IN FORCE Advance Authorisation

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Government of India / भारत सरकार

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

Directorate General of Foreign Trade, Delhi / िवदेश व्यापार महािनदेशालय, िदल्ली VANIJYA BHAWAN, AKBAR ROAD, CENTRAL DELHI, DELHI, 110011 / वािणज्य भवन, अकबर रोड, नई िदल्ली Email Office : dgft@nic.in , Phone Office : 011-23062777

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Mar/202324/25 DATED: 11/03/2024

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:
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/Mar/202324/25 dated 11/03/2024 of Norms Committee - III for the year 2023-24 was held on 11/03/2024 under the Chairmanship of to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

cations for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

	Name and Designation of Representatives
1	UTTAM SARKAR,Assistant Section Officer	DGFT(HQ)
2	Raman Kumar,Deputy DGFT	DGFT(HQ)
3	NAND Lal,Technical Consultant	DPIIT
4	SHAISH KUMAR,Technical Consultant	DGFT
5	DINESHNARAIN MATHUR,Technical<br>Consultant	DGFT
6	Nand Lal,Technical Consultant	DGFT

1 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-03-2024 12:32:57.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	MEDREICH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006691AM24
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it has been observed that Advance Authorisation<br>appears to be old. The export and import quantity given in the application are not matching. DML and MBF are not<br>available to check. Therefore, it was decided to call the firm for attendingPersonal Hearing<br>before Norms<br>Committee to explain its case along with following information / documents from the firm:-<br>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.<br>Details of indigenous input with quantity.<br>v.<br>Sample of shipping bills and bill of entry of the export products along with statement of Input-output as<br>per export documents of the said authorization.<br>vi.<br>Copy of Master Batch Formula<br>vii.<br>Copy of Drug Manufacturing License<br>viii.

g with statement of Input-output as** per export documents of the said authorization. vi. Copy of Master Batch Formula vii. Copy of Drug Manufacturing License viii.||

ii. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.

Case No.	Case No.	2 / NC/3/MEET/Mar/202324/25	2 / NC/3/MEET/Mar/202324/25	2 / NC/3/MEET/Mar/202324/25	2 / NC/3/MEET/Mar/202324/25	2 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		SMILAX LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM REVIW00008717AM24
RA File Number		NA
Licence No and<br>Date		NA
Norms Committee Decision:<br>The Committee considered the request of the firm for fixation of ad-hoc norms against Advance AuthorisationNo.<br>0910061527dated13/01/2015havingRA File No. 092404000574AM15and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol.1 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.

This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-03-2024 12:32:57.

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

This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-03-2024 12:32:57.

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(R)-3- (Tert-butyl dimethyl	1	Dimethyl-3-Hydroxy Glutarate	1.106 kg.
silyloxy)-pentane-dioic acid mono
tert-butyl ester (TB-17) (TERT-<br>BUTYL 3R-TERT-	2	Ditertbutyl Dicarbonate	1.564 kg.
BUTYL DIMETHYL SILYLOXY-
GLUTARATE)	3	Tertiary Butyl dimethyl Silyl Chloride	2.136 kg.
	4	Imidazole	1.319 kg.
	5	R-Phenylethyl amine	0.480 kg.
	6	Tertiary Butanol	1.310 kg.

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

Case No.<br>3 / NC/3/MEET/Mar/202324/25
Case Status<br>Case Approved
Party Name<br>AQUILA ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number<br>HQRNORM REVIW00008898AM24
RA File Number<br>NA
Licence No and<br>Date<br>0310830783/null
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided
by the firm, it was decided to revise ad-hoc norms as under:-
Export Product	Qty.	Sl. No.	Import Items	**Qty.

ew 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.|| |7-Acetyl-1,1,3,4,6-Hexamethyl 1,2,3,4-Tetrahydro| 1 kg.|1|2,3 Dimethyl 1 Butene|1.19 kg.|| |Napthalene (GANOLID)|||||| |||2|PARACYMENE|1.03 kg.|| |RA concerned may take further necessary action as per above decision of NC.||||||

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Case No.	Case No.	4 / NC/3/MEET/Mar/202324/25	4 / NC/3/MEET/Mar/202324/25	4 / NC/3/MEET/Mar/202324/25	4 / NC/3/MEET/Mar/202324/25	4 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM REVIW00008782AM24
RA File Number		092404000481 AM16
Licence No and<br>Date		0910062849/10/11/2015
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>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.

	Simeprevir Sodium		1 kg	1	(2R3aR10Z11aS12aR14aR)-	120 kg
			.		,,,,,<br>2,3,3a,4,5,6,7,8,9,11a,12,13,14,14a-	.

Export Product*||Qty.|Sl. No.|Import Items|Qty. allowed.| |||||||| ||Simeprevir Sodium||1 kg|1|(2R3aR10Z11aS12aR14aR)-|120 kg| ||||.||,,,,, 2,3,3a,4,5,6,7,8,9,11a,12,13,14,14a-|. .| ||||||Tetradecahydro-2-[[7- methoxy-8-methyl-2-[4-(1-|| |RA|||||methylethyl)-2-thiazolyl]-4-quinolinyl]oxy]-5- methyl-4,14-dioxocyclopenta [c] cyclopropa [g][1,6]diazacyclotetradecine-12a(1H)-carboxylic acid|| ||concerned may take further necessary action as per above decision of NC.|||||| |||||||| |Cas|e No.|5 / NC/3/MEET/Mar/202324/25||||| |Cas|e Status|Case Deferred||||| |Par|ty Name|AETHER INDUSTRIES LIMITED||||| |Me and|eting Number Date|NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024||||| |HQ|File Number|HQRNORM REVIW00008734AM24||||| |RA|File Number|522404000036 AM18||||| |Lic Dat|ence No and e|5210042414/23/10/2017||||| |Nor Th|ms Committee Decision: e case is under consideration for want of comments of TE.|||||| |||||||| |Cas|e No.|6 / NC/3/MEET/Mar/202324/25||||| |Cas|e Status|Case Deferred||||| |Party Name||AETHER INDUSTRIES LIMITED|||||

Case No.	5 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM REVIW00008734AM24
RA File Number	522404000036 AM18
Licence No and<br>Date	5210042414/23/10/2017
Norms Committee Decision:
The case is under consideration for want of comments of TE.

REVIW00008734AM24| |RA File Number|522404000036 AM18| |Licence No and Date|5210042414/23/10/2017| |Norms Committee Decision:|| |The case is under consideration for want of comments of TE.||

Case No.	6 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED

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Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM REVIW00008733AM24
RA File Number	522404000016 AM19
Licence No and<br>Date	5210042638/10/05/2018
Norms Committee Decision:
The case is under consideration for want of comments of TE.

Case No.	7 / NC/3/MEET/Mar/202324/25
Case Status	Case Rejected
Party Name	PUROGENE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006886AM24
RA File Number	NA
Licence No and<br>Date	0910067074/18/01/2019
Norms Committee Decision:
The committee considered the request of firm and it was observed that the firm neither submitted their application in
the Head of (Review of norms) nor paid composition fees of Rs.5000/-. Therefore, the committee decided to
withdrawthe application of the firm and advised to submit their application in the Head of review of Norms on DGFT
Back Office Portal.

f Rs.5000/-. Therefore, the committee decided to|| |withdrawthe application of the firm and advised to submit their application in the Head of review of Norms on DGFT|| |Back Office Portal.||

Case No.<br>8 / NC/3/MEET/Mar/202324/25
Case Status<br>Case Approved
Party Name<br>AETHER INDUSTRIES LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number<br>HQRNORM REVIW00008735AM24
RA File Number<br>522404000085 AM19
Licence No and Date<br>5210043000/19/03/2019
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Feb/202324/23 dated 19/02/2024against advance authorization
No. 5210043441 dated 16/06/2020,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty. allowed.
1<br>4-METHYL-2-CYANOBIPHENYL<br>1 kg.	PARA CHLOROTOLUENE	1.34 kg..

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	2	TETRAHYDROFURAN	1.00 kg.
	3	2-CHLOROBENZONITRILE	1.235 kg.

allowed.**|| |1 4-METHYL-2-CYANOBIPHENYL 1 kg.|PARA CHLOROTOLUENE|1.34 kg..||

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	2	TETRAHYDROFURAN	1.00 kg.
	3	2-CHLOROBENZONITRILE	1.235 kg.


2<br>TETRAHYDROFURAN<br>1.00 kg.<br>3<br>2-CHLOROBENZONITRILE<br>1.235 kg.<br>RA concerned may take further necessary action as per above decision of NC.				2		TETRAHYDROFURAN	1.00 kg.
				3		2-CHLOROBENZONITRILE	1.235 kg.


Cas	e No.	9 / NC/3/MEET/Mar/20232	4/25
Cas	e Status	Case Deferred
Par	ty Name	VDH ORGANICS PRIVA	TE LIMITED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Mar/ 20232	4/ 25 and 11/0		3/2024
HQ	File Number	HQRNORM REVIW00008	896AM24
RA	File Number	052404000721 AM19
Lic<br>Dat	ence No and<br>e	0510410010/20/03/2019
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Pt Yild f ti<br>1	ms Committee Decision:
ercenage e o reacon<br>.<br>Stoichiometric balance on molar basis to arrive at the quantity of raw material asked.<br>2.<br>3. Copy of authorized technical literature.

|||| |ercenage e o reacon . Stoichiometric balance on molar basis to arrive at the quantity of raw material asked. 2. 3. Copy of authorized technical literature.|||||||||||


C N		10 / NC/3/MEET/M/202324/25
ase o.		ar
C S		C Rd
ase tatus		ase ejecte
P N		AARTI DRUGS LIMITED
arty ame
Meeting Number<br>d D		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
an ate
H Fil Nb		HRNORM REVIW00008627AM24
Q e umer		Q
RA Fil Nb		039404001134 AM19
e umer
Licence No and<br>D		0310829511/10/06/2019
ate
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not<br>provided any technical justification / information for enhancement. Hence, it was decided torejectthe case<br>maintaining thestatus quo.

Cas	e No.	11 / NC/3/MEET/Mar/202324/25
Cas	e Status	Case Deferred
Par<br>	ty Name<br>	CONCORD BIOTECH LIM<br>	ITED<br>
MeetingNumber		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024

Case No.	11 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	CONCORD BIOTECH LIMITED
MeetingNumber	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024

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ase No.	11 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	CONCORD BIOTECH LIMITED
MeetingNumber	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024

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and Date
HQ File Number	HQRNORM REVIW00008666AM24
RA File Number	082404000101 AM20
Licence No and<br>Date	0810145581/27/06/2019
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing
before Norms Committee to explain its case along with relevant documents from the firm.

Case No.	12 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	AVIK PHARMACEUTICAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM REVIW00008636AM24
RA File Number	039404000496 AM20
Licence No and<br>Date	0310831890/27/09/2019
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

Case No.	13 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	AVIK PHARMACEUTICAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM REVIW00008637AM24
RA File Number	039404000497 AM20
Licence No and<br>Date	0310831894/27/09/2019
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

IW00008637AM24| |RA File Number|039404000497 AM20| |Licence No and Date|0310831894/27/09/2019| |Norms Committee Decision:|| |The case is under|consideration for want of comments of TE.|

Case No.	14 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM REVIW00008587AM24
RA File Number	522404000007 AM21
Licence No and<br>Date	5210043401/22/05/2020
Norms Committee Decision:

7 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-03-2024 12:32:57.

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The committee considered the request of firm for review of ad-hoc norms and it was decided to call for following information/documents from the firm:-

i. Complete justification for higher norms asked for making the revised quantity.
ii. Production/Consumption data for the three years certified by Chartered Accountant.
iii. In Appendix-4E, the quantity of NN Dimethyl Foramide asked for is different from the license / application quantity and to give detailed justification of quantity requested for.

iii. In Appendix-4E, the quantity of NN Dimethyl Foramide asked for is different from the license / application quantity and to give detailed justification of quantity requested for.

Case No.	15 / NC/3/MEET/Mar/202324/25	15 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	MAC-CHEM PRODUCTS	(INDIA) PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM REVIW00008759AM24
RA File Number	NA
Licence No and<br>Date	0311000187/15/12/2020
Norms Committee Decision:
The Committee considered the request of firm		for fixation of ad-hoc norms and it was decided to fix ad-hoc norms under
Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product		Qty.<br>Sl. No. Import Items	Qty. allowed.
Hydrocortisone Sodium Succinate for		<br>1 kg.<br>1<br>HYDROCORTISON E IP/USP/EP	0.80 kg.
Injection((Lyophilised sterile Bulk))
RA concerned may take further necessary action as per above decision of NC.

Succinate for|| 1 kg. 1 HYDROCORTISON E IP/USP/EP|0.80 kg.|| |Injection((Lyophilised sterile Bulk))||||| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No.	16 / NC/3/MEET/Mar/202324/25
Case Status	Case Rejected
Party Name	MAHIMA LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM REVIW00008699AM24
RA File Number	05AA04029372 AM21
Licence No and<br>Date	0511001191/09/02/2021
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not
provided any technical justification / information for enhancement. Hence, it was decided torejectthe case

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maintaining the status quo.

Case No.	17 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM REVIW00008904AM24
RA File Number	31AA04007907 AM21
Licence No and<br>Date	3111000255/30/03/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>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. AMINO ETHYL PIPERAZINE (ORGANIC CHEMICAL) 1 kg 1 MONO ETHANOL AMINE 1.4186 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	18 / NC/3/MEET/Mar/202324/25	18 / NC/3/MEET/Mar/202324/25	18 / NC/3/MEET/Mar/202324/25	18 / NC/3/MEET/Mar/202324/25	18 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		GARUDA CHEMICALS
Meeting Number and<br>Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM REVIW00008758AM24
RA File Number		03AA04031910 AM21
Licence No and Date		0311003270/22/04/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

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MONOETHYLAMINE	MONOETHYLAMINE	70
HYDROCHIORIDE	PERCENTAGE	AQUEOUS
	SOLUTION IN LIQUID	FORM IN
(MEA-HCI) IN POWDER FORM	ISO TANKS

MONOETHYLAMINE	MONOETHYLAMINE	70
HYDROCHIORIDE	PERCENTAGE	AQUEOUS
	SOLUTION IN LIQUID	FORM IN
(MEA-HCI) IN POWDER FORM	ISO TANKS

Case No.	19 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM REVIW00008736AM24
RA File Number	52AA04008175 AM22
Licence No and<br>Date	5211001047/26/07/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	20 / NC/3/MEET/Mar/202324/25	20 / NC/3/MEET/Mar/202324/25	20 / NC/3/MEET/Mar/202324/25	20 / NC/3/MEET/Mar/202324/25	20 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM REVIW00008737AM24
RA File Number		52AA04012264 AM22
Licence No and<br>Date		5211001107/05/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Sep/202324/14dated27/09/2023against advance authorization<br>No. 5210043358 dated 06/03/2020,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.

d 06/03/2020,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. ORGANO-INORGANIC COMPOUNDS, HETEROCYCLIC COMPOUNDS, NECLEIC ACIDS AND THEIR SALTS AND 1 kg. 1 1, 5 PENTANEDIOL 1.486 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||ORGANO-INORGANIC COMPOUNDS, HETEROCYCLIC COMPOUNDS, NECLEIC ACIDS AND THEIR SALTS AND||1 kg.|1|1, 5 PENTANEDIOL|1.486 kg.|

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SULPHONAMIDES, DELTAVALEROLACTONE

Case No.	21 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM REVIW00008902AM24
RA File Number	31AX04000040 AM22
Licence No and<br>Date	3111000876/14/01/2022
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

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. AMINO ETHYL PIPERAZINE 1 kg. 1 MONO ETHANOL AMINE 1.4186 kg. 2 MONO ETHANOL AMINE 1.06 kg. ETHYLENEDIAMINE 1 kg 3 AMMONIA ANHYDROUS 0.294 kg. 4 MONO ETHANOL AMINE 1.184 kg. DI ETHYLENE TRI AMINE 1 kg 5 AMMONIA ANHYDROUS 0.165 kg. PIPERAZINE 1 kg 6 MONO ETHANOL AMINE 1.481 kg. AMINO ETHYL ETHANOL AMINE 1 kg 7 MONO ETHANOL AMINE 1.173 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00537223AM24

