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/Aug/202324/11 DATED: 22/08/2023

Please Note

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

Meeting No. NC/3/MEET/Aug/202324/11 dated 22/08/2023 of Norms Committee - III for the year 2023-24 was held on 22/08/2023 under the Chairmanship of Rajiv Soni ,Joint DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 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:-

S.No.	Name and Designation of Representatives	Department
1	T SONGZALIAN,Deputy DGFT	DGFT(HQ)
2	UTTAM SARKAR,Assistant Section Officer	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

This document has been digitally signed by T SONGZALIAN, Deputy DGFT on 20-09-2023 18:09:16.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00000449AM24
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>4,6 Dichloro 5-Methoxy Pyrimidine (DCMP)<br>0.78 kg.<br>Sulfadoxine<br>1 Kg.<br>2<br>SULFANILAMIDE<br>0.90 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	2 / NC/3/MEET/Aug/202324/11	2 / NC/3/MEET/Aug/202324/11	2 / NC/3/MEET/Aug/202324/11	2 / NC/3/MEET/Aug/202324/11	2 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM APPLY 00000763AM24
RA File Number		NA
Licence No and<br>Date		NA

S LIMITED||||| |Meeting Number and Date||NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023||||| |HQ File Number||HQRNORM APPLY 00000763AM24||||| |RA File Number||NA||||| |Licence No and Date||NA||||| |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/Aug/202122/7 dated 13/08/2021against advance authorizationNo.0810143923 dated 20/11/2018, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.|

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AZITHROMYCIN ORAL SUSPENSION USP	1 Number	1	AZITHROMYCIN DIHYDRATE	330.12 mg.
100MG/5ML (300MG/15ML BOTTLE) ((ACTIVE			USP
INGREDIENT: AZITHROMYCIN DIHYDRATE USP
EQUIVALENT TO AZITHROMYCIN USP - NET WT.
265.196 KGS))		2	SUCROSE NF FINE GRADE	11616.00 mg.
			(COMPRESSUC PS)
AZITHROMYCIN ORAL SUSPENSION USP	1 Number	1	AZITHROMYCIN DIHYDRATE	660.24 mg.
200MG/5ML (600MG/15ML BOTTLE) ((ACTIVE			USP
INGREDIENT: AZITHROMYCIN DIHYDRATE USP
EQUIVALENT TO AZITHROMYCIN USP - NET WT.
742.553 KGS))		2	SUCROSE NF FINE GRADE	11616.00 mg.
			(COMPRESSUC PS)
AZITHROMYCIN ORAL SUSPENSION USP	1 Number	1	AZITHROMYCIN DIHYDRATE	990.36 mg.
200MG/5ML (900MG/22.5ML BOTTLE) ((ACTIVE			USP
INGREDIENT: AZITHROMYCIN DIHYDRATE USP

.| ||||(COMPRESSUC PS)|| |AZITHROMYCIN ORAL SUSPENSION USP|1 Number|1|AZITHROMYCIN DIHYDRATE|990.36 mg.| |200MG/5ML (900MG/22.5ML BOTTLE) ((ACTIVE|||USP|| |INGREDIENT: AZITHROMYCIN DIHYDRATE USP||||| |EQUIVALENT TO AZITHROMYCIN USP - NET WT.||||| |836.953 KGS))||2|SUCROSE NF FINE GRADE|17424.00 mg.| ||||(COMPRESSUC PS)|| |AZITHROMYCIN ORAL SUSPENSION USP|1 Number|1|AZITHROMYCIN DIHYDRATE|1320.48 mg.| |200MG/5ML (1200MG/30ML BOTTLE) ((ACTIVE|||USP|| |INGREDIENT: AZITHROMYCIN DIHYDRATE USP||||| |EQUIVALENT TO AZITHROMYCIN USP - NET WT.||||| |1275.898 KGS))||2|SUCROSE NF FINE GRADE|23232.00 mg.| ||||(COMPRESSUC PS)||

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

Case No.<br>3 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Approved
Party Name<br>PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number<br>HQRNORM APPLY 00004181AM23
RA File Number<br>NA
Licence No and<br>Date<br>NA
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/202223/12dated18/11/2022against advance			authorizationNo.0510401740dated21/02/2017,
it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever
is less:-
Export Product	Qty.	Sl. No.		Import Items	Qty.

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.||

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PLASTICIZER (DI ISONONYL PHTHALATE)	1 kg.	1	PHTHALI ANHYDRIDE	0.372 kg.
(OILY LIQUID PHTHALATE EASTER)
		2	ISO NONANOL	0.726 kg.

Case No.	4 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	INNOVASSYNTH TECHNOLOGIES (INDIA ) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00004451AM24
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	5 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004198AM24
RA File Number	092404000579 AM12
Licence No and<br>Date	0910051360/21/02/2012
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Committee to explain its case.		Personal Hearing<br>before Norms

ms Committee Decision: The Committee considered the case as per agenda and it was decided to call the firm for attending Committee to explain its case.||Personal Hearing before Norms|

Case No.	6 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	MYLAN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00003162AM23
RA File Number	092404000288 AM13
Licence No and<br>Date	0910053905/26/09/2012
Norms Committee Decision:

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The case is under consideration for want of comments of TE.


The case is under co		nsideration for want of comments of TE.



Case No.			7 / NC/3/MEET/Aug/202324/11

Case Status			Case Approved
Part Name			BAYER CROPSCIENCE LIMITED
y
Meetin Number a		d Date	NC/ 3/ MEET/ Au/ 202324/ 11 and 22/08/2023
g			g
HQ File Number			HQRNORM REVIW00004885AM24

RA File Number			039404000797 AM14

Licence No and Date			0310772503/28/02/2014
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 Vol.<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>1<br>PHTHALOYL DICHLORIDE (PDC)<br>2<br>2-METHYL-1-METHLTHIO-2-<br>PROPANAMINE(SAA)<br>3<br>2-METHYL-4-<br>SOD ( N2-(1,1-DIMETHYL-2-METHYLSULFINYLETHYL)(-<br>N1-(2-METHYL-4-(1,2,2,2-TETRAFLUORO-1-<br>(TRIFLUOROMETHYL)ETHYL)PHENYL)PHTHALAMIDE)<br>1<br>Kg							I as per

	Export Product			Qty	Sl	Import Items		Qty.
				.	.<br>No.

-(1,2,2,2-TETRAFLUORO-1- (TRIFLUOROMETHYL)ETHYL)PHENYL)PHTHALAMIDE) 1 Kg|||||||||||||I as per|| |||||||||||||||| ||Export Product||||||||Qty|Sl|Import Items|||Qty.| ||||||||||.|. No.||||| ||SOD ( N2-(1,1-DIMETHYL-2-METHYLSULF N1-(2-METHYL-4-(1,2,2,2-TETRAFLUORO- (TRIFLUOROMETHYL)ETHYL)PHENYL)P||||INYLETHY 1- HTHALAM||L)(- IDE)| |1 Kg|1|PHTHALOYL DICHLORID|E (PDC)||0.461 kg| |||||||||||||||0.283 kg| |||||||||||2|2-METHYL-1-METHLTHIO-2- PROPANAMINE(SAA)|||| |||||||||||3|2-METHYL-4-|||0.581 kg| |||||||||||||||| |||||||||||||||| |||||||||||||||0.190 kg| |||||||||||4|TOLUENE|||| |||||||||||||||| |||||||||||||||| |||||||||||||||| |||||||||||||||| |RA concerned ma||y take further necessary action as per above decision of NC.||||||||||||| |||||||||||||||| |||||||||||||||| |||||||||||||||| |Case No.||8 / NC/3/MEET/Aug/202324/11||||||||||||| |Case Status||Case Approved||||||||||||| |Party Name||PAYAL POLYPLAST PRIVATE LIMITED||||||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023||||||||||||| |HQ|File Number|HQRNORM APPLY 00005396AM23||||||||||||| |RA|File Number|NA||||||||||||| |Lic Dat|ence No and e|0510386128/09/05/2014|||||||||||||

Case No.	8 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00005396AM23
RA File Number	NA
Licence No and	0510386128/09/05/2014
Date

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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 authorization No.0510408806 dated 06/12/2018 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.
DI OCTYL TERE PHTHALATE (DOTP)	1 kg.	1	PURE TERE PHTHALIC ACID	0.447 kg.
		2	2 ETHYL HEXANOL	0.680 kg.

Case No.	9 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	ADCOCK INGRAM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00005418AM23
RA File Number	NA
Licence No and<br>Date	0710106181/25/07/2014
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 Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>GLYCINE USP/BP/EP<br>535.7 mg.<br>CAL - SUP TABLETS CALCIUM<br>CARBONATE 1250 MG + GLYCINE 535.7<br>MG (No of tabs -4000000) (Glycine -<br>2142.800 Kgs + Calcium - 5000.000 Kgs)<br>1 Number<br>2<br>CALCIUM CARBONATE<br>DENSE BP/USP<br>1275.00 mg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 10 / NC/3/MEET/Aug/202324/11

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CALCIUM CARBONATE DENSE BP/USP 1275.00 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No. 10 / NC/3/MEET/Aug/202324/11

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Cas	e Status	e Status	Case Ap	proved
Part	y Name		BAYER	CROPSCIEN	CE LIM	ITED
Meeting Number and Date
			NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number			HQRNORM REVIW00004881AM24
RA File Number			039404000405 AM15
Licence No and Date			0310788397/26/08/2014
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 Vol. I as per details<br>given below or as applied by the firm, whichever is less:-


The Committee con<br>		sidered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

y the firm, whichever is less:-|||||||||||||| ||||||||||||||| ||||||||||||||| |The Committee con ||sidered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per det |||||||||||| |given below or as a||plied by the firm, whichever is less:-|||||||||||| ||||||||||||||| ||Exort Pro|duct||||Qt||Sl|Imort Items|||Qt|| ||p|||||y.||. No.|p|||y.|| ||SOD = N2 - ( 1, 1-DIMETHYL-2- METHYLSULFINYLETHYL)-N1-(2-METHYL-4-(1,2,2,2- TETRAFLUORO(-1- |||||1 Kg||1|PHTHALOYL DICHLORIDE (PDC)|||0.50 kg|00| ||||||||||||||| ||(TRIFLUOROMETHYL)ETHYL)PHENYL)PHTHALAMIDE)|||||||2|2-METHYL-1-METHLTHIO-2- PROPANAMINE (SAA)||||| |||||||||||||g|| ||||||||||||||45| |||||||||3|2-METHYL-4- HEPTAFLUOROISOPROPYLAMINE(RFA)|||0.56 k|| |||||||||||||g|| ||||||||||||||0| |||||||||4|TOLUENE|||0.20 || |||||||||||||kg|| ||||||||||||||| ||||||||||||||| |RA concerned may take further necessary action as per above decision of NC.|||||||||||||| ||||||||||||||| |Case No.||11 / NC/3/MEET/Aug/202324/11|||||||||||| |Case Status||Case Deferred|||||||||||| |Party Name||INCHEM LABORATORIES PRIVATE LIMITED|||||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023|||||||||||| |HQ File Number||HQRNORM REVIW00003010AM24|||||||||||| |RA File Number||092404000374 AM15|||||||||||| |Licence No and||0910061119/17/10/2014|||||||||||| |Date|||||||||||||| |||||||||||||||

|||||||||| |HQ File Number||HQRNORM REVIW00003010AM24|||||||||||| |RA File Number||092404000374 AM15|||||||||||| |Licence No and||0910061119/17/10/2014|||||||||||| |Date|||||||||||||| ||||||||||||||| |Norms Committee The Committee cons||Decision: idered the case as per agenda and it was decided to call the firm for attending||||||||Personal Hearing before Norms|||| | Committee to explain|| its case.|||||||| |||| |||||||||||||||

Case No.	11 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00003010AM24
RA File Number	092404000374 AM15
Licence No and<br>Date	0910061119/17/10/2014
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing		<br>before Norms
Committee to explain its case.

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e 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.|||

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Case No.		12 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		BAYER CROPSCIENCE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM REVIW00004883AM24
RA File Number		039404000710 AM15
Licence No and Date		0310791177/18/11/2014
Nor<br>Th<br>det	ms Committee Decision:<br>e 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<br>ails given below or as applied by the firm, whichever is less:-

	Export Product			Qty	. Sl.<br>No.	Import Items		Qty.

	SOD = N2 - ( 1, 1-DIMETHYL-2-<br>		<br>	1<br>	1	PHTHALOYL DICHLORIDE (PD	C)	0.5000<br>
	METHYLSULFINYLETHYL)-N1-(2-METHYL-4-(1,2,2,2-<br>TETRAFLUORO(-1-<br>(TRIFLUOROMETHYL)ETHYL)PHENYL)PHTHALAMIDE)<br>			Kg				kg
					2	2-METHYL-1-METHLTHIO-2-<br>PROPANAMINE (SAA)		0.3090<br>kg


					3	2-METHYL-4-		0.5645
						HEPTAFLUOROISOPROPYLAMINE(RFA)		kg


					4	TOLUENE		0.200
								kg

||3|2-METHYL-4-||0.5645| ||||||||||||HEPTAFLUOROISOPROPYLAMINE(RFA)||kg| ||||||||||||||| ||||||||||||||| |||||||||||4|TOLUENE||0.200| ||||||||||||||kg| ||||||||||||||| ||||||||||||||| ||||||||||||||| |RA concerned may take further necessary action as per above decision of NC.|||||||||||||| ||||||||||||||| |Cas|e No.|||13 / NC/3/MEET/Au|||g/202324/11||||||| |Cas|e Status|||Case Approved|||||||||| |Par|||||||||||||| ||ty Name|||BAYER CR||OPSCIE|NCE LIM||ITED||||| |Me|eting Number and Date|||NC/ 3/ MEE||T/ Aug/|202324/ 1||1 and 22/08/2023||||| |HQ|File Number|||HQRNORM||REVIW|00004884||AM24||||| ||||||||||||||| |RA|File Number|||0394040009||30 AM1|5||||||| |Lic|ence No and Date|||0310793539||/03/02/2|015||||||| |Nor Th det|ms Committee Decision:||||||||||||| ||e Committee considered the case as per agenda and it was ails given below or as applied by the firm, whichever is les||||||decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per s:-||||||| |||||||||||||||

Case No.	13 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	BAYER CROPSCIENCE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004884AM24
RA File Number	039404000930 AM15
Licence No and Date	0310793539/03/02/2015
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:-

UDIN00269027AM24

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:-||

UDIN00269027AM24


Export Product	Qty.	Sl.	Import Items	Qty.
		No.
SOD = N2 - ( 1, 1-DIMETHYL-2-	1	1	PHTHALOYL DICHLORIDE (PDC)	0.5000
METHYLSULFINYLETHYL)-N1-(2-METHYL-4-(1,2,2,2-	Kg			kg
TETRAFLUORO(-1-
(TRIFLUOROMETHYL)ETHYL)PHENYL)PHTHALAMIDE)		2	2-METHYL-1-METHLTHIO-2-	0.3090
			PROPANAMINE (SAA)	kg
		3	2-METHYL-4-	0.5645
			HEPTAFLUOROISOPROPYLAMINE(RFA)	kg
		4	TOLUENE	0.200
				kg
concerned may take further necessary action as per above decision of NC.

Case No.<br>14 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Rejected
Party Name<br>AMI ORGANICS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number<br>HQRNORM REVIW00004183AM23
RA File Number<br>522404000058 AM15
Licence No and<br>Date<br>5210041428/13/02/2015
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms andit was observed that the firm has not
provided any technical justification / information for enhancement. Hence, it was decided torejectthe case
maintaining the status quo.
RA concerned may take further necessary action as per above decision of NC.

ustification / information for enhancement. Hence, it was decided torejectthe case| |maintaining the status quo.| |RA concerned may take further necessary action as per above decision of NC.|


Case No.	15 / N	/3/MEET/Aug/202324/11

Case Status	Case A	pproved

Party Name	OPTIM	US DRUGS PRIVATE LIMITED

Meeting Number<br>and Date	NC/ 3/	MEET/ Aug/ 202324/ 11 and 22/08/2023

HQ File Number	HQRN	ORM REVIW00004477AM24

RA File Number	092404	000028 AM16

UDIN00269027AM24

Lic<br>Dat	ence No<br>e	and	0910061955/01	/05/2015
Nor<br>Th<br>det<br>RA	ms Com<br>e Commi<br>ails give	mittee Decision:<br>ttee considered the case a<br>n below or as applied by t		s per agenda<br>he firm, which	and it wa	s decided to fix ad-hoc norms under Para 4.07 of H	BP Vol. I as per
					ever is le	ss:-
	Export P	roduct<br>	Qty.	Sl.

or as applied by t|||||s per agenda he firm, which|||and it wa|s decided to fix ad-hoc norms under Para 4.07 of H||BP Vol. I as per| |||||||||||ever is le|ss:-||| ||Export P|roduct |||Qty.||Sl. No.||Impo|rt Items||Qty|.| ||||||||||||||| ||SOFOS|BUVIR |||1 kg.||1||Cyti dibe|dine,N-b nzoate,(2|enzoyl-2-deoxy-2-fluoro-2-methyl-3,5- r)|Not|required| ||||||||||||||| ||||||||2||2-de|oxy-2-flu|oro-2-C-methyluridine|0.8|7 kg.| ||||||||3||N-[( L-ala||||| |||||||||||S)-(2,3,4, nine 1-m|5,6-Pentafluorophenoxy) phenoxyphosphinyl]- ethylethyl ester|Not|required| ||||||||4||L-Al||||| |||||||||||anine iso|propyl ester hydrochloride|1.8|0 kg.| ||||||||5||Phen|yl dichlo|rophosphate|1.5|8 kg.| ||||||||||||||| ||||||||6||Pent|afluoroph|enol|1.1|6 kg.| ||Note:|The above norms a|||||re for regul||||||| |||||||||||arizatio|n and closure purpose only.||| ||concern|ed may take further neces|||||sary action as|||per abov|e decision of NC.||| ||||||||||||||| ||||||||||||||| |Cas|e No.||||16 / NC/||3/MEET/Aug|||/202324|/11||| |Cas|e Status||||Case Ap||proved||||||| ||||||||||||||| |Par|ty Name||||OPTIMU||S DRUGS P|||RIVAT|E LIMITED||| |Me Dat|eting Nu e|mber and|||NC/ 3/ M||EET/ Aug/ 2|||02324/|11 and 22/08/2023||| ||||||||||||||| |HQ|File Nu|mber|||HQRNO||RM REVIW|||0000447|8AM24||| |RA|File Nu|mber|||0924040||00223 AM16||||||| |Lic|ence No|and Date|||0910062||361/22/07/20|||15|||| |Nor Th 4.0|ms Com|mittee Decision:|||||||||||| ||e Commi 7 of HBP|ttee considered the reque Vol.

|mber|||0924040||00223 AM16||||||| |Lic|ence No|and Date|||0910062||361/22/07/20|||15|||| |Nor Th 4.0|ms Com|mittee Decision:|||||||||||| ||e Commi 7 of HBP|ttee considered the reque Vol. I as per details give|||||st of firm for n below or as|||fixation applied b|of ad-hoc norms and it was decided to fix ad-hoc n y the firm, whichever is less:-||orms under Para| ||Export|Product||Qty.||S|l. No.|Impor||t Items|||Qty.| |||||||||||||||

Case No.<br>16 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Approved
Party Name<br>OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number<br>HQRNORM REVIW00004478AM24
RA File Number<br>092404000223 AM16
Licence No and Date<br>0910062361/22/07/2015
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<br>Qty.<br>Sl. No.<br>Import Items	Qty.

