IN FORCE Advance Authorisation

DGFT Minutes

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Government of India / भारत सरकार

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

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

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Jun/202324/8 DATED: 30/06/2023

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/Jun/202324/8 dated 30/06/2023 of Norms Committee - III for the year 2023-24 was held on 30/06/2023 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 03-08-2023 17:56:08.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	SOMERSET THERAPEUTICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00006933AM23
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<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Cyanocobalamin Vitamin<br>B12 crystalline<br>7461.60 gm.<br>2<br>13MM 4432/50 B2-42<br>GRY CHL/R/S WESTAR<br>RUBBERS STOPPERS<br>Relevant as per<br>packing policy<br>Cyanocobalamin Injection USP<br>1000mcg/mL - 1mL (Preparation<br>of Vitamins - of Vitamin B12)<br>6783275.0 Vials<br>3<br>13 MM YELLOW<br>COLOURED FLIP OFF<br>ALUMINIUM SEALS<br>Relevant as per<br>packing policy<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	2 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007124AM23
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:

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nd Date|NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023| |HQ File Number|HQRNORM APPLY 00007124AM23| |RA File Number|NA| |Licence No and Date|NA| |Norms Committee Decision:||

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The Committee considered the request of firm for fixation of ad-hoc norms against Advance Authorization No. 0910062554 dated 04.09.2015 having RA F. No. 09/24/040/00323/AM16 and it was decided to fix adhoc 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.
Sofosbuvir	1 kg.	1	2-Deoxy-2-fluoro-2-C-methyluridine (or) 1-	0.625 kg.
			[(2R 3R 4R 5R)-3-fluoro-4-hydroxy-5-
			(hydroxymethyl)-3-methy
			ltetrahydrofuran-2-yl]pyrimidine-2 4(1H 3H)-
			dione (2-deoxy-2-fluoro-2-C-methyluridine)
		2	L-Alanine Isopropyl Ester Hydro Chloride	1.687 kg.
		3	Phenyl Diclorophosphate	1.50 kg.
		4	Penta Fluorophenol	1.16 kg.

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

ine Isopropyl Ester Hydro Chloride|1.687 kg.| |||3|Phenyl Diclorophosphate|1.50 kg.| |||4|Penta Fluorophenol|1.16 kg.|

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

Case No.<br>3 / NC/3/MEET/Jun/202324/8
Case Status<br>Case Approved
Party Name<br>OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number<br>HQRNORM APPLY 00007125AM23
RA File Number<br>NA
Licence No and<br>Date<br>NA
Norms Committee Decision:
The Committee considered the request of firm for fixation of ad-hoc norms against Advance Authorization No. 0910063875
dated 30.06.2016 having RA F. No. 09/24/040/00143/AM17 and it was decided to fix adhoc 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.
2-Deoxy-2-Fluoro-2-C-Methyluridine (or) (2R)-2-<br>Sofosbuvir<br>1 kg.<br>1	0.625 kg

or as applied by the firm, whichever is less: -||| |Export Product Qty. Sl. No. Import Items|Qty.|| |2-Deoxy-2-Fluoro-2-C-Methyluridine (or) (2R)-2- Sofosbuvir 1 kg. 1|0.625 kg||

Case No.<br>3 / NC/3/MEET/Jun/202324/8
Case Status<br>Case Approved
Party Name<br>OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number<br>HQRNORM APPLY 00007125AM23
RA File Number<br>NA
Licence No and<br>Date<br>NA
Norms Committee Decision:
The Committee considered the request of firm for fixation of ad-hoc norms against Advance Authorization No. 0910063875
dated 30.06.2016 having RA F. No. 09/24/040/00143/AM17 and it was decided to fix adhoc 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.
2-Deoxy-2-Fluoro-2-C-Methyluridine (or) (2R)-2-<br>Sofosbuvir<br>1 kg.<br>1	0.625 kg

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	Deoxy-2-Fluoro-2-Methyluridine
2	N-[(S)-(2,3,4,5,6-Pentafluorophenoxy) Phenoxy	1.50 kg.
	Phosphinyl]-L-alanine 1-Methylethyl Ester (OR)
	propan-2-y(2S)-2-{[pentafluorophenoxy)
	(phenoxy)phosphory1]amino} propanoate.

N-[(S)-(2,3,4,5,6-Pentafluorophenoxy) Phenoxy|1.50 kg.| |||Phosphinyl]-L-alanine 1-Methylethyl Ester (OR)|| |||propan-2-y(2S)-2-{[pentafluorophenoxy)|| |||(phenoxy)phosphory1]amino} propanoate.||

Deoxy-2-Fluoro-2-Methyluridine<br>2<br>N-[(S)-(2,3,4,5,6-Pentafluorophenoxy) Phenoxy<br>Phosphinyl]-L-alanine 1-Methylethyl Ester (OR)<br>propan-2-y(2S)-2-{[pentafluorophenoxy)<br>(phenoxy)phosphory1]amino} propanoate.<br>1.50 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Deoxy-2-Fluoro-2-Methyluridine<br>2<br>N-[(S)-(2,3,4,5,6-Pentafluorophenoxy) Phenoxy<br>Phosphinyl]-L-alanine 1-Methylethyl Ester (OR)<br>propan-2-y(2S)-2-{[pentafluorophenoxy)<br>(phenoxy)phosphory1]amino} propanoate.<br>1.50 kg.<br>RA concerned may take further necessary action as per above decision of NC.					Deoxy-2-Fluoro-2-Methyluridine	Deoxy-2-Fluoro-2-Methyluridine
				2		N-[(S)-(2,3,4,5,6-Pentafluorophenoxy) Phenoxy<br>Phosphinyl]-L-alanine 1-Methylethyl Ester (OR)<br>		1.50 kg.
	A					propan-2-y(2S)-2-{[pentafluorophenoxy)<br>(phenoxy)phosphory1]amino} propanoate.
		d k fh i			b dii		f
	concern	may tae urter necessary act			n as per aove ecson		o NC.

C	ase No.		4 / NC/3/MEET/Jun/202324		/8
C	ase Status		Case Approved
P	arty Name		CLEAN SCIENCE AND T		ECHNOLOGY LIMITE		D
M<br>a

o NC.|||| ||||||||||||||| |C|ase No.|||4 / NC/3/MEET/Jun/202324|||/8||||||| |C|ase Status|||Case Approved|||||||||| |P|arty Name|||CLEAN SCIENCE AND T|||ECHNOLOGY LIMITE|||D|||| |M a|||||||||||||| ||eeting Num nd Date||ber|NC/ 3/ MEET/ Jun/ 202324/|||8 and 30/06/2023||||||| |H|Q File Num||ber|HQRNORM APPLY 00000|||483AM24||||||| |R|A File Num||ber|NA|||||||||| ||||||||||||||| |L D|icence No a ate||nd|3110067929/20/11/2020|||||||||| |Norms Committee Decision: Committee considered the case as per agenda and it was decided to fi as per details given below or as applied by the firm, whichever is less: Export Product Qty. Sl. No. 1 1,3-Dicyclo Hexyl Carbodimide (DCC) 1 kg.|orms Com ||mittee Decision: ||||||||||| ||ommittee s per detail||considered the case as per agenda s given below or as applied by the||||and it was decided to f firm, whichever is less:|||x ad-hoc norms under P -|ara 4.07 of HBP Vol. I||| ||||||||||||||| ||||||||||||||| |||Export Product||||||Qty.|Sl. No.|Import Items||Qty.|| |||1,3-Dicyclo Hexyl Carbodimide (DCC)||||||1 kg.|1|Cyclohexylamine (CHA)||1.41 kg.|| ||||||||||||||| ||||||||||2|Idi||0013|| |||||||||||one||.|| ||||||||||||||| ||||||||||3|Methanol||0.08 kg.|| ||||||||||||||| ||||||||||4|Phosphorus Qxy Chloride||1.49 kg.|| ||||||||||||||| ||||||||||||||| ||||||||||5|Ammonia||0.72 kg.|| ||||||||||||||| |RA concerned may take further necessary action as per above decision of NC.|||||||||||||| |||||||||||||||

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| ||||||||||||||| ||||||||||5|Ammonia||0.72 kg.|| ||||||||||||||| |RA concerned may take further necessary action as per above decision of NC.|||||||||||||| |||||||||||||||

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Case No.	5 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	SALICYLATES & CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00006995AM23
RA File Number	NA
Licence No and<br>Date	0911004487/17/02/2023
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:-
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.
Stoichiometric balance between import and export on molar basis.<br>iv.
Details of indigenous input with quantity.<br>v.
Sample of shipping bills and bill of entry of the export products along with statement of Input-output as<br>vi.
per export documents of the said authorization.

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

documents of the said authorization.**||

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

Case No.	6 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	SALICYLATES & CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007000AM23
RA File Number	NA
Licence No and<br>Date	0911004488/17/02/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-
Step wise manufacturing process.<br>i.
Compete chemical reactions with molecular and structural formula and molecular weights along with<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.
Stoichiometric balance between import and export on molar basis.<br>iv.
Details of indigenous input with quantity.<br>v.
Sample of shipping bills and bill of entry of the export products along with statement of Input-output as<br>vi.
per export	documents of the said authorization.

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

documents of the said authorization.|

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

Case No.	7 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	LYRUS LIFE SCIENCES PRIVATE LIMITED

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Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00000932AM24
RA File Number		NA
Licence No and<br>Date		0711006647/07/03/2023
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.<br>Import Items<br>Qty.<br>NITROFURANTOIN ORAL<br>SUSPENSION 1.5G/300ML<br>1 Number<br>1<br>Nitrofurantoin monohydrate<br>1.575 gm<br>NITROFURANTOIN ORAL<br>SUSPENSION 3G/300ML<br>1 Number<br>2<br>Nitrofurantoin monohydrate<br>3.15 gm<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl.

ORAL SUSPENSION 3G/300ML 1 Number 2 Nitrofurantoin monohydrate 3.15 gm RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||NITROFURANTOIN ORAL SUSPENSION 1.5G/300ML||1 Number|1|Nitrofurantoin monohydrate|1.575 gm| ||NITROFURANTOIN ORAL SUSPENSION 3G/300ML||1 Number|2|Nitrofurantoin monohydrate|3.15 gm| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	Case No.	8 / NC/3/MEET/Jun/202324/8	8 / NC/3/MEET/Jun/202324/8	8 / NC/3/MEET/Jun/202324/8	8 / NC/3/MEET/Jun/202324/8	8 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		LYRUS LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00000943AM24
RA File Number		NA
Licence No and<br>Date		0711006648/07/03/2023
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/202223/24dated13/04/2023against advance authorizationNo.0311016795dated02/08/2022,<br>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<br>is less:-<br>Export Product<br>Qty.<br>Sl.

*dated02/08/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. ALVERINE CITRATE 60MG CAPSULES STOMACH PAIN & CRAMPS 1 Number 1 ALVERINE CITRATE 61.20 mg / Capsule||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||ALVERINE CITRATE 60MG CAPSULES STOMACH PAIN & CRAMPS|| 1 Number|1|ALVERINE CITRATE|61.20 mg / Capsule|

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RELIEF(ALVERIN	CITRATE	60MG
CAPSULES NLS P -	STOMACH	PAIN &
CRAMPS RELIEF 100's)
ALVERINE CITRATE	120MG CAPSULES		<br>1 Number	2	ALVERINE CITRATE	122.40 mg / Capsule
STOMACH<br>PAIN	&	CRAMPS
RELIEF(ALVERIN	CITRATE	120MG
CAPSULES NLS P -	STOMACH	PAIN &
CRAMPS RELIEF 60's)

RELIEF(ALVERIN<br>CITRATE<br>60MG<br>CAPSULES NLS P - STOMACH PAIN &<br>CRAMPS RELIEF 100's)	<br>
ALVERINE CITRATE 120MG CAPSULES<br>STOMACH<br>PAIN<br>&<br>CRAMPS<br>RELIEF(ALVERIN<br>CITRATE<br>120MG	<br> <br> <br>1 Number	2	ALVERINE CITRATE	122.40 mg / Capsule
<br>CAPSULES NLS P - STOMACH PAIN &<br>CRAMPS RELIEF 60's)
concerned may take further necessary action a	s per above de

1 Number|2|||ALVERINE CITRATE|122.40 mg / Capsule||| ||| CAPSULES NLS P - STOMACH PAIN & CRAMPS RELIEF 60's)||||||||||| |||concerned may take further necessary action a|||s per above de|||||||| |||||||cision of NC.||||||| |||||||||||||| |Case No.|||9 / NC/3/MEET/Jun/202324/8|||||||||| |Case Status|||Case Approved|||||||||| |Party Name|||INTAS PHARMACEUTICALS LIMITED|||||||||| |||||||||||||| |Meeting Number d|||NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023|||||||||| |an Date||||||||||||| |H Fil Nb|||HRNORM APPLY 00006903AM23|||||||||| |Q e umer|||Q|||||||||| |RA Fil Nb|||08AX04001994 AM23|||||||||| |e umer||||||||||||| |Li N d||||||||||||| |cence o an Date|||0811007523/10/03/2023|||||||||| |N Ci|||ii|||||||||| |orms ommttee|||ecson:|||||||||| |The Committee co|||nsidered 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 be|||low or as applied by the firm, whichever is less:-|||||||||| |||||||||||||| |||Export Product|||Qty.|Sl. No.|Import Items|||Qty.||| |||ENALAPRIL MALEATE TABLETS USP 5 MG(EACH UNCOATED TABLET|||1 Number|1|ENALAPRIL MALEATE|||5.1 mg / 5 mg tablet||| ||| CONTAINS: ENALAPRIL MALEATE USP 5 MG)|||||EP /|BP / IP / USP / PH. EUR||||| |||||||||||||| |||ENALAPRIL MALEATE TABLETS USP 10 MG(EACH UNCOATED TABLET CONTAINS: ENALAPRIL MALEATE USP 10 MG)|||1 Number|2|ENA|LAPRIL MALEATE||10.2 bl|mg / 10 mg.|| ||||||||EP /|BP / IP / USP / PH.

|||ENALAPRIL MALEATE TABLETS USP 10 MG(EACH UNCOATED TABLET CONTAINS: ENALAPRIL MALEATE USP 10 MG)|||1 Number|2|ENA|LAPRIL MALEATE||10.2 bl|mg / 10 mg.|| ||||||||EP /|BP / IP / USP / PH. EUR||taet||| |||||||||||||| |||ENALAPRIL MALEATE TABLETS USP 20 MG(EACH UNCOATED TABLET CONTAINS: ENALAPRIL MALEATE USP 20 MG [IN WHICH ACTIVE INGREDIENT ||| 1 Number|3|ENALAPRIL MALEATE EP / BP / IP / USP / PH. EUR|||20.4 mg / 20 mg tablet||| |||ENALAPRIL MALEATE USED IS 274.000||||||||||| |||||||||||||| ||||||||||||||

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KGS.])

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

Case No.	10 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	NICHINO INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00006905AM23
RA File Number	09AX04001098 AM23
Licence No and<br>Date	0911004668/10/03/2023
Norms Committee Decision:<br>The case is under consideration for want of comments ofTE. Also, sample shipping bills and bill of entry of the<br>export products and statement of export import of the Authorization.

br>The case is under consideration for want of comments ofTE. Also, sample shipping bills and bill of entry of the export products and statement of export import of the Authorization.||

Case No.	11 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	MAHIMA LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00006908AM23
RA File Number	05AX04003427 AM23
Licence No and<br>Date	0511017696/10/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>No technical details available.<br>1.<br>Complete chemical reactions, Molecular Weight and percentage yield on molar basis for entire process.<br>2.<br>Also, sample shipping bills and bill of entry of the export products and statement of export import of the<br>Authorization.<br>3.

Case No.	12 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00006909AM23
RA File Number	08AX04001977 AM23

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Licence No and 0811007532/10/03/2023 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:-

ion:

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

|Export Product|Qty.|Sl. No.|Import Items|Qty.|
|---|---|---|---|---|
|Formulated Aromatic Amine 1|1 kg.|1|Aniline|0.683 kg.|
|||2|Di Ethyl Toluene Diamine | Ethacure 100 ||0.118 kg.|
||||Lonzacure DETDA 80 | DETDA 80 |||
||||DETDA||
|||3|Iso Phoron Diamine|0.101 kg.|

Case No.<br>13 / NC/3/MEET/Jun/202324/8	Case No.<br>13 / NC/3/MEET/Jun/202324/8
Case Status<br>Case Approved
Party Name<br>INTAS PHARMACEUTICALS LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number<br>HQRNORM APPLY 00006910AM23
RA File Number<br>08AX04002018 AM23
Licence No and Date<br>0811007534/10/03/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product
in meeting No.NC/3/MEET/Apr/202324/1dated28/04/2023against advance authorizationNo.0811006675dated07/12/2022, it
was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by				the firm, whichever is
less:-
Export Product	Qty.	Sl. No.	Import Items	Qty.
NALTREXONE HYDROCHLORIDE	1 Number	1	NALTREXONE	51.93 mg/tablet
TABLETS USP 50 MG(EACH			HYDROCHLORIDE EP / BP
UNCOATED TABLET CONTAINS:			/ IP / USP / PH.

uct|Qty.|Sl. No.|Import Items|Qty.|| |NALTREXONE HYDROCHLORIDE|1 Number|1|NALTREXONE|51.93 mg/tablet|| |TABLETS USP 50 MG(EACH|||HYDROCHLORIDE EP / BP||| |UNCOATED TABLET CONTAINS:|||/ IP / USP / PH. EUR (All||| |NALTREXONE HYDROCHLORIDE USP|||Alcoholic Solvents and water||| |50 MG [IN WHICH ACTIVE|||content NLT 1.86% as per|||

Case No.<br>13 / NC/3/MEET/Jun/202324/8	Case No.<br>13 / NC/3/MEET/Jun/202324/8
Case Status<br>Case Approved
Party Name<br>INTAS PHARMACEUTICALS LIMITED
Meeting Number and<br>Date<br>NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number<br>HQRNORM APPLY 00006910AM23
RA File Number<br>08AX04002018 AM23
Licence No and Date<br>0811007534/10/03/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product
in meeting No.NC/3/MEET/Apr/202324/1dated28/04/2023against advance authorizationNo.0811006675dated07/12/2022, it
was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by				the firm, whichever is
less:-
Export Product	Qty.	Sl. No.	Import Items	Qty.
NALTREXONE HYDROCHLORIDE	1 Number	1	NALTREXONE	51.93 mg/tablet
TABLETS USP 50 MG(EACH			HYDROCHLORIDE EP / BP
UNCOATED TABLET CONTAINS:			/ IP / USP / PH. EUR (All
NALTREXONE HYDROCHLORIDE USP			Alcoholic Solvents and water
50 MG [IN WHICH ACTIVE			content NLT 1.86% as per

UDIN00204730AM24

COATED TABLET CONTAINS:|||/ IP / USP / PH. EUR (All||| |NALTREXONE HYDROCHLORIDE USP|||Alcoholic Solvents and water||| |50 MG [IN WHICH ACTIVE|||content NLT 1.86% as per|||

UDIN00204730AM24

INGREDIENT NALTREXONE			COA of Import item).
HYDROCHLORIDE USED IS
379.500 KGS.])

