Olopatadine Hydrochloride and<br>Mometasone Furoate Nasal Spray<br>600mcg/25mcg (RYALTRIS) 240<br>MD((Net Wt. of Mometasone Furoate<br>mono.

r>1 Mometasone Furoate Monohydrate 4284.00 gm. Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 240 MD((Net Wt. of Mometasone Furoate mono. is 2100 Grams)) 350000 Numbers 2 Mometasone Furoate Monohydrate 2142.00 gm. Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 120 MD((Net Wt. of Mometasone Furoate mono. is 2100 Grams)) 700000 Numbers 3 Mometasone Furoate Monohydrate 2142.00 gm. Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 120 MD((Net Wt of Mometasone Furoate mono. is 1050 Grams)) 350000 Numbers 4 Mometasone Furoate Monohydrate 1071.00 gm. Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 400000 Numbers 5 Mometasone Furoate Monohydrate 571.20 gm.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 240 MD((Net Wt. of Mometasone Furoate mono. is 4200 Grams))||700000 Numbers|1|Mometasone Furoate Monohydrate|4284.00 gm.| ||Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 240 MD((Net Wt. of Mometasone Furoate mono. is 2100 Grams))||350000 Numbers|2|Mometasone Furoate Monohydrate|2142.00 gm.| ||Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 120 MD((Net Wt. of Mometasone Furoate mono.

Numbers|2|Mometasone Furoate Monohydrate|2142.00 gm.| ||Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 120 MD((Net Wt. of Mometasone Furoate mono. is 2100 Grams))||700000 Numbers|3|Mometasone Furoate Monohydrate|2142.00 gm.| ||Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray 600mcg/25mcg (RYALTRIS) 120 MD((Net Wt of Mometasone Furoate mono. is 1050 Grams))||350000 Numbers|4|Mometasone Furoate Monohydrate|1071.00 gm.| ||Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray||400000 Numbers|5|Mometasone Furoate Monohydrate|571.20 gm.|

UDIN00584001AM25

600mcg/25mcg (RYALTRIS) 56 MD((Net Wt.of Mometasone Furoate mono. is 560 Grams))

Case No.	Case No.	55 / NC/3/MEET/Jan/202425/15	55 / NC/3/MEET/Jan/202425/15	55 / NC/3/MEET/Jan/202425/15	55 / NC/3/MEET/Jan/202425/15	55 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		IND SWIFT LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00000384AM24
RA File Number		30AX04000022 AM24
Licence No and<br>Date		3011003465/25/04/2023
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. 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 Clarithromycin 0.2727 kg. 2 Carbopol 0.2000 kg. 3 HPMC Phthalate 0.5400 kg. Clarithromycin Granules 27.5% (Suspension Grade) 1 kg. 4 Acetate 1.0500 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Clarithromycin Granules 27.5% (Suspension Grade)||1 kg.|1|Clarithromycin|0.2727 kg.| |||||2|Carbopol|0.2000 kg.| |||||3|HPMC Phthalate|0.5400 kg.| |||||4|Acetate|1.0500 kg.| |||||as per above decision of NC.|||

UDIN00584001AM25

Case No.	56 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000404AM24
RA File Number	05AX04000234 AM24
Licence No and<br>Date	0511018526/25/04/2023
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.<br>No.<br>Import Items<br>Qty.<br>allowed.<br>Kombinil-DUO Eye/Ear Drops 5ml<br>Vial (Each ml contains 1 mg.

vise ad-hoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. allowed. Kombinil-DUO Eye/Ear Drops 5ml Vial (Each ml contains 1 mg. of Dexamethasone) 1 Number 1 Dexamethasone Micronised PH EUR USP JP 5.10 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	57 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	ALKALOIDS PVT LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
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 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:-

UDIN00584001AM25

Certificate of Analysis (CoA) of import item from Foreign Supplier showing percentage content of active ingredient.

Case No.	Case No.	58 / NC/3/MEET/Jan/202425/15	58 / NC/3/MEET/Jan/202425/15	58 / NC/3/MEET/Jan/202425/15	58 / NC/3/MEET/Jan/202425/15	58 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00000425AM24
RA File Number		34AX04000059 AM24
Licence No and<br>Date		3411003627/26/04/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo. NC/3/MEET/Jun/202425/5 dated 14/06/2024against advance<br>authorizationNo.3411001598 dated 28/12/2021, 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>Clomipramine Hydrochloride USP<br>25.50 mg.<br>2<br>Microcrystalline Cellulose<br>(Avicel PH 301)<br>148.80 mg.<br>3<br>Pregelatinized starch<br>(Starch 1500 LM)<br>39.60 mg.<br>4<br>Colloidal silicon dioxide<br>(Aerosil 200 Pharma)<br>2.20 mg.<br>CLOMIPRAMINE HCL CAP<br>USP 25 MG<br>1 Number<br>5<br>Magnesium Stearate<br>(Vegetable Source)<br>4.40 mg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

ma) 2.20 mg. CLOMIPRAMINE HCL CAP USP 25 MG 1 Number 5 Magnesium Stearate (Vegetable Source) 4.40 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||CLOMIPRAMINE HCL CAP USP 25 MG||1 Number|1|Clomipramine Hydrochloride USP|25.50 mg.| |||||2|Microcrystalline Cellulose (Avicel PH 301)|148.80 mg.| |||||3|Pregelatinized starch (Starch 1500 LM)|39.60 mg.| |||||4|Colloidal silicon dioxide (Aerosil 200 Pharma)|2.20 mg.| |||||5|Magnesium Stearate (Vegetable Source)|4.40 mg.|

UDIN00584001AM25

6<br>Clomipramine Hydrochloride USP<br>51.00 mg.<br>7<br>Microcrystalline Cellulose<br>(Avicel PH 301)<br>210.70 mg.<br>8<br>Pregelatinized starch<br>(Starch 1500 LM)<br>59.40 mg.<br>9<br>Colloidal silicon dioxide<br>(Aerosil 200 Pharma)<br>3.30 mg.<br>CLOMIPRAMINE HCL CAP<br>USP 50 MG<br>1 Number<br>10<br>Magnesium Stearate<br>(Vegetable Source)<br>6.60 mg.<br>11<br>Clomipramine Hydrochloride USP<br>76.50 mg.<br>12<br>Microcrystalline Cellulose<br>(Avicel PH 301)<br>205.45 mg.<br>13<br>Pregelatinized starch<br>(Starch 1500 LM)<br>63.90 mg.<br>14<br>Colloidal silicon dioxide<br>(Aerosil 200 Pharma)<br>3.55 mg.<br>CLOMIPRAMINE HCL CAP<br>USP 75 MG<br>1 Number<br>15<br>Magnesium Stearate<br>(Vegetable Source)<br>7.10 mg.<br>RA concerned may take further necessary action as per above decision of NC.	CLOMIPRAMINE HCL CAP<br>USP 50 MG	1 Number	6	Clomipramine Hydrochloride USP	51.00 mg.
			7	Microcrystalline Cellulose<br>(Avicel PH 301)	210.70 mg.

CLOMIPRAMINE HCL CAP<br>USP 50 MG	1 Number	6	Clomipramine Hydrochloride USP	51.00 mg.
		7	Microcrystalline Cellulose<br>(Avicel PH 301)	210.70 mg.
		8	Pregelatinized starch<br>(Starch 1500 LM)	59.40 mg.
		9	Colloidal silicon dioxide<br>(Aerosil 200 Pharma)	3.30 mg.
		10	Magnesium Stearate<br>(Vegetable Source)	6.60 mg.
CLOMIPRAMINE HCL CAP<br>USP 75 MG	1 Number	11	Clomipramine Hydrochloride USP	76.50 mg.
		12	Microcrystalline Cellulose<br>(Avicel PH 301)	205.45 mg.
		13	Pregelatinized starch<br>(Starch 1500 LM)	63.90 mg.
		14	Colloidal silicon dioxide<br>(Aerosil 200 Pharma)	3.55 mg.
		15	Magnesium Stearate<br>(Vegetable Source)	7.10 mg.