UDIN00269027AM24

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.||

UDIN00269027AM24


	Simeprevir	1 kg.	1	(2R,3aR,10Z,11aS,12aR,14aR)-<br>2334567891112131414Tdhd27	1.309 kg.
				,,a,,,,,,,a,,,,a-etraecayro--[[-<br>methoxy-8-methyl-2-[4-(1-methylethyl)-2-thiazolyl]-4-
				quinolinyl]oxy]-5-methyl-4,14-dioxocyclopenta<br>[c]cyclopropa[g][1,6]diazacyclotetradecine-12a(1H)-carboxylic
				acid


			2	(2R,3aR,10Z,11aS,12aR,14aR)-<br>2,3,3a,4,5,6,7,8,9,11a,12,13,14,14a-Tetradecahydro-2-[[7-	Not Required
methoxy-8-methyl-2-[4-(1-methylethyl)-2-thiazolyl]-4-<br>quinolinyl]oxy]-5-methyl-4,14-dioxocyclopenta<br>[c]cyclopropa[g][1,6]diazacyclotetradecine-12a(1H)-carboxamide<br>RA concerned may take further necessary action as per above decision of NC				methoxy-8-methyl-2-[4-(1-methylethyl)-2-thiazolyl]-4-<br>quinolinyl]oxy]-5-methyl-4,14-dioxocyclopenta<br>[c]cyclopropa[g][1,6]diazacyclotetradecine-12a(1H)-carboxamide

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

nolinyl]oxy]-5-methyl-4,14-dioxocyclopenta [c]cyclopropa[g][1,6]diazacyclotetradecine-12a(1H)-carboxamide|| ||||||||

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


Case No.		17 / NC/3/	EET/Aug/202324/11

Case Status		Case Defer	red

Party Name		AMI ORG	NICS LIMITED

Meeting Number<br>and Date		NC/ 3/ ME	ET/ Aug/ 202324/ 11 and 22/08/2023

HQ File Number		HQRNOR	REVIW00004182AM23

RA File Number		522404000	034 AM16

Licence No and
<br>Date		5210041610/14/08/2015
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 Chemistry with chemical reaction, indicating molecular weight of both reactant and proeducts,<br>giving yield of the reaction.<br>1.<br>Justification of wastage at each stage of reaction.<br>2.<br>Production/consumption data duly certified by CA.<br>3.
	Complete Chemistry with chemical reaction, in<br>giving yield of the reaction.<br>1.<br>ifii f h f i<br>2				dicating<br>	molecula	r weight of both reactant and pr	oeducts,
	Justcaton o wastage at eac stage o reacto<br>.<br>Production/consumption data duly certified by<br>3.				.<br>CA.


Cas	e No.			18 / NC/3/MEET/A	ug/20232	4/11

aton o wastage at eac stage o reacto** . Production/consumption data duly certified by 3.||||. CA.||||| ||||||||||| ||||||||||| |Cas|e No.|||18 / NC/3/MEET/A|ug/20232|4/11|||| |Cas|e Status|||Case Approved|||||| |Par|ty Name|||BAYER CROPSCI|ENCE LI|MITED|||| |Me|eting Number and Date|||NC/ 3/ MEET/ Aug/ 202324||/ 11 and 22/08/2023|||| |HQ|File Number|||HQRNORM REVIW000048||82AM24|||| |RA File Number||||039404000443 AM16|||||| |Licence No and Date||||0310800060/05/11/2015|||||| ||||||||||| |Norms Committee Decision:||||||||||

Case No.	18 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	BAYER CROPSCIENCE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004882AM24
RA File Number	039404000443 AM16
Licence No and Date	0310800060/05/11/2015
Norms Committee Decision:

UDIN00269027AM24

|Th det RA|e 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 ails given below or as applied by the firm, whichever is less:-|e 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 ails given below or as applied by the firm, whichever is less:-|e Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

f HBP Vol. I as per ails given below or as applied by the firm, whichever is less:-|e 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 ails given below or as applied by the firm, whichever is less:-|e 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 ails given below or as applied by the firm, whichever is less:-|e 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 ails given below or as applied by the firm, whichever is less:-| |---|---|---|---|---|---| ||Export Product|Qty|. Sl. No.|Import Items|Qty.| ||SOD = N2 - ( 1, 1-DIMETHYL-2- METHYLSULFINYLETHYL)-N1-(2-METHYL-4-(1,2,2,2- TETRAFLUORO (-1- (TRIFLUOROMETHYL)ETHYL)PHENYL)PHTHALAMIDE)|1 Kg|1|PHTHALOYL DICHLORIDE (PDC)|0.5000 kg| ||||2|2-METHYL-1-METHLTHIO-2- PROPANAMINE (SAA)|0.3090 kg| ||||3|2-METHYL-4- HEPTAFLUOROISOPROPYLAMINE(RFA)|0.5645 kg| ||||4|TOLUENE|0.200 kg| ||concerned may take further necessary action as per above decision of NC.|||||

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:-

Case No.	19 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	VENUS REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004227AM24
RA File Number	222404000101 AM16
Licence No and<br>Date	2210015410/09/02/2016
Norms Committee Decision:<br>The committee has considered the case of the firm as per agenda and it has been observed that name of import item has already been<br>corrected in theMeeting No. 10/AM19 dated 13.11.2018.Therefore, the committee decided to withdraw the application of the<br>firm. The firm may also check the Minutes of the Meeting dated 13.11.2018 uploaded in the DGFT website Portal.

Case No.	20 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004184AM23
RA File Number	522404000042 AM17

UDIN00269027AM24

UDIN00269027AM24

Licence No and<br>Date<br>5210042032/30/09/2016
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:-
Stage wise yield of the reaction giving justification of wastage at each stage of reaction.<br>1.
By-product value, if any.<br>2.

Case No.	21 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	ARIHANTA SIDDHA LABORATORIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00003978AM24
RA File Number	318304000162 AM17
Licence No and<br>Date	3110066602/28/02/2017
Norms Committee Decision:
The committee has considered the case of the firm as per agenda and it has been observed that name of import item has already been
corrected in theMeeting No. 05/AM20 dated 02.08.2019. Therefore, the committee decided to withdraw the application of the
firm. The firm may also check the Minutes of the Meeting dated 02.08.2019 uploaded in the DGFT website Portal.

08.2019**. Therefore, the committee decided to withdraw the application of the|| |firm. The firm may also check the Minutes of the Meeting dated 02.08.2019 uploaded in the DGFT website Portal.||

Case No.	22 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00001053AM24
RA File Number	039404000115 AM18
Licence No and<br>Date	0310813394/18/05/2017
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.
N-Methyl Pyrrolidone (Purity Minimum 99.8%,		1 kg.	1	N-Methyl Pyrrolidone (Purity Maximum	<br>1.23 kg.
Moisture Less Than 1000 PPM)				86.27%, Moisture 5% to 7%)

UDIN00269027AM24

Pyrrolidone (Purity Minimum 99.8%,||1 kg.|1|N-Methyl Pyrrolidone (Purity Maximum| 1.23 kg.|| |Moisture Less Than 1000 PPM)||||86.27%, Moisture 5% to 7%)||| ||||||||

UDIN00269027AM24

Case No.	23 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00005839AM23
RA File Number	039404000733 AM18
Licence No and<br>Date	0310817950/20/12/2017
Norms Committee Decision:<br>RA concerned may take further necessary action as per above decision of NC.<br>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<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>ACETONITRILE<br>(Purity minimum 99.9%)<br>1.0 MT<br>1<br>ACETONITRILE<br>( LOW PURITY ) (Purity 98%)<br>1.19 MT

Case No.	24 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	SIDDHARTH CARBOCHEM PRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00000275AM24
RA File Number	039504000992 AM18
Licence No and<br>Date	0310819448/28/02/2018
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it<br>was decided to revise ad-hoc norms as under:-

UDIN00269027AM24

tee 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:-||

UDIN00269027AM24

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>SALICYLIC ACID<br>1.1715 kg.<br>METHYL SALICYLATE (MIN 99 PERCENT)<br>(PHENOL FREE)<br>1 kg.<br>2<br>METHANOL<br>0.244 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty.
	METHYL SALICYLATE (MIN 99 PERCENT)<br>(PHENOL FREE)	1 kg.	1	SALICYLIC ACID	1.1715 kg.
			2	METHANOL	0.244 kg.

Case No.	25 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00000299AM24
RA File Number	039404000160 AM19
Licence No and<br>Date	0310822659/27/07/2018
Norms Committee Decision:<br>The committee has considered the case of the firm as per agenda and it has been observed that the case of the firm had already been<br>approved in its meetingNo.NC/3/MEET/Jul/20202324/09 dated 28/07/2023 (Manual Case).Therefore, the committee decided to<br>withdraw the application of the firm. The firm may also check the Minutes of the Meeting dated 28/07/2023 uploaded in the DGFT<br>website Portal.

Case).**Therefore, the committee decided to withdraw the application of the firm. The firm may also check the Minutes of the Meeting dated 28/07/2023 uploaded in the DGFT website Portal.||

Case No.	26 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00000300AM24
RA File Number	039404000126 AM19
Licence No and<br>Date	0310822660/27/07/2018
Norms Committee Decision:<br>The committee has considered the case of the firm as per agenda and it has been observed that the case of the firm had already been<br>approved in its meetingNo.NC/3/MEET/Jul/20202324/09 dated 28/07/2023 (Manual Case).Therefore, the committee decided to<br>withdraw the application of the firm. The firm may also check the Minutes of the Meeting dated 28/07/2023 uploaded in the DGFT<br>website Portal.

Case No.	27 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	INDO AMINES LIMITED

UDIN00269027AM24

ed 28/07/2023 uploaded in the DGFT website Portal.||

Case No.	27 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	INDO AMINES LIMITED

UDIN00269027AM24

Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM REVIW00001307AM24
RA File Number		039404000336 AM19
Licence No and<br>Date		0310822662/27/07/2018
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it<br>was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>N METHYL MORPHOLINE OXIDE 50% OR IAL NMMO 50%<br>1 kg.<br>1<br>MORPHOLINE<br>0.46 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	N METHYL MORPHOLINE OXIDE 50% OR IAL NMMO 50%		1 kg.	1	MORPHOLINE	0.46 kg.
	concerned may take further necessary action as per above decision of NC.

duct||Qty.|Sl. No.|Import Items|Qty.| ||N METHYL MORPHOLINE OXIDE 50% OR IAL NMMO 50%||1 kg.|1|MORPHOLINE|0.46 kg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	28 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00000298AM24
RA File Number	039404000142 AM19
Licence No and<br>Date	0310822704/30/07/2018
Norms Committee Decision:<br>The committee has considered the case of the firm as per agenda and it has been observed that the case of the firm had already been<br>approved in its meetingNo.NC/3/MEET/Jul/20202324/09 dated 28/07/2023 (Manual Case).Therefore, the committee decided to<br>withdraw the application of the firm. The firm may also check the Minutes of the Meeting dated 28/07/2023 uploaded in the DGFT<br>website Portal.

Case No.	29 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00000301AM24
RA File Number	039404000141 AM19
Licence No and<br>Date	0310822729/31/07/2018
Norms Committee Decision:

UDIN00269027AM24

and 22/08/2023| |HQ File Number|HQRNORM REVIW00000301AM24| |RA File Number|039404000141 AM19| |Licence No and Date|0310822729/31/07/2018| |Norms Committee Decision:||

UDIN00269027AM24

The committee has considered the case of the firm as per agenda and it has been observed that the case of the firm had already been approved in its meeting No.NC/3/MEET/Jul/20202324/09 dated 28/07/2023 (Manual Case). Therefore, the committee decided to withdraw the application of the firm. The firm may also check the Minutes of the Meeting dated 28/07/2023 uploaded in the DGFT website Portal.

Case No.	30 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00000302AM24
RA File Number	039404000158 AM19
Licence No and<br>Date	0310822734/31/07/2018
Norms Committee Decision:<br>The committee has considered the case of the firm as per agenda and it has been observed that the case of the firm had already been<br>approved in its meetingNo.NC/3/MEET/Jul/20202324/09 dated 28/07/2023 (Manual Case).Therefore, the committee decided to<br>withdraw the application of the firm. The firm may also check the Minutes of the Meeting dated 28/07/2023 uploaded in the DGFT<br>website Portal.

Case).**Therefore, the committee decided to withdraw the application of the firm. The firm may also check the Minutes of the Meeting dated 28/07/2023 uploaded in the DGFT website Portal.||

Case No.	31 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00000304AM24
RA File Number	039404000162 AM19
Licence No and<br>Date	0310822732/31/07/2018
Norms Committee Decision:<br>The committee has considered the case of the firm as per agenda and it has been observed that the case of the firm had already been<br>approved in its meetingNo.NC/3/MEET/Jul/20202324/09 dated 28/07/2023 (Manual Case).Therefore, the committee decided to<br>withdraw the application of the firm. The firm may also check the Minutes of the Meeting dated 28/07/2023 uploaded in the DGFT<br>website Portal.

Case No.	32 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	BALAJI AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00001088AM24
RA File Number	318304000082 AM19
Licence No and<br>Date	3110067147/20/08/2018
Norms Committee Decision:

UDIN00269027AM24

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 wastage at each stage of reaction with yield.

Case No.<br>33 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Approved
Party Name<br>KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number<br>HQRNORM REVIW00001047AM24
RA File Number<br>039404000403 AM19
Licence No and<br>Date<br>0310823513/04/09/2018
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.
N-Methyl Pyrrolidone (Purity Minimum 99.8%,	1 kg.	1	N-Methyl Pyrrolidone (Purity Maximum	<br>1.23 kg.
Moisture Less Than 1000 PPM)			86.27%, Moisture 5% to 7%)
RA concerned may take further necessary action as per above decision of NC.

N-Methyl Pyrrolidone (Purity Maximum| 1.23 kg.|| |Moisture Less Than 1000 PPM)|||86.27%, Moisture 5% to 7%)||| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	34 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00000481AM24
RA File Number	039404000506 AM19
Licence No and<br>Date	0310823810/18/09/2018
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/Mar/202223/22dated24/03/2023against advance authorizationNo.0310839173dated28/10/2020,
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:-

UDIN00269027AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
Norfloxacin	1 kg.	1	2,4 Dichloro-5-Fluoro Acetophenone(DCFA)	1.123 kg.
		2	Dimethyl Carbonate	1.010 kg.
		3	Sodium Hydride	0.289 kg.
		4	Toluene	0.800 kg.
		5	Acetic Acid	0.289 kg.
		6	Dimethyl Sulphate	0.670 kg.
		7	Dimethyl Formamide	0.500 kg.
		8	Mono Ethyl Amine (70%)	0.557 kg.
		9	Caustic Flakes	0.410 kg.
		10	Sulfuric Acid	Not Importable item
		11	Methanol	1.20 kg.

e|0.670 kg.| |||7|Dimethyl Formamide|0.500 kg.| |||8|Mono Ethyl Amine (70%)|0.557 kg.| |||9|Caustic Flakes|0.410 kg.| |||10|Sulfuric Acid|Not Importable item| |||11|Methanol|1.20 kg.|

Case No.	35 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00002992AM24
RA File Number	039404000699 AM19
Licence No and<br>Date	0310824906/05/11/2018
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:-

UDIN00269027AM24

Export Product		Qty.	Sl. No.	Import Items	Qty.
Azelastine Hydrochloride and Fluticasone		1 Number	1	Azelastine Hydrochloride	16.44 mg.
Propionate Nasal Spray / Dymista Nasal
Spray (Pack 120MD)(Each Spray
			2	Fluticasone Propionate	6.00 mg.
delivers:<br>Azelastine<br>Hydrochloride	BP
137mcg Fluticasone Propionate 50mcg)
			3	140 mcl pumps	Net to Net
			4	25ml USP type 1 amber glass vial	Net+1%
			5	Nasal actuator	Net to Net

Azelastine Hydrochloride|BP||||| |137mcg Fluticasone Propionate 50mcg)|||||| ||||3|140 mcl pumps|Net to Net| ||||4|25ml USP type 1 amber glass vial|Net+1%| ||||5|Nasal actuator|Net to Net|

Case No.		36 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		LUPIN LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM REVIW00001950AM24
RA File Number		039504000814 AM19
Licence No and<br>Date		0310825247/27/11/2018
Norms Committee	Decision:
The application of		the firm was considered on the basis of agenda and the committee has observed that case of the firm
comes under para	4.18 (Non-Infringing process) which does not require approval of NC. However, the Norms of the said
item had inadvertently fixed by the Committee in its meeting No. 3/82-ALC4/2019 dated 05.07.2019. Therefore, the
committee decided	to withdraw the application of the firm and the decision which is taken in the meeting dated 05.07.2019
may also be withdrawn.
RA concerned may	take further necessary action under para 4.18 of HBP as per the above decision of NC.