Case No.<br>14 / NC/3/MEET/Jun/202324/8
Case Status<br>Case Deferred
Party Name<br>CANPEX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number<br>HQRNORM APPLY 00006911AM23
RA File Number<br>31AX04000365 AM23
Licence No and<br>Date<br>3111002080/10/03/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-
CoA report of calcium cyanamide.<br>1.
Also, sample shipping bills and bill of entry of the export products and statement of export import of the<br>2.
Authorization.

the firm:-| |CoA report of calcium cyanamide. 1.| |Also, sample shipping bills and bill of entry of the export products and statement of export import of the 2.| |Authorization.|

Case No.	15 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	KusuMa PharMa
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00006918AM23
RA File Number	03AX04005815 AM23
Licence No and<br>Date	0311022080/11/03/2023
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.
SODIUM SACCHARIN (PURE DENTAL GRADE)		10000 kg.	1	SODIUM	10000 kg.
				SACCHARIN

UDIN00204730AM24

irm, whichever is less:-||||||| |Export Product||Qty.|Sl. No.|Import Items|Qty.|| |SODIUM SACCHARIN (PURE DENTAL GRADE)||10000 kg.|1|SODIUM|10000 kg.|| |||||SACCHARIN|||

UDIN00204730AM24

Case No.<br>16 / NC/3/MEET/Jun/202324/8
Case Status<br>Case Deferred
Party Name<br>NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number<br>HQRNORM APPLY 00006922AM23
RA File Number<br>03AX04005933 AM23
Licence No and<br>Date<br>0311022084/11/03/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-
Molecular weight of finished product.<br>1.
Percentage yield at different stage.<br>2.
Justification of low yield of 59.3% (overall).<br>3.
Justification for import of solvent as per process all the solvent are recovered.<br>4.
Also, sample shipping bills and bill of entry of the export products and statement of export import of the<br>5.
Authorization.

t as per process all the solvent are recovered**. 4.| |Also, sample shipping bills and bill of entry of the export products and statement of export import of the 5.| |Authorization.|

Case No.	17 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	BELCHEM INDUSTRIES (INDIA) PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00006926AM23
RA File Number	03AX04005865 AM23
Licence No and<br>Date	0311022096/13/03/2023
Norms Committee Decision:
The case is under	consideration for want for comments of TE. Also, sample shipping bills and bill of entry of the
export products and statement of export import of the Authorization.

Case No.	18 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	BELCHEM INDUSTRIES (INDIA) PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00006927AM23
RA File Number	03AX04005864 AM23

UDIN00204730AM24

Licence No and 0311022097/13/03/2023 Date Norms Committee Decision: The case is under consideration for want for comments of TE. Also, sample shipping bills and bill of entry of the export products and statement of export import of the Authorization.

Decision: The case is under consideration for want for comments of TE. Also, sample shipping bills and bill of entry of the export products and statement of export import of the Authorization.

Case No.	19 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00006951AM23
RA File Number	08AX04002097 AM23
Licence No and<br>Date	0811007554/14/03/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the<br>export products and statement of export import of the Authorization.

Case No.	20 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00006953AM23
RA File Number	34AX04001113 AM23
Licence No and<br>Date	3411003468/14/03/2023
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.<br>Import Items<br>Qty.<br>Fulvestrant Injection 250 mg / 5 ML<br>(50mg/ML)(Fulvestrant Injection 250 mg / 5<br>ML (50mg/ML) (Net content of active<br>ingredients 19.192 kgs ))<br>One 5 ml.

r>Sl. No. Import Items Qty. Fulvestrant Injection 250 mg / 5 ML (50mg/ML)(Fulvestrant Injection 250 mg / 5 ML (50mg/ML) (Net content of active ingredients 19.192 kgs )) One 5 ml. Prefilled Syringe 1 Fulvestrant USP 262.349 mg/vial RA concerned may take further necessary action as per above decision of NC.||

UDIN00204730AM24

Case No.	Case No.	21 / NC/3/MEET/Jun/202324/8	21 / NC/3/MEET/Jun/202324/8	21 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00006960AM23
RA File Number		05AX04003321 AM23
Licence No and<br>Date		0511017736/14/03/2023
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/Apr/202324/1dated28.04.2023against advance authorizationNo.0510415575dated20.10.2020, it<br>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<br>less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Deferoxamine Mesylate Sterile<br>1 Kg<br>1<br>Deferoxamine Mesylate USP<br>1.02 Kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl.

Deferoxamine Mesylate Sterile 1 Kg 1 Deferoxamine Mesylate USP 1.02 Kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Deferoxamine Mesylate Sterile||1 Kg|1|Deferoxamine Mesylate USP|1.02 Kg| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	22 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00006963AM23
RA File Number	05AX04003473 AM23
Licence No and<br>Date	0511017740/14/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Manufacturing Process<br>1.<br>Chemistry giving molecular weight of reaction with yield.<br>2.<br>Material Balance.<br>3.<br>Also, sample shipping bills and bill of entry of the export products and statement of export import of the<br>Authorization.<br>4.

Case No. 23 / NC/3/MEET/Jun/202324/8

UDIN00204730AM24

sample shipping bills and bill of entry of the export products and statement of export import of the** Authorization. 4.||

Case No. 23 / NC/3/MEET/Jun/202324/8

UDIN00204730AM24

Case Status	Case Deferred
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00006981AM23
RA File Number	03AX04006011 AM23
Licence No and<br>Date	0311022155/15/03/2023
Norms Committee Decision:
The case is under	consideration for want ofcomments of TE. Also, sample shipping bills and bill of entry of the
export products and statement of export import of the Authorization.

Cas	e Status	Case Deferred	Case Deferred	Case Deferred	Case Deferred	Case Deferred
Par	ty Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ	File Number	HQRNORM APPLY 00006981AM23

RA	File Number	03AX04006011 AM23
Lic<br>Dat	ence No and<br>e	0311022155/15/03/2023
Nor<br>Th<br>exp	ms Committee Decision:<br>e case is under consideration for want ofcomments of TE.<br>ort products and statement of export import of the Autho		Als<br>riz	o, sa<br>i	mple shipping bills and bill of entry of<br>	the
				to	.

ort products and statement of export import of the Autho**|||||Als riz|o, sa i|mple shipping bills and bill of entry of ||the|| ||||||||to|.|||| ||||||||||||| |Cas|e No.|24 / NC/3/MEET/Jun/202324/8|||||||||| |Cas|e Status|Case Approved|||||||||| |Par|ty Name|TORRENT PHARMACEUTICALS LTD|||||||||| |Me and|eting Number Date|NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023|||||||||| ||||||||||||| |HQ|File Number|HQRNORM APPLY 00006990AM23|||||||||| |RA|File Number|08AX04002116 AM23|||||||||| |Lic Dat|ence No and e|0811007571/15/03/2023|||||||||| |Nor Th|ms Committee Decision: Ci idd h d d i didd fi dh d P 407 f HBP Vl I||||||||||| | er|ommttee consere te case as per agena an t was ece to x a-oc norms uner ara . o o. as details iven below or as alied b the firm whichever is less:-||||||||||| |p|g|pp y ,|||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||Export Pro|duct|Qty.|Sl. No.|Import Items||||Qty.||| ||||1 Nb|1|BISOPROLOL FUMARATE USP||||1275 /125 tblt||| ||BISOPROLOL TABLETS 1.25|FUMARATE MG(EACH FILM|umer|.|||||. mg.

|| ||||||||||||| ||Export Pro|duct|Qty.|Sl. No.|Import Items||||Qty.||| ||||1 Nb|1|BISOPROLOL FUMARATE USP||||1275 /125 tblt||| ||BISOPROLOL TABLETS 1.25|FUMARATE MG(EACH FILM|umer|.|||||. mg. mg ae||| || COATED TAB BISOPROLOL| LET CONTAINS: FUMARATE USP|||||||||| ||1.25 MG NET CONTENT OF BISOPROLOL FUMARATE SHOULD NOT BE LESS THAN 0.375 KG IN EXPORT ITEM.)||||||||||| ||||||||||||| ||BISOPROLOL FUMARATE ||1 Number|2.|BISOPROLOL FUMARATE USP||||2.55 mg/ 2.5 mg tablet||| ||TABLETS 2.5 COATED TAB|G(EACH FILM LET ONTAINS:|||||||||| || BISOPROLOL| FUMARATE USP|||||||||| ||2.5 MG NET C |ONTENT OF |||||||||| ||BISOPROLOL SHOULD NOT 2750 KG IN E|FUMARATE BE LESS THAN PORT ITEM)|||||||||| ||.|.|||||||||| |||||||||||||

Cas	e Status	Case Deferred	Case Deferred	Case Deferred	Case Deferred	Case Deferred
Par	ty Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ	File Number	HQRNORM APPLY 00006981AM23

RA	File Number	03AX04006011 AM23
Lic<br>Dat	ence No and<br>e	0311022155/15/03/2023
Nor<br>Th<br>exp	ms Committee Decision:<br>e case is under consideration for want ofcomments of TE.<br>ort products and statement of export import of the Autho		Als<br>riz	o, sa<br>i	mple shipping bills and bill of entry of<br>	the

tion for want ofcomments of TE. ort products and statement of export import of the Autho|||||Als riz|o, sa i|mple shipping bills and bill of entry of ||the|| ||||||||to|.**|||| ||||||||||||| |Cas|e No.|24 / NC/3/MEET/Jun/202324/8|||||||||| |Cas|e Status|Case Approved|||||||||| |Par|ty Name|TORRENT PHARMACEUTICALS LTD|||||||||| |Me and|eting Number Date|NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023|||||||||| ||||||||||||| |HQ|File Number|HQRNORM APPLY 00006990AM23|||||||||| |RA|File Number|08AX04002116 AM23|||||||||| |Lic Dat|ence No and e|0811007571/15/03/2023|||||||||| |Nor Th|ms Committee Decision: Ci idd h d d i didd fi dh d P 407 f HBP Vl I||||||||||| | er|ommttee consere te case as per agena an t was ece to x a-oc norms uner ara . o o. as details iven below or as alied b the firm whichever is less:-||||||||||| |p|g|pp y ,|||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||Export Pro|duct|Qty.|Sl. No.|Import Items||||Qty.||| ||||1 Nb|1|BISOPROLOL FUMARATE USP||||1275 /125 tblt||| ||BISOPROLOL TABLETS 1.25|FUMARATE MG(EACH FILM|umer|.|||||. mg.

UDIN00204730AM24

|BISOPROLOL FUMARATE TABLETS 5 MG(EACH FILM COATED TABLET CONTAINS: BISOPROLOL FUMARATE USP 5 MG NET CONTENT OF BISOPROLOL FUMARATE SHOULD NOT BE LESS THAN 1.500 KG IN EXPORT ITEM.) 1 Number 3. BISOPROLOL FUMARATE USP 5.10 mg/ 5 mg tablet BISOPROLOL FUMARATE TABLETS 10 MG(EACH FILM COATED TABLET CONTAINS: BISOPROLOL FUMARATE USP 10 MG NET CONTENT OF BISOPROLOL FUMARATE SHOULD NOT BE LESS THAN 18.000 KG IN EXPORT ITEM.) 1 Number 4. BISOPROLOL FUMARATE USP 10.20 mg/ 10 mg tablet RA concerned may take further necessary action as per above decision of NC.|BISOPROLOL FUMARATE TABLETS 5 MG(EACH FILM COATED TABLET CONTAINS: BISOPROLOL FUMARATE USP 5 MG NET CONTENT OF BISOPROLOL FUMARATE SHOULD NO

ssary action as per above decision of NC.	BISOPROLOL FUMARATE<br>TABLETS 5 MG(EACH FILM<br>COATED TABLET CONTAINS:<br>BISOPROLOL FUMARATE USP 5<br>MG NET CONTENT OF<br>BISOPROLOL FUMARATE<br>SHOULD NOT BE LESS THAN<br>1.500 KG IN EXPORT ITEM.)	1 Number	3.	BISOPROLOL FUMARATE USP	5.10 mg/ 5 mg tablet
	BISOPROLOL FUMARATE<br>TABLETS 10 MG(EACH FILM<br>COATED TABLET CONTAINS:<br>BISOPROLOL FUMARATE USP 10<br>MG NET CONTENT OF<br>BISOPROLOL FUMARATE<br>SHOULD NOT BE LESS THAN<br>18.000 KG IN EXPORT<br>ITEM.)	1 Number	4.	BISOPROLOL FUMARATE USP	10.20 mg/ 10 mg tablet

Case No.	Case No.	25 / NC/3/MEET/Jun/202324/8	25 / NC/3/MEET/Jun/202324/8	25 / NC/3/MEET/Jun/202324/8	25 / NC/3/MEET/Jun/202324/8	25 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00007003AM23
RA File Number		03AX04005636 AM23
Licence No and<br>Date		0311022182/16/03/2023
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 in meeting No.<br>NC/3/MEET/Dec/202223/15dated29.12.2022against advance authorizationNo.0311015623dated17.06.2022, it was decided to fix ad-hoc<br>norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.

23dated17.06.2022**, 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. Rosuvastatin Calcium USP / BP / EP / IH 1 Kg 1. Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4- fluorophenyl)-6-isopropyl-2-(N- methylmethylsulfonamido)pyrimidin-5- yl)vinyl)-2,2-di dimethyl-1,3-dioxan-4- yl)acetate 1.30 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Rosuvastatin Calcium USP / BP / EP / IH||1 Kg|1.|Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4- fluorophenyl)-6-isopropyl-2-(N- methylmethylsulfonamido)pyrimidin-5- yl)vinyl)-2,2-di dimethyl-1,3-dioxan-4- yl)acetate|1.30 kg|

UDIN00204730AM24

Case No.	26 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	VENUS REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007009AM23
RA File Number	30AX04000578 AM23
Licence No and<br>Date	3011003279/16/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>**Details of Export item mentioned against Sl.

mmittee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following information/documents from the firm:- Details of Export item mentioned against Sl. No.2 in the Appendix-4E is incorrect, please explain. i. Please provide complete export description and relevant documents. ii. Also, sample shipping bills and bill of entry of the export products and statement of export import of the Authorization. iii.||

Case No.	27 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007011AM23
RA File Number	07AX04001891 AM23
Licence No and<br>Date	0711006773/16/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm: -<br>Complete Chemistry giving molecular weight of reaction with yield.<br>1.<br>Also, sample shipping bills and bill of entry of the export products and statement of export import of the<br>Authorization.<br>2.

Case No.	28 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007016AM23

UDIN00204730AM24

UDIN00204730AM24

RA File Number	05AX04003495 AM23
Licence No and<br>Date	0511017773/16/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was observed that the description of export<br>product is incomplete. The Committee has directed to amend the Advance Authorisation from the concerned RA.

Case No.	Case No.	29 / NC/3/MEET/Jun/202324/8	29 / NC/3/MEET/Jun/202324/8	29 / NC/3/MEET/Jun/202324/8	29 / NC/3/MEET/Jun/202324/8	29 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00007028AM23
RA File Number		09AX04001087 AM23
Licence No and<br>Date		0911004707/16/03/2023
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.

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. Daptomycin for Injection 350mg/vial (Consist of 52.50 Kgs Daptomycin)(Daptomycin for Injection 350mg/vial (Consist of 68.25 Kgs Daptomycin)) 195000.0 Numbers 1 Daptomycin 75.08 Kg Daptomycin for Injection 500mg/vial (Consist of 150.00Kgs Daptomycin)(Daptomycin for Injection 500mg/vial (Consist of 125.00Kgs Daptomycin)) 250000.0 Numbers 2 Daptomycin 137.5 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Daptomycin for Injection 350mg/vial (Consist of 52.50 Kgs Daptomycin)(Daptomycin for Injection 350mg/vial (Consist of 68.25 Kgs Daptomycin))||195000.0 Numbers|1|Daptomycin|75.08 Kg| ||Daptomycin for Injection 500mg/vial (Consist of 150.00Kgs Daptomycin)(Daptomycin for Injection 500mg/vial (Consist of 125.00Kgs Daptomycin))||250000.0 Numbers|2|Daptomycin|137.5 kg| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	30 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	HAFFKINE BIO PHARMACEUTICAL CORPORATION LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007033AM23
RA File Number	03AX04006031 AM23
Licence No and<br>Date	0311022201/16/03/2023

UDIN00204730AM24

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.	31 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	KOPRAN LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007070AM23
RA File Number	03AX04005973 AM23
Licence No and<br>Date	0311022272/20/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was observed that review case of the firm<br>for same export item against the Advance Authorisation No. 0311004745 dated 19/06/2021 is already under consideration.<br>Hence, the committee decided to defer the case till the finalization of review case.

Case No.	32 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	KOPRAN LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007071AM23
RA File Number	03AX04005971 AM23
Licence No and<br>Date	0311022273/20/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was observed that review case of the firm<br>for same export item against the Advance Authorisation No. 0311004745 dated 19/06/2021 is already under consideration.<br>Hence, the committee decided to defer the case till the finalization of review case.

ort item against the Advance Authorisation No. 0311004745 dated 19/06/2021 is already under consideration. Hence, the committee decided to defer the case till the finalization of review case.||

Case No.	33 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	HUMAN PHARMA LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007080AM23
RA File Number	08AX04002016 AM23
Licence No and<br>Date	0811007616/20/03/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import

UDIN00204730AM24

product in meeting No. 13/82-ALC4/2018 dated 14.01.2019 against advance authorization No.3410041070 dated 20.03.2015 , 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.
CLOBETASOL PROPIONATE	1 kg	1.	BETAMETHASONE	1.00 kg

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
CLOBETASOL PROPIONATE	1 kg	1.	BETAMETHASONE	1.00 kg

Case No.	Case No.	34 / NC/3/MEET/Jun/202324/8	34 / NC/3/MEET/Jun/202324/8	34 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00007085AM23
RA File Number		03AX04006126 AM23
Licence No and<br>Date		0311022297/20/03/2023
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 meeting No.NC/3/MEET/Apr/202324/1dated28.04.2023against advance authorizationNo.0311019863 dated 08.12.2022; it<br>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<br>less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1.<br>DIBENZYLAMINE<br>0.74 kg<br>TETRA BENZYL THIURAM<br>DISULFIDE (QUREACC<br>TBZTD)(TETRA BENZYL<br>THIURAM DISULFIDE<br>(QUREACC TBZTD))<br>1 Kg<br>2.<br>CARBON DISULPHIDE<br>0.285 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl.