Case No.	22 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM REVIW00008588AM24
RA File Number	52AX04000039 AM23
Licence No and<br>Date	5211002485/13/05/2022

| |Meeting Number and Date|NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024| |HQ File Number|HQRNORM REVIW00008588AM24| |RA File Number|52AX04000039 AM23| |Licence No and Date|5211002485/13/05/2022| |Norms Committee Decision: The committee considered the request of firm for review of ad-hoc norms and it was decided to call for following information/documents from the firm:- Complete justification for higher norms asked for making the revised quantity. i. Production/Consumption data for the three years certified by Chartered Accountant. ii. In Appendix-4E, the quantity of**NN Dimethyl Foramide asked for is different from the license /** application quantity and to give detailed justification of quantity requested for. iii.||

Case No.	23 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM REVIW00008738AM24
RA File Number	52AX04000220 AM23
Licence No and Date	5211002594/03/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Feb/202324/23 dated 19/02/2024against advance authorization<br>No5210043427 dated 09/06/2020,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.

d 09/06/2020,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 2, 6 DICHLOROTOLUENE 1.42 kg. ORGANIC-AROMATIC ETHERS AND THEIR HALOGENATED, SULPHONATED, NITRATED OR NITROSATED DERIVATES:2- METHOXY-6-CHLOROTOLUENE 1 kg. 2 DIMETHYLSULFOXIDE 0.66 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00537223AM24

Case No.	24 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	GUJARAT FLUOROCHEMICALS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006792AM24
RA File Number	NA
Licence No and Date	3411002592/29/07/2022
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

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 METHANOL IN BULK 0.729 MT 2 Fluorspar Containing by weight more than 97 Percent of calcium fluoride 2.809 MT 3 CHLOROFORM 0.330 MT 4 SILICA GEL IMPORTED MODEL FNG-1 0.0003 MT 5 SILICA GEL MODEL-A 0.00007 MT 6 ALUMINA CATALYST 55659368 0.00005 MT PENTAFLUOROETHANE (HFC-125) PENTAFLUOROETHANE,R125, ISO TANK 1.0 MT 7 TRIBUTYLAMINE 0.04 MT RA concerned may take further necessary action as per above decision of NC.||

Case No.	25 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	ARCH PROTECTION CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024

UDIN00537223AM24

HQ	File Number	HQRNO
RA	File Number	NA
Licence No and<br>Date
		0311021465/15/02/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

| |RA|File Number|NA||||| |Licence No and Date||||||| |||0311021465/15/02/2023||||| |Norms Committee Decision: The case is under consideration for want of comments of TE.||||||| ||||||||

Case No.	26 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006570AM24
RA File Number	03AX04003275 AM24
Licence No and<br>Date	0311028379/01/11/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing
before Norms Committee to explain its case along relevant documents from the firm.

Case No.	27 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006571AM24
RA File Number	03AX04003274 AM24
Licence No and<br>Date	0311028380/01/11/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing
before Norms Committee to explain its case along relevant documents from the firm.

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

Case No.	28 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006591AM24
RA File Number	03AX04003361 AM24
Licence No and<br>Date	0311028403/02/11/2023
Norms Committee Decision:

14 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-03-2024 12:32:57.

UDIN00537223AM24

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

Case No.	29 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006592AM24
RA File Number	03AX04003362 AM24
Licence No and<br>Date	0311028404/02/11/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case along relevant documents from the firm.		Personal Hearing

tee considered the case as per agenda and it was decided to call the firm for attending before Norms Committee to explain its case along relevant documents from the firm.||Personal Hearing|

Case No.	Case No.	30 / NC/3/MEET/Mar/202324/25	30 / NC/3/MEET/Mar/202324/25	30 / NC/3/MEET/Mar/202324/25	30 / NC/3/MEET/Mar/202324/25	30 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00006595AM24
RA File Number		08AX04001379 AM24
Licence No and<br>Date		0811009841/02/11/2023
Norms Committee Decision:<br>Decision:The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-<br>hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Opipramol Dihydrochloride Tablets 50<br>MG (OPIPRAMOL HEUMANN 50<br>MG)(Each film coated tablet contains:<br>Opipramol Dihydrochloride 50 mg<br>Excipient..q.s. Net content of active<br>ingredient Opipramol Dihydrochloride<br>should not be less than 95.00 kgs in<br>export product.)<br>1900000<br>Numbers<br>1<br>Opipramol Dihydrochloride<br>96.9 kg.<br>Opipramol Dihydrochloride Tablets 100<br>980000<br>2<br>Opipramol Dihydrochloride<br>100.00 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

hydrochloride 96.9 kg. Opipramol Dihydrochloride Tablets 100 980000 2 Opipramol Dihydrochloride 100.00 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Opipramol Dihydrochloride Tablets 50 MG (OPIPRAMOL HEUMANN 50 MG)(Each film coated tablet contains: Opipramol Dihydrochloride 50 mg Excipient..q.s. Net content of active ingredient Opipramol Dihydrochloride should not be less than 95.00 kgs in export product.)||1900000 Numbers|1|Opipramol Dihydrochloride|96.9 kg.| ||Opipramol Dihydrochloride Tablets 100||980000|2|Opipramol Dihydrochloride|100.00 kg.|

UDIN00537223AM24

MG (OPIPRAMOL HEUMANN 100<br>MG)(Each film coated tablet contains:<br>Opipramol Dihydrochloride 100 mg<br>Excipients…q.s. Net content of active<br>ingredient Opipramol Dihydrochloride<br>should not be less than 98.000 kgs in<br>export product.)<br>Numbers	MG (OPIPRAMOL HEU<br>MG)(Each film coated ta<br>Opipramol Dihydrochlor<br>Excipients…q.s. Net con	MANN 1<br>blet conta<br>ide 100 m<br>tent of act	00<br>ins:<br>g<br>ive		Numbers
	ingredient Opipramol Dihydrochloride<br>should not be less than 98.000 kgs in<br>export product.)
RA concerned may take further necessary action as per above decision of NC.

| ||ingredient Opipramol Dihydrochloride should not be less than 98.000 kgs in export product.)|||||||| |RA concerned may take further necessary action as per above decision of NC.|||||||||


Case No		31 / NC/3/MEET/Mar/202324/25
.
Case Status		Case Aroved
		pp
Part Name		TORRENT PHARMACEUTICALS LTD
y
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024

HQ File Number		HQRNORM APPLY 00006596AM24

RA File Number		08AX04001392 AM24

Licence No and<br>Date		0811009842/02/11/2023

Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Metamizole Sodium, Pitofenone<br>Hydrochloride &Fenpiverinium Bromide<br>Tablets. (Spasmalin Tablets<br>500mg).(Each coated tablet contains 500<br>MG of Metamizole Sodium B P mg<br>Excipients...as per q.s. Net content of<br>Metamizole Sodium B P should not be<br>less that 9000.00 kg in export item.)<br>1800000<br>Numbers<br>1<br>Metamizole Sodium B. P.<br>9180 kg.<br>Metamizole Sodium, Pitofenone<br>Hydrochloride &Fenpiverinium Bromide<br>Tablets.

not be less that 9000.00 kg in export item.) 1800000 Numbers 1 Metamizole Sodium B. P. 9180 kg. Metamizole Sodium, Pitofenone Hydrochloride &Fenpiverinium Bromide Tablets. (Spasmalin Tablets 500mg).(Each coated tablet contains 500 MG of Metamizole Sodium B P mg Excipients...as per q.s. Net content of Metamizole Sodium B P should not be 10000000 Numbers 2 Metamizole Sodium B. P. 5100 kg.||||||||||| |||||||||||| ||Export Product||Qty.|S|**l. No. **|Imp|ort Items|||Qty. allowed.| |||||||||||| ||Metamizole Sodium, Pitofenone Hydrochloride &Fenpiverinium Bromide Tablets. (Spasmalin Tablets 500mg).(Each coated tablet contains 500 MG of Metamizole Sodium B P mg Excipients...as per q.s. Net content of Metamizole Sodium B P should not be less that 9000.00 kg in export item.)||1800000 Numbers|1||Met|amizole So|dium B. P.||9180 kg.| |||||||||||| ||Metamizole Sodium, Pitofenone Hydrochloride &Fenpiverinium Bromide Tablets. (Spasmalin Tablets 500mg).(Each coated tablet contains 500 MG of Metamizole Sodium B P mg Excipients...as per q.s. Net content of Metamizole Sodium B P should not be 10000000 Numbers 2|||||||||| ||||10000000 Numbers|2||Met|amizole So|dium B. P.||5100 kg.| ||||||||||||

UDIN00537223AM24

less that 5000.00 kg in export item.)

P should not be 10000000 Numbers 2|||||||||| ||||10000000 Numbers|2||Met|amizole So|dium B. P.||5100 kg.| ||||||||||||

UDIN00537223AM24

less that 5000.00 kg in export item.)

Case No.	32 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006599AM24
RA File Number	03AX04003360 AM24
Licence No and<br>Date	0311028414/02/11/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing
before Norms Committee to explain its case along relevant documents from the firm.

Case No.<br>33 / NC/3/MEET/Mar/202324/25
Case Status<br>Case Approved
Party Name<br>YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202324/ 25 and	11/03/2024
HQ File Number<br>HQRNORM APPLY 00006624AM24
RA File Number<br>03AX04003548 AM24
Licence No and<br>Date<br>0311028480/03/11/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo. NC/3/MEET/Feb/202324/23dated19/02/2024against advance authorization
No. 0311029216 dated 26/10/2023,it was decided to	fix ad-hoc norms under Para 4.07 of HBP Vol.

meetingNo. NC/3/MEET/Feb/202324/23dated19/02/2024against advance authorization||||| |No. 0311029216 **dated 26/10/2023,**it was decided to|fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details|||| |given below or as applied by the firm, whichever is less:-||||| |Export Product Qty.|**Sl. No. **|Import Items|Qty. allowed.|| |2,5-bis-( Tert-Nonyldithio)-1,3,4,- 1 kg.|1|HYDRAZINE HYDRATE 80%|0.134 kg.|| |thiadizole( YALUB DM -113)(2,5-bis-||(H.H)||| |( Tert-Nonyldithio)-1,3,4,-thiadizole||||| |(YALUB DM -113))||||| ||2|CARBON DISULPHIDE|0.3502 kg.||

Case No.<br>33 / NC/3/MEET/Mar/202324/25
Case Status<br>Case Approved
Party Name<br>YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202324/ 25 and	11/03/2024
HQ File Number<br>HQRNORM APPLY 00006624AM24
RA File Number<br>03AX04003548 AM24
Licence No and<br>Date<br>0311028480/03/11/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo. NC/3/MEET/Feb/202324/23dated19/02/2024against advance authorization
No. 0311029216 dated 26/10/2023,it was decided to	fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	**Qty.

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.|| |2,5-bis-( Tert-Nonyldithio)-1,3,4,- 1 kg.|1|HYDRAZINE HYDRATE 80%|0.134 kg.|| |thiadizole( YALUB DM -113)(2,5-bis-||(H.H)||| |( Tert-Nonyldithio)-1,3,4,-thiadizole||||| |(YALUB DM -113))||||| ||2|CARBON DISULPHIDE|0.3502 kg.||

UDIN00537223AM24

	3	TERT -NONYL MERCAPTAN (S-	0.700 kg.
		MERCAPTAN)

Case No.	34 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006633AM24
RA File Number	03AX04003515 AM24
Licence No and<br>Date	0311028487/04/11/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

Case No.	35 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006646AM24
RA File Number	34AX04000591 AM24
Licence No and<br>Date	3411004295/06/11/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for
following information/documents from the firm:-
Copy of Master Batch Formula showing net content of all inputs in the export products.<br>1.

ad-hoc norms and it was decided to call for|| |following information/documents from the firm:-|| |Copy of Master Batch Formula showing net content of all inputs in the export products. 1.||

Case No.	36 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	COPMED PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006677AM24
RA File Number	05AX04002347 AM24
Licence No and<br>Date	0511021908/07/11/2023

UDIN00537223AM24

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:-

|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:-|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:-|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:-|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:-|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:-|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.

below or as applied by the firm, whichever is less:-|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:-|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:-|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:-|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:-|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:-|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 Produ|ct||Qty.||Sl. No.||Import Items|**Qty.

etails given below or as applied by the firm, whichever is less:-| |---|---|---|---|---|---|---|---|---|---|---| |||||||||||| ||Export Produ|ct||Qty.||Sl. No.||Import Items|Qty. allowed.|| |||||||||||| |||||||||||| ||Moxikind-CV and Potassium|375 Tablets (Amoxicillin Clavulanate Tablets BP|| 1 Number||1||CLAVULANATE POTASSIUM + MICRO| 303.773 mg.|| ||250/125 mg)|||||||CRYSTALLINE||| |||||||||CELLULOSE (1:1) I.P. / EP ||| |||||||||/ USP||| |||||||||||| ||Moxikind-CV 625 Tablets (Amoxicillin and Potassium Clavulanate Tablets BP 500/125 mg)||| 1 Number||2||CLAVULANATE POTASSIUM + MICRO CRYSTALLINE | 303.773 mg.|| |||||||||CELLULOSE (1:1) I.P. / EP / USP||| ||Moxikind-CV 1000 Tablets ||| 1 Number||3||CLAVULANATE | 303.773 mg.|| ||(Amoxicillin |and Potassium ||||||POTASSIUM + MICRO ||| ||Clavulanate T|blets BP 875/125 mg)||||||CRYSTALLINE CELLULOSE (1:1) IP / EP||| |||||||||.. / USP||| |||||||||||| |||||||||||| ||Moxikind-CV |457 (Amoxicillin and || 1 Number||4||CLAVULANATE | 2828.386 mg.|| ||Potassium Cla BP 400/5|vulanate Oral suspension h 5l 100 ML||||||POTASSIUM + SILICON DIOXIDE 11 IP / EP /| || ||7 mg|eac m)||||||(:) .. USP||| |RA||||||||||| ||Moxikind-CV 228.5 (Amoxicillin and Potassium Clavulanate Oral suspension BP 200/28.5 mg each 5ml) 100 ML||| 1 Number||5||CLAVULANATE POTASSIUM + SILICON DIOXIDE (1:1) I.P.

||||| ||Moxikind-CV 228.5 (Amoxicillin and Potassium Clavulanate Oral suspension BP 200/28.5 mg each 5ml) 100 ML||| 1 Number||5||CLAVULANATE POTASSIUM + SILICON DIOXIDE (1:1) I.P. / EP / USP| 1414.193 mg|| |||||||||||| ||concerned may take further necessary a||ction as p||er above||decision of NC.|||| |||||||||||| |Cas||||||||||| ||e No.|37 / NC/3/MEET/Mar/20|2324/25|||||||| |Cas|e Status|Case Approved||||||||| |Par|ty Name|ALEMBIC PHARMACE|UTICAL||S LIMIT||ED|||| |||||||||||| |Me and|eting Number Date|NC/ 3/ MEET/ Mar/ 202|324/ 25 an||d 11/03/||2024|||| |HQ|File Number|HQRNORM APPLY 00006682AM|||24|||||| |RA|File Number|34AX04000610 AM24||||||||| |||||||||||| |Licence No and Date||3411004316/07/11/2023|||||||||

Case No.	37 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006682AM24
RA File Number	34AX04000610 AM24
Licence No and<br>Date	3411004316/07/11/2023

UDIN00537223AM24

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:-

below or as applied by the firm, whichever is less:-|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:-|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.| ||Lidocaine and Prilocaine Cream USP 2.5%||1000000|1|Lidocaine USP|127.49 kg.| ||and 2.5% 5 gm|Tube(Lidocaine and Prilocaine| Numbers|||| |||||||| ||Cream USP 2. |5% and 2.5% 5 gm Tube (Net ||2|Prilocaine Base USP|12749 k| ||content of acti |ve ingredients 125.00 kgs and||||. g.| ||125.00 kgs))|||||| |||||||| ||Lidocaine and|Prilocaine Cream USP 2.5%|1150000|3|Lidocaine USP|879.74 kg.| ||and 2.5% 30 g|m tube(Lidocaine and|Numbers|||| |||||||| ||Prilocaine Cre tube (Net cont |am USP 2.5% and 2.5% 30 gm ent of active ingredients ||4|Prilocaine Base USP|879.74 kg.| ||862.500 kgs and 862.500 kgs))|||||| ||Lidocaine Ointment USP 5% 30 gm ||5000 |5|Lidocaine USP|7.64 kg.| ||tube(Lidocaine Ointment USP 5% 30 gm tube (Net content of active ingredients 7.5 kgs ))||Numbers|||| ||Lidi Oi|t USP 5% 3544|5000|6|Lidi USP|903 k| ||ocane n tube(Lidocain|men . gm e Ointment USP 5% 3544 gm| Numbers||ocane|.

br>(Net content of active ingredients 7.5 kgs ))||Numbers|||| ||Lidi Oi|t USP 5% 3544|5000|6|Lidi USP|903 k| ||ocane n tube(Lidocain|men . gm e Ointment USP 5% 3544 gm| Numbers||ocane|. g.| || tube (Net cont|. ent of active ingredients 8.86||||| || kgs))|||||| |||||||| ||Lidocaine Oin jar(Lidocaine|tment USP 5% 50 gm Ointment USP 5% 50 m jar|5000 Numbers|7|Lidocaine USP|12.74 kg.| || (Net content o|g f active ingredients 12.50||||| |kgs))|kgs))|||||| |RA concerned may take further necessary action as per above decision of NC.|||||||

Case No.	38 / NC/3/MEET/Mar/202324/25

Case Status	Case Approved

Party Name	PLAKSHA INDUSTRIES PRIVATE LIMITED

Meeting Number
<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024

UDIN00537223AM24

HQ File Number<br>HQRNORM APPLY 00006683AM24
RA File Number<br>08AX04001504 AM24
Licence No and<br>Date<br>0811009884/07/11/2023
Norms Committee Decision:
The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to				fix ad-hoc norms
under Para 4.07 of HBP Vol. I as per details given below	or as applied by the firm, whichever is less:-
Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
LAUROYL CHILORIDE (LAUROYL CHILORIDE	<br>1 kg.	1	LAURIC ACID	0.925 kg.
NET CONTENT OF EXPORT PRODUCT -
LAURIC ACID IS 96000.00 KGS)
RA concerned may take further necessary action as per above decision of NC.