Case No.	37 / NC/3/MEET/Aug/202324/11
Case Status	Case Rejected
Party Name	ROYAL PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00000092AM24
RA File Number	039504000945 AM19
Licence No and	0310825646/13/12/2018

UDIN00269027AM24

Date

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 to reject the case maintaining the status quo.

Case No.		38 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		LUPIN LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM REVIW00001951AM24
RA File Number		039504001008 AM19
Licence No and<br>Date		0310826059/01/01/2019
Norms Committee	Decision:
The application of		the firm was considered on the basis of agenda and the committee has observed that case of the firm
comes under para	4.18 (Non-Infringing process) which does not require approval of NC. However, the Norms of the said
item had inadvertently fixed by the Committee in its meeting No. 15/82-ALC4/2018 dated 22.03.2019. Therefore, the
committee decided	to withdraw the application of the firm and the decision which is taken in the meeting dated 22.03.2019
may also be withdrawn.
RA concerned may	take further necessary action under para 4.18 of HBP as per the above decision of NC.

which is taken in the meeting dated 22.03.2019**|| |may also be withdrawn.||| |RA concerned may|take further necessary action under para 4.18 of HBP as per the above decision of NC.||

Case No.		39 / NC/3/MEET/Aug/202324/11
Case Status		Case Deferred
Party Name		ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM REVIW00000817AM24
RA File Number		082404000026 AM20
Licence No and<br>Date		0810145127/30/04/2019
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<br>1.	chemistry giving molecular weight of reactant and products, with stage wise yield (also over all
yield)
Justification of wastage at each stage of reaction.<br>2.

UDIN00269027AM24

Case No.	40 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00002204AM23
RA File Number	052304000048 AM20
Licence No and<br>Date	0510410475/03/05/2019
Norms Committee Decision:
The case is under consideration for want of comments of TE.

REVIW00002204AM23| |RA File Number|052304000048 AM20| |Licence No and Date|0510410475/03/05/2019| |Norms Committee Decision:|| |The case is under consideration for want of comments of TE.||

Case No.	41 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	NOVEL NUTRIENTSS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00001063AM24
RA File Number	072404000056 AM20
Licence No and<br>Date	0710115041/11/06/2019
Norms Committee Decision:
The committee considered the request of the firm for review of ad-hoc norms and it has been observed that the details in
reply of DL have not given by the firm. Thereafter, it was decided to call the firm for attendingPersonal Hearing		<br>before
Norms Committee to explain its case alongwith following information / documents:-
Copy of approval from Food & Drugs Administration (FDA) for the export product.<br>1.
COA for import item from foreign supplier.<br>2.

ngwith following information / documents:-||| |Copy of approval from Food & Drugs Administration (FDA) for the export product. 1.||| |COA for import item from foreign supplier. 2.|||

Case No.	42 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	MENTHA AND ALLIED PRODUCTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	018205000763AM20
RA File Number	052404000375 AM20
Licence No and<br>Date	0510412231/23/10/2019
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:-

UDIN00269027AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
ORANGE ALDEHYDE	92.27 kg.	1	ORANGE OIL	96.88 kg.
D LIMONENE	11764.00 kg.	1	ORANGE OIL	12352.20 kg.
ORANGE OIL 10X	1291.73 kg.	1	ORANGE OIL	1356.31 kg.

ems|Qty.| |---|---|---|---|---|---| ||ORANGE ALDEHYDE|92.27 kg.|1|ORANGE OIL|96.88 kg.| ||D LIMONENE|11764.00 kg.|1|ORANGE OIL|12352.20 kg.| ||ORANGE OIL 10X|1291.73 kg.|1|ORANGE OIL|1356.31 kg.|

Case No.	43 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00006311AM23
RA File Number	039504000760 AM20
Licence No and<br>Date	0310832692/11/11/2019
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	44 / NC/3/MEET/Aug/202324/11	44 / NC/3/MEET/Aug/202324/11	44 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM REVIW00000940AM24
RA File Number		072404000229 AM20
Licence No and<br>Date		0710115939/27/12/2019
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Rosecrystals Ex Benzaldehyde<br>1 kg.<br>1<br>Benzaldehyde<br>0.465 kg.
	Export Product		Qty.	Sl.

the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. Rosecrystals Ex Benzaldehyde 1 kg. 1 Benzaldehyde 0.465 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Rosecrystals Ex Benzaldehyde||1 kg.|1|Benzaldehyde|0.465 kg.|

Case No.	Case No.	44 / NC/3/MEET/Aug/202324/11	44 / NC/3/MEET/Aug/202324/11	44 / NC/3/MEET/Aug/202324/11	44 / NC/3/MEET/Aug/202324/11	44 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM REVIW00000940AM24
RA File Number		072404000229 AM20
Licence No and<br>Date		0710115939/27/12/2019
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Rosecrystals Ex Benzaldehyde<br>1 kg.<br>1<br>Benzaldehyde<br>0.465 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Rosecrystals Ex Benzaldehyde		1 kg.	1	Benzaldehyde	0.465 kg.

UDIN00269027AM24

(Trichloro-Phenyl Methyl Corbinyl Acetate)

g.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Rosecrystals Ex Benzaldehyde||1 kg.|1|Benzaldehyde|0.465 kg.|

UDIN00269027AM24

(Trichloro-Phenyl Methyl Corbinyl Acetate)

Case No.	45 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	REFLUX PHARMACEUTICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00001517AM24
RA File Number	NA
Licence No and<br>Date	0310833815/01/01/2020
Norms Committee Decision:
The committee considered the request of the firm and observed that the firm has filed dual application on same license
number as mentioned at case No.46, therefore, the committee has decided to withdraw the application of the firm.

Case No.<br>46 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Approved
Party Name<br>REFLUX PHARMACEUTICALS
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number<br>HQRNORM REVIW00002730AM24
RA File Number<br>039504000931 AM20
Licence No and<br>Date<br>0310833815/01/01/2020
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<br>Qty.	Sl.

n 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.|| |TOLFENAMIC ACID(B ULK DRUG) 1 kg.|1|ORTHO CHLOROBENZOIC ACID|0.75 kg.|| ||2|3-CHLORO-2-METHYLANILINE|0.67 kg.|| |RA concerned may take further necessary action as per above decision of NC.|||||

UDIN00269027AM24

Case No.	47 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	ARCH PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00000303AM24
RA File Number	039404000888 AM20
Licence No and<br>Date	0310834332/20/01/2020
Norms Committee Decision:
The case is under consideration for want of comments of TE.

Case No.	48 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	AURA LIFECARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00001012AM24
RA File Number	342404000323 AM20
Licence No and<br>Date	3410045804/23/01/2020
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 Drugs Manufacturing License (DML) showing approved composition for each export items.<br>1.
Why percentage_Dextrose_content is different in different pack size?<br>2.

-|| |Copy of Drugs Manufacturing License (DML) showing approved composition for each export items. 1.|| |Why percentage**_Dextrose_content is different in different pack size?** 2.||

Case No.	49 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00000113AM24
RA File Number	318304000140 AM20
Licence No and<br>Date	3110067673/06/02/2020
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:-

UDIN00269027AM24

Export Product	Qty.	Sl. No.	Import Items<br>	Qty.
Acetyl Anisole (4 Methoxy Acetophenone)	1 kg.	1	Phenol<br>	0.74 kg.
		2	Methanol<br>	0.283 kg.
		3	Acetic Anhydride PURITY 99%<br>	0.755 kg.

ort Items |Qty.| |---|---|---|---|---|---| ||Acetyl Anisole (4 Methoxy Acetophenone)|1 kg.|1|Phenol |0.74 kg.| ||||2|Methanol |0.283 kg.| ||||3|Acetic Anhydride PURITY 99% |0.755 kg.|

Case No.	Case No.	50 / NC/3/MEET/Aug/202324/11	50 / NC/3/MEET/Aug/202324/11	50 / NC/3/MEET/Aug/202324/11	50 / NC/3/MEET/Aug/202324/11	50 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM REVIW00000946AM24
RA File Number		072404000276 AM20
Licence No and<br>Date		0710116142/18/02/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Rosecrystals Ex Benzaldehyde<br>(Trichloro-Phenyl Methyl Corbinyl Acetate)<br>1 kg.<br>1<br>Benzaldehyde<br>0.465 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Rosecrystals Ex Benzaldehyde<br>(Trichloro-Phenyl Methyl Corbinyl Acetate)		1 kg.	1	Benzaldehyde	0.465 kg.
	concerned may take further necessary action as per above decision of NC.

Qty.| ||Rosecrystals Ex Benzaldehyde (Trichloro-Phenyl Methyl Corbinyl Acetate)||1 kg.|1|Benzaldehyde|0.465 kg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	51 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00005394AM23
RA File Number	052404000004 AM21

UDIN00269027AM24

Licence No and<br>Date<br>0510414006/16/04/2020
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<br>Qty.<br>Sl. No.	Import Items	Qty.
CEFEPIME FOR INJECTION<br>1 kg.<br>1	CEFEPIME HCL (NON STERILE)	0.655 kg.
RA concerned may take further necessary action as per above decision of NC.

br>Qty. Sl. No.|Import Items|Qty.|| |CEFEPIME FOR INJECTION 1 kg. 1|CEFEPIME HCL (NON STERILE)|0.655 kg.|| |RA concerned may take further necessary action as per above decision of NC.||||

Case No.<br>52 / NC/3/MEET/Aug/202324/11	Case No.<br>52 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Approved
Party Name<br>OPTRIX LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number<br>HQRNORM REVIW00000929AM24
RA File Number<br>092404000059 AM21
Licence No and<br>Date<br>0910068716/01/05/2020
Norms Committee Decision:
The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to ratify 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.
FAVIPIRAVIR<br>1 kg.<br>1	6-bromo-3-hydroxy pyrazine-2-carboxamide	2.32 Kg.
RA concerned may take further necessary action as per above decision of NC.


Case No.	53 / NC/3/MEET/Aug/202324/11

Case Status	Case Approved

Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED

Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023

HQ File Number	HQRNORM REVIW00000114AM24

UDIN00269027AM24

ty Name|CLEAN SCIENCE AND TECHNOLOGY LIMITED| ||| |Meeting Number and Date|NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023| ||| |HQ File Number|HQRNORM REVIW00000114AM24|

UDIN00269027AM24

RA File Number	318304000006 AM21
Licence No and<br>Date	3110067737/18/05/2020
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.
Acetyl Anisole (4 Methoxy Acetophenone)		1 kg.	1	Phenol	0.74 kg.
			2	Methanol	0.283 kg.
			3	Acetic Anhydride PURITY 99%	0.755 kg.
RA concerned may take further necessary action as per above decision			of NC.

Case No.	54 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	NOVEL NUTRIENTSS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00001058AM24
RA File Number	072404000038 AM21
Licence No and<br>Date	0710116503/26/05/2020
Norms Committee Decision:
The committee considered the request of the firm for review of ad-hoc norms and it has been observed that the details in
reply of DL have not given by the firm.

0|| |Norms Committee Decision:||| |The committee considered the request of the firm for review of ad-hoc norms and it has been observed that the details in||| |reply of DL have not given by the firm. Thereafter, it was decided to call the firm for attendingPersonal Hearing|| before| |Norms Committee to explain its case alongwith following information / documents:-||| |Copy of approval from Food & Drugs Administration (FDA) for the export product. 1.||| |COA for import item from foreign supplier. 2.|||

Case No.	55 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	CLARIANT INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023

UDIN00269027AM24

HQ File Number	018205001343AM21
RA File Number	039404000110 AM21
Licence No and<br>Date	0310836469/01/06/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing		<br>before
Norms Committee to explain its case.

Case No.	56 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	BROOKS LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004249AM24
RA File Number	302404000010 AM21
Licence No and<br>Date	3010105213/02/06/2020
Norms Committee Decision:
The case is under	consideration for want of comments of TE

VIW00004249AM24| |RA File Number|302404000010 AM21| |Licence No and Date|3010105213/02/06/2020| |Norms Committee Decision:|| |The case is under|consideration for want of comments of TE|

Case No.		57 / NC/3/MEET/Aug/202324/11
Case Status		Case Deferred
Party Name		CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM REVIW00000118AM24
RA File Number		318304000011 AM21
Licence No and<br>Date		3110067749/03/06/2020
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<br>i.	chemical reactions with molecular and structural formula and molecular weights along with
stage wise	percentage yields on molar basis.
End use of<br>ii.	final product

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

Case No.	58 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	OPTRIX LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023

UDIN00269027AM24

02324/11| |---|---| |Case Status|Case Approved| |Party Name|OPTRIX LABORATORIES PRIVATE LIMITED| |Meeting Number and Date|NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023|

UDIN00269027AM24

HQ File Number	HQRNORM REVIW00000931AM24
RA File Number	092404000262 AM21
Licence No and<br>Date	0910069046/17/08/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to ratify ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>FAVIPIRAVIR<br>1 kg.<br>1<br>6-bromo-3-hydroxy pyrazine-2-carboxamide<br>2.32 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	59 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	AURA LIFECARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00001123AM24
RA File Number	342404000133 AM21
Licence No and<br>Date	3410046298/18/08/2020
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 Drugs Manufacturing License (DML) showing approved composition for each export items.<br>i.<br>Why percentage_Dextrose_content is different in different pack size?<br>ii.

Copy of Drugs Manufacturing License (DML) showing approved composition for each export items. i. Why percentage**_Dextrose_content is different in different pack size?** ii.||

Case No.	60 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00005055AM23
RA File Number	092404000282 AM21
Licence No and<br>Date	0910069242/22/09/2020
Norms Committee Decision:

UDIN00269027AM24

The case is under consideration for want of comments of TE

Case No.<br>61 / NC/3/MEET/Aug/202324/11	Case No.<br>61 / NC/3/MEET/Aug/202324/11	Case No.<br>61 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Approved
Party Name<br>SRI CHEMICALS
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number<br>HQRNORM REVIW00004706AM24
RA File Number<br>042404000109 AM21
Licence No and<br>Date<br>0410167147/07/10/2020
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.	Sl. No.	Import Items	Qty.
EN DEFOAM-A	1 kg	1	POLY ETHYLENE GLYCOL BUTYL ETHER	0.997 kg.
(Monovalent Defoamer Alcohol base)
RA concerned may take further necessary action as per above decision of NC.

Qty.|| |EN DEFOAM-A|1 kg|1|POLY ETHYLENE GLYCOL BUTYL ETHER|0.997 kg.|| |(Monovalent Defoamer Alcohol base)|||||| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	62 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	SMILAX LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004228AM24
RA File Number	092404000358 AM21
Licence No and<br>Date	0910069312/08/10/2020
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.

UDIN00269027AM24

GURATIMOD 1 kg. 1 4-Chloro-3-Nitro Anisole 1.87 kg.

Case No.	63 / NC/3/MEET/Aug/202324/11
Case Status	Case Rejected
Party Name	ROYAL PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00000094AM24
RA File Number	039504000439 AM21
Licence No and<br>Date	0310838908/15/10/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms andit was observed that the firm has not<br>provided any technical justification / information for enhancement.

ee Decision: The Committee considered the request of firm for review of ad-hoc norms andit was observed that the firm has not provided any technical justification / information for enhancement. Hence, it was decided torejectthe case maintaining the status quo. RA concerned may take further necessary action as per above decision of NC.||

Case No.	64 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004153AM23
RA File Number	039404000571 AM21
Licence No and<br>Date	0310839148/27/10/2020
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.		Personal Hearing

Case No.	65 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00007179AM23
RA File Number	018205001835 AM21
Licence No and<br>Date	3410046524/05/11/2020

UDIN00269027AM24

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Feb/202223/20 dated 24/02/2023 against advance authorization No. 3410045200 dated 10/06/2019 , 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.
Gamma Nonalactone or Aldehyde C18	1 kg.	1	Hexyl Alcohol or N-Hexanol	1.36 kg.
		2	Acrylic Acid	0.96 kg.
		3	Di-tert Butyl Peroxide	0.229 kg.

Case No.	Case No.	66 / NC/3/MEET/Aug/202324/11	66 / NC/3/MEET/Aug/202324/11	66 / NC/3/MEET/Aug/202324/11	66 / NC/3/MEET/Aug/202324/11	66 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM APPLY 00034564AM21
RA File Number		05AA04017512 AM21
Licence No and<br>Date		0511000078/09/12/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.

tion 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. OXALIPLATIN(USP) 1 kg. 1 Platinum Sponge Powder 0.85 kg. 2 (1R,2R)-(-)-1,2-Diamino Cyclo Hexane. 0.49 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||OXALIPLATIN(USP)||1 kg.|1|Platinum Sponge Powder|0.85 kg.| |||||2|(1R,2R)-(-)-1,2-Diamino Cyclo Hexane.|0.49 kg.| ||concerned may take further necessary action as per above decision of NC.||||||

UDIN00269027AM24

Case No.	Case No.	67 / NC/3/MEET/Aug/202324/11	67 / NC/3/MEET/Aug/202324/11	67 / NC/3/MEET/Aug/202324/11	67 / NC/3/MEET/Aug/202324/11	67 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM REVIW00000489AM24
RA File Number		03AA04019523 AM21
Licence No and<br>Date		0311001089/20/01/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>in meetingNo.NC/3/MEET/Mar/202223/22dated24/03/2023against advance authorizationNo.0310839173dated28/10/2020,<br>it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

duct in meetingNo.NC/3/MEET/Mar/202223/22dated24/03/2023against advance authorizationNo.0310839173dated28/10/2020, 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. 1 2,4 Dichloro-5-Fluoro Acetophenone(DCFA) 1.123 kg. 2 Dimethyl Carbonate 1.010 kg. 3 Dimethyl Formamide 0.50 kg. 4 Mono Ethyl Amine(70%) 0.557 kg. 5 Piperazine Anhydrous 0.665 kg. Norfloxacin(Norflo) 1 kg. 6 Methanol 1.20 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Norfloxacin(Norflo)||1 kg.|1|2,4 Dichloro-5-Fluoro Acetophenone(DCFA)|1.123 kg.| |||||2|Dimethyl Carbonate|1.010 kg.| |||||3|Dimethyl Formamide|0.50 kg.| |||||4|Mono Ethyl Amine(70%)|0.557 kg.| |||||5|Piperazine Anhydrous|0.665 kg.| |||||6|Methanol|1.20 kg.| ||concerned may take further necessary action a|||s per above decision of NC.|||

Case No.	68 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	REFLUX PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00001513AM24
RA File Number	NA
Licence No and<br>Date	0311001445/03/02/2021

UDIN00269027AM24

Norms Committee Decision:

The case is under consideration for want of comments of TE.

