DGFT Minutes

Government of India / भारत सरकार

MINUTES OF THE NORMS COMMITTEE- III

Please Note

Case Details and Decision(s):

Norms Committee Decision:

I. Justificationofabout23%lossesfromCrudeFractonetoPureFractonebased onpurityofexportandCOA of export product.

3. Also submit shipping bill and bill of entry of the export products.

IN FORCE Advance Authorisation

Reliability

In force — no superseding record on file.

Document text

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

MEETING No. NC/3/MEET/Apr/202324/1 DATED: 28/04/2023

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/Apr/202324/1 dated 28/04/2023 of Norms Committee - III for the year 2023-24 was held on 28/04/2023 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:-

	Name and Designation of Representatives
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 24-05-2023 11:02:16.

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Case No.	1 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM REVIW00004822AM23
RA File Number	039404001053 AM18
Licence No and<br>Date	0310819947/20/03/2018
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and based on information<br>provided by the firm, it was decided to revise ad-hoc norms as under: -<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>PARA TERTIARY BUTYL<br>PHENOL<br>0.820 kg.<br>2<br>5% RHODIUM ON ALUMINA<br>CATALYST<br>0.00012 kg.<br>PARA<br>TERTIARY<br>BUTYL<br>CYCLOHEXYL ACETATE - SUPER<br>1 kg.<br>3<br>ACETIC ACID<br>0.300 kg<br>RA concerned may take further necessary action as per above decision taken by NC

Case No.	2 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM REVIW00006806AM23
RA File Number	318304000162 AM19
Licence No and<br>Date	3110067309/06/02/2019
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to ratify ad-

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hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: -

tion of ad-hoc norms and it was decided to ratify ad-||

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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.
DNOVO BP818 (Tetra Methyl<br>Bisphenol F)	1 MT<br>	1	2,6 xylenol	1.06 MT
		2	Paraformaldehyde	0.1302 MT
		3	Methanol	0.10 MT

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

Case No.	Case No.	3 / NC/3/MEET/Apr/202324/1	3 / NC/3/MEET/Apr/202324/1	3 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		CONCORD BIOTECH LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM REVIW00004550AM23
RA File Number		082404000101 AM20
Licence No and<br>Date		0810145581/27/06/2019
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to ratify ad-<br>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>Everolimus Premix 2%<br>1 kg.<br>1<br>Sirolimus crude<br>267 gm.<br>Everolimus Premix 9.09%<br>1 kg.<br>1<br>Sirolimus crude<br>1211 gm<br>The ad-hoc has been fixed with following conditions:
	Export Product		Qty.	Sl.

kg. 1 Sirolimus crude 267 gm. Everolimus Premix 9.09% 1 kg. 1 Sirolimus crude 1211 gm The ad-hoc has been fixed with following conditions:||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Everolimus Premix 2%||1 kg.|1|Sirolimus crude|267 gm.| ||Everolimus Premix 9.09%||1 kg.|1|Sirolimus crude|1211 gm| ||The ad-hoc has been fixed with following conditions:||||||

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The firm has changed the export item as above.
The firm is advised to get their Advance Authorization amended for above export items for which the norms have been fixed by Norms Committee.

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

Case No.	4 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM REVIW00004154AM23
RA File Number	039404000526 AM20
Licence No and<br>Date	0310832396/23/10/2019
Norms Committee Decision:
Deferred for the comments of TE. Also submit shipping bill and bill of entry of the export products.

000526 AM20| |Licence No and Date|0310832396/23/10/2019| |Norms Committee Decision:|| |Deferred for the comments of TE. Also submit shipping bill and bill of entry of the export products.||

Case No.<br>5 / NC/3/MEET/Apr/202324/1
Case Status<br>Case Approved
Party Name<br>SRF LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202324/ 1	and 28/04/2023
HQ File Number<br>HQRNORM REVIW00007268AM23
RA File Number<br>052404000501 AM20
Licence No and<br>Date<br>0510412619/25/11/2019
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty.
2,2-difluoro-1,3-benzodioxole<br>1 Kg.	1	1,3-Benzodioxole	0.9306 kg.
		(1,2- Methylenedioxybenzene)

Case No.<br>5 / NC/3/MEET/Apr/202324/1
Case Status<br>Case Approved
Party Name<br>SRF LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202324/ 1	and 28/04/2023
HQ File Number<br>HQRNORM REVIW00007268AM23
RA File Number<br>052404000501 AM20
Licence No and<br>Date<br>0510412619/25/11/2019
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl.

ase as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP||||| |Vol. I as per details given below or as applied by the firm, whichever is less:-||||| |Export Product Qty.|Sl. No.|Import Items|Qty.|| |2,2-difluoro-1,3-benzodioxole 1 Kg.|1|1,3-Benzodioxole|0.9306 kg.|| |||(1,2- Methylenedioxybenzene)|||

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

Case No.	6 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	ARENE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM REVIW00004461AM23
RA File Number	092404000024 AM21
Licence No and<br>Date	0910068681/28/04/2020
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call<br>for following information/documents from the firm: -<br>Production and consumption data with respect to present Advance Authorisation duly certified<br>by Central Taxes and GST Authorities.<br>1.<br>Also submit shipping bill and bill of entry of the export products.<br>2.

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: -

Production and consumption data with respect to present Advance Authorisation duly certified by Central Taxes and GST Authorities.

call for following information/documents from the firm: -

Production and consumption data with respect to present Advance Authorisation duly certified by Central Taxes and GST Authorities.

Case No.	7 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM REVIW00007266AM23
RA File Number	052404000225 AM21
Licence No and<br>Date	0510414951/20/08/2020
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

Case No.	8 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	SHARP MINT LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM REVIW00004537AM23
RA File Number	052404000265 AM21
Licence No and<br>Date	0510415091/02/09/2020
Norms Committee Decision:

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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.
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.

etails 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. Also submit shipping bill and bill of entry of the export products.

Case No.	9 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM REVIW00007269AM23
RA File Number	052404000333 AM21
Licence No and<br>Date	0510415443/08/10/2020
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>1,3-BENZODIOXOLE<br>0.9306 kg.<br>2,2-difluoro-1,3-benzodioxole(DFBD)<br>1 Kg.<br>2<br>BENZOTRIFLUORIDE (BTF)<br>0.15 kg.<br>RA concerned may take further necessary action as per above decision of NC

Case No.	10 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM REVIW00004313AM23
RA File Number	052404000355 AM21

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Licence No and<br>Date	0510415575/20/10/2020	0510415575/20/10/2020	0510415575/20/10/2020
Norms Committee Decision:
The Committee	considered the request of firm for fixation of				ad-hoc norms and it was decided to ratify
ad-hoc norms under Para 4.07 of			HBP Vol. I as	per details given below or as applied		by the firm,
whichever is less: -
Export Product			Qty.	Sl. No.	Import Items		Qty.
Deferoxamine		Mesylate	<br>1 kg.	1	Deferoxamine Mesylate USP		1.02 kg.
Sterile					(non-sterile)
RA concerned may take		further necessary action as per above decision of NC.

Case No.	11 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM REVIW00004138AM23
RA File Number	092404000365 AM21
Licence No and<br>Date	0910069368/22/10/2020
Norms Committee Decision:
Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

4000365 AM21| |Licence No and Date|0910069368/22/10/2020| |Norms Committee Decision:|| |Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.||

Case No.	12 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM REVIW00004153AM23
RA File Number	039404000571 AM21
Licence No and<br>Date	0310839148/27/10/2020
Norms Committee Decision:
Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

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Case No.	13 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM REVIW00007267AM23
RA File Number	052404000395 AM21
Licence No and<br>Date	0510415782/09/11/2020
Norms Committee Decision:
Deferred for the	comments of TE.Also submit shipping bill and bill of entry of the export products.

Case No.	14 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	AVA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM REVIW00004365AM23
RA File Number	03AA04020902 AM21
Licence No and<br>Date	0311001331/28/01/2021
Norms Committee Decision:
Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

4020902 AM21| |Licence No and Date|0311001331/28/01/2021| |Norms Committee Decision:|| |Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.||

Case No.<br>15 / NC/3/MEET/Apr/202324/1
Case Status<br>Case Approved
Party Name<br>BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number<br>HQRNORM REVIW00004494AM23
RA File Number<br>34AA04002284 AM21
Licence No and<br>Date<br>3411000167/29/01/2021
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and based on information
provided by the firm, it was decided to revise ad-hoc norms as under: -
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty.
Hexyl Salicylate ((n-Hexyl-ortho-1 kg.<br>1	n-Hexanol (Lorol C 6/ Nacol 6-99)	0.510 kg.

Case No.<br>15 / NC/3/MEET/Apr/202324/1
Case Status<br>Case Approved
Party Name<br>BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number<br>HQRNORM REVIW00004494AM23
RA File Number<br>34AA04002284 AM21
Licence No and<br>Date<br>3411000167/29/01/2021
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and based on information
provided by the firm, it was decided to revise ad-hoc norms as under: -
Export Product<br>Qty.<br>Sl.

ttee considered the request of firm for review of ad-hoc norms and based on information|||| |provided by the firm, it was decided to revise ad-hoc norms as under: -|||| |Export Product Qty. Sl. No.|Import Items|Qty.|| |Hexyl Salicylate ((n-Hexyl-ortho-1 kg. 1|n-Hexanol (Lorol C 6/ Nacol 6-99)|0.510 kg.||

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Hydroxy Benzoate))
		2	Salicylic Acid	0.682	kg.

Case No.	16 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM REVIW00005060AM23
RA File Number	07AA04002414 AM22
Licence No and<br>Date	0711000982/27/04/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to ratify ad-<br>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.<br>No.<br>Import Items<br>Qty.<br>L-ORNITHINE-L-ASPARTATE<br>(Pure-<br>pharma)<br>(L-ORNITHINE-L-ASPARTATE<br>(Pure-pharma))<br>2.0 MT<br>1<br>L-ORNITHINE-L-<br>ASPARTATE<br>(TECHNICAL GRADE)<br>2.02 MT<br>RA concerned may take further necessary action as per above decision of NC.

NITHINE-L-ASPARTATE (Pure-pharma)) 2.0 MT 1 L-ORNITHINE-L- ASPARTATE (TECHNICAL GRADE) 2.02 MT RA concerned may take further necessary action as per above decision of NC.||

Case No.	17 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	MEHK CHEMICALS PVT LTD
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM REVIW00004318AM23
RA File Number	03AA04061020 AM22
Licence No and Date	0311006197/16/08/2021

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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: -

II. Production / Consumption data duly certified by GST.
III. Also submit shipping bill and bill of entry of the export products.

Case No.	18 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM REVIW00007301AM23
RA File Number	05AA04061713 AM22
Licence No and<br>Date	0511004657/10/09/2021
Norms Committee Decision:
Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

Case No.<br>19 / NC/3/MEET/Apr/202324/1
Case Status<br>Case Deferred
Party Name<br>AMINES AND PLASTICIZERS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number<br>HQRNORM REVIW00004678AM23
RA File Number<br>03AA040113998 AM22
Licence No and<br>Date<br>0311008443/11/11/2021
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to
call for following information/documents from the firm:-
Complete calculation based on chemistry using MMEA-40% & Ethylene Oxide.<br>1.
Production/Consumption Data duly certified by GST/CA.<br>2.
Yield of reaction with justification and to give complete Stoichiometricmaterial balance.<br>3.
Also submit shipping bill and bill of entry of the export products.<br>4.

T/CA.** 2.| |Yield of reaction with justification and to give complete Stoichiometricmaterial balance. 3.| |Also submit shipping bill and bill of entry of the export products. 4.|

Case No.	20 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023

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and Date
HQ File Number	HQRNORM REVIW00006236AM23
RA File Number	31AX04000028 AM23
Licence No and<br>Date	3111001358/17/05/2022
Norms Committee Decision:
The Committee	considered the case as per		agenda and it was decided to ratify 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.
DNOVO<br>BP818		(Tetra<br>1 Kg.		1	OCP 50	1.00 kg.
Methyl Bisphenol F)
				2	Paraformaldehyde	0.141 kg.
				3	Methanol	0.66 kg.
				4	Katalco 71 5	0.004 kg.
RA concerned may take further necessary action				as per the above decision of NC.

ol F)|||||||| |||||2|Paraformaldehyde|0.141 kg.|| |||||3|Methanol|0.66 kg.|| |||||4|Katalco 71 5|0.004 kg.|| |RA concerned may take further necessary action||||as per the above decision of NC.||||

Case No.<br>21 / NC/3/MEET/Apr/202324/1
Case Status<br>Case Approved
Party Name<br>BIOXERA PHARMA PRIVATE LIMITED
Meeting Number and Date<br>NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number<br>HQRNORM APPLY 00004824AM23
RA File Number<br>03AX04004276 AM23
Licence No and Date<br>0311019771/06/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking	cue from the earlier decision for same export
product/import product in meeting No.NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance
authorization No.0311019279 dated 17/11/2022, it was decided to ratify ad-hoc norms under Para 4.07
of HBP Vol. I as per details given below or as applied by the	firm, whichever is less.
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty.

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BENFOTIAMINE(BENFOTIAMINE)	BENFOTIAMINE(BENFOTIAMINE)	BENFOTIAMINE(BENFOTIAMINE)	1	kg	1	THIAMINE	0.922	kg.
						HYDROCHLORIDE

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BENFOTIAMINE(BENFOTIAMINE)	BENFOTIAMINE(BENFOTIAMINE)	BENFOTIAMINE(BENFOTIAMINE)	1	kg	1	THIAMINE	0.922	kg.
						HYDROCHLORIDE

Case No.	22 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00004851AM23
RA File Number	04AX04000768 AM23
Licence No and<br>Date	0411004581/07/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Isobutyl Acetophenone<br>1.11 kg.<br>2<br>Sodium Metal<br>0.235 kg.<br>3<br>Monochloro Acetic Acid<br>0.919 kg.<br>4<br>Isopropyl Alcohol<br>0.50 kg.<br>IBUPROFEN<br>1 kg.<br>5<br>Sodium Dichromate<br>0.630 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	23 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	NATCO PHARMA LIMITED

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

Case No.	23 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	NATCO PHARMA LIMITED

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Me	eting Number and Date	NC/ 3/	MEET/ Apr/ 2	MEET/ Apr/ 2	02324/ 1	02324/ 1	and 28/04/2023
HQ	File Number	HQRN	ORM APPLY		0000485		9AM23
RA	File Number	09AX	04000769 AM2
					3
Lic	ence No and Date	09110	04106/07/12/20		22
Nor<br>Th<br>pr<br>au<br>H	ms Committee Decision:<br>e Committee considered the<br>oduct/import product in mee<br>thorizationNo.0911002121<br>BP Vol. I as per details given		case as per ag<br>tingNo.NC/<br>dated 21/12/2<br>below or as a					ision for same export<br>023aainst advance
					enda an<br>3/MEE		d taking cue from the earlier dec<br>T/Dec/202223/17 dated 13/01/2
					<br>021, it<br>pplied b		<br>was decided to ratify ad-hoc norm<br>y the firm, whichever is less: -	g<br>s under Para 4.07 of

	Export Product			Qty.		Sl	.

d 13/01/2**|||| ||||||| 021, it pplied b|| was decided to ratify ad-hoc norm y the firm, whichever is less: -||g s under Para 4.07 of|| ||||||||||||| ||Export Product||||Qty.||Sl|. No.|Import Items||Qty.| ||NITROGLYCERIN SUBLINGUAL TABLETS USP 0.3 mg (Each Tablet contains Nitroglycerin USP 0.3 |||| 1 Number||1||DILUTED NITROGLYCERIN USP 1.95 %||15.70 mg.| ||||||||||||| ||mg) (1x1,80,000=1,80,000||||||2||Glyceryl Monosterate ||1.255 mg.| ||Tablets)||||||||(Imwitor 491 powder)||| ||||||||||||| ||||||||||||| ||NITROGLY|CERIN|||1 Number||3||DILUTED||20.93 mg.| ||SUBLINGU USP 0.4m|AL TABLETS (Each Tablet||| ||||NITROGLYCERIN USP 1.95 %||| || contains Nitr| oglycerin USP|||||||||| ||||||||||||| ||0.4mg) (2x12,00,00|0=24,00,000|||||4||Glyceryl Monosterate (Imwitor 491 powder)||1.255 mg.| |R|Tablets)||||||||||| ||A concerned may take further necessary action||||||as per above decision of NC.||||| ||||||||||||| |Cas|e No.|24 / NC/3/MEE||T/Apr/202324/1|||||||| |Cas|e Status|Case Approved|||||||||| |Par|||||||||||| ||y Name|INTAS PHARM||ACEUTICAL||LIMIT||D|||| |Me and|eting Number Date|NC/ 3/ MEET/ A||pr/ 202324/ 1||and 28/0||4/2023|||| |HQ|File Number|HQRNORM AP||PLY 00004860||AM23|||||| |RA|File Number|08AX04001421||AM23|||||||| |Lic Dat|ence No and e|0811006675/07/||12/2022|||||||| |Nor|ms Committee Decision:|||||||||||

|HQ|File Number|HQRNORM AP||PLY 00004860||AM23|||||| |RA|File Number|08AX04001421||AM23|||||||| |Lic Dat|ence No and e|0811006675/07/||12/2022|||||||| |Nor|ms Committee Decision:|||||||||||

Case No.	24 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00004860AM23
RA File Number	08AX04001421 AM23
Licence No and<br>Date	0811006675/07/12/2022
Norms Committee Decision:

UDIN00081605AM24

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/202223/22 dated 24/03/2023 against advance authorization No. 0811006399 dated 09/11/2022 , it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: -

Export product	Qty.	Sl. No.	Import items	Qty.
NALTREXONE<br>HYDROCHLORIDE TABLETS<br>USP<br>50<br>MG(EACH<br>FILM<br>COATED TABLET CONTAINS:<br>NALTREXONE<br>HYDROCHLORIDE USP 50 MG<br>[IN<br>WHICH<br>ACTIVE<br>INGREDIENT<br>NALTREXONE<br>HYDROCHLORIDE USED IS<br>308.505 KGS.])	1 Number	1	NALTREXONE HYDROCHLORID E<br>EP / BP / IP / USP / PH. EUR (All<br>Alcoholic Solvents and water content NLT<br>1.86% as per COA of import item)	<br> <br> <br>51.93 mg /<br>Tablet

Case No.	Case No.	25 / NC/3/MEET/Apr/202324/1	25 / NC/3/MEET/Apr/202324/1	25 / NC/3/MEET/Apr/202324/1	25 / NC/3/MEET/Apr/202324/1	25 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		BIODEAL PHARMACEUTICALS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00004862AM23
RA File Number		05AX04002637 AM23
Licence No and Date		0511016240/07/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance<br>authorization No.0511015214 dated 11/10/2022, it was decided to ratify ad-hoc norms under Para 4.07<br>of HBP Vol.

uct in meeting No.NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance authorization No.0511015214 dated 11/10/2022, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: - Export Product Qty. Sl. No. Import Items Qty. 1 NASAL ADAPTOR FOR MFG OF NASAL SPRAY Relevant, on Net-to-Net basis with accountability NASAL SPRAY(SNAP-ON, S20 WHITE SMOOTH, NASAL ADAPTOR AT PAG136, AM TL 17 ML, 14- 0388-004,WHITE, BOTTLE 99000 Numbers||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||NASAL SPRAY(SNAP-ON, S20 WHITE SMOOTH, NASAL ADAPTOR AT PAG136, AM TL 17 ML, 14- 0388-004,WHITE, BOTTLE||99000 Numbers|1|NASAL ADAPTOR FOR MFG OF NASAL SPRAY|Relevant, on Net-to-Net basis with accountability| ||||||||

UDIN00081605AM24

WITH CHEMICALS AS PER		2	NASAL BOTTLE	Relevant,	on
THE DRUG LICENSE)				Net-to-Net basis
				with
				accountability

ity| ||||||||

UDIN00081605AM24

WITH CHEMICALS AS PER		2	NASAL BOTTLE	Relevant,	on
THE DRUG LICENSE)				Net-to-Net basis
				with
				accountability

Case No.	26 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00004863AM23
RA File Number	52AX04001711 AM23
Licence No and<br>Date	5211003710/07/12/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to<br>call for following information/documents from the firm:-<br>Correct chemistry giving chemical reaction and function of import item 1, 3 & 5 in the<br>reaction.<br>1.<br>Complete calculation based on chemistry of all the raw materials with yield and justification of<br>wastage.<br>2.<br>Also submit shipping bill and bill of entry of the export products.<br>3.