Case No.	59 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved

UDIN00584001AM25

Party Name	NASENSE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000429AM24
RA File Number	09AX04000054 AM24
Licence No and<br>Date	0911004884/26/04/2023
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.

f 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 4-Cyanopyridine 1.0 kg. 2 Cp HCl (33 percent) 1.14 kg. 3 Acrylic Acid 0.70 kg. 4 Dimethylamine 40 percent Solution 1.5 kg. 5 Caustic Soda Flakes 1.15 kg. 4 Dimethyl Aminopyridine 1 kg. 6 Toluene 0.2 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	60 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000446AM24
RA File Number	07AX04000091 AM24
Licence No and	0711007425/27/04/2023

UDIN00584001AM25

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.
CALCIUM CITRATE MALATE USP	1 kg.	1	CITRIC ACID<br>ANY GRADE	0.477 kg.
		2	DL-MALIC ACID	0.499 kg.
		3	CALCIUM<br>CARBONATE	0.712 kg.

Import Items*|Qty. allowed.| |---|---|---|---|---| |CALCIUM CITRATE MALATE USP|1 kg.|1|CITRIC ACID ANY GRADE|0.477 kg.| |||2|DL-MALIC ACID|0.499 kg.| |||3|CALCIUM CARBONATE|0.712 kg.|

Case No.	Case No.	61 / NC/3/MEET/Jan/202425/15	61 / NC/3/MEET/Jan/202425/15	61 / NC/3/MEET/Jan/202425/15	61 / NC/3/MEET/Jan/202425/15	61 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00000488AM24
RA File Number		34AX04000058 AM24
Licence No and<br>Date		3411003648/29/04/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.NC/3/MEET/Dec/202425/13 dated 07/01/2025against advance authorization<br>No.3411002610 dated 04/08/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00584001AM25

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

UDIN00584001AM25

Midodrine HCL Tabs USP 2.5 mg	1 Number	1	Midodrine Hydrochloride USP<br>(Micronized)	2.55 mg.
		2	Microcrystalline Cellulose<br>(Avicel PH 102)	74.50 mg.
		3	Crospovidone<br>(Type-A) (Polyplasdone) XL	8.00 mg.
		4	Hydroxypropyl cellulose<br>(KLUCEL LF PHARM)	1.50 mg.
		5	Colloidal Silicon dioxide<br>(Aerosil 200 Pharma)	2.00 mg.
		6	Magnesium Stearate	1.50 mg.
Midodrine HCL Tabs USP 5 mg	1 Number	7	Midodrine Hydrochloride USP<br>(Micronized)	5.10 mg.
		8	Microcrystalline Cellulose<br>(Avicel PH 102)	149.00 mg.
		9	Crospovidone<br>(Type-A) (Polyplasdone) XL	16.00 mg.
		10	Hydroxypropyl cellulose<br>(KLUCEL LF PHARM)	3.00 mg.
		11	Colloidal Silicon dioxide<br>(Aerosil 200 Pharma)	4.00 mg.
		12	Magnesium Stearate	3.00 mg.
Midodrine HCL Tabs USP 10 mg	1 Number	13	Midodrine Hydrochloride USP<br>(Micronized)	10.20 mg.

UDIN00584001AM25

and Date||NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025||||| |HQ File Number||HQRNORM APPLY 00000508AM24||||| |RA File Number||08AX04000018 AM24||||| |Licence No and Date||0811008029/01/05/2023||||| |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 meetingNo.NC/3/MEET/Nov/202425/10 dated 22/11/2024against advance authorizationNo.0311031505 dated 27/02/2024, 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.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

UDIN00584001AM25

DEXAMETHASONE 1 kg. 1 16 Alpha-Methyl Epoxide (8-DM) 0.811 kg.

Case No.	63 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	AVIK PHARMACEUTICAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000541AM24
RA File Number	52AX04000022 AM24
Licence No and<br>Date	5211004680/03/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Prednisolone Sodium Metasulfobenzoate (PSB) 1 kg. 1 Prednisolone 1.00 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	64 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000547AM24
RA File Number	08AX04000159 AM24
Licence No and Date	0811008069/03/05/2023

UDIN00584001AM25

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.
PYRIDOSTIGMINE BROMIDE	1Number	1	PYRIDOSTIGMINE	61.20 mg.
TABLETS USP 60 MG			BROMIDE USP
(ACTIVE INGREDIENT)
		2	ANHYDROUS LACTOSE	297.37 mg.
			NF/BP

Case No.<br>65 / NC/3/MEET/Jan/202425/15	Case No.<br>65 / NC/3/MEET/Jan/202425/15
Case Status<br>Case Approved
Party Name<br>CLAROID PHARMACEUTICALS PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number<br>HQRNORM APPLY 00000559AM24
RA File Number<br>08AX04000122 AM24
Licence No and Date<br>0811008065/03/05/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was		decided to fix ad-hoc norms	under Para 4.07
of HBP Vol. I as per details given below or as applied by the		firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty. allowed.
ERYTHROMYCIN 500 MG<br>1 Number	1	ERYTHROMYCIN	668 mg/Tablet
(1,42,00,000 TABLETS )		STEARATE
(ERYTHROMYCIN
STEARATE 706 MG IS
EQUILENT TO

UDIN00584001AM25

ERYTHROMYCIN 500 MG)

Note: The committee decided to recommend for revision of SION A-334.

Case No.	Case No.	66 / NC/3/MEET/Jan/202425/15	66 / NC/3/MEET/Jan/202425/15	66 / NC/3/MEET/Jan/202425/15	66 / NC/3/MEET/Jan/202425/15	66 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		ALKEM LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00000683AM24
RA File Number		03AX04000499 AM24
Licence No and<br>Date		0311023438/09/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Venlafaxine Hydrochloride Extended<br>Release Tablets 37.5 mg(Each<br>extended release tablet contains:<br>Venlafaxine<br>Hydrochloride equivalent to<br>venlafaxine 37.5mg. Net content of<br>Venlafaxine 15.374 kgs)<br>409980<br>Numbers<br>1<br>Venlafaxine Hydrochloride USP<br>17.68 kg.<br>Venlafaxine Hydrochloride Extended<br>Release Tablets 150 mg(Each<br>extended release tablet contains:<br>Venlafaxine<br>Hydrochloride equivalent to<br>venlafaxine 150 mg. Net content of<br>Venlafaxine 270 kgs)<br>1800000<br>Numbers<br>2<br>Venlafaxine Hydrochloride USP<br>299.7 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

xine 150 mg. Net content of Venlafaxine 270 kgs) 1800000 Numbers 2 Venlafaxine Hydrochloride USP 299.7 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Venlafaxine Hydrochloride Extended Release Tablets 37.5 mg(Each extended release tablet contains: Venlafaxine Hydrochloride equivalent to venlafaxine 37.5mg. Net content of Venlafaxine 15.374 kgs)|| 409980 Numbers|1|Venlafaxine Hydrochloride USP|17.68 kg.| ||Venlafaxine Hydrochloride Extended Release Tablets 150 mg(Each extended release tablet contains: Venlafaxine Hydrochloride equivalent to venlafaxine 150 mg. Net content of Venlafaxine 270 kgs)|| 1800000 Numbers|2|Venlafaxine Hydrochloride USP|299.7 kg.|

Case No.	Case No.	66 / NC/3/MEET/Jan/202425/15	66 / NC/3/MEET/Jan/202425/15	66 / NC/3/MEET/Jan/202425/15	66 / NC/3/MEET/Jan/202425/15	66 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		ALKEM LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00000683AM24
RA File Number		03AX04000499 AM24
Licence No and<br>Date		0311023438/09/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Venlafaxine Hydrochloride Extended Release Tablets 37.5 mg(Each extended release tablet contains: Venlafaxine Hydrochloride equivalent to venlafaxine 37.5mg. Net content of Venlafaxine 15.374 kgs) 409980 Numbers 1 Venlafaxine Hydrochloride USP 17.68 kg. Venlafaxine Hydrochloride Extended Release Tablets 150 mg(Each extended release tablet contains: Venlafaxine Hydrochloride equivalent to venlafaxine 150 mg. Net content of Venlafaxine 270 kgs) 1800000 Numbers 2 Venlafaxine Hydrochloride USP 299.7 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Venlafaxine Hydrochloride Extended Release Tablets 37.5 mg(Each extended release tablet contains: Venlafaxine Hydrochloride equivalent to venlafaxine 37.5mg. Net content of Venlafaxine 15.374 kgs)|| 409980 Numbers|1|Venlafaxine Hydrochloride USP|17.68 kg.| ||Venlafaxine Hydrochloride Extended Release Tablets 150 mg(Each extended release tablet contains: Venlafaxine Hydrochloride equivalent to venlafaxine 150 mg. Net content of Venlafaxine 270 kgs)|| 1800000 Numbers|2|Venlafaxine Hydrochloride USP|299.7 kg.|