513AM24| |RA File Number|NA| |Licence No and Date|0311001445/03/02/2021|

UDIN00269027AM24

Norms Committee Decision:

The case is under consideration for want of comments of TE.

Case No.	69 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	INDOCO REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004407AM24
RA File Number	03AA04023340 AM21
Licence No and<br>Date	0311001698/16/02/2021
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:-
No justification is given for the above reasons of rejections. The firm has applied Brimonidine whereas DML shows
Brimonidite Tartrate in the approved composition.

Case No.	70 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00101696AM21
RA File Number	09AA04005325 AM21
Licence No and<br>Date	0911000494/11/03/2021
Norms Committee Decision:
The case is under consideration for want of comments of TE.

PPLY 00101696AM21| |RA File Number|09AA04005325 AM21| |Licence No and Date|0911000494/11/03/2021| |Norms Committee Decision:|| |The case is under consideration for want of comments of TE.||

Case No.	71 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	RECKITT BENCKISER HEALTHCARE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00103707AM21
RA File Number	05AA04039234 AM21
Licence No and<br>Date	0511001736/15/03/2021
Norms Committee Decision:

UDIN00269027AM24

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.
Corn Foam Cushion	280000.0<br>Numbers	1	LACQUERED DUAL LAYER	1.05 SQM/SQM content in<br>export.
		2	TECHNOMELT PSM 551 DERMA-TEK	1.05<br>kg./kg.<br>content<br>in<br>export.
		3	RELEASE PAPER 2PE160/ 11 WH	1.05 SQM/SQM content in<br>export.
Soft Corn Cushions	20000.0<br>Numbers	4	LACQUERED DUAL LAYER	1.05 SQM/SQM content in<br>export.
		5	TECHNOMELT PSM 551 DERMA-TEK	1.05<br>kg./kg.<br>content<br>in<br>export.
		6	RELEASE PAPER 2PE160/ 11 WH	1.05 SQM/SQM content in<br>export.
CALLUS<br>FOAM<br>CUSHION	<br>50000.0<br>Numbers	7	LACQUERED DUAL LAYER	1.05 SQM/SQM content in<br>export.
		8	TECHNOMELT PSM 551 DERMA-TEK	1.05<br>kg./kg.<br>content<br>in<br>export.

br>export.| |CALLUS FOAM CUSHION| 50000.0 Numbers|7|LACQUERED DUAL LAYER|1.05 SQM/SQM content in export.| |||8|TECHNOMELT PSM 551 DERMA-TEK|1.05 kg./kg. content in export.| |||9|RELEASE PAPER 2PE160/ 11 WH|1.05 SQM/SQM content in export.|

Case No.	72 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	BROOKS LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004240AM24
RA File Number	30AA04005114 AM21

UDIN00269027AM24

Licence No and 3011000438/25/03/2021 Date Norms Committee Decision:

The case is under consideration for want of comments of TE.

Case No.<br>73 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Approved
Party Name<br>AURORIUM INDIA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number<br>HQRNORM REVIW00002075AM24
RA File Number<br>03AA04032376 AM21
Licence No and<br>Date<br>0311002851/31/03/2021
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<br>Qty.<br>Sl. No.	Import Items		Qty.
4 Cyanopyridine<br>1 kg<br>1	Gamma Picoline		1.098 kg.
RA concerned may take further necessary action as per the above decision of NC.

Case No.	74 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	CLARIANT INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004498AM24
RA File Number	03AA04009823 AM22
Licence No and<br>Date	0311003530/04/05/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing		<br>before
Norms Committee to explain its case.

Case No.	75 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved

UDIN00269027AM24

for attending Personal Hearing|| before| |Norms Committee to explain its case.|||

Case No.	75 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved

UDIN00269027AM24

Party Name	Party Name	RUMIT LIFE CARE	RUMIT LIFE CARE	RUMIT LIFE CARE	RUMIT LIFE CARE	RUMIT LIFE CARE
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM REVIW00000680AM24
RA File Number		03AA04021934 AM22
Licence No and<br>Date		0311004279/03/06/2021
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 under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>Betamethasone Dipropionate ( Net Content Betamethasone<br>17 Propionate BP/EP/USP = 100 kgs)(Betamethasone<br>Dipropionate ( Net Content Betamethasone 17 Propionate<br>BP/EP/USP = 100 kgs))<br>1 kg.<br>1<br>Betamethasone 17 Propionate<br>0.94 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Betamethasone Dipropionate ( Net Content Betamethasone<br>17 Propionate BP/EP/USP = 100 kgs)(Betamethasone<br>Dipropionate ( Net Content Betamethasone 17 Propionate<br>BP/EP/USP = 100 kgs))		1 kg.	1	Betamethasone 17 Propionate	0.94 kg.
	concerned may take further necessary action as per above decision of NC.

e ( Net Content Betamethasone 17 Propionate BP/EP/USP = 100 kgs))||1 kg.|1|Betamethasone 17 Propionate|0.94 kg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	76 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	NAPROD LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004760AM24
RA File Number	03AA04021964 AM22
Licence No and<br>Date	0311004323/04/06/2021
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>COA of import item from foreign supplier showing actual potency of import.

Case No.	77 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	SWISS PARENTERALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00003403AM23
RA File Number	08AA04007143 AM22

UDIN00269027AM24

Licence No and 0811001742/15/06/2021 Date Norms Committee Decision: The case is under consideration for want of comments of TE.

|RA File Number|08AA04007143 AM22|

UDIN00269027AM24

Licence No and 0811001742/15/06/2021 Date Norms Committee Decision: The case is under consideration for want of comments of TE.

Case No.	78 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	ORGANIC INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00129686AM22
RA File Number	06AA04003603 AM22
Licence No and<br>Date	0611000533/02/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to refer the case to NC-6 for obtaining their comments.

Case No.	79 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	CUTCH OIL AND ALLIED INDUSTRIES 1949 PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00000966AM24
RA File Number	02AA04007136 AM22
Licence No and<br>Date	0211000893/05/07/2021
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) report of both import and export items, indicating composition and moisture<br>1.
content.
Justification for 27% wastage of import item.<br>2.

Case No.	80 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023

2.|| ||| |Case No.|80 / NC/3/MEET/Aug/202324/11| |Case Status|Case Deferred| |Party Name|LAURUS SYNTHESIS PRIVATE LIMITED| |Meeting Number and Date|NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023| |HQ File Number|HQRNORM APPLY 00138116AM22| |RA File Number|26AA04002063 AM22| |Licence No and Date|2611000198/13/07/2021| |Norms Committee Decision:||

UDIN00269027AM24

The case is under consideration for want of comments of TE

Case No.	81 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	DIAMINES AND CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00145203AM22
RA File Number	34AA04005573 AM22
Licence No and<br>Date	3411000885/22/07/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	82 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	SYNOKEM PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00147457AM22
RA File Number	05AA04059070 AM22
Licence No and<br>Date	0511003826/26/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed the following based on the documents furnished by<br>the firm:-<br>Export item is shown as 20 mg. Tube which appears to be wrong in view of DML received.<br>1.<br>Description of import item is confusing in view of CoA now received.<br>2.<br>In view of the above, the committee has decided to call the firm for attendingPersonal Hearing<br>before Norms Committee to<br>explain its case.

using in view of CoA now received. 2. In view of the above, the committee has decided to call the firm for attendingPersonal Hearing** before Norms Committee to explain its case.||

Case No.	83 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	SUNDYOTA NUMANDIS PROBIOCEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004161AM24
RA File Number	08AA04021121 AM22
Licence No and	0811002324/16/08/2021

UDIN00269027AM24

Date Norms Committee Decision: The Committee considered the case as per agenda and it was decided to refer the case to Deptt. of Bio-Technology for obtaining their comments.

Case No.	84 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00005936AM23
RA File Number	34AA04006527 AM22
Licence No and<br>Date	3411000984/17/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

Case No.	85 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00006174AM23
RA File Number	NA
Licence No and<br>Date	3411000984/17/08/2021

TE LIMITED|| |Meeting Number and Date|NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023|| |HQ File Number|HQRNORM REVIW00006174AM23|| |RA File Number|NA|| |Licence No and Date|3411000984/17/08/2021|| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call the firm for attending Norms Committee to explain its case.||Personal Hearing before| |||| |Case No.|86 / NC/3/MEET/Aug/202324/11|| |Case Status|Case Deferred|| |Party Name|INTAS PHARMACEUTICALS LIMITED|| |Meeting Number and Date|NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023|| |HQ File Number|HQRNORM APPLY 00170502AM22|| |RA File Number|08AA04022482 AM22|| |Licence No and Date|0811002393/25/08/2021|| |Norms Committee Decision: The case is under consideration for want of comments of TE.|||

UDIN00269027AM24

Case No.<br>87 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Approved
Party Name<br>BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number<br>HQRNORM REVIW00001335AM24
RA File Number<br>31AA04025740 AM22
Licence No and<br>Date<br>3111000548/26/08/2021
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.

e 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.|| |DI ETHYLENE TRI AMINE|1 kg.|1|MONOETHANOLAMINE|1.184 kg.|| |(ORGANIC CHEMICALS)|||||| |||2|AMMONIAANHYDROUS|0.165 kg.|| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.<br>88 / NC/3/MEET/Aug/202324/11	Case No.<br>88 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Approved
Party Name<br>INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ	File Number<br>HQRNORM APPLY 00178977AM22
RA File Number<br>08AA04026034 AM22
Licence No and<br>Date<br>0811002528/07/09/2021
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<br>Qty.	Sl. No.	Import Items	Qty.
	METHOTREXATE INJECTION BP 25MG/ML<br>1 Number Vial	1	METHOTREXATE EP / BP / IP / USP /	61.87 mg/vial
	[2ML VIAL](EACH ML CONTAINS:		PH. EUR.

UDIN00269027AM24

|Import Items|Qty.|| ||METHOTREXATE INJECTION BP 25MG/ML 1 Number Vial|1|METHOTREXATE EP / BP / IP / USP /|61.87 mg/vial|| ||[2ML VIAL](EACH ML CONTAINS:||PH. EUR.|||

UDIN00269027AM24

METHOTREXATE PH. EUR. 25MG)	METHOTREXATE PH. EUR. 25MG)				(Moisture and Residual Solvents content<br>not less than 12.49% in API)	(Moisture and Residual Solvents content<br>not less than 12.49% in API)	(Moisture and Residual Solvents content<br>not less than 12.49% in API)
METHOTREXATE INJECTION BP<br>100MG/ML [5 ML VIAL](EACH ML<br>CONTAINS: METHOTREXATE PH. EUR.<br>100 MG)		1 Number Vial		2	METHOTREXATE EP / BP / IP / USP /<br>PH. EUR.<br>(Moisture and Residual Solvents content			618.70 mg/vial
					not less than	12.49% in API)

METHOTREXATE INJECTION BP<br>100MG/ML [10ML VIAL](EACH ML<br>CONTAINS: METHOREXATE PH. EUR.<br>100MG)		1 Number V	ial	3	METHOTRE<br>PH. EUR.<br>(Moisture an<br>not less than	XATE EP / BP / IP / USP /<br>d Residual Solvents content<br>12.49% in API)	<br>	1237.39 mg/vial
METHOTREXATE INJECTION USP<br>25MG/ML [10ML VIAL](EACH ML<br>CONTAINS: METHOTREXATE USP 25MG)		1 Number Vial		4	METHOTREXATE EP / BP / IP / USP /<br>PH. EUR.<br>(Moisture and Residual Solvents content<br>t l th 1249% i API)			306.867 mg/vial
					no ess an . n
		<br>
METHOTREXAT<br>[20ML VIAL](EA	E INJECTION BP 25MG/ML<br>CH ML CONTAINS:	<br>1 Number Vial		5	METHOTREXATE EP / BP /<br>PH.

% i API)||||306.867 mg/vial| ||||||||no ess an . n||||| |||| ||||||||| ||METHOTREXAT [20ML VIAL](EA|E INJECTION BP 25MG/ML CH ML CONTAINS:| 1 Number Vial||5||METHOTREXATE EP / BP / PH. EUR.||IP / USP /||590.57 mg/vial| || METHOTREXAT| E PH. EUR. 25MG)|||||||||| ||||||||(Moisture and Residual Solve not less than 12.49% in API)||nts content||| ||||||||||||| ||METHOTREXAT [40ML VIAL](EA|E INJECTION BP 25MG/ML CH ML CONTAINS:| 1 Number Vial||6||METHOTREXATE EP / BP / PH EUR||IP / USP /||1181.15 mg/vial| || METHOTREXAT| E PH. EUR. 25MG)|||||. . (Moisture and Residual Solve ||nts content||| ||||||||not less than 12.49% in API)||||| ||METHOTREXATE INJECTION BP 100MG/ML [50ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR.||1 Number Vial||7||METHOTREXATE EP / BP / PH. EUR.||||5737.00 mg/vial| ||||||||||IP / USP /||| ||100MG [IN WHICH ACTIVE INGREDIENT ||||||(Moisture and Residual Solvents content ||||| ||METHOTREXAT|E USED IS 32.500 KGS.])|||||not less than 12.49% in API)||||| ||||||||||||| ||||||||||||| |RA concerned ma||y take further necessary action as per above decision of NC.|||||||||| ||||||||||||| ||||||||||||| ||||||||||||| |Case No.||89 / NC/3/MEET/Aug/202324/11|||||||||| ||||||||||||| |Case Status||Case Deferred|||||||||| ||||||||||||| |Party Name||SRF LIMITED|||||||||| |Meeting Number ||NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023|||||||||| |and Date|||||||||||| |HQ File Number||HQRNORM REVIW00004715AM24|||||||||| |RA File Number||05AA04071036 AM22||||||||||

|||| |Meeting Number ||NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023|||||||||| |and Date|||||||||||| |HQ File Number||HQRNORM REVIW00004715AM24|||||||||| |RA File Number||05AA04071036 AM22|||||||||| |Licence No and Dt||0511004601/08/09/2021|||||||||| |ae|||||||||||| |Norms Committee Decision:||||||||||||

Case No.	89 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004715AM24
RA File Number	05AA04071036 AM22
Licence No and<br>Date	0511004601/08/09/2021
Norms Committee Decision:

UDIN00269027AM24

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. Legible copy of chemical reaction sheet.
ii. Percentage of solvents recovered & commercial value of spent solvent.
iii. In chemical reaction Trifluoro Phenyl Chloride is used while import is Triflouro Phenyl Fluoride.

Sample of shipping bills and bill of entry of the export products along with statement of Input-output as per export documents of the said authorization.

mport is Triflouro Phenyl Fluoride.**

Sample of shipping bills and bill of entry of the export products along with statement of Input-output as per export documents of the said authorization.

Case No.	90 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	DIAMINES AND CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00184161AM22
RA File Number	34AA04007354 AM22
Licence No and<br>Date	3411001111/15/09/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	91 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	CUCKOS PHARMACEUTICAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00184568AM22
RA File Number	33AA04006480 AM22
Licence No and<br>Date	3311000430/15/09/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	92 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00187904AM22
RA File Number	08AA04029099 AM22
Licence No and<br>Date	0811002644/20/09/2021
Norms Committee Decision:

UDIN00269027AM24

nd 22/08/2023| |HQ File Number|HQRNORM APPLY 00187904AM22| |RA File Number|08AA04029099 AM22| |Licence No and Date|0811002644/20/09/2021| |Norms Committee Decision:||

UDIN00269027AM24

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.