THIURAM DISULFIDE (QUREACC TBZTD)) 1 Kg 2. CARBON DISULPHIDE 0.285 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||TETRA BENZYL THIURAM DISULFIDE (QUREACC TBZTD)(TETRA BENZYL THIURAM DISULFIDE (QUREACC TBZTD))||1 Kg|1.|DIBENZYLAMINE|0.74 kg| |||||2.|CARBON DISULPHIDE|0.285 kg| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	35 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved

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Party Name	Party Name	ARORA AROMATICS PRIVATE LIMITED	ARORA AROMATICS PRIVATE LIMITED	ARORA AROMATICS PRIVATE LIMITED	ARORA AROMATICS PRIVATE LIMITED	ARORA AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00007093AM23
RA File Number		05AX04003521 AM23
Licence No and<br>Date		0511017888/21/03/2023
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/May/202324/4dated26.05.2023against advance authorizationNo.0310835906 dated 25.04.2020,<br>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<br>is less:-<br>Export Product<br>Qty.<br>Sl.

6 dated 25.04.2020**, 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. Menthol Crystals 1 Kg 1 L Menthol 1.02 kg RA concerned may take further necessary action as per above decision of NC||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Menthol Crystals||1 Kg|1|L Menthol|1.02 kg| ||concerned may take further necessary action as per above decision of NC||||||

Case No.	Case No.	36 / NC/3/MEET/Jun/202324/8	36 / NC/3/MEET/Jun/202324/8	36 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		FDC LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00007106AM23
RA File Number		03AX04006166 AM23
Licence No and Date		0311022327/21/03/2023
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.<br>Import Items<br>Qty.<br>CHLORAMPHENICOL EYE DROPS 10 ML<br>((EACH<br>VIAL<br>CONTAINS<br>CHLORAMPHENICOL MICRONIZED<br>0.050GM NET WT OF BULK DRUG IS 12.30<br>KGS))<br>246000.0<br>Numbers<br>1<br>CHLORAMPHENICOL<br>MICRONIZED<br>12.546 kg
	Export Product		Qty.	Sl.

CONTAINS CHLORAMPHENICOL MICRONIZED 0.050GM NET WT OF BULK DRUG IS 12.30 KGS)) 246000.0 Numbers 1 CHLORAMPHENICOL MICRONIZED 12.546 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||CHLORAMPHENICOL EYE DROPS 10 ML ((EACH VIAL CONTAINS CHLORAMPHENICOL MICRONIZED 0.050GM NET WT OF BULK DRUG IS 12.30 KGS))|| 246000.0 Numbers|1|CHLORAMPHENICOL MICRONIZED|12.546 kg| ||||||||

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Case No.	37 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007120AM23
RA File Number	04AX04001125 AM23
Licence No and<br>Date	0411005085/21/03/2023
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<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>IBUPROFEN DC (Directly Compressible) 90 grade<br>1 kg.<br>1<br>Ibuprofen<br>0.909 kg.<br>RA concerned may take further necessary action as per above decision of NC.

o. Import Items Qty. IBUPROFEN DC (Directly Compressible) 90 grade 1 kg. 1 Ibuprofen 0.909 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	38 / NC/3/MEET/Jun/202324/8	38 / NC/3/MEET/Jun/202324/8	38 / NC/3/MEET/Jun/202324/8	38 / NC/3/MEET/Jun/202324/8	38 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00007121AM23
RA File Number		04AX04001126 AM23
Licence No and<br>Date		0411005084/21/03/2023
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.<br>Import Items<br>Qty.<br>1<br>Ibuprofen<br>0.683 kg.<br>Ibuprofen Lysine (Lysinate) (Chemical and Allied product)<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Ibuprofen Lysine (Lysinate) (Chemical and Allied product)		1 kg.	1	Ibuprofen	0.683 kg.

UDIN00204730AM24

2 DL-Lysinate 50% 0.970 kg.

||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Ibuprofen Lysine (Lysinate) (Chemical and Allied product)||1 kg.|1|Ibuprofen|0.683 kg.|

UDIN00204730AM24

2 DL-Lysinate 50% 0.970 kg.

Case No.	39 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	CHEMIPRIME IMPEX PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007144AM23
RA File Number	03AX04006176 AM23
Licence No and<br>Date	0311022361/23/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Chemistry giving molecular weight of reaction with yield.<br>1.<br>Indigenous item to use in manufacturing the export item and accordingly to fill 4E for unit production.<br>2.<br>Also, sample shipping bills and bill of entry of the export products and statement of export import of the<br>Authorization.<br>3.

accordingly to fill 4E for unit production.** 2. Also, sample shipping bills and bill of entry of the export products and statement of export import of the Authorization. 3.||

Case No.	Case No.	Case No.	40 / NC/3/MEET/Jun/202324/8	40 / NC/3/MEET/Jun/202324/8
Case Status			Case Approved
Party Name			UNIMAX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number			HQRNORM APPLY 00007148AM23
RA File Number			03AX04006070 AM23
Licence No and<br>Date			0311022366/23/03/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance authorization No.<br>0311019353 dated 18.11.2022, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given<br>below or as applied by the firm, whichever is less:<br>Sl. No.<br>Export Product<br>SION No.<br>1<br>Erythromycin Base/Erythromycin<br>A-215
	Sl. No.	Export Product		SION No.
	1	Erythromycin Base/Erythromycin		A-215

UDIN00204730AM24

2 Erythromycin Oxime Base (Erythromycin A-9 Oxime) A-2244

Base/Erythromycin A-215||||| ||Sl. No.|Export Product||SION No.| ||1|Erythromycin Base/Erythromycin||A-215|

UDIN00204730AM24

2 Erythromycin Oxime Base (Erythromycin A-9 Oxime) A-2244

Case No.	41 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	SOHAN HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007173AM23
RA File Number	31AX04000352 AM23
Licence No and<br>Date	3111002109/24/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Copy of Master Batch Formula<br>1.<br>Copy of Drug Manufacturing License (DML).<br>2.<br>Also, sample shipping bills and bill of entry of the export products and statement of export import of the<br>Authorization.<br>3.

Case No.	Case No.	42 / NC/3/MEET/Jun/202324/8	42 / NC/3/MEET/Jun/202324/8	42 / NC/3/MEET/Jun/202324/8	42 / NC/3/MEET/Jun/202324/8	42 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00007176AM23
RA File Number		03AX04006189 AM23
Licence No and<br>Date		0311022409/24/03/2023
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.

|| |Licence No and Date||0311022409/24/03/2023||||| |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. 1. HYDROQUINONE 0.579 kg YAPOX CL 30/10 "HYDROQUINONE BIS"(2 HYDROXY ETHYL ETHER) 1 Kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||YAPOX CL 30/10 "HYDROQUINONE BIS"(2 HYDROXY ETHYL ETHER)||1 Kg|1.|HYDROQUINONE|0.579 kg| ||||||||

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ETHYLENE CARBONATE 0.934 kg.

Case No.	Case No.	43 / NC/3/MEET/Jun/202324/8	43 / NC/3/MEET/Jun/202324/8	43 / NC/3/MEET/Jun/202324/8	43 / NC/3/MEET/Jun/202324/8	43 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		STYRAX LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00007178AM23
RA File Number		09AX04001138 AM23
Licence No and<br>Date		0911004743/24/03/2023
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 meeting No.NC/3/MEET/Mar/202223/22dated24.03.2023against advance authorizationNo.0911003830dated18.10.2022,<br>it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

uct in meeting No.NC/3/MEET/Mar/202223/22dated24.03.2023against advance authorizationNo.0911003830dated18.10.2022, 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. 1. GLYOXALIC ACID 50PCT 0.752 kg 2. CYCLOHEXANE 1.41 kg L MENTHYL GLYOXYLATE HYDRATE 1 Kg 3. L MENTHOL 0.45 kg RA concerned may take further necessary action as per above decision of NC||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||L MENTHYL GLYOXYLATE HYDRATE||1 Kg|1.|GLYOXALIC ACID 50PCT|0.752 kg| |||||2.|CYCLOHEXANE|1.41 kg| |||||3.|L MENTHOL|0.45 kg| ||concerned may take further necessary action as per above decision of NC||||||

Case No.	44 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007187AM23
RA File Number	05AX04003575 AM23
Licence No and<br>Date	0511017985/24/03/2023

UDIN00204730AM24

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.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/<br>5ml(Having net conent of 100.440 kg of Bulk drug)	1 Number	1.	TOBRAMYCIN USP	306 mg

Case No.	Case No.	45 / NC/3/MEET/Jun/202324/8	45 / NC/3/MEET/Jun/202324/8	45 / NC/3/MEET/Jun/202324/8	45 / NC/3/MEET/Jun/202324/8	45 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		INDO AMINES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00007211AM23
RA File Number		03AX04006139 AM23
Licence No and<br>Date		0311022441/25/03/2023
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/Dec/202223/15dated29.12.2022against advance authorizationNo.0311016706 dated 29.07.2022,<br>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<br>is less:-<br>Export Product<br>Qty.<br>Sl.

6 dated 29.07.2022**, 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. COCO AMINE or COCO AMINE DISTILLED or IAL CA or IAL CAD 1 kg 1. Distilled Coconut Fatty acid or Coconut Fatty Acid 1.02 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||COCO AMINE or COCO AMINE DISTILLED or IAL CA or IAL CAD|| 1 kg|1.|Distilled Coconut Fatty acid or Coconut Fatty Acid| 1.02 kg| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	46 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	AMINES AND PLASTICIZERS LIMITED

UDIN00204730AM24

Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number<br>HQRNORM APPLY 00007212AM23
RA File Number<br>03AX04006163 AM23
Licence No and<br>Date<br>0311022443/25/03/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>i.
stage wise percentage yields on molar basis.
Reason for higher quantity of ethylene oxide with justification.<br>ii.

cular and structural formula and molecular weights along with** i.| |stage wise percentage yields on molar basis.| |Reason for higher quantity of ethylene oxide with justification. ii.| |Also, sample shipping bills and bill of entry of the export products and statement of export import of the iii.| |Authorization.|

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

Case No.<br>47 / NC/3/MEET/Jun/202324/8
Case Status<br>Case Approved
Party Name<br>INDO AMINES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202324/ 8 and	30/06/2023
HQ File Number<br>HQRNORM APPLY 00007213AM23
RA File Number<br>03AX04006199 AM23
Licence No and<br>Date<br>0311022448/25/03/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it	was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per
details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.		Sl. No.	Import Items	Qty.
IAL<br>ADMA-10<br>OR<br>N,N-<br>1 kg		1	Capric Acid 99% or Decanoic Acid or	0.920 kg
DIMETHYL DECANAMIDE			C10 fatty Acid
RA concerned may take further necessary action as per above decision of			NC.

Case No.	48 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023

UDIN00204730AM24

/ NC/3/MEET/Jun/202324/8| |---|---| |Case Status|Case Approved| |Party Name|SANDHYA ORGANIC CHEMICALS PVT LTD| |Meeting Number|NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023|

UDIN00204730AM24

and Date	and Date
HQ File Number		HQRNORM APPLY 00007221AM23
RA File Number		03AX04006258 AM23
Licence No and<br>Date		0311022483/27/03/2023
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.<br>Import Items<br>Qty.<br>1<br>PHENOL<br>0.712 kg.<br>2<br>TRIDECYL ALCOHOL<br>0.495 kg.<br>Diphenyl<br>Tridecyl<br>Phosphite<br>((DPTDP))<br>1 kg.<br>3<br>YELLOW PHOSPHORUS<br>0.076 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Diphenyl<br>Tridecyl<br>Phosphite<br>((DPTDP))		<br>1 kg.	1	PHENOL	0.712 kg.
				2	TRIDECYL ALCOHOL	0.495 kg.
				3	YELLOW PHOSPHORUS	0.076 kg.
	concerned may take further necessary action as per above decision of NC.

((DPTDP))|| 1 kg.|1|PHENOL|0.712 kg.| |||||2|TRIDECYL ALCOHOL|0.495 kg.| |||||3|YELLOW PHOSPHORUS|0.076 kg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	Case No.	49 / NC/3/MEET/Jun/202324/8	49 / NC/3/MEET/Jun/202324/8	49 / NC/3/MEET/Jun/202324/8	49 / NC/3/MEET/Jun/202324/8	49 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		TOPNOTCH CHEMICALS PVT LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00007232AM23
RA File Number		03AX04006148 AM23
Licence No and<br>Date		0311022508/27/03/2023
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.<br>Import Items<br>Qty.<br>ARTEMETHER<br>1 kg.<br>1<br>ARTEMISININ<br>1.04 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	ARTEMETHER		1 kg.	1	ARTEMISININ	1.04 kg.

UDIN00204730AM24

Qty. ARTEMETHER 1 kg. 1 ARTEMISININ 1.04 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||ARTEMETHER||1 kg.|1|ARTEMISININ|1.04 kg.| ||||||||

UDIN00204730AM24

Case No.	Case No.	50 / NC/3/MEET/Jun/202324/8	50 / NC/3/MEET/Jun/202324/8	50 / NC/3/MEET/Jun/202324/8	50 / NC/3/MEET/Jun/202324/8	50 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		ADCOCK INGRAM LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00007238AM23
RA File Number		07AX04001972 AM23
Licence No and Date		0711007204/27/03/2023
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.10/82-ALC4/2018 dated 16/10/2018against advance authorizationNo.0710112431dated20/11/2017, it was<br>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:-<br>Export Product<br>Qty.<br>Sl.

31dated20/11/2017**, 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. 1 ORPHENADRINE CITRATE BP/EP/USP/PH.EUR 102.00 mg / tablet NORFLEX 100mg TABLETS (Orphenadrine Citrate 100mg + Lactose Monohydrate 167mg Tablets (NORFLEX 100mg TABLETS) (Orphenadrine-1400.000+ Lactose-2338.000 KGS = Total KGS-3738.000 (No: Tablets: 14000000) BP/EP/USP/PH.EUR/NF/USNF) 1 Tablet 2 PHARMATOSE R 130M MILLED LACTOSE MONOHYDRATE USP-NF/ PH.EUR/JP 167.00 mg / tablet RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||NORFLEX 100mg TABLETS (Orphenadrine Citrate 100mg + Lactose Monohydrate 167mg Tablets (NORFLEX 100mg TABLETS) (Orphenadrine-1400.000+ Lactose-2338.000 KGS = Total KGS-3738.000 (No: Tablets: 14000000) BP/EP/USP/PH.EUR/NF/USNF)||1 Tablet|1|ORPHENADRINE CITRATE BP/EP/USP/PH.EUR|102.00 mg / tablet| |||||2|PHARMATOSE R 130M MILLED LACTOSE MONOHYDRATE USP-NF/ PH.EUR/JP|167.00 mg / tablet| ||concerned may take further necessary action as per above decision of NC.||||||

.00 mg / tablet| |||||2|PHARMATOSE R 130M MILLED LACTOSE MONOHYDRATE USP-NF/ PH.EUR/JP|167.00 mg / tablet| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	51 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007251AM23
RA File Number	34AX04001136 AM23
Licence No and<br>Date	3411003538/28/03/2023
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:-

UDIN00204730AM24

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Methotrexate<br>Tablets<br>USP<br>2.5<br>mg(Methotrexate Tablets USP 2.5 mg (net<br>content of active ingredients = 42.47 kgs))<br>1 Number<br>1<br>Methotrexate Sodium<br>(Methotrexate Disodiun<br>Salt Milled)<br>2.55 mg / tablet<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty.
	Methotrexate<br>Tablets<br>USP<br>2.5<br>mg(Methotrexate Tablets USP 2.5 mg (net<br>content of active ingredients = 42.47 kgs))	<br> <br>1 Number	1	Methotrexate Sodium<br>(Methotrexate Disodiun<br>Salt Milled)	2.55 mg / tablet

Case No.	Case No.	52 / NC/3/MEET/Jun/202324/8	52 / NC/3/MEET/Jun/202324/8	52 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00007254AM23
RA File Number		05AX04003629 AM23
Licence No and<br>Date		0511018016/28/03/2023
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.<br>Import Items<br>Qty.<br>1<br>2-n-propyl-4-methyl-6-(1-<br>methylbenzimidazol-2-yl)<br>0.621 kg.<br>2<br>2-Cyano-4-Methyl Biphenyl<br>(OTBN)<br>Not showing in the<br>process/ chemistry<br>3<br>Acetic Acid<br>0.90 kg.<br>4<br>Toluene<br>1.71 kg.<br>5<br>N-Butanol<br>1.34 kg.<br>TELMISARTAN USP/BP/EP/JP/IP(Powder)<br>2-Cyano-4-Methyl Biphenyl (OTBN)<br>1 kg.<br>6<br>METHANOL<br>1.25 kg.
	Export Product		Qty.	Sl.

br>Toluene 1.71 kg. 5 N-Butanol 1.34 kg. TELMISARTAN USP/BP/EP/JP/IP(Powder) 2-Cyano-4-Methyl Biphenyl (OTBN) 1 kg. 6 METHANOL 1.25 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||TELMISARTAN USP/BP/EP/JP/IP(Powder) 2-Cyano-4-Methyl Biphenyl (OTBN)||1 kg.|1|2-n-propyl-4-methyl-6-(1- methylbenzimidazol-2-yl)|0.621 kg.| |||||2|2-Cyano-4-Methyl Biphenyl (OTBN)|Not showing in the process/ chemistry| |||||3|Acetic Acid|0.90 kg.| |||||4|Toluene|1.71 kg.| |||||5|N-Butanol|1.34 kg.| |||||6|METHANOL|1.25 kg.| ||||||||

UDIN00204730AM24

Case No.	53 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	AMBACO CHEMICALS AND LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007271AM23
RA File Number	03AX04006291 AM23
Licence No and<br>Date	0311022549/29/03/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm: -
Complete chemical reactions with molecular and structural formula and molecular weights.<br>1.
Production/Consumption data duly certified by CA.<br>2.
Also, sample shipping bills and bill of entry of the export products and statement of export import of the<br>3.
Authorization.

ction/Consumption data duly certified by CA.** 2.|| |Also, sample shipping bills and bill of entry of the export products and statement of export import of the 3.|| |Authorization.||

Case No.	54 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007275AM23
RA File Number	03AX04006282 AM23
Licence No and<br>Date	0311022550/29/03/2023
Norms Committee Decision:
Under consideration for physical verification.