UDIN00584001AM25

Venlafaxine Hydrochloride equivalent to venlafaxine 150 mg. Net content of Venlafaxine 270 kgs)|| 1800000 Numbers|2|Venlafaxine Hydrochloride USP|299.7 kg.|

UDIN00584001AM25

Venlafaxine Hydrochloride Extended<br>Release Tablets 75 mg(Each	<br>8	40000	3	Ven	lafaxine Hydrochloride USP	70.56 kg.
extended release tablet contains:<br>Venlafaxine<br>Hydrochloride equivalent to<br>venlafaxine 75 mg. Net content of<br>Venlafaxine 63 kgs)	N	umbers


Venlafaxine Hydrochloride Extended<br>Release Tablets 37.5 mg(Each<br>extended release tablet contains:<br>Venlafaxine<br>Hydrochloride equivalent to<br>venlafaxine 37.5mg. Net content of<br>Venlafaxine 4.687 kgs)	<br>1<br>N	25010<br>umbers	4	Ven	lafaxine Hydrochloride USP	5.39 kg.



Venlafaxine Hydrochloride Extended<br>Release Tablets 150 mg(Each<br>extended release tablet contains:<br>Venlafaxine<br>Hydrochloride equivalent to<br>venlafaxine 150 mg. Net content of<br>Venlafaxine 247.500 kgs)	<br>1<br>N	650000<br>umbers
			5	Ven	lafaxine Hydrochloride USP	274.725 kg.



Venlafaxine Hydrochloride Extended<br>Rl Tbl 225 Eh	<br>3<br>	80010<br>b	6	Ven	lafaxine Hydrochloride USP	94.052 kg.
eease aets mg(ac<br>extended release tablet contains:<br>Venlafaxine<br>Hydrochloride equivalent to	umers
venlafaxine 225mg.

r>|80010 b||6|Ven|lafaxine Hydrochloride USP||94.052 kg.| ||eease aets mg(ac extended release tablet contains: Venlafaxine Hydrochloride equivalent to||umers|||||||| ||venlafaxine 225mg. Net content of Venlafaxine 85.500 kgs)|||||||||| ||Venlafaxine Hydrochloride Extended|| 90000||7||Venlafaxine Hydrochloride USP||3.881 kg.|| ||Release Tablets 37.5 |mg(Each |Numbers|||||||| ||extended release table |t contains:||||||||| ||Venlafaxine|||||||||| ||Hydrochloride equiva venlafaxine 37.5mg.|lent to Net content of||||||||| || Venlafaxine 3.375kgs| )||||||||| |||||||||||| |||||||||||| ||Venlafaxine Hydroch|oride Extended| 180000||8||Venlafaxine Hydrochloride USP||1512 kg|| || Release Tablets 75 mg(Each|| Numbers||||||. .|| || extended release tablet contains:||||||||||

UDIN00584001AM25

Venlafaxine
Hydrochloride equivalent to
venlafaxine 75 mg. Net content of
Venlafaxine 13.5 kgs)
Venlafaxine Hydrochloride Extended	<br>164970	9	Venlafaxine Hydrochloride USP	27.466 kg.
Release Tablets 150 mg(Each	Numbers
extended release tablet contains:
Venlafaxine
Hydrochloride equivalent to
venlafaxine 150 mg. Net content of
Venlafaxine 24.745 kgs)
Venlafaxine Hydrochloride Extended	<br>189990	10	Venlafaxine Hydrochloride USP	47.021 kg.
Release Tablets 225 mg(Each	Numbers
extended release tablet contains:
Venlafaxine
Hydrochloride equivalent to
venlafaxine 225mg. Net content of
Venlafaxine 42.747 kgs)

e Tablets 225 mg(Each|Numbers|||| |extended release tablet contains:||||| |Venlafaxine||||| |Hydrochloride equivalent to||||| |venlafaxine 225mg. Net content of||||| |Venlafaxine 42.747 kgs)|||||

Case No.	Case No.	67 / NC/3/MEET/Jan/202425/15	67 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		BLUE JET HEALTHCARE	LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jan/ 202425/	15 and 28/01/2025
HQ	File Number	HQRNORM APPLY 00000740AM24
RA File Number		03AX04000488 AM24
Licence No and Date		0311023468/10/05/2023
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.

UDIN00584001AM25

5-Amino -N,N-bis (2,3 -	1	ISOPHTHALIC ACID	0.350 kg.
dihydroxypropyl)-2,4,6 -triiodo
1,3-benzenedicarboxamide	2	3-AMINO-1,2-	0.320 kg.
		PROPANEDIOL (APD)
	3	EPICHLOROHYDRIN	Not required
	4	PALLADIUM CARBON	0.0001 kg.
	5	METHANOL	2.00 kg.
	6	IODINE	0.50 kg.

||| |1,3-benzenedicarboxamide||2|3-AMINO-1,2-|0.320 kg.| ||||PROPANEDIOL (APD)|| |||3|EPICHLOROHYDRIN|Not required| |||4|PALLADIUM CARBON|0.0001 kg.| |||5|METHANOL|2.00 kg.| |||6|IODINE|0.50 kg.|

Case No.<br>68 / NC/3/MEET/Jan/202425/15
Case Status<br>Case Approved
Party Name<br>INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number<br>HQRNORM APPLY 00000743AM24
RA File Number<br>08AX04000207 AM24
Licence No and<br>Date<br>0811008136/10/05/2023
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 meetingNo.NC/3/MEET/Apr/202324/1 dated 28/04/2023against advance
authorizationNo.0811006808 dated 21/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty. allowed.
ASPIRIN TABLETS 75 MG(EACH<br>1 Number	1	ASPIRIN (ACETYL	76.5 mg.
UNCOATED TABLET CONTAINS		SALICYLIC ACID) EP / BP /

UDIN00584001AM25

Sl. No.**|Import Items|Qty. allowed.|| |ASPIRIN TABLETS 75 MG(EACH 1 Number|1|ASPIRIN (ACETYL|76.5 mg.|| |UNCOATED TABLET CONTAINS||SALICYLIC ACID) EP / BP /|||

UDIN00584001AM25

ACETYL SALICYLIC ACID EP 75<br>MG)<br>IP / USP / PH. EUR.<br>ASPIRIN ENTERIC COATED<br>TABLETS 81 MG "ECOTRIN<br>81"(EACH ENTERIC COATED<br>TABLET CONTAINS<br>ASPIRIN BP 81 MG [IN WHICH<br>ACTIVE<br>INGREDIENT<br>ASPIRIN<br>(ACETYL SALICYLIC ACID) USED<br>IS 1240.500 KGS.])<br>1 Number<br>2<br>ASPIRIN (ACETYL<br>SALICYLIC ACID) EP / BP /<br>IP / USP / PH. EUR.<br>82.62 mg.<br>RA concerned may take further necessary action as per above decision of NC.	ACETYL SALICYLIC ACID EP 75<br>MG)			IP / USP / PH. EUR.
	ASPIRIN ENTERIC COATED<br>TABLETS 81 MG "ECOTRIN<br>81"(EACH ENTERIC COATED<br>TABLET CONTAINS<br>ASPIRIN BP 81 MG [IN WHICH<br>ACTIVE<br>INGREDIENT<br>ASPIRIN<br>(ACETYL SALICYLIC ACID) USED<br>IS 1240.500 KGS.])	1 Number	2	ASPIRIN (ACETYL<br>SALICYLIC ACID) EP / BP /<br>IP / USP / PH. EUR.	82.62 mg.