DE| 1 kg.|1|LAURIC ACID|0.925 kg.|| |NET CONTENT OF EXPORT PRODUCT -|||||| |LAURIC ACID IS 96000.00 KGS)|||||| |RA concerned may take further necessary action as per above decision of NC.||||||

HQ File Number	HQ File Number	HQRNORM APPLY 00006683AM24	HQRNORM APPLY 00006683AM24	HQRNORM APPLY 00006683AM24	HQRNORM APPLY 00006683AM24	HQRNORM APPLY 00006683AM24
RA File Number		08AX04001504 AM24
Licence No and		0811009884/07/11/2023
Date
Norms Committee		Decision:
The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>LAUROYL CHILORIDE (LAUROYL CHILORIDE<br>NET CONTENT OF EXPORT PRODUCT -<br>LAURIC ACID IS 96000.00 KGS)<br>1 kg.<br>1<br>LAURIC ACID<br>0.925 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

kg. 1 LAURIC ACID 0.925 kg. RA concerned may take further necessary action as per above decision of NC.|||||||||||| ||Export Product||||Qty.||Sl. No.||Import Items||Qty. allowed.| ||LAUROYL CHILORIDE (LAUROYL CHILORIDE |||| |1 kg.|1||LAURIC ACID||0.925 kg.| ||NET CONTENT OF EXPORT PRO LAURIC ACID IS 96000.00 KGS)|||UCT -|||||||| ||concerned may take further necessary action|||as per above||decision of||NC.|||| ||||||||||||| |Cas|e No.|39 / NC/3/MEET/Mar/202324/||25|||||||| |Cas|e Status|Case Approved|||||||||| ||||||||||||| |Par|ty Name|PUNISKA HEALTHCARE P||RIVATE LI||MITED|||||| |Me and|eting Number|NC/ 3/ MEET/ M/ 202324/||5 d 11/03||2024|||||| ||Date|ar an|||||||||| |HQ|File Number|HQRNORM APPLY 00006696AM24|||||||||| |RA File Number||08AX04001328 AM24|||||||||| |Licence No and|||||||||||| |Date||0811009658/07/11/2023|||||||||| |Norms Committee Decision: **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 er details iven below or as alied b the firm whichever is less:-|||||||||||| ||.|g pp y ,|||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||Export Produ|ct|Qty.|||Sl. No.|Import Items||||**Qty.

or as alied b the firm whichever is less:-|||||||||||| ||.|g pp y ,|||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||Export Produ|ct|Qty.|||Sl. No.|Import Items||||Qty. allowed.| |||||||| |||| | ||Calcium Gluco i 2|nate in Sodium Chloride 1 5|214900 b|||1|CALCIUM GLUCONATE A|||| 225.645 kg.| ||Injecton, 0 m (Calcium Gluc Injection 20|g/mL (000 mg/0 mL) onate in Sodium Chloride /mL (1000 m/50 mL))|Numers||||MONOHYDRTE USP||||| ||, g Calcium Gluconate in Sodium Chloride Injection 20 m/mL (2000 m/100 mL)||||||||||| ||||109940 Numbers|||2|CALCIUM GLUCONATE MONOHYDRATE USP|||| 230.874 kg.| ||, g g (Calcium Gluconate in Sodium Chloride Injection, 20 mg/mL (2000 mg/100 mL))|||||||||||

UDIN00537223AM24

Case No.	40 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006698AM24
RA File Number	08AX04001495 AM24
Licence No and<br>Date	0811009892/07/11/2023
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:-<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. Tranexamic Acid in 0.7% Sodium Chloride Injection 1,000 mg per 100 mL (10 mg/mL)(Tranexamic Acid in 0.7% Sodium Chloride Injection 1,000 mg per 100 mL (10 mg/mL)) 65220 Numbers 1 Tranexamic acid 68.481 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	41 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006699AM24
RA File Number	08AX04001494 AM24
Licence No and<br>Date	0811009893/07/11/2023
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:-

UDIN00537223AM24

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Tranexamic Acid in 0.7% Sodium Chloride<br>Injection 1,000 mg per 100 mL (10<br>mg/mL)(Tranexamic Acid in 0.7% Sodium<br>Chloride Injection 1,000 mg per 100 mL<br>(10 mg/mL))	<br>86960 Numbers	1	Tranexamic acid	91.308 kg.

Case No.	42 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006734AM24
RA File Number	34AX04000582 AM24
Licence No and<br>Date	3411004327/08/11/2023
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:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Aldehyde C10 (Capric Aldehyde)<br>1 kg.<br>1<br>Fatty Alcohol C10 98<br>1.066 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	43 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006759AM24
RA File Number	03AX04003628 AM24

UDIN00537223AM24

UDIN00537223AM24

Licence No and<br>Date	Licence No and<br>Date	0311028603/08/11/2023	0311028603/08/11/2023	0311028603/08/11/2023	0311028603/08/11/2023	0311028603/08/11/2023
Norms Committee Decision:<br>The Committee considered the case as er aenda and takin cue from the earlier decision for same exort
<br>product/import p		p g g p<br>roduct in meetingNo. NC/3/MEET/Jan/202324/231 dated 24/01/2024against advance
<br>authorizationNo.		<br> 0311029329 dated 14/12/2023,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I
as	per details give	n below or as applied by the firm, whichever is less:-



	Export P	roduct	Qty.	Sl. No.	Import Items	Qty. allowed.

	Attti C	li Tblt USP	1 Nb	1	Attti Cli Pl	11415
	orvasan acum aes<br>10mg((Net Content of Import Sr. No.<br>1 is 308.205 kgs, Sr. No. 2 is<br>1743.606 kg, Sr. No. 3 is 487.323 kg,<br>Sr. No. 4 is 303000 Nos.))		umer<br>Tablet		orvasan acum ropyene<br>Glycol Solvate USP	.

Net Content of Import Sr. No. 1 is 308.205 kgs, Sr. No. 2 is 1743.606 kg, Sr. No. 3 is 487.323 kg, Sr. No. 4 is 303000 Nos.))||umer Tablet||||orvasan acum ropyene Glycol Solvate USP||. mg.|| ||||||2||Microcrystalline Cellulose (MCC) NF (Avicel PH 102)||64.578 mg.|| |||||||||||| ||||||3||C|alcium Acetate||18.049 mg.| |||||||||||| ||||||4||Silica Ge Activa|l Dessicants - Packaged ted Carbon (Strippax ||Relevant, as per packing policy.| |||||||||Sorbent)||| ||Atorvastatin Calcium Tablets USP 20 mg((Net Content of Import Sr. No. 1 is 205.470 kgs, Sr. No. 2 is 1164.843||1 Number Tablet||5|||||| ||||||||Atorvast Gl|atin Calcium Propylene ycol Solvate USP||22.830 mg.| || kg, Sr. No. 3 is 324.810 kg, Sr. No. 4 is 101000 Nos.))||||6||Microcrystalline Cellulose (MCC) NF (Avicel PH 102)||129.427 mg.|| |||||||||||| ||||||7||Calcium Acetate||36.090 mg.|| ||||||8||Silica Gel Dessicants - Packaged Activated Carbon (Strippax||Relevant, as per packing policy.|| |||||||| Sorbent)|||| |||||||||||| |||||||||||| ||Atorvastatin C|alcium Tablets USP|1 Number||9||Atorvastatin Calcium Prolene||45595 m|| || 40mg((Net Co 1 is 3857.337| ntent of Import Sr. No. kgs, Sr. No. 2 is| Tablet||||py Glycol Solvate USP||. g.|| || 21833.568 kg,| Sr. No. 3 is 6088.070||||||||| || kg, Sr. No. 4 i| s 949400 Nos.))|||10||Microcrystalline Cellulose ||258.08 mg.|| ||||||||(MCC) NF (Avicel PH 102)|||| |||||||||||| ||||||||||||

8 kg,| Sr. No. 3 is 6088.070||||||||| || kg, Sr. No. 4 i| s 949400 Nos.))|||10||Microcrystalline Cellulose ||258.08 mg.|| ||||||||(MCC) NF (Avicel PH 102)|||| |||||||||||| ||||||||||||

Licence No and<br>Date	Licence No and<br>Date	0311028603/08/11/2023	0311028603/08/11/2023	0311028603/08/11/2023	0311028603/08/11/2023	0311028603/08/11/2023
Norms Committee Decision:<br>The Committee considered the case as er aenda and takin cue from the earlier decision for same exort
<br>product/import p		p g g p<br>roduct in meetingNo. NC/3/MEET/Jan/202324/231 dated 24/01/2024against advance
<br>authorizationNo.		<br> 0311029329 dated 14/12/2023,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I
as	per details give	n below or as applied by the firm, whichever is less:-



	Export P	roduct	Qty.	Sl. No.	Import Items	Qty. allowed.

	Attti C	li Tblt USP	1 Nb	1	Attti Cli Pl	11415
	orvasan acum aes<br>10mg((Net Content of Import Sr. No.<br>1 is 308.205 kgs, Sr. No. 2 is<br>1743.606 kg, Sr. No. 3 is 487.323 kg,<br>Sr. No. 4 is 303000 Nos.))		umer<br>Tablet		orvasan acum ropyene<br>Glycol Solvate USP	.

UDIN00537223AM24

88.070||||||||| || kg, Sr. No. 4 i| s 949400 Nos.))|||10||Microcrystalline Cellulose ||258.08 mg.|| ||||||||(MCC) NF (Avicel PH 102)|||| |||||||||||| ||||||||||||

UDIN00537223AM24

		11	Calcium Acetate	71.963 mg
		12	Silica Gel Dessicants - Packaged	Relevant, as per
			Activated Carbon (Strippax	packing policy.
			Sorbent)
Atorvastatin Calcium Tablets USP	1 Number	13	Atorvastatin Calcium Propylene	91.20 mg.
80mg((Net Content of Import Sr. No.	Tablet		Glycol Solvate USP
1 is 2052.000 kgs, Sr. No. 2 is
11659.635 kg, Sr. No. 3 is 3260.903<br>kg, Sr. No. 4 is 252500 Nos.))		14	Microcrystalline Cellulose<br>(MCC) NF (Avicel PH 102)	518.206 mg.
		15	Calcium Acetate	144.929 mg.
		16	Silica Gel Dessicants - Packaged	Relevant, as per
			Activated Carbon (Strippax	packing policy.
			Sorbent)

Note: The above norms are valid only for subject to fulfillment of following conditions:-

Export Product being Patented Medicine, be filed with USFDA filing ANDA (A New Drug Application) of Apotex Corp, US. Agend for Apotex Inc., Canada.
Export to USA only.
Firm holding Certificate of Manufacturing Exclusively.

Case No.	Case No.	44 / NC/3/MEET/Mar/202324/25	44 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00006764AM24
RA File Number		08AX04001484 AM24
Licence No and<br>Date		0811009927/09/11/2023
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.

r 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.||

Case No.	Case No.	44 / NC/3/MEET/Mar/202324/25	44 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00006764AM24
RA File Number		08AX04001484 AM24
Licence No and<br>Date		0811009927/09/11/2023
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.

UDIN00537223AM24

| |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.||

UDIN00537223AM24


CLINDAMYCI<br>	N PHOSPHATE TOPICAL<br>	1 Number	1	CLINDAMYCIN<br>	363.50 mg.
SOLUTION US<br>CONTAIN CLI	P 1% 30ML (EACH ML<br>DAMYCIN PHOSPHATE			PHOSPHATE USP
<br>USP EQUIVAL<br>10((ACTIVE IN	<br>ENT CLINDAMYCIN<br>GREDIENT:
			2	BOTTLE 1OZ ROUND	Relevant, as per
<br>CLINDAMYCI	<br>N PHOSPHATE USP			WHITE OPAQU HDPE	packing policy
EQUIVALENT	TO CLINDAMYCIN - NET			JERHEL PT
WT. 94.988 KG	S))
			3	CLOSURE 24MM WHITE	<br>Relevant as per
				<br>PP SG75 MOLDRITE	<br>,<br>packing policy
			4	CLOSURE 24MM WHITE	<br>Relevant as per
				<br>STEP UP & APP DAB O<br>MATIC	<br>,<br>packing policy
CLINDAMYCIN PHOSPHATE TOPICAL		1 Nb	5	CLINDAMYCIN	72720
<br>SOLUTION US	<br>P 1% 60ML (EACH ML	umer		<br>PHOSPHATE USP	. mg.
<br>CONTAIN CLI	<br>NDAMYCIN PHOSPHATE
USP EQUIVAL	ENT CLINDAMYCIN
10((ACTIVE IN<br>CLINDAMYCI	GREDIENT:<br>N PHOSPHATE USP		6	BOTTLE 2OZ ROUN<br>WHITE OPAQUE HDPE<br>	Relevant, as per<br>packing policy
EQUIVALENT<br>	TO CLINDAMYCIN - NET<br>			JERHEL PT
WT.

|10((ACTIVE IN CLINDAMYCI|GREDIENT: N PHOSPHATE USP||6|BOTTLE 2OZ ROUN WHITE OPAQUE HDPE |Relevant, as per packing policy| ||EQUIVALENT |TO CLINDAMYCIN - NET |||JERHEL PT|| ||WT. 414.996 K|S))||||| |||||||| |||||7|CLOSURE 24MM WHITE PP SG75 MOLDRITE| Relevant, as per packing policy| |||||||| |||||8|CLOSURE 24MM WHITE STEP UP & APP DAB O| Relevant, as per packing policy| |MATIC |||||MATIC|| |RA concerned m||ay take further necessary action as per above decision of NC.||||| |||||||| |||||||| |Case No.||45 / NC/3/MEET/Mar/202324/25||||| |||||||| |Case Status||Case Approved||||| |Party Name||ZYDUS LIFESCIENCES LIMITED||||| |||||||| |Meeting Number||||||| | and Date||NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024||||| |||||||| |HQ File Number||HQRNORM APPLY 00006765AM24||||| |RA File Number||08AX04001483 AM24||||| |||||||| |Licence No and Date||0811009928/09/11/2023||||| |Norms Committee Decision:||||||| ||||||||

Case No.	45 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006765AM24
RA File Number	08AX04001483 AM24
Licence No and<br>Date	0811009928/09/11/2023
Norms Committee Decision:

UDIN00537223AM24

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:-

ion:** 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.
CLINDAMYCIN PHOSPHATE GEL	283325	1	CLINDAMYCIN	103.022 kg.
USP 1% 30GM (EACH GRAM			PHOSPHATE USP
CONTAIN CLINDAMYCIN	Numbers
PHOSPHATE USP EQUIVALENT
CLINDAMYCIN 10 MG) ((ACTIVE
INGREDIENT: CLINDAMYCIN
PHOSPHATE USP EQUIVALENT TO
CLINDAMYCIN - NET WT. 84.998 KGS))
CLINDAMYCIN PHOSPHATE GEL	191650	2	CLINDAMYCIN	139.374 kg.
USP 1% 60GM (EACH GRAM			PHOSPHATE USP
CONTAIN CLINDAMYCIN	Numbers
PHOSPHATE USP EQUIVALENT
CLINDAMYCIN 10 MG) ((ACTIVE
INGREDIENT: CLINDAMYCIN
PHOSPHATE USP EQUIVALENT TO
CLINDAMYCIN - NET WT. 114.990 KGS))

Case No.	46 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006766AM24
RA File Number	08AX04001473 AM24
Licence No and<br>Date	0811009930/09/11/2023
Norms Committee Decision:
The committee considered the case as per agenda and it was decided to fix ad-hoc norms as perSION A-412.