Case No.	55 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	WANKSONS CHEMICALS INDUSTRIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007281AM23
RA File Number	03AX04006181 AM23
Licence No and<br>Date	0311022552/29/03/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product

UDIN00204730AM24

in meeting No. NC/3/MEET/Nov/202223/12 dated 18/11/2022 against advance authorization No.0311014492 dated 05/05/2022 it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.
CHLORAL	1 kg.	1	DENATURED ETHYL ALCOHOL	0.878 kg.

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
CHLORAL	1 kg.	1	DENATURED ETHYL ALCOHOL	0.878 kg.

Case No.	Case No.	56 / NC/3/MEET/Jun/202324/8	56 / NC/3/MEET/Jun/202324/8	56 / NC/3/MEET/Jun/202324/8	56 / NC/3/MEET/Jun/202324/8	56 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		HONOUR LAB LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00007286AM23
RA File Number		09AX04001127 AM23
Licence No and<br>Date		0911004777/29/03/2023
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>5 -(2-fluoropheny 1)-1H-pyrrole-3 -carbaldehyde<br>0.757 kg.<br>VONOPRAZAN FUMARATE<br>(Other heterocyclic compounds)<br>1 kg.<br>2<br>Pyridine-3-sulfonyl chloride<br>0.856 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	VONOPRAZAN FUMARATE<br>(Other heterocyclic compounds)		1 kg.	1	5 -(2-fluoropheny 1)-1H-pyrrole-3 -carbaldehyde	0.757 kg.
				2	Pyridine-3-sulfonyl chloride	0.856 kg.
	concerned may take further necessary action as per above decision of NC.

||1 kg.|1|5 -(2-fluoropheny 1)-1H-pyrrole-3 -carbaldehyde|0.757 kg.| |||||2|Pyridine-3-sulfonyl chloride|0.856 kg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	57 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	NATCO PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023

UDIN00204730AM24

HQ File Number	HQ File Number	HQRNORM APPLY 00007287AM23	HQRNORM APPLY 00007287AM23	HQRNORM APPLY 00007287AM23	HQRNORM APPLY 00007287AM23
RA File Number		09AX04001148 AM23
Licence No and
Date		0911004779/29/03/2023
Norms Committee<br>		Decision:<br>
Th<br>pro<br>dat<br>ap	e Committee considered the case as per agenda and taking cue<br>duct in meetingNo.NC/3/MEET/Dec/202223/17dated13/<br>ed21/12/2021, it was decided to fix ad-hoc norms under Pa<br>					from the earlier decision for same export product/import<br>01/2023against advance authorization No.0911002121<br>ra 4.07 of HBP Vol. I as per details given below or as
	plied by the firm, whichever is less:-


	Export Product		Qty.	Sl	.

o.0911002121 ra 4.07 of HBP Vol. I as per details given below or as|||||||| ||plied by the firm, whichever is less:-|||||||||||||| |||||||||||||||| |||||||||||||||| ||Export Product||Qty.|Sl|. No.||Import I|te|ms||||Q|ty.| |||||||||||||||| |||||||||||||||| ||NITROGLYCERIN SUBLINGUAL TABLETS USP 0.3 mg (Each Tablet ti Nitli USP 03)||1 Number|1|||Diluted|Ni|troglyceri|n USP 1.95 percent||||15.70 mg| |||||||||||||||| |||||||||||||||| ||conans rogycern .mg (Export In Qty. 8.308 Kgs)|||2|||Glyceryl M||onosterate||||1|.255 mg| |||||||||||||||| ||NITROGLYCERIN SUBLINGUAL TABLETS USP 04 Eh Tblt||1 Number|3 |||Diluted Nitroglycerin USP 1.95 percent||||||20.93 mg|| ||.mg (ac ae contains Nitroglycerin USP 0.4mg)|||||||||||||| |||||||||||||||| |||||||||||||||| ||(Export in Qty.|196.925 Kgs)||4 |||Glyceryl Monosterate||||||1.255 mg|| |||||||||||||||| |||||||||||||||| |||||||||||||||| ||NITROGLYCE|RIN SUBLINGUAL|1 Number|5 |||Diluted Nitroglycerin USP 1.95 percent||||||31.40 mg|| |||||||||||||||| ||TABLETS USP |0.6 mg (Each Tablet ||||||||||||| |||||||||||||||| ||contains Nitrogl|ycerin USP 0.6mg)||||||||||||| ||(Export in Qty.|5.538 Kgs)||6 |||Glyceryl Monosterate||||||1.255 mg|| |||||||||||||||| |||||||||||||||| |||||||||||||||| |||||||||||||||| |||||||||||||||| |||||||||||||||| |RA concerned may||take further necessary action as||per above decision of NC.||||||||||| |||||||||||||||| |||||||||||||||| |Case No.||58 / NC/3/MEET/Jun/202324/8||||||||||||| |Case Status||Case Deferred|||||||||||||

||take further necessary action as||per above decision of NC.||||||||||| |||||||||||||||| |||||||||||||||| |Case No.||58 / NC/3/MEET/Jun/202324/8||||||||||||| |Case Status||Case Deferred||||||||||||| |Party Name||SANDHYA ORGANIC CHEMICALS PVT LTD||||||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023||||||||||||| |HQ File Number||HQRNORM APPLY 00007310AM23||||||||||||| |RA File Number||03AX04006257 AM23||||||||||||| |Licence No and||||||||||||||| | Date||0311022584/30/03/2023||||||||||||| |||||||||||||||| |Norms Committee||Decision:||||||||||||| |||||||||||||||| |||||||||||||||| |The committee con||sidered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following||||||||||||| | || ||||||||||||| |information/docum||ents from the firm:-||||||||||||| |||||||||||||||| |||||||||||||||| ||||||||||||||||

Case No.	58 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007310AM23
RA File Number	03AX04006257 AM23
Licence No and<br>Date	0311022584/30/03/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-

UDIN00204730AM24

i. Step wise manufacturing process.

of firm for review/fixation of ad-hoc norms and it was decided to call for following|| |information/documents from the firm:-||

UDIN00204730AM24

i. Step wise manufacturing process.
ii. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.
iii. Complete technical details as per Annexure to Appendix 4E for chemical products.
iv. Stoichiometric balance between import and export on molar basis.
Details of indigenous input with quantity.
v.
vi. 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.	59 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007313AM23
RA File Number	07AX04002003 AM23
Licence No and<br>Date	0711007245/30/03/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the
export products and statement of export import of the Authorization.

The case is under*|consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the| |export products and statement of export import of the Authorization.||

Case No.<br>60 / NC/3/MEET/Jun/202324/8	Case No.<br>60 / NC/3/MEET/Jun/202324/8
Case Status<br>Case Approved
Party Name<br>ENVEE DRUGS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number<br>HQRNORM APPLY 00007320AM23
RA File Number<br>34AX04001132 AM23
Licence No and<br>Date<br>3411003556/30/03/2023
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.
BECLOMETHASONE	1 Kg.	1	16B METHYL EPOXIDE DB 11	0.88 Kg.
DIPROPIONATE(IP/EP/BP/USP)

UDIN00204730AM24

ver is less:-|||||| |Export Product|Qty.|Sl. No.|Import Items|Qty.|| |BECLOMETHASONE|1 Kg.|1|16B METHYL EPOXIDE DB 11|0.88 Kg.|| |DIPROPIONATE(IP/EP/BP/USP)|||||| |||||||

UDIN00204730AM24


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



Case No		61 / NC/3/MEET/Jun/202324/8
.
Case Status		Case Approved

Party Name		PIRAMAL PHARMA LIMITED
Mi Nb
e<br>and	tng umer<br>Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ	File Number	HQRNORM APPLY 00007323AM23
RA	File Number	03AX040	06336 AM2	3
Lic	ence No and
Dat		03110226	10/31/03/20	23
	e
Nor	ms Committee	Decision:

Th<br>in<br>it	e Committee con<br>meetingNo. NC/<br>was decided to fix	sidered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>3/MEET/Apr/202324/1 dated 28/04/2023against advance authorization No.0311020450 dated 03.01.2023,<br>ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever
<br>is less: -





	Export Product				Qty.	Sl.

l. I as per details given below or as applied by the firm, whichever||||||||| | is less: -||||||||||| |||||||||||| |||||||||||| |||||||||||| |||||||||||| |||||||||||| ||Export Product||||Qty.||Sl. No.|Import Items||Qty.| |||||||||||i| |||||||||||(n mg)| |||||||||||| ||Atorvastatin Ca |lcium Tablets USP 10mg((Net ||| 1 Number ||1|Atorvastatin Calcium Propylene || 11.415| ||Content of Impo 2 i 3487212 k|rt Sr. No. 1 is 616.410 kgs, Sr. No. S N 3 i 974646 k S N 4||| Tablet|||Glycol Solvate USP||| ||s . is 606000 Nos.)|, r. o. s . g, r. o. )||||||||| ||||||||2|Microcrystalline Cellulose|| 64.578| |||||||||(MCC) NF (Avicel PH 102)||| ||||||||3|Calcium Acetate||18.049| ||||||||4|Silica Gel Dessicants - Packaged|| Relevant as per| |||||||||Activated Carbon (Strippax || packing policy| |||||||||Sorbent)||| |||||||||||| |||||||||||| ||Atorvastatin Ca|lcium Tablets USP 20 mg((Net|||1 Number||5|Atorvastatin Calcium Propylene|| 22.830| ||Content of Impo 2 i 1164843 k|rt Sr. No. 1 is 205.470 kgs, Sr. No. S N 3 i 324810 k S N 4||| Tablet|||Glycol Solvate USP||| ||s . i 101000 N|, r. o. s . g, r. o. ||||||||| |||||||||||| ||s os.)||||||6|Microcrystalline Cellulose|| 129.427| |||||||||(MCC) NF (Avicel PH 102)||| |||||||||||| |||||||||||| ||||||||7|Calcium Acetate||36090| |||||||||||.| ||||||||8|Sili Gl Di Pkd||Rl| |||||||||ca e esscants - acage||eevant as per|

UDIN00204730AM24

(Avicel PH 102)||| |||||||||||| |||||||||||| ||||||||7|Calcium Acetate||36090| |||||||||||.| ||||||||8|Sili Gl Di Pkd||Rl| |||||||||ca e esscants - acage||eevant as per|

UDIN00204730AM24

					Activated<br>Carbon<br>(Strippax<br>Sorbent)	packing policy

Attti C	i Tblt USP 40((Nt		1 Nb	9	Attti Cli Pl	<br>45595
orvasan a	cum aes mge		umer		orvasan acum ropyene	<br>.
Content of Impo	rt Sr. No. 1 is 3939.408 kgs, Sr.		Tablet		Glycol Solvate USP
<br>	<br>
No. 2 is 22298.	12 kg, Sr. No. 3 is 6217.603 kg,
Sr No 4 is 969	600 Nos))
. .	.			10	Microcrystalline<br>Cellulose	<br>258.08
					(MCC) NF (Avicel PH 102)



				11	Calcium Acetate	71.963


				12	Sili Gl Di Pkd	<br>Rl
					ca e esscants - acage<br>Activated<br>Carbon<br>(Strippax<br>Sorbent)	<br>eevant as per<br>packing policy

Atorvastatin Calcium Tablets USP 80mg((Net<br>Content of Import Sr. No. 1 is 2872.800 kgs Sr.			1 Number<br>Tablet	13	Atorvastatin Calcium Propylene<br>Glycol Solvate USP	<br>91.20
		,
No. 2 is 16323.489 kg, Sr. No. 3 is 4565.2		64 kg,
Sr. No.

r.|||1 Number Tablet|||||13|||Atorvastatin Calcium Propylene Glycol Solvate USP||| 91.20||| ||||,||||||||||||||| ||No. 2 is 16323.489 kg, Sr. No. 3 is 4565.2||64 kg,||||||||||||||| ||Sr. No. 4 is 353|500 Nos.))|||||||14|||Microcrystalline Cellulose||| 518||.206| ||||||||||||| (MCC) NF (Avicel PH 102)||| ||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||15|||Calcium Acetate|||144||.929| ||||||||||||||||||| ||||||||||16|||Silica Gel Dessicants - Packaged ||| Relevant as per ||| |||||||||||||Activated Carbon (Strippax Sorbent)|||packing policy||| ||||||||||||||||||| ||Note: The abov|e norms are valid only for subject to fulfillment|||||||of following conditions:||||||||| ||Et 1|Pdt bi Pttd Mdii b fild ith USFDA fili ANDA (A N D Aliti) f|||||||||||||||| ||xpor Apotex .|rouc eng aene ecne, e e w ng ew rug ppcaon o Corp, US. Agent for Apotex Inc., Canada.|||||||||||||||| || Export 2. Firm h 3.| to USA only. olding Certificate of Manufacturing Exclusivity.|||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| |RA|concerned may t|ake further necessary action as per above de|||||cision of NC.||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| |Cas|e No.|62 / NC/3/MEET/Jun/202324/8|||||||||||||||| |Cas|e Status|Case Approved|||||||||||||||| |Par|ty Name|HETERO LABS LIMITED|||||||||||||||| |Me and|eting Number Date|NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023||||||||||||||||

||||||||||||||| |Cas|e Status|Case Approved|||||||||||||||| |Par|ty Name|HETERO LABS LIMITED|||||||||||||||| |Me and|eting Number Date|NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023|||||||||||||||| |HQ|File Number|HQRNORM APPLY 00007328AM23|||||||||||||||| ||||||||||||||||||| |RA|File Number|09AX04001041 AM23|||||||||||||||| ||||||||||||||||||| |Lic|ence No and|1144122|||||||||||||||| |Date||090078/3/03/03||||||||||||||||

Case No.	62 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	HETERO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007328AM23
RA File Number	09AX04001041 AM23
Licence No and<br>Date	0911004784/31/03/2023

UDIN00204730AM24

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.
TELMISARTAN<br>(Other heterocyclic compounds)	1 kg.	1	2-N-Propyl-4-Methyl-6-(1-<br>Methylbenzimidazol-2-Yl) Benzimidazole	0.621 kg.

Case No.	Case No.	63 / NC/3/MEET/Jun/202324/8	63 / NC/3/MEET/Jun/202324/8	63 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		HETERO LABS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00007329AM23
RA File Number		09AX04001059 AM23
Licence No and Date		0911004785/31/03/2023
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.<br>Import Items<br>Qty.<br>1<br>D-RIBOSE<br>2.09 kg.<br>2<br>5-FLUORO CYTOSINE<br>0.55 kg.<br>3<br>DI METHYL SULFOXIDE<br>3.17 kg.<br>4<br>N-PENTYL CHLORO FORMATE<br>0.813 kg.<br>5<br>SODIUM BORO HYDRIDE<br>0.58 kg.<br>CAPECITABINE(Nucleic acids and their salts,<br>whether or not chemically defined; other<br>heterocyclic compounds, Other)<br>1 kg.<br>6<br>2-2-DIMETHOXYPROPANE<br>1.81 kg.
	Export Product		Qty.	Sl.

TABINE(Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds, Other) 1 kg. 6 2-2-DIMETHOXYPROPANE 1.81 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||CAPECITABINE(Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds, Other)||1 kg.|1|D-RIBOSE|2.09 kg.| |||||2|5-FLUORO CYTOSINE|0.55 kg.| |||||3|DI METHYL SULFOXIDE|3.17 kg.| |||||4|N-PENTYL CHLORO FORMATE|0.813 kg.| |||||5|SODIUM BORO HYDRIDE|0.58 kg.| |||||6|2-2-DIMETHOXYPROPANE|1.81 kg.|

UDIN00204730AM24

Case No.	Case No.	64 / NC/3/MEET/Jun/202324/8	64 / NC/3/MEET/Jun/202324/8	64 / NC/3/MEET/Jun/202324/8	64 / NC/3/MEET/Jun/202324/8	64 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		CENTRIENT PHARMACEUTICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00007332AM23
RA File Number		30AX04000589 AM23
Licence No and<br>Date		3011003363/31/03/2023
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.

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 6-Amino Penicillanic Acid 0.596 kg. 2 D-Alpha Pheynl Glycine Base 0.417 kg. AMPICILLIN TRIHYDRATE THROUGH 6- APA ROUTE THROUGH ENZYMATIC ROUTE 1 Kg. 3 Elcolase Enzyme 0.005 kg. RA concerned may take further necessary action as per above decision of NC||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||AMPICILLIN TRIHYDRATE THROUGH 6- APA ROUTE THROUGH ENZYMATIC ROUTE|| 1 Kg.|1|6-Amino Penicillanic Acid|0.596 kg.| |||||2|D-Alpha Pheynl Glycine Base|0.417 kg.| |||||3|Elcolase Enzyme|0.005 kg.| ||concerned may take further necessary action as per above decision of NC||||||

Case No.	65 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	CENTRIENT PHARMACEUTICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007333AM23
RA File Number	30AX04000588 AM23
Licence No and<br>Date	3011003364/31/03/2023
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:-

UDIN00204730AM24

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:-||

UDIN00204730AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
AMOXYCILLIN TRIHYDRATE THROUGH<br>6-APA ROUTE THROUGH ENZYMATIC<br>ROUTE	<br> <br>1 Kg.	1	6-Amino Penicillanic Acid ( 6APA)	0.55 kg.
		2	D(-) P-Hydroxy Phenyl Glycine<br>Methyester	0.468 kg.
		3	Elcolase Enzyme	0.004 kg.

Case No.	Case No.	66 / NC/3/MEET/Jun/202324/8	66 / NC/3/MEET/Jun/202324/8	66 / NC/3/MEET/Jun/202324/8	66 / NC/3/MEET/Jun/202324/8	66 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		AVIK PHARMACEUTICAL LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00007336AM23
RA File Number		52AX04001819 AM23
Licence No and<br>Date		5211004531/31/03/2023
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. 3/82-ALC4/2020dated07/08/2020against advance authorizationNo.0310831890dated27/09/2019, it was<br>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:-<br>Export Product<br>Qty.<br>Sl.