The Committee con<br>	The Committee con<br>	sidered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it<br>	sidered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it<br>	sidered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it<br>	sidered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it<br>	sidered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it<br>	sidered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it<br>	sidered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it<br>	sidered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it<br>	sidered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it<br>
was decided to revise ad-hoc norms as under.

eview of ad-hoc norms and on the basis of information provided by the firm, it | |---|---|---|---|---|---|---|---|---|---|---| |was decided to revise ad-hoc norms as under.||||||||||| |||||||||||| ||Export Product||Qty.||Sl. No.|Import Items|||Qty.|| |||||||||||| |||||||||||| ||METHOTREXAT|E INJECTION BP|1 Number Vial||1|METHOTREXATE EP / BP / IP / USP /||| 61.87 mg/vial|| ||25MG/ML [2ML|VIAL](EACH ML||||PH. EUR.||||| ||CONTAINS: ME 25MG)|THOTREXATE PH. EUR.||||(Moisture and Residual Solvents content not less than 12.49% in API)||||| |||||||||||| ||METHOTREXAT|E INJECTION BP|1 Number Vial||2|METHOTREXATE EP / BP / IP / USP /||| 61870 mg/vial|| || 100MG/ML [5 M CONTAINS: ME | L VIAL](EACH ML THOTREXATE PH. EUR.|||| PH. EUR. ||| .|| ||100 MG)|||||(Moisture and Residual Solvents content not less than 12.49% in API)||||| ||METHOTREXATE INJECTION BP||1 Number Vial||3|METHOTREXATE EP / BP / IP / USP /||| 1237.39 mg/vial|| ||100MG/ML [10ML VIAL](EACH ML|||||PH. EUR.||||| ||CONTAINS: ME 100MG)|THOREXATE PH. EUR.||||(Moisture and Residual Solvents content||||| ||||||| not less than 12.49% in API)||||| |||||||||||| |||||||||||| ||METHOTREXAT 25MG/ML [10ML|E INJECTION USP VIAL](EACH ML|1 Number Vial||4|METHOTREXATE EP / BP / IP / USP / PH.

t||||| ||||||| not less than 12.49% in API)||||| |||||||||||| |||||||||||| ||METHOTREXAT 25MG/ML [10ML|E INJECTION USP VIAL](EACH ML|1 Number Vial||4|METHOTREXATE EP / BP / IP / USP / PH. EUR.||| 306.867 mg/vial|| ||CONTAINS: ME 25MG|THOTREXATE USP||||(Mit d Ridl Slt tt||||| ||)|||||osure an esua ovens conen not less than 12.49% in API)||||| |||||||||||| ||METHOTREXA|E INJECTION BP|1 Nb Vil||5|METHOTREXATE EP / BP / IP / USP /||| 59057 /il|| | 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) umer a PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) . mgva METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 6 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 1181.15 mg/vial METHOTREXATE INJECTION BP 100MG/ML [50ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100MG [IN WHICH ACTIVE INGREDIENT METHOTREXATE USED IS 32.500 KGS.]) 1 Number Vial 7 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API) 5737.00 mg/vial RA concerned may take further necessary action as per above decision of NC.| 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)||umer a||| PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)||| .

ision of NC.| 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)||umer a||| PH. EUR. (Moisture and Residual Solvents content not less than 12.49% in API)||| . mgva|| ||METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)||1 Number Vial||6|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content||| 1181.15 mg/vial|| |||||||not|less than 12.4|9% in API)||| |||||||||| || ||METHOTREXATE INJECTION BP 100MG/ML [50ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100MG [IN WHICH ACTIVE INGREDIENT METHOTREXATE USED IS|| 1 Num|ber Vial|7|ME PH. (Mo not|THOTREXAT EUR. isture and Res less than 12.4|E EP / BP / IP / USP / idual Solvents content 9% in API)| 57|37.00 mg/vial| ||32.500 KGS.])||||||||||

UDIN00269027AM24

Case No.	93 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	ASOJ SOFT CAPS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00190578AM22
RA File Number	34AA04007816 AM22
Licence No and<br>Date	3411001148/22/09/2021
Norms Committee Decision:
The case is under consideration for want of comments of TE.

PPLY 00190578AM22| |RA File Number|34AA04007816 AM22| |Licence No and Date|3411001148/22/09/2021| |Norms Committee Decision:|| |The case is under consideration for want of comments of TE.||

Case No.	94 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00195372AM22
RA File Number	34AA04006808 AM22
Licence No and<br>Date	3411001180/27/09/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing		<br>before
Norms Committee to explain its case.

Case No.	95 / NC/3/MEET/Aug/202324/11	95 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00001473AM23
RA File Number	08AA04029213 AM22
Licence No and<br>Date	0811002696/27/09/2021
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.
TOPOTECAN INJECTION 1 MG/ML, 1 ML		1 Number	1	TOPOTECAN HYDROCHLORIDE	1.313 mg.
VIAL(EACH ML CONTAINS TOPOTECAN
HYDROCHLORIDE EQ.

||||||| |Export Product||Qty.|Sl. No.|Import Items|Qty.|| |TOPOTECAN INJECTION 1 MG/ML, 1 ML||1 Number|1|TOPOTECAN HYDROCHLORIDE|1.313 mg.|| |VIAL(EACH ML CONTAINS TOPOTECAN||||||| |HYDROCHLORIDE EQ. TO TOPOTECAN||||(Water and Residual solvents content not|||

UDIN00269027AM24

1MG )			less than 9.0% in the API)
TOPOTECAN INJECTION 1 MG/ML, 4 ML	1 Number	2	TOPOTECAN HYDROCHLORIDE	5.16 mg.
VIAL(EACH ML CONTAINS TOPOTECAN
HYDROCHLORIDE EQ. TO TOPOTECAN			(Water and Residual solvents content not
1 MG)			less than 9.0% in the API)
TOPOTECAN HYDROCHLORIDE FOR	1 Number	3	TOPOTECAN HYDROCHLORIDE	5.16 mg
INJECTION 4MG/VIAL (5ML VIAL)
(EACH VIAL CONTAINS TOPOTECAN			(Water and Residual solvents content not
HYDROCHLORIDE EQ. TO TOPOTECAN			less than 9.0% in the API)
4 MG [IN WHICH ACTIVE INGREDIENT
TOPOTECAN HYDROCHLORIDE USED IS
98.000 GRAMS] )

Case No.<br>96 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Approved
Party Name<br>KALPSUTRA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number<br>HQRNORM APPLY 00205042AM22
RA File Number<br>03AA040108575 AM22
Licence No and<br>Date<br>0311007542/07/10/2021
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.

ase 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.|| |Isobornyl Cyclohexanol 1 kg.|1|Gum Turpentine Oil|1.582 kg.|| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No.	97 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023

UDIN00269027AM24

HQ File Number	HQRNORM APPLY 00212058AM22
RA File Number	03AA040109332 AM22
Licence No and<br>Date	0311007711/14/10/2021
Norms Committee Decision:
The case is under consideration for want of comments of TE.

HQ File Number	HQ File Number	HQRNORM APPLY 00212058AM22	HQRNORM APPLY 00212058AM22	HQRNORM APPLY 00212058AM22	HQRNORM APPLY 00212058AM22	HQRNORM APPLY 00212058AM22	HQRNORM APPLY 00212058AM22	HQRNORM APPLY 00212058AM22	HQRNORM APPLY 00212058AM22	HQRNORM APPLY 00212058AM22	HQRNORM APPLY 00212058AM22
RA File Number		03AA040109332 AM22
Licence No and
		0311007711/14/10/2021
Date

Norms Committee		Decision:

The case is under co		nsideration for want of comments of TE.



Case No.		98 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved

is under co**||nsideration for want of comments of TE.|||||||||| ||||||||||||| ||||||||||||| ||||||||||||| |Case No.||98 / NC/3/MEET/Aug/202324/11|||||||||| |Case Status||Case Approved|||||||||| |Party Name||INTAS PHARMACEUTICALS LIMITED|||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023|||||||||| |HQ|File Number|HQRNORM REVIW00001474AM23|||||||||| |RA|File Number|08AA04033170 AM22|||||||||| |Lic Dat|ence No and e|0811002920/20/10/2021|||||||||| ||||||||||||| ||||||||||||| |Nor|ms Committee Decision:||||||||||| |Th|e Committee con|sidered the request of firm for re||view of ad-h|oc norms a|||nd on the basis of information prov|||ided by the firm, it| |wa|s decided to revis|e ad-hoc norms as under.|||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||Export Product||Qty.||Sl. No.||Import Items||||Qty.| ||METHOTREXAT|E INJECTION BP 25MG/ML| 1 Number Vial||1||METHOTREXATE EP / BP / IP / USP /|||| 6187 m/vial| |||| |||||||| . g| ||[2ML VIAL](EAC|H ML CONTAINS:|||||PH. EUR.||||| ||METHOTREXAT|E PH. EUR. 25MG)|||||(Moisture and Residual Solvents content||||| |||||||| not less than 12.49% in API)||||| ||||||||||||| ||||||||||||| ||||||||||||| ||METHOTREXAT 100MG/ML [5 M |E INJECTION BP L VIAL](EACH ML |1 Number Vial||2||METHOTREXATE EP / BP / IP / USP / PH. EUR.|||| 618.70 mg/vial| ||CONTAINS: ME 100 MG)|THOTREXATE PH.

|METHOTREXAT 100MG/ML [5 M |E INJECTION BP L VIAL](EACH ML |1 Number Vial||2||METHOTREXATE EP / BP / IP / USP / PH. EUR.|||| 618.70 mg/vial| ||CONTAINS: ME 100 MG)|THOTREXATE PH. EUR.|||||(Moisture and Residual Solvents content||||| |||||||| not less than 12.49% in API)||||| ||||||||||||| ||||||||||||| ||METHOTREXAT|E INJECTION BP|1 Number Vial||3||METHOTREXATE EP / BP / IP / USP /|||| 1237.39 mg/vial| ||100MG/ML [10M CONTAINS: ME 100MG|L VIAL](EACH ML THOREXATE PH. EUR.|||||PH. EUR. (Moisture and Residual Solvents content|||| | ||)|||||| not less than 12.49% in API)||||| ||||||||||||| ||||||||||||| ||METHOTREXAT 25MG/ML [10ML|E INJECTION USP VIAL](EACH ML|1 Number Vial||4||METHOTREXATE EP / BP / IP / USP / PH. EUR.|||| 306.867 mg/vial| ||CONTAINS: METHOTREXATE USP 25MG)||||||(Moisture and Residual Solvents content||||| ||||||||not less||than 12.49% in API)||| |||| |||||||| | ||METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS:|| 1 Num|ber Vial||5|METH PH. EU||TREXATE EP / BP / IP / R.|SP /| 590.57 mg/vial| |||||||||||||

UDIN00269027AM24

OTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS:|| 1 Num|ber Vial||5|METH PH. EU||TREXATE EP / BP / IP / R.|SP /| 590.57 mg/vial| |||||||||||||

UDIN00269027AM24

METHOTREXATE PH. EUR. 25MG)			(Moisture and Residual Solvents content
			not less than 12.49% in API)
METHOTREXATE INJECTION BP 25MG/ML	<br>1 Number Vial	6	METHOTREXATE EP / BP / IP / USP /	<br>1181.15 mg/vial
[40ML VIAL](EACH ML CONTAINS:			PH. EUR.
METHOTREXATE PH. EUR. 25MG)
			(Moisture and Residual Solvents content
			not less than 12.49% in API)
METHOTREXATE INJECTION BP	1 Number Vial	7	METHOTREXATE EP / BP / IP / USP /	<br>5737.00 mg/vial
100MG/ML [50ML VIAL](EACH ML			PH. EUR.
CONTAINS: METHOTREXATE PH. EUR.
100MG [IN WHICH ACTIVE INGREDIENT			(Moisture and Residual Solvents content
METHOTREXATE USED IS 32.500 KGS.])			not less than 12.49% in API)

Case No.	99 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	NAARI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00220580AM22
RA File Number	05AA04091063 AM22
Licence No and<br>Date	0511005553/21/10/2021
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:-
Complete chemistry, molecular weight, percentage yields on molar basis.<br>1.
Past production/consumption certificate certified by CA.<br>2.

|information/documents from the firm:-|| |Complete chemistry, molecular weight, percentage yields on molar basis. 1.|| |Past production/consumption certificate certified by CA. 2.||

Case No.	100 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	NAARI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00220582AM22
RA File Number	05AA04091028 AM22
Licence No and<br>Date	0511005555/21/10/2021
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:-

UDIN00269027AM24

i. Complete chemistry, molecular weight, percentage yields on molar basis.
ii. Past production/consumption certificate certified by CA.

Case No.<br>101 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Approved
Party Name<br>THEMIS NUTRITIONALS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number<br>HQRNORM APPLY 00221695AM22
RA File Number<br>03AA040108212 AM22
Licence No and<br>Date<br>0311007847/22/10/2021
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.

e 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.|| |Enalapril 5 mg Tablets(Enalapril) 1 Number Tablet 1|ENALAPRIL MALEATE EP||5.10 mg/Tablet|| |Enalapril 10 mg Tablets(Enalapril) 1 Number Tablet 2|ENALAPRIL MALEATE EP||10.2 mg/Tablet|| |Enalapril 20 mg Tablets(Enalapril) 1 Number Tablet 3|ENALAPRIL MALEATE EP||20.4 mg/Tablet|| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No.	102 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	TOJO VIKAS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00226905AM22
RA File Number	05AA04094141 AM22
Licence No and<br>Date	0511005704/26/10/2021
Norms Committee Decision:
The case is under consideration for want of comments of TE.

Case No. 103 / NC/3/MEET/Aug/202324/11

UDIN00269027AM24

Case Status	Case Deferred
Party Name	BHARAT PARENTERALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00239596AM22
RA File Number	34AA04008748 AM22
Licence No and<br>Date	3411001363/02/11/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00239596AM22| |RA File Number|34AA04008748 AM22| |Licence No and Date|3411001363/02/11/2021| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	104 / NC/3/MEET/Aug/202324/11	104 / NC/3/MEET/Aug/202324/11	104 / NC/3/MEET/Aug/202324/11	104 / NC/3/MEET/Aug/202324/11	104 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM APPLY 00253243AM22
RA File Number		34AA04009242 AM22
Licence No and<br>Date		3411001396/15/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-




	Export Produ	ct	Qty.	Sl. No.	Import Items	Qty.

	Ointment(Clobeta	sol Propionate Ointment	<br>1 Number	1	CLOBETASOL PROPIONATE	7.65 mg/pack
	<br>USP 0.05% 15 g<br>	<br>m ( net content of active<br>	<br>		USP (MICRONIZED)
	ingredients 187.50	gm. ))

	Ointment(Clobeta<br>	sol Propionate Ointment<br>	<br> <br>1 Number	2	CLOBETASOL PROPIONATE<br>	15.30 mg/pack
	USP 0.05% 30 gm ( net content of active<br>ingredients 225.00 gm.

m. ))||||| |||||||| ||Ointment(Clobeta |sol Propionate Ointment | 1 Number|2|CLOBETASOL PROPIONATE |15.30 mg/pack| ||USP 0.05% 30 gm ( net content of active ingredients 225.00 gm. ))||||USP (MICRONIZED)|| ||Ointment(Clobetasol Propionate Ointment|| 1 Number|3|CLOBETASOL PROPIONATE|2295 mg/pack| || USP 0.05% 45 gm ( net content of active|| || USP (MICRONIZED)|.| ||ingredients 114.75|gm. ))||||| |||||||| |||||||| ||Ointment(Clobeta |sol Propionate Ointment | 1 Number|4|CLOBETASOL PROPIONATE |30.60 mg/pack| ||USP 0.05% 60 g ingredients 900.00|m ( net content of active gm. ))|||USP (MICRONIZED)|| |||| |||| ||Foam(Clobetasol 005% 50gm (|Propionate Foam USP net content of active| 1 Number|5|CLOBETASOL PROPIONATE USP (MICRONIZED)|25.50 mg/pack| ||. .||||||

UDIN00269027AM24

ingredients 475.00 gm. ))
Foam(Clobetasol Propionate Foam USP	<br>1 Number	6	CLOBETASOL PROPIONATE	51.00 mg/pack
0.05% 100 gm. ( net content of active			USP (MICRONIZED)
ingredients 550.00 gm. ))

-|---|---|---| |Foam(Clobetasol Propionate Foam USP| 1 Number|6|CLOBETASOL PROPIONATE|51.00 mg/pack| |0.05% 100 gm. ( net content of active|||USP (MICRONIZED)|| |ingredients 550.00 gm. ))|||||

Case No.	105 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00261092AM22
RA File Number	09AA04016734 AM22
Licence No and<br>Date	0911001888/22/11/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing		<br>before Norms
Committee to explain its case.

Case No.<br>106 / NC/3/MEET/Aug/202324/11	Case No.<br>106 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Approved
Party Name<br>FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and		22/08/2023
HQ	File Number<br>HQRNORM APPLY 00262423AM22
RA File Number<br>05AA04098088 AM22
Licence No and<br>Date<br>0511006367/23/11/2021
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.

e 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.|| ||Docetaxel Trihydrate.(Anti cancer bulk 1 kg|1|Taxus Baccatta Leaves|1340 kg|| ||drug)||||| |||2|DSC -9 [4S,5R)-2-(4-|0.888 kg|| ||||methoxyphenyl)-N-t-boc-phenyl-|||

UDIN00269027AM24

oxazolidine-5-carboxylic acid]

Case No.	107 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	LAZERHEAD LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00266328AM22
RA File Number	09AA04012424 AM22
Licence No and<br>Date	0911001950/26/11/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to refer the case to Deptt. of Bio-Technology for
obtaining their comments.

Case No.	108 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00272724AM22
RA File Number	03AA040127775 AM22
Licence No and<br>Date	0311009114/02/12/2021
Norms Committee Decision:
The case is under consideration for want of comments of TE.

PLY 00272724AM22| |RA File Number|03AA040127775 AM22| |Licence No and Date|0311009114/02/12/2021| |Norms Committee Decision:|| |The case is under consideration for want of comments of TE.||

Case No.	109 / NC/3/MEET/Aug/202324/11
Case Status	Case Rejected
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00000792AM24
RA File Number	07AA04040783 AM22
Licence No and<br>Date	0711002512/02/12/2021
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms andit was observed that the firm has not

UDIN00269027AM24

provided any technical justification / information for enhancement. Hence, it was decided to reject the case maintaining the status quo.

Case No.	110 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004710AM24
RA File Number	03AA040124486 AM22
Licence No and<br>Date	0311009090/02/12/2021
Norms Committee Decision:
The case is under consideration for want of comments of TE.

EVIW00004710AM24| |RA File Number|03AA040124486 AM22| |Licence No and Date|0311009090/02/12/2021| |Norms Committee Decision:|| |The case is under consideration for want of comments of TE.||

Case No.<br>111 / NC/3/MEET/Aug/202324/11	Case No.<br>111 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Approved
Party Name<br>RAKSHIT PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and		22/08/2023
HQ File Number<br>HQRNORM APPLY 00276086AM22
RA File Number<br>09AA04016769 AM22
Licence No and<br>Date<br>0911002001/06/12/2021
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/Apr/202324/1 dated 28.04.2023			against advance authorization No.0911004282 dated
09.01.2023,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.
MYCOPHENOLATE SODIUM(SOLID)	1 Kg	1		Mycophenolic Acid	0.90 kg
		2		Toluene	0.66 kg
		3		Methanol	0.70 kg

UDIN00269027AM24

ort Product|Qty.|Sl. No.||Import Items|Qty.|| |MYCOPHENOLATE SODIUM(SOLID)|1 Kg|1||Mycophenolic Acid|0.90 kg|| |||2||Toluene|0.66 kg|| |||3||Methanol|0.70 kg|| ||||||||

UDIN00269027AM24

R	A conce	rned may take further necessary action as per above decision of NC.	rned may take further necessary action as per above decision of NC.