Case No.	47 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred

UDIN00537223AM24

ered the case as per agenda and it was decided to fix ad-hoc norms as perSION A-412.||

Case No.	47 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred

UDIN00537223AM24

Party Name	RALLIS INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006775AM24
RA File Number	03AX04003377 AM24
Licence No and<br>Date	0311028623/09/11/2023
Norms Committee Decision:
The case is under consideration for want of comments of TE.

Case No.	48 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	AKUMS DRUGS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006789AM24
RA File Number	05AX04002288 AM24
Licence No and<br>Date	0511022010/09/11/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-
Copy of Drug Manufacturing Licence (DML) showing approved composition of export item.

ion of ad-hoc norms and it was decided to call for following|| |information/documents from the firm:-|| |Copy of Drug Manufacturing Licence (DML) showing approved composition of export item.||

Case No.	49 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	TOJO VIKAS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006797AM24
RA File Number	05AX04002297 AM24
Licence No and<br>Date	0511022013/10/11/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.
Stoichiometric balance between import and export on molar basis.<br>iv.
Details of indigenous input with quantity.<br>v.

ii. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.

28 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-03-2024 12:32:57.

UDIN00537223AM24

and molecular weights along with stage wise percentage yields on molar basis.**

28 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-03-2024 12:32:57.

UDIN00537223AM24

Case No.	50 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006801AM24
RA File Number	52AX04000234 AM24
Licence No and<br>Date	5211006397/10/11/2023
Norms Committee Decision:
The case is under consideration for want of comments of TE.

Case No.	51 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006807AM24
RA File Number	34AX04000624 AM24
Licence No and<br>Date	3411004346/10/11/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-
Copy of Master Batch Formula for each export item.

he request of firm for review/fixation of ad-hoc norms and it was decided to call for following|| |information/documents from the firm:-|| |Copy of Master Batch Formula for each export item.||

Case No.	52 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006809AM24
RA File Number	05AX04002413 AM24
Licence No and<br>Date	0511022034/10/11/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-
Copy of Drug Manufacturing License (DML) for the export item.<br>1.
Material Balance for entire process showing wastage of API in each step.<br>2.

Case No. 53 / NC/3/MEET/Mar/202324/25

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wastage of API in each step.** 2.||

Case No. 53 / NC/3/MEET/Mar/202324/25

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Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006827AM24
RA File Number	03AX04003708 AM24
Licence No and<br>Date	0311028699/13/11/2023
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:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>DIPHENYLAMINE<br>0.405 kg.<br>2<br>DI ISOBUTYLENE<br>0.622 kg.<br>OCTYLATED DIPHENYLAMINE<br>(OCD FLAKES/POWDER)<br>1 kg.<br>3<br>ACTIVATED CLAY<br>0.10 kg.<br>RA concerned may take further necessary action as per above decision of NC.

BUTYLENE 0.622 kg. OCTYLATED DIPHENYLAMINE (OCD FLAKES/POWDER) 1 kg. 3 ACTIVATED CLAY 0.10 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	54 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006837AM24
RA File Number	09AX04000734 AM24
Licence No and<br>Date	0911006227/14/11/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Complete and Balanced chemical reactions, molar weight and percentage yield on molar basis, for each<br>step.<br>i.<br>Production/Consumption data for last three years duly certified by GST Authorities.<br>ii.

ii. Production/Consumption data for last three years duly certified by GST Authorities.
Case No. 55 / NC/3/MEET/Mar/202324/25

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ed by GST Authorities.** ii.||

ii. Production/Consumption data for last three years duly certified by GST Authorities.
Case No. 55 / NC/3/MEET/Mar/202324/25

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Case Status	Case Deferred
Party Name	METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006838AM24
RA File Number	09AX04000733 AM24
Licence No and<br>Date	0911006228/14/11/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-
Complete and Balanced chemical reactions, molar weight and percentage yield on molar basis, for each<br>i.
step.
Production/Consumption data for last three years duly certified by GST Authorities.<br>ii.

Case No.<br>56 / NC/3/MEET/Mar/202324/25
Case Status<br>Case Deferred
Party Name<br>AKUMS DRUGS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number<br>HQRNORM APPLY 00006849AM24
RA File Number<br>05AX04001479 AM23
Licence No and<br>Date<br>0511021951/15/11/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for
following information/documents from the firm:-
Copy of Drug Manufacturing License (DML) showing approved composition of export item.<br>1.

ion of ad-hoc norms and it was decided to call for| |following information/documents from the firm:-| |Copy of Drug Manufacturing License (DML) showing approved composition of export item. 1.| |Certificate of Analysis (CoA) of import item from foreign supplier. 2.|

Case No.<br>57 / NC/3/MEET/Mar/202324/25
Case Status<br>Case Approved
Party Name<br>RECKITT BENCKISER (INDIA) PRIVATE LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number<br>HQRNORM APPLY 00006851AM24
RA File Number<br>05AX04002451 AM24
Licence No and Date<br>0511022069/15/11/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo. NC/3/MEET/Sep/202324/13 dated 14/09/2023against advance
authorizationNo. 0511019590 dated 30/06/2023,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:-

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

31 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-03-2024 12:32:57.

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Qty.	Sl. No.	Import Items	Qty. allowed.
<br>1 Number<br>Tablet	1	SACCHARIN BASE 55Ox	1.00 mg.
	2	GLYCINE EP	133.30 mg.
1 Number<br>Tablet	3	SACCHARIN BASE 55Ox	0.334 mg.
	4	GLYCINE EP	44.40 mg.

Case No.	58 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006857AM24
RA File Number	03AX04003687 AM24
Licence No and<br>Date	0311028732/16/11/2023
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:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Sacubitril+Calcium<br>(Sacubitril Calcium)<br>1 kg.<br>1<br>2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert-<br>butoxycarbonyl)amino)-2-methylpentanoic acid<br>(BMPA)<br>1.237 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 59 / NC/3/MEET/Mar/202324/25

r>butoxycarbonyl)amino)-2-methylpentanoic acid (BMPA) 1.237 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No. 59 / NC/3/MEET/Mar/202324/25

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Case Status	Case Deferred
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006896AM24
RA File Number	08AX04001535 AM24
Licence No and<br>Date	0811009983/17/11/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Copy of Drug Manufacturing Licence (DML) showing vial size of each export item.

Case No.	Case No.	Case No.	60 / NC/3/MEET/Mar/202324/25	60 / NC/3/MEET/Mar/202324/25	60 / NC/3/MEET/Mar/202324/25
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number			HQRNORM APPLY 00006908AM24
RA File Number			03AX04003714 AM24
Licence No and<br>Date			0311028792/20/11/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>Sl. No<br>Export Product<br>Quantity<br>1<br>Medical Creams and Ointments(CICLOPIROX SOLUTION TOPICAL 8% 6.6ML Tot<br>WT 1980Kgs.

vise ad-hoc norms for export to US only are as under:- Sl. No Export Product Quantity 1 Medical Creams and Ointments(CICLOPIROX SOLUTION TOPICAL 8% 6.6ML Tot WT 1980Kgs. (Net Cont : Ciclopirox 158.40Kgs, Isoprop 613.80Kg, Ethyl ace 613.80Kgs, Buty est 594Kgs, Glass bottle 300000 Nos, brush 300000 Nos, Cap ribb 300000 Nos)) 1 Number S. No Import Product Quantity allowed. 1 Relevant Bulk Drugs Net content in the export product plus 3% wastage. 2 Relevant Excipients Net content in the export product plus 3% wastage.|||||| ||Sl. No|Export Product |||Quantity| ||1|Medical Creams and Ointments(CICLOPIROX SOLUTION TOPICAL 8% 6.6ML Tot WT 1980Kgs. (Net Cont : Ciclopirox 158.40Kgs, Isoprop 613.80Kg, Ethyl ace 613.80Kgs, Buty est 594Kgs, Glass bottle 300000 Nos, brush 300000 Nos, Cap ribb 300000 Nos)) |||1 Number| ||||||| ||S. No|Import Product||Quantity allowed.|| ||1|Relevant Bulk Drugs||Net content in the export product plus 3% wastage.|| ||2|Relevant Excipients||Net content in the export product plus 3% wastage.||

port Product**||Quantity allowed.|| ||1|Relevant Bulk Drugs||Net content in the export product plus 3% wastage.|| ||2|Relevant Excipients||Net content in the export product plus 3% wastage.||

Case No.	Case No.	Case No.	60 / NC/3/MEET/Mar/202324/25	60 / NC/3/MEET/Mar/202324/25
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number			HQRNORM APPLY 00006908AM24
RA File Number			03AX04003714 AM24
Licence No and<br>Date			0311028792/20/11/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>Sl. No<br>Export Product<br>Quantity<br>1<br>Medical Creams and Ointments(CICLOPIROX SOLUTION TOPICAL 8% 6.6ML Tot<br>WT 1980Kgs. (Net Cont : Ciclopirox 158.40Kgs, Isoprop 613.80Kg, Ethyl ace<br>613.80Kgs, Buty est 594Kgs, Glass bottle 300000 Nos, brush 300000 Nos, Cap ribb<br>300000 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 3% wastage.<br>2<br>Relevant Excipients<br>Net content in the export product plus 3% wastage.
	Sl. No	Export Product<br>		Quantity
	1	Medical Creams and Ointments(CICLOPIROX SOLUTION TOPICAL 8% 6.6ML Tot<br>WT 1980Kgs.

r>Net content in the export product plus 3% wastage.|||||| ||Sl. No|Export Product |||Quantity| ||1|Medical Creams and Ointments(CICLOPIROX SOLUTION TOPICAL 8% 6.6ML Tot WT 1980Kgs. (Net Cont : Ciclopirox 158.40Kgs, Isoprop 613.80Kg, Ethyl ace 613.80Kgs, Buty est 594Kgs, Glass bottle 300000 Nos, brush 300000 Nos, Cap ribb 300000 Nos)) |||1 Number| ||||||| ||S. No|Import Product||Quantity allowed.|| ||1|Relevant Bulk Drugs||Net content in the export product plus 3% wastage.|| ||2|Relevant Excipients||Net content in the export product plus 3% wastage.||

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3 Relevant Packaging Material Relevant as per Packing Policy

Note:

i. 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments solely for export to US.
ii. 1.02 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments for the export to other than US.
iii. The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

Case No.	61 / NC/3/MEET/Mar/202324/25	61 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	LINCOLN PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006918AM24
RA File Number	08AX04001563 AM24
Licence No and<br>Date	0811009996/20/11/2023
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.
ALENDRONATE SODIUM TABLETS		1 Number	1	SODIUM	<br>ALENDRONATE	<br>93.20 mg.
USP 70 MG (PACKING1x4 = 4 NOS IN				TRIHYDRATE
EACH PACK.)((TOTAL SODIUM
ALENDRONATE TRIHYDRATE
USED i.e. 206000 x 91.37 /
1000000=18.82 KG NET))

.20 mg.|| |USP 70 MG (PACKING1x4 = 4 NOS IN||||TRIHYDRATE|||| |EACH PACK.)((TOTAL SODIUM|||||||| |ALENDRONATE TRIHYDRATE|||||||| |USED i.e. 206000 x 91.37 /|||||||| |1000000=18.82 KG NET))||||||||

Case No.	61 / NC/3/MEET/Mar/202324/25	61 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	LINCOLN PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006918AM24
RA File Number	08AX04001563 AM24
Licence No and<br>Date	0811009996/20/11/2023
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.
ALENDRONATE SODIUM TABLETS		1 Number	1	SODIUM	<br>ALENDRONATE	<br>93.20 mg.
USP 70 MG (PACKING1x4 = 4 NOS IN				TRIHYDRATE
EACH PACK.)((TOTAL SODIUM
ALENDRONATE TRIHYDRATE
USED i.e. 206000 x 91.37 /
1000000=18.82 KG NET))

UDIN00537223AM24

ING1x4 = 4 NOS IN||||TRIHYDRATE|||| |EACH PACK.)((TOTAL SODIUM|||||||| |ALENDRONATE TRIHYDRATE|||||||| |USED i.e. 206000 x 91.37 /|||||||| |1000000=18.82 KG NET))||||||||

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Case No.	62 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	ALTA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006944AM24
RA File Number	03AX04003747 AM24
Licence No and<br>Date	0311028819/21/11/2023
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 product in meetingNo.NC/3/MEET/Jun/202324/6 dated 14/06/2023against advance authorization<br>No. 0311021244 dated 08/02/2023, 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.<br>1<br>PARAHYDROXY BENZOIC ACID<br>0.97 kg.<br>METHYL PARABEN<br>1 kg.<br>2<br>METHANOL<br>0.50 kg.<br>RA concerned may take further necessary action as per above decision of NC.

ty. allowed.** 1 PARAHYDROXY BENZOIC ACID 0.97 kg. METHYL PARABEN 1 kg. 2 METHANOL 0.50 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	63 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	GELTEC PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006949AM24
RA File Number	03AX04003778 AM24
Licence No and<br>Date	0311028827/21/11/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed that the matter pertains to Norms<br>Committee-6, therefore, it has been decided to refer the case toNorms Committee-6for further necessary action at

UDIN00537223AM24

their end.

Case No.	64 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006966AM24
RA File Number	08AX04001564 AM24
Licence No and<br>Date	0811010011/22/11/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

Case No	Case No	64 / NC/3/MEET/Mar/202324/25	64 / NC/3/MEET/Mar/202324/25	64 / NC/3/MEET/Mar/202324/25	64 / NC/3/MEET/Mar/202324/25	64 / NC/3/MEET/Mar/202324/25
.
Case Status		Case Deferred

Party Name		ASCENT FINECHEM PRIVATE LIMITED

Meeting Number
<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00006966AM24

RA File Number		08AX04001564 AM24

Licence No and
<br>Date		0811010011/22/11/2023
Norms Committee		Decision:
<br>The case is under consideration for want of comments of TE.

Case No.		65 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		ASTEC LIFESCIENCES LIMITED
Meeting Number
<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00006975AM24
RA File Number		03AX04003793 AM24
Licence No and<br>Date		0311028844/22/11/2023
Norms Committee		Decision:

11/03/2024||||| |HQ File Number||HQRNORM APPLY 00006975AM24||||| |RA File Number||03AX04003793 AM24||||| |Licence No and Date||0311028844/22/11/2023||||| |Norms Committee||Decision:||||| |||||||| |The Committee product/import pr ||considered the case as per agenda and taking cue from the earlier decision for same export oduct in meetingNo.NC/3/MEET/Feb/202223/20 dated 24/02/2023against advance authorization ||||| |No. 0311013033 dated 17/03/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||DEXTRINOL||1 kg.|1|CROTONIC ACID|0.849 kg.| |||||2|BUTADIENE|0.629 kg.| |||||||| |||||||| |||||||| |RA concerned may||take further necessary action as per above decision of NC.||||| |||||||| |||||||| |Case No.||66 / NC/3/MEET/Mar/202324/25||||| ||||||||

Case No. 66 / NC/3/MEET/Mar/202324/25

UDIN00537223AM24

further necessary action as per above decision of NC.||||| |||||||| |||||||| |Case No.||66 / NC/3/MEET/Mar/202324/25||||| ||||||||

Case No. 66 / NC/3/MEET/Mar/202324/25

UDIN00537223AM24

Case Status<br>Case Deferred
Party Name<br>MEDICLONE HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number<br>HQRNORM APPLY 00006991AM24
RA File Number<br>04AX04000678 AM24
Licence No and<br>Date<br>0411006454/22/11/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for
following information/documents from the firm:-
Certificate of Analysis (CoA) of import item from Foreign Supplier<br>I.
Bill of Entry for import item.<br>II.