90dated27/09/2019**, 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. TRIAMICINOLONE IP/EP/BP/USP 1 kg. 1 3,20-DIOXOPREGNA-1,4,9(11),16 - TETRAEN - 21- YLACETATE (3 TR) 1.00 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||TRIAMICINOLONE IP/EP/BP/USP||1 kg.|1|3,20-DIOXOPREGNA-1,4,9(11),16 - TETRAEN - 21- YLACETATE (3 TR)|1.00 kg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	67 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	TOJO VIKAS INTERNATIONAL PRIVATE LIMITED

UDIN00204730AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007338AM23
RA File Number	05AX04003614 AM23
Licence No and<br>Date	0511018112/31/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Justification for 47% wastage<br>1.<br>Commercial value of by-product obtained.<br>2.<br>Last two years Production/Consumption data duly certified by GST.<br>3.

ts from the firm:- Justification for 47% wastage 1. Commercial value of by-product obtained. 2. Last two years Production/Consumption data duly certified by GST. 3.||

Case No.	Case No.	68 / NC/3/MEET/Jun/202324/8	68 / NC/3/MEET/Jun/202324/8	68 / NC/3/MEET/Jun/202324/8	68 / NC/3/MEET/Jun/202324/8	68 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		ALCHYMARS ICM SM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00007342AM23
RA File Number		04AX04001116 AM23
Licence No and<br>Date		0411005194/31/03/2023
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.<br>Import Items<br>Qty.<br>CLINDAMYCIN<br>HYDROCHLORIDE<br>ACTIVE<br>PHARMACEUTICAL INGREDIENT<br>1 Kg<br>1<br>LINCOMYCIN<br>HYDROCHLORIDE<br>RAW MATERIAL<br>1.43 Kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	CLINDAMYCIN<br>HYDROCHLORIDE<br>ACTIVE<br>PHARMACEUTICAL INGREDIENT		<br>1 Kg	1	LINCOMYCIN<br>HYDROCHLORIDE<br>RAW MATERIAL	1.43 Kg.
	concerned may take further necessary action as per above decision of NC.

ROCHLORIDE ACTIVE PHARMACEUTICAL INGREDIENT|| 1 Kg|1|LINCOMYCIN HYDROCHLORIDE RAW MATERIAL|1.43 Kg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	69 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00007348AM23
RA File Number	07AX04002002 AM23

UDIN00204730AM24

Licence No and 0711007268/31/03/2023 Date Norms Committee Decision:

The case is under consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the export products and statement of export import of the Authorization

Case No.	Case No.	70 / NC/3/MEET/Jun/202324/8	70 / NC/3/MEET/Jun/202324/8	70 / NC/3/MEET/Jun/202324/8	70 / NC/3/MEET/Jun/202324/8	70 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00000026AM24
RA File Number		09AX04001170 AM23
Licence No and<br>Date		0911004800/06/04/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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 2-Phenyloxirane (Styrene Oxide) 1.11 kg. 2 2-Aminopyridine 0.87 kg. 3 Potassium Tertiary Butoxide Powder 0.70 kg. 4 Toluene 1.45 kg. 5 Isopropyl Alcohol (IPA) 2.58 kg. 6 Methanol 1.125 kg. Phenyramidol Hydrochloride 1 kg. 7 Isopropyl Alcohol HCl 1.228 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Phenyramidol Hydrochloride||1 kg.|1|2-Phenyloxirane (Styrene Oxide)|1.11 kg.| |||||2|2-Aminopyridine|0.87 kg.| |||||3|Potassium Tertiary Butoxide Powder|0.70 kg.| |||||4|Toluene|1.45 kg.| |||||5|Isopropyl Alcohol (IPA)|2.58 kg.| |||||6|Methanol|1.125 kg.| |||||7|Isopropyl Alcohol HCl|1.228 kg.| ||concerned may take further necessary action as per above|||decision of NC.|||

Case No.	71 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved

UDIN00204730AM24

|1.228 kg.| ||concerned may take further necessary action as per above|||decision of NC.|||

Case No.	71 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved

UDIN00204730AM24

Party Name	Party Name	SOLARA ACTIVE PHARMA SCIENCES LIMITED	SOLARA ACTIVE PHARMA SCIENCES LIMITED	SOLARA ACTIVE PHARMA SCIENCES LIMITED	SOLARA ACTIVE PHARMA SCIENCES LIMITED	SOLARA ACTIVE PHARMA SCIENCES LIMITED	SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00000027AM24
RA File Number		04AX04001155 AM23

Lic<br>Dat	ence No and<br>e	041100	5200/06/04/2	023
Nor<br>Th<br>in<br>wa<br>les<br>RA	ms Committee Decisio<br>e Committee considered t<br>meetingNo.NC/3/MEET<br>s decided to fix ad-hoc n<br>s:-		n:<br>he case as per<br>/Apr/202324/1<br>orms under Par	agenda and<br>dated28/0	taking cue from the earlier decision for same<br>4/2023against advance authorizationNo.04		export product/import product<br>11004581dated07/12/2022, it
				a 4.07 of H	BP Vol. I as per details given below or as ap		plied by the firm, whichever is

	Export Product			Qty.		Sl.

uct/import product 11004581dated07/12/2022, it|| |||||a 4.07 of H|BP Vol. I as per details given below or as ap|||plied by the firm, whichever is|| ||||||||||| ||Export Product|||Qty.||Sl. No.|Import Items||Qty.| ||IBUPROFEN|||1 Kg.||1|ISOBUTYL ACETOPHENONE||1.11 kg.| |||||||2|SODIUM METAL||0.235 kg.| ||||||||||| |||||||3|MONOCHLORO AC ACID|ETIC|0.919 kg.| ||||||||||| |||||||4|ISO PROPYL ALCO|HOL|0.50 kg.| |||||||5|SODIUM DICHROM|ATE|0.630 kg.| ||||||||||| ||concerned may take furth||er necessary ac||||||| |||||tion as per|above decision of NC.||||| ||||||||||| |Case No.|e No.|72 / NC|/3/MEET/Jun|/202324/8|||||| ||||||||||| |Case Status||Case Approved|||||||| |Party Name||SOLARA ACTIVE PHARMA SCIENCES LIMITED|||||||| |Meeting Number and Date||NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023|||||||| ||||||||||| |H Fil Nb||HRNORM APPLY 00000028AM24|||||||| |Q e umer||Q|||||||| |RA Fil Nb||04AX04001157 AM23|||||||| |e umer|||||||||| |Li N d|||||||||| |cence o an Date||0411005201/06/04/2023|||||||| ||||||||||| |Norms Committee||Decision:|||||||| |The Committee con||sidered the case as per agenda and taking cue from the earlier decision for same export product/import product|||||||| ||||||||||| |||||||||||

orms Committee||Decision:|||||||| |The Committee con||sidered the case as per agenda and taking cue from the earlier decision for same export product/import product|||||||| ||||||||||| |||||||||||

Case No.	72 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000028AM24
RA File Number	04AX04001157 AM23
Licence No and<br>Date	0411005201/06/04/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product

UDIN00204730AM24

in meeting No.NC/3/MEET/Apr/202324/1 dated 28/04/2023 against advance authorization No.0411004581 dated 07/12/2022 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.
IBUPROFEN	1 Kg.	1	ISOBUTYL<br>ACETOPHENONE	1.11 kg.
		2	SODIUM METAL	0.235 kg.
		3	MONOCHLORO ACETIC<br>ACID	0.919 kg.
		4	ISO PROPYL ALCOHOL	0.50 kg.
		5	SODIUM DICHROMATE	0.630 kg.

-| |IBUPROFEN|1 Kg.|1|ISOBUTYL ACETOPHENONE|1.11 kg.| |||2|SODIUM METAL|0.235 kg.| |||3|MONOCHLORO ACETIC ACID|0.919 kg.| |||4|ISO PROPYL ALCOHOL|0.50 kg.| |||5|SODIUM DICHROMATE|0.630 kg.|

Case No.	Case No.	73 / NC/3/MEET/Jun/202324/8	73 / NC/3/MEET/Jun/202324/8	73 / NC/3/MEET/Jun/202324/8	73 / NC/3/MEET/Jun/202324/8	73 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		HUMAN PHARMA LABS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00000030AM24
RA File Number		08AX04002228 AM23
Licence No and<br>Date		0811007805/06/04/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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>CLOBETASOL PROPIONATE<br>1 Kg.<br>1<br>BETAMETHASONE<br>1.00 Kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	CLOBETASOL PROPIONATE		1 Kg.	1	BETAMETHASONE	1.00 Kg.

UDIN00204730AM24

OL PROPIONATE 1 Kg. 1 BETAMETHASONE 1.00 Kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||CLOBETASOL PROPIONATE||1 Kg.|1|BETAMETHASONE|1.00 Kg.|

UDIN00204730AM24

Case No.	74 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000031AM24
RA File Number	08AX04002207 AM23
Licence No and<br>Date	0811007809/06/04/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the
export products and statement of export import of the Authorization.

Case No.	75 / NC/3/MEET/Jun/202324/8	75 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000033AM24
RA File Number	08AX04002165 AM23
Licence No and<br>Date	0811007811/06/04/2023
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.
CLOZAPINE	TABLETS 25 MG(EACH	<br>1 Number	1	CLOZAPINE EP / BP / IP / USP /	25.50 mg / tablet
UNCOATED	TABLET<br>CONTAINS:			PH. EUR.
CLOZAPINE PH.EUR.

roduct||Qty.|Sl. No.|Import Items|Qty.|| |CLOZAPINE|TABLETS 25 MG(EACH| 1 Number|1|CLOZAPINE EP / BP / IP / USP /|25.50 mg / tablet|| |UNCOATED|TABLET CONTAINS:|||PH. EUR.||| |CLOZAPINE PH.EUR. 25 MG)||||||| |CLOZAPINE|TABLETS 50 MG(EACH| 1 Number|2|CLOZAPINE EP / BP / IP / USP /|51.00 mg / tablet|| |UNCOATED|TABLET CONTAINS:|||PH. EUR.||| |CLOZAPINE PH.EUR. 50 MG)||||||| |CLOZAPINE|TABLETS 100 MG(EACH| 1 Number|3|CLOZAPINE EP / BP / IP / USP /|102.0 mg / tablet|| |UNCOATED|TABLET CONTAINS:|||PH. EUR.|||

UDIN00204730AM24

	CLOZAPINE PH.EUR. 100 MG)

	CLOZAPINE TABLETS 200 MG(EACH<br>	1 Number	4	CLOZAPINE EP / BP / IP / USP /<br>	204.00 mg / tablet
	UNCOATED TABLET CONTAINS:<br>CLOZAPINE PHEUR 200 MG [IN			PH. EUR.
	..
	WHICH<br>ACTIVE<br>INGREDIENT<br>
CLOZAPINE USED IS 191.250 KGS.])	CLOZAPINE USED IS 191.250 KGS.])

RA d tk fth ti b dii f NC
concerne may ae urer necessary acon as per aove ecson o .

IENT ||||| |CLOZAPINE USED IS 191.250 KGS.])|CLOZAPINE USED IS 191.250 KGS.])||||| ||||||| |RA d tk fth ti b dii f NC|||||| |concerne may ae urer necessary acon as per aove ecson o .||||||

Case No.	Case No.	76 / NC/3/MEET/Jun/202324/8	76 / NC/3/MEET/Jun/202324/8	76 / NC/3/MEET/Jun/202324/8	76 / NC/3/MEET/Jun/202324/8	76 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		AVIK PHARMACEUTICAL LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number
		HQRNORM APPLY 00000034AM24
RA File Number		52AX04001820 AM23
Licence No and Date		5211004538/06/04/2023

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. 3/82-ALC4/2020dated07/08/2020against advance authorizationNo.0310831890dated27/09/2019, it was<br>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.


	TRIAMICINOLONE<br>ACETONIDE		1 kg	1	3,20-DIOXOPREGNA-	1.00 kg.
	IP/EP/BP/USP(TRIAMICINOLONE<br>ACETONIDE IP/EP/BP/USP)				1,4,9(11),16 - TETRAEN - 21-<br>YLACETATE (3 TR)


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

RIAMICINOLONE ACETONIDE IP/EP/BP/USP)||||1,4,9(11),16 - TETRAEN - 21- YLACETATE (3 TR)|| |||||||| |||||||| |RA concerned may take further necessary action as per above decision of NC.|||||||

Case No.	77 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000035AM24
RA File Number	07AX04000011 AM24
Licence No and	0711007283/06/04/2023

UDIN00204730AM24

Date

Norms Committee Decision:

The case is under consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the export products and statement of export import of the Authorization.

Case No.	78 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000059AM24
RA File Number	03AX04006327 AM23
Licence No and<br>Date	0311022677/10/04/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the
export products and statement of export import of the Authorization.

Case No.<br>79 / NC/3/MEET/Jun/202324/8
Case Status<br>Case Approved
Party Name<br>AMINES AND PLASTICIZERS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number<br>HQRNORM APPLY 00000062AM24
RA File Number<br>03AX04006344 AM23
Licence No and<br>Date<br>0311022681/10/04/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix		ad-hoc norms under Para 4.07 of HBP Vol. I as per
details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty.
DI-BUTYL ETHANOLAMINE<br>1 kg.	1	DI BUTYL AMINE	0.793 kg.
RA concerned may take further necessary action as per above decision of NC.

| |Export Product Qty.|Sl. No.|Import Items|Qty.|| |DI-BUTYL ETHANOLAMINE 1 kg.|1|DI BUTYL AMINE|0.793 kg.|| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No.	80 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred

UDIN00204730AM24

Party Name	VINS BIOPRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000068AM24
RA File Number	09AX04001155 AM23
Licence No and<br>Date	0911004801/10/04/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to refer the case toDeptt. of Bio-Technologyfor
obtaining their comments.

Case No.	81 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000075AM24
RA File Number	08AX04002209 AM23
Licence No and<br>Date	0811007825/10/04/2023
Norms Committee Decision:
The case is under consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the
export products and statement of export import of the Authorization.

|The case is under consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the|| |export products and statement of export import of the Authorization.||

Case No.	82 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	HONOUR LAB LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000079AM24
RA File Number	09AX04001142 AM23
Licence No and<br>Date	0911004803/10/04/2023
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.
Ethanediamide,	N1-(5-chloro-2-pyridinyl)-N2-	1 kg.	1	N-((1R,2S,5S)-2-Amino-5-	1.17 kg.
[(1S,2R,4S)-4-[(dimethylamino) carbonyl]-2-				(Dimethyllamino) carbonyl)
[[(4,5,6,7-tetrahydro-5- Methylthi (Diloxanide				cyclohexyl) carbamic acid, 1,1-

UDIN00204730AM24

7 kg.|| |[(1S,2R,4S)-4-[(dimethylamino) carbonyl]-2-||||(Dimethyllamino) carbonyl)||| |[[(4,5,6,7-tetrahydro-5- Methylthi (Diloxanide||||cyclohexyl) carbamic acid, 1,1-|||

UDIN00204730AM24

	dimethyl ester, Ethanedioate
2	2-[(5-Chloro-2-Pyridinyl)-2-<br>oxoacetate acid, Ethyl Ester<br>hydrochloride	0.80 kg.
3	4,5,6,7-tetrahydro-5-<br>methlthiazolo[5,4-c] pyride-2-<br>carboxylic acid Hydrochloride	0.50 kg.
4	Tetra Hydro Furan	2.85 kg.
5	1-(3-Dimethylaminopyl)-3-<br>Ethylcarbodiimide Hydrochloride	0.90 kg.
6	Dimethyl formamide	2.50 kg.
7	N,N-Di Isopropyl ethyl amine	0.72 kg.

kg.| ||||4|Tetra Hydro Furan|2.85 kg.| ||||5|1-(3-Dimethylaminopyl)-3- Ethylcarbodiimide Hydrochloride|0.90 kg.| ||||6|Dimethyl formamide|2.50 kg.| ||||7|N,N-Di Isopropyl ethyl amine|0.72 kg.|

Case No.	83 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000093AM24
RA File Number	03AX04000048 AM24
Licence No and<br>Date	0311022711/11/04/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Decision:Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise<br>percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.<br>Details of indigenous input with quantity.<br>v.<br>Sample of shipping bills and bill of entry of the export products along with statement of Input-output as per export<br>documents of the said authorization.<br>vi.

UDIN00204730AM24

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. vi.||

UDIN00204730AM24

Case No.	Case No.	84 / NC/3/MEET/Jun/202324/8	84 / NC/3/MEET/Jun/202324/8	84 / NC/3/MEET/Jun/202324/8	84 / NC/3/MEET/Jun/202324/8	84 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		AMNEAL INJECTABLES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00000096AM24
RA File Number		08AX04002081 AM23
Licence No and<br>Date		0811007830/11/04/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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>Triamcinolone<br>Acetonide<br>Injection,<br>USP<br>40mg/mL(Triamcinolone Acetonide Injection, USP<br>40mg/mL)<br>1 Vial<br>1<br>TRIAMCINOLONE<br>ACETONIDE<br>MICRONIZED STERILE<br>44 mg / 1 ml. Injection<br>Triamcinolone<br>Acetonide<br>Injection,<br>USP<br>200mg/5mL(Triamcinolone Acetonide Injection,<br>USP 200mg/5mL)<br>1 Vial<br>2<br>TRIAMCINOLONE<br>ACETONIDE<br>MICRONIZED STERILE<br>220 mg / 5 ml.<br>Injection<br>Triamcinolone<br>Acetonide<br>Injection,<br>USP<br>400mg/10mL(Triamcinolone Acetonide Injection,<br>USP 400mg/10mL)<br>1 Vial<br>3<br>TRIAMCINOLONE<br>ACETONIDE<br>MICRONIZED STERILE<br>440.0 mg.

Triamcinolone Acetonide Injection, USP 400mg/10mL(Triamcinolone Acetonide Injection, USP 400mg/10mL) 1 Vial 3 TRIAMCINOLONE ACETONIDE MICRONIZED STERILE 440.0 mg. / 10 ml. Injection RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Triamcinolone Acetonide Injection, USP 40mg/mL(Triamcinolone Acetonide Injection, USP 40mg/mL)|| 1 Vial|1|TRIAMCINOLONE ACETONIDE MICRONIZED STERILE|44 mg / 1 ml. Injection| ||Triamcinolone Acetonide Injection, USP 200mg/5mL(Triamcinolone Acetonide Injection, USP 200mg/5mL)|| 1 Vial|2|TRIAMCINOLONE ACETONIDE MICRONIZED STERILE|220 mg / 5 ml. Injection| ||Triamcinolone Acetonide Injection, USP 400mg/10mL(Triamcinolone Acetonide Injection, USP 400mg/10mL)|| 1 Vial|3|TRIAMCINOLONE ACETONIDE MICRONIZED STERILE|440.0 mg. / 10 ml. Injection| ||RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	85 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	LITMUS ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000097AM24
RA File Number	03AX04006355 AM23
Licence No and<br>Date	0311022717/11/04/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-

| |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:-||

UDIN00204730AM24

i. Step wise manufacturing process.
ii. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.
iii. Complete technical details as per Annexure to Appendix 4E for chemical products.
iv. Stoichiometric balance between import and export on molar basis.
Details of indigenous input with quantity.
v.
vi. 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.	86 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	GENERIC HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000102AM24
RA File Number	31AX04000374 AM23
Licence No and<br>Date	3111002194/11/04/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the
export products and statement of export import of the Authorization.