Correct chemistry giving chemical reaction and function of import item 1, 3 & 5 in the reaction.
Complete calculation based on chemistry of all the raw materials with yield and justification of wastage.

y giving chemical reaction and function of import item 1, 3 & 5 in the reaction.**

Complete calculation based on chemistry of all the raw materials with yield and justification of wastage.

Case No.	27 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	TRANSPEK INDUSTRY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00004865AM23
RA File Number	34AX04000797 AM23
Licence No and<br>Date	3411003093/07/12/2022
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

Case No.	28 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED

UDIN00081605AM24

Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ A	pr/ 202324/ 1	and 28/0
HQ	File Number	HQRNORM AP	PLY 00004866	AM23

RA	File Number	08AX04001419	AM23
Lic<br>Dat	ence No and<br>e	0811006678/07/	12/2022

Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Feb/202223/20 dated 24/02/2023against advance<br>authorizationNo.0811006214 dated 10/10/2022,it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol.

oduct in meeting No.NC/3/MEET/Feb/202223/20 dated 24/02/2023against advance authorizationNo.0811006214 dated 10/10/2022,it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export product Qty. Sl. No. Import items Qty. DOXYCYCLINE DISPERSIBLE TABLETS 100 MG(EACH UNCOATED DISPERSIBLE TABLET CONTAINS: DOXYCYCLINE 1 Number 1 DOXYCYCLINE MONOHYDRATE EP / BP / IP / USP / PH. EUR. 102.908 mg||ms Committee Decision: e Committee considered the oduct/import product in meet thorizationNo.0811006214 BP Vol. I as per details given||case as per ag ing No.NC/3 dated 10/10/2 below or as a|||||||| |||||||enda an /MEET ||d taking cue from the earlier deci /Feb/202223/20 dated 24/02/202 ||sion for same export 3against advance s under Para 4.07 of|| |||||||**022,**it pplied b||was decided to ratify ad-hoc norm y the firm, whichever is less:-|||| ||E|xport product|||Qty.||Sl. N|o.|Import items||Qty.| ||DOXYCYCLINE DISPERSIBLE TABLETS 100 MG(EACH UNCOATED DISPERSIBLE TABLET CONTAINS: DOXYCYCLINE ||||1 Number||1||DOXYCYCLINE MONOHYDRATE EP / BP / IP / USP / PH. EUR.|| 102.908 mg| ||MONOHYDRATE PH.EUR.

100 MG(EACH UNCOATED DISPERSIBLE TABLET CONTAINS: DOXYCYCLINE ||||1 Number||1||DOXYCYCLINE MONOHYDRATE EP / BP / IP / USP / PH. EUR.|| 102.908 mg| ||MONOHYDRATE PH.EUR. EQ. ||||||||||| ||TO DOXYCYC WHICH ACTI||LINE 100 MG [IN E INGREDIENT||||||||| || DOXYCYCLIN|| E||||||||| || MONOHYDRA|| TE USED IS||||||||| ||53.000 KGS.])||||||||||| ||||||||||||| |RA concerned m|||ay take further necessary action as per above decision of NC||||||||| ||||||||||||| ||||||||||||| |Case No|||29 / NC/3/MEET/Ar/202324/1||||||||| |.|||p||||||||| |Case Status|||Case Approved||||||||| |Party Name|||DEEPAK PHENOLICS LIMITED||||||||| |Meeting Number and Date|||NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023||||||||| |HQ File Number|||HQRNORM APPLY 00004886AM23||||||||| |RA File Number|||34AX04000825 AM23||||||||| |Licence No and|||3411003096/08/12/2022||||||||| |Date|||||||||||| |Norms Committee|||Decision:||||||||| |The Committee|||considered the case as er aenda and takin cue from the earlier decision for same exort||||||||| | product/import hii N|||p g g p product in meetingNo. NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance 3411002878 dtd 11/10/2022i didd if dh d P 407 f||||||||| |autorzaton HBP Vl I|||.ae, t was ece to raty a-oc norms uner ara . o dtil i bl lid b th fi hih i l||||||||| |o. as p|||r eas gven eow or as appe y e rm, wcever s ess: -||||||||| |||||||||||||

on HBP Vl I|||.ae, t was ece to raty a-oc norms uner ara . o dtil i bl lid b th fi hih i l||||||||| |o. as p|||r eas gven eow or as appe y e rm, wcever s ess: -||||||||| |||||||||||||

Case No.	29 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00004886AM23
RA File Number	34AX04000825 AM23
Licence No and<br>Date	3411003096/08/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo. NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance
authorization No.3411002878 dated 11/10/2022, it was decided to ratify ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less: -

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/202223/22 dated 24/03/2023 against advance authorization No. 3411002878 dated 11/10/2022 , it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: -

UDIN00081605AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
Phenol	1 MT	1	Cumene	0.84466 MT

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

UDIN00081605AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
Phenol	1 MT	1	Cumene	0.84466 MT

Case No.	30 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00004888AM23
RA File Number	09AX04000649 AM23
Licence No and<br>Date	0911004131/08/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Feb/202122/14 dated 21/02/2023against advance<br>authorizationNo.0910069242dated 22/09/2020, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>Tobramycin for Inhalation solution 60 mg<br>/ ml (300 mg / 5 ml)<br>1 Number<br>1<br>Tobramycin Sulfate<br>370.20 mg.<br>Tobramycin for Inhalation solution 75 mg<br>/ ml (300 mg / 4 ml)<br>1 Number<br>1<br>Tobramycin Sulfate<br>370.20 mg.<br>RA concerned may take further necessary action as per above decision of NC

Case No.	31 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
MeetingNumber and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023

UDIN00081605AM24

|31 / NC/3/MEET/Apr/202324/1| |---|---| |Case Status|Case Approved| |Party Name|MANKIND PHARMA LIMITED| |MeetingNumber and Date|NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023|

UDIN00081605AM24

HQ File Number	HQRNORM APPLY 00004890AM23
RA File Number	05AX04002644 AM23
Licence No and Date	0511016259/08/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Feb/202122/14 dated 21/02/2023against advance<br>authorizationNo.051044600dated 10/07/2020, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>ACETAZOLAMIDE TABLETS USP<br>125 MG<br>1 Number<br>1<br>ACETAZOLAMIDE USP 127.50 mg.<br>ACETAZOLAMIDE TABLETS USP<br>250 MG<br>1 Number<br>1<br>ACETAZOLAMIDE USP 255.00 mg.<br>RA concerned may take further necessary action as per above decision of NC.

CETAZOLAMIDE USP 127.50 mg. ACETAZOLAMIDE TABLETS USP 250 MG 1 Number 1 ACETAZOLAMIDE USP 255.00 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	32 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00004891AM23
RA File Number	05AX04002651 AM23
Licence No and<br>Date	0511016260/08/12/2022
Norms Committee Decision:<br>T<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to<br>call for following information/documents from the firm:-<br>Get the export item amended to show net content of API in each unit export in line with DML.<br>1.<br>Copy of DML for each export item.<br>2.<br>Also submit shipping bill and bill of entry of the export products.<br>3.

Case No.	33 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved

UDIN00081605AM24

** 2. Also submit shipping bill and bill of entry of the export products. 3.||

Case No.	33 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved

UDIN00081605AM24

Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00004896AM23
RA File Number	08AX04001469 AM23
Licence No and Date	0811006711/08/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.1/82-ALC4/2013 dated 04/04/2013against advance authorization<br>No.0810117768dated 23/01/2013, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>MOXONIDINE<br>0.2MG<br>TABLETS<br>MOXONIDINE HEUMANN 0.2MG (EACH<br>FILM<br>COATED<br>TABLET<br>CONTAINS<br>:MOXONIDINE PH. EUR 0.2MG. NET<br>CONTENT OF MOXONIDINE EP SHOULD<br>NOT BE LESS THAN 3.000 KGS IN<br>EXPORT PRODUCT)<br>1 tablet<br>1<br>MOXONIDINE EP 0.204 mg.<br>MOXONIDINE<br>0.3MG<br>TABLETS<br>MOXONIDINE HEUMANN 0.3MG (EACH<br>FILM<br>COATED<br>TABLET<br>CONTAINS:MOXONIDINE<br>PH.<br>EUR<br>0.3MG. NET CONTENT OF MOXONIDINE<br>EP SHOULD NOT BE LESS THAN 5.250<br>KGS IN EXPORT PRODUCT)<br>1 tablet<br>2<br>MOXONIDINE EP 0.306 mg.<br>MOXONIDINE<br>0.4MGTABLETS<br>MOXONIDINE HEUMANN 0.4MG (EACH<br>FILM<br>COATED<br>TABLET<br>CONTAINS:<br>MOXONIDINE PH.

5.250 KGS IN EXPORT PRODUCT) 1 tablet 2 MOXONIDINE EP 0.306 mg. MOXONIDINE 0.4MGTABLETS MOXONIDINE HEUMANN 0.4MG (EACH FILM COATED TABLET CONTAINS: MOXONIDINE PH. EUR 0.4MG. NET CONTENT OF MOXONIDINE EP SHOULD NOT BE LESS THAN 6.000 KGS IN EXPORTPRODUCT) 1 tablet 3 MOXONIDINE EP 0.408 mg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00081605AM24

Case No.	Case No.	34 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		YASHO INDUSTRIES LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00004899AM23
RA File Number		03AX04004574 AM23

Licence No and Date		0311019863/08/12/2022

Norms Committee	Decision:


The Committee<br>product/import	considered the case as per agenda and taking cue from the earlier decision for same export<br>product in meeting No.NC/3/MEET/Feb/202223/20 dated 24/02/2023against advance
authorizationNo<br>	.0311016039dated 03/07/2022, it was decided to ratify ad-hoc norms under Para 4.07 of<br>
HBP Vol.

/Feb/202223/20 dated 24/02/2023against advance|||||||||| |authorizationNo** |||.0311016039dated 03/07/2022, it was decided to ratify ad-hoc norms under Para 4.07 of |||||||||| |HBP Vol. I as p|||er details given below or as applied by|||||||the firm, whichever is less:-||| |||||||||||||| |Export Product Qty. Sl. No. Import Items 1 DIBENZYLAMINE TETRA BENZYL THIURAM DISULFIDE(QUREACC TBZTD)(TETRA BENZYL THIURAMDISULFIDE (QUREACC TBZTD)) 1 kg. 2 CARBON DISULPHIDE RA concerned may take further necessary action as per above decision of NC||Export Product||||||Qty.||Sl. No.|Import Items|Qty.| |||TETRA BENZYL THIURA DISULFIDE(QUREACC TBZTDTETRA BENZ|||||M L| 1 kg.||1|DIBENZYLAMINE|0.74 kg.| |||||||||||||| |||)( THIURAMDISULFIDE ||||||||2|CARBON DISULPHIDE|0.285 kg.| ||(QUREACC TBZTD)) RA concerned may take further|(QUREACC TBZTD))||||||||||| |||||||necessa||||||| ||||||||ry actio||n as per above decision of NC|||| |||||||||||||| |C|ase No.|||35 / NC/3/||MEET/A|pr/20232||4/1|||| |C|ase Status|||Case Appr||oved||||||| |||||||||||||| |P|arty Name|||GLENMA||RK PHA|RMACE||UTICALS LIMITED|||| |M D|eeting Number and|||||||||||| ||ate|||NC/ 3/ MEET/ Apr/|||202324/ 1 and 28/04/2023|||||| |HQ File Number||||HQRNORM APPLY 00004907AM23||||||||| |||||||||||||| |RA File Number||||03AX04004528 AM23||||||||| |Licence No and Da|||te|0311019883/09/12/2022||||||||| |Norms Committee|||Decision:||||||||||

umber||||HQRNORM APPLY 00004907AM23||||||||| |||||||||||||| |RA File Number||||03AX04004528 AM23||||||||| |Licence No and Da|||te|0311019883/09/12/2022||||||||| |Norms Committee|||Decision:|||||||||| |The Committee|||considered the case as per agenda and it was decided to ratify ad-hoc norms under Para|||||||||| | 4.07 of HBP V details iven bel||| ol. I considering**NC3 meet March 202223/22 dated 24.03.2023**on prorate basis as per ow or as alied b the firm whichever is less: -|||||||||| |g|||pp y ,|||||||||| |||||||||||||| ||||||||||||||

Case No.	35 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00004907AM23
RA File Number	03AX04004528 AM23
Licence No and Date	0311019883/09/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify ad-hoc norms under Para
4.07 of HBP Vol. I considering*NC3 meet March 202223/22 dated 24.03.2023*on prorate basis as per
details given below or as applied by the firm, whichever is less: -

UDIN00081605AM24

07 of HBP Vol. I considering**NC3 meet March 202223/22 dated 24.03.2023**on prorate basis as per|| |details given below or as applied by the firm, whichever is less: -||

UDIN00081605AM24

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Colesevelam HCL for oral suspension<br>3.75<br>GM<br>(Per<br>Pack<br>30<br>Pouchs)(Colesevelam HCL for oral<br>suspension 3.75 GM (Per Pack 30<br>Pouchs)<br>(Net.<br>Content<br>of<br>Colesevelam Hydrochloride is 787.50<br>kgs))<br>7000<br>Number<br>Packs<br>1<br>Colesevelam Hydrochloride 826.875 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty.
	Colesevelam HCL for oral suspension<br>3.75<br>GM<br>(Per<br>Pack<br>30<br>Pouchs)(Colesevelam HCL for oral<br>suspension 3.75 GM (Per Pack 30<br>Pouchs)<br>(Net.<br>Content<br>of<br>Colesevelam Hydrochloride is 787.50<br>kgs))	<br> <br> <br> <br> <br> <br>7000<br>Number<br>Packs	1	Colesevelam Hydrochloride	826.875 kg.

Case No.	Case No.	36 / NC/3/MEET/Apr/202324/1	36 / NC/3/MEET/Apr/202324/1	36 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		KREATIVE ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00004909AM23
RA File Number		09AX04000790 AM23
Licence No and<br>Date		0911004140/09/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Jan/202223/18 dated 23/01/2023against advance<br>authorizationNo.0911003550dated 26/08/2022, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>2 ETHYL ANILINE or 2 ETHYL<br>BENZENEAMINE<br>1.058 kg.<br>2<br>2 3 DIHYDROFURANE<br>0.330 kg.<br>3<br>METHYL 3 OXO PENTONOATE<br>0.455 kg.<br>ETODOLAC<br>METHYL<br>ESTER<br>(ETODOLAC<br>METHYL<br>ESTER)<br>1 kg.
	Export Product		Qty.	Sl.

.058 kg. 2 2 3 DIHYDROFURANE 0.330 kg. 3 METHYL 3 OXO PENTONOATE 0.455 kg. ETODOLAC METHYL ESTER (ETODOLAC METHYL ESTER) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||ETODOLAC METHYL ESTER (ETODOLAC METHYL ESTER)|| 1 kg.|1|2 ETHYL ANILINE or 2 ETHYL BENZENEAMINE| 1.058 kg.| |||||2|2 3 DIHYDROFURANE|0.330 kg.| |||||3|METHYL 3 OXO PENTONOATE|0.455 kg.|

UDIN00081605AM24

					4	4	Methanol<br>	Methanol<br>	1.133 kg.