Case No.	67 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00006994AM24
RA File Number	03AX04003758 AM24
Licence No and<br>Date	0311028853/23/11/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-
Justification of low yield of 27.88% in first stage with any documentary evidence such as any patent process.

it was decided to call for following|| |information/documents from the firm:-|| |Justification of low yield of 27.88% in first stage with any documentary evidence such as any patent process.||

Case No.	68 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007003AM24
RA File Number	03AX04003781 AM24
Licence No and<br>Date	0311028861/23/11/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Jul/202324/9 dated 28/07/2023against advance authorization
No. 0310819230	dated 19/02/2018, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details
given below or as	applied by the firm, whichever is less:-

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

37 This document has been digitally signed by Raman Kumar, Deputy DGFT on 20-03-2024 12:32:57.

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Export Product	Qty.	Sl. No.	Import Items		Qty. allowed.
Sodium Lactate (Hartmann's)	<br>1 Number	1	SODIUM LACTATE		Net content in export
1000ml AUS			(PURASAL SP/F 50)(EP)		+ 2% wastage.
		2	POTASSIUM CHLORIDE EP		Net content in export<br>+ 2% wastage.
		3	CALCIUM CHLORIDE EP		Net content in export<br>+ 2% wastage.
		4	Sodium Chloride (SANAL) (EP)		Net content in export<br>+ 2% wastage.
		5	SF9-11 195/140 (PLASTIC FILM<br>(NON-PVC) FOR PRIMARY<br>PACKING) (0369631)		Net content in<br>export + 1%<br>wastage.
		6	OFR2-11 120/524<br>PHTALATFREE (PLASTIC FILM<br>(NON-PVC) FOR SECONDARY<br>PACKING (0369681)		Net content in<br>export + 1%<br>wastage.
		7	UFR	2-11 150/524	Net content in export
			PHT<br>(NO<br>PAC	ALATFREE (PLASTIC FILM<br>N-PVC) FOR SECONDARY<br>KING (0369661)	<br>+ 1% wastage.
		8	SSC	Infusion Port (0434181)	Net content in export<br>+ 1% wastage.
		9	SSC Injection Port (Art. 0434371)		Net content in export<br>+ 1% wastage.
		10	BOP Infusion Port (Art.No<br>0434171)		Net content in export<br>+ 1% wastage.
		11	BOP Injection Port (Art. 0434481)		Net content in export<br>+ 1% wastage.

UDIN00537223AM24

12 Hot Stamping foil (Art. 0368991) Net content in export + 1% wastage.

% wastage.| ||||11|BOP Injection Port (Art. 0434481)|||||Net content in export + 1% wastage.|

UDIN00537223AM24

12 Hot Stamping foil (Art. 0368991) Net content in export + 1% wastage.

Case No.	Case No.	69 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007004AM24
RA File Number		03AX04003819 AM24
Licence No and<br>Date		0311028867/23/11/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>Sl. No<br>Export Product<br>Quantity<br>1<br>Medical Creams and Onitments (Fluorouracil Topical Solution USP 5%, 10ml)<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 3% wastage.<br>2<br>Relevant Excipients<br>Net content in the export product plus 3% wastage.<br>3<br>Relevant Packaging Material<br>Relevant as per Packing Policy<br>Note:<br>1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export<br>of Medicinal Cream/Ointmentssolely for export to US.<br>i.
	**Sl.

ote: 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointmentssolely for export to US. i.|||||| ||Sl. No|Export Product |||Quantity| ||1|Medical Creams and Onitments (Fluorouracil Topical Solution USP 5%, 10ml) |||1 Number| ||||||| ||S. No|Import Product||Quantity allowed.|| ||1|Relevant Bulk Drugs||Net content in the export product plus 3% wastage.|| ||2|Relevant Excipients||Net content in the export product plus 3% wastage.|| ||3|Relevant Packaging Material||Relevant as per Packing Policy|| ||Note: 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointmentssolely for export to US.** i.|||||

i. 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments solely for export to US.

UDIN00537223AM24

ii. 1.02 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments for the export to other than US.
iii. The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

al Cream/Ointments for the export to other than US.

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


Case No.		70 / NC/3/MEET/Mar/202324/25

Case Status		Case Approved

Party Name		PRACHI PHARMACEUTICALS PRIVATE LIMITED

Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024

HQ File Number		HQRNORM APPLY 00007007AM24

RA File Number		03AX04003817 AM24

Licence No and<br>Date		0311028871/23/11/2023

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 product in meetingNo.NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization<br>No.0311023358 dated 04/05/2023,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.<br>THIAMINE HYDROCHLORIDE<br>1 kg.<br>1<br>THIAMINE MONONITRATE<br>0.922<br>RA concerned may take further necessary action as per above decision of NC.

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

E MONONITRATE 0.922 RA concerned may take further necessary action as per above decision of NC.||||||||||| |||||||||||| ||Export Product|||Qty.|Sl.|No.||Import Items||Qty. allowed.| |||||||||||| ||THIAMINE HYDROCHLORIDE|||1 kg.|1||THIA|MINE MONONITRAT|E|0.922| |||||||||||| ||concerned may take further necessary action as||per above dec|||ision of N||C.||| |||||||||||| |Cas|e No.|71 / NC/3/MEET/Mar/202324/25||||||||| |Case Status||Case Approved||||||||| |Party Name||HARMAN FINOCHEM LIMITED||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024||||||||| |HQ File Number||HQRNORM APPLY 00007029AM24||||||||| |RA File Number||03AX04003854 AM24|||||||||

Case No.	71 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007029AM24
RA File Number	03AX04003854 AM24

UDIN00537223AM24

UDIN00537223AM24

Licence No and Date

0311028907/24/11/2023

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. Sacubitril+Calcium (Sacubitril Calcium) 1 kg. 1 2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert- butoxycarbonyl)amino)-2-methylpentanoic acid (BMPA) 1.237 kg. RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	72 / NC/3/MEET/Mar/202324/25	72 / NC/3/MEET/Mar/202324/25	72 / NC/3/MEET/Mar/202324/25	72 / NC/3/MEET/Mar/202324/25	72 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		UNIMAX LABORATORIES
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007035AM24
RA File Number		05AX04002563 AM24
Licence No and<br>Date		0511022259/24/11/2023
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:-<br>Export Product<br>Qty.<br>**Sl.

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. Spiramycin Tablets 1.5 MIU (Each tablet contains Spiramycin EP) 1 Number 1 Spiramycin EP 373.02 mg. Azithromycin Tablets 250 mg USP (Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin) 1 Number 2 Azithromycin Dihydrate USP 267.27 mg.||||||| ||Export Product Spiramycin Tablets 1.5 MIU (Each tablet contains Spiramycin EP) Azithromycin Tablets 250 mg USP (Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin)||Qty.|Sl. No.|Import Items|Qty. allowed.| ||||1 Number|1|Spiramycin EP|373.02 mg.| ||||1 Number|2|Azithromycin Dihydrate USP|267.27 mg.|

Case No.	Case No.	72 / NC/3/MEET/Mar/202324/25	72 / NC/3/MEET/Mar/202324/25	72 / NC/3/MEET/Mar/202324/25	72 / NC/3/MEET/Mar/202324/25	72 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		UNIMAX LABORATORIES
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007035AM24
RA File Number		05AX04002563 AM24
Licence No and<br>Date		0511022259/24/11/2023
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.

|Licence No and Date||0511022259/24/11/2023||||| |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. Spiramycin Tablets 1.5 MIU (Each tablet contains Spiramycin EP) 1 Number 1 Spiramycin EP 373.02 mg. Azithromycin Tablets 250 mg USP (Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin) 1 Number 2 Azithromycin Dihydrate USP 267.27 mg.||||||| ||Export Product Spiramycin Tablets 1.5 MIU (Each tablet contains Spiramycin EP) Azithromycin Tablets 250 mg USP (Each tablet contains : Azithromycin USP (As Dihydrate) Eq. to Anhydrous Azithromycin)||Qty.|Sl. No.|Import Items|Qty. allowed.| ||||1 Number|1|Spiramycin EP|373.02 mg.| ||||1 Number|2|Azithromycin Dihydrate USP|267.27 mg.|

UDIN00537223AM24

s Azithromycin)||Qty.|Sl. No.|Import Items|Qty. allowed.| ||||1 Number|1|Spiramycin EP|373.02 mg.| ||||1 Number|2|Azithromycin Dihydrate USP|267.27 mg.|

UDIN00537223AM24

	Azithromycin Tablets 500 mg USP<br>(Each tablet contains : Azithromycin	Azithromycin Tablets 500 mg USP<br>(Each tablet contains : Azithromycin	1 Number	3	Azithromycin Dihydrate USP	534.54 mg.
	<br>USP (As Dihydrate) Eq. to Anhydrous<br>Azithromycin)

	Azithromycin	Tablets 250 mg IP(Each	1 Number	4	Azithromycin Dihydrate IP	267.27 mg.
	tablet contains	: Azithromycin IP (As
	Dihydrate) Eq	. to Anhydrous
	Azithromycin)

	Azithromycin<br>	Tablets 500 mg IP(Each<br>	1 Number	5	Azithromycin Dihydrate IP	534.54 mg.
	tablet contains<br>Dihydrate) Eq	: Azithromycin IP (As<br>. to Anhydrous
Azithromycin)	Azithromycin)
RA concerned may take further necessary action as per above decision of NC.

ablet contains Dihydrate) Eq|: Azithromycin IP (As . to Anhydrous||||| |Azithromycin)|Azithromycin)|||||| |RA concerned may take further necessary action as per above decision of NC.|||||||

C N	C N	73 / NC/3/MEET/M/202324/25	73 / NC/3/MEET/M/202324/25	73 / NC/3/MEET/M/202324/25	73 / NC/3/MEET/M/202324/25
ase o.		ar
C Stt		C Dfd
ase aus		ase eerre
Pt N		GLOBAL CALCIUM PRIVATE LIMITED
ary ame
Mti Nb
eeng umer<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
H Fil Nb		HRNORM APPLY 00007038AM24
Q e umer		Q
RA Fil Nb		07AX04001334 AM24
e umer
Li N d
cence o an<br>Date		0711009791/24/11/2023
N Citt		Dii
orms ommee ecson:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Complete Chemical reaction, indicating molecular weight of reactant/s and product/s with overall yield<br>of the reaction for both the export items.<br>1.<br>Production specifically for both the export items vis a vis consumption of raw materials for the last three<br>years duly certified by Chartered Accountant.<br>2.<br>A copy of minutes of norms committee, if approved in the past.<br>3.
	A copy of minutes of norms com<br>3.		mittee, if a	pproved in	the past.

Cas	e No.	74 / NC/3/MEET/Mar/2	02324/25
Cas	e Status	Case Deferred

past.** 3.||||||| ||A copy of minutes of norms com 3.||mittee, if a|pproved in|the past.|| |||||||| |Cas|e No.|74 / NC/3/MEET/Mar/2|02324/25|||| |Cas|e Status|Case Deferred||||| |Par|ty Name|GLOBAL CALCIUM P|RIVATE|||| |||||IMITED||| |Me and|eting Number Date|NC/ 3/ MEET/ Mar/ 20|2324/ 25 a|nd 11/03/20|24||

Complete Chemical reaction, indicating molecular weight of reactant/s and product/s with overall yield of the reaction for both the export items.

Case No.	74 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024

UDIN00537223AM24

HQ File Number	HQRNORM APPLY 00007039AM24
RA File Number	07AX04001335 AM24
Licence No and<br>Date	0711009794/24/11/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Complete Chemical reaction, indicating molecular weight of reactant/s and product/s with overall yield<br>of the reaction for both the export items.<br>i.<br>Production specifically for both the export items viz-a-viz consumption of raw materials for the last three<br>years duly certified by Chartered Accountant.<br>ii.<br>A copy of minutes of norms committee, if approved in the past.<br>iii.

-a-viz consumption of raw materials for the last three** years duly certified by Chartered Accountant. ii. A copy of minutes of norms committee, if approved in the past. iii.||

i. Complete Chemical reaction, indicating molecular weight of reactant/s and product/s with overall yield of the reaction for both the export items.

Case No.	75 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007114AM24
RA File Number	07AX04001360 AM24
Licence No and<br>Date	0711009823/30/11/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	76 / NC/3/MEET/Mar/202324/25	76 / NC/3/MEET/Mar/202324/25	76 / NC/3/MEET/Mar/202324/25	76 / NC/3/MEET/Mar/202324/25	76 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007126AM24
RA File Number		03AX04003953 AM24
Licence No and<br>Date		0311029026/30/11/2023
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:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

Case No.	Case No.	76 / NC/3/MEET/Mar/202324/25	76 / NC/3/MEET/Mar/202324/25	76 / NC/3/MEET/Mar/202324/25	76 / NC/3/MEET/Mar/202324/25	76 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007126AM24
RA File Number		03AX04003953 AM24
Licence No and<br>Date		0311029026/30/11/2023
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:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00537223AM24

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

UDIN00537223AM24

1<br>DIPHENYLAMINE<br>0.405 kg.<br>2<br>DI ISOBUTYLENE<br>0.622 kg.<br>OCTYLATED DIPHENYLAMINE<br>(OCD FLAKES/POWDER)<br>1 kg.<br>3<br>ACTIVATED CLAY<br>0.10 kg.<br>RA concerned may take further necessary action as per above decision of NC.	OCTYLATED DIPHENYLAMINE<br>(OCD FLAKES/POWDER)	1 kg.	1	DIPHENYLAMINE	0.405 kg.
			2	DI ISOBUTYLENE	0.622 kg.
			3	ACTIVATED CLAY	0.10 kg.

Case No.	Case No.	77 / NC/3/MEET/Mar/202324/25	77 / NC/3/MEET/Mar/202324/25	77 / NC/3/MEET/Mar/202324/25	77 / NC/3/MEET/Mar/202324/25	77 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007132AM24
RA File Number		34AX04000670 AM24
Licence No and<br>Date		3411004394/30/11/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import product in meetingNo.NC/3/MEET/Feb/202324/23 dated 19/02/2024against advance<br>authorizationNo.3411004140 dated 21/09/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

in meetingNo.NC/3/MEET/Feb/202324/23 dated 19/02/2024against advance authorizationNo.3411004140 dated 21/09/2023, 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 Amantadine Hydrochloride USP 102.00 mg. 2 Microcrystalline cellulose (Avicel PH301) 106.00 mg. 3 Hydroxypropyl Cellulose (Klucel LF) 2.00 mg. 4 Croscarmellose Sodium (Ac-Di-Sol) 10.00 mg. Amantadine Hydrochloride capsules USP 100mg (Net content of active ingredients 300.00 kgs ) 1 Number Capsule||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Amantadine Hydrochloride capsules USP 100mg (Net content of active ingredients 300.00 kgs )||1 Number Capsule|1|Amantadine Hydrochloride USP|102.00 mg.| |||||2|Microcrystalline cellulose (Avicel PH301)|106.00 mg.| |||||3|Hydroxypropyl Cellulose (Klucel LF)|2.00 mg.| |||||4|Croscarmellose Sodium (Ac-Di-Sol)|10.00 mg.|

UDIN00537223AM24

||2|Microcrystalline cellulose (Avicel PH301)|106.00 mg.| |||||3|Hydroxypropyl Cellulose (Klucel LF)|2.00 mg.| |||||4|Croscarmellose Sodium (Ac-Di-Sol)|10.00 mg.|

UDIN00537223AM24

		5	Colloidal Silicon Dioxide<br>(Aerosil 200 Pharma)	1.00 mg.
		6	Magnesium Stearate<br>(Vegetable Source)	1.00 mg.
Amantadine Hydrochloride<br>Tablets USP 100mg<br>(Net content of active ingredients<br>350.00 kgs )	1 Number<br>Tablet	7	Amantadine Hydrochloride USP	102.00 mg.
		8	Microcrystalline Cellulose<br>(Avicel PH 101)	33.65 mg.
		9	Povidone (Kollidon 90F)	3.00 mg.
		10	Lake Pigment HT 5285 FD&C<br>Yellow 6 Sunset Yellow FCF<br>Aluminum Lake	0.300 mg
		11	Sodium Starch Glycolate (Type A)<br>(EXPLOTAB)	4.50 mg.

mg.| ||||9|Povidone (Kollidon 90F)|3.00 mg.| ||||10|Lake Pigment HT 5285 FD&C Yellow 6 Sunset Yellow FCF Aluminum Lake|0.300 mg| ||||11|Sodium Starch Glycolate (Type A) (EXPLOTAB)|4.50 mg.| ||||12|Povidone (K-30)|3.00 mg.| ||||13|Colloidal Silicon Dioxide (Aerosil 200 Pharma)|0.75 mg.| ||||14|Magnesium Stearate|0.80 mg.|

Case No.	78 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007137AM24
RA File Number	07AX04001359 AM24
Licence No and<br>Date	0711009827/01/12/2023

UDIN00537223AM24

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Mar/202324/25 dated 11/03/2024 against advance authorization No.0711009827 dated 01/12/2023, 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	Qty.	Sl. No.	Import Items	Qty. allowed.
NORTRIPTYLINE HCL(IP/BP/USP)	1 kg.	1	1 BROMO 3 CHLORO PROPANE	0.96 kg.
		2	TETRA HYDRO FURAN	0.71 kg.
		3	ACETONE	1.00 kg.
		4	TOLUENE	1.00 kg.