The case is under*|consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the| |export products and statement of export import of the Authorization.||

Case No.	87 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000105AM24
RA File Number	07AX04000010 AM24
Licence No and<br>Date	0711007318/11/04/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import
product in meeting No.NC/3/MEET/Feb/202223/20dated24/02/2023against advance authorizationNo.0711005409
dated06/10/2022,	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(PREMIX OF		6300 kg.	1	NIFUROXAZIDE EP/BP	3512.376 kg.
NIFUROXAZIDE (1 GM OF PREMIX
CONTAINS 0.552 GMS OF NIFUROXAZIDE)

t||Qty.|Sl. No.|Import Items|Qty.|| |PREMIX OF NIFUROXAZIDE(PREMIX OF||6300 kg.|1|NIFUROXAZIDE EP/BP|3512.376 kg.|| |NIFUROXAZIDE (1 GM OF PREMIX||||||| |CONTAINS 0.552 GMS OF NIFUROXAZIDE)|||||||

Case No.	87 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000105AM24
RA File Number	07AX04000010 AM24
Licence No and<br>Date	0711007318/11/04/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import
product in meeting No.NC/3/MEET/Feb/202223/20dated24/02/2023against advance authorizationNo.0711005409
dated06/10/2022,	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(PREMIX OF		6300 kg.	1	NIFUROXAZIDE EP/BP	3512.376 kg.
NIFUROXAZIDE (1 GM OF PREMIX
CONTAINS 0.552 GMS OF NIFUROXAZIDE)

UDIN00204730AM24

Net content 3477.60KG)

ROXAZIDE(PREMIX OF||6300 kg.|1|NIFUROXAZIDE EP/BP|3512.376 kg.|| |NIFUROXAZIDE (1 GM OF PREMIX||||||| |CONTAINS 0.552 GMS OF NIFUROXAZIDE)|||||||

UDIN00204730AM24

Net content 3477.60KG)

Case No.	Case No.	88 / NC/3/MEET/Jun/202324/8	88 / NC/3/MEET/Jun/202324/8	88 / NC/3/MEET/Jun/202324/8	88 / NC/3/MEET/Jun/202324/8	88 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00000110AM24
RA File Number		08AX04002256 AM23
Licence No and Date		0811007841/11/04/2023
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/Jun/202324/6dated14/06/2023against advance authorizationNo.0811007285dated10/02/2023, it<br>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<br>less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>HYDROXYCHLOROQUINE SULFATE TABLETS USP<br>100 MG(EACH FILM COATED TABLET CONTAINS:<br>HYDROXYCHLOROQUINE SULFATE USP 100MG<br>EQ. TO HYDROXYCHLOROQUINE 77.5 MG)<br>1 Number<br>1<br>HYDROXYCHLOROQUINE SULFATE EP<br>/ BP / IP / USP / PH. EUR.<br>102.00 mg.<br>HYDROXYCHLOROQUINE SULFATE TABLETS USP<br>200 MG(EACH FILM COATED TABLET CONTAINS:<br>HYDROXYCHLOROQUINE SULFATE USP 200MG<br>EQ.

CHLOROQUINE SULFATE EP / BP / IP / USP / PH. EUR. 102.00 mg. HYDROXYCHLOROQUINE SULFATE TABLETS USP 200 MG(EACH FILM COATED TABLET CONTAINS: HYDROXYCHLOROQUINE SULFATE USP 200MG EQ. TO HYDROXYCHLOROQUINE 155 MG) 1 Number 2 HYDROXYCHLOROQUINE SULFATE EP / BP / IP / USP / PH. EUR. 204.00 mg. HYDROXYCHLOROQUINE SULFATE TABLETS USP 300 MG(EACH FILM COATED TABLET CONTAINS: HYDROXYCHLOROQUINE SULFATE USP 300MG EQ. TO HYDROXYCHLOROQUINE 232.50 mg) 1 Number 3 HYDROXYCHLOROQUINE SULFATE EP / BP / IP / USP / PH. EUR. 306.00 mg. HYDROXYCHLOROQUINE SULFATE TABLETS USP 400 MG(EACH FILM COATED TABLET CONTAINS: HYDROXYCHLOROQUINE SULFATE USP 400MG EQ. TO HYDROXYCHLOROQUINE 310 MG [IN WHICH ACTIVE INGREDIENT HYDROXYCHLOROQUINE SULFATE USED IS 2602.000 KGS.]) 1 Number 4 HYDROXYCHLOROQUINE SULFATE EP / BP / IP / USP / PH. EUR. 408.00 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||HYDROXYCHLOROQUINE SULFATE TABLETS USP 100 MG(EACH FILM COATED TABLET CONTAINS: HYDROXYCHLOROQUINE SULFATE USP 100MG EQ. TO HYDROXYCHLOROQUINE 77.5 MG)||1 Number|1|HYDROXYCHLOROQUINE SULFATE EP / BP / IP / USP / PH. EUR.| 102.00 mg.| ||HYDROXYCHLOROQUINE SULFATE TABLETS USP 200 MG(EACH FILM COATED TABLET CONTAINS: HYDROXYCHLOROQUINE SULFATE USP 200MG EQ. TO HYDROXYCHLOROQUINE 155 MG)||1 Number|2|HYDROXYCHLOROQUINE SULFATE EP / BP / IP / USP / PH.

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. Pilocarpine HCL Eye Drops BP 4.0%(Pilocarpine HCL Eye Drops BP 4.0% (" Each 15 ml contains : Pilocarpine HCL Eye Drops BP 4.0% w/v Benzalkonium Chloride BP 0.01% w/v Water for Injections BP q.s.) (net content of Pilocarpine HCL not less than 27.523 kgs)) 45872.0 Numbers 1 Pilocarpine HCL 28.074 Kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Pilocarpine HCL Eye Drops BP 4.0%(Pilocarpine HCL Eye Drops BP 4.0% (" Each 15 ml contains : Pilocarpine HCL Eye Drops BP 4.0% w/v Benzalkonium Chloride BP 0.01% w/v Water for Injections BP q.s.) (net content of Pilocarpine HCL not less than 27.523 kgs))||45872.0 Numbers|1|Pilocarpine HCL|28.074 Kg.|

UDIN00204730AM24

ium Chloride BP 0.01% w/v Water for Injections BP q.s.) (net content of Pilocarpine HCL not less than 27.523 kgs))||45872.0 Numbers|1|Pilocarpine HCL|28.074 Kg.|

UDIN00204730AM24

Case No.	Case No.	100 / NC/3/MEET/Jun/202324/8	100 / NC/3/MEET/Jun/202324/8	100 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		CLAROID PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00000180AM24
RA File Number		08AX04002022 AM23
Licence No and<br>Date		0811007855/13/04/2023
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. 7/82-ALC4/2015 dated 24/07/2015against advance authorizationNo.0710107918 dated 25/03/2015,it was<br>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:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Ciprofloxacin 500 mg Tablets (33898305<br>Tablets)(Ciprofloxacin Hydrochloride 590 mg is<br>equivalent to Ciprofloxacin 500 mg)<br>1 Number<br>1<br>Ciprofloxacin Hydrochlorid<br>550 mg / tablet<br>RA concerned may take further necessary action as per above decision of NC
	Export Product		Qty.	Sl.

Ciprofloxacin 500 mg) 1 Number 1 Ciprofloxacin Hydrochlorid 550 mg / tablet RA concerned may take further necessary action as per above decision of NC||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Ciprofloxacin 500 mg Tablets (33898305 Tablets)(Ciprofloxacin Hydrochloride 590 mg is equivalent to Ciprofloxacin 500 mg)||1 Number|1|Ciprofloxacin Hydrochlorid|550 mg / tablet| ||concerned may take further necessary action as per above decision of NC||||||

Case No.	101 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	OCTOCHEM PHARMA AND FLAVOURS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000183AM24
RA File Number	05AX04000079 AM24
Licence No and<br>Date	0511018315/13/04/2023
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/May/202324/4 dated 26.05.2023against advance authorizationNo.0310835906 dated 25.04.2020,<br>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<br>is less:-

UDIN00204730AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
Menthol / Menthol Crystals	1 Kg	1	L Menthol	1.02 Kg.

lied by the firm, whichever is less:-||

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Export Product	Qty.	Sl. No.	Import Items	Qty.
Menthol / Menthol Crystals	1 Kg	1	L Menthol	1.02 Kg.

Case No.	102 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	AMINES AND PLASTICIZERS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000207AM24
RA File Number	03AX04006365 AM23
Licence No and<br>Date	0311022817/17/04/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>i.
stage wise percentage yields on molar basis.
Also, sample shipping bills and bill of entry of the export products and statement of export import of the<br>ii.
Authorization.

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

t of the** ii.|| |Authorization.||

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

Case No.<br>103 / NC/3/MEET/Jun/202324/8
Case Status<br>Case Approved
Party Name<br>TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number<br>HQRNORM APPLY 00000216AM24
RA File Number<br>08AX04000066 AM24
Licence No and<br>Date<br>0811007877/17/04/2023
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.

UDIN00204730AM24

CLOZAPINE TABLETS (ZIPROC 25MG) (EACH	1 Number	1	CLOZAPINE BP	25.50 mg / tablet
UNCOATED TABLET CONTAINS : CLOZAPINE
BP 25 MG NET CONTENT OF CLOZAPINE BP
SHOULD NOT BE LESS THAN 6.250 KGS. IN
EXPORT ITEM)
CLOZAPINE TABLETS (ZIPROC 100MG) (EACH	1 Number	2	CLOZAPINE BP	102.00 mg / tablet
UNCOATED TABLET CONTAINS : CLOZAPINE
BP 100 MG NET CONTENT OF CLOZAPINE BP
SHOULD NOT BE LESS THAN 666.000 KGS. IN
EXPORT ITEM)

1 Number|2|CLOZAPINE BP|102.00 mg / tablet| |UNCOATED TABLET CONTAINS : CLOZAPINE||||| |BP 100 MG NET CONTENT OF CLOZAPINE BP||||| |SHOULD NOT BE LESS THAN 666.000 KGS. IN||||| |EXPORT ITEM)|||||

Case No.	104 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	S KANT CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000218AM24
RA File Number	03AX04000033 AM24
Licence No and<br>Date	0311022832/17/04/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the
export products and statement of export import of the Authorization.

Case No.<br>105 / NC/3/MEET/Jun/202324/8
Case Status<br>Case Approved
Party Name<br>ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number<br>HQRNORM APPLY 00000231AM24
RA File Number<br>08AX04002261 AM23
Licence No and<br>Date<br>0811007887/17/04/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import
product in meetingNo. 2/82-ALC4/2020dated10/07/2020against advance authorizationNo.0810147575 dated
03/04/2020, 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:-

UDIN00204730AM24

dated| |03/04/2020, 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:-|

UDIN00204730AM24

Sl. No.	Export Product	Qty.
1	AMIODARONE HYDROCHLORIDE TABLETS USP 100 MG((ACTIVE INGREDIENT: AMIODARONE	1 Number
	HYDROCHLORIDE USP - NET WT. 1979.973 KGS))
2	AMIODARONE HYDROCHLORIDE TABLETS USP 200 MG((ACTIVE INGREDIENT: AMIODARONE	1 Number
	HYDROCHLORIDE USP - NET WT. 1079.364 KGS))
3	AMIODARONE HYDROCHLORIDE TABLETS USP 400 MG((ACTIVE INGREDIENT: AMIODARONE	1 Number
	HYDROCHLORIDE USP - NET WT. 2309.904 KGS))

Sl. No.	Import Items	For export of 1 Number Tablet	For export of 1 Number Tablet	For export of 1 Number Tablet
		100 mg	200 mg	400 mg
1<br>	AMIODARONE HYDROCHLORIDE USP	102.0 mg	204.0 mg	408.0 mg
2<br>	CORN STARCH NF	21.375 mg	42.75 mg	85.50 mg
3<br>	LACTOSE MONOHYDRATE NF/PH.EU	35.00 mg	70.00 mg	140.00 mg
4<br>	MAGNESIUM STEARATE PH.E/NF/JP	1.25 mg	2.50 mg	5.00 mg
5<br>	POVIDONE USP (K-30)	7.50 mg	15.00 mg	30.00 mg
6<br>	SODIUM STARCH GLYCOLATE NF	9.00 mg	18.00 mg	36.00 mg

Case No.	106 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000232AM24

UDIN00204730AM24

UDIN00204730AM24

RA File Number	RA File Number	05AX04003663 AM23	05AX04003663 AM23	05AX04003663 AM23	05AX04003663 AM23	05AX04003663 AM23
Licence No and<br>Date		0511018335/17/04/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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>Cefuroxime Sodium Sterile<br>1 Kg.<br>1<br>Cefuroxime Acid<br>1.04 Kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Cefuroxime Sodium Sterile		1 Kg.	1	Cefuroxime Acid	1.04 Kg.
	concerned may take further necessary action as per above decision of NC.

Case No.	107 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	MOREPEN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000238AM24
RA File Number	05AX04000110 AM24
Licence No and<br>Date	0511018340/17/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the<br>export products and statement of export import of the Authorization.

r>The case is under consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the export products and statement of export import of the Authorization.||

Case No.	108 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	MOREPEN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000239AM24
RA File Number	05AX04000111 AM24
Licence No and<br>Date	0511018341/17/04/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-

UDIN00204730AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
ROSUVASTATIN CALCIUM	1 kg	1	tert-Butyl-2-((4R,6S)-6-((E)-2-(4(-(4-<br>fluorophenyl)-6-isopropyl-2-[N-methyl<br>(methylsulphonyl)amino] pyrimidin-5-yl) viny	1.30 kg.
		2	Methanol	2.53 kg.
		3	tert-butyl methyl ether (MTBE)	0.79 kg.

(4R,6S)-6-((E)-2-(4(-(4- fluorophenyl)-6-isopropyl-2-[N-methyl (methylsulphonyl)amino] pyrimidin-5-yl) viny|1.30 kg.| ||||2|Methanol|2.53 kg.| ||||3|tert-butyl methyl ether (MTBE)|0.79 kg.|

Case No.	109 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000243AM24
RA File Number	04AX04000012 AM24
Licence No and<br>Date	0411005247/17/04/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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>CIPROFLOXACIN TABLETS USP<br>500mg(CIPROFLOXACIN TABLETS USP<br>500mg (8000x100x10`s )- 8000000<br>Nos - 4000 KGS)<br>1 Number<br>1<br>CIPROFLOXACIN<br>HYDROCHLORIDE USP<br>500 mg. / tablet<br>RA concerned may take further necessary action as per above decision of NC

Case No.	110 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	ZYDUS LIFESCIENCES LIMITED
MeetingNumber	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023

UDIN00204730AM24

No.	110 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	ZYDUS LIFESCIENCES LIMITED
MeetingNumber	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023

UDIN00204730AM24

and Date	and Date
HQ File Number		HQRNORM APPLY 00000245AM24
RA File Number		08AX04002224 AM23
Licence No and
Date		0811007903/18/04/2023
Norms Committee<br>		Decision:<br>
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Par<br>details given below or as applied by the firm, whichever is less:-						a 4.07 of HBP Vol. I as per

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

	FLUOCINONI	E TOPICAL SOLUTION	2624400	1	FLUOCINONIDE USP		8031 k
	<br>USP 0.05% (60	<br>ML) (0.5 MG/ML)	.<br>Numbers				. g.
	((ACTIVE ING<br>FLUOCINONI<br>	REDIENT:<br>DE USP - NET WT. 7.873<br>		2	60ML18-410 FLAT OVAL<br>		Relevant as per<br>
	KGS FOR 2624	40 NOS))			HDPE BOTTLE		Packing Policy


				3	.015 NATURAL LDPE<br>DROPPER TIP		Relevant as per<br>Packing Policy

				4	18MM WHITE PPCAP (FOR<br>DROPPER TIP)		<br>Relevant as per<br>Packing Policy

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



Case No.		111 / NC/3/MEET/Jun/202324/8

Case Status		Case Deferred
Party Name		ZYDUS LIFESCIENCES LIMITED
Meeting Number		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
and Date

/202324/8|||||| ||||||||| |Case Status||Case Deferred|||||| |Party Name||ZYDUS LIFESCIENCES LIMITED|||||| |Meeting Number||NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023|||||| |and Date|||||||| ||||||||| |HQ File Number||HQRNORM APPLY 00000266AM24|||||| |RA File Number||08AX04002260 AM23|||||| |Licence No and Date||0811007905/18/04/2023|||||| |Norms Committee Decision: The case is under consideration for want of comments of TE. Also sample shipping bill||||||s and bill of entry of the|| |, export products and statement of export import of the Authorization.|||||||| ||||||||| ||||||||| |Case No.||112 / NC/3/MEET/Jun/202324/8|||||| |Case Status||Case Approved|||||| |Party Name||UNIMAX LABORATORIES||||||

Case No.	111 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000266AM24
RA File Number	08AX04002260 AM23
Licence No and<br>Date	0811007905/18/04/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the
export products and statement of export import of the Authorization.