					5		Toluene<br>		Not shown in
									the process


					6		Sodium Nitrite<br>		0.40 kg.

					7		Sodium Sulfite<br>		2.20 kg.


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

C	ase No.			37 / NC/3/MEET/Apr/202324/1
C	ase Status			Case Approved
P	arty Nam		e	J B CHEMICALS AND PHARMAC		EUTICALS L		IMITED
M<br>a	eeting N<br>		umber	NC/ 3/ MEET/ Apr/ 202324/ 1 and 2		8/04/2023
	d Date

se Approved|||||||||||| |P|arty Nam||e|J B CHEMICALS AND PHARMAC||||EUTICALS L|||IMITED||||| |M a|eeting N ||umber|NC/ 3/ MEET/ Apr/ 202324/ 1 and 2||||8/04/2023|||||||| ||d Date||||||||||||||| |H|Q File N||umber|HQRNORM APPLY 00004910AM2||||3|||||||| |R|A File N||umber|03AX04004432 AM23|||||||||||| |L D|icence N ||o and|0311019886/09/12/2022|||||||||||| ||ate||||||||||||||| |N p a |orms Co The Co roduct/||mmittee Decision: mmittee considered the case as per agend import product in meeting No.NC/3/M|||||a and taking c EET/Sep/20|||ue fro 2223/9||m the earlier decision dated 07/10/2022|for same export against advance|| || uthoriz HBP Vo|| ationNo.0311012326dated 07/03/2022, l. I as per details given below or as appli||||| it was decide ed by the firm||| d to rat , which|| ify ad-hoc norms un ever is less:-| der Para 4.07 of|| ||||||||||||||||| ||Sl. No.||Export product||||Q|ty.||Sl. N|o.|Imp|ort items||Qty.| ||1||Rinza sip with Vitamin C (Flavours Orange/ Lemon/ Black Currant/ Other flavours) ||||1 Sa|Number chet||1||Caff|eine Anhydrous Powder||30.30 mg| ||||&(Rinza Sip (Flavours Orange/ Lemon/ Black currant/ Cranberry/ Honey Lemon/ Other flavours). Each sachet of 5gm contains Caffeine Anhydrous Powder 30mg. Net content of Caffeine Anhydrous Powder||||||||||||| ||||923.64 Kgs.)||||||||||||| ||2||Rinza Tablets.

ey Lemon/ Other flavours). Each sachet of 5gm contains Caffeine Anhydrous Powder 30mg. Net content of Caffeine Anhydrous Powder||||||||||||| ||||923.64 Kgs.)||||||||||||| ||2||Rinza Tablets. Each tablet Contains Caffeine Anhydrous Powder 30 mg and Paracetamol|||| 1 Ta|Number blet||2||Caff|eine Anhydrous Powder||30.60 mg| ||||BP 500 mg.(Net Content of Caffeine Anhydrous Powder - 960 Kgs and|||| |||3||Paracetamol BP|||510 mg|

UDIN00081605AM24

	Paracetamol BP- 16000 Kgs)
3	Rinza Sip for Children (Flavours Raspberry/	<br>1 Number	4	Paracetamol BP	282.80 mg
	other flavours). Each sachet of 3gm contains	<br>Sachet
	Paracetamol BP - 280mg.(Net content- 576.92
	Kgs.)

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

Case No.<br>38 / NC/3/MEET/Apr/202324/1
Case Status<br>Case Approved
Party Name<br>SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number<br>HQRNORM APPLY 00004911AM23
RA File Number<br>05AX04002628 AM23
Licence No and<br>Date<br>0511016274/09/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided		to ratify ad-hoc norms under Para
4.07 of HBP Vol. Iconsidering*NC3 meet March 202223/22 dated 24.03.2023*on prorate basis as per
details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl.

f HBP Vol. Iconsidering**NC3 meet March 202223/22 dated 24.03.2023**on prorate basis as per||||| |details given below or as applied by the firm, whichever is less:-||||| |Export Product Qty.|Sl. No.|Import Items|Qty.|| |Brimonidine Tartrate 0.1% Solution 5ml 785299 Vials|1|Brimonidine Tartrate|4.00 kg.|| |Santabrim(Brimonidine Tartrate 0.1%||||| |Solution 5ml Santabrim)||||| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No.	39 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00004917AM23
RA File Number	03AX04004371 AM23
Licence No and	0311019903/12/12/2022

UDIN00081605AM24

e
ms Committee Decision:
e Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07
HBP Vol. I as per details given below or as applied by the firm, whichever is less: -
Export Product	Qty.	Sl.

case as per agenda and it was decided to ratify adhoc norms under Para 4.07|||||| |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.|| |Medical creams & Ointment| 1 Number|1 Relevant Bulk|Drug| Will decide in|| |(Mesalamine Rectal||(Mesalamine USP)||due course|| |Suspension, USP Enema 4.0 g/|||||| |60 ml (Tot Wt: 41777.19 Kgs (Net Cont: Mesalamine 2840.85 Kgs, LDPE Bottle| |2 Packaging Material||Relevant as per Packing Policy.|| |677981 Nos, Enema Applicator||3 Applicator|||| |677981 Nos.))|||||| |A concerned may take further necessary action as per above decision of NC||||||

Date Norms Committee Decision:

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

Case No.<br>40 / NC/3/MEET/Apr/202324/1
Case Status<br>Case Approved
Party Name<br>SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number<br>HQRNORM APPLY 00004923AM23
RA File Number<br>05AX04002676 AM23
Licence No and<br>Date<br>0511016292/12/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking	cue from	the earlier decision for same export
product/import product in meeting No.NC/3/MEET/Sep/202223/9 dated 07/10/2022against advance

tee 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/Sep/202223/9 dated 07/10/2022against advance||||| |authorizationNo.0511006625dated 03/12/2021, it was decided to ratify ad-hoc norms|||under Para 4.07 of|| |HBP Vol. I as per details given below or as applied by the firm, whichever is less: -||||| |Export Product Qty.|Sl. No.|Import Items|Qty.||

UDIN00081605AM24

Mydrimax Eye Drops 5 ml<br>(Mydrimax Eye Drops 5 ml)<br>(Each<br>ml<br>Containing<br>8<br>mg<br>Tropicamide)<br>1 Number<br>1<br>Tropicamide<br>40.8 mg / 5 ml vial<br>RA concerned may take further necessary action as per above decision of NC.	Mydrimax Eye Drops 5 ml<br>(Mydrimax Eye Drops 5 ml)<br>(Each<br>ml<br>Containing<br>8<br>mg<br>Tropicamide)	<br>1 Number	1	Tropicamide	40.8 mg / 5 ml vial

Case No.	Case No.	41 / NC/3/MEET/Apr/202324/1	41 / NC/3/MEET/Apr/202324/1	41 / NC/3/MEET/Apr/202324/1	41 / NC/3/MEET/Apr/202324/1	41 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		GRANULES INDIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00004926AM23
RA File Number		26AX04000074 AM23
Licence No and<br>Date		2611000782/12/12/2022

and Date||NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023||||| |HQ File Number||HQRNORM APPLY 00004926AM23||||| |RA File Number||26AX04000074 AM23||||| |Licence No and Date||2611000782/12/12/2022||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Mar/202223/24 dated 13/04/2023against advance authorizationNo.0911000376dated 18/02/2021, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: - Export Product Qty. Sl. No. Import Items Qty. 1 Tamoxifen citrate 45.60 mg. 2 Calcium hydrogen phosphate dihydrate 258.40 mg. 3 Povidone K 25 6.00 mg. 4 Sodium starch glycolate, type A 30.00 mg. Tamoxifen 30 mg (Tamoxifen 30mg (Each Uncoated Tablets Contains: Tamoxifen Citrate Equivalent to Tamoxifen 30 mg)) 1 number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Tamoxifen 30 mg (Tamoxifen 30mg (Each Uncoated Tablets Contains: Tamoxifen Citrate Equivalent to Tamoxifen 30 mg))|| 1 number|1|Tamoxifen citrate|45.60 mg.| |||||2|Calcium hydrogen phosphate dihydrate| 258.40 mg.| |||||3|Povidone K 25|6.00 mg.| |||||4|Sodium starch glycolate, type A| 30.00 mg.|

UDIN00081605AM24

ate|45.60 mg.| |||||2|Calcium hydrogen phosphate dihydrate| 258.40 mg.| |||||3|Povidone K 25|6.00 mg.| |||||4|Sodium starch glycolate, type A| 30.00 mg.|

UDIN00081605AM24

5<br>Magnesium stearate<br>5.00 mg.<br>6<br>Cellulose<br>microcrystalline<br>33.00 mg.<br>7<br>Silica<br>colloidal<br>anhydrous<br>2.00 mg.<br>RA concerned may take further necessary action as per above decision of NC.			5	Magnesium stearate	5.00 mg.
			6	Cellulose<br>microcrystalline	33.00 mg.
			7	Silica<br>colloidal<br>anhydrous	<br>2.00 mg.

Case No.	42 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00004943AM23
RA File Number	03AX04004593 AM23
Licence No and<br>Date	0311019936/12/12/2022
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products

04004593 AM23| |Licence No and Date|0311019936/12/12/2022| |Norms Committee Decision: Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products||

Case No.	Case No.	43 / NC/3/MEET/Apr/202324/1	43 / NC/3/MEET/Apr/202324/1	43 / NC/3/MEET/Apr/202324/1	43 / NC/3/MEET/Apr/202324/1	43 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		ADCOCK INGRAM LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00004944AM23
RA File Number		07AX04001347 AM23
Licence No and Date		0711005911/12/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.6/82-ALC4/2020 dated 13/11/2020against advance authorization<br>No.0710117061dated 25/09/2020, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.
	Export Product		Qty.	Sl.<br>No.	Import Items	Qty.

UDIN00081605AM24

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.|

UDIN00081605AM24

NORFLEX<br>100<br>mg<br>TABLETS<br>-	1	ORPHENADRINE	102.00
(Orphenadrine Citrate 100mg + Lactose		CITRATE	mg/tablet
167mg + Aerosil 200 - 8mg + Ethyl		BP/EP/USP/PH.EUR
Cellulose<br>20mg)<br>(Orphen-1600.000+
Lactose- 2672.000+Aerosil-128.000+Ethyl-<br>320.000 KGS = Total KGS-4720.000 (No:<br>Tablets:<br>16000000)BP/EP/USP/PH.EUR/NF/USNF)	2	PHARMATOSE<br>R<br>130M<br>MILLED<br>LACTOSE<br>MONOHYDRATE	<br> <br>167.00<br>mg/tablet
		USP-NF/ PH.EUR/JP

Case No.<br>44 / NC/3/MEET/Apr/202324/1
Case Status<br>Case Approved
Party Name<br>AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number<br>HQRNORM APPLY 00004960AM23
RA File Number<br>03AX04004425 AM23
Licence No and<br>Date<br>0311019954/13/12/2022
Norms Committee Decision:
.
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meeting No.NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance
authorizationNo.0311019499dated 24/11/2022, it	was decided to ratify ad-hoc norms under Para 4.07 of
HBP Vol.

in meeting No.NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance||||| |authorizationNo.0311019499dated 24/11/2022, it|was decided to ratify ad-hoc norms under Para 4.07 of|||| |HBP Vol. I as per details given below or as applied|by the firm, whichever is less:-|||| |Export Product Qty. Sl.|No.|Import Items|Qty.|| |Oxcarbazepine USP / BP / EP / IH 1 kg.|1|10-Methoxy Iminostilbene|1.10 kg.|| |RA concerned may take further necessary action as|per above decision of NC||||

Case No.	45 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved

UDIN00081605AM24

Party Name	ANNORA PHARMA PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00004967AM23
RA File Number	09AX04000796 AM23
Licence No and Date	0911004105/13/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.

as per agenda and it was decided to ratify 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. SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION 100 mg/Packet (SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION 100 mg/Packet) 1 Number 1 SAPROPTERIN DIHYDROCHLORIDE 102.00 mg. SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION 500 mg/Packet (SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION 500 mg/Packet) 1 Number 2 SAPROPTERIN DIHYDROCHLORIDE 510.00 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	46 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00004971AM23
RA File Number	31AX04000271 AM23
Licence No and<br>Date	3111001889/13/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export

UDIN00081605AM24

product/import product in meeting No. NC/3/MEET/Mar/202223/22 dated 24/03/2023 against advance authorization No.3111001793dated 03/11/2022 , it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: -

ance authorization No.3111001793dated 03/11/2022 , it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: -

	Export Product	Export Product	Qty.	Sl.<br>No.	Import items	Qty.<br>(in kg.)
	Radicate Spot on 6% for Cats (Pack size 0.75ml x<br>6 pipettes),(Each ml contains: Selamectin BP<br>60mg, Net Weight =0.810 Kgs)		<br>3000<br>Number	1	Selamectin BP / EP /<br>USP	0.825
	Radicate Spot on 6% for Cats (Pack size 0.75ml<br>x 1 pipettes),(Each ml contains: Selamectin BP<br>60mg, Net Weight =0.090 Kgs)		2000<br>Number	2	Selamectin BP / EP /<br>USP	0.092
	Radicate Spot on 12% for Dog (Small Dog)<br>(Pack size 0.5ml x 1 pipettes),(Each ml contains:<br>Selamectin BP 12% NetWeight = 0.102 Kgs)		1700<br>Number	3	Selamectin BP / EP /<br>USP	0.1040
(iv)		,
	Rad	icate Spot on 12% for Dog (Medium Dog)	1600	4	Selamectin BP / EP /	0.1958
	(Pa<br>Sel	ck size 1 ml x 1 pipettes),(Each ml contains:<br>mectin BP 12%Net Weiht = 0192 Ks)	Number		USP
		, g . g

(v)	Rad	icate Spot on 12% for Dog (Large Dog)	1500	5	Selamectin BP / EP /	0.368
	(Pack size 2 ml x 1 pipettes),(Each ml contains:<br>Selamectin BP 12% NetWeiht = 0360 Ks)		Number		USP
		, g . g

	Radicate Spot on 12% for Dog (Extra Large<br>Dog) (Pack size 3 ml x 1 pipettes),(Each ml<br>contains: Selamectin BP 12%,Net Weight =<br>0.360 Kgs)		1000<br>Number	6	Selamectin BP / EP /<br>USP

adicate Spot on 12% for Dog (Extra Large Dog) (Pack size 3 ml x 1 pipettes),(Each ml contains: Selamectin BP 12%,Net Weight = 0.360 Kgs)||1000 Number|6||Selamectin BP / EP / USP|||

Case No.	47 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	DELTA FINOCHEM PRIVATE LIMITED
MeetingNumber	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023

UDIN00081605AM24

and Date
HQ File Number	HQRNORM APPLY 00004995AM23
RA File Number	03AX04004505 AM23
Licence No and<br>Date	0311019991/15/12/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to<br>call for following information/documents from the firm:-<br>Chemistry with molecular weight of both reactant & product giving efficiency of the reaction.<br>1.<br>COA report of 2& 3 export item and also import item no.1<br>2.<br>Calculation for the requirement of import item no 2 & 3 duly certified by charter engineer.<br>3.<br>Also submit shipping bill and bill of entry of the export products.<br>4.

Case No.	48 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	B G P HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005000AM23
RA File Number	34AX04000827 AM23
Licence No and<br>Date	3411003121/15/12/2022
Norms Committee Decision:<br>Deferred for the comments of TE. Also submit shipping bill and bill of entry of the export products.

000827 AM23| |Licence No and Date|3411003121/15/12/2022| |Norms Committee Decision: Deferred for the comments of TE. Also submit shipping bill and bill of entry of the export products.||

Case No.	49 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005001AM23
RA File Number	03AX04004455 AM23
Licence No and<br>Date	0311019998/15/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance<br>authorizationNo.0311019499dated 24/11/2022, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00081605AM24

Export Product	Qty.		Sl. No.	Import Items	Qty.
Oxcarbazepine USP / BP / EP /	<br>1 kg.	1		10-Methoxy Iminostilbene	1.10 kg.
IH

-||

UDIN00081605AM24

Export Product	Qty.		Sl. No.	Import Items	Qty.
Oxcarbazepine USP / BP / EP /	<br>1 kg.	1		10-Methoxy Iminostilbene	1.10 kg.
IH

Case No.	50 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	LAVINIA LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005002AM23
RA File Number	03AX04004301 AM23
Licence No and<br>Date	0311020004/15/12/2022
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to
call for following information/documents from the firm:-
Copy of DML showing approved composition of export item.<br>1.
Copy of Master-Batch Formula.<br>2.
Also submit shipping bill and bill of entry of the export products<br>3.

Case No.	51 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	VINYL PRODUCTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005004AM23
RA File Number	05AX04002721 AM23
Licence No and<br>Date	0511016406/15/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meeting No.NC/3/MEET/Nov/202223/12 dated 18/11/2022against advance
authorizationNo.0510408806dated 06/12/2018, it was decided to ratify ad-hoc norms under Para 4.07 of
HBP Vol.

oduct in meeting No.NC/3/MEET/Nov/202223/12 dated 18/11/2022against advance|| |authorizationNo.0510408806dated 06/12/2018, it was decided to ratify ad-hoc norms under Para 4.07 of|| |HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||

UDIN00081605AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
PHTHALATE (PVC) PLASTICIZER (DOP)	1 kg.	1	Phthalic Anhydride	0.447 kg.
[PHTHALATE (PVC) PLASTICIZER
(DOP)]		2	2 Ethyl Hexanol	0.680 kg.

Case No.	52 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	VINYL PRODUCTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005005AM23
RA File Number	05AX04002728 AM23
Licence No and<br>Date	0511016407/15/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from					the earlier decision for	same export
product/import product in meeting No.NC/3/MEET/Nov/202223/12					dated 18/11/2022against advance
authorizationNo.0510408806dated 06/12/2018,		it	was decided to ratify ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied			by the firm, whichever is less:-
Export Product			Qty.	Sl.