Case No.	Case No.	79 / NC/3/MEET/Mar/202324/25	79 / NC/3/MEET/Mar/202324/25	79 / NC/3/MEET/Mar/202324/25	79 / NC/3/MEET/Mar/202324/25	79 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007138AM24
RA File Number		07AX04001361 AM24
Licence No and<br>Date		0711009828/01/12/2023
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 product in meetingNo.NC/3/MEET/Apr/202223/1 dated 29/04/2022against advance authorization<br>No.0711001528 dated 22/07/2021,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

ort product in meetingNo.NC/3/MEET/Apr/202223/1 dated 29/04/2022against advance authorization **No.0711001528 dated 22/07/2021,**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. 1 1 BROMO 3 CHLORO PROPANE 0.95 kg. CYCLOBENZAPRINE HCL(USP) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||CYCLOBENZAPRINE HCL(USP)||1 kg.|1|1 BROMO 3 CHLORO PROPANE|0.95 kg.|

UDIN00537223AM24

	2	TETRA HYDRO FURAN	0.25 kg.
	3	ACETONE	0.75 kg.

Case No.	80 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007145AM24
RA File Number	07AX04001362 AM24
Licence No and<br>Date	0711009832/01/12/2023
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 product in meetingNo.NC/3/MEET/Mar/202223/24 dated 13/04/2023against advance<br>authorizationNo.0711003633 dated 06/04/2022,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. 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 1 BROMO 3 CHLORO PROPANE 0.85 kg. 2 IMINODIBENZYL 1.00 kg. 3 METHANOL 1.20 kg. 4 IPA 0.50 kg. 5 TOLUENE 0.50 kg. CLOMIPRAMINE HCL(BP/EP/USP/JP) 1 kg. 6 ACETONE 1.00 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00537223AM24

Case No.	Case No.	81 / NC/3/MEET/Mar/202324/25	81 / NC/3/MEET/Mar/202324/25	81 / NC/3/MEET/Mar/202324/25	81 / NC/3/MEET/Mar/202324/25	81 / NC/3/MEET/Mar/202324/25
Case Status		Case Deferred
Party Name		PRASHI PHARMA PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007147AM24
RA File Number		03AX04003935 AM24
Licence No and Date		0311029047/01/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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 SULPHAMETHOXAZOLE 408.00 mg. COTRIMOXAZOLE TABLETS BP 480MG(COTRIMOXAZOLE TABLETS BP 480MG EACH TABLET CONTAINS: SULPHAMETHOXAZOLE BP 400MG TRIMETHOPRIM BP 80MG 340000 X 10 X 10T) 1 Number 2 TRIMETHOPRIM 81.60 mg. 3 SULPHAMETHOXAZOLE 816.00 mg. DAVITRIM FORT TABLETS(DAVITRIM FORT TABLETS EACH TABLET CONTAINS : SULPHAMETHOXAZOLE BP 800MG TRIMETHOPRIM BP 160MG 80000 X 10 X 1 X 10T) 1 Number 4 TRIMETHOPRIM 163.20 mg. RA concerned may take further necessary action as per above decision of NC.||||was decided to fix ad-hoc norms under Para 4.07 of HBP whichever is less:-||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||COTRIMOXAZOLE TABLETS BP 480MG(COTRIMOXAZOLE TABLETS BP 480MG EACH TABLET CONTAINS: SULPHAMETHOXAZOLE BP 400MG TRIMETHOPRIM BP 80MG 340000 X 10 X 10T)||1 Number|1|SULPHAMETHOXAZOLE|408.00 mg.| |||||2|TRIMETHOPRIM|81.60 mg.| ||DAVITRIM FORT TABLETS(DAVITRIM FORT TABLETS EACH TABLET CONTAINS : SULPHAMETHOXAZOLE BP 800MG TRIMETHOPRIM BP 160MG 80000 X 10 X 1 X 10T)||1 Number|3|SULPHAMETHOXAZOLE|816.00 mg.| |||||4|TRIMETHOPRIM|163.20 mg.|

RT TABLETS EACH TABLET CONTAINS : SULPHAMETHOXAZOLE BP 800MG TRIMETHOPRIM BP 160MG 80000 X 10 X 1 X 10T)||1 Number|3|SULPHAMETHOXAZOLE|816.00 mg.| |||||4|TRIMETHOPRIM|163.20 mg.|

Case No.	82 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007165AM24
RA File Number	03AX04003897 AM24
Licence No and<br>Date	0311029063/02/12/2023

UDIN00537223AM24

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.
Sacubitril+Calcium<br>(Sacubitril Calcium)	1 kg.	1	2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert-<br>butoxycarbonyl)amino)-2-methylpentanoic<br>acid (BMPA)	1.237 kg.

Case No.	83 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	AARTI INDUSTRIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007168AM24
RA File Number	03AX04003918 AM24
Licence No and<br>Date	0311029075/04/12/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

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

Case No.	94 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	KALPSUTRA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007224AM24
RA File Number	03AX04003995 AM24
Licence No and<br>Date	0311029148/06/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00537223AM24

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Isobornyl Cyclohexanol	1kg	1	Gum Turpentine Oil	1.582 kg.

Case No.	95 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007236AM24
RA File Number	03AX04003565 AM24
Licence No and<br>Date	0311029156/06/12/2023

|Meeting Number and Date|NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024| |HQ File Number|HQRNORM APPLY 00007236AM24| |RA File Number|03AX04003565 AM24| |Licence No and Date|0311029156/06/12/2023| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo.NC/3/MEET/Feb/202324/23 dated 19/02/2024against advance authorization No.0311018798 dated 22/10/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 NONYL PHENOL 1.066 kg. TRIS NONYL PHENYL PHOSPHITE((TNPP)) 1 kg. 2 YELLOW PHOSPHORUS 0.0506 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	96 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	UNIMAX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007237AM24

UDIN00537223AM24

UDIN00537223AM24

RA File Number<br>03AX04003928 AM24	RA File Number<br>03AX04003928 AM24
Licence No and<br>Date<br>0311029157/06/12/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision		for same export
product/import product in meeting	No.NC/3/MEET/Nov/202223/12 dated 18/11/2022	against advance
authorizationNo.0311013922 dated 18.04.2022, 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.<br>Sl. No.<br>Import Items	Qty. allowed.
Azithromycin Dihydrate	1 Kg<br>1<br>Azithromycin Amine	0.9434 kg.
(Tech. Spec.: Pharmacopeial Grade)
RA concerned may take further necessary	action as per above decision of NC.

ed.**|| |Azithromycin Dihydrate|1 Kg 1 Azithromycin Amine|0.9434 kg.|| |(Tech. Spec.: Pharmacopeial Grade)|||| |RA concerned may take further necessary|action as per above decision of NC.|||

Case No.<br>97 / NC/3/MEET/Mar/202324/25
Case Status<br>Case Approved
Party Name<br>BROOKS STERISCIENCE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number<br>HQRNORM APPLY 00007260AM24
RA File Number<br>34AX04000689 AM24
Licence No and<br>Date<br>3411004418/07/12/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Nov/202324/16 dated 17/11/2023against advance
authorizationNo.3010105213 dated 02.06.2020, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I
as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty. allowed.
Meropenem Injection USP1000 mg.Each vial contains<br>1 Number	1	MEROPENEM WITH	1.29 gm.
Sterile Meropenem Trihydrate USP equ to Anhydrous		SODIUM CARBONATE
Meropenem1000mg (SterileSodium Carbonate USP equ		USP
to Sodium 90.2mg with Pre-Import condition in terms of
Para 4.13(iii) of FTP 2015-20 import should be made 1st
&EO shall be fulfilled within 12 months from the dt. of

equ||USP||| |to Sodium 90.2mg with Pre-Import condition in terms of||||| |Para 4.13(iii) of FTP 2015-20 import should be made 1st||||| |&EO shall be fulfilled within 12 months from the dt. of|||||

Case No.<br>97 / NC/3/MEET/Mar/202324/25
Case Status<br>Case Approved
Party Name<br>BROOKS STERISCIENCE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number<br>HQRNORM APPLY 00007260AM24
RA File Number<br>34AX04000689 AM24
Licence No and<br>Date<br>3411004418/07/12/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Nov/202324/16 dated 17/11/2023against advance
authorizationNo.3010105213 dated 02.06.2020, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I
as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty. allowed.
Meropenem Injection USP1000 mg.Each vial contains<br>1 Number	1	MEROPENEM WITH	1.29 gm.
Sterile Meropenem Trihydrate USP equ to Anhydrous		SODIUM CARBONATE
Meropenem1000mg (SterileSodium Carbonate USP equ		USP
to Sodium 90.2mg with Pre-Import condition in terms of
Para 4.13(iii) of FTP 2015-20 import should be made 1st
&EO shall be fulfilled within 12 months from the dt. of

UDIN00537223AM24

.2mg with Pre-Import condition in terms of||||| |Para 4.13(iii) of FTP 2015-20 import should be made 1st||||| |&EO shall be fulfilled within 12 months from the dt. of|||||

UDIN00537223AM24

import of each consignment in terms of Appdix-4J)<br>Export Item Name: Meropenem Injection 500 mg<br>USPEach vial contains Sterile Meropenem Trihydrate<br>USP equ to Anhydrous Meropenem 500mg<br>(SterileSodium Carbonate USP equ to Sodium 90.2mg<br>with Pre-Import condition in terms of Para 4.13(iii) of<br>FTP 2015-20 import shud be made 1st &EO shall be<br>fulfilled within 12 months from the dt. of import of each<br>consignment in terms of Appdix-4J)<br>1 Number<br>2<br>MEROPENEM WITH<br>SODIUM CARBONATE<br>USP<br>0.645 gm.<br>RA concerned may take further necessary action as per above decision of NC.	import of each consignment in terms of Appdix-4J)
	Export Item Name: Meropenem Injection 500 mg<br>USPEach vial contains Sterile Meropenem Trihydrate<br>USP equ to Anhydrous Meropenem 500mg<br>(SterileSodium Carbonate USP equ to Sodium 90.2mg<br>with Pre-Import condition in terms of Para 4.13(iii) of<br>FTP 2015-20 import shud be made 1st &EO shall be<br>fulfilled within 12 months from the dt. of import of each<br>consignment in terms of Appdix-4J)	1 Number	2	MEROPENEM WITH<br>SODIUM CARBONATE<br>USP	0.645 gm.

Case No.	98 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	AMI LIFESCIENCES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007264AM24
RA File Number	34AX04000693 AM24
Licence No and<br>Date	3411004416/07/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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.<br>Import Items<br>Qty. allowed.<br>Betahistine Dihydrochloride<br>1 kg.<br>1<br>Pyridine 2 Ethanol<br>0.931 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	99 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007283AM24
RA File Number	07AX04001377 AM24

UDIN00537223AM24

UDIN00537223AM24

Licence No and Date

0711009901/08/12/2023

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. 1 2 CHLORO PHENOTHIAZINE 0.95 kg 2 1 BROMO 3 CHLORO PROPANE 0.90 kg 3 TOLUENE 1.92 kg CHLORPROMAZINE HYDROCHLORIDE (BP/EP/USP/IP) 1Kg 4 ACETONE 1.65 kg RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	100 / NC/3/MEET/Mar/202324/25	100 / NC/3/MEET/Mar/202324/25	100 / NC/3/MEET/Mar/202324/25	100 / NC/3/MEET/Mar/202324/25	100 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		OMEGA COLORS PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007293AM24
RA File Number		03AX04003836 AM24
Licence No and Date		0311029233/08/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol.

|| |Licence No and Date||0311029233/08/12/2023||||| |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. 1 Caps and Closures for Bottles Relevant as per packing policy with accountability. INTRAVEOUS INFUSION /INJECTION 500ml (LIFEPORT NS 500ml)(Sodium Chloride 600000 Numbers||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||INTRAVEOUS INFUSION /INJECTION 500ml (LIFEPORT NS 500ml)(Sodium Chloride||600000 Numbers|1|Caps and Closures for Bottles|Relevant as per packing policy with accountability.| ||Intravenous Solution BP||||||

UDIN00537223AM24

|(0.9% w/v)) 4 Polypropylene Granules Relevant as per packing policy with accountability. 2 Caps and Closures for Bottles Relevant as per packing policy with accountability. INTRAVEOUS INFUSION/INJECTION 500ml (LIFEPORT DNS 500ml)(Glucose 5.0% w/v and Sodium Chloride 0.9% w/v Intravenous Infusion BP) 500000 Numbers 5 Polypropylene Granules Relevant as per packing policy with accountability. 3 Caps and Closures for Bottles Relevant as per packing policy with accountability. INTRAVEOUS INFUSION/INJECTION 500ml (LIFEPORT RL 500ml)(Compound Sodium Lactate IV Infusion BP (Ringer Lactate So

(0.9% w/v))		4	Polypropylene Granules	Relevant as per packing<br>policy with<br>accountability.
INTRAVEOUS<br>INFUSION/INJECTION 500ml<br>(LIFEPORT DNS<br>500ml)(Glucose 5.0% w/v and<br>Sodium Chloride<br>0.9% w/v Intravenous Infusion<br>BP)	<br>500000<br>Numbers	2	Caps and Closures for Bottles	Relevant as per packing<br>policy with<br>accountability.
		5	Polypropylene Granules	Relevant as per packing<br>policy with<br>accountability.
INTRAVEOUS<br>INFUSION/INJECTION 500ml<br>(LIFEPORT RL<br>500ml)(Compound Sodium<br>Lactate IV Infusion BP<br>(Ringer Lactate Solution for<br>Intravenous Infusion BP))	<br>500000<br>Numbers	3	Caps and Closures for Bottles	Relevant as per packing<br>policy with<br>accountability.
		6	Polypropylene Granules	Relevant as per packing<br>policy with<br>accountability.

Note: RA will work-out the requirement of Polypropylene Granules as per Packing Policy.

y.| ||||6|Polypropylene Granules|Relevant as per packing policy with accountability.|

Note: RA will work-out the requirement of Polypropylene Granules as per Packing Policy.

Case No.	Case No.	101 / NC/3/MEET/Mar/202324/25	101 / NC/3/MEET/Mar/202324/25	101 / NC/3/MEET/Mar/202324/25	101 / NC/3/MEET/Mar/202324/25	101 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007302AM24
RA File Number		09AX04000794 AM24
Licence No and<br>Date		0911006352/11/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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.<br>Import Items<br>Qty. allowed.<br>Daptomycin for Injection 350mg/vial 1s USA<br>(Consist of 50.75 Kgs Daptomycin)<br>145000<br>Numbers<br>1<br>Daptomycin<br>55.825 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Daptomycin for Injection 350mg/vial 1s USA<br>(Consist of 50.75 Kgs Daptomycin)		<br>145000<br>Numbers	1	Daptomycin	55.825 kg.

roduct**||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Daptomycin for Injection 350mg/vial 1s USA (Consist of 50.75 Kgs Daptomycin)|| 145000 Numbers|1|Daptomycin|55.825 kg.|

Case No.	Case No.	101 / NC/3/MEET/Mar/202324/25	101 / NC/3/MEET/Mar/202324/25	101 / NC/3/MEET/Mar/202324/25	101 / NC/3/MEET/Mar/202324/25	101 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007302AM24
RA File Number		09AX04000794 AM24
Licence No and<br>Date		0911006352/11/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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.<br>Import Items<br>Qty. allowed.<br>Daptomycin for Injection 350mg/vial 1s USA<br>(Consist of 50.75 Kgs Daptomycin)<br>145000<br>Numbers<br>1<br>Daptomycin<br>55.825 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Daptomycin for Injection 350mg/vial 1s USA<br>(Consist of 50.75 Kgs Daptomycin)		<br>145000<br>Numbers	1	Daptomycin	55.825 kg.