Case No.	112 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	UNIMAX LABORATORIES

UDIN00204730AM24

and statement of export import of the Authorization.**||

Case No.	112 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	UNIMAX LABORATORIES

UDIN00204730AM24

Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00000270AM24
RA File Number		05AX04000038 AM24
Licence No and<br>Date		0511018168/18/04/2023
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/Jan/202021/4dated 12/02/2021 against advance authorizationNo.0310835458 dated 17/03/2020, it<br>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<br>less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Amoxicillin Capsules BP, 500mg (Each capsules<br>contains : : Amoxicillin<br>(As Amoxicillin Trihydrate BP))<br>1 Number<br>1<br>Amoxicillin Trihydrate<br>Compacted BP<br>585.282 mg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.<br>	Sl.

ate BP)) 1 Number 1 Amoxicillin Trihydrate Compacted BP 585.282 mg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty. |Sl. No.|Import Items|Qty.| ||Amoxicillin Capsules BP, 500mg (Each capsules contains : : Amoxicillin (As Amoxicillin Trihydrate BP))|| 1 Number |1|Amoxicillin Trihydrate Compacted BP|585.282 mg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	Case No.	113 / NC/3/MEET/Jun/202324/8	113 / NC/3/MEET/Jun/202324/8	113 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		HOSTER LABS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00000274AM24
RA File Number		09AX04000033 AM24
Licence No and<br>Date		0911004837/18/04/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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>IMINO DI BENZYL<br>0.91 kg.<br>10-METHOXY-5H-DIBENZO[B.F]<br>AZEPINE<br>(Diloxanide<br>furoate,<br>Cimetidine,<br>Oxyclozanide,<br>Famotidine: Other)<br>1 Kg.<br>2<br>Triphosgene<br>1.03 kg.
	Export Product		Qty.	Sl.

g. 10-METHOXY-5H-DIBENZO[B.F] AZEPINE (Diloxanide furoate, Cimetidine, Oxyclozanide, Famotidine: Other) 1 Kg. 2 Triphosgene 1.03 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||10-METHOXY-5H-DIBENZO[B.F] AZEPINE (Diloxanide furoate, Cimetidine, Oxyclozanide, Famotidine: Other)||1 Kg.|1|IMINO DI BENZYL|0.91 kg.| |||||2|Triphosgene|1.03 kg.|

UDIN00204730AM24

Case No.<br>114 / NC/3/MEET/Jun/202324/8
Case Status<br>Case Approved
Party Name<br>FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number<br>HQRNORM APPLY 00000276AM24
RA File Number<br>04AX04000046 AM24
Licence No and<br>Date<br>0411005256/18/04/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07			of HBP Vol. I as per
details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items		Qty.
CIPROFLOXACIN TABLETS USP<br>1 Number	1	CIPROFLOXACIN		500 mg / tablet
500mg(CIPROFLOXACIN TABLETS USP		HYDROCHLORIDE USP
500mg (10000x100x10`s) - 10000000 Nos -5000
KGS)
RA concerned may take further necessary action as per above decision of NC.

g(CIPROFLOXACIN TABLETS USP||HYDROCHLORIDE USP|||| |500mg (10000x100x10`s) - 10000000 Nos -5000|||||| |KGS)|||||| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	115 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	HONOUR LAB LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000285AM24
RA File Number	09AX04001141 AM23
Licence No and<br>Date	0911004840/19/04/2023
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:-

UDIN00204730AM24

|Export Product Qty. Sl. No. Import Items Qty. (in kg.) 1 N-((1R,2S,5S)-2-Amino-5- (Dimethyllamino) carbonyl) cyclohexyl) carbamic acid, 1,1-dimethyl ester, Ethanedioate 1.17 2 2-[(5-Chloro-2-Pyridinyl)-2-oxoacetate acid, Ethyl Ester hydrochloride 0.80 3 4,5,6,7-tetrahydro-5-methlthiazolo[5,4-c] pyride-2-carboxylic acid Hydrochloride 0.50 4 Tetra Hydro Furan 2.85 5 1-(3-Dimethylaminopyl)-3- Ethylcarbodiimide Hydrochloride 0.90 6 Dimethyl formamide 2.50 Ethanediamide, N1-(5-chloro-2-pyridinyl)- N2-[(1S,2R,4S)-4-[(dimethylamino) carbonyl]-2-[[(4,5,6,7-tetrahydro-5- Methylthi (Diloxanide furoate, Cimetidine, Oxyclozanide, Famotidine: Other) 1 Kg. 7 N,N-Di Isopropyl ethyl amine 0.72 RA concerned may take further nec

Export Product	Qty.	Sl. No.	Import Items	Qty.<br>(in kg.)
Ethanediamide, N1-(5-chloro-2-pyridinyl)-<br>N2-[(1S,2R,4S)-4-[(dimethylamino)<br>carbonyl]-2-[[(4,5,6,7-tetrahydro-5-<br>Methylthi (Diloxanide furoate, Cimetidine,<br>Oxyclozanide, Famotidine: Other)	1 Kg.	1	N-((1R,2S,5S)-2-Amino-5-<br>(Dimethyllamino) carbonyl) cyclohexyl)<br>carbamic acid, 1,1-dimethyl ester,<br>Ethanedioate	1.17
		2	2-[(5-Chloro-2-Pyridinyl)-2-oxoacetate<br>acid, Ethyl Ester hydrochloride	0.80
		3	4,5,6,7-tetrahydro-5-methlthiazolo[5,4-c]<br>pyride-2-carboxylic acid Hydrochloride	0.50
		4	Tetra Hydro Furan	2.85
		5	1-(3-Dimethylaminopyl)-3-<br>Ethylcarbodiimide Hydrochloride	0.90
		6	Dimethyl formamide	2.50
		7	N,N-Di Isopropyl ethyl amine	0.72

Hydrochloride|0.50| ||||4|Tetra Hydro Furan|2.85| ||||5|1-(3-Dimethylaminopyl)-3- Ethylcarbodiimide Hydrochloride|0.90| ||||6|Dimethyl formamide|2.50| ||||7|N,N-Di Isopropyl ethyl amine|0.72|

Case No.	Case No.	116 / NC/3/MEET/Jun/202324/8	116 / NC/3/MEET/Jun/202324/8	116 / NC/3/MEET/Jun/202324/8	116 / NC/3/MEET/Jun/202324/8	116 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		HONOUR LAB LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00000286AM24
RA File Number		09AX04001128 AM23
Licence No and<br>Date		0911004841/19/04/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Qty.<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items
	Export Product		Qty.	Sl. No.	Import Items	Qty.

UDIN00204730AM24

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

UDIN00204730AM24

				(in kg.)
(2R,3R,4R,5S,6S)-2-(acetoxymethyl)-6-(4-<br>chloro-3-(4-ethoxybenzyl)phenyl)tetrahydro-<br>2H-pyran-3,4,5-triyl Triacetate (Diloxanide<br>furoate, Cimetidine, Oxyclozanide, Famotidine:<br>Other )	1 Kg.	1	5-Bromo-2-chlorobenzoic Acid	1.105
		2	Trimethyl silyl chloride	2.60
		3	(3R,4S,5S,6R)-3,4,5-Trihydroxy-6-<br>(hydroxy methyl) tetrahydro-2H-pyran-2-<br>one (THO)/Glucono-Delta-Lactone	0.707
		4	Triethyl silane	2.11
		5	Tetra hydro furan	5.00
		6	Ethyl phenyl ether/Phenetole	0.707
		7	n-Methylmorpholine	3.00

tetrahydro-2H-pyran-2- one (THO)/Glucono-Delta-Lactone|0.707| ||||4|Triethyl silane|2.11| ||||5|Tetra hydro furan|5.00| ||||6|Ethyl phenyl ether/Phenetole|0.707| ||||7|n-Methylmorpholine|3.00|

Case No.	Case No.	117 / NC/3/MEET/Jun/202324/8	117 / NC/3/MEET/Jun/202324/8	117 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		COHANCE LIFESCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00000289AM24
RA File Number		09AX04000024 AM24
Licence No and<br>Date		0911004848/19/04/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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>Isosorbide Mononitrate Extended-Relesed<br>Tablets USP 30-MG(Each Extended-<br>Released Tablets Contains : Diluted ISMN<br>(40% Diluted With Lactose Monohydate )<br>1 Number<br>1<br>IS5MN 60 % LACTOSE 200 G<br>40% (containing 60% Isosorbide<br>Mononitrate and 40% Lactose)<br>50.90 mg.
	Export Product		Qty.	Sl.

br>(40% Diluted With Lactose Monohydate ) 1 Number 1 IS5MN 60 % LACTOSE 200 G 40% (containing 60% Isosorbide Mononitrate and 40% Lactose) 50.90 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Isosorbide Mononitrate Extended-Relesed Tablets USP 30-MG(Each Extended- Released Tablets Contains : Diluted ISMN (40% Diluted With Lactose Monohydate )||1 Number|1|IS5MN 60 % LACTOSE 200 G 40% (containing 60% Isosorbide Mononitrate and 40% Lactose)|50.90 mg.|

UDIN00204730AM24

USP Equivelent to ISMN 30Mg Colour : Titanium Dioxide Excipient q.s. Net Content of Active Ingredient ISMN Should Not Be Less than 3868.40-Kgs)

Case No.	118 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	COHANCE LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000290AM24
RA File Number	09AX04000023 AM24
Licence No and<br>Date	0911004849/19/04/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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>Isosorbide Mononitrate Extended-Relesed<br>Tablets USP 120-MG(Each Extended<br>Released Tablets Contains : Diluted ISMN<br>(40% Diluted With Lactose Monohydate )<br>USP Equivelent to ISMN 120Mg Colour :<br>Titanium Dioxide Excipient q.s.

d Tablets USP 120-MG(Each Extended Released Tablets Contains : Diluted ISMN (40% Diluted With Lactose Monohydate ) USP Equivelent to ISMN 120Mg Colour : Titanium Dioxide Excipient q.s. Net Content of Active Ingredient ISMN Should Not Be Less than 1771.35-Kgs) 1 Number 1 IS5MN 60% LACTOSE 200 G 40 % (containing 60% Isosorbide Mononitrate and 40% Lactose) 203.60 mg / tablet RA concerned may take further necessary action as per above decision of NC.||

Case No.	119 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	COHANCE LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000291AM24
RA File Number	09AX04000022 AM24

UDIN00204730AM24

Licence No and 0911004850/19/04/2023 Date Norms Committee Decision:

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
Isosorbide Mononitrate Extended-Relesed<br>Tablets USP 60-MG(Each Extended-<br>Released Tablets Contains : Diluted ISMN<br>(40% Diluted With Lactose Monohydate )<br>USP Equivelent to ISMN 60Mg Colour :<br>Titanium Dioxide Excipient q.s. Net<br>Content of Active Ingredient ISMN Should<br>Not Be Less than 712.60-Kgs)	1 Number	1	IS5MN 60 % LACTOSE<br>200 G40% (containing 60%<br>Isosorbide Mononitrate and<br>40% Lactose)	101.80 mg. / tablet

Case No.	120 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000292AM24
RA File Number	03AX04000045 AM24
Licence No and<br>Date	0311022935/19/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the<br>export products and statement of export import of the Authorization.

Case No.	121 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	AVIK PHARMACEUTICAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000310AM24
RA File Number	52AX04000016 AM24
Licence No and<br>Date	5211004602/20/04/2023
Norms Committee Decision:

UDIN00204730AM24

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.
CLOBETASOL PROPIONATE EP/BP/USP	1 Kg.	1	BETAMETHASONE	1.00 kg.

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
CLOBETASOL PROPIONATE EP/BP/USP	1 Kg.	1	BETAMETHASONE	1.00 kg.

Case No.	122 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	HIKAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000312AM24
RA File Number	03AX04000161 AM24
Licence No and<br>Date	0311022971/20/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the<br>export products and statement of export import of the Authorization.

Case No.	Case No.	123 / NC/3/MEET/Jun/202324/8	123 / NC/3/MEET/Jun/202324/8	123 / NC/3/MEET/Jun/202324/8	123 / NC/3/MEET/Jun/202324/8	123 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		AVIK PHARMACEUTICAL LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00000313AM24
RA File Number		52AX04000017 AM24
Licence No and<br>Date		5211004605/20/04/2023
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 meeting No.NC/3/MEET/Apr/202324/1dated28/04/2023against advance authorizationNo. 0311020160 dated 20/12/2022,<br>it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

oduct in meeting No.NC/3/MEET/Apr/202324/1dated28/04/2023against advance authorizationNo. 0311020160 dated 20/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.|

UDIN00204730AM24

BETAMETHASONE DIPROPIONATE EP/BP/USP 1 kg. 1 BETAMETHASONE 0.868 kg.

Case No.	124 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	ZENITH DYEINTERMEDIATES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000315AM24
RA File Number	03AX04000135 AM24
Licence No and<br>Date	0311022977/20/04/2023
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 meeting No.NC/3/MEET/Feb/202223/20dated24/02/2023against advance authorizationNo. 0311018319 dated 03/10/2022,<br>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<br>is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>NAS-5((2-Diazo -1-Napthol-5-Sulfonic Acid, Sodium Salt))<br>1 kg.<br>1<br>Tobias Acid<br>1.20 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Items Qty. NAS-5((2-Diazo -1-Napthol-5-Sulfonic Acid, Sodium Salt)) 1 kg. 1 Tobias Acid 1.20 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	125 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	HERANBA INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000321AM24
RA File Number	03AX04000177 AM24
Licence No and<br>Date	0311022986/20/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the<br>export products and statement of export import of the Authorization.

UDIN00204730AM24

Case No.	126 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	SIDDHARTH CARBOCHEM PRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000322AM24
RA File Number	03AX04000098 AM24
Licence No and<br>Date	0311022987/20/04/2023

| |Meeting Number and Date|NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023| |HQ File Number|HQRNORM APPLY 00000322AM24| |RA File Number|03AX04000098 AM24| |Licence No and Date|0311022987/20/04/2023| |Norms Committee Decision: The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following information/documents from the firm:- Step wise manufacturing process. i. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis. ii. Complete technical details as per Annexure to Appendix 4E for chemical products. iii. Stoichiometric balance between import and export on molar basis. iv. Details of indigenous input with quantity. v. 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 vi.||

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

nts of the said authorization** vi.||

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

Case No.	127 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000325AM24
RA File Number	03AX04000169 AM24
Licence No and<br>Date	0311022998/21/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the<br>export products and statement of export import of the Authorization.

Case No.	128 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000327AM24
RA File Number	34AX04001191 AM23
Licence No and<br>Date	3411003610/21/04/2023

UDIN00204730AM24

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Mar/202223/24 dated 13.04.2023 against advance authorization No. 3411001942 dated 10.03.2022 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

|Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Mar/202223/24 dated 13.04.2023against advance authorization No.3411001942 dated 10.03.2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 Amantadine Hydrochloride USP 102.00 mg 2 Microcrystalline cellulose (Avicel PH301) 106.00 mg 3 Hydroxypropyl Cellulose (Klucel LF) 2.00 mg 4 Croscarmellose Sodium (Ac-Di-Sol) 10.00 mg 5 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 1.00 mg Amantadine Hydrochloride capsules USP 100mg(Amantadine Hydrochloride capsules USP 100mg (Net content of active ingredients 360.00 kgs )) 1 Number Capsule 6 Magnesium Stearate (Vegetable Source) 1.00 mg 7 Amantadine Hydrochloride USP 102.00 mg 8 Microcrystalline Cellulose (Avicel PH 101) 33.65 mg 9 Povidone (Kollidon 90F)

nesium Stearate (Vegetable Source) 1.00 mg 7 Amantadine Hydrochloride USP 102.00 mg 8 Microcrystalline Cellulose (Avicel PH 101) 33.65 mg 9 Povidone (Kollidon 90F) 3.00 mg 10 Lake Pigment HT 5285 FD&C Yellow 6 Sunset Yellow FCF Aluminum Lake 0.300 mg 11 Sodium Starch Glycolate (Type A) (EXPLOTAB) 4.50 mg 12 Povidone (K-30) 3.00 mg 13 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 0.75 mg Amantadine Hydrochloride Tablets USP 100mg(Amantadine Hydrochloride Tablets USP 100mg (Net content of active ingredients 940.00 kgs )) 1 Number Tablet|Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Mar/202223/24 dated 13.04.2023against advance authorization No.3411001942 dated 10.03.2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl.

br>dated 10.03.2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 Amantadine Hydrochloride USP 102.00 mg 2 Microcrystalline cellulose (Avicel PH301) 106.00 mg 3 Hydroxypropyl Cellulose (Klucel LF) 2.00 mg 4 Croscarmellose Sodium (Ac-Di-Sol) 10.00 mg 5 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 1.00 mg Amantadine Hydrochloride capsules USP 100mg(Amantadine Hydrochloride capsules USP 100mg (Net content of active ingredients 360.00 kgs )) 1 Number Capsule 6 Magnesium Stearate (Vegetable Source) 1.00 mg 7 Amantadine Hydrochloride USP 102.00 mg 8 Microcrystalline Cellulose (Avicel PH 101) 33.65 mg 9 Povidone (Kollidon 90F) 3.00 mg 10 Lake Pigment HT 5285 FD&C Yellow 6 Sunset Yellow FCF Aluminum Lake 0.300 mg 11 Sodium Starch Glycolate (Type A) (EXPLOTAB) 4.50 mg 12 Povidone (K-30) 3.00 mg 13 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 0.75 mg Amantadine Hydrochloride Tablets USP 100mg(Amantadine Hydrochloride Tablets USP 100mg (Net content of active ingredients 940.00 kgs )) 1 Number Tablet|Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Mar/202223/24 dated 13.04.2023against advance authorization No.