06/12/2018**,||it|was decided to ratify ad-hoc norms under Para 4.07 of|||||| |HBP Vol. I as per details given below or as applied|||by the firm, whichever is less:-|||||| |Export Product|||Qty.|Sl. No.||Import Items|Qty.|| |PHTHALATE (PVC) PLASTICIZER (DOP)||1|kg.|1||Phthalic Anhydride|0.447 kg.|| |[PHTHALATE (PVC) PLASTICIZER||||||||| |(DOP)]||||2||2 Ethyl Hexanol|0.680 kg.|| |RA concerned may take further necessary action as|||per above|decision|of NC.||||

Case No.	53 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred

UDIN00081605AM24

Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005018AM23
RA File Number	09AX04000828 AM23
Licence No and<br>Date	0911004164/15/12/2022
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

4000828 AM23| |Licence No and Date|0911004164/15/12/2022| |Norms Committee Decision: Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.||

Case No.	Case No.	54 / NC/3/MEET/Apr/202324/1	54 / NC/3/MEET/Apr/202324/1	54 / NC/3/MEET/Apr/202324/1	54 / NC/3/MEET/Apr/202324/1	54 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00005021AM23
RA File Number		03AX04004519 AM23
Licence No and Date		0311020036/16/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Apr/202223/1 dated 29/04/2022against advance<br>authorizationNo.0310796757dated 23/06/2015, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>AZITHROMYCIN<br>AMINE<br>1.04 kg.<br>AZITHROMYCIN<br>DIHYDRATE(AZITHROMYCIN<br>DIHYDRATE)<br>1 kg.<br>2<br>ACETONE<br>0.90 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	AZITHROMYCIN<br>DIHYDRATE(AZITHROMYCIN<br>DIHYDRATE)		1 kg.	1	AZITHROMYCIN<br>AMINE	1.04 kg.
				2	ACETONE	0.90 kg.
				decision of NC.

| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||AZITHROMYCIN DIHYDRATE(AZITHROMYCIN DIHYDRATE)||1 kg.|1|AZITHROMYCIN AMINE|1.04 kg.| |||||2|ACETONE|0.90 kg.| |||||decision of NC.|||

Case No.	55 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005039AM23
RA File Number	03AX04004536 AM23

UDIN00081605AM24

Licence No and 0311020073/16/12/2022 Date 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/Jan/202021/4 dated 12/02/2021 against advance authorization No.0310836053dated 01/05/2020 , it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.
GENTAMICIN EAR/EYE DROPS 10<br>ML((EACH VIAL CONTAINS<br>GENTAMICIN SULPHATE 0.030GM NET<br>WT OF BULK DRUG IS 7.49 KGS))	249780<br>vials	1	Gentamicin Sulphate	9.18 kg.
GENTAMICIN EAR/EYE DROPS 5<br>ML((EACH VIAL CONTAINS<br>GENTAMICIN SULPHATE 0.015GM NET<br>WT OF BULK DRUG IS 0.69 KGS))	46000 vials	2	Gentamicin Sulphate	0.845 kg.

entamicin Sulphate|9.18 kg.| |GENTAMICIN EAR/EYE DROPS 5 ML((EACH VIAL CONTAINS GENTAMICIN SULPHATE 0.015GM NET WT OF BULK DRUG IS 0.69 KGS))|46000 vials|2|Gentamicin Sulphate|0.845 kg.|

Case No.	56 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005040AM23
RA File Number	03AX04004644 AM23
Licence No and<br>Date	0311020074/16/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Feb/202223/20 dated 24/02/2023against advance<br>authorizationNo.0311015041dated 27/05/2022, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00081605AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
N-HEXYL BROMIDE	1 kg.	1	1-HEXANOL	0.763
		2	HYDROBROMIC ACID 48%	1.260

whichever is less:-||

UDIN00081605AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
N-HEXYL BROMIDE	1 kg.	1	1-HEXANOL	0.763
		2	HYDROBROMIC ACID 48%	1.260

Case No.	57 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005047AM23
RA File Number	05AX04002739 AM23
Licence No and<br>Date	0511016427/16/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meeting No.NC/3/MEET/Dec/202223/15 dated 29/12/2022against advance
authorizationNo.0511013563dated 04/07/2022,		it	was decided to ratify ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied			by the	firm, whichever is less:-
Export Product			Qty.	Sl. No.	Import Items	Qty.
Deferoxamine Mesylate USP (Sterile		1	kg.	1	Deferoxamine Mesylate	1.02 kg.
Powder)(Deferoxamine Mesylate USP<br>(Sterile Powder))					(Non-Sterile)
RA concerned may take further necessary action as			per above decision of NC.

Case No.	58 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023

UDIN00081605AM24

3/MEET/Apr/202324/1| |---|---| |Case Status|Case Approved| |Party Name|DR.REDDY'S LABORATORIES LTD| |Meeting Number and Date|NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023|

UDIN00081605AM24

HQ File Number	HQRNORM APPLY 00005069AM23
RA File Number	09AX04000826 AM23
Licence No and<br>Date	0911004171/19/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify ad-hoc norms under Para 4.07<br>of HBP Vol. I considering*NC3 meet Jan 202223/18 dated 23.01.2023*on prorate basis as per details given<br>below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Daptomycin for Injection 500mg/vial (Consists<br>of Daptomycin 115 Kgs)(Daptomycin for<br>Injection 500mg/vial (Consists of Daptomycin<br>115 Kgs))<br>23000 Numbers<br>1<br>Daptomycin<br>126.5 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	59 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005075AM23
RA File Number	03AX04004710 AM23
Licence No and<br>Date	0311020115/19/12/2022
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

4004710 AM23| |Licence No and Date|0311020115/19/12/2022| |Norms Committee Decision: Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.||

Case No.	60 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	SHREE GANESH REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005087AM23
RA File Number	34AX04000836 AM23
Licence No and<br>Date	3411003129/19/12/2022
Norms Committee Decision:

UDIN00081605AM24

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:-

End use of export product.
Exact type of residual obtained during distillation and its commercial value.
Production/Consumption data for last one year duly certified by GST.
Also submit shipping bill and bill of entry of the export products.

g distillation and its commercial value.**

Production/Consumption data for last one year duly certified by GST.
Also submit shipping bill and bill of entry of the export products.

Case No.<br>61 / NC/3/MEET/Apr/202324/1
Case Status<br>Case Approved
Party Name<br>BIOXERA PHARMA PRIVATE LIMITED
Meeting Number and Date<br>NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number<br>HQRNORM APPLY 00005137AM23
RA File Number<br>03AX04004770 AM23
Licence No and Date<br>0311020153/20/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking	cue from the earlier decision for same export
product/import product in meeting No.NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance
authorizationNo.0311019279dated 17/11/2022, it was decided to ratify ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty.
BENFOTIAMINE(BENFOTIAMINE) 1 kg<br>1	THIAMINE	0.922 kg.
	HYDROCHLORIDE
RA concerned may take further necessary action as per above	decision of NC.

Case No.	62 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005138AM23
RA File Number	34AX04000860 AM23
Licence No and<br>Date	3411003138/20/12/2022
Norms Committee Decision:

UDIN00081605AM24

and 28/04/2023| |HQ File Number|HQRNORM APPLY 00005138AM23| |RA File Number|34AX04000860 AM23| |Licence No and Date|3411003138/20/12/2022| |Norms Committee Decision:||

UDIN00081605AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
Glycopyrrolate injection USP<br>0.2 mg - 1 ml (Glycopyrrolate<br>injection USP 0.2 mg - 1 ml<br>(net content of active<br>ingredients 75.00 gm ))	1 Number	1	Glycopyrrolate USP	0.22 mg.
		2	Serum Stopper (Rubber<br>Stopper)	Relevant as per<br>Packing Policy.
Glycopyrrolate injection USP<br>0.2 mg - 2 ml (Glycopyrrolate<br>injection USP 0.2 mg - 2 ml<br>(net content of active<br>ingredients 77.00 gm))	1 Number	3	Glycopyrrolate USP	0.44 mg.
		4	Serum Stopper (Rubber<br>Stopper)	Relevant as per<br>Packing Policy.
Glycopyrrolate injection USP<br>0.2 mg- 5 ml (Glycopyrrolate<br>injection USP 0.2 mg- 5 ml<br>(net content of active<br>ingredients 92.50 gm ))	1 Number	5	Glycopyrrolate USP	1.10 mg.
		6	Stopper (Rubber Stopper)	Relevant as per<br>Packing Policy.
Glycopyrrolate injection USP<br>0.2 mg - 20 ml (Glycopyrrolate<br>injection USP 0.2 mg - 20<br>ml(net content of active<br>ingredients 20.00 gm ))	<br>1 Number	7	Glycopyrrolate USP	4.20 mg.
		8	Serum Stopper (Rubber<br>Stopper)	Relevant as per<br>Packing Policy.

ction USP 0.2 mg - 20 ml(net content of active ingredients 20.00 gm ))| 1 Number|7|Glycopyrrolate USP|4.20 mg.| |||8|Serum Stopper (Rubber Stopper)|Relevant as per Packing Policy.|

Case No.	63 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	RUMIT LIFE CARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005139AM23
RA File Number	03AX04004667 AM23
Licence No and	0311020160/20/12/2022

UDIN00081605AM24

Date 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/202223/22 dated 24/03/2023 against advance authorization No.0311018575dated 14/10/2022 , it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.
Betamethasone Dipropionate IP/BP/EP/USP<br>(Betamethasone Dipropionate<br>IP/BP/EP/USP)	1 kg.	1	Betamethasone IP/BP/EP/USP	0.868 kg.

roduct	Qty.	Sl. No.	Import Items	Qty.
Betamethasone Dipropionate IP/BP/EP/USP<br>(Betamethasone Dipropionate<br>IP/BP/EP/USP)	1 kg.	1	Betamethasone IP/BP/EP/USP	0.868 kg.

Case No.	Case No.	64 / NC/3/MEET/Apr/202324/1	64 / NC/3/MEET/Apr/202324/1	64 / NC/3/MEET/Apr/202324/1	64 / NC/3/MEET/Apr/202324/1	64 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		RUMIT LIFE CARE
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00005140AM23
RA File Number		03AX04004668 AM23
Licence No and<br>Date		0311020161/20/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance<br>authorizationNo.0311018575dated 14/10/2022, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>Betamethasone Dipropionate IP/BP/EP/USP<br>(Betamethasone Dipropionate<br>IP/BP/EP/USP)<br>1 kg.<br>1<br>Betamethasone IP/BP/EP/USP 0.868 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Betamethasone Dipropionate IP/BP/EP/USP<br>(Betamethasone Dipropionate<br>IP/BP/EP/USP)		1 kg.	1	Betamethasone IP/BP/EP/USP	0.868 kg.

UDIN00081605AM24

||Qty.|Sl. No.|Import Items|Qty.| ||Betamethasone Dipropionate IP/BP/EP/USP (Betamethasone Dipropionate IP/BP/EP/USP)||1 kg.|1|Betamethasone IP/BP/EP/USP|0.868 kg.|

UDIN00081605AM24

Case No.	65 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005141AM23
RA File Number	34AX04000846 AM23
Licence No and<br>Date	3411003139/20/12/2022
Norms Committee Decision:
T
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to
call for following information/documents from the firm:-
Copy of DML for each export items.<br>1.
COA of import item from Foreign Supplier showing potency of import item<br>2.
Wastage applied in each export.<br>3.
Also submit shipping bill and bill of entry of the export products.<br>4.

rt item from Foreign Supplier showing potency of import item** 2.|| |Wastage applied in each export. 3.|| |Also submit shipping bill and bill of entry of the export products. 4.||

Case No.<br>66 / NC/3/MEET/Apr/202324/1
Case Status<br>Case Approved
Party Name<br>INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number<br>HQRNORM APPLY 00005156AM23
RA File Number<br>08AX04001548 AM23
Licence No and<br>Date<br>0811006808/21/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and	it was decided to ratify 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.	Sl.	Import Items	Qty.
	No.

Case No.<br>66 / NC/3/MEET/Apr/202324/1
Case Status<br>Case Approved
Party Name<br>INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number<br>HQRNORM APPLY 00005156AM23
RA File Number<br>08AX04001548 AM23
Licence No and<br>Date<br>0811006808/21/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and	it was decided to ratify 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.	Sl.	Import Items	Qty.
	No.

UDIN00081605AM24

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.|Import Items|Qty.|| ||No.||||

UDIN00081605AM24

ASPIRIN TABLETS 75 MG (EACH<br>UNCOATED TABLET CONTAINS<br>ACETYL SALICYLIC ACID EP 75<br>MG)<br>1 Number<br>1<br>ASPIRIN (ACETYL<br>SALICYLIC ACID) EP / BP /<br>IP / USP / PH. EUR.<br>76.5 mg.<br>ASPIRIN ENTERIC COATED<br>TABLETS 81 MG "ECOTRIN<br>81"(EACH ENTERIC COATED<br>TABLET CONTAINS ASPIRIN BP<br>81 MG [IN WHICH ACTIVE<br>INGREDIENT ASPIRIN (ACETYL<br>SALICYLIC ACID) USED IS<br>2861.250 KGS.])<br>1 Number<br>2<br>ASPIRIN (ACETYL<br>SALICYLIC ACID) EP / BP /<br>IP / USP / PH. EUR.<br>82.62 mg.<br>RA concerned may take further necessary action as per above decision of NC.	ASPIRIN TABLETS 75 MG (EACH<br>UNCOATED TABLET CONTAINS<br>ACETYL SALICYLIC ACID EP 75<br>MG)	<br> <br> <br>1 Number	1	ASPIRIN (ACETYL<br>SALICYLIC ACID) EP / BP /<br>IP / USP / PH. EUR.	76.5 mg.
	ASPIRIN ENTERIC COATED<br>TABLETS 81 MG "ECOTRIN<br>81"(EACH ENTERIC COATED<br>TABLET CONTAINS ASPIRIN BP<br>81 MG [IN WHICH ACTIVE<br>INGREDIENT ASPIRIN (ACETYL<br>SALICYLIC ACID) USED IS<br>2861.250 KGS.])	1 Number	2	ASPIRIN (ACETYL<br>SALICYLIC ACID) EP / BP /<br>IP / USP / PH. EUR.	82.62 mg.

Case No.	Case No.	67 / NC/3/MEET/Apr/202324/1	67 / NC/3/MEET/Apr/202324/1	67 / NC/3/MEET/Apr/202324/1	67 / NC/3/MEET/Apr/202324/1	67 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00005179AM23
RA File Number		34AX04000868 AM23
Licence No and<br>Date		3411003144/21/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance<br>authorization No.3411002878 dated 11/10/2022, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Phenol<br>1 MT<br>1<br>Cumene<br>0.84466 MT
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Phenol		1 MT	1	Cumene	0.84466 MT

UDIN00081605AM24

Import Items Qty. Phenol 1 MT 1 Cumene 0.84466 MT||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Phenol||1 MT|1|Cumene|0.84466 MT| ||||||||

UDIN00081605AM24

Case No.	68 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005180AM23
RA File Number	34AX04000869 AM23
Licence No and<br>Date	3411003145/21/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance<br>authorization No.3411002878 dated 11/10/2022, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Phenol<br>1 MT<br>1<br>Cumene<br>0.84466 MT<br>RA concerned may take further necessary action as per above decision of NC.

less:- Export Product Qty. Sl. No. Import Items Qty. Phenol 1 MT 1 Cumene 0.84466 MT RA concerned may take further necessary action as per above decision of NC.||

Case No.	69 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005182AM23
RA File Number	08AX04001545 AM23
Licence No and Date	0811006814/21/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00081605AM24

Export Product	Qty.		Import Items	Qty.
CINNARIZINE<br>AND	1 Number	1	DIMENHYDRINATE	40.80 mg.
DIMENHYDRINATE 20 MG + 40 MG			MICRONIZED
TABLETS<br>(CINZATOR)<br>(EACH			PH.EUR
UNCOATED<br>TABLETSCONTAINS:
CINNARIZINE PH. EUR. 20 MG &
DIMENHYDRINATE PH. EUR. 40 MG
NET<br>CONTENT<br>OF
DIMENHYDRINATE SHOULD NOT
BE LESS THAN 30 KGS IN EXPORT
PRODUCT)

S:|||||| |CINNARIZINE PH. EUR. 20 MG &|||||| |DIMENHYDRINATE PH. EUR. 40 MG|||||| |NET CONTENT OF|||||| |DIMENHYDRINATE SHOULD NOT|||||| |BE LESS THAN 30 KGS IN EXPORT|||||| |PRODUCT)||||||

Case No.	70 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	SHARON BIO-MEDICINE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005222AM23
RA File Number	03AX04004798 AM23
Licence No and<br>Date	0311020213/22/12/2022
Norms Committee Decision:
Deferred for comments of TE.Also submit shipping bill and bill of entry of the export products.

Case No.		71 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		ADCOCK INGRAM LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00005239AM23
RA File Number		07AX04001406 AM23
Licence No and<br>Date		0711005991/23/12/2022
Norms Committee	Decision:
The Committee	considered the case as per agenda and taking cue from the earlier decision for same export
product/import	product in meeting No.3/82-ALC4/2018 dated 05/06/2018against advance authorization
No.0710108351dated 10/06/2015, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as

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

8351dated 10/06/2015**, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as|||

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
CAL - SUP TABLETS (CAL - SUP	<br>1 Number	1	GLYCINE USP/BP/EP	535.7 mg/tablet
TABLETS<br>(CALCIUM
CARBONATE 1250mg+ GLYCINE
535.7mg) (Glycine -
1000.000 KGS + Calcium - 2333.396
KGS)-Total KGS-3333.396 KGS (No:
Tablets: - 1866716) USP/BP/EP)

Case No.<br>72 / NC/3/MEET/Apr/202324/1
Case Status<br>Case Approved
Party Name<br>J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number and Date<br>NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number<br>HQRNORM APPLY 00005240AM23
RA File Number<br>03AX04004677 AM23
Licence No and Date<br>0311020234/23/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meeting No.NC/3/MEET/Mar/202223/22	dated 24/03/2023against			advance
authorizationNo.0311019482 dated 24/11/2022, it was decided to ratify ad-hoc norms under Para 4.07 of
HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
S.No. Export Product	Qty.	Sl.No.	Import	Qty.
			Items
(i)<br>Benzocaine and Cetylpyridinium Chloride Anaesthetic Throat	<br>1	1	Benzocaine	12.24
Lozenges.

rm, whichever is less:-||||||| |S.No. Export Product||Qty.|Sl.No.|Import|Qty.|| |||||Items||| |(i) Benzocaine and Cetylpyridinium Chloride Anaesthetic Throat|| 1|1|Benzocaine|12.24|| |Lozenges. Flavours Black Current, Honey Lemon & Other||Number|||mg|| |Flavour (Each Lozenge Contains 12mg Benzocaine. Net||||||| |content of Benzocaine - 90.323 Kgs.)|||||||

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(ii)	Benzocaine and Cetylpyridinium Chloride Anaesthetic Throat<br>Lozenges. Flavours Black Current and Lime & Lemon and<br>Other (Flavours. Each Lozenge contains 10mg Benzocaine. Net<br>content of Benzocaine - 20.339 Kgs.)	<br> <br>1<br>Number	2	Benzocaine	10.20<br>mg.
(iii)	Benzocaine, Cetylpyridinium Chloride And Dextromethorphan<br>Hydrobromide Anaesthetic Throat Lozenges.(Each Lozenge<br>Contains 1.25mg Benzocaine. Net content of Benzocaine -<br>2.367 Kgs.)	<br> <br>1<br>Number	3	Benzocaine	1.275<br>mg.
(iv)	: Life Brand Sore Throat & Nasal Congestion Relief Extra<br>Strength (Flavours Cherry/Honey & Lemon/Other flavours)<br>(SugarFree Lozenges. Each Lozenge Contains Bezocaine 15<br>mg & Isomalt ST-M 2571 Mg. Net Content Benzocaine 9.934<br>Kgs and Isomalt ST-M - 1702.742 Kgs.)	1<br>Number	4	Benzocaine	15.30<br>mg.
			5	Isomalt<br>ST-M	2571.00<br>mg.
(v)	Personnelle Oral Anesthetic Sore Throat Lozenges Extra<br>Strenght Sugar Free (Flavours Cherry/Honey Lemon/Other<br>flavours) (Each Lozenge Contains Bezocaine 15 mg &<br>Isomalt ST-M 2571 Mg.