UDIN00537223AM24

Daptomycin for Injection 500mg/vial	500000	2	Daptomycin	275.00 kg.
	Numbers
(Consist of 250.00Kgs Daptomycin)

Daptomycin|55.825 kg.|

UDIN00537223AM24

Daptomycin for Injection 500mg/vial	500000	2	Daptomycin	275.00 kg.
	Numbers
(Consist of 250.00Kgs Daptomycin)

Case No.	102 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	S KANT HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007308AM24
RA File Number	03AX04004027 AM24
Licence No and<br>Date	0311029247/11/12/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	103 / NC/3/MEET/Mar/202324/25	103 / NC/3/MEET/Mar/202324/25	103 / NC/3/MEET/Mar/202324/25	103 / NC/3/MEET/Mar/202324/25	103 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		ANUH PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007325AM24
RA File Number		03AX04004081 AM24
Licence No and<br>Date		0311029265/12/12/2023
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 product in meetingNo.NC/3/MEET/Nov/202324/16 dated 17/11/2023against advance<br>authorizationNo.0311014743 dated 17.05.2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl.

17.05.2022**, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Erythromycin Thiocyanate 1.22 kg.A Erythromycin 11,12 Carbonate IP/BP/EP/USP 1 Kg 2 Ethylene Carbonate 0.975 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Erythromycin 11,12 Carbonate IP/BP/EP/USP||1 Kg|1|Erythromycin Thiocyanate|1.22 kg.A| |||||2|Ethylene Carbonate|0.975 kg|

Case No.	Case No.	103 / NC/3/MEET/Mar/202324/25	103 / NC/3/MEET/Mar/202324/25	103 / NC/3/MEET/Mar/202324/25	103 / NC/3/MEET/Mar/202324/25	103 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		ANUH PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007325AM24
RA File Number		03AX04004081 AM24
Licence No and<br>Date		0311029265/12/12/2023
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 product in meetingNo.NC/3/MEET/Nov/202324/16 dated 17/11/2023against advance<br>authorizationNo.0311014743 dated 17.05.2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. 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 Erythromycin Thiocyanate 1.22 kg.A Erythromycin 11,12 Carbonate IP/BP/EP/USP 1 Kg 2 Ethylene Carbonate 0.975 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Erythromycin 11,12 Carbonate IP/BP/EP/USP||1 Kg|1|Erythromycin Thiocyanate|1.22 kg.A| |||||2|Ethylene Carbonate|0.975 kg|

UDIN00537223AM24

Case No.	104 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and	11/03/2024
HQ File Number	HQRNORM APPLY 00007327AM24
RA File Number	03AX04004105 AM24
Licence No and<br>Date	0311029268/12/12/2023
Norms Committee Decision:
The Committee considered the case as per agenda and		taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Apr/202324/1			dated 28/04/2023against advance authorization
No.0311020073 dated 16.12.2022, 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		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.|| |GENTAMICIN EYE/EAR DROPS 10||138000Vials||1|Gentamicin Sulphate|5.072 kg|| |ML((EACH VIAL CONTAINS GENTAMICIN|||||||| |SULPHATE 0.030GM NET WT OF BULK|||||||| |DRUG IS 4.140 KGS))|||||||| |RA concerned may take further necessary action as per||above decision of NC.||||||

Case No.	105 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007334AM24
RA File Number	03AX04004079 AM24
Licence No and<br>Date	0311029276/12/12/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Dec/202324/19 dated 05.01.2024against advance authorization No.

UDIN00537223AM24

0311019783 dated 06.12.2022 ; 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:

UDIN00537223AM24

0311019783 dated 06.12.2022 ; 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:

|0311019783 dated 06.12.2022; 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: Sl. No. Export Product Qty. Import items Qty. allowed 1 FLUCORT N SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 322660 Packs 2 FLUCORT SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 322660 Packs 3 FLUCORT SKIN CREAM 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.) 242000 Packs 4 FLUCORT SKIN CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 968000 Packs 5 FLUOCINOLONE CREAM (TDR) ET 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 96800 Packs 6 CYNOZET CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs 7 CYNOZET CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 64532 Packs 8 SUPRICORT CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 580800 Packs 9 SUPRICORT CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 193596 Packs 10 SUPR

Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 580800 Packs 9 SUPRICORT CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 193596 Packs 10 SUPRICORT CREAM 0.025% (Pack Size 250 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 3873 Packs FLUOCINOLONE ACETONIDE BP 11 SUPRICORT N CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs 9.10 kg|0311019783 dated 06.12.2022; 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: Sl. No. Export Product Qty. Import items Qty. allowed 1 FLUCORT N SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 322660 Packs 2 FLUCORT SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 322660 Packs 3 FLUCORT SKIN CREAM 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.) 242000 Packs 4 FLUCORT SKIN CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 968000 Packs 5 FLUOCINOLONE CREAM (TDR) ET 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 96800 Packs 6 CYNOZET CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs 7 CYNOZET CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)

M 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs 7 CYNOZET CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 64532 Packs 8 SUPRICORT CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 580800 Packs 9 SUPRICORT CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 193596 Packs 10 SUPRICORT CREAM 0.025% (Pack Size 250 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 3873 Packs FLUOCINOLONE ACETONIDE BP 11 SUPRICORT N CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs 9.10 kg|0311019783 dated 06.12.2022; 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: Sl. No. Export Product Qty. Import items **Qty.

norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Sl. No. Export Product Qty. Import items Qty. allowed 1 FLUCORT N SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 322660 Packs 2 FLUCORT SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 322660 Packs 3 FLUCORT SKIN CREAM 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.) 242000 Packs 4 FLUCORT SKIN CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 968000 Packs 5 FLUOCINOLONE CREAM (TDR) ET 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 96800 Packs 6 CYNOZET CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs 7 CYNOZET CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 64532 Packs 8 SUPRICORT CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 580800 Packs 9 SUPRICORT CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 193596 Packs 10 SUPRICORT CREAM 0.025% (Pack Size 250 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 3873 Packs FLUOCINOLONE ACETONIDE BP 11 SUPRICORT N CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs

ONE ACETONIDE BP is 0.242 Kgs.) 3873 Packs FLUOCINOLONE ACETONIDE BP 11 SUPRICORT N CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs 9.10 kg|0311019783 dated 06.12.2022; 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: Sl. No. Export Product Qty. Import items Qty. allowed 1 FLUCORT N SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 322660 Packs 2 FLUCORT SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 322660 Packs 3 FLUCORT SKIN CREAM 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.) 242000 Packs 4 FLUCORT SKIN CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 968000 Packs 5 FLUOCINOLONE CREAM (TDR) ET 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 96800 Packs 6 CYNOZET CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs 7 CYNOZET CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 64532 Packs 8 SUPRICORT CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 580800 Packs 9 SUPRICORT CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 193596 Packs<br

gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 580800 Packs 9 SUPRICORT CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 193596 Packs 10 SUPRICORT CREAM 0.025% (Pack Size 250 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 3873 Packs FLUOCINOLONE ACETONIDE BP 11 SUPRICORT N CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs 9.10 kg|0311019783 dated 06.12.2022; 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: Sl. No. Export Product Qty. Import items Qty. allowed 1 FLUCORT N SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 322660 Packs 2 FLUCORT SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 322660 Packs 3 FLUCORT SKIN CREAM 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.) 242000 Packs 4 FLUCORT SKIN CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 968000 Packs 5 FLUOCINOLONE CREAM (TDR) ET 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 96800 Packs 6 CYNOZET CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs 7 CYNOZET CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is

YNOZET CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs 7 CYNOZET CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 64532 Packs 8 SUPRICORT CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 580800 Packs 9 SUPRICORT CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 193596 Packs 10 SUPRICORT CREAM 0.025% (Pack Size 250 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 3873 Packs FLUOCINOLONE ACETONIDE BP 11 SUPRICORT N CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs 9.10 kg|0311019783 dated 06.12.2022; 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: Sl. No. Export Product Qty. Import items **Qty.

ONE ACETONIDE BP is 0.242 Kgs.) 3873 Packs FLUOCINOLONE ACETONIDE BP 11 SUPRICORT N CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.) 193600 Packs 9.10 kg| |---|---|---|---|---|---| ||Sl. No.|Export Product|Qty.|Import items|Qty. allowed| ||1|FLUCORT N SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)| 322660 Packs|FLUOCINOLONE ACETONIDE BP|9.10 kg| ||2|FLUCORT SKIN CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)|322660 Packs||| ||3|FLUCORT SKIN CREAM 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.)|242000 Packs||| ||4|FLUCORT SKIN CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)|968000 Packs||| ||5|FLUOCINOLONE CREAM (TDR) ET 0.025% (Pack Size 10 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)| 96800 Packs||| ||6|CYNOZET CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)| 193600 Packs||| ||7|CYNOZET CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)| 64532 Packs||| ||8|SUPRICORT CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.)| 580800 Packs||| ||9|SUPRICORT CREAM 0.025% (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.)| 193596 Packs||| ||10|SUPRICORT CREAM 0.025% (Pack Size 250 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)| 3873 Packs|||

ms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.)| 193596 Packs||| ||10|SUPRICORT CREAM 0.025% (Pack Size 250 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)| 3873 Packs||| ||11|SUPRICORT N CREAM 0.025% (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)| 193600 Packs|||

UDIN00537223AM24

12	SUPRICORT N CREAM 0.025% (Pack Size 15 gms) (Net Wt.of	<br>64532 Packs
	FLUOCINOLONE ACETONIDE BP is 0.242Kgs.)
13	Flucort C Cream 0.01% (Pack Size 15 gms) (Net Wt.of	<br>63332 Packs
	FLUOCINOLONE ACETONIDE BP is 0.095 Kgs)
14	FLUCORT C OINTMENT 0.025% (Pack Size 15 gms) (Net	<br>161330 Packs
	Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.)
15	GLENCORT GEL 0.025% (Pack Size 5 gms) (Net Wt.of	<br>361600 Packs
	FLUOCINOLONE ACETONIDE BP is 0.452 Kgs.)
16	GLENCORT GEL 0.025% (Pack Size 30 gms) (Net Wt.of	<br>64535 Packs
	FLUOCINOLONE ACETONIDE BP is 0.484 Kgs.)
17	FLUCORT MZ SKIN OINTMENT 0.01% (Pack Size 15 gms)	<br>96798 Packs
	(Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.145 Kgs.)

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

MZ SKIN OINTMENT 0.01% (Pack Size 15 gms)| 96798 Packs||| ||(Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.145 Kgs.)||||

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

Case No.<br>106 / NC/3/MEET/Mar/202324/25
Case Status<br>Case Approved
Party Name<br>KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number<br>HQRNORM APPLY 00007335AM24
RA File Number<br>03AX04004073 AM24
Licence No and<br>Date<br>0311029277/12/12/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision		for same export
product/import product in meetingNo.NC/3/MEET/Feb/202324/23 dated 19/02/2024against advance authorization
No.0311027272 dated 21/09/2023, 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.
TETRAHYDROFURAN<br>1 kg.<br>1	1.4 Butandiol (Purity Min. 95%)		1.42 kg.
(PURITY 99%)

UDIN00537223AM24

Product** Qty. **Sl. No. **|Import Items||Qty. allowed.|| |TETRAHYDROFURAN 1 kg. 1|1.4 Butandiol (Purity Min. 95%)||1.42 kg.|| |(PURITY 99%)|||||

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Case No.	107 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007339AM24
RA File Number	03AX04004064 AM24
Licence No and<br>Date	0311029280/12/12/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	108 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	ZENTIVA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007341AM24
RA File Number	03AX04004117 AM24
Licence No and<br>Date	0311029284/12/12/2023
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 product in meetingNo.NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance authorization<br>No.0311026873 dated 04/09/2023, 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. 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. Agomelatine Citric Acid Co-Crystal 1 kg. 1 (7-METHOXY 1 NAPHTHYL) ACETONITRILE 0.60 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No. 109 / NC/3/MEET/Mar/202324/25

UDIN00537223AM24

Case Status	Case Status	Case Approved	Case Approved	Case Approved	Case Approved	Case Approved
Party Name		SRI KRISHNA PHARMACEUTICALS LIMITED

Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007346AM24
RA File Number		09AX04000824 AM24

Licence No and<br>Date		0911006368/12/12/2023

Norms Committee		Decision:

The Committee<br>product/import pr		considered the case as per agenda and taking cue from the earlier decision for same export<br>oduct in meetingNo.NC/3/MEET/Feb/202324/23 dated 19/02/2024against advance authorization
No.0911005810 d<br>		ated 20.09.2023, it was decided to fix ad-hoc no<br>		rms 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.

||rms 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.| |||| |||| ||CARBIDOPA 12.5 MG LEVODOPA 50 MG TABLETS|| 1 Number|1|CARBIDOPA|12.75 mg| |||||2|LEVODOPA|51.00 mg| ||CARBIDOPA|25 MG LEVODOPA 100 MG| 1 Number|3|CARBIDOPA|2550 m| || TABLETS|| |||. g| |||||||| |||||4|LEVODOPA|102.00 mg| |||||||| |||||||| |||||||| |RA concerned may||take further necessary action as per above decision of NC.||||| |||||||| |||||||| |Case No.||110 / NC/3/MEET/Mar/202324/25||||| |Case Status||Case Approved||||| |Party Name||ZIM LABORATORIES LIMITED.||||| |||||||| |Meeting Number and Date||NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024||||| |HQ File Number||HQRNORM APPLY 00007349AM24||||| |RA File Number||50AX04000067 AM24||||| |Licence No and||||||| |Date||5011001200/12/12/2023||||| |Norms Committee||Decision:||||| |The Committee ||considered the case as per agenda and taking cue from the earlier decision for same export ||||| |product/import pr No5011000169 d||oduct in meetingNo.NC/3/MEET/Jun/202223/5 dated 08/07/2022against advance authorization ated 24062021it was decided to fix ad-hoc norms under Para 407 of HBP Vol I as er details||||| |.||.., . . p|||||

2223/5 dated 08/07/2022against advance authorization ated 24062021it was decided to fix ad-hoc norms under Para 407 of HBP Vol I as er details||||| |.||..**, . . p|||||

Case No.		110 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		ZIM LABORATORIES LIMITED.
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007349AM24
RA File Number		50AX04000067 AM24
Licence No and<br>Date		5011001200/12/12/2023
Norms Committee Decision:
The Committee	considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Jun/202223/5 dated 08/07/2022against advance authorization
No.5011000169	dated 24.06.2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details

UDIN00537223AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Doxyzim 100 (Doxycycline Capsules<br>BP 100 mg)	<br>1 Number	1	Doxycycline Hyclate CEP<br>Grade	<br>117.73 mg

ct**	Qty.	Sl. No.	Import Items	Qty. allowed.
Doxyzim 100 (Doxycycline Capsules<br>BP 100 mg)	<br>1 Number	1	Doxycycline Hyclate CEP<br>Grade	<br>117.73 mg

Case No.	111 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	SRI KRISHNA PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007387AM24
RA File Number	09AX04000787 AM24
Licence No and<br>Date	0911006373/13/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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.<br>Import Items<br>Qty. allowed.<br>1<br>PARA AMINO<br>PHENOL<br>0.727 kg<br>PARACETAMOL GRANULES DC GRADE 90%<br>1 Kg<br>2<br>ACETIC<br>ANHYDRIDE<br>0.682 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	112 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	SHARON BIO-MEDICINE LIMITED

UDIN00537223AM24

necessary action as per above decision of NC.||

Case No.	112 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	SHARON BIO-MEDICINE LIMITED

UDIN00537223AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007402AM24
RA File Number	03AX04004187 AM24
Licence No and<br>Date	0311029349/14/12/2023
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 product in meetingNo.NC/3/MEET/Dec/202324/19 dated 05/01/2024against advance authorization<br>No.0311020778 dated 18/01/2023, 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. Import Items<br>Qty. allowed.<br>1<br>Alpha-(2,4-Dichlorophenyl)-1H- Imidazole-<br>1-Ethanol<br>0.662 kg.<br>MICONAZOLE NITRATE<br>1 kg.<br>2<br>2,4,Dichloro Benzyl Chloride?<br>0.504 kg.<br>RA concerned may take further necessary action as per above decision of NC.