Case No.	69 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	MEONE HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000746AM24
RA File Number	04AX04000118 AM24
Licence No and<br>Date	0411005383/10/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br>allowed.<br>FOSCARNET<br>SODIUM<br>INJECTION-250 ML<br>1 Number<br>1<br>Foscarnet Sodium API (Foscarnet<br>Sodium Hexahydrate EP 8.0)<br>6.30 gm.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00584001AM25

1 Number 1 Foscarnet Sodium API (Foscarnet Sodium Hexahydrate EP 8.0) 6.30 gm. RA concerned may take further necessary action as per above decision of NC.||

UDIN00584001AM25

Case No.	Case No.	70 / NC/3/MEET/Jan/202425/15	70 / NC/3/MEET/Jan/202425/15	70 / NC/3/MEET/Jan/202425/15	70 / NC/3/MEET/Jan/202425/15	70 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		MEDREICH LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00000768AM24
RA File Number		07AX04000187 AM24
Licence No and<br>Date		0711007535/11/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.NC/3/MEET/Aug/202425/8 dated 28/08/2024against advance<br>authorizationNo.0711005482 dated 19/10/2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>ATORVASTATIN CALCIUM<br>TRIHYDRATE<br>11.059 mg.<br>Atorvastatin Tablets 10mg<br>1 Number<br>2<br>D MANNITOL<br>40.0 mg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

mg 1 Number 2 D MANNITOL 40.0 mg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Atorvastatin Tablets 10mg||1 Number|1|ATORVASTATIN CALCIUM TRIHYDRATE|11.059 mg.| |||||2|D MANNITOL|40.0 mg.| |||||as per above decision of NC.|||

Case No.	71 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	SATYADEVA PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000775AM24
RA File Number	09AX04000090 AM24
Licence No and<br>Date	0911005025/11/05/2023
Norms Committee Decision:

UDIN00584001AM25

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

|Case No.|72 / NC/3/MEET/Jan/202425/15|
|---|---|
|Case Status|Case Approved|
|Party Name|ATUL LIMITED|
|Meeting Number<br>and Date|NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025|
|HQ File Number|HQRNORM APPLY 00000842AM24|
|RA File Number|08AX04000116 AM24|
|Licence No and<br>Date|0811008184/15/05/2023|
|Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>**Export Product**<br>**Qty.**<br>**Sl. No. Import Items**<br>**Qty. allowed.**<br>1<br>Palmerol 1214 Lauryl-Myristyl<br>Alchol | Ecorol - 24 Lauryl-<br>Myristyl Alchol | Fatty Alchol<br>C1214<br>0.72 kg.<br>Lapox ARD-13<br>(Glycidyl ether of fatty alcohol)<br>1 kg.<br>2<br>Epichlorohydrin<br>0.454 kg.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No.	73 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000850AM24
RA File Number	34AX04000113 AM24

UDIN00584001AM25

UDIN00584001AM25

Licence No and 3411003716/15/05/2023 Date Norms Committee Decision: The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was decided to call for following information/documents from the firm:- Copy of Master-Batch Formula for each export item showing net content of all inputs in the formulations.

Case No.	74 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	SARAL CHEMTECH LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000865AM24
RA File Number	33AX04000105 AM23
Licence No and<br>Date	3311001206/16/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Personal Hearing<br>before Norms Committee to explain its case along with following information /<br>documents from the firm:<br>Drug Manufacturing License (DML) for each export.<br>1.<br>Import list is confusing. Give justification for each import item.<br>2.<br>Production/consumption data for last three years duly certified by Chartered Accountant.<br>3.

ort.** 1. Import list is confusing. Give justification for each import item. 2. Production/consumption data for last three years duly certified by Chartered Accountant. 3.||

Case No.	75 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	MAXCURE NUTRAVEDICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000872AM24
RA File Number	05AX04000388 AM24
Licence No and<br>Date	0511018844/16/05/2023
Norms Committee Decision:

68 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-02-2025 11:52:09.

UDIN00584001AM25

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Aug/202425/8 dated 28/08/2024 against advance authorization No.0811011244 dated 08/04/2024 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
PIPERACILLIN AND<br>TAZOBACTUM FOR<br>INJECTION 4.5gm (EACH<br>VIAL CONTAINS<br>PIPERACILLIN SODIUM<br>EQUIVALENT TO 4 GM<br>PIPERACILLIN AND<br>TAZOBACTUM SODIUM<br>EQUIVALENT TO 0.5 GM<br>TAZOBACTUM))	1 Number Vial	1	Piperacillin Sodium and<br>Tazobactum Sodium<br>(8:1) Sterile Powder	4.80 gm/vial

Case No.	Case No.	76 / NC/3/MEET/Jan/202425/15	76 / NC/3/MEET/Jan/202425/15	76 / NC/3/MEET/Jan/202425/15	76 / NC/3/MEET/Jan/202425/15	76 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00000876AM24
RA File Number		08AX04000284 AM24
Licence No and<br>Date		0811008214/16/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00584001AM25

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

UDIN00584001AM25

CLOZAPINE TABLETS 25<br>MG (EACH UNCOATED<br>TABLET CONTAINS:<br>CLOZAPINE PH.EUR. 25<br>MG)<br>1 Number<br>1<br>CLOZAPINE EP / BP / IP /<br>USP / PH. EUR.<br>25.50 mg/Tablet<br>CLOZAPINE TABLETS 50<br>MG(EACH UNCOATED<br>TABLET CONTAINS:<br>CLOZAPINE PH.EUR. 50<br>MG)<br>1 Number<br>2<br>CLOZAPINE EP / BP / IP /<br>USP / PH. EUR.<br>51.00 mg/Tablet<br>CLOZAPINE TABLETS 100<br>MG (EACH UNCOATED<br>TABLET CONTAINS:<br>CLOZAPINE PH.EUR. 100<br>MG)<br>1 Number<br>3<br>CLOZAPINE EP / BP / IP /<br>USP / PH. EUR.<br>102.00 mg/Tablet<br>CLOZAPINE TABLETS 200<br>MG (EACH UNCOATED<br>TABLET CONTAINS:<br>CLOZAPINE PH.EUR. 200<br>MG [IN<br>WHICH ACTIVE<br>INGREDIENT CLOZAPINE<br>USED IS 96.500 KGS.])<br>1 Number<br>4<br>CLOZAPINE EP / BP / IP /<br>USP / PH. EUR.<br>204.00 mg/Tablet<br>RA concerned may take further necessary action as per above decision of NC.	CLOZAPINE TABLETS 25<br>MG (EACH UNCOATED<br>TABLET CONTAINS:<br>CLOZAPINE PH.EUR. 25<br>MG)	1 Number	1	CLOZAPINE EP / BP / IP /<br>USP / PH. EUR.	25.50 mg/Tablet
	CLOZAPINE TABLETS 50<br>MG(EACH UNCOATED<br>TABLET CONTAINS:<br>CLOZAPINE PH.EUR. 50<br>MG)	1 Number	2	CLOZAPINE EP / BP / IP /<br>USP / PH. EUR.	51.00 mg/Tablet
	CLOZAPINE TABLETS 100<br>MG (EACH UNCOATED<br>TABLET CONTAINS:<br>CLOZAPINE PH.EUR. 100<br>MG)	1 Number	3	CLOZAPINE EP / BP / IP /<br>USP / PH.

INE EP / BP / IP / USP / PH. EUR.|51.00 mg/Tablet| ||CLOZAPINE TABLETS 100 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 100 MG)|1 Number|3|CLOZAPINE EP / BP / IP / USP / PH. EUR.|102.00 mg/Tablet| ||CLOZAPINE TABLETS 200 MG (EACH UNCOATED TABLET CONTAINS: CLOZAPINE PH.EUR. 200 MG [IN WHICH ACTIVE INGREDIENT CLOZAPINE USED IS 96.500 KGS.])|1 Number|4|CLOZAPINE EP / BP / IP / USP / PH. EUR.|204.00 mg/Tablet|

Case No.	77 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000897AM24
RA File Number	05AX04000410 AM24
Licence No and<br>Date	0511018871/17/05/2023

UDIN00584001AM25

Norms Committee Decision:

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

Case No.	78 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000920AM24
RA File Number	08AX04000086 AM24
Licence No and<br>Date	0811008233/18/05/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|08AX04000086 AM24| |Licence No and Date|0811008233/18/05/2023| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	79 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	INNOVARE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00000950AM24
RA File Number	09AX04000137 AM24
Licence No and<br>Date	0911005059/18/05/2023
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>To give chemical reaction indicating molecular weight of both reactants and products and yield with<br>justification.<br>1.<br>To give Stoichiometric material balance of the reaction and the value of the by-product/s, if any.<br>2.<br>Production of export item vis-à-vis consumption of all the raw materials for the last three years<br>duly certified by the Chartered Accountant.<br>3.