.| |(v)|Personnelle Oral Anesthetic Sore Throat Lozenges Extra Strenght Sugar Free (Flavours Cherry/Honey Lemon/Other flavours) (Each Lozenge Contains Bezocaine 15 mg & Isomalt ST-M 2571 Mg. Net Content Benzocaine 9.934 Kgs and Isomalt ST-M - 1702.742Kgs.)| 1 Number|6|Benzocaine|15.30 mg.| ||||7|Isomalt ST-M|2571.00 mg| |(vi)|Option+Oral Lozenges Sore Throat & Nasal Congestion Relief Extra Strenght (Flavours Cherry/Honey Lemon /Other flavours). (Each Lozenge Contains Bezocaine 15 mg & Isomalt ST-M 2571 Mg. Net Content Benzocaine 9.934 Kgs and Isomalt ST-M -1702.742 Kgs.)| 1 Number|8|Benzocaine|15.30 mg| ||||9|Isomalt ST-M|2571.00 mg.| |(vii)|Biomedic Oral Anesthetic Lozenges Sore Throat & Nasal Congestion Relief Extra Strength Cherry ST & NCRELEX (Lozenges(FlavoursCherry/HoneyLemon/Otherflavours)Each LozengeContainsBezocaine15mg&IsomaltST-M2571 Mg.Net Content Benzocaine 9.934 Kgs and Isomalt ST-M - 1702.742 Kgs.)|1 Number|10|Benzocaine|15.30 mg.| ||||11|Isomalt ST-M|2571.00 mg| |(viii)|Atoma Sore Throat & Nasal Congestion Relief Extra Strength Lozenges Cherry/Honey & Lemon Flavour.(Each Lozenge Contains Bezocaine 15 mg & Isomalt ST-M 2700 Mg. Net| 1 Number|12|Benzocaine|15.30 mg.| ||||13|Isomalt|2700.00|

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	Content Benzocaine	6.623	Kgs and Isomalt ST-M -	1135.148			ST-M	mg.
	Kgs.)

aine|15.30 mg.| ||||13|Isomalt|2700.00|

UDIN00081605AM24

	Content Benzocaine	6.623	Kgs and Isomalt ST-M -	1135.148			ST-M	mg.
	Kgs.)

Case No.	73 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005244AM23
RA File Number	08AX04001456 AM23
Licence No and Date	0811006827/23/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br>Isoproterenol<br>Hydrochloride<br>Injection<br>USP, 0.2mg/ml (5ml)<br>1 Number<br>1<br>Isoproterenol<br>HydrochlorideInjection,USP1mg/5ml(0.2mg/ml)<br>1.10 mg<br>RA concerned may take further necessary action as per above decision of NC

Case No.	74 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005247AM23
RA File Number	08AX04001457 AM23
Licence No and<br>Date	0811006828/23/12/2022
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for

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following information/documents from the firm:-

e Decision: The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for||

UDIN00081605AM24

following information/documents from the firm:-

Both export and import items are same. Appears to be an error. Firm may be advised to get the license amended.
Also submit shipping bill and bill of entry of the export products.

Case No.	75 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005250AM23
RA File Number	05AX04002812 AM23
Licence No and<br>Date	0511016521/23/12/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call<br>for following information/documents from the firm:-<br>Approved composition of export item.<br>1.<br>Copy of Master Batch Formula.<br>2.<br>COA of export item.<br>3.<br>COA of Import item from Foreign Supplier<br>4.<br>Wastage claimed.<br>5.<br>Also submit shipping bill and bill of entry of the export products.<br>6.

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:-

of the export products.** 6.||

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:-

Case No.	76 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005251AM23
RA File Number	34AX04000877 AM23
Licence No and<br>Date	3411003175/23/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance<br>authorization No.3411002878 dated 11/10/2022, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

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Export Product	Qty.	Sl. No.	Import Items	Qty.
Phenol	1 MT	1	Cumene	0.84466 MT

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

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Export Product	Qty.	Sl. No.	Import Items	Qty.
Phenol	1 MT	1	Cumene	0.84466 MT

Case No.	77 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005256AM23
RA File Number	34AX04000871 AM23
Licence No and<br>Date	3411003177/23/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Feb/202223/20 dated 24/02/2023against advance<br>authorizationNo.3411001750 dated 04/02/2022, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Propionaldehyde<br>0.842 kg.<br>2<br>1-Pentanol / N Amyl Alcohol<br>0.639 kg.<br>Undecavertol (Kakdinol)<br>((4-Methyl-3-decen- 5-ol) )<br>1 kg.<br>3<br>Magnesium Turning<br>0.142 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	78 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023

UDIN00081605AM24

/MEET/Apr/202324/1| |---|---| |Case Status|Case Approved| |Party Name|DHANUKA LABORATORIES LIMITED| |Meeting Number and Date|NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023|

UDIN00081605AM24

HQ File Number	HQ File Number	HQRNORM APPLY 00005272AM23	HQRNORM APPLY 00005272AM23	HQRNORM APPLY 00005272AM23
RA File Number		05AX04002766 AM23
Licence No and<br>Date		0511016533/26/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance<br>authorizationNo.0511015457 dated 21/10/2022, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.(in kg.)<br>1<br>Pencillin<br>G<br>Potassium<br>First<br>Crystal<br>8.515<br>2<br>METHYLENE<br>CHLORIDE<br>/Dichloromethane<br>76.165<br>3<br>Triethylamine<br>3.214<br>4<br>Methanol<br>41.137<br>5<br>Ethyl-4-chloroacetoacetate<br>1.82<br>6<br>Methyl-3-methoxy acrylate<br>1.62<br>7<br>Prenol<br>3.114<br>8<br>N,N-Dimethyl Formamide<br>12.16<br>9<br>Acetonitrile<br>7.50<br>10<br>Activated carbon<br>0.200<br>11<br>Acetone<br>1.20<br>12<br>Toluene<br>23.00<br>CEFTIBUTEN JP(POWDER)<br>1 kg.
	Export Product		Qty.	Sl.

rmamide 12.16 9 Acetonitrile 7.50 10 Activated carbon 0.200 11 Acetone 1.20 12 Toluene 23.00 CEFTIBUTEN JP(POWDER) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.(in kg.)| ||CEFTIBUTEN JP(POWDER)||1 kg.|1|Pencillin G Potassium First Crystal| 8.515| |||||2|METHYLENE CHLORIDE /Dichloromethane| 76.165| |||||3|Triethylamine|3.214| |||||4|Methanol|41.137| |||||5|Ethyl-4-chloroacetoacetate|1.82| |||||6|Methyl-3-methoxy acrylate|1.62| |||||7|Prenol|3.114| |||||8|N,N-Dimethyl Formamide|12.16| |||||9|Acetonitrile|7.50| |||||10|Activated carbon|0.200| |||||11|Acetone|1.20| |||||12|Toluene|23.00|

HQ File Number	HQ File Number	HQRNORM APPLY 00005272AM23	HQRNORM APPLY 00005272AM23	HQRNORM APPLY 00005272AM23	HQRNORM APPLY 00005272AM23	HQRNORM APPLY 00005272AM23
RA File Number		05AX04002766 AM23
Licence No and<br>Date		0511016533/26/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance<br>authorizationNo.0511015457 dated 21/10/2022, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.

ted 21/10/2022**, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty.(in kg.) 1 Pencillin G Potassium First Crystal 8.515 2 METHYLENE CHLORIDE /Dichloromethane 76.165 3 Triethylamine 3.214 4 Methanol 41.137 5 Ethyl-4-chloroacetoacetate 1.82 6 Methyl-3-methoxy acrylate 1.62 7 Prenol 3.114 8 N,N-Dimethyl Formamide 12.16 9 Acetonitrile 7.50 10 Activated carbon 0.200 11 Acetone 1.20 12 Toluene 23.00 CEFTIBUTEN JP(POWDER) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.(in kg.)| ||CEFTIBUTEN JP(POWDER)||1 kg.|1|Pencillin G Potassium First Crystal| 8.515| |||||2|METHYLENE CHLORIDE /Dichloromethane| 76.165| |||||3|Triethylamine|3.214| |||||4|Methanol|41.137| |||||5|Ethyl-4-chloroacetoacetate|1.82| |||||6|Methyl-3-methoxy acrylate|1.62| |||||7|Prenol|3.114| |||||8|N,N-Dimethyl Formamide|12.16| |||||9|Acetonitrile|7.50| |||||10|Activated carbon|0.200| |||||11|Acetone|1.20| |||||12|Toluene|23.00|

UDIN00081605AM24

13 Acetic acid 5.50

l|3.114| |||||8|N,N-Dimethyl Formamide|12.16| |||||9|Acetonitrile|7.50| |||||10|Activated carbon|0.200| |||||11|Acetone|1.20| |||||12|Toluene|23.00|

UDIN00081605AM24

13 Acetic acid 5.50

Case No.	79 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005274AM23
RA File Number	03AX04004717 AM23
Licence No and<br>Date	0311020258/26/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Oct/202223/11 dated 31/10/2022against advance<br>authorizationNo.0311009599 dated 17/12/2021, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>CEFEPIME HCL NON STERILE<br>0.655 kg.<br>2<br>LARGININE<br>0.370 kg.<br>CEFEPIME FOR INJECTION<br>(CEFEPIME FOR INJECTION)<br>1 kg.<br>3<br>PACKING MATERIALS<br>Relevant as<br>per packing<br>policy<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	80 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	AURA PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023

UDIN00081605AM24

r/202324/1| |---|---| |Case Status|Case Deferred| |Party Name|AURA PHARMACEUTICALS PRIVATE LIMITED| |Meeting Number and Date|NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023|

UDIN00081605AM24

HQ File Number	HQRNORM APPLY 00005276AM23
RA File Number	03AX04004700 AM23
Licence No and<br>Date	0311020263/26/12/2022
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

Case No.	81 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	MAIVA PHARMA PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005281AM23
RA File Number	07AX04001346 AM23
Licence No and Date	0711005988/26/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. 7/82-ALC4/2019 dated 06/09/2019against advance authorization<br>No.0710111042 dated 31/01/2017, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.

ted 31/01/2017**, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. Glycopyrrolate Injection USP 0.2mg/mL- 1ml 2ml 5ml Vial Each ml contains 0.2mg of Glycopyrrolate as Bulk Drug(TotalExport Qty 991094 Vials of which 380000 nos are 1ml vial and 360568 nos are 2ml vial and 250526 Vials are 5ml vial for which total export Qty is 991094 nos required for considering 10% wastage as per SION(A205) ) 900994.0 Numbers 1 (V-35 4432/50/GREY Westar? RS SIL 1)13mm Chlorobutyl R/S V- 35 4432/50 Grey - RFS Relevant as per Packing Policy. RA concerned may take further necessary action as per above decision of NC.||

Case No. 82 / NC/3/MEET/Apr/202324/1

UDIN00081605AM24

Case Status	Case Deferred
Party Name	KAVALIFE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005283AM23
RA File Number	07AX04001408 AM23
Licence No and<br>Date	0711006001/26/12/2022

| |Meeting Number and Date|NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023| |HQ File Number|HQRNORM APPLY 00005283AM23| |RA File Number|07AX04001408 AM23| |Licence No and Date|0711006001/26/12/2022| |Norms Committee Decision: The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following information/documents from the firm:- Difference between Import and Export item. 1. Complete COA of import from supplier. 2. COA of complete export giving% of another component. 3. Justification of wastage claimed. 4. Also submit shipping bill and bill of entry of the export products. 5.||

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:-

Case No.	83 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005300AM23
RA File Number	09AX04000869 AM23
Licence No and<br>Date	0911004207/26/12/2022
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

4000869 AM23| |Licence No and Date|0911004207/26/12/2022| |Norms Committee Decision: Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.||

Case No.	84 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	MAIVA PHARMA PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005306AM23
RA File Number	07AX04001424 AM23
Licence No and Date	0711006015/26/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Nov/202223/12 dated 18/11/2022against advance<br>authorizationNo.0711003587 dated 03/04/2022, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00081605AM24


Export Product	Qty.	Sl. No.	Import Items	Qty.
Sterile Water for Injection 10mL<br>Vial(Sterile Water for injection,<br>filled in 10mL Vial and capped<br>with<br>13mmGreySerum<br>ChlorobutyI Rubber Stopper)	<br> <br> <br> <br>900000<br>Numbers	1	13mm GraySerum Chlorobutyl<br>R/S-RFS-C14226422GS6TP3	<br>Relevant as per<br>Packing Policy
A concerned may take further necessary action as per above decision of NC.

900000 Numbers|1|13mm GraySerum Chlorobutyl R/S-RFS-C14226422GS6TP3| Relevant as per Packing Policy| ||A concerned may take further necessary action as per above decision of NC.|||||

Case No.	85 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	VACHICHEM INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005310AM23
RA File Number	07AX04001398 AM23
Licence No and<br>Date	0711006018/26/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Sep/202223/8 dated 23/09/2022against advance<br>authorizationNo.0711002024 dated 30/09/2021, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>6-(2-PROPENY)-ERGOLINE-8-<br>CARBOXYLIC ACID CAS NO<br>81409-74-7(6-(2-PROPENY)-<br>ERGOLINE-8-<br>CARBOXYLIC<br>ACID CAS NO 81409-74-7)<br>1 kg.<br>1<br>LYSERGOL (9,10 DIDEHYDRO 6<br>METHYLERGOLINE<br>-8B-<br>METHANOL CAS NO 602-85-7)<br>2.98 kg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00081605AM24

ERGOL (9,10 DIDEHYDRO 6 METHYLERGOLINE -8B- METHANOL CAS NO 602-85-7) 2.98 kg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00081605AM24

Case No.	86 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005311AM23
RA File Number	03AX04004688 AM23
Licence No and<br>Date	0311020288/27/12/2022
Norms Committee Decision:<br>Deferred for the comments of TE. Also call shipping bill and bill of entry.

Case No.	87 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	ADCOCK INGRAM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005317AM23
RA File Number	07AX04001362 AM23
Licence No and<br>Date	0711006024/27/12/2022
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

4001362 AM23| |Licence No and Date|0711006024/27/12/2022| |Norms Committee Decision: Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.||

Case No.	88 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	LYRUS LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005325AM23
RA File Number	07AX04001423 AM23
Licence No and<br>Date	0711006029/27/12/2022
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Copy of DML for each export item.<br>1.<br>Detailed calculation/Justification for the import quantity in line with DML.<br>2.<br>Also submit shipping bill and bill of entry of the export products.<br>3.

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:-

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Case No.	89 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	CANPEX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005335AM23
RA File Number	31AX04000284 AM23
Licence No and<br>Date	3111001917/27/12/2022
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

4000284 AM23| |Licence No and Date|3111001917/27/12/2022| |Norms Committee Decision: Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.||

Case No.	90 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	INDIA GLYCOLS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005340AM23
RA File Number	05AX04002859 AM23
Licence No and<br>Date	0511016572/27/12/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to<br>call for following information/documents from the firm:-<br>Activity % of Silver Catalyst.<br>1.<br>Function of Alumina Catalyst in the reaction with its activity %.<br>2.<br>Also submit shipping bill and bill of entry of the export products<br>3.

Case No.	91 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005380AM23
RA File Number	34AX04000907 AM23
Licence No and<br>Date	3411003203/28/12/2022
Norms Committee Decision:<br>.<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance

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as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo.NC/3/MEET/Mar/202223/22 dated 24/03/2023against advance||

UDIN00081605AM24

authorization No. 3411002878 dated 11/10/2022 , it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.
Phenol	1 MT	1	Cumene	0.84466 MT

Case No.	92 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	MEDREICH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005381AM23
RA File Number	07AX04001433 AM23
Licence No and<br>Date	0711006048/28/12/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call<br>for following information/documents from the firm:-<br>Copy of Master Batch Formula showing net content of inputs in the export item.<br>1.<br>Also submit shipping bill and bill of entry of the export products.<br>2.

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:-

of the export products.** 2.||

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:-

Case No.	93 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005387AM23
RA File Number	05AX04002796 AM23
Licence No and<br>Date	0511016607/28/12/2022
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

Case No. 94 / NC/3/MEET/Apr/202324/1

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Case Status	Case Status	Case Approved	Case Approved	Case Approved	Case Approved	Case Approved
Party Name		MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00005395AM23
RA File Number		07AX04001425 AM23
Licence No and<br>Date		0711006007/28/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jun/202122/2 dated 02/07/2021against advance<br>authorization No.0711000869 dated 09/04/2021, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol.

oduct in meetingNo.NC/3/MEET/Jun/202122/2 dated 02/07/2021against advance authorization No.0711000869 dated 09/04/2021, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. Bumetanide Injection 0.25mg/mL, 4mL vial(Bumetanide Injection 0.25mg/mL, 4mL vial -0.25 mg of bulk drug filled in4 mL vial and selaed with 13mm stopper) 259600 Numbers 1 V-35 4416/50 GRY SIL 3 Westar SELECT RS/ P02(13mm stopper RFS-V-35 4416/50 GRY SIL Westar RS/SP02-R/S Relevant as per packing policy Bumetanide Injection 0.25mg/mL, 10mL vial(Bumetanide Injection 0.25mg/mL, 10mL vial -0.25 mg of bulk drug filledin 10 mL vial and selaed with 13mm stopper) 189200 Numbers 2 V-35 4416/50 GRY SIL 3 Westar SELECT RS/ P02(13mm stopper RFS-V-35 4416/50 GRY SIL Westar RS/SP02-R/S Relevant as per packing policy Famotidine Injection 10mg/mL, 2mL vial(Famotidine Injection 10mg/mL, 2mL vial -10mg of bulk drug filled in 2mLvial and selaed with 13mm stopper) 748000 Numbers 3 V-35 4416/50 GRY SIL 3 Westar SELECT RS/ P02(13mm stopper RFS-V-35 4416/50 GRY SIL Westar RS/SP02-R/S Relevant as per packing policy||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.|

SIL 3 Westar SELECT RS/ P02(13mm stopper RFS-V-35 4416/50 GRY SIL Westar RS/SP02-R/S Relevant as per packing policy||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Bumetanide Injection 0.25mg/mL, 4mL vial(Bumetanide Injection 0.25mg/mL, 4mL vial -0.25 mg of bulk drug filled in4 mL vial and selaed with 13mm stopper)|| 259600 Numbers|1|V-35 4416/50 GRY SIL 3 Westar SELECT RS/ P02(13mm stopper RFS-V-35 4416/50 GRY SIL Westar RS/SP02-R/S| Relevant as per packing policy| ||Bumetanide Injection 0.25mg/mL, 10mL vial(Bumetanide Injection 0.25mg/mL, 10mL vial -0.25 mg of bulk drug filledin 10 mL vial and selaed with 13mm stopper)|| 189200 Numbers|2|V-35 4416/50 GRY SIL 3 Westar SELECT RS/ P02(13mm stopper RFS-V-35 4416/50 GRY SIL Westar RS/SP02-R/S| Relevant as per packing policy| ||Famotidine Injection 10mg/mL, 2mL vial(Famotidine Injection 10mg/mL, 2mL vial -10mg of bulk drug filled in 2mLvial and selaed with 13mm stopper)|| 748000 Numbers|3|V-35 4416/50 GRY SIL 3 Westar SELECT RS/ P02(13mm stopper RFS-V-35 4416/50 GRY SIL Westar RS/SP02-R/S| Relevant as per packing policy| ||||||||

UDIN00081605AM24

16/50 GRY SIL 3 Westar SELECT RS/ P02(13mm stopper RFS-V-35 4416/50 GRY SIL Westar RS/SP02-R/S| Relevant as per packing policy| ||||||||

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Case No.	95 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005401AM23
RA File Number	34AX04000903 AM23
Licence No and<br>Date	3411003211/29/12/2022
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

Case No.	96 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	CENTRIENT PHARMACEUTICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005408AM23
RA File Number	30AX04000407 AM23
Licence No and<br>Date	3011002957/29/12/2022
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

4000407 AM23| |Licence No and Date|3011002957/29/12/2022| |Norms Committee Decision: Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.||

Case No.	97 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	VINYL PRODUCTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005409AM23
RA File Number	05AX04002878 AM23
Licence No and<br>Date	0511016621/29/12/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to<br>call for following information/documents from the firm:-<br>Step wise manufacturing process.<br>i.