C	ase No.		112 / NC/3/MEET/Aug/202324/11
C	ase Statu	s	Case Approved
P	N		VENUS REMEDIES LIMITED
	rty am	e
M	eeting N	umber
an	d Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
H	Q File N	umber	HQRNORM APPLY 00276997AM22
R	A File N	umber	30AX04000001 AM22
Li	cence N	o and
D	ate		3011001471/06/12/2021
N	orms Co	mmittee	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.

|||||||| |D|ate|||3011001471/06/12/2021||||||| |N|orms Co||mmittee|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:-||||||||||| |||||||||||| |||||||||||| |||||||||||| |||E|xport Pro|duct|Qty.|Sl.|No.|Import Items ||Qty.| |||||||||||| |||||||||||| |||||||||||| |||VINO|RELBINE|SOLUTION FOR INJECTION|1450.0||1|VINORELBINE|TARTRATE |100.05 gm.| ||| (50M| G/5ML)(1| ML OF SOLUTION CONTAINS:| Vials|||| || |||VINO |RELBINE |TARTRATE , EQUIVALENT TO ||||||| |||VINO|RELBIN|10MG EXCIPIENTS: TARTARIC||||||| ||| ACID| WATER| FOR INJECTION||||||| ||||,|)||||||| |||||||||||| |||||||||||| |||VINO (10M |RELBINE SOLUTION FOR INJECTION G5ML)(1 ML OF SOLUTION CONTAINS: ||7250.0 Vials||2|VINORELBINE|TARTRATE |100.05 gm.| |||VINO VINO ACID|RELBINE TARTRATE , EQUIVALENT TO RELBINE 10MG EXCIPIENTS: TARTARIC , WATER FOR INJECTION)|||||||| |||||||||||| |||||||||||| |||||||||||| |||||||||||| |||||||||||| |R|A|concern|ed may t|ake further necessary action as per above decision of N|||.|||| |||||||||||| |||||||||||| |||||||||||| |Case No||||113 / NC/3/MEET/Au/202324/11||||||| |.||||g||||||| |Case Status||||Case Aroved||||||| |||||pp||||||| |Part Name||||AURA PHARMACEUTICALS PRIVATE LIMITED||||||| |y||||||||||| |Meeting Number||||NC/ 3/ MEET/ Au/ 202324/ 11 and 22/08/2023||||||| |and Date||||g||||||| |||||||||||| |HQ File Number||||HQRNORM APPLY 00277561AM22|||||||

ICALS PRIVATE LIMITED||||||| |y||||||||||| |Meeting Number||||NC/ 3/ MEET/ Au/ 202324/ 11 and 22/08/2023||||||| |and Date||||g||||||| |||||||||||| |HQ File Number||||HQRNORM APPLY 00277561AM22||||||| |RA File Number||||03AA040123116 AM22||||||| |Licence No and Date||||0311009243/07/12/2021||||||| |Norms Committee||||Decision:||||||| ||||||||||||

Case No.	113 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	AURA PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00277561AM22
RA File Number	03AA040123116 AM22
Licence No and<br>Date	0311009243/07/12/2021
Norms Committee Decision:

UDIN00269027AM24

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.
ARGYROL 0.5% / SILVER VITELLINATE NASAL	1 Number	1	SILVER VITELLINATE	51.00 mg.
DROPS 0.5 % w/v (EACH 10 ML CONTAINS 52 MG
OF SILVER VITELLINATE)
ARGYROL 1 % / SILVER VITELLINATE NASAL	1 Number	2	SILVER VITELLINATE	102.00 mg
DROPS 1 % w/v (EACH 10 ML CONTAINS 104 MG
OF SILVER VITELLINATE)

r>PERINDOPRIL ERBUMINE 1 kg. 8 N-(S)-1-CARBETHOXYBUTYALANINE 0.85 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||PERINDOPRIL ERBUMINE||1 kg.|1|(S)-2-CARBOXY OCTAHYDROINDOLE|0.60 kg.| |||||2|1,1-CARBONYLDIIMIDAZOLE|0.64 kg.| |||||3|ACETIC ACID GLACIAL|0.48 kg.| |||||4|ACETONE|6.88 kg.| |||||5|ACETONITRILE|3.90 kg.| |||||6|ISOPROPYL ALCOHOL|1.97 kg.| |||||7|METHYLENE CHLORIDE (MDC)|6.15 kg.| |||||8|N-(S)-1-CARBETHOXYBUTYALANINE|0.85 kg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	143 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	HETERO LABS LIMITED

UDIN00269027AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00002168AM23
RA File Number	09AX04000297 AM23
Licence No and<br>Date	0911003374/21/07/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per
details given below or as applied by the firm, whichever is less:-
Export Product		Qty.	Sl. No.	Import Items	Qty.
(3R)-TETRAHYDRO-3-FURANYL-4-METHYLBENZENE		1 kg	1	Tetra Hydro Furan	4.00 kg.
SULFONATE
RA concerned may take further necessary action as per above decision		of NC.

rt Items|Qty.|| |(3R)-TETRAHYDRO-3-FURANYL-4-METHYLBENZENE||1 kg|1|Tetra Hydro Furan|4.00 kg.|| |SULFONATE||||||| |RA concerned may take further necessary action as per above decision||of NC.|||||

Case No.<br>144 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Approved
Party Name<br>VASUDHA PHARMA CHEM LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number<br>HQRNORM APPLY 00002239AM23
RA File Number<br>26AX04000026 AM23
Licence No and<br>Date<br>2611000646/25/07/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was	decided to	fix ad-hoc norms under Para 4.07 of HBP Vol. I as per
details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty.
2-BUTYL-4-FORMYL IMIDAZOLE (OR) 2-<br>1 kg.	1	2 N BUTYL 4 CHLORO 5 FORMYL	<br>1.41 kg.
BUTYL-1H-IMIDAZOLE-5-		IMIDAZOLE
CARBOXALDEHYDE
	2	METHANOL	0.96 kg.
	3	METHYLENE DI CHLORIDE OR	<br>0.83 kg.

UDIN00269027AM24

		METHYLENE CHLORIDE
	4	ACTIVATED CARBON SC 40 V	0.05 kg.

BOXALDEHYDE||||| ||2|METHANOL|0.96 kg.|| ||3|METHYLENE DI CHLORIDE OR| 0.83 kg.||

UDIN00269027AM24

		METHYLENE CHLORIDE
	4	ACTIVATED CARBON SC 40 V	0.05 kg.

Case No.	Case No.	145 / NC/3/MEET/Aug/202324/11	145 / NC/3/MEET/Aug/202324/11	145 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		VASUDHA PHARMA CHEM LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM APPLY 00002240AM23
RA File Number		26AX04000027 AM23
Licence No and<br>Date		2611000647/25/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>2 CYANO 4 BROMOMETHYL BIPHENYL<br>0.75 kg.<br>2<br>TOLUENE<br>0.444 kg.<br>3<br>2 N BUTYL 4 CHLORO 5 FORMYL<br>IMIDAZOLE<br>0.50 kg.<br>4<br>METHANOL<br>0.815 kg.<br>5<br>SODIUM BORO HYDRIDE<br>0.048 kg.<br>6<br>SODIUM AZIDE<br>0.38 kg.<br>7<br>ACTIVATED CARBON SC 40 V<br>0.100 kg.<br>LOSARTAN<br>POTASSIUM<br>(OR)<br>LOSARTAN POTASSIUM USP<br>(White to off white Powder)<br>1 kg.<br>8<br>ISO PROPYL ALCOHOL<br>0.91 kg.
	Export Product		Qty.	Sl.

CARBON SC 40 V 0.100 kg. LOSARTAN POTASSIUM (OR) LOSARTAN POTASSIUM USP (White to off white Powder) 1 kg. 8 ISO PROPYL ALCOHOL 0.91 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||LOSARTAN POTASSIUM (OR) LOSARTAN POTASSIUM USP (White to off white Powder)|| 1 kg.|1|2 CYANO 4 BROMOMETHYL BIPHENYL|0.75 kg.| |||||2|TOLUENE|0.444 kg.| |||||3|2 N BUTYL 4 CHLORO 5 FORMYL IMIDAZOLE| 0.50 kg.| |||||4|METHANOL|0.815 kg.| |||||5|SODIUM BORO HYDRIDE|0.048 kg.| |||||6|SODIUM AZIDE|0.38 kg.| |||||7|ACTIVATED CARBON SC 40 V|0.100 kg.| |||||8|ISO PROPYL ALCOHOL|0.91 kg.|

UDIN00269027AM24

Case No.	Case No.	146 / NC/3/MEET/Aug/202324/11	146 / NC/3/MEET/Aug/202324/11	146 / NC/3/MEET/Aug/202324/11	146 / NC/3/MEET/Aug/202324/11	146 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		HETERO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM APPLY 00002246AM23
RA File Number		09AX04000299 AM23
Licence No and<br>Date		0911003396/25/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.

e case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 Nortropinone.HCl 1.88 kg. 2 Tetra Hydro Furan 3.32 kg. 3-(3-ISOPROPYL-5-METHYL-4H-1,2,4-TRIAZOL-4- YL)EXO-8-AZA-BICYCLO[3.2.1] OCTANE 1 kg. 3 ACETONITRILE 3.77 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||3-(3-ISOPROPYL-5-METHYL-4H-1,2,4-TRIAZOL-4- YL)EXO-8-AZA-BICYCLO[3.2.1] OCTANE||1 kg.|1|Nortropinone.HCl|1.88 kg.| |||||2|Tetra Hydro Furan|3.32 kg.| |||||3|ACETONITRILE|3.77 kg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	147 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	S.V.CHEM INTERMEDIATES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00002400AM23
RA File Number	04AX04000404 AM23
Licence No and<br>Date	0411003747/02/08/2022
Norms Committee Decision:<br>The case under consideration for want of comments of TE.

Case No.	148 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred

UDIN00269027AM24

s Committee Decision: The case under consideration for want of comments of TE.||

Case No.	148 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred

UDIN00269027AM24

Party Name	NIFTY LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00002449AM23
RA File Number	09AX04000391 AM23
Licence No and<br>Date	0911003436/03/08/2022
Norms Committee Decision:<br>The case under consideration for want of comments of TE.

Case No.	149 / NC/3/MEET/Aug/202324/11
Case Status	Case Rejected
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00000793AM24
RA File Number	07AX04000657 AM23
Licence No and<br>Date	0711004850/05/08/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms andit was observed that the firm has not<br>provided any technical justification / information for enhancement. Hence, it was decided torejectthe case<br>maintaining the status quo.<br>RA concerned may take further necessary action as per above decision of NC.

ification / information for enhancement. Hence, it was decided torejectthe case maintaining the status quo. RA concerned may take further necessary action as per above decision of NC.||

Case No.	150 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	PRACHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00002520AM23
RA File Number	08AX04000754 AM23
Licence No and<br>Date	0811005702/08/08/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	151 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00002560AM23

UDIN00269027AM24

RA	File Number	34AX04000414 AM	23
Licence No and<br>Date	ence No and<br>	3411002630/10/08/2	022

Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

--|---|---|---|---| |Licence No and Date|ence No and |3411002630/10/08/2|022|||| |||||||| |Norms Committee Decision: The case is under consideration for want of comments of TE.|||||||

Case No.	Case No.	152 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ	File Number	HQRNORM APPLY 00002625AM23
RA File Number		34AX04000448 AM23
Licence No and<br>Date		3411002646/12/08/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms					under Para 4.07 of HBP Vol. I as per
details given below or as applied by the firm, whichever is less:-
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Cyclo Hexyl Salicylate(Cyclohexyl-2-Hydroxy Benzoate)		1 kg.	1	Methyl Salicylate	0.725 kg.
RA concerned may take further necessary action as per above decision of NC.

Case No.	153 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00002668AM23
RA File Number	05AX04001382 AM23
Licence No and<br>Date	0511014320/17/08/2022
Norms Committee Decision:
The case is under consideration for want of comments of TE.

Case No.	154 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved

UDIN00269027AM24

ommittee Decision:|| |The case is under consideration for want of comments of TE.||

Case No.	154 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved

UDIN00269027AM24

Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00002697AM23
RA File Number	08AX04000846 AM23
Licence No and<br>Date	0811005777/22/08/2022
Norms Committee Decision:<br>The committee considered the case as per agenda and it was decided to fix ad-hoc norms as perSION A-412.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	155 / NC/3/MEET/Aug/202324/11	155 / NC/3/MEET/Aug/202324/11	155 / NC/3/MEET/Aug/202324/11	155 / NC/3/MEET/Aug/202324/11	155 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		MICRO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM APPLY 00002737AM23
RA File Number		07AX04000747 AM23
Licence No and<br>Date		0711005078/23/08/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>in meetingNo. NC-3/MEET/Feb/202223/20 dated 24/02/2023against advance authorizationNo. 0711005409 dated 06/10/2022<br>, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

ingNo. NC-3/MEET/Feb/202223/20 dated 24/02/2023against advance authorizationNo. 0711005409 dated 06/10/2022 , 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. PREMIX OF NIFUROXAZIDE(( Each gm of Premix Contains Nifuroxazide BP 0.552 gm) {Nifuroxazide Net Content is 3477.60kg }) 6300 kg. 1 NIFUROXAZIDE BP / EP 3512.376 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||PREMIX OF NIFUROXAZIDE(( Each gm of Premix Contains Nifuroxazide BP 0.552 gm) {Nifuroxazide Net Content is 3477.60kg })||6300 kg.|1|NIFUROXAZIDE BP / EP|3512.376 kg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	156 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023

UDIN00269027AM24

56 / NC/3/MEET/Aug/202324/11| |---|---| |Case Status|Case Approved| |Party Name|TIDE INDUSTRIES| |Meeting Number and Date|NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023|

UDIN00269027AM24

HQ File Number<br>HQRNORM APPLY 00002755AM23
RA File Number<br>34AX04000497 AM23
Licence No and<br>Date<br>3411002675/24/08/2022
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/Oct/202223/11dated31/10/2022against	advance authorizationNo. 3411000697 dated 04/06/2021,
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<br>Qty.	Sl. No.	Import Items	Qty.
Gamma Undecalactone(Aldehyde C14)<br>1 kg.	1	Acrylic Acid	0.843 kg.
	2	Di tert Butyl Peroxide	0.25 kg.
RA concerned may take further necessary action as per above decision of NC.

ty.|| |Gamma Undecalactone(Aldehyde C14) 1 kg.|1|Acrylic Acid|0.843 kg.|| ||2|Di tert Butyl Peroxide|0.25 kg.|| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No.	Case No.		157 / NC/3/MEET/Aug/202324/11
Case Status			Case Approved
Party Name			HONOUR LAB LIMITED
Meeting Number and Date			NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ	File Number		HQRNORM REVIW00004631AM24
RA File Number			09AX04000430 AM23
Licence No and Date			0911003559/30/08/2022
Norms Committee Decision:
The Committee considered		the request of firm for fixation of ad-hoc norms and it was decided to ratify 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.
	EMPAGLIFLOZIN		1<br>(3R,4S,5S,6R)-3,4,5-Trihydroxy-6-(Hydroxymethyl) tetrahydro-<br>1 kg.	Not Required
			2H-pyran-2-one
			2<br>(S)-3-(4-(5-Bromo-2-Chloro benzyl) phenoxy) tetrahydrofuran	Not Required
			(2R,3R,4R,5S,6S)-2-(Acetoxymethyl)-6-(4-chloro-3-(4-(((S)-<br>3	1.525 kg.
			tetrahydrofuran-3-yl)oxy)benzyl)phenyl)tetrahydro-2H-pyran- 3,4

UDIN00269027AM24

,5-triyl triacetate/(1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)tetrahydro3furanyl]oxy]phenyl]methyl]phenyl]Dglucitol tetraacetate

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

yl triacetate/(1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)tetrahydro3furanyl]oxy]phenyl]methyl]phenyl]Dglucitol tetraacetate

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

Case No.	158 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	HI-PURITY CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00002877AM23
RA File Number	03AX04002948 AM23
Licence No and<br>Date	0311017592/01/09/2022
Norms Committee Decision:
The case is under consideration for want of comments of TE.

Case No.	159 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00003036AM23
RA File Number	05AX04001577 AM23
Licence No and<br>Date	0511014727/09/09/2022
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:-4.
Yield given in last step is very low. Please give technical justification supported by technical literature.<br>1.
By-product<br>2.	from last step alongwith sale-value
Since the firm is also exporting Ceftibutene, complete details upto API stage may be furnished.<br>3.
Requirements of**7-Amin-3 Nor-3-cephem-4-carboxylic acid per kg. of Ceftibutene may be furnished.**<br>4.

xporting Ceftibutene, complete details upto API stage may be furnished. 3.|| |Requirements of**7-Amin-3 Nor-3-cephem-4-carboxylic acid per kg. of Ceftibutene may be furnished. 4.||


Case No.	160 / NC/3/MEET/Aug/202324/11

Case Status	Case Deferred

Party Name	SRF LIMITED

Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023

UDIN00269027AM24

HQ File Number	HQRNORM APPLY 00003064AM23
RA File Number	05AX04001671 AM23
Licence No and<br>Date	0511014757/12/09/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	161 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00003158AM23
RA File Number	05AX04001697 AM23
Licence No and<br>Date	0511014860/16/09/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00003158AM23| |RA File Number|05AX04001697 AM23| |Licence No and Date|0511014860/16/09/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	162 / NC/3/MEET/Aug/202324/11	162 / NC/3/MEET/Aug/202324/11	162 / NC/3/MEET/Aug/202324/11	162 / NC/3/MEET/Aug/202324/11	162 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		TULIP LAB PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM APPLY 00003167AM23
RA File Number		03AX04003046 AM23
Licence No and<br>Date		0311017934/16/09/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Tugyna 500 Tablets<br>(Tranexamic Acid 500 MG Tablets)<br>1 Number<br>1<br>Tranexamic Acid BP (DMF)<br>500 mg.<br>Tranexamic Acid 500 MG Tablets<br>1 Number<br>2<br>Tranexamic Acid BP (DMF)<br>500 mg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Tugyna 500 Tablets<br>(Tranexamic Acid 500 MG Tablets)		1 Number	1	Tranexamic Acid BP (DMF)	500 mg.
	Tranexamic Acid 500 MG Tablets		1 Number	2	Tranexamic Acid BP (DMF)	500 mg.