71 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-02-2025 11:52:09.

UDIN00584001AM25

e last three years** duly certified by the Chartered Accountant. 3.||

71 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-02-2025 11:52:09.

UDIN00584001AM25

Case No.	Case No.	80 / NC/3/MEET/Jan/202425/15	80 / NC/3/MEET/Jan/202425/15	80 / NC/3/MEET/Jan/202425/15	80 / NC/3/MEET/Jan/202425/15	80 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00001008AM24
RA File Number		03AX04000694 AM24
Licence No and<br>Date		0311023767/22/05/2023
Norms Committee Decision:
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:-
	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((Net content of exempted material is 447.20 kgs) (10000 NOS))||| 1 Number|1||PROPYLENE GLYCOL|39.52 gm/Vial| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 100ml vial((Net content of exempted material is 1252.16 kgs) (14000 NOS))||| 1 Number|2||PROPYLENE GLYCOL|79.04 gm/Vial| ||Ashoxy 5% (Oxytetracycline Hydrochloride Injection 50mg) 250ml vial((Net content of exempted material is 603.72 kgs) (2700 NOS))||| 1 Number|3||PROPYLENE GLYCOL|197.60 gm/Vial| |||||||||| |||||||||| ||Ashox |y 5% (Oxytetracycline ||1 Number|4||PROPYLENE GLYCOL|395.20 gm/Vial| ||Hydroc vial((N|hloride Injection 50mg) 500ml et content of exemted material is||||||| || 894.40|p kgs) (2000 NOS))||||||| |||||||||| ||Ashox 100mg|y 10% (Oxytetracycline Injection ) 50ml vial((Net content of||1 Number|5||PROPYLENE GLYCOL|35.256 gm/Vial| || exempted material is 426.40 kgs) (10000 NOS))||||||||

UDIN00584001AM25

10% (Oxytetracycline Injection ) 50ml vial((Net content of||1 Number|5||PROPYLENE GLYCOL|35.256 gm/Vial| || exempted material is 426.40 kgs) (10000 NOS))||||||||

UDIN00584001AM25

Ashoxy 10% (Oxytetracycline Injection<br>100mg) 100ml vial((Net content of	Ashoxy 10% (Oxytetracycline Injection<br>100mg) 100ml vial((Net content of	Ashoxy 10% (Oxytetracycline Injection<br>100mg) 100ml vial((Net content of	1 Number	6	PROPYLENE GLYCOL	70.512 gm/Vial
<br>exempted material is	<br>1705.60 kgs)
<br>(20000 NOS))


Ashoxy 10% (Oxyte<br>100m) 250ml vial((	tracycline Injection<br>Net content of		1 Number	7	PROPYLENE GLYCOL	176.28 gm/Vial
g<br>exempted material is	<br>1066.00 kgs) (5000
<br>NOS))

PAN Ashoxy 3% (Oxytetracycline<br>Injection 30mg) 100ml vial((Net content<br>of exempted material is 852.80 kgs)<br>(10000 NOS))			1 Number	8	PROPYLENE GLYCOL	70.512 gm/Vial
Ashoxy 20% LA (Oxytetracycline<br>			1 Number	9	PROPYLENE GLYCOL	9.00 gm/Vial
Dihydrate Injection eq Oxytetracy<br>200mg) 50ml vial((Net content of<br>exempted material is 93.60 kgs) (1		cline<br> <br>0000
NOS))

Ashoxy 20% LA (Oxytetracycline<br>Dihydrate Injection eq Oxytetracycline<br>200mg) 100ml vial((Net content of<br>exempted material is 187.20 kgs) (10000<br>NOS))			1 Number	10	PROPYLENE GLYCOL	18.00 gm/Vial

LA (Oxytetracycline Dihydrate Injection eq Oxytetracycline 200mg) 100ml vial((Net content of exempted material is 187.20 kgs) (10000 NOS))||||1 Number||10|PROPYLENE GLYCOL|18.00 gm/Vial|| |||||||||||| |||||||||||| ||Ashoxy 20% LA (O |xytetracycline |||1 Number||11|PROPYLENE GLYCOL|45.00 gm/Vial|| ||Dihydrate Injection e 200m) 250ml il(|q Oxytetracycline Nt ntnt f||||||||| ||g va exempted material is NOS))|e coe o 468.00 kgs) (10000||||||||| |||||||||||| |||||| |||||| ||Ashiver 1% (Ivermec |tin 10 Mg Injection) ||| 1 Number||12|PROPYLENE GLYCOL|10.40 gm/Vial|| ||10ml viaL((Net content of exempted material is 101.92 kgs) (10000 NOS))|||||||||| ||Ashiver 1% (Ivermectin 10 Mg Injection) 50ml vial((Net content of exempted material is 509.60 kgs) (10000 NOS))|||| 1 Number||13|PROPYLENE GLYCOL|52.00 gm/Vial|| |||||||||||| ||Ashiver 1% (Ivermectin 10 Mg Inje 100ml vial((Net content of exe material is 203840 ks) (20000 NO|||ction) mpted ))| 1 Number||14|PROPYLENE GLYCOL||104.00 gm/Vial| ||. g||||||||||

UDIN00584001AM25

Inje 100ml vial((Net content of exe material is 203840 ks) (20000 NO|||ction) mpted ))| 1 Number||14|PROPYLENE GLYCOL||104.00 gm/Vial| ||. g||||||||||

UDIN00584001AM25

Ashiver 1% (Ivermectin 10 Mg Injection)<br>250ml vial((Net content of exempted<br>material is 1274.00 kgs) (5000 NOS))	<br> <br>1 Number	15	PROPYLENE GLYCOL	260.00 gm/Vial
Ashiver 1% (Ivermectin 10 Mg Injection)<br>500ml vial((Net content of exempted<br>material is 1017.12 kgs) (2000 NOS))	<br> <br>1 Number	16	PROPYLENE GLYCOL	520.00 gm/Vial
Ashiver Forte (Ivermectin 10mg and<br>Clorsulon 100mg Injection) 50ml<br>viaL((Net content of exempted material<br>is 512.72 kgs) (10000 NOS))	1 Number	17	PROPYLENE GLYCOL	50.96 gm/Vial
Ashiver Forte (Ivermectin 10mg and<br>Clorsulon 100mg Injection) 100ml<br>vial((Net content of exempted material is<br>1029.60 kgs) (10000 NOS))	<br>1 Number	18	PROPYLENE GLYCOL	101.92 gm/Vial
Ashienro 10% (Enrofloxacin Injection<br>100mg)<br>50ml<br>vial((Net<br>content<br>of<br>exempted material is 52.00 kgs) (10000<br>NOS))	<br> <br> <br>1 Number	19	PROPYLENE GLYCOL	5.20 gm/Vial
Ashienro 10% (Enrofloxacin Injection<br>100mg) 100ml vial((Net content of<br>exempted material is 104.00 kgs) (10000<br>NOS))	1 Number	20	PROPYLENE GLYCOL	10.40 gm/Vial
Ashienro 10% (Enrofloxacin Injection<br>100mg) 250ml vial((Net content of<br>exempted material is 260.00 kgs) (10000<br>NOS))	1 Number	21	PROPYLENE GLYCOL	26.00 gm/Vial

YLENE GLYCOL|10.40 gm/Vial| ||Ashienro 10% (Enrofloxacin Injection 100mg) 250ml vial((Net content of exempted material is 260.00 kgs) (10000 NOS))|1 Number|21|PROPYLENE GLYCOL|26.00 gm/Vial| ||Ashityl 20% (Tylosin Tartrate injection eq to Tylosin 200mg) 100ml vial((Net content of exempted material is 104.00 kgs) (10000 NOS))|1 Number|22|PROPYLENE GLYCOL|Not matching with Master-Batch Formula| ||Ashityl 20% (Tylosin Tartrate injection eq to Tylosin 200mg) 100ml vial((Net content of exempted material is 208.00 kgs) (10000 NOS))|1 Number|23|PROPYLENE GLYCOL|20.80 gm/Vial| ||Ashityl 20% (Tylosin Tartrate injection|1 Number|24|PROPYLENE GLYCOL|Not matching with|