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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.
v. Details of indigenous input with quantity.
vi. Also submit shipping bill and bill of entry of the export products.

g.| |---|---|---|---|---|---| ||||2|N OCTYL D GLUCAMINE|0.36 kg.| ||||3|TRIS AMINO BUFFER TROMETHAMINE|0.36 kg.|

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

Case No.	109 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	ZENITH DYEINTERMEDIATES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005458AM23
RA File Number	03AX04004689 AM23
Licence No and<br>Date	0311020392/02/01/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to<br>call for following information/documents from the firm:-<br>Chemistry of reaction giving complete calculation for requirements of raw materials based on<br>molecular height.<br>1.<br>Yield of the reaction with justification.<br>2.<br>To fill 4E annexure indicating imported & indigenous items.<br>3.<br>Production/consumption for last three years duly certify by CA.<br>4.<br>Also submit shipping bill and bill of entry of the export products.<br>5.

Case No.	110 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	SPAK ORGOCHEM (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005464AM23
RA File Number	03AX04004881 AM23
Licence No and<br>Date	0311020403/02/01/2023
Norms Committee Decision:

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and 28/04/2023| |HQ File Number|HQRNORM APPLY 00005464AM23| |RA File Number|03AX04004881 AM23| |Licence No and Date|0311020403/02/01/2023| |Norms Committee Decision:||

UDIN00081605AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
Sorbitan Mono Laurate	1 Kg.	1	Palm Kernel Fatty Acid/Coconut<br>Fatty Acid (95% Active Content)	0.66 kg.
		2	SORBITOL 70% SOLUTION	0.71 kg.

Case No.	111 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	BELCHEM INDUSTRIES (INDIA) PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005480AM23
RA File Number	03AX04004595 AM23
Licence No and<br>Date	0311020433/03/01/2023
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

4004595 AM23| |Licence No and Date|0311020433/03/01/2023| |Norms Committee Decision: Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.||

Case No.	112 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005484AM23
RA File Number	03AX04004899 AM23
Licence No and Date	0311020446/03/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jan/202223/18 dated 23/01/2023against advance<br>authorization No.0311003736 dated 12/05/2021, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00081605AM24

3736 dated 12/05/2021**, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||

UDIN00081605AM24

|Export product Qty. Sl. No. Import items Qty. 1 (R)-3-AMINO-1-BUTANOL 19.635 mg 2 1-(2,2-dimethoxyethyl)-5- methoxy-6(methoxycarbonyl) 4- oxo-1,4-dihydropyridine-3- carboxylic acid Indigenously procured 3 Lithium bromide anhydrous Indigenously procured 4 (R)-9-(2-phosphonomethoxy propyl)-adenine 205.02 mg Lamivudine 300mg + Tenofovir disoproxil Fumarate 300mg + Dolutegravir Sodium 50mg tablets(Lamivudine 300mg + Tenofovir disoproxil Fumarate 300mg + Dolutegravir Sodium 50mg tablets (Net content: 3080.240 kgs Dolutegravir Sodium + 18481.440 kgs Tenofovir Disoproxil Fumarate + 18481.440 kgs Lamivudine)) 1 Number 5 LAMIVUDINE Indigenously procured RA concerned may take further necessary action as per above decision of NC.|Export product|Qty.|Sl.

Export product	Qty.	Sl. No.	Import items	Qty.
Lamivudine<br>300mg<br>+<br>Tenofovir<br>disoproxil<br>Fumarate<br>300mg<br>+<br>Dolutegravir<br>Sodium<br>50mg<br>tablets(Lamivudine 300mg + Tenofovir<br>disoproxil<br>Fumarate<br>300mg<br>+<br>Dolutegravir Sodium 50mg tablets (Net<br>content: 3080.240 kgs Dolutegravir<br>Sodium + 18481.440 kgs Tenofovir<br>Disoproxil Fumarate + 18481.440 kgs<br>Lamivudine))	<br> <br> <br> <br> <br> <br> <br> <br> <br>1 Number	1	(R)-3-AMINO-1-BUTANOL	19.635 mg
		2	1-(2,2-dimethoxyethyl)-5-<br>methoxy-6(methoxycarbonyl) 4-<br>oxo-1,4-dihydropyridine-3-<br>carboxylic acid	Indigenously<br>procured
		3	Lithium bromide anhydrous	Indigenously<br>procured
		4	(R)-9-(2-phosphonomethoxy<br>propyl)-adenine	205.02 mg
		5	LAMIVUDINE	Indigenously<br>procured

c acid|Indigenously procured| ||||3|Lithium bromide anhydrous|Indigenously procured| ||||4|(R)-9-(2-phosphonomethoxy propyl)-adenine|205.02 mg| ||||5|LAMIVUDINE|Indigenously procured|

Case No.	Case No.	113 / NC/3/MEET/Apr/202324/1	113 / NC/3/MEET/Apr/202324/1	113 / NC/3/MEET/Apr/202324/1	113 / NC/3/MEET/Apr/202324/1	113 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		MANKIND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00005486AM23
RA File Number		05AX04002919 AM23
Licence No and<br>Date		0511016690/03/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Tobramycin<br>Inhalation<br>Solution,<br>USP, 300mg/ 4ml (Having net<br>content of 23.10 kg of Bulk drug)<br>1 Number<br>1<br>TOBRAMYCIN USP<br>306 mg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Tobramycin<br>Inhalation<br>Solution,<br>USP, 300mg/ 4ml (Having net<br>content of 23.10 kg of Bulk drug)		1 Number	1	TOBRAMYCIN USP	306 mg.

UDIN00081605AM24

Sl. No.|Import Items|Qty.| ||Tobramycin Inhalation Solution, USP, 300mg/ 4ml (Having net content of 23.10 kg of Bulk drug)||1 Number|1|TOBRAMYCIN USP|306 mg.|

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Case No.	114 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	MAYA BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005487AM23
RA File Number	30AX04000416 AM23
Licence No and<br>Date	3011002973/03/01/2023
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

Case No.	Case No.	115 / NC/3/MEET/Apr/202324/1	115 / NC/3/MEET/Apr/202324/1	115 / NC/3/MEET/Apr/202324/1	115 / NC/3/MEET/Apr/202324/1	115 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00005490AM23
RA File Number		03AX04004959 AM23
Licence No and<br>Date		0311020450/03/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jan/202223/18 dated 23/01/2023against advance<br>authorization No.0311013612 dated 05/04/2022, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol.

uct in meetingNo. NC/3/MEET/Jan/202223/18 dated 23/01/2023against advance authorization No.0311013612 dated 05/04/2022, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: - Export Product Qty. Sl. No. Import Items Qty. (in mg) 1 Atorvastatin Calcium Propylene Glycol Solvate USP 11.415 Microcrystalline Atorvastatin Calcium Tablets USP 10mg((Net wt. of Import Sr. No. 1 is 495.945kgs, Sr. No. 2 is 2746.71kg, Sr. No. 3 is 779.985kg, Sr. No. 4 is 505000 Nos.)) 1 Number Tablet 2 64.578||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. (in mg)| ||Atorvastatin Calcium Tablets USP 10mg((Net wt. of Import Sr. No. 1 is 495.945kgs, Sr. No. 2 is 2746.71kg, Sr. No. 3 is 779.985kg, Sr. No. 4 is 505000 Nos.))|| 1 Number Tablet|1 |Atorvastatin Calcium Propylene Glycol Solvate USP| 11.415| |||||2|Microcrystalline|64.578|

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. 4 is 505000 Nos.))|| 1 Number Tablet|1 |Atorvastatin Calcium Propylene Glycol Solvate USP| 11.415| |||||2|Microcrystalline|64.578|

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			Cellulose<br>(MCC)<br>NF<br>(Avicel PH 102)
		3	Calcium Acetate	18.049
		4	Silica Gel Dessicants -<br>Packaged<br>Activated<br>Carbon<br>(Strippax<br>Sorbent)	<br> <br> <br>Relevant as<br>per<br>packing<br>policy
Atorvastatin<br>Calcium<br>Tablets<br>USP<br>20mg((Net wt. of Import Sr. No. 1 is<br>59.513kgs, Sr. No. 2 is 330.772kg, Sr. No.<br>3 is93.879kg, Sr. No. 4 is 30300 Nos.))	<br> <br> <br>1<br>Number<br>Tablet	5<br>	Atorvastatin<br>Calcium<br>Propylene Glycol Solvate<br>USP	<br> <br>22.830
		6	Microcrystalline<br>Cellulose<br>(MCC)<br>NF<br>(Avicel PH 102)	<br>129.427
		7	Calcium Acetate	36.090
		8	Silica Gel Dessicants -<br>Packaged<br>Activated<br>Carbon<br>(Strippax<br>Sorbent)	<br> <br> <br>Relevant as<br>per<br>packing<br>policy
Atorvastatin<br>Calcium<br>Tablets<br>USP<br>40mg((Net wt. of Import Sr. No. 1 is<br>3570.804kgs, Sr. No. 2 is 19777.77kg, Sr.<br>No. 3is 5616.216kg, Sr. No. 4 is 909000<br>Nos.))	<br> <br> <br> <br>1<br>Number<br>Tablet	9<br>	Atorvastatin<br>Calcium<br>Propylene Glycol Solvate<br>USP	<br> <br>45.595
		10	Microcrystalline<br>Cellulose<br>(MCC)<br>NF<br>(Avicel PH 102)	<br>258.08
		11	Calcium Acetate	71.963
		12	Silica Gel Dessicants -<br>Packaged<br>Activated<br>Carbon<br>(Strippax<br>Sorbent)	<br> <br> <br>Relevant as<br>per<br>packing<br>policy

UDIN00081605AM24

1|Calcium Acetate|71.963| ||||12|Silica Gel Dessicants - Packaged Activated Carbon (Strippax Sorbent)| Relevant as per packing policy|

UDIN00081605AM24

13<br>	Atorvastatin<br>Calcium<br>Propylene Glycol Solvate<br>USP	<br> <br>91.20
14	Microcrystalline<br>Cellulose<br>(MCC)<br>NF<br>(Avicel PH 102)	<br>518.206
15	Calcium Acetate	144.929
16	Silica Gel Dessicants -<br>Packaged<br>Activated<br>Carbon<br>(Strippax<br>Sorbent)	<br> <br> <br>Relevant as<br>per<br>packing<br>policy

PH 102)| 518.206| ||||15|Calcium Acetate|144.929| ||||16|Silica Gel Dessicants - Packaged Activated Carbon (Strippax Sorbent)| Relevant as per packing policy|

Case No.	Case No.	116 / NC/3/MEET/Apr/202324/1	116 / NC/3/MEET/Apr/202324/1	116 / NC/3/MEET/Apr/202324/1	116 / NC/3/MEET/Apr/202324/1	116 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00005496AM23
RA File Number		03AX04004960 AM23
Licence No and<br>Date		0311020457/04/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Dec/202223/17 dated 13/01/2023against advance<br>authorization No.0311017097 dated 11/08/2022, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.
	Export Product		Qty.	Sl. No.	Import items	Qty.

UDIN00081605AM24

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.|

UDIN00081605AM24

1<br>Bempedoic Acid<br>189.90 mg<br>Bempedoic Acid and Ezetimibe Fixed Dose<br>Combination Tablets (Each Tablet content<br>Bempedoic<br>Acid<br>180mg<br>and<br>Ezetimibe<br>10mg((Net content of Bempedoic Acid 2700 kgs<br>and Ezetimibe 150 kgs in total Export Qty) (AA<br>for Free of cost material as per Para 4.11 of HBP<br>&Para 4.19 of FTP &RBI Master Circular C-26 -<br>Disallowing remittances for material being<br>supplied free of cost))<br>1 Number<br>2<br>Ezetimibe<br>10.55 mg<br>Note: The above norms are valid only for subject to fulfillment of following conditions:<br>Export Product being Patented Medicine, be filed with USFDA as an NDA (New Drug Application.<br>1.<br>Export to USA and Europe only.<br>2.<br>Firm holding Certificate of Manufacturing Exclusivity.<br>3.<br>RA concerned may take further necessary action as per above decision of NC	Bempedoic Acid and Ezetimibe Fixed Dose<br>Combination Tablets (Each Tablet content<br>Bempedoic<br>Acid<br>180mg<br>and<br>Ezetimibe<br>10mg((Net content of Bempedoic Acid 2700 kgs<br>and Ezetimibe 150 kgs in total Export Qty) (AA<br>for Free of cost material as per Para 4.11 of HBP<br>&Para 4.19 of FTP &RBI Master Circular C-26 -<br>Disallowing remittances for material being<br>supplied free of cost))	<br> <br> <br> <br> <br> <br> <br> <br>1 Number	1	Bempedoic Acid	189.90 mg

I Master Circular C-26 - Disallowing remittances for material being supplied free of cost))| 1 Number|1|Bempedoic Acid|189.90 mg| |---|---|---|---|---|---| ||||2|Ezetimibe|10.55 mg| ||Note: The above norms are valid only for subject to fulfillment of following conditions: Export Product being Patented Medicine, be filed with USFDA as an NDA (New Drug Application. 1. Export to USA and Europe only. 2. Firm holding Certificate of Manufacturing Exclusivity. 3.|||||

Case No.	117 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	ZEOLITES AND ALLIED PRODUCTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005510AM23
RA File Number	03AX04004898 AM23
Licence No and<br>Date	0311020475/04/01/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to<br>justify from the firm on following issue: -<br>Step wise manufacturing process.<br>I.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>II.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>III.<br>Stoichiometric balance between import and export on molar basis.<br>IV.<br>Details of indigenous input with quantity.<br>V.<br>Also submit shipping bill and bill of entry of the export products.<br>VI.

ance between import and export on molar basis.** IV. Details of indigenous input with quantity. V. Also submit shipping bill and bill of entry of the export products. VI.||

UDIN00081605AM24

Case No.	118 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	RAKSHIT DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005513AM23
RA File Number	09AX04000866 AM23
Licence No and<br>Date	0911004255/04/01/2023
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

Case No.<br>	119 / NC/3/MEET/Apr/202324/1
Case Status<br>	Case Deferred
Party Name<br>	AUROBINDO PHARMA LTD
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number<br>	HQRNORM APPLY 00005526AM23
RA File Number<br>	09AX04000891 AM23
Licence No and<br>Date<br>	0911004257/04/01/2023
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

891 AM23| |Licence No and Date |0911004257/04/01/2023| |Norms Committee Decision: Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.||

Case No.	Case No.	120 / NC/3/MEET/Apr/202324/1	120 / NC/3/MEET/Apr/202324/1	120 / NC/3/MEET/Apr/202324/1	120 / NC/3/MEET/Apr/202324/1	120 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		VHB MEDI SCIENCES LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00005528AM23
RA File Number		03AX04004952 AM23
Licence No and Date		0311020485/04/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import product in meetingNo. NC/3/MEET/Jan/202021/4 dated 12/02/2021against<br>advance authorization No.0310834259 dated 16/01/2020, it was decided to ratify ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.
	Export Product		Qty.	Sl.<br>No.	Import Items	Qty.

UDIN00081605AM24

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.|

UDIN00081605AM24

COLISIN-RD<br>1MIU<br>Injection<br>(COLISTIMETHATE SODIUM BP for<br>injection 1 MIU) (Net content of Import<br>item = 5.101 kgs)(COLISIN-RD 1MIU<br>Injection<br>(COLISTIMETHATE<br>SODIUM BP for injection 1 MIU) (Net<br>content of Import item = 5.101 kgs))<br>66250<br>Numbers<br>1<br>COLISTIMETHAT<br>E<br>SODIUM STERILE EP<br>5.20 kg.<br>RA concerned may take further necessary action as per above decision of NC.	COLISIN-RD<br>1MIU<br>Injection<br>(COLISTIMETHATE SODIUM BP for<br>injection 1 MIU) (Net content of Import<br>item = 5.101 kgs)(COLISIN-RD 1MIU<br>Injection<br>(COLISTIMETHATE<br>SODIUM BP for injection 1 MIU) (Net<br>content of Import item = 5.101 kgs))	<br> <br> <br> <br> <br> <br>66250<br>Numbers	1	COLISTIMETHAT<br>E<br>SODIUM STERILE EP	<br>5.20 kg.

Case No.	121 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005545AM23
RA File Number	07AX04001477 AM23
Licence No and<br>Date	0711006102/05/01/2023
Norms Committee Decision:<br>Deferred for comments of TE Also submit shipping bill and bill of entry of the export products.