dazole- 1-Ethanol 0.662 kg. MICONAZOLE NITRATE 1 kg. 2 2,4,Dichloro Benzyl Chloride? 0.504 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	113 / NC/3/MEET/Mar/202324/25	113 / NC/3/MEET/Mar/202324/25	113 / NC/3/MEET/Mar/202324/25	113 / NC/3/MEET/Mar/202324/25	113 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		DISTO PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007425AM24
RA File Number		09AX04000809 AM24
Licence No and<br>Date		0911006387/15/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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.<br>Import Items<br>Qty. allowed.<br>MINOCYCLINE<br>IR<br>PELLETS<br>35%<br>W/W(PELLETS)<br>200 Kg<br>1<br>MINOCYLINE<br>70.7 Kg
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	MINOCYCLINE<br>IR<br>PELLETS<br>35%<br>W/W(PELLETS)		<br>200 Kg	1	MINOCYLINE	70.7 Kg

MINOCYLINE 70.7 Kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||MINOCYCLINE IR PELLETS 35% W/W(PELLETS)|| 200 Kg|1|MINOCYLINE|70.7 Kg|

Case No.	Case No.	113 / NC/3/MEET/Mar/202324/25	113 / NC/3/MEET/Mar/202324/25	113 / NC/3/MEET/Mar/202324/25	113 / NC/3/MEET/Mar/202324/25	113 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		DISTO PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007425AM24
RA File Number		09AX04000809 AM24
Licence No and<br>Date		0911006387/15/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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.<br>Import Items<br>Qty. allowed.<br>MINOCYCLINE<br>IR<br>PELLETS<br>35%<br>W/W(PELLETS)<br>200 Kg<br>1<br>MINOCYLINE<br>70.7 Kg
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	MINOCYCLINE<br>IR<br>PELLETS<br>35%<br>W/W(PELLETS)		<br>200 Kg	1	MINOCYLINE	70.7 Kg

UDIN00537223AM24

||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||MINOCYCLINE IR PELLETS 35% W/W(PELLETS)|| 200 Kg|1|MINOCYLINE|70.7 Kg|

UDIN00537223AM24

RA	concerned may take further necessary action as pe	concerned may take further necessary action as pe
			r above decisio	n of NC.

Cas	e No.	114 / NC/3/MEET/Mar/202324/25
Cas	e Status	Case Deferred
Par	ty Name	BLUE JET HEALTHCARE LIMIT	ED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and	11/03/2024

HQ	File Number	HQRNORM APPLY 00007460AM	24
RA	File Number	03AX04004237 AM24
Licence No and<br>Date
		0311029470/19/12/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	115 / NC/3/MEET/Mar/202324/25	115 / NC/3/MEET/Mar/202324/25	115 / NC/3/MEET/Mar/202324/25	115 / NC/3/MEET/Mar/202324/25	115 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		HARMAN FINOCHEM LIMITED

Meeting Number<br>		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
and Date

HQ File Number		HQRNORM APPLY 00007461AM24
RA File Number		03AX04004235 AM24

Licence No and<br>		0311029471/19/12/2023
Date

Norms Committee<br>The Committee c		Decision:<br>onsidered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP
<br>Vol.

1/19/12/2023||||| |Date||||||| |||||||| |Norms Committee The Committee c||Decision: onsidered 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.| ||Sacubitril+Calcium||1 kg.|1|2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert-|1.237 kg.| ||||||butoxycarbonyl)amino)-2-methylpentanoic acid|| ||(Sacubitril Ca|lcium)|||(BMPA)|| |||||||| |||||||| |||||||| |RA concerned may||take further necessary action as per above decision of NC.||||| |||||||| |||||||| |||||||| |Case No.||116 / NC/3/MEET/Mar/202324/25||||| |||||||| |Case Status||Case Approved||||| ||||||||

Case No.	116 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved

UDIN00537223AM24

Party Name<br>HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number<br>HQRNORM APPLY 00007462AM24
RA File Number<br>03AX04004236 AM24
Licence No and<br>Date<br>0311029472/19/12/2023
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.<br>Sl. No.<br>Import Items	**Qty.

ix 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.|| |Sacubitril+Calcium 1 kg. 1 2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert-|1.237 kg.|| |butoxycarbonyl)amino)-2-methylpentanoic acid||| |(Sacubitril Calcium) (BMPA)||| |RA concerned may take further necessary action as per above decision of NC.|||

Case No.	Case No.	117 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		KAWAKEN STERLING SURFACTANTS PRIVATE		LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ	File Number	HQRNORM APPLY 00007478AM24
RA File Number		03AX04004180 AM24
Licence No and<br>Date		0311029499/20/12/2023
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.
	STEROCARE	<br>EGDS<br>(Ethylene<br>Glycol<br>57000 Kg.	1	STEARIC ACID 1842		55597.8 kg.
	Distearate )				(triple pressed)
			2	Mono Ethylene Glycol		6070.5 kg.

UDIN00537223AM24

==> picture [464 x 180] intentionally omitted <==

g.|1|STEARIC ACID 1842||55597.8 kg.|| ||Distearate )||||(triple pressed)||| ||||2|Mono Ethylene Glycol||6070.5 kg.||

UDIN00537223AM24

==> picture [464 x 180] intentionally omitted <==

----- Start of picture text ----- (MEG) STEROCARE EGMS (Ethylene Glycol 57000 kg. 3 STEARIC ACID 1842 50342.4 kg. Monostearate ) (triple pressed) 4 Mono Ethylene Glycol 11257.5 kg. (MEG) STEROCARE GMS (GLYCEROL MONO 57000 kg. 5 STEARIC ACID 1842 46124.4 kg. STEARATE ) (triple pressed) ----- End of picture text -----

								(MEG)
RA
	STEROCARE<br>EGMS<br>(Ethylene<br>Glycol<br>Monostearate )			<br>57000 kg.			3	STEARIC ACID 1842<br>(triple pressed)	50342.4 kg.
							4	Mono Ethylene Glycol	11257.5 kg.
								(MEG)

	STEROCARE GMS (GLYCEROL<br>STEARATE )		MONO	<br>5	7000 kg.		5	STEARIC ACID 1842<br>(triple pressed)	46124.4 kg.
	concerned may take further necessary		action as p
					er above d	ecision of NC.


Cas	e No.	118 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		CHEMIPRIME IMPEX PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007498AM24
RA File Number		03AX04004009 AM24
Licence No and<br>		0311029541/20/12/2023
Date

Norms Committee		Decision:

LY 00007498AM24||||||||||| |RA File Number||03AX04004009 AM24||||||||||| |Licence No and ||0311029541/20/12/2023||||||||||| |Date||||||||||||| |||||||||||||| |Norms Committee||Decision:||||||||||| |The Committee c Vol. I as per detai||onsidered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP ls given below or as applied by the firm, whichever is less:-||||||||||| |||||||||||||| |||||||||||||| |||||||||||||| ||Export Produ|ct||||Qty.||Sl. No.||Import Items||Qty. allowed.| |||||||||||||| ||Cycloaliphatic amine ((Epocure HD 1618))|||||1 kg.||1||Epoxy Hardener||0.5025 kg.| |||||||||2||Benzyl Alcohol||0.3015 kg.| |||||||||3||Liquid Epoxy Resin||0.201 kg.| |||||||||||||| |||||||||||||| |||||||||||||| |||||||||||||| |RA concerned may||take further necessary action as per above decision of NC.||||||||||| |||||||||||||| ||||||||||||||

UDIN00537223AM24

Case No.	119 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007500AM24
RA File Number	03AX04004231 AM24
Licence No and<br>Date	0311029543/20/12/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for
following information/documents from the firm:-
**Import item No.

ee Decision:|| |The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for|| |following information/documents from the firm:-|| |Import item No. 9 does not match with export item No.6 as claimed in the application. 1.|| |Justification/Amendment may be furnished. 2.||

Case No.<br>120 / NC/3/MEET/Mar/202324/25
Case Status<br>Case Approved
Party Name<br>ANUH PHARMA LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number<br>HQRNORM APPLY 00007501AM24
RA File Number<br>03AX04004051 AM24
Licence No and<br>Date<br>0311029544/20/12/2023
Norms Committee Decision:
The Committee considered the case as per agenda and	taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Jan/202324/21 dated 24/01/2024against advance authorization
No.0311023591 dated 15/05/2023, 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.
Triamcinolone Acetonide<br>1 kg.<br>1		9'11B-Epoxidetriamcinolone(5TR)	1.00 kg.
IP/BP/USP/EP
RA concerned may take further necessary action as per above decision of NC.

Case No.	121 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	CHEMPLAST SANMAR LIMITED

UDIN00537223AM24

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

Case No.	121 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	CHEMPLAST SANMAR LIMITED

UDIN00537223AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007529AM24
RA File Number	04AX04000830 AM24
Licence No and<br>Date	0411006605/21/12/2023
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-
Chemical reaction of the product indicating name and molecular weight of the reactants and products<br>1.
and stage wise yield.
The end use of the product and the value of by-product formed during the process.<br>2.

Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number		HQRNORM APPLY 00007529AM24
RA File Number		04AX04000830 AM24
Licence No and<br>Date		0411006605/21/12/2023

|---|---|---|---|---|---|---|---|---|---|---| |HQ File Number||HQRNORM APPLY 00007529AM24||||||||| |RA File Number||04AX04000830 AM24||||||||| |Licence No and Date||0411006605/21/12/2023||||||||| |Norms Committee Decision: The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following information/documents from the firm:- Chemical reaction of the product indicating name and molecular weight of the reactants and products and stage wise yield. 1. The end use of the product and the value of by-product formed during the process. 2.||||||||||| |||||||||||| |Cas|e No.|122 / NC/3/MEET/Mar/202|||324/25|||||| |Cas||||||||||| ||e Status|Case Approved||||||||| |Par|ty Name|HARMAN FINOCHEM LI|||MITED|||||| |Me and|eting Number|||||||||| || Date|NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024||||||||| |HQ|File Number|HQRNORM APPLY 00007547AM24||||||||| |RA File Number||03AX04004274 AM24||||||||| |Licence No and||||||||||| |Date||0311029606/22/12/2023||||||||| |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 detai||s given below or as applied by the firm, whichever is less:-||||||||| |||||||||||| |||||||||||| |||||||||||| ||Export Pr|duct|Qty.|Sl. No.||Import Items|||**Qty.

. I as per detai||s given below or as applied by the firm, whichever is less:-||||||||| |||||||||||| |||||||||||| |||||||||||| ||Export Pr|duct|Qty.|Sl. No.||Import Items|||Qty. allowed.|| |||||||||||| ||Sacubitril+C|alcium|1 kg.|1||2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert- |||1.237 kg.|| ||(Sacubitril C|alcium)||||butoxycarbonyl)amino)-2-methylpentanoic acid (BMPA)||||| |RA concerned may take further necessary action as per above decision of NC||||||||||| |.|||||||||||

Case No.	Case No.	123 / NC/3/MEET/Mar/202324/25
Case Status		Case Approved
Party Name		HARMAN FINOCHEM LIMITED
Meeting Number an	d	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
Date
HQ File Number		HQRNORM APPLY 00007550AM24

UDIN00537223AM24

RA File Number

03AX04004273 AM24

Licence No and Date

0311029607/22/12/2023

2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert- butoxycarbonyl)amino)-2-methylpentanoic acid (BMPA) 1.237 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	124 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	AMNEAL INJECTABLES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007557AM24
RA File Number	08AX04001743 AM24
Licence No and<br>Date	0811010331/22/12/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	125 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	USV PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007595AM24
RA File Number	03AX04004322 AM24
Licence No and<br>Date	0311029676/27/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00537223AM24

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:-||

UDIN00537223AM24

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Propafenone HCL ER Capsules<br>USP<br>225<br>MG<br>60'<br>s<br>us<br>(Ris((13,998<br>Bottles<br>X<br>60<br>Capsules Per Bottles = 8,39,880<br>Capsules)(Total<br>Weight<br>of<br>Export Product = 188.97 Kgs)<br>(Net Content weight of Import<br>Product = 207.87 kgs))	<br> <br> <br> <br> <br> <br> <br>839880<br>Numbers	1	Propafenone Hydrochloride	192.75 kg
Propafenone HCL ER Capsules<br>USP<br>325<br>MG<br>60'<br>s<br>us<br>(Ris((40,838<br>Bottles<br>X<br>60<br>Capsules Per Bottles = 24,50,280<br>Capsules ) (Total Weight of<br>Export Product = 796.34 Kgs)<br>(Net Content weight of Import<br>Product = 875.98 kgs))	<br> <br> <br> <br> <br> <br> <br>2450280<br>Numbers	2	Propafenone Hydrochloride	812.27 kg

Case No.	126 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007599AM24
RA File Number	03AX04004373 AM24
Licence No and<br>Date	0311029682/27/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case along relevant documents from the firm.		Personal Hearing

tee considered the case as per agenda and it was decided to call the firm for attending before Norms Committee to explain its case along relevant documents from the firm.||Personal Hearing|

Case No.	127 / NC/3/MEET/Mar/202324/25
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024

UDIN00537223AM24

HQ File Number	HQRNORM APPLY 00007600AM24
RA File Number	03AX04004374 AM24
Licence No and<br>Date	0311029686/27/12/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	128 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007607AM24
RA File Number	09AX04000784 AM24
Licence No and<br>Date	0911006446/28/12/2023
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 product in meetingNo. NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance<br>authorizationNo.0911005617 dated 10.08.2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl.

10.08.2023**, 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. 1 PENICILLIN G POTASSIUM FIRST CRYSTAL 1.375 kg 2 ACETONE 1.971 kg 3 METHYLENE CHLORIDE MDC 3.29 kg 4 2 MERCAPTO BENZO THIAZOLE MBT 0.511 kg GCLE (7-PHENYLACETAMIDEO- 3- CHLOROMETHYL CEPHALOSPORANIC ACID PARA METHOXY BENZYL ESTER) (WHITE CRYSTALLINE POWDER) 1 kg 5 METHANOL 1.971 kg RA concerned may take further necessary action as per above decision of NC.||

UDIN00537223AM24

Case No.	129 / NC/3/MEET/Mar/202324/25
Case Status	Case Approved
Party Name	NAPROD LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number	HQRNORM APPLY 00007629AM24
RA File Number	03AX04004329 AM24
Licence No and<br>Date	0311029758/29/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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.<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. Fluorouracil INJ BP 500 MG/10ML 68230 Vials 1 Fluorouracil IP BP 36.708 kg Fluorouracil INJ BP 1000 MG/20 ML 69650 Vials 2 Fluorouracil IP BP 73.133 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	Case No.<br>	130 / NC/3/MEET/Mar/202324/25	130 / NC/3/MEET/Mar/202324/25	130 / NC/3/MEET/Mar/202324/25	130 / NC/3/MEET/Mar/202324/25	130 / NC/3/MEET/Mar/202324/25
Case Status<br>		Case Approved
Party Name<br>		MSN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date<br>		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number<br>		HQRNORM APPLY 00007630AM24
RA File Number<br>		09AX04000831 AM24
Licence No and<br>Date<br>		0911006451/29/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

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

Case No.<br>	Case No.<br>	130 / NC/3/MEET/Mar/202324/25	130 / NC/3/MEET/Mar/202324/25	130 / NC/3/MEET/Mar/202324/25	130 / NC/3/MEET/Mar/202324/25	130 / NC/3/MEET/Mar/202324/25
Case Status<br>		Case Approved
Party Name<br>		MSN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date<br>		NC/ 3/ MEET/ Mar/ 202324/ 25 and 11/03/2024
HQ File Number<br>		HQRNORM APPLY 00007630AM24
RA File Number<br>		09AX04000831 AM24
Licence No and<br>Date<br>		0911006451/29/12/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00537223AM24

Aliskiren Hemifumarate (API)	1	kg	1	Tert-Butyl(1S,3S)-1-((2S,4S)-4-	1.18 kg
				isopropyl-5-oxotetrahydro furan-2-
				yl)-3-(4-methoxy-3-(3-methoxy
				propoxy)benzyl)-4-methyl
				pentylcarbamate

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