UDIN00584001AM25

eq to Tylosin 200mg) 100ml vial((Net<br>content of exempted material is 520.00<br>kgs) (10000 NOS))<br>Master-Batch<br>Formula<br>Ashityl 5% (Tylosin Tartrate injection eq<br>to Tylosin 50mg) 50ml vial((Net content<br>of exempted material is 104.00 kgs)<br>(10000 NOS))<br>1 Number<br>25<br>PROPYLENE GLYCOL<br>10.40 gm/Vial<br>Ashital 10% (Closantel 10% Inj) 100ml<br>vial((Net content of exempted material is<br>551.20 kgs) (10000 NOS))<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.	eq to Tylosin 200mg) 100ml vial((Net<br>content of exempted material is 520.00<br>kgs) (10000 NOS))				Master-Batch<br>Formula

necessary action as per above decision of NC.	eq to Tylosin 200mg) 100ml vial((Net<br>content of exempted material is 520.00<br>kgs) (10000 NOS))				Master-Batch<br>Formula
	Ashityl 5% (Tylosin Tartrate injection eq<br>to Tylosin 50mg) 50ml vial((Net content<br>of exempted material is 104.00 kgs)<br>(10000 NOS))	<br>1 Number	25	PROPYLENE GLYCOL	10.40 gm/Vial
	Ashital 10% (Closantel 10% Inj) 100ml<br>vial((Net content of exempted material is<br>551.20 kgs) (10000 NOS))	<br> <br>1 Number	26	PROPYLENE GLYCOL	55.12 gm/Vial

Case No.	Case No.	81 / NC/3/MEET/Jan/202425/15	81 / NC/3/MEET/Jan/202425/15	81 / NC/3/MEET/Jan/202425/15	81 / NC/3/MEET/Jan/202425/15	81 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00001048AM24
RA File Number		08AX04000163 AM24
Licence No and<br>Date		0811008261/23/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>QUETIAPINE TABLETS 25<br>MG(EACH FILM COATED<br>TABLET CONTAINS:<br>QUETIAPINE FUMARATE PH.<br>EUR. EQ.

:- Export Product Qty. Sl. No. Import Items Qty. allowed. QUETIAPINE TABLETS 25 MG(EACH FILM COATED TABLET CONTAINS: QUETIAPINE FUMARATE PH. EUR. EQ. TO QUETIAPINE 25 MG) 40200000 Numbers 1 QUETIAPINE FUMARATE EP / BP / IP / USP / PH. EUR. 1055.351 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||QUETIAPINE TABLETS 25 MG(EACH FILM COATED TABLET CONTAINS: QUETIAPINE FUMARATE PH. EUR. EQ. TO QUETIAPINE 25 MG)||40200000 Numbers|1|QUETIAPINE FUMARATE EP / BP / IP / USP / PH. EUR.|1055.351 kg.|

UDIN00584001AM25

QUETIAPINE PROLONGED<br>RELEASE TABLETS 50 MG(EACH<br>FILM COATED PROLONGED<br>RELEASE TABLET CONTAINS:<br>QUETIAPINE FUMARATE<br>PH.EUR. EQ. TO QUETIAPINE 50<br>MG)	27000000<br>Numbers	2	QUETIAPINE FUMARATE<br>EP / BP / IP / USP / PH.<br>EUR.	1397.52 kg.
QUETIAPINE TABLETS 100<br>MG(EACH FILM COATED<br>TABLET CONTAINS:<br>QUETIAPINE FUMARATE EQ. TO<br>QUETIAPINE 100 MG)	12000000<br>Numbers	3	QUETIAPINE FUMARATE<br>EP / BP / IP / USP / PH.<br>EUR.	1253.88 kg.
QUETIAPINE PROLONGED<br>RELEASE TABLETS 150<br>MG(EACH FILM COATED<br>PROLONGED RELEASE TABLET<br>CONTAINS: QUETIAPINE<br>FUMARATE PH. EUR. EQ. TO<br>QUETIAPINE 150 MG)	7200000<br>Numbers	4	QUETIAPINE FUMARATE<br>EP / BP / IP / USP / PH.<br>EUR.	1137.024 kg.
QUETIAPINE PROLONGED<br>RELEASE TABLETS 200 MG<br>(EACH FILM COATED<br>PROLONGED RELEASE TABLET<br>CONTAINS: QUETIAPINE<br>FUMARATE PH. EUR. EQ.

TE EP / BP / IP / USP / PH. EUR.|1137.024 kg.| ||QUETIAPINE PROLONGED RELEASE TABLETS 200 MG (EACH FILM COATED PROLONGED RELEASE TABLET CONTAINS: QUETIAPINE FUMARATE PH. EUR. EQ. TO QUETIAPINE 200 MG)|4800000 Numbers|5|QUETIAPINE FUMARATE EP / BP / IP / USP / PH. EUR.|993.984 kg.| ||QUETIAPINE PROLONGED RELEASE TABLETS 300 MG(EACH FILM COATED PROLONGED RELEASE TABLET CONTAINS: QUETIAPINE FUMARATE PH. EUR. EQ. TO QUETIAPINE 300 MG)|3000000 Numbers|6|QUETIAPINE FUMARATE EP / BP / IP / USP / PH. EUR.|918.09 kg.| ||QUETIAPINE PROLONGED RELEASE TABLETS 400 MG (EACH FILM COATED PROLONGED RELEASE TABLET CONTAINS: QUETIAPINE FUMARATE PH.EUR. EQ. TO QUETIAPINE 400MG [IN WHICH ACTIVE INGREDIENT QUETIAPINE FUMARATE USED|900000 Numbers|7|QUETIAPINE FUMARATE EP / BP / IP / USP / PH. EUR.|374.76 kg.|

UDIN00584001AM25

IS 6855.000 KGS.])

Case No.	82 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	HINDYS LAB PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00001037AM24
RA File Number	09AX04001157 AM23
Licence No and<br>Date	0911005091/23/05/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|09AX04001157 AM23| |Licence No and Date|0911005091/23/05/2023| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	83 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	AGRO SOLVENT PRODUCTS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00001107AM24
RA File Number	56AX04000449 AM23
Licence No and<br>Date	5611001909/25/05/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Certificate of Analysis (CoA) of import item from foreign supplier.<br>1.<br>Manufacturing process for each export item.<br>2.<br>Justification for 84% wastage for export item no. 3.<br>3.<br>Complete chemistry and molecular weight for export item no.3.<br>4.

UDIN00584001AM25

or each export item.** 2. Justification for 84% wastage for export item no. 3. 3. Complete chemistry and molecular weight for export item no.3. 4.||

UDIN00584001AM25

Case No.	84 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	AARTI PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00001158AM24
RA File Number	03AX04000849 AM24
Licence No and<br>Date	0311024010/29/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>ETHANOL<br>0.746 kg.<br>2<br>SO3<br>1.29 kg.<br>3<br>SODIUM SULPHATE<br>0.114 kg.<br>DI ETHYL SULPHATE<br>1 kg.<br>4<br>UREA<br>0.19 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	85 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	UNITED MUD-CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00001185AM24
RA File Number	03AX04000897 AM24
Licence No and<br>Date	0311024056/30/05/2023

UDIN00584001AM25

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.
RHEOLOGY MODIFIER	200 MT	1	Dimer Acid	164.96 MT

Case No.	Case No.	86 / NC/3/MEET/Jan/202425/15	86 / NC/3/MEET/Jan/202425/15	86 / NC/3/MEET/Jan/202425/15	86 / NC/3/MEET/Jan/202425/15	86 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		MAYA BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00001225AM24
RA File Number		30AX04000609 AM23
Licence No and<br>Date		3011003608/31/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.NC/3/MEET/Dec/202324/17 dated 20/12/2023against advance<br>authorizationNo.3011002599 dated 19/09/2022, it was decided to fix ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<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 Urokinase 1043.46 mg. 2 Mannitol 0.5% 128.52 gm. 3 Sodium Chloride (50 mg/vial) 128.52 gm. Injection Urokinase 1000 Vials 4 Sodium Hydroxide 3.06 gm.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Injection Urokinase||1000 Vials|1|Urokinase|1043.46 mg.| |||||2|Mannitol 0.5%|128.52 gm.| |||||3|Sodium Chloride (50 mg/vial)|128.52 gm.| |||||4|Sodium Hydroxide|3.06 gm.|