UDIN00269027AM24

(**Tranexamic Acid 500 MG Tablets)||1 Number|1|Tranexamic Acid BP (DMF)|500 mg.| ||Tranexamic Acid 500 MG Tablets||1 Number|2|Tranexamic Acid BP (DMF)|500 mg.| ||||||||

UDIN00269027AM24

Case No.	163 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	MAYA BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00003190AM23
RA File Number	30AX04000248 AM23
Licence No and<br>Date	3011002599/19/09/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to refer the case toDeptt. of Bio-Technologyfor
obtaining their comments

Case No.	164 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00003244AM23
RA File Number	34AX04000595 AM23
Licence No and<br>Date	3411002799/20/09/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing		<br>before
Norms Committee to explain its case.

Committee Decision:||| |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.|||

Case No.	165 / NC/3/MEET/Aug/202324/11
Case Status	Case Rejected
Party Name	LASENOR INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00003295AM23
RA File Number	50AX04000050 AM23
Licence No and<br>Date	5011000587/22/09/2022
Norms Committee Decision:
The committee considered the application of the firm and it has been observed that the firm has not appeared for personal
hearing before committee to explain their case, therefore, the committee decided to reject the application of the firm.

Case No. 166 / NC/3/MEET/Aug/202324/11

UDIN00269027AM24

Case Status<br>Case Approved
Party Name<br>MANKIND PHARMA LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number<br>HQRNORM APPLY 00003330AM23
RA File Number<br>05AX04001819 AM23
Licence No and<br>Date<br>0511014976/23/09/2022
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/Apr/202324/1 dated 28/04/2023against advance authorizationNo.0511016690 dated

from the earlier decision for same export|||||product/import||| |product in meeting No.NC/3/MEET/Apr/202324/1 dated 28/04/2023against advance authorizationNo.0511016690 dated|||||||| |03/01/2023, 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.|| |Tobramycin Inhalation Solution, USP, 300mg/ 4ml|1|Number| 1|TOBRAMYCIN USP||306 mg.|| ||Pack||||||| |(Having net content of 25.20 kg of Bulk drug)|||||||| |RA concerned may take further necessary action as per above decision of||NC.||||||

Case No.	Case No.		167 / NC/3/MEET/Aug/202324/11
Case Status			Case Approved
Party Name			HONOUR LAB LIMITED
Meeting Number and Date			NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ	File Number		HQRNORM REVIW00004632AM24
RA File Number			09AX04000541 AM23
Licence No and Date			0911003683/23/09/2022
Norms Committee Decision:
The Committee considered		the request of firm for fixation of ad-hoc norms and it was decided to ratify 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.
	EMPAGLIFLOZIN		1<br>(3R,4S,5S,6R)-3,4,5-Trihydroxy-6-(Hydroxymethyl) tetrahydro-<br>1 kg.	Not Required
			2H-pyran-2-one
			2<br>(S)-3-(4-(5-Bromo-2-Chloro benzyl) phenoxy) tetrahydrofuran	Not Required

|1 (3R,4S,5S,6R)-3,4,5-Trihydroxy-6-(Hydroxymethyl) tetrahydro- 1 kg.|Not Required|| ||||2H-pyran-2-one||| ||||2 (S)-3-(4-(5-Bromo-2-Chloro benzyl) phenoxy) tetrahydrofuran|Not Required||

Case No.	Case No.		167 / NC/3/MEET/Aug/202324/11
Case Status			Case Approved
Party Name			HONOUR LAB LIMITED
Meeting Number and Date			NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ	File Number		HQRNORM REVIW00004632AM24
RA File Number			09AX04000541 AM23
Licence No and Date			0911003683/23/09/2022
Norms Committee Decision:
The Committee considered		the request of firm for fixation of ad-hoc norms and it was decided to ratify 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.
	EMPAGLIFLOZIN		1<br>(3R,4S,5S,6R)-3,4,5-Trihydroxy-6-(Hydroxymethyl) tetrahydro-<br>1 kg.	Not Required
			2H-pyran-2-one
			2<br>(S)-3-(4-(5-Bromo-2-Chloro benzyl) phenoxy) tetrahydrofuran	Not Required

UDIN00269027AM24

	3	(2R,3R,4R,5S,6S)-2-(Acetoxymethyl)-6-(4-chloro-3-(4-(((S)-	1.525 kg.
		tetrahydrofuran-3-yl)oxy)benzyl)phenyl)tetrahydro-2H-pyran- 3,4
		,5-triyl triacetate/(1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-
		tetrahydro3furanyl]oxy]phenyl]methyl]phenyl]Dglucitol
		tetraacetate

-yl)oxy)benzyl)phenyl)tetrahydro-2H-pyran- 3,4|| |||,5-triyl triacetate/(1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-|| |||tetrahydro3furanyl]oxy]phenyl]methyl]phenyl]Dglucitol|| |||tetraacetate||

Case No.	168 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	BLUE JET HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00003358AM23
RA File Number	03AX04002988 AM23
Licence No and<br>Date	0311018145/25/09/2022
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:-
Yields given in the reply are confusing and not conforming to applied norms.<br>i.
Material Balance for each step not given.<br>ii.
Requirement and Recovery of solvents not shown in the details given.<br>iii.

Case No.	169 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	VINS BIOPRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00003701AM23
RA File Number	09AX04000630 AM23
Licence No and<br>Date	0911003795/13/10/2022
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:-
Details of steps involved in the manufacturing of Tetanus Antitoxin I.H.S/B.P 1500 IU including wastage at<br>1.

it was decided to call for following|| |information/documents from the firm:-|| |Details of steps involved in the manufacturing of Tetanus Antitoxin I.H.S/B.P 1500 IU including wastage at 1.|| |each steps of manufacturing||

UDIN00269027AM24

Justification of claiming 12% wastage.
Batch manufacturing record and material reconciliation sheet duly signed by dealing executive/manager. 4. DML (Drug manufacturing License)

Case No.<br>170 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Approved
Party Name<br>SALICYLATES & CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number<br>HQRNORM APPLY 00003801AM23
RA File Number<br>09AX04000575 AM23
Licence No and<br>Date<br>0911003827/18/10/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix		ad-hoc norms under Para 4.07 of HBP Vol. I as per
details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty.
HOMOSALATE<br>1 kg.	1	METHYL SALICYLATE	0.649 kg.
RA concerned may take further necessary action as per above decision of NC.

ss:-||||| |Export Product Qty.|Sl. No.|Import Items|Qty.|| |HOMOSALATE 1 kg.|1|METHYL SALICYLATE|0.649 kg.|| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No.		171 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		HAFFKINE BIO PHARMACEUTICAL CORPORATION LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM APPLY 00003863AM23
RA File Number		03AX04003507 AM23
Licence No and<br>Date		0311018754/20/10/2022
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/May/202324/2dated12/05/2023against advance authorizationNo.0311009905dated30/12/2021, 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:-

UDIN00269027AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
Oral Polio Vaccine (OPV) with VVM	5000000.0	1	Monovalent Bulk for Poliomyelitis Type I665.5 Liters
	Numbers
		2	Monovalent Bulk for Poliomyelitis Type	423.5 Liters
			III
		3	Vaccine Vial (VVM)	5120000
				Numbers

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

|||| |||2|Monovalent Bulk for Poliomyelitis Type|423.5 Liters| ||||III|| |||3|Vaccine Vial (VVM)|5120000| |||||Numbers|

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

Case No.	172 / NC/3/MEET/Aug/202324/11
Case Status	Case Rejected
Party Name	LASENOR INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00004068AM23
RA File Number	50AX04000062 AM23
Licence No and<br>Date	5011000669/04/11/2022
Norms Committee Decision:
The committee considered the application of the firm and it has been observed that the firm has not appeared for personal
hearing before committee to explain their case, therefore, the committee decided to reject the application of the firm.

Case No.	173 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00004336AM23
RA File Number	05AX04002273 AM23
Licence No and<br>Date	0511015796/14/11/2022
Norms Committee Decision:
The case is under consideration for want of comments of TE.

Case No.	174 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED

UDIN00269027AM24

sideration for want of comments of TE.**||

Case No.	174 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED

UDIN00269027AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00004468AM23
RA File Number	34AX04000711 AM23
Licence No and<br>Date	3411003022/18/11/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing		<br>before
Norms Committee to explain its case.

Meeting Number	NC/ 3/ MEET/ Au/ 202324/ 11 and 22/08/2023
and Date	g
HQ File Number	HQRNORM APPLY 00004468AM23
RA File Number	34AX04000711 AM23
Licence No and	3411003022/18/11/2022
Date
Norms Committee	Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

Case No.	175 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	BIOLOGICAL E.

ing Norms Committee to explain its case.||||||Personal Hearing before|| ||||||||| |Case No.||175 / NC/3/MEET/Aug/202324/11|||||| |Case Status||Case Approved|||||| |Party Name||BIOLOGICAL E. LIMITED|||||| |Meeting Number ||NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023|||||| |and Date|||||||| |HQ File Number||HQRNORM APPLY 00004503AM23|||||| |RA File Number||09AX04000712 AM23|||||| |Licence No and||0911003988/21/11/2022|||||| |Date|||||||| |Norms Committee||Decision:|||||| |The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-|||||||| ||||||||| ||Export Pro|duct|Qty.|Sl. No.|Import Items||Qty.| ||||||||| ||||||||| ||TYPHOID C|ONJUGATE VACCINE| 10,00,000 vials|1 |GLASS VIALS||10,20,000| ||MONOVALEN WITH VACCIN|T 5 DOSE 2.5ML VIAL E VIAL MONITOR|||||Numbers| ||||||||| ||(VVM)|||2|RUBBER STOPPERS||10,20,000| |||||||| Numbers| ||||||||| |||||3|HEATMARKER VACCINE VIAL||1010000| |||||| MONITOR LABELS (VVM LABELS)||, Numbers| |||||4|SHIPPING INDICATORS (Q TAGS)||660 Numbers| |||||5|FILTERS & FILTER AIDS||21 Numbers| ||||||||| ||||||||| |RA|concerned may t|ake further necessary action as per above decision of NC.|||||| ||||||||| ||||||||| |||||||||

UDIN00269027AM24

|FILTERS & FILTER AIDS||21 Numbers| ||||||||| ||||||||| |RA|concerned may t|ake further necessary action as per above decision of NC.|||||| ||||||||| ||||||||| |||||||||

UDIN00269027AM24

Case No.<br>176 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Deferred
Party Name<br>BIOLOGICAL E. LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number<br>HQRNORM APPLY 00004512AM23
RA File Number<br>09AX04000684 AM23
Licence No and<br>Date<br>0911003996/21/11/2022
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:-
Details of steps involved in the manufacturing wastage at each steps of manufacturing.<br>1.
Justification of claiming 20% wastage.<br>2.
Batch manufacturing record and material reconciliation sheet duly signed by dealing executive/manager.<br>3.
DML (Drug manufacturing License)<br>4.

Case No.	177 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	INDO AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00001065AM24
RA File Number	03AX04004219 AM23
Licence No and<br>Date	0311019745/05/12/2022
Norms Committee Decision:
The case is under consideration for want of comments of TE.

REVIW00001065AM24| |RA File Number|03AX04004219 AM23| |Licence No and Date|0311019745/05/12/2022| |Norms Committee Decision:|| |The case is under consideration for want of comments of TE.||

Case No.	178 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00002179AM24
RA File Number	05AX04002676 AM23
Licence No and<br>Date	0511016292/12/12/2022
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:-

UDIN00269027AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
Mydrimax Eye Drops 5 ml	1 Number Vial	1	Tropicamide	40.8 mg / 5 ml vial
(Each ml containing 8 mg Tropicamide)

Case No.	179 / NC/3/MEET/Aug/202324/11
Case Status	Case Rejected
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004236AM24
RA File Number	03AX04004519 AM23
Licence No and<br>Date	0311020036/16/12/2022
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms andit was observed that the firm has not
provided any technical justification / information for enhancement.

ee Decision:|| |The Committee considered the request of firm for review of ad-hoc norms andit was observed that the firm has not|| |provided any technical justification / information for enhancement. Hence, it was decided torejectthe case|| |maintaining the status quo.|| |RA concerned may take further necessary action as per above decision of NC.||

Case No.	180 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	AURA PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00005276AM23
RA File Number	03AX04004700 AM23
Licence No and<br>Date	0311020263/26/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was		decided to fix	ad-hoc norms under Para 4.07 of HBP Vol. I as per
details given below or as applied by the firm, whichever is less:-
Export Product		Qty.	Sl. No.	Import Items	Qty.

s||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.||

Case No.	180 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	AURA PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00005276AM23
RA File Number	03AX04004700 AM23
Licence No and<br>Date	0311020263/26/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was		decided to fix	ad-hoc norms under Para 4.07 of HBP Vol. I as per
details given below or as applied by the firm, whichever is less:-
Export Product		Qty.	Sl. No.	Import Items	Qty.

UDIN00269027AM24

ARGYROL 0.5% / SILVER VITELLINATE NASAL	1 Number	1	SILVER VITELLINATE	51.00 mg.
DROPS 0.5 % w/v (EACH 10 ML CONTAINS 52 MG
OF SILVER VITELLINATE)
ARGYROL 1 % / SILVER VITELLINATE NASAL	1 Number	2	SILVER VITELLINATE	102.00 mg
DROPS 1 % w/v (EACH 10 ML CONTAINS 104 MG
OF SILVER VITELLINATE)

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

L|1 Number|2|SILVER VITELLINATE|102.00 mg| |DROPS 1 % w/v (EACH 10 ML CONTAINS 104 MG||||| |OF SILVER VITELLINATE)|||||

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

Case No.	181 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00005387AM23
RA File Number	05AX04002796 AM23
Licence No and<br>Date	0511016607/28/12/2022
Norms Committee Decision:
The case is under consideration for want of comments of TE.

Case No.<br>182 / NC/3/MEET/Aug/202324/11	Case No.<br>182 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Approved
Party Name<br>CENTRIENT PHARMACEUTICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number<br>HQRNORM APPLY 00005408AM23
RA File Number<br>30AX04000407 AM23
Licence No and<br>Date<br>3011002957/29/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per
details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty.
1<br>Atorvastatin Calcium<br>1 kg.	Thorase Enzyme	0.134 kg.

UDIN00269027AM24

or as applied by the firm, whichever is less:-|||| |Export Product Qty. Sl. No.|Import Items|Qty.|| |1 Atorvastatin Calcium 1 kg.|Thorase Enzyme|0.134 kg.||

UDIN00269027AM24

2	Chloroacetaldehyde SOL 45% CAA	0.81 kg.
3	Heptane	0.63 kg.
4	Iso Propyl Alcohol	3.40 kg.
5	2,2 Dimethoxy Propane	0.60 kg.

Case No.	Case No.	183 / NC/3/MEET/Aug/202324/11	183 / NC/3/MEET/Aug/202324/11	183 / NC/3/MEET/Aug/202324/11	183 / NC/3/MEET/Aug/202324/11	183 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		CENTRIENT PHARMACEUTICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM APPLY 00005440AM23
RA File Number		30AX04000435 AM23
Licence No and<br>Date		3011002966/30/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.

e case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 Thorase Enzyme 2230.0 kg 2 Chloroacetaldehyde SOL 45% CAA 13460.0 kg 3 Heptane S 10490.0 kg 4 2,2 Dimethoxy Propane 8700.0 kg 5 BTSH (2-Mercapto-I-H-Bezothiazole 8940.0 kg 6 Iso Propyl Alcohol 70560.0 kg Rosuvastatin Calcium 10000 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Rosuvastatin Calcium||10000 kg.|1|Thorase Enzyme|2230.0 kg| |||||2|Chloroacetaldehyde SOL 45% CAA|13460.0 kg| |||||3|Heptane S|10490.0 kg| |||||4|2,2 Dimethoxy Propane|8700.0 kg| |||||5|BTSH (2-Mercapto-I-H-Bezothiazole|8940.0 kg| |||||6|Iso Propyl Alcohol|70560.0 kg|

Case No.	Case No.	183 / NC/3/MEET/Aug/202324/11	183 / NC/3/MEET/Aug/202324/11	183 / NC/3/MEET/Aug/202324/11	183 / NC/3/MEET/Aug/202324/11	183 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		CENTRIENT PHARMACEUTICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM APPLY 00005440AM23
RA File Number		30AX04000435 AM23
Licence No and<br>Date		3011002966/30/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

|| |Licence No and Date||3011002966/30/12/2022||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 Thorase Enzyme 2230.0 kg 2 Chloroacetaldehyde SOL 45% CAA 13460.0 kg 3 Heptane S 10490.0 kg 4 2,2 Dimethoxy Propane 8700.0 kg 5 BTSH (2-Mercapto-I-H-Bezothiazole 8940.0 kg 6 Iso Propyl Alcohol 70560.0 kg Rosuvastatin Calcium 10000 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Rosuvastatin Calcium||10000 kg.|1|Thorase Enzyme|2230.0 kg| |||||2|Chloroacetaldehyde SOL 45% CAA|13460.0 kg| |||||3|Heptane S|10490.0 kg| |||||4|2,2 Dimethoxy Propane|8700.0 kg| |||||5|BTSH (2-Mercapto-I-H-Bezothiazole|8940.0 kg| |||||6|Iso Propyl Alcohol|70560.0 kg|

UDIN00269027AM24

7	Z8(RSV Side Chain) 4-(4-Fluorolphenyl)-6-Isopropyl -	13130.0 kg
	2(Nmethyl Sulfonyl amino)pyrimidinyl-5-yl-fomyl
8	2-Methyl Tetrahydrofuran	70520.0 kg
9	Furfurylamine	2850.0 kg

e Chain) 4-(4-Fluorolphenyl)-6-Isopropyl -|13130.0 kg| |---|---|---|---| |||2(Nmethyl Sulfonyl amino)pyrimidinyl-5-yl-fomyl|| ||8|2-Methyl Tetrahydrofuran|70520.0 kg| ||9|Furfurylamine|2850.0 kg|

Case No.	184 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00005442AM23
RA File Number	05AX04002802 AM23
Licence No and<br>Date	0511016635/30/12/2022
Norms Committee Decision:
The case is under consideration for want of comments of TE.