4001477 AM23| |Licence No and Date|0711006102/05/01/2023| |Norms Committee Decision: Deferred for comments of TE Also submit shipping bill and bill of entry of the export products.||

Case No.	Case No.	122 / NC/3/MEET/Apr/202324/1	122 / NC/3/MEET/Apr/202324/1	122 / NC/3/MEET/Apr/202324/1	122 / NC/3/MEET/Apr/202324/1	122 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		BIODEAL PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00005556AM23
RA File Number		05AX04002933 AM23
Licence No and<br>Date		0511016741/05/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import product in meetingNo. NC/3/MEET/Jan/202223/18 dated 23/01/2023against<br>advance authorization No.0511014609 dated 02/09/2022, it was decided to ratify ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Qty.<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items
	Export Product		Qty.	Sl. No.	Import Items	Qty.

UDIN00081605AM24

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.|

UDIN00081605AM24

NASAL SPRAY(U SAVE DE 6 ML<br>CLEAR GLASS TYPE 1, NECK<br>FINISH FEA 20, GLASS BOTTLE<br>WITH CHEMICALS AS PER THE<br>DRUG LICENSE)<br>99000<br>Numbers<br>1<br>NASAL BOTTLE<br>Relevant, on Net to<br>Net basis with<br>accountability<br>RA concerned may take further necessary action as per above decision of NC.
	NASAL SPRAY(U SAVE DE 6 ML<br>CLEAR GLASS TYPE 1, NECK<br>FINISH FEA 20, GLASS BOTTLE<br>WITH CHEMICALS AS PER THE<br>DRUG LICENSE)	99000<br>Numbers	1	NASAL BOTTLE	Relevant, on Net to<br>Net basis with<br>accountability

Case No.	123 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	BIODEAL PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005557AM23
RA File Number	05AX04002931 AM23
Licence No and<br>Date	0511016742/05/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import product in meetingNo. NC/3/MEET/Jan/202223/18 dated 23/01/2023against<br>advance authorization No.0511014609 dated 02/09/2022, it was decided to ratify ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl.

dated 02/09/2022**, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: - Export Product Qty. Sl. No. Import Items Qty. NASAL SPRAY (U SAVE DE 6 ML CLEAR GLASS TYPE 1, NECK FINISH FEA 20, GLASS BOTTLE WITH CHEMICALS AS PER THE DRUG LICENSE) 99000 Numbers 1 NASAL BOTTLE Relevant, on Net-to- Net basis with accountability RA concerned may take further necessary action as per above decision of NC.||

UDIN00081605AM24

Case No.	124 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	BIODEAL PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005558AM23
RA File Number	05AX04002932 AM23
Licence No and<br>Date	0511016743/05/01/2023
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

4002932 AM23| |Licence No and Date|0511016743/05/01/2023| |Norms Committee Decision: Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.||

Case No.<br>	Case No.<br>	125 / NC/3/MEET/Apr/202324/1	125 / NC/3/MEET/Apr/202324/1	125 / NC/3/MEET/Apr/202324/1	125 / NC/3/MEET/Apr/202324/1	125 / NC/3/MEET/Apr/202324/1
Case Status<br>		Case Approved
Party Name<br>		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number<br>		HQRNORM APPLY 00005567AM23
RA File Number<br>		08AX04001580 AM23
Licence No and<br>Date<br>		0811006936/05/01/2023
Norms Committee Decision:<br>T<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Mar/202223/22dated24/03/2023against advance<br>authorization No.0811006399 dated 09/11/2022, it was decided to ratify ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>NALTREXONE<br>HYDROCHLORIDE TABLETS<br>USP<br>50<br>MG(EACH<br>FILM<br>COATED TABLET CONTAINS:<br>NALTREXONE<br>HYDROCHLORIDE USP 50 MG<br>[IN<br>WHICH<br>ACTIVE<br>INGREDIENT<br>NALTREXONE<br>HYDROCHLORIDE USED IS<br>76.050 KGS.])<br>1 Number<br>1<br>NALTREXONE HYDROCHLORID E<br>EP / BP / IP / USP / PH.

NE HYDROCHLORIDE USP 50 MG [IN WHICH ACTIVE INGREDIENT NALTREXONE HYDROCHLORIDE USED IS 76.050 KGS.]) 1 Number 1 NALTREXONE HYDROCHLORID E EP / BP / IP / USP / PH. 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.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||NALTREXONE HYDROCHLORIDE TABLETS USP 50 MG(EACH FILM COATED TABLET CONTAINS: NALTREXONE HYDROCHLORIDE USP 50 MG [IN WHICH ACTIVE INGREDIENT NALTREXONE HYDROCHLORIDE USED IS 76.050 KGS.])||1 Number|1|NALTREXONE HYDROCHLORID E EP / BP / IP / USP / PH. 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.||||||

UDIN00081605AM24

Case No.	126 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005568AM23
RA File Number	34AX04000926 AM23
Licence No and<br>Date	3411003231/05/01/2023
Norms Committee Decision:
Deferred for the	comments of TE.Also submit shipping bill and bill of entry of the export products.

0926 AM23| |Licence No and Date|3411003231/05/01/2023| |Norms Committee Decision:|| |Deferred for the|comments of TE.Also submit shipping bill and bill of entry of the export products.|

Case No.	Case No.	126 / NC/3/MEET/Apr/202324/1	126 / NC/3/MEET/Apr/202324/1	126 / NC/3/MEET/Apr/202324/1	126 / NC/3/MEET/Apr/202324/1	126 / NC/3/MEET/Apr/202324/1
Case Status		Case Deferred
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00005568AM23
R	A File Number	34AX04000926 AM23
L<br>D	icence No and<br>ate	3411003231/05/01/20		23

N<br>D	orms Committee Decision:<br>eferred for the comments		f TEA	lso sub	it shiin bill and bill of entr of the exo	t roducts
			.		ppg y p	p.

C	ase No.	127 / NC/3/M	EET/Apr
				/202324/	1
C	ase Status	Case Approv	ed
P	arty Name	CIPLA LIMI	TED

M<br>a	eeting Number<br>nd Date	NC/ 3/ MEET	/ Apr/ 20	2324/ 1	and 28/04/2023
H	Q File Number	HQRNORM	APPLY 0	0005573	AM23
R	A File Number	03AX040048	90 AM23
L<br>D	icence No and<br>ate	0311020522/	06/01/202
				3

24/ 1|and 28/04/2023|||||| |H|Q File Number||HQRNORM|APPLY 0|0005573|AM23|||||| |R|A File Number||03AX040048|90 AM23|||||||| |L D|icence No and ate||0311020522/|06/01/202|||||||| ||||||3||||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo. NC/3/MEET/Dec/202223/15dated29/12/2022against advance authorization No.0311015826 dated 24/06/2022, it was decided to ratify ad-hoc norms under Para 4.07|orms Committee Decision:||||||||||| |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|and Amlodipine Tablets||||1 Number|1|Amlodipine||10.20 mg| |||40/10mg / E Telmisartan| ach uncoated tablets contains: 40 mg(Telmisartan 40|||||| Besilate||| |||mgequivalent| to Telmisartan granules||||||||| ||| 67.36mg Am| lodipine Besilate equivalent to||||||||| ||| Amlodipine Telmisartan| USP 10mg Net wt of Granules is2,020.800 Kgs. Net||||||||| ||| wt of Amlodipine Besilate is 300.000 Kgs.)|||||||||| |||Telmisartan and Amlodiine Tablets|||||1 Number|2|Amlodiine||1020 m| ||| p 80/10mg / Each uncoated tablets contains: Telmisartan 80 mg (Telmisartan 80|||||||p Besilate||. g.|

UDIN00081605AM24

||1 Number|2|Amlodiine||1020 m| ||| p 80/10mg / Each uncoated tablets contains: Telmisartan 80 mg (Telmisartan 80|||||||p Besilate||. g.|

UDIN00081605AM24

	mgequivalent<br>to<br>Telmisartan<br>granules<br>13472 Aldii Bilt ilt	mgequivalent<br>to<br>Telmisartan<br>granules<br>13472 Aldii Bilt ilt
	.mg<br>to Amlodi	mopne esae equvaen<br>ne USP 10m Net wt of
	p<br>Telmisartan	g<br>Granules is 10777600 Kgs
	<br>Net wt of A	,. .<br>mlodipine Besilate is 800000
	<br>Kgs.)	.

	Telmisartan	and<br>Amlodipine<br>Tablets	1 Number	3	Amlodipine	5.10 mg.
	40/5mg / Ea<br>Telmisartan	ch uncoated tablets contains:<br>40 mg (Telmisartan 40 mg			Besilate
	equivalent to Telmisartan granules 67.36mg<br>Amlodipine<br>Besilate<br>equivalent<br>to<br>Amlodipine<br>USP<br>5mg<br>Net<br>wt<br>of<br>
	Telmisartan Granules is 6,286.933 Kgs. Net<br>wt of Amlodipine Besilate is 466.667 Kgs.)
	Telmisartan<br>and<br>Amlodipine<br>Tablets		1 Number	4	Amlodipine	5.10 mg.
	80/5mg / Ea	ch uncoated tablets contains:			Besilate
	Telmisartan	80<br>mg<br>(Telmisartan<br>80
	mgequivalen<br>	t to Telmisartan granules<br>
	134.72mg A<br>to Amlodip	mlodipine Besilate equivalent<br>ine USP 5mg Net wt of
	Telmisartan	Granules is 10,777.600 Kgs.
	Net wt of A<br>	mlodipine Besilate is 400.000
Kgs.)	Kgs.)

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

10,777.600 Kgs.||||| ||Net wt of A |mlodipine Besilate is 400.000||||| |Kgs.)|Kgs.)|||||| |||||||| |RA concerned may take further necessary action as per above decision of NC.||||||| ||||||||

Case No.	128 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED

Meeting Number
<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005588AM23
RA File Number	05AX04002947 AM23
Licence No and
<br>Date	0511016763/06/01/2023
Norms Committee	Decision:
Deferred for the	comments of TE. Also submit shipping bill and bill of entry of the export products.

Case No. 129 / NC/3/MEET/Apr/202324/1

UDIN00081605AM24

Case Status	Case Deferred
Party Name	MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005594AM23
RA File Number	07AX04001479 AM23
Licence No and<br>Date	0711006109/06/01/2023
Norms Committee Decision:<br>Deferred for the comments of TE. Also submit shipping bill and bill of entry of the export products.

001479 AM23| |Licence No and Date|0711006109/06/01/2023| |Norms Committee Decision: Deferred for the comments of TE. Also submit shipping bill and bill of entry of the export products.||

Case No.	130 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005595AM23
RA File Number	07AX04001473 AM23
Licence No and<br>Date	0711006137/06/01/2023
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

Case No.	Case No.	131 / NC/3/MEET/Apr/202324/1	131 / NC/3/MEET/Apr/202324/1	131 / NC/3/MEET/Apr/202324/1	131 / NC/3/MEET/Apr/202324/1	131 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		MICRO LABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00005596AM23
RA File Number		07AX04001471 AM23
Licence No and<br>Date		0711006138/06/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jan/202223/18dated23/01/2023against advance<br>authorization No.0711005273 dated 19/09/2022, it was decided to ratify ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl.

dated 19/09/2022**, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: - Export Product Qty. Sl. No. Import Items Qty.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.|

UDIN00081605AM24

TRANEXAMIC ACID INJECTION<br>SOLUTION 1000MG/10ML<br>(TRANEXAMIC ACID INJECTION<br>SOLUTION 1000MG/10MG<br>(226.44KG))<br>1 Number<br>1<br>TRANEXAMIC<br>ACID<br>1100 mg/<br>10 ml Vial<br>RA concerned may take further necessary action as per above decision of NC.	TRANEXAMIC ACID INJECTION<br>SOLUTION 1000MG/10ML<br>(TRANEXAMIC ACID INJECTION<br>SOLUTION 1000MG/10MG<br>(226.44KG))	1 Number	1	TRANEXAMIC<br>ACID	1100 mg/<br>10 ml Vial

Cas	e No.	132 / NC/3/MEET/Apr/202324/1
Cas	e Status	Case Approved
Par	ty Name	MAIVA PHARMA PRIVATE LIMITED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ	File Number	HQRNORM APPLY 00005598AM23
RA	File Number	07AX04001475 AM23
Lic<br>Dat	ence No and<br>e	0711006139/06/01/2023
No<br>Th<br>pr<br>au<br>of<br>R	rms Committee Decision:<br>e Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>oduct/import product in meeting**No.

Th pr au of R|rms Committee Decision: e Committee considered the case as per agenda and taking cue from the earlier decision for same export oduct/import product in meetingNo. NC/3/MEET/Dec/202223/15dated29/12/2022against advance thorization No.0711004345 dated 17/06/2022, it was decided to ratify ad-hoc norms under Para 4.07 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 Chloride Injection USP 90mg per 10mL Vial.(Sodium Chloride Injection USP 90mg per 10mL Vial - filled with 90mg of Sodium Chloride as bulk drug filled in 10mL Vial and capped with 13mm GreySerum ChlorobutyI Rubber Stopper)|| 1 Number|1|10ml Unprinted Clear Glass Vial Zenith| Relevant as per packing policy| ||A concerned may take further necessary action as per above decision of NC.||||||

1 Number|1|10ml Unprinted Clear Glass Vial Zenith| Relevant as per packing policy| ||A concerned may take further necessary action as per above decision of NC.||||||

Cas	e No.	132 / NC/3/MEET/Apr/202324/1	132 / NC/3/MEET/Apr/202324/1	132 / NC/3/MEET/Apr/202324/1
Cas	e Status	Case Approved
Par	ty Name	MAIVA PHARMA PRIVATE LIMITED
Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ	File Number	HQRNORM APPLY 00005598AM23
RA	File Number	07AX04001475 AM23
Lic<br>Dat	ence No and<br>e	0711006139/06/01/2023
No<br>Th<br>pr<br>au<br>of<br>R	rms Committee Decision:<br>e Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>oduct/import product in meetingNo. NC/3/MEET/Dec/202223/15dated29/12/2022against advance<br>thorization No.0711004345 dated 17/06/2022, it was decided to ratify ad-hoc norms under Para 4.07<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-
	Export Product		Qty.	Sl.

4345 dated 17/06/2022**, it was decided to ratify ad-hoc norms under Para 4.07 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 Chloride Injection USP 90mg per 10mL Vial.(Sodium Chloride Injection USP 90mg per 10mL Vial - filled with 90mg of Sodium Chloride as bulk drug filled in 10mL Vial and capped with 13mm GreySerum ChlorobutyI Rubber Stopper)|| 1 Number|1|10ml Unprinted Clear Glass Vial Zenith| Relevant as per packing policy| ||A concerned may take further necessary action as per above decision of NC.||||||

Case No.	133 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved

UDIN00081605AM24

Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005605AM23
RA File Number	03AX04005022 AM23
Licence No and Date	0311020561/09/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jan/202223/18 dated 23/01/2023against advance<br>authorization No.0311003736 dated 12/05/2021, it was decided to ratify ad-hoc norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.

ted 12/05/2021**, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 (R)-3-AMINO-1-BUTANOL 19.635 mg. 2 1-(2,2-dimethoxyethyl)-5-methoxy- 6(methoxycarbonyl) 4-oxo-1,4- dihydropyridine-3-carboxylic acid Indigenously procured 3 (R)-9-(2-phosphonomethoxy propyl)- adenine 205.02 mg Lamivudine 300mg + Tenofovir disoproxil Fumarate 300mg + Dolutegravir Sodium 50mg tablets(Lamivudine 300mg + Tenofovir disoproxil Fumarate 300mg + Dolutegravir Sodium 50mg tablets (Net content: 3690.000 kgs Dolutegravir Sodium + 22140.000 kgs Tenofovir Disoproxil Fumarate + 22140.000 kgs Lamivudine)) 1 Number 4 LAMIVUDINE Indigenously procured RA concerned may take further necessary action as per above decision of NC.||

ovir Disoproxil Fumarate + 22140.000 kgs Lamivudine)) 1 Number 4 LAMIVUDINE Indigenously procured RA concerned may take further necessary action as per above decision of NC.||

Case No.	134 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	RAKSHIT PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005612AM23
RA File Number	09AX04000843 AM23
Licence No and<br>Date	0911004282/09/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Mar/202223/24dated13/04/2023against advance<br>authorization No.0911002001 dated 06/12/2021, it was decided to ratify ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00081605AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
Mycophenolate Sodium(Solid)	1 kg.	1	Mycophenolic Acid	0.90 kg.
		2	Toluene	0.66 kg.
		3	Methanol	0.70 kg.

0081605AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
Mycophenolate Sodium(Solid)	1 kg.	1	Mycophenolic Acid	0.90 kg.
		2	Toluene	0.66 kg.
		3	Methanol	0.70 kg.

Case No.	Case No.	135 / NC/3/MEET/Apr/202324/1	135 / NC/3/MEET/Apr/202324/1	135 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		BIODEAL PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00005629AM23
RA File Number		05AX04002930 AM23
Licence No and<br>Date		0511016789/10/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Mar/202223/22dated24/03/2023against advance<br>authorization No.0511015214 dated 11/10/2022, it was decided to ratify ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>NASAL SPRAY(SNAP-ON,<br>S20 WHITE SMOOTH,<br>NASAL ADAPTOR WITH<br>CHEMICALS AS PER THE<br>DRUG LICENSE)<br>99000<br>Numbers<br>1<br>SNAP-ON, S20 WHITE<br>SMOOTH, NASAL<br>ADAPTOR FOR MFG.<br>OF NASAL SPRAY<br>Relevant, on Net to<br>Net basis with<br>accountability.
	Export Product		Qty.	Sl.

SE) 99000 Numbers 1 SNAP-ON, S20 WHITE SMOOTH, NASAL ADAPTOR FOR MFG. OF NASAL SPRAY Relevant, on Net to Net basis with accountability.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||NASAL SPRAY(SNAP-ON, S20 WHITE SMOOTH, NASAL ADAPTOR WITH CHEMICALS AS PER THE DRUG LICENSE)||99000 Numbers|1|SNAP-ON, S20 WHITE SMOOTH, NASAL ADAPTOR FOR MFG. OF NASAL SPRAY|Relevant, on Net to Net basis with accountability.| ||||||||

UDIN00081605AM24

Case No.	136 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	APOTHECARY PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005666AM23
RA File Number	31AX04000290 AM23
Licence No and<br>Date	3111001945/11/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jun/202223/5dated08/07/2022against advance<br>authorization No.3111000421 dated 23/06/2021, it was decided to ratify ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.

ted 23/06/2021**, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. Levostin ( Levofloxacin 10 percent w/v and colistin sulphate 1.5 percent w/v oral liquid ) (Net Weight of Import Item is 0.015 kgs per liter in the export item) 10000 Litres 1 COLISTIN SULPHATE 150 kg. RA concerned may take further necessary action as per above decision of NC||

Case No.	137 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	GMFC LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005667AM23
RA File Number	09AX04000895 AM23
Licence No and<br>Date	0911004300/11/01/2023
Norms Committee Decision:

UDIN00081605AM24

The Committee considered the case as per agenda and it was decided to ratify 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.
Diisopropyl<br>azodicarboxylate<br>(Net<br>content of Isopropyl chloroformate is<br>29400 Kgs)	1 kg.	1	Isopropyl chloroformate	1.347 kg.

ct	Qty.	Sl. No.	Import Items	Qty.
Diisopropyl<br>azodicarboxylate<br>(Net<br>content of Isopropyl chloroformate is<br>29400 Kgs)	1 kg.	1	Isopropyl chloroformate	1.347 kg.