ed the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Mar/202223/24 dated 13.04.2023against advance authorization No.3411001942 dated 10.03.2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 Amantadine Hydrochloride USP 102.00 mg 2 Microcrystalline cellulose (Avicel PH301) 106.00 mg 3 Hydroxypropyl Cellulose (Klucel LF) 2.00 mg 4 Croscarmellose Sodium (Ac-Di-Sol) 10.00 mg 5 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 1.00 mg Amantadine Hydrochloride capsules USP 100mg(Amantadine Hydrochloride capsules USP 100mg (Net content of active ingredients 360.00 kgs )) 1 Number Capsule 6 Magnesium Stearate (Vegetable Source) 1.00 mg 7 Amantadine Hydrochloride USP 102.00 mg 8 Microcrystalline Cellulose (Avicel PH 101) 33.65 mg 9 Povidone (Kollidon 90F) 3.00 mg 10 Lake Pigment HT 5285 FD&C Yellow 6 Sunset Yellow FCF Aluminum Lake 0.300 mg 11 Sodium Starch Glycolate (Type A) (EXPLOTAB) 4.50 mg 12 Povidone (K-30) 3.00 mg 13 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 0.75 mg Amantadine Hydrochloride Tablets USP 100mg(Amantadine Hydrochloride Tablets USP 100mg (Net content of active ingredients 940.00 kgs )) 1 Number Tablet|Norms Committee Decision: The Com

antadine Hydrochloride Tablets USP 100mg(Amantadine Hydrochloride Tablets USP 100mg (Net content of active ingredients 940.00 kgs )) 1 Number Tablet|Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Mar/202223/24 dated 13.04.2023against advance authorization No.3411001942 dated 10.03.2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 Amantadine Hydrochloride USP 102.00 mg 2 Microcrystalline cellulose (Avicel PH301) 106.00 mg 3 Hydroxypropyl Cellulose (Klucel LF) 2.00 mg 4 Croscarmellose Sodium (Ac-Di-Sol) 10.00 mg 5 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 1.00 mg Amantadine Hydrochloride capsules USP 100mg(Amantadine Hydrochloride capsules USP 100mg (Net content of active ingredients 360.00 kgs )) 1 Number Capsule 6 Magnesium Stearate (Vegetable Source) 1.00 mg 7 Amantadine Hydrochloride USP 102.00 mg 8 Microcrystalline Cellulose (Avicel PH 101) 33.65 mg 9 Povidone (Kollidon 90F) 3.00 mg 10 Lake Pigment HT 5285 FD&C Yellow 6 Sunset Yellow FCF Aluminum Lake 0.300 mg 11 Sodium Starch Glycolate (Type A) (EXPLOTAB) 4.50 mg 12 Povidone (K-30) 3.00 mg 13 Colloidal Silicon Dioxide (Aerosil 200 Pharma)<b

low FCF Aluminum Lake 0.300 mg 11 Sodium Starch Glycolate (Type A) (EXPLOTAB) 4.50 mg 12 Povidone (K-30) 3.00 mg 13 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 0.75 mg Amantadine Hydrochloride Tablets USP 100mg(Amantadine Hydrochloride Tablets USP 100mg (Net content of active ingredients 940.00 kgs )) 1 Number Tablet|Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Mar/202223/24 dated 13.04.2023against advance authorization No.3411001942 dated 10.03.2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 Amantadine Hydrochloride USP 102.00 mg 2 Microcrystalline cellulose (Avicel PH301) 106.00 mg 3 Hydroxypropyl Cellulose (Klucel LF) 2.00 mg 4 Croscarmellose Sodium (Ac-Di-Sol) 10.00 mg 5 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 1.00 mg Amantadine Hydrochloride capsules USP 100mg(Amantadine Hydrochloride capsules USP 100mg (Net content of active ingredients 360.00 kgs )) 1 Number Capsule 6 Magnesium Stearate (Vegetable Source) 1.00 mg 7 Amantadine Hydrochloride USP 102.00 mg 8 Microcrystalline Cellulose (Avicel PH 101) 33.65 mg 9 Povidone (Kollidon 90F) 3.00 mg 10 Lake Pigment HT 5285 FD&C Yell

r>7 Amantadine Hydrochloride USP 102.00 mg 8 Microcrystalline Cellulose (Avicel PH 101) 33.65 mg 9 Povidone (Kollidon 90F) 3.00 mg 10 Lake Pigment HT 5285 FD&C Yellow 6 Sunset Yellow FCF Aluminum Lake 0.300 mg 11 Sodium Starch Glycolate (Type A) (EXPLOTAB) 4.50 mg 12 Povidone (K-30) 3.00 mg 13 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 0.75 mg Amantadine Hydrochloride Tablets USP 100mg(Amantadine Hydrochloride Tablets USP 100mg (Net content of active ingredients 940.00 kgs )) 1 Number Tablet|Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Mar/202223/24 dated 13.04.2023against advance authorization No.3411001942 dated 10.03.2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl.

br>dated 10.03.2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 Amantadine Hydrochloride USP 102.00 mg 2 Microcrystalline cellulose (Avicel PH301) 106.00 mg 3 Hydroxypropyl Cellulose (Klucel LF) 2.00 mg 4 Croscarmellose Sodium (Ac-Di-Sol) 10.00 mg 5 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 1.00 mg Amantadine Hydrochloride capsules USP 100mg(Amantadine Hydrochloride capsules USP 100mg (Net content of active ingredients 360.00 kgs )) 1 Number Capsule 6 Magnesium Stearate (Vegetable Source) 1.00 mg 7 Amantadine Hydrochloride USP 102.00 mg 8 Microcrystalline Cellulose (Avicel PH 101) 33.65 mg 9 Povidone (Kollidon 90F) 3.00 mg 10 Lake Pigment HT 5285 FD&C Yellow 6 Sunset Yellow FCF Aluminum Lake 0.300 mg 11 Sodium Starch Glycolate (Type A) (EXPLOTAB) 4.50 mg 12 Povidone (K-30) 3.00 mg 13 Colloidal Silicon Dioxide (Aerosil 200 Pharma) 0.75 mg Amantadine Hydrochloride Tablets USP 100mg(Amantadine Hydrochloride Tablets USP 100mg (Net content of active ingredients 940.00 kgs )) 1 Number Tablet| |---|---|---|---|---|---| ||Export Product|Qty.|Sl.

oride Tablets USP 100mg(Amantadine Hydrochloride Tablets USP 100mg (Net content of active ingredients 940.00 kgs )) 1 Number Tablet| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty.| ||Amantadine Hydrochloride capsules USP 100mg(Amantadine Hydrochloride capsules USP 100mg (Net content of active ingredients 360.00 kgs ))|1 Number Capsule|1|Amantadine Hydrochloride USP|102.00 mg| ||||2|Microcrystalline cellulose (Avicel PH301)|106.00 mg| ||||3|Hydroxypropyl Cellulose (Klucel LF)|2.00 mg| ||||4|Croscarmellose Sodium (Ac-Di-Sol)|10.00 mg| ||||5|Colloidal Silicon Dioxide (Aerosil 200 Pharma)|1.00 mg| ||||6|Magnesium Stearate (Vegetable Source)|1.00 mg| ||Amantadine Hydrochloride Tablets USP 100mg(Amantadine Hydrochloride Tablets USP 100mg (Net content of active ingredients 940.00 kgs ))|1 Number Tablet|7|Amantadine Hydrochloride USP|102.00 mg| ||||8|Microcrystalline Cellulose (Avicel PH 101)|33.65 mg| ||||9|Povidone (Kollidon 90F)|3.00 mg| ||||10|Lake Pigment HT 5285 FD&C Yellow 6 Sunset Yellow FCF Aluminum Lake|0.300 mg| ||||11|Sodium Starch Glycolate (Type A) (EXPLOTAB)|4.50 mg| ||||12|Povidone (K-30)|3.00 mg| ||||13|Colloidal Silicon Dioxide (Aerosil 200 Pharma)|0.75 mg|

UDIN00204730AM24

14 Stearate 0.80 mg

m Starch Glycolate (Type A) (EXPLOTAB)|4.50 mg| ||||12|Povidone (K-30)|3.00 mg| ||||13|Colloidal Silicon Dioxide (Aerosil 200 Pharma)|0.75 mg|

UDIN00204730AM24

14 Stearate 0.80 mg

Case No.	129 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000330AM24
RA File Number	08AX04000051 AM24
Licence No and<br>Date	0811007934/21/04/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import<br>product in meeting No.NC/3/MEET/Apr/202324/1 dated 28.04.2023against advance authorization No.0811006675 dated<br>07.12.2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the<br>firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>NALTREXONE HYDROCHLORIDE<br>TABLETS 50 MG(EACH FILM COATED<br>TABLET CONTAINS: NALTREXONE<br>HYDROCHLORIDE PH.EUR 50 MG [IN<br>WHICH ACTIVE INGREDIENT<br>NALTREXONE HYDROCHLORIDE<br>USED IS<br>38.250 KGS.])<br>1 Number<br>1<br>NALTREXONE<br>HYDROCHLORIDE EP / BP / IP /<br>USP / PH. EUR (All Alcoholic<br>Solvents and water content NLT<br>1.86% as per COA of Import item).<br>51.93<br>mg/tablet<br> RA concerned may take further necessary action as per above decision of NC.

H. EUR (All Alcoholic Solvents and water content NLT 1.86% as per COA of Import item). 51.93 mg/tablet RA concerned may take further necessary action as per above decision of NC.||

Case No.	130 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000357AM24
RA File Number	03AX04000234 AM24
Licence No and<br>Date	0311023026/24/04/2023

UDIN00204730AM24

Norms Committee Decision:

The case is under consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the export products and statement of export import of the Authorization.

Case No.<br>131 / NC/3/MEET/Jun/202324/8
Case Status<br>Case Approved
Party Name<br>PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number<br>HQRNORM APPLY 00000377AM24
RA File Number<br>05AX04000084 AM24
Licence No and<br>Date<br>0511018482/24/04/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking	cue from the earlier decision for same export product/import
product in meeting No.2/82-ALC4/2018 dated 16.05.2018against		advance authorization No.0510393822 dated
01.04.2015, it was decided to fix ad-hoc norms under Para 4.07 of HBP		Vol.

|| |product in meeting No.2/82-ALC4/2018 dated 16.05.2018against||advance authorization No.0510393822 dated||| |01.04.2015, 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 Iso Butyl Phthalate (DIBP)(Oily Liquid 1 Kg|1|Phthalic Anhydride|0.560 kg|| |Phthalate Easter)||||| ||2|Iso Butanol|0.560 kg|| |RA concerned may take further necessary action as per above decision||of NC.|||

Case No.	132 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	IND SWIFT LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000384AM24
RA File Number	30AX04000022 AM24
Licence No and<br>Date	3011003465/25/04/2023
Norms Committee Decision:
The case is under	consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the
export products and statement of export import of the Authorization.

UDIN00204730AM24

nsideration for want of comments of TE. Also, sample shipping bills and bill of entry of the**| |export products and statement of export import of the Authorization.||

UDIN00204730AM24

Case No.	Case No.	133 / NC/3/MEET/Jun/202324/8	133 / NC/3/MEET/Jun/202324/8	133 / NC/3/MEET/Jun/202324/8	133 / NC/3/MEET/Jun/202324/8	133 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00000385AM24
RA File Number		08AX04000115 AM24
Licence No and<br>Date		0811007966/25/04/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 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>ISOSORBIDE MONONITRATE EXTENDED<br>RELEASE TABLETS USP 60 MG(EACH<br>FILM COATED EXTENDED RELEASE<br>TABLETS CONTAINS: DILUTED<br>ISOSORBIDE MONONITRATE (50%<br>DILUTED WITH LACTOSE<br>MONOHYDRATE) USP EQUIVALENT TO<br>ISOSORBIDE MONONITRATE 60MG, NET<br>CONTENT OF ACTIVE INGREDIENT<br>ISMN SHOULD NOT BE LESS<br>THAN 1237.200 KGS.)<br>1 Number<br>1<br>Isosorbide Mononitrate 50 percent<br>Assay.<br>Diluted<br>ISMN<br>(50%<br>diluted with lactose monohydrate)<br>USP<br>122.40 mg.<br>ISOSORBIDE MONONITRATE<br>EXTENDED RELEASE TABLETS USP 120<br>MG(EACH FILM COATED EXTENDED<br>RELEASE TABLETS CONTAINS:<br>DILUTED ISO

(50% diluted with lactose monohydrate) USP 122.40 mg. ISOSORBIDE MONONITRATE EXTENDED RELEASE TABLETS USP 120 MG(EACH FILM COATED EXTENDED RELEASE TABLETS CONTAINS: DILUTED ISOSORBIDE MONONITRATE (50% DILUTED WITH LACTOSE MONOHYDRATE) USP EQUIVALENT TO ISOSORBIDE MONONITRATE 120MG, NET CONTENT OF ACTIVE INGREDIENT ISMN SHOULD NOT BE LESS THAN 720.000 KGS.) 1 Number 1 Isosorbide Mononitrate 50 percent Assay. Diluted ISMN (50% diluted with lactose monohydrate) USP 244.80 mg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||ISOSORBIDE MONONITRATE EXTENDED RELEASE TABLETS USP 60 MG(EACH FILM COATED EXTENDED RELEASE TABLETS CONTAINS: DILUTED ISOSORBIDE MONONITRATE (50% DILUTED WITH LACTOSE MONOHYDRATE) USP EQUIVALENT TO ISOSORBIDE MONONITRATE 60MG, NET CONTENT OF ACTIVE INGREDIENT ISMN SHOULD NOT BE LESS THAN 1237.200 KGS.)|| 1 Number|1|Isosorbide Mononitrate 50 percent Assay. Diluted ISMN (50% diluted with lactose monohydrate) USP| 122.40 mg.|

SHOULD NOT BE LESS THAN 1237.200 KGS.)|| 1 Number|1|Isosorbide Mononitrate 50 percent Assay. Diluted ISMN (50% diluted with lactose monohydrate) USP| 122.40 mg.| ||ISOSORBIDE MONONITRATE EXTENDED RELEASE TABLETS USP 120 MG(EACH FILM COATED EXTENDED RELEASE TABLETS CONTAINS: DILUTED ISOSORBIDE MONONITRATE (50% DILUTED WITH LACTOSE MONOHYDRATE) USP EQUIVALENT TO ISOSORBIDE MONONITRATE 120MG, NET CONTENT OF ACTIVE INGREDIENT ISMN SHOULD NOT BE LESS THAN 720.000 KGS.)||1 Number|1|Isosorbide Mononitrate 50 percent Assay. Diluted ISMN (50% diluted with lactose monohydrate) USP| 244.80 mg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No. 134 / NC/3/MEET/Jun/202324/8

UDIN00204730AM24

Case Status	Case Deferred
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000387AM24
RA File Number	05AX04000213 AM24
Licence No and<br>Date	0511018490/25/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the<br>export products and statement of export import of the Authorization.

r>The case is under consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the export products and statement of export import of the Authorization.||

Case No.	135 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000388AM24
RA File Number	05AX04000214 AM24
Licence No and<br>Date	0511018497/25/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the<br>export products and statement of export import of the Authorization.

Case No.	Case No.	136 / NC/3/MEET/Jun/202324/8	136 / NC/3/MEET/Jun/202324/8	136 / NC/3/MEET/Jun/202324/8	136 / NC/3/MEET/Jun/202324/8	136 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00000389AM24
RA File Number		03AX04000308 AM24
Licence No and<br>Date		0311023086/25/04/2023
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/202122/15dated17/03/2022against advance authorizationNo.0310819238dated19/02/2018,<br>it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

duct in meetingNo.NC/3/MEET/Mar/202122/15dated17/03/2022against advance authorizationNo.0310819238dated19/02/2018, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.|

Case No.	Case No.	136 / NC/3/MEET/Jun/202324/8	136 / NC/3/MEET/Jun/202324/8	136 / NC/3/MEET/Jun/202324/8	136 / NC/3/MEET/Jun/202324/8	136 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00000389AM24
RA File Number		03AX04000308 AM24
Licence No and<br>Date		0311023086/25/04/2023
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/202122/15dated17/03/2022against advance authorizationNo.0310819238dated19/02/2018,<br>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<br>is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

UDIN00204730AM24

Terpineol -AB08019 1 kg. 1 Alpha Pinene 1.36 kg.

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

UDIN00204730AM24

Terpineol -AB08019 1 kg. 1 Alpha Pinene 1.36 kg.

Case No.	Case No.	137 / NC/3/MEET/Jun/202324/8	137 / NC/3/MEET/Jun/202324/8	137 / NC/3/MEET/Jun/202324/8	137 / NC/3/MEET/Jun/202324/8	137 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00000390AM24
RA File Number		03AX04000301 AM24
Licence No and<br>Date		0311023087/25/04/2023
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. 5/82-ALC4/2018 dated 25/07/2018against advance authorizationNo.2910025262 dated 23/09/2016, it was<br>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:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Terpineol -AB08019<br>1 Kg.<br>1<br>GUM TURPENTINE OIL<br>1.352 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Terpineol -AB08019		1 Kg.	1	GUM TURPENTINE OIL	1.352 kg.
	concerned may take further necessary action as per above decision of NC.

||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Terpineol -AB08019||1 Kg.|1|GUM TURPENTINE OIL|1.352 kg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	138 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000391AM24
RA File Number	03AX04000303 AM24
Licence No and<br>Date	0311023088/25/04/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-

UDIN00204730AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
CAMPHOR TECHNICAL AB08002	1 kg.	1	GUM TURPENTINE OIL	1.33 kg.

Case No.	139 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000392AM24
RA File Number	03AX04000300 AM24
Licence No and<br>Date	0311023089/25/04/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>ii.

|information/documents from the firm:-|| |Step wise manufacturing process. i.|| |Complete chemical reactions with molecular and structural formula and molecular weights along with ii.|| |stage wise percentage yields on molar basis.|| |Complete technical details as per Annexure to Appendix 4E for chemical products. iii.|| |Stoichiometric balance between import and export on molar basis. iv.|| |Details of indigenous input with quantity. v.|| |Sample of shipping bills and bill of entry of the export products along with statement of Input-output as vi.|| |per export|documents of the said authorization|

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

Case No.	140 / NC/3/MEET/Jun/202324/8
Case Status	Case Approved
Party Name	ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000393AM24
RA File Number	03AX04000306 AM24
Licence No and<br>Date	0311023090/25/04/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product
in meetingNo. 12/82-ALC4/2018dated12/12/2018against advance authorizationNo.0310821177 dated 23/05/2018, 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:-

UDIN00204730AM24

177** dated 23/05/2018, 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:-||

UDIN00204730AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
CAMPHOR TECHNICAL AB08002	1 kg.	1	Alpha Pinene	1.04 kg.

Case No.	Case No.	141 / NC/3/MEET/Jun/202324/8	141 / NC/3/MEET/Jun/202324/8	141 / NC/3/MEET/Jun/202324/8
Case Status		Case Approved
Party Name		DR J PHARMACHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number		HQRNORM APPLY 00000396AM24
RA File Number		31AX04000012 AM24
Licence No and<br>Date		3111002228/25/04/2023
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. 82-ALC4/2018dated19/06/20218against advance authorizationNo.3110066982dated13/02/2018, it was<br>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:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>SODIUM BENZOATE MICRONISED<br>1 kg<br>1<br>SODIUM BENZOATE POWDER<br>1.00 kg.<br>RA concerned may take further necessary action as per above decision of NC
	Export Product		Qty.	Sl.

r>Qty. SODIUM BENZOATE MICRONISED 1 kg 1 SODIUM BENZOATE POWDER 1.00 kg. RA concerned may take further necessary action as per above decision of NC||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||SODIUM BENZOATE MICRONISED||1 kg|1|SODIUM BENZOATE POWDER|1.00 kg.| ||concerned may take further necessary action as per above decision of NC||||||

Case No.	142 / NC/3/MEET/Jun/202324/8
Case Status	Case Deferred
Party Name	ALKALOIDS PVT LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number	HQRNORM APPLY 00000398AM24
RA File Number	02AX04000047 AM24
Licence No and<br>Date	0211004284/25/04/2023
Norms Committee Decision:

UDIN00204730AM24

The case is under consideration for want of comments of TE. Also, sample shipping bills and bill of entry of the export products and statement of export import of the Authorization.

Case No.<br>143 / NC/3/MEET/Jun/202324/8
Case Status<br>Case Deferred
Party Name<br>SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202324/ 8 and 30/06/2023
HQ File Number<br>HQRNORM APPLY 00000404AM24
RA Fi

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