Case No.	185 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	SIDDHARTH CARBOCHEM PRODUCTS	LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00003327AM24
RA File Number	03AX04004857 AM23
Licence No and<br>Date	0311020368/30/12/2022
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.
METHYL SALICYLATE (MIN 99 PERCENT)		1 kg.	1	SALICYLIC ACID	1.1715 kg.
(PHENOL FREE)

UDIN00269027AM24

norms as under:-||||||| |Export Product||Qty.|Sl. No.|Import Items|Qty.|| |METHYL SALICYLATE (MIN 99 PERCENT)||1 kg.|1|SALICYLIC ACID|1.1715 kg.|| |(PHENOL FREE)|||||||

UDIN00269027AM24

Case No.<br>186 / NC/3/MEET/Aug/202324/11
Case Status<br>Case Approved
Party Name<br>ZENITH DYEINTERMEDIATES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number<br>HQRNORM APPLY 00005458AM23
RA File Number<br>03AX04004689 AM23
Licence No and<br>Date<br>0311020392/02/01/2023
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and on the basis			of information provided by the firm, it
was decided to revise ad-hoc norms as under:-
Export Product	Qty.	Sl. No.	Import Items	Qty.
NAS5((2-Diazo -1-Napthol-5-Sulfonic Acid, Sodium Salt))	999000 kg.	1	Tobias Acid	161638.0 kg.
RA concerned may take further necessary action as per above decision of NC.

ort Items|Qty.|| |NAS5((2-Diazo -1-Napthol-5-Sulfonic Acid, Sodium Salt))|999000 kg.|1|Tobias Acid|161638.0 kg.|| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	Case No.	187 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and	22/08/2023
HQ	File Number	HQRNORM APPLY 00005594AM23
RA File Number		07AX04001479 AM23
Licence No and<br>Date		0711006109/06/01/2023
Norms Committee Decision:
The Committee considered the request of firm for review of			ad-hoc norms and on the basis of information provided by the firm, it
was decided to revise ad-hoc norms as under:-
	Export Product			Qty.	Sl. No.	Import Items	Qty.

Case No.	Case No.	187 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and	22/08/2023
HQ	File Number	HQRNORM APPLY 00005594AM23
RA File Number		07AX04001479 AM23
Licence No and<br>Date		0711006109/06/01/2023
Norms Committee Decision:
The Committee considered the request of firm for review of			ad-hoc norms and on the basis of information provided by the firm, it
was decided to revise ad-hoc norms as under:-
	Export Product			Qty.	Sl. No.	Import Items	Qty.

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.||

UDIN00269027AM24

RA	Furosemide Injection 10mg/mL - 10mL Vial<br>(Furosemide Injection 10mg/mL-10mL Vial - filled with<br>100mg of furosemide as bulk drug mixed in water for<br>injection and filled in 10mL Vial and capped with 20mm<br>Bromobutyl Grey Rubber Stopper)	<br> <br>1 Numbers	1	S-127<br>4432/50/GREY<br>Westar? RS SIL 1(20mm<br>Grey Chlorobutyl Rubber<br>Stopper - RFS)	<br> <br> <br>Relevant as per<br>Packing Policy
	Rocuronium Bromide Injection 5mg/ml - 5mL Vial<br>(Rocuronium Bromide Injection 5mg/ml-5mL Vial -<br>Filled with 50mg of Rocuronium Bromide USP 10 mg<br>as bulk drug filled in 5mL vial and capped with 20mm<br>Bromobutyl Grey Rubber Stopper)	<br> <br> <br> <br>1 Numbers	2	S-127<br>4432/50/GREY<br>Westar? RS SIL 1(20mm<br>Grey Chlorobutyl Rubber<br>Stopper - RFS)	<br> <br> <br>Relevant as per<br>Packing Policy
	concerned may take further necessary action as per above decision of NC.

Case No.	188 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00005595AM23
RA File Number	07AX04001473 AM23
Licence No and<br>Date	0711006137/06/01/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00005595AM23| |RA File Number|07AX04001473 AM23| |Licence No and Date|0711006137/06/01/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	189 / NC/3/MEET/Aug/202324/11	189 / NC/3/MEET/Aug/202324/11	189 / NC/3/MEET/Aug/202324/11	189 / NC/3/MEET/Aug/202324/11	189 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		MACLEODS PHARMACEUTICALS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM REVIW00002168AM24
RA File Number		03AX04005022 AM23
Licence No and<br>Date		0311020561/09/01/2023
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 Vol. I as per<br>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.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

UDIN00269027AM24

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

UDIN00269027AM24


	Lamivudine 30<br>	0mg + Tenofovir disoproxil<br>	1 Number	1	(R)-3-AMINO-1-BUTANOL	19.635 mg.
	Fumarate 300m<br>50mg tablets(L	g + Dolutegravir Sodium<br>amivudine 300mg + Tenofovir

	<br>disoproxil Fum	<br>arate 300mg + Dolutegravir		2	1-(2,2-dimethoxyethyl)-5-	70.125 mg
	Sodium 50mg t<br>kgs Dolutegrav<br>	ablets (Net content: 3690.000<br>ir Sodium + 22140.000 kgs<br>			methoxy-6(methoxycarbonyl) 4-<br>oxo-1,4-dihydropyridine-3-<br>
	Tenofovir Diso<br>kgs Lamivudin	proxil Fumarate + 22140.000<br>e))			carboxylic acid

				3	(R)-9-(2-phosphonomethoxy<br>propyl)-adenine	205.02 mg
4<br>LAMIVUDINE<br>306.00 mg<br>RA concerned may take further necessary action as per above decision of NC.
				4	LAMIVUDINE	306.00 mg

-(2-phosphonomethoxy propyl)-adenine|205.02 mg| |4 LAMIVUDINE 306.00 mg RA concerned may take further necessary action as per above decision of NC.||||||| |||||4|LAMIVUDINE|306.00 mg|

Case No.	Case No.	190 / NC/3/MEET/Aug/202324/11	190 / NC/3/MEET/Aug/202324/11	190 / NC/3/MEET/Aug/202324/11	190 / NC/3/MEET/Aug/202324/11	190 / NC/3/MEET/Aug/202324/11	190 / NC/3/MEET/Aug/202324/11	190 / NC/3/MEET/Aug/202324/11	190 / NC/3/MEET/Aug/202324/11	190 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		MICRO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM APPLY 00005741AM23
RA File Number		07AX04001550 AM23
Licence No and<br>Date		0711006194/16/01/2023
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 Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.

se as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. LISINOPRIL 2.5MG TABLETS(LISINOPRIL 2.5MG TABLETS 7.50 KG) 1 Number 1 LISINOPRIL DIHYDRATE BP/EP/IP/USP 2.55 mg/tablet LISINOPRIL 5MG TABLETS(LISINOPRIL 5MG TABLETS 30 KG) 1 Number 2 LISINOPRIL DIHYDRATE BP/EP/IP/USP 5.10 mg/tablet LISINOPRIL 10 MG TABLETS(LISINOPRIL 10 MG TABLETS - 130 KG) 1 Number 3 LISINOPRIL DIHYDRATE BP/EP/IP/USP 10.2 mg/tablet LISINOPRIL 20MG TABLETS(LISINOPRIL 20MG TABLETS - 240 KG) 1 Number 4 LISINOPRIL DIHYDRATE BP/EP/IP/USP 20.4 mg/tablet||||||||||| ||Export Product|||Q|ty.||Sl. No.|Import Items|Qty.|| |||||||||||| ||LISINOPRIL 2.5MG TABLETS(LISINOPRIL 2.5 7.50 KG)||MG TABLETS| 1|Number||1|LISINOPRIL DIHYDRATE BP/EP/IP/USP|2.5|5 mg/tablet| |||||||||||| ||LISINOPRIL 5MG TABLETS(LISINOPRIL 5MG KG)||TABLETS 30| 1|Number||2|LISINOPRIL DIHYDRATE BP/EP/IP/USP|5.1|0 mg/tablet| ||LISINOPRIL 10 MG TABLETS(LISINOPRIL 10 130 KG)||MG TABLETS -| 1||||LISINOPRIL DIHYDRATE||| ||||||Number||3| BP/EP/IP/USP|10.|mg/tablet| ||LISINOPRIL 20MG TABLETS(LISINOPRIL 20M 240 KG)||G TABLETS -| 1|Number||4|LISINOPRIL DIHYDRATE|20.|4 mg/tablet| |||||||||BP/EP/IP/USP||| ||||||||||||

UDIN00269027AM24

|mg/tablet| ||LISINOPRIL 20MG TABLETS(LISINOPRIL 20M 240 KG)||G TABLETS -| 1|Number||4|LISINOPRIL DIHYDRATE|20.|4 mg/tablet| |||||||||BP/EP/IP/USP||| ||||||||||||

UDIN00269027AM24

Case No.	191 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004701AM24
RA File Number	07AX04001546 AM23
Licence No and<br>Date	0711006197/16/01/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	192 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00005768AM23
RA File Number	05AX04003041 AM23
Licence No and<br>Date	0511016882/17/01/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	193 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	CLARIANT INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004661AM24
RA File Number	03AX04005405 AM23
Licence No and<br>Date	0311021129/03/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case.		Personal Hearing<br>before

Case No. 194 / NC/3/MEET/Aug/202324/11

d the case as per agenda and it was decided to call the firm for attending Norms Committee to explain its case.||Personal Hearing before|

Case No. 194 / NC/3/MEET/Aug/202324/11

UDIN00269027AM24

Case Status	Case Status	Case Approved	Case Approved	Case Approved
Party Name		PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM APPLY 00006286AM23
RA File Number		03AX04005525 AM23
Licence No and
Date		0311021390/13/02/2023
Norms Committee<br>		Decision:<br>
The Committee con<br>in meetingNo NC/		sidered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>3/MEET/Dec/202223/17dated 13/01/2023against advance authorizationNo0311017097dated 11/08/2022
.<br>it was decided to fix		. ,<br>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.

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.|| ||Bempedoic Acid and Ezetimibe Fixed Dose Combination Tbl Eh Tbl Bdi Aid 180 d||||1 Number||1||Bempedoic Acid|189.90 mg.|| ||aets (ac aet content empeoc c mg an Ezetimibe 10mg(Net content of Bempedoic Acid 3492 kg and Ezetimibe 194 kg in total Export Qty) (AA for Free of ||||||||||| ||||||||2||Ezetimibe|1|0.55 mg.| ||cost material as per Para 4.11 of HBP & Para 4.19 of FTP & RBI Master Circular C-26 Disallowing remittances for material being supplied free of cost.)||||||||||| ||Note:The above norms are valid only for subject to fulfillmen Export Product being Patented Medicine, be filed 1. Ert t USA nd Er nl 2|||t of following with USFDA a|||||||| |||||||condition s an NDA||s:- (New Drug Application|||)| ||xpo o a uope oy. . Firm holding Certificate of Manufacturing Exclusivity. 3.||||||||||| ||||||||||||| |RA|concerned may take further necessary action as per above decision of NC.||||||||||| ||||||||||||| ||||||||||||| |Case No.||195 / N|C/3/MEET/Aug/202324/11||||||||| |Case Status||Case A|pproved||||||||| |Party Name||BELC|HEM INDUSTRIES (INDIA) PVT LTD||||||||| |Meeting Number||NC/ 3/|MEET/ A/ 202324/ 11 and 22/08/2023||||||||| |and Date|||ug||||||||| |HQ File Number||HQRN|ORM APPLY 00006352AM23||||||||| |RA File Number||03AX04005586 AM23||||||||||

|||||||| |Meeting Number||NC/ 3/|MEET/ A/ 202324/ 11 and 22/08/2023||||||||| |and Date|||ug||||||||| |HQ File Number||HQRN|ORM APPLY 00006352AM23||||||||| |RA File Number||03AX04005586 AM23|||||||||| |Licence No and Date||0311021482/16/02/2023|||||||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per|||||||||||| |||||||||||||

Case No.	195 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	BELCHEM INDUSTRIES (INDIA) PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00006352AM23
RA File Number	03AX04005586 AM23
Licence No and<br>Date	0311021482/16/02/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per

UDIN00269027AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
BELGUARD PBSA<br>(Phenylbenzimidazole Sulfonic Acid)	1 kg.	1	Ortho Phenylene Diamine	0.4925 kg.

firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.
BELGUARD PBSA<br>(Phenylbenzimidazole Sulfonic Acid)	1 kg.	1	Ortho Phenylene Diamine	0.4925 kg.

Case No.	Case No.	196 / NC/3/MEET/Aug/202324/11	196 / NC/3/MEET/Aug/202324/11	196 / NC/3/MEET/Aug/202324/11	196 / NC/3/MEET/Aug/202324/11	196 / NC/3/MEET/Aug/202324/11
Case Status		Case Approved
Party Name		SALICYLATES & CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number		HQRNORM APPLY 00006401AM23
RA File Number		09AX04001029 AM23
Licence No and<br>Date		0911004487/17/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>ORTHO PHENYLENEDIAMINE<br>0.55 kg.<br>SALISOL HS (PBSA) / Ensulizole<br>(2-Phenylbenzimidazole-5-sulfonic acid)<br>1 kg.<br>2<br>BENZALDEHYDE<br>0.545 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	SALISOL HS (PBSA) / Ensulizole<br>(2-Phenylbenzimidazole-5-sulfonic acid)		1 kg.	1	ORTHO PHENYLENEDIAMINE	0.55 kg.
				2	BENZALDEHYDE	0.545 kg.
	concerned may take further necessary action as per above decision of NC.

br>(2-Phenylbenzimidazole-5-sulfonic acid)||1 kg.|1|ORTHO PHENYLENEDIAMINE|0.55 kg.| |||||2|BENZALDEHYDE|0.545 kg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	197 / NC/3/MEET/Aug/202324/11
Case Status	Case Approved
Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM REVIW00004527AM24

UDIN00269027AM24

RA File Number	03AX04005710 AM23
Licence No and<br>Date	0311021583/24/02/2023
Norms Committee Decision:
The Committee considered the case as per agenda		and it was decided to fix		ad-hoc norms under Para 4.07 of HBP Vol. I as per
details given below or as applied by the firm, whichever is less:-
Export Product		Qty.	Sl. No.	Import Items	Qty.
Lamivudine 300mg + Tenofovir disoproxil		1 Number	1	(R)-3-AMINO-1-BUTANOL	19.635 mg.
Fumarate 300mg + Dolutegravir Sodium 50mg
tablets(Lamivudine 300mg + Tenofovir
disoproxil Fumarate 300mg + Dolutegravir			2	1-(2,2-dimethoxyethyl)-5-	70.125 mg
Sodium 50mg tablets (Net content: 5400.000				methoxy-6(methoxycarbonyl) 4-
kgs Dolutegravir Sodium + 32400.000 kgs				oxo-1,4-dihydropyridine-3-
Tenofovir Disoproxil Fumarate + 32400.000				carboxylic acid
kgs Lamivudine))
			3	(R)-9-(2-phosphonomethoxy	205.02 mg
				propyl)-adenine
			4	LAMIVUDINE	306.00 mg
RA concerned may take further necessary action as per above decision of NC.

vudine))||||||| ||||3|(R)-9-(2-phosphonomethoxy|205.02 mg|| |||||propyl)-adenine||| ||||4|LAMIVUDINE|306.00 mg|| |RA concerned may take further necessary action as per above decision of NC.|||||||

Case No.	198 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	SIDDHARTH CARBOCHEM PRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00006742AM23
RA File Number	03AX04005555 AM23
Licence No and<br>Date	0311021882/03/03/2023
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:-
Copy of Shipping Bill and Bill of Entry.<br>1.
Production/Consumption data for last year duly certified by GST.<br>2.
Quantity and value of By-Product obtained with copy of invoice.<br>3.

UDIN00269027AM24

Case No.	199 / NC/3/MEET/Aug/202324/11
Case Status	Case Deferred
Party Name	ANUH PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number	HQRNORM APPLY 00006763AM23
RA File Number	03AX04005850 AM23
Licence No and<br>Date	0311021914/06/03/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00006763AM23| |RA File Number|03AX04005850 AM23| |Licence No and Date|0311021914/06/03/2023| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.<br>	Case No.<br>	200 / NC/3/MEET/Aug/202324/11	200 / NC/3/MEET/Aug/202324/11	200 / NC/3/MEET/Aug/202324/11
Case Status<br>		Case Approved
Party Name<br>		AUROBINDO PHARMA LTD
Meeting Number<br>and Date<br>		NC/ 3/ MEET/ Aug/ 202324/ 11 and 22/08/2023
HQ File Number<br>		HQRNORM APPLY 00006808AM23
RA File Number<br>		09AX04001078 AM23
Licence No and<br>Date<br>		0911004655/08/03/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>Allylamine<br>0.9467 kg.<br>2<br>2,2'-Azobis(2-Methylpropionamidine)<br>Dihydrochloride(AAPH)<br>0.0368 kg.<br>3<br>Methanol<br>2.74 kg.<br>SEVELAMER CARBONATE<br>1 kg.<br>4<br>Epichlorohydrin<br>0.116 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl.

hanol 2.74 kg. SEVELAMER CARBONATE 1 kg. 4 Epichlorohydrin 0.116 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||SEVELAMER CARBONATE||1 kg.|1|Allylamine|0.9467 kg.| |||||2|2,2'-Azobis(2-Methylpropionamidine) Dihydrochloride(AAPH)|0.0368 kg.| |||||3|Methanol|2.74 kg.| |||||4|Epichlorohydrin|0.116 kg.| ||concerned may take further necessary action as|||per above decision of NC.|||

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