Case No.	138 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	AMNEAL INJECTABLES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005679AM23
RA File Number	08AX04001685 AM23
Licence No and<br>Date	0811006983/11/01/2023
Norms Committee Decision:<br>Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

Case No.	139 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	SOHAN HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005687AM23
RA File Number	31AX04000281 AM23
Licence No and<br>Date	3111001952/12/01/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call<br>for following information/documents from the firm: -<br>Process details given in Attachment 1 is for 83.33 % w/w, not matching with export item.<br>1.<br>Copy of Master-Batch Formula may be furnished.<br>2.

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: -

UDIN00081605AM24

Not shown in

the process

Sodium Nitrite

Sodium Sulfite

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

	Also<br>3.	submit shipping bill and bill of entr	submit shipping bill and bill of entr	y of the expo

Cas	e No.		140 / NC/3/MEET/Apr/20232	4/1
Cas	e Status		Case Approved
Party Name
			MAIVA PHARMA PRIVATE LIMITED
Meeting Number an		d
<br>Date			NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number			HQRNORM APPLY 00005707AM23
RA File Number			07AX04001495 AM23
Licence No and Da		te	0711006134/13/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and<br>of HBP Vol. I as per details given below or as applied<br>Export Product<br>Qty.<br>Sl.

/13/01/2023||||||||||||||| |Norms Committee Decision: The Committee considered the case as per agenda and of HBP Vol. I as per details given below or as applied Export Product Qty. Sl. N Valproate Sodium Injection 100mg/mL, 5ml(Valproate Sodium Injection 100mg/mL, 5ml Vial - filled with 500mg of Valporate Sodium as bulk drug is filled in 5mL Vial and capped with 20mm chlorobutyle Rubber Stopper) 272727.0 Numbers 1|orms Committee Decision: he Committee considered the case as|||||||per agen||da and|||t was decided to ratify adhoc norms und||||||er Para 407| || f HBP Vol. I as per details given belo Export Product Valproate Sodium Injection 100mg/mL, 5ml(Valproate Sodium Injection 100mg/mL, 5ml Vial - filled with 500mg of Valorate Sodium as bulk 2 N||||||| w or as a|| pplied||| by the firm, whichever is less: -||||||.| ||||||||||||||||||||| |||Export Product||||||Qty.|||l||||||||| ||||||||||||S.||o.|Import Items||||Qty|.| ||||||||||||||||||||| |||Valproate Sodium Injectio||||n| 2|72727.|0||||||||| || ||||||||||||1|||WPS S10-F451 4432/50G|||2-| Rel|evant as per| ||| 100mg/mL, 5ml(Valproat Sodium Injection 100mg/mL 5ml Vial - filled with 500mg o Valorate Sodium as bulk|||| e , f | N|umbers||||||40 WESTARRS1m/PK (20m Chlorobutyle Rubber Stopper)|||m | Pac| king Policy.| ||||||||||||||||||||| |||||||||||||||||||||

ium as bulk|||| e , f | N|umbers||||||40 WESTARRS1m/PK (20m Chlorobutyle Rubber Stopper)|||m | Pac| king Policy.| ||||||||||||||||||||| ||||||||||||||||||||| |||p drug is filled in 5mL Vial and capped with 20mm chlorobutyle Rubber Stopper)|||| |||||||||||||| ||||||||||||||||||||| ||||||||||||||||||||| ||||||||||||||||||||| ||||||||||||||||||||| ||||||||||||||||||||| ||||||||||||||||||||| |RA||concerned m||take further ne||essar act|||ion as er||||above decision of NC||||||| |||||y||y|||p||||.||||||| ||||||||||||||||||||| ||||||||||||||||||||| |Cas||e No.||141 / NC/3/MEET/Apr/202324|||||/1||||||||||| ||||||||||||||||||||| |Case Status||||Case Approved|||||||||||||||| ||||||||||||||||||||| ||||||||||||||||||||| |Party Name||||DEEPAK NITRITE LIMITED|||||||||||||||| ||||||||||||||||||||| |Meeting Number and Date||||NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023|||||||||||||||| ||||||||||||||||||||| |HQ File Number||||HQRNORM APPLY 00005711AM23|||||||||||||||| |RA File Number||||34AX04000943 AM23|||||||||||||||| ||||||||||||||||||||| |Licence No and|||||||||||||||||||| |||||3411003244/13/01/2023|||||||||||||||| |Date|||||||||||||||||||| ||||||||||||||||||||| |Norms Committee||||Decision:|||||||||||||||| ||||||||||||||||||||| ||||||||||||||||||||| |||||||||||||||||||||

411003244/13/01/2023|||||||||||||||| |Date|||||||||||||||||||| ||||||||||||||||||||| |Norms Committee||||Decision:|||||||||||||||| ||||||||||||||||||||| ||||||||||||||||||||| |||||||||||||||||||||

Case No.	141 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	DEEPAK NITRITE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005711AM23
RA File Number	34AX04000943 AM23
Licence No and<br>Date	3411003244/13/01/2023
Norms Committee Decision:

UDIN00081605AM24

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Feb/202223/20 dated 24/02/2023 against advance authorization No. 3411000043 dated 17/02/2021 , it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.
3-TRIFLUOROMETHYL ACETO<br>PHENONE	1 kg.	1	Benzo Trifluoride	1.26 kg.
		2	Toluene	0.1075 kg.
		3	Caustic Soda Lye 47 PERCENT	0.50 kg.
		4	Acetaldoxime 50 PERCENT Min<br>Solution in Water	0.951 kg.
		5	Soda Ash	0.005
		6	Nitric Acid 72 Percent	Not allowed

|||2|Toluene|0.1075 kg.| |||3|Caustic Soda Lye 47 PERCENT|0.50 kg.| |||4|Acetaldoxime 50 PERCENT Min Solution in Water|0.951 kg.| |||5|Soda Ash|0.005| |||6|Nitric Acid 72 Percent|Not allowed|

Case No.	142 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005714AM23
RA File Number	04AX04000873 AM23
Licence No and<br>Date	0411004751/13/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: -

UDIN00081605AM24

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 Acetic Acid	0.919 kg.
		4	Isopropyl 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|Isopropyl Alcohol|0.50 kg.| ||||5|Sodium Dichromate|0.630 kg.|

Case No.	Case No.	143 / NC/3/MEET/Apr/202324/1	143 / NC/3/MEET/Apr/202324/1	143 / NC/3/MEET/Apr/202324/1	143 / NC/3/MEET/Apr/202324/1	143 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number		HQRNORM APPLY 00005715AM23
RA File Number		04AX04000871 AM23
Licence No and<br>Date		0411004703/13/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Isobutyl Acetophenone<br>1.11 kg.<br>2<br>Sodium Metal<br>0.235 kg.<br>3<br>Monochloro Acetic Acid<br>0.919 kg.<br>IBUPROFEN<br>1 kg.
	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 Acetic Acid	0.919 kg.

UDIN00081605AM24

	4	Isopropyl Alcohol	0.50 kg.
	5	Sodium Dichromate	0.630 kg.

ne|1.11 kg.| |||||2|Sodium Metal|0.235 kg.| |||||3|Monochloro Acetic Acid|0.919 kg.|

UDIN00081605AM24

	4	Isopropyl Alcohol	0.50 kg.
	5	Sodium Dichromate	0.630 kg.


			4		Isopropyl Alcohol		0.50 kg.



			5		Sodium Dichromate		0630 k
							. g.




RA concerned	a take further necessar action as er above decision of NC
	y y p .




Case No.		144 / NC/3/MEET/Apr/202324/1
Case Status		Case Approved
Party Name		J B CHEMICALS AND			PHARMACEUTICALS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ A/ 202			324/ 1 d 28/04/2023
				pr	a	n
HQ File Number		HQRNORM A		PPLY 00	005735	AM23
RA File Number		03AX0400504		7 AM23
Licence No and Date		0311020724/1		6/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import product in meetingNo. NC/3/MEET/Mar/202223/22dated24/03/2023against<br>advance authorizationNo. 0311018957 dated 31/10/2022, it was decided to ratify ad-hoc norms under<br>Para 4.07 of HBP Vol.

t in meetingNo. NC/3/MEET/Mar/202223/22dated24/03/2023against advance authorizationNo. 0311018957 dated 31/10/2022, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-|||||||||||||||||| ||||||||||||||||||| ||||||||||d|d|ki||f h li|di||f|| ||||||||||ena an NC/3/M 31/10/202||tang EET/M 2, it wa||cue rom te eare ar/202223/22dated s decided to ratify a|ecson or same 24/03/2023against d-hoc norms under|||| ||||||||||low or as||applied||by the firm, whichev|er is less:-|||| ||||||||||||||||||| ||||||||||||||||||| ||Export Product||||||Qt||y.|Sl.|No.|Imp|ort Items||||Qty.| ||||||||||||||||||(in mg.)| ||||||||||||||||||| |||||||| ||||||||||| ||GLIPIZIDE RELEASE |EXTENDED TABLETS 10 MG. ||||| 1 Number|||1||GLIPIZIDE USP|||||10.20| ||||||||||||||||||| ||Each tablet SP 10|contains (i) Glipizide ii E||||| |||2||EASTMAN (TM) CELLULOSE||||| 29.70| ||U- |mg(() astman ||||||||||ACETATE (CA 398-10NF/EP)|||||| ||(TMCellulos 10NF/EP)|eAcetate(CA398- 2970(iii)|||||||||||||||| ||||||||||||||||||| ||- |.mg ||||||||||||||| | ||entrPoo|WR NFPNF-||||||||||ENTRY PLYX WR N||||| 171| ||yy 17810| m(iv)Sentr|||||||||| FP NF||||| .| ||. PolyoxWSR3 100mNetc|gy 03 NF- ntent (i) 31712 Ks||||| ||||||||||| ||||||||||||||||||| ||g. (ii) 94184|.

br>171| ||yy 17810| m(iv)Sentr|||||||||| FP NF||||| .| ||. PolyoxWSR3 100mNetc|gy 03 NF- ntent (i) 31712 Ks||||| ||||||||||| ||||||||||||||||||| ||g. (ii) 94184|. g s (iii) 564785 Ks||||| |||4||SENTRY POLYOX WSR 303 NF|||||100.00| ||. (iv) 317117|g . g Kgs)|||||||||||||||| ||.|.|||||||||||||||| ||||||||||||||||||| ||GLIPIZIDE EXTENDED||||||1 Number|||5||GLIPIZIDE USP|||||5.10| |||||||||||||||||||

UDIN00081605AM24

RELEASE TABLETS 5 MG. Each		6	EASTMAN (TM) CELLULOSE	<br>20.40
tablet contains (i) Glipizide USP- 5			ACETATE (CA 398-10NF/EP)
mg((ii)<br>Eastman
(TMCelluloseAcetate(CA398-<br>10NF/EP)-<br>20.40mg(iii)<br>SentryPolyoxWSR<br>N80FPNF-		7	SENTRY POLYOX WSR N80<br>FP NF	<br>89.05
89.05<br>mg(iv)Sentry
PolyoxWSR303 NF-50mg.Net		8	SENTRY POLYOX WSR 303 NF50.00
content (i) 256.76 Kgs (ii) 1047.57
Kgs (iii) 4572.84 Kgs (iv) 2567.57
Kgs.)
GLIPIZIDE<br>EXTENDED	1 Number	9	GLIPIZIDE USP	2.55
RELEASE TABLETS 2.5 MG.
Each tablet contains (i) Glipizide<br>USP-<br>2.5<br>mg((ii)<br>Eastman<br>(TMCellulose Acetate (CA 398-		10	EASTMAN (TM) CELLULOSE<br>ACETATE (CA 398-10NF/EP)	<br>20.40
10NF/EP)- 20.40 mg (iii) Sentry
Polyox WSR N80 FP NF- 89.05		11	SENTRY POLYOX WSR N80	<br>89.05
mg (iv) Sentry Polyox WSR 303			FP NF
NF- 50 mg. Netcontent (i) 101.80
Kgs (ii) 830.70 Kgs (iii) 3626.18<br>Kgs (iv) 2036.04 Kgs.)		12	SENTRY POLYOX WSR 303 NF50.00

WSR N80| 89.05| |mg (iv) Sentry Polyox WSR 303|||FP NF|| |NF- 50 mg. Netcontent (i) 101.80||||| |Kgs (ii) 830.70 Kgs (iii) 3626.18 Kgs (iv) 2036.04 Kgs.)||12|SENTRY POLYOX WSR 303 NF50.00||

Case No.	145 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005741AM23
RA File Number	07AX04001550 AM23
Licence No and<br>Date	0711006194/16/01/2023
Norms Committee Decision:
Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

Case No.	146 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	MICRO LABS LIMITED

UDIN00081605AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005743AM23
RA File Number	07AX04001552 AM23
Licence No and<br>Date	0711006196/16/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import product in meetingNo. NC/3/MEET/Feb/202223/20dated24/02/2023against<br>advance authorizationNo. 0711005409 dated 06/10/2022, it was decided to ratify ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.

ted 06/10/2022**, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. PREMIX OF NIFUROXAZIDE ((Each gm of Premix Contains Nifuroxazide BP 0.552 gm) Nifuroxazide Net Content is 3477.60 kg)) 6300 kg. 1 NIFUROXAZIDE BP/EP 3512.376 kg RA concerned may take further necessary action as per above decision of NC||

Case No.	147 / NC/3/MEET/Apr/202324/1
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005744AM23
RA File Number	07AX04001546 AM23
Licence No and Date	0711006197/16/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same<br>export product/import product in meetingNo. NC/3/MEET/Feb/202223/20dated24/02/2023against<br>advance authorizationNo. 0811006214 dated 10/10/2022, it was decided to ratify ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00081605AM24

6214 dated 10/10/2022**, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||

UDIN00081605AM24


	Expor	t Product	Qty.	Sl. No.	Import Items	Qty.


	DOXYCYCL<br>DISPERSIBL	INE<br>100MG<br>E<br>TABLETS<br>	<br> <br>1 Number	1	DOXYCYCLINE<br>MONOHYDRATE USP/BP	102.908 mg.
	<br>((equivalent	<br> <br>to<br>anhydrous	<br>		....
	<br>doxycycline	<br> <br>100mg) USP/IP
	<br>(600.00 KG))	<br>

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

Case No.	Case No.	148 / NC/3/MEET/Apr/202324/1
Case Status		Case Aroved
		pp
Part Name		MICRO LABS LIMITED
y
Meetin Number a	d Date	NC/ 3/ MEET/ Ar/ 202324/ 1 and 28/04/2023
g		p
HQ File Number		HQRNORM APPLY 00005745AM23

RA File Number		07AX04001545 AM23

Licence No and Da	e	0711006198/16/01/2023

Norms Committee	ecision:
The Committee<br>export product/i	considered the case as per agenda and taking cue from the earlier decision for same<br>mport product in meeting**No.

|||||||| |Norms Committee|||ecision:||||||||| |The Committee export product/i|||considered the case as per agenda and taking cue from the earlier decision for same mport product in meetingNo. 7/AM-18dated24/08/2018against advance authorization||||||||| | No. 0710109368 dated 04/02/2016, it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 AMOXICILLIN TRIHYDRATE BP/EP/USP/IP 3012.83 mg/bottle AMOXICILLIN 125MG + FLUCLOXACILLIN 125MG/5ML ORAL SUSPENSION 100ML BOTTLES(AMOXICILLIN 125MG + FLUCLOXACILLIN 125MG/5ML ORAL SUSPENSION 100ML BOTTLES 250.00 KG) 1 No. bottle 2 FLUCLOXACILLIN SODIUM BP/EP/USP/IP 2856.33 mg/bottle|||||||||||| |||Export Product|||Qty.||Sl|. No.|Import Items||Qty.| ||||||||||||| |||AMOXICILLIN 125MG + FLUCLOXACILLIN ||| 1 No. bo|ttle|1||A T|MOXICILLIN RIHYDRATE BP/EP/USP/IP|3012.83 mg/bottle| |||125MG/5ML ORAL SUSPENSION 100ML BOTTLES(AMOXICILLIN 125MG + FLUCLOXACILLIN 125MG/5ML ORAL||| ||||||| ||||||||2||F |LUCLOXACILLIN |2856.33 | ||||||||||S|ODIUM BP/EP/USP/IP|mg/bottle| ||| SUSPENSION 100ML BOTTLES 250.00 KG)||| ||||||| ||||||||||||| |||AMOXICILLIN 250MG + FLUCLOXACILLIN 250MG||| 1 No. Capsules||3 ||AMOXICILLIN TRIHYDRATE BP/EP/USP/IP||292.68 mg/capsule|

KG)||| ||||||| ||||||||||||| |||AMOXICILLIN 250MG + FLUCLOXACILLIN 250MG||| 1 No. Capsules||3 ||AMOXICILLIN TRIHYDRATE BP/EP/USP/IP||292.68 mg/capsule|

UDIN00081605AM24

CAPSULES(AMOXICILLIN		FLUCLOXACILLIN	277.47
250MG + FLUCLOXACILLIN		SODIUM BP/EP/USP/IP	mg/capsule
250MG<br>CAPSULES	-
2499.980 KG)

Case No.	149 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	PRACHI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005760AM23
RA File Number	03AX04005177 AM23
Licence No and<br>Date	0311020750/16/01/2023
Norms Committee Decision:
Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

Case No.	150 / NC/3/MEET/Apr/202324/1
Case Status	Case Deferred
Party Name	AMNEAL INJECTABLES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Apr/ 202324/ 1 and 28/04/2023
HQ File Number	HQRNORM APPLY 00005762AM23
RA File Number	08AX04001684 AM23
Licence No and<br>Date	0811007029/16/01/2023
Norms Committee Decision:
Deferred for the comments of TE.Also submit shipping bill and bill of entry of the export products.

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