UDIN00584001AM25

Case No.	87 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00001205AM24
RA File Number	03AX04000864 AM24
Licence No and<br>Date	0311024068/31/05/2023
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to fix ad-hoc norms as under:-<br>**Sl.

ecision: The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of information provided by the firm, it was decided to fix ad-hoc norms as under:- Sl. No Export Product Quantity 1 Medical cream, ointment, gel(Betamethasone Dipropionate Cream USP 0.05% 15 gm tube(Wt 2352.96 Kgs Net cont: Sodiumpho7.06Kgs, polyoxyl42.35Kgs, ceto169.41Kgs, petrolatum 352.94kgs ,Minoil 141.18Kgs, Prevantol 2.35Kgs, Propylene 117.65Kgs,Betameth1.65kgs, Tubes 156864 Nos)) 1 Number 2 Medical cream, ointment, gel(Betamethasone Dipropionate Cream USP 0.05% 45 gm tube (Wt 2352.92 Kgs Net cont: Sodiumpho 7.06Kgs, polyoxyl 42.35Kgs, ceto 169.41Kgs, petrolatum 352.94kgs, Minoil 141.17Kgs, Prevantol 2.35Kgs, Propylene 117.65Kgs, Betameth1.65kgs, Tubes 52287 Nos)) 1 Number 3 Medical cream, ointment, gel(Betamethasone Dipropionate Ointment USP 0.05% 15 Gm (Wt 2941.16 Kgs Net cont: Petrolatum 2909.98 kgs, Min oil 29.41Kgs, Betameth 1.76Kgs, kgs, Tubes 196077 Nos)) 1 Number 4 Medical cream, ointment, gel(Betamethasone Dipropionate Ointment USP 0.05% 45 Gm (Wt 2941.11 Kgs Net cont: Petrolatum 2909.93kgs, Min oil 29.41Kgs, Betameth 1.76 Kgs, kgs, Tubes 65358 Nos)) 1 Number Name: Medical cream, ointment, gel(Betamethasone Dipropionate USP Ointment Aug 0.05% 15 Gm tube (Wt 589.50 Kgs Netcont: Petrolatum 483.04 5 1 Number||

UDIN00584001AM25

1 Number Name: Medical cream, ointment, gel(Betamethasone Dipropionate USP Ointment Aug 0.05% 15 Gm tube (Wt 589.50 Kgs Netcont: Petrolatum 483.04 5 1 Number||

UDIN00584001AM25

kgs, White Wax 35.37 Kgs, Propylene Glycol 11.79 Kgs, Propylene USP<br>58.95Kgs Betameth 0.35kgs, Tubes 39300 Nos))<br>6<br>Medical cream, ointment, gel(Betamethasone Dipropionate USP Ointment Aug<br>0.05% 45 Gm tube (Wt 589.50 Kgs Netcont : Petrolatum 483.04kgs,<br>WhiteWax35.37Kgs,<br>PropyleneGlycol11.79Kgs,<br>Propylene<br>USP58.95Kgs<br>Betameth0.35kgs, Tubes13100 Nos))<br>1 Number<br>S. No<br>Import Product<br>Quantity allowed.<br>1<br>Relevant Bulk Drugs<br>Net content in the export product plus 2% wastage.<br>2<br>Relevant Excipients<br>Net content in the export product plus 2% wastage.<br>3<br>Relevant Packaging Material<br>Relevant as per Packing Policy & General Notes.<br>Note:<br>The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA<br>concerned for redemption.<br>i.<br>RA concerned may take further necessary action as per above decision of NC.		kgs, White Wax 35.37 Kgs, Propylene Glycol 11.79 Kgs, Propylene USP<br>58.95Kgs Betameth 0.35kgs, Tubes 39300 Nos))	kgs, White Wax 35.37 Kgs, Propylene Glycol 11.79 Kgs, Propylene USP<br>58.95Kgs Betameth 0.35kgs, Tubes 39300 Nos))	1 Number

USP 58.95Kgs Betameth 0.35kgs, Tubes 39300 Nos))|kgs, White Wax 35.37 Kgs, Propylene Glycol 11.79 Kgs, Propylene USP 58.95Kgs Betameth 0.35kgs, Tubes 39300 Nos))|1 Number| |---|---|---|---|---| ||6|Medical cream, ointment, gel(Betamethasone Dipropionate USP Ointment Aug 0.05% 45 Gm tube (Wt 589.50 Kgs Netcont : Petrolatum 483.04kgs, WhiteWax35.37Kgs, PropyleneGlycol11.79Kgs, Propylene USP58.95Kgs Betameth0.35kgs, Tubes13100 Nos))||| |||||| ||S. No|Import Product|Quantity allowed.|| ||1|Relevant Bulk Drugs|Net content in the export product plus 2% wastage.|| ||2|Relevant Excipients|Net content in the export product plus 2% wastage.|| ||3|Relevant Packaging Material|Relevant as per Packing Policy & General Notes.||

Note:

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

Case No.	88 / NC/3/MEET/Jan/202425/15
Case Status	Case Rejected
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00001246AM24
RA File Number	09AX04000952 AM23
Licence No and<br>Date	0911005147/01/06/2023
Norms Committee Decision:<br>The firm vide letter dated 01/06/2023 has informed that they have surrendered their above license to RA.

81 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-02-2025 11:52:09.

UDIN00584001AM25

Therefore, the Committee decided to close the application of the firm.

Case No.	89 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	SHREE GANESH REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00001244AM24
RA File Number	34AX04000140 AM24
Licence No and<br>Date	3411003769/01/06/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it has been observed the<br>firm has not furnished the complete reply of DL as sought by the Committee during the meeting held on<br>30/04/2024.

d the request of firm for fixation of ad-hoc norms and it has been observed the firm has not furnished the complete reply of DL as sought by the Committee during the meeting held on 30/04/2024. Hence it was decided to call for following information/documents from the firm:- Percentage yield at every stage of reaction. 1. Stichometric balance between import and export to arrive at the norms applied for. 2.||

Case No.	Case No.	Case No.	90 / NC/3/MEET/Jan/202425/15	90 / NC/3/MEET/Jan/202425/15
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number			HQRNORM APPLY 00001233AM24
RA File Number			03AX04000925 AM24
Licence No and<br>Date			0311024109/01/06/2023
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 :-<br>Sl.<br>Export Product<br>Quantity
	Sl.	Export Product		Quantity

UDIN00584001AM25

No
(i)	CLOTRIMAZOLE OINTMENT 1 % 20G Tot Wt: 7440 kgs (Net Cont: Clotri	<br>1 Number
	79.35Kgs, Cetomacro 171.86Kgs, Ceto 559.49Kgs)(Medicinal Cream /
	Ointments)

No
(i)	CLOTRIMAZOLE OINTMENT 1 % 20G Tot Wt: 7440 kgs (Net Cont: Clotri	<br>1 Number
	79.35Kgs, Cetomacro 171.86Kgs, Ceto 559.49Kgs)(Medicinal Cream /
	Ointments)

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	Relevant as per Packing Policy and General Notes.

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

Case No.	91 / NC/3/MEET/Jan/202425/15
Case Status	Case Rejected
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM REVIW00001056AM25
RA File Number	09AX04000845 AM23
Licence No and<br>Date	0911005139/01/06/2023
Norms Committee Decision:<br>The firm vide letter dated 09/11/2-024 has informed that they have surrendered their above license to RA.<br>Therefore, the Committee decided toclosethe application of the firm.

83 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-02-2025 11:52:09.

UDIN00584001AM25

Case No.	92 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00001261AM24
RA File Number	03AX04000895 AM24
Licence No and<br>Date	0311024147/02/06/2023
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. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Ortho Chloro Phenyl Diphenyl Chloromethane 1.03 kg. Clotrimazole USP / BP / EP / IH 1 kg. 2 Imidazole 0.310 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	93 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00001260AM24
RA File Number	03AX04000922 AM24
Licence No and<br>Date	0311024145/02/06/2023
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

UDIN00584001AM25

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>1.03 kg.
			Chloromethane
		2	Imidazole	0.310 kg.

. No.**|Import Items|Qty. allowed.| |---|---|---|---|---| |Clotrimazole USP / BP / EP / IH|1 kg.|1|Ortho Chloro Phenyl Diphenyl| 1.03 kg.| ||||Chloromethane|| |||2|Imidazole|0.310 kg.|

Case No.	Case No.	94 / NC/3/MEET/Jan/202425/15
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number		HQRNORM APPLY 00001257AM24
RA File Number		03AX04000921 AM24
Licence No and<br>Date		0311024140/02/06/2023
Norms Committee Decision:
The Committee considered the request of firm for fixation of ad-hoc norms and on the basis of information provided
by the firm, it was decided to fix ad-hoc norms as under:-
	Sl. No<br>Export Product		Quantity
	1<br>MEDICAL CREAM OINTMENT GEL(Clotrimazole 1 % Cream 1/2 OZ 14 Gm Tube Tot		<br>1 Number
	Wt: 840Kgs (Net Cont: Clotri 8.62Kgs, Ceto 84Kgs, Octy 113.4Kgs, Cetyl 25.20Kgs,
	Sorb 16.80Kgs, Poly 12.60Kgs, Benzyl 8.4Kgs))
	2<br>MEDICAL CREAM OINTMENT GEL(Clotrimazole 1 % Cream 1 OZ 28 Gm Tube Tot		1 Number
	Wt: 5320.00Kgs (Net Cont: Clotri 54.56Kgs, Ceto 532Kgs, Octy 718.20Kgs, Cetyl
	159.60Kgs, Sorb 106.40Kgs, Poly 79.80Kgs, Benzyl 53.20Kgs))
	MEDICAL CREAM OINTMENT GEL(Clotrimazole 1 % Cream 45 Gm Tube with 1<br>3			1 Number

UDIN00584001AM25

0Kgs, Cetyl||||| ||159.60Kgs, Sorb 106.40Kgs, Poly 79.80Kgs, Benzyl 53.20Kgs))||||| ||MEDICAL CREAM OINTMENT GEL(Clotrimazole 1 % Cream 45 Gm Tube with 1 3|||1 Number||

UDIN00584001AM25

	Applicator Tot Wt: 45Kgs (Net Cont: Clotri 0.46 Kgs, Ceto 4.50 Kgs, Octy 6.08Kgs,
	Cetyl 1.35Kgs, Sorb 0.90Kgs, Poly 0.68Kgs, Benzyl 0.45Kgs, App 1000 Nos))
4	MEDICAL CREAM OINTMENT GEL(Clotrimazole 1 % Cream 45 Gm Tube with 7	1 Number
	Applicator Tot Wt: 1530Kgs (Net Cont: Clotri 15.69 Kgs, Ceto 153 Kgs, Octy 206.55
	Kgs, Cetyl 45.90 Kgs, Sorb 30.60Kgs, Poly 22.95Kgs, Benzyl 15.30Kgs, App 34000
	Nos))

S. No	Import Product	Quantity allowed.
1	Relevant Bulk Drugs	Net content in the export product plus 2% wastage.
2	Relevant Excipients	Net content in the export product plus 2% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy & General Notes.

Note:

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

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

Case No.	95 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	AARTI PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00001283AM24
RA File Number	03AX04000485 AM24
Licence No and<br>Date	0311024202/05/06/2023
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

86 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-02-2025 11:52:09.

UDIN00584001AM25

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
DI ETHYL SULPHATE	1 kg.	1	ETHANOL	0.746 kg.
		2	SO3	1.29 kg.
		3	SODIUM SULPHATE	0.114 kg.
		4	UREA	0.19 kg.

Qty.|Sl. No.|Import Items|Qty. allowed.| |---|---|---|---|---| |DI ETHYL SULPHATE|1 kg.|1|ETHANOL|0.746 kg.| |||2|SO3|1.29 kg.| |||3|SODIUM SULPHATE|0.114 kg.| |||4|UREA|0.19 kg.|

Case No.	96 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00001348AM24
RA File Number	08AX04000333 AM24
Licence No and<br>Date	0811008323/06/06/2023
Norms Committee Decision:<br>The Committee considered the cases as per agenda. The representatives of the firm had attended the<br>Personal Hearing through Video Conference The representative of the firm explained their case and also<br>furnish the information required by TE.<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	97 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	INTIGREAT CONSULTING SERVICES LLP

UDIN00584001AM25

Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00001324AM24
RA File Number	03AX04000737 AM24
Licence No and<br>Date	0311024265/06/06/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

|RA File Number|03AX04000737 AM24| |Licence No and Date|0311024265/06/06/2023| |Norms Committee Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	98 / NC/3/MEET/Jan/202425/15
Case Status	Case Deferred
Party Name	SHILPA PHARMA LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00001330AM24
RA File Number	07AX04000315 AM24
Licence No and<br>Date	0711007735/06/06/2023
Norms Committee Decision:<br>The case is under consideration and TE was requested to expedite his comments.

Case No.	99 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00001425AM24
RA File Number	03AX04000550 AM24
Licence No and<br>Date	0311024389/09/06/2023
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 :-

88 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-02-2025 11:52:09.

UDIN00584001AM25

ream/Ointments and accordingly decided to fix the ad-hoc norms as under :-||

88 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-02-2025 11:52:09.

UDIN00584001AM25

Sl. No	Export Product	Quantity
(i)	MEDICAL CREAM OINTMENT GEL(Ozonol Ointment 30 Gm Tube (Net	1 Number
	Wt: 999.99 Kgs Wax 72 Kgs, Pharmalan 86.90 Kgs, Ichthammol 2.90 Kgs,
	Orig Oil 4.10 Kgs, Tubes 33333 Nos))
(ii)	MEDICAL CREAM OINTMENT GEL(Ozonol Ointment 60 Gm Tube (Net	1 Number
	Wt: 2000.04 Kgs Wax 144 Kgs, Pharmalan 173.80 Kgs, Ichthammol 5.80
	Kgs, Orig Oil 8.20Kgs, Tubes 33334 Nos))

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	Relevant as per Packing Policy and General Notes.

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

Case No.	100 / NC/3/MEET/Jan/202425/15
Case Status	Case Approved
Party Name	UNIMAX LABORATORIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Jan/ 202425/ 15 and 28/01/2025
HQ File Number	HQRNORM APPLY 00001505AM24
RA File Number	05AX04000673 AM24
Licence No and<br>Date	0511019298/12/06/2023
Norms Committee Decision:

89 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-02-2025 11:52:09.

UDIN00584001AM25

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/202324/25 dated 11/03/2024 against advance authorization No.0511022259 dated 24/11/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

advance authorization No.0511022259 dated 24/11/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Azithromycin Tablets 250 mg<br>IP(Each tablet contains :<br>Azithromycin IP (As Dihydrate) Eq.<br>to Anhydrous Azithromycin)	1 Number	1	Azithromycin Dihydrate<br>IP	267.27 mg.
Azithromycin Tablets 500 mg<br>IP(Each tablet contains :<br>Azithromycin IP (As Dihydrate) Eq.<br>to Anhydrous Azithromycin)	1 Number	2	Azithromycin Dihydrate<br>IP	534.54 mg.
Spiramycin Tablets 1.5 MIU(Each<br>tablet contains Spiramycin EP 1.5<br>million i.u. Eq. to (379.12 mg /<br>tablet))	1 Number	3	Spiramycin EP	373.02 mg.
Spiramycin Tablets 3.0 MIU(Each<br>tablet contains Spiramycin EP 1.5<br>million i.u. Eq. to (758.24 mg /<br>tablet))	1 Number	4	Spiramycin EP	Does not match with<br>DML
Azithromycin Tablets 250 mg<br>USP(Each tablet contains :<br>Azithromycin USP (As Dihydrate)<br>Eq. to Anhydrous Azithromycin)	1 Number	5	Azithromycin Dihydrate<br>USP	267.27 mg.
Azithromycin Tablets 500 mg<br>USP(Each tablet contains :<br>Azithromycin USP (As Dihydrate)<br>Eq. to Anhydrous Azithromycin)	1 Number	6	Azithromycin Dihydrate<br>USP	534.54 mg.

UDIN00584001AM25

91 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-02-2025 11:52:09.

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

Analysis

No analysis generated for this document yet (analysis runs over brief docs + on-demand). Run build_analysis.py --ids 8073 --apply.