IN FORCE Advance Authorisation

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Government of India / भारत सरकार

Ministry of Commerce and Industry / वािणज्य और उद्योग मंत्रालय Department of Commerce / वािणज्य िवभाग Directorate General of Foreign Trade, Delhi / िवदेश व्यापार महािनदेशालय, िदल्ली

VANIJYA BHAWAN, AKBAR ROAD, CENTRAL DELHI, DELHI, 110011 / वािणज्य भवन, अकबर रोड, नई िदल्ली Email Office : dgft@nic.in , Phone Office : 011-23062777

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/May/202425/3 DATED: 16/05/2024

Please Note

I. For information of exporters, Norms Committee - III handles all cases pertaining to fixation/ratification of norms for Export Products falling under ITC (HS) Chapter 29, 30 .Communications in respect of cases/pertaining to NC- III may be sent to email address: 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.
IV. RAs shall also ensure compliance of SION, General Notes and Chapter Notes wherever applicable.
V. RAs shall ensure that authorization is issued or redeemed based on the wastages/consumption as retified by the Committee or as wastages claimed in the application, whichever is less. In this regard full compliance of the provisions of Para 4.12 of FTP, Para 4.16; Para 4.21; and Para 4.51 of HBP shall be made.

mittee or as wastages claimed in the application, whichever is less. In this regard full compliance of the provisions of Para 4.12 of FTP, Para 4.16; Para 4.21; and Para 4.51 of HBP shall be made.

Meeting No. NC/3/MEET/May/202425/3 dated 16/05/2024 of Norms Committee - III for the year 2024-25 was held on 16/05/2024 under the Chairmanship of Shri Rakesh Kumar,Additional DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2023.

The following members were present in the meeting:-

	S.No.	Name and Designation of Representatives		Department
1		Shri Rakesh Kumar, Addl. DGFT	DGFT(HQ)

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2	Shri Raman Kumar,Deputy DGFT	DGFT(HQ)
3	Shri Dinesh Narain Mathur, Technical Expert	Consultant (Pharma)
4	Shri Nand Lal, Technical Expert	Consultant (Chemical)
5	Shri Uttam Dey Sarkar, ASO	DGFT (HQ)

2 This document has been digitally signed by Raman Kumar, Deputy DGFT on 11-06-2024 10:22:59.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/May/202425/3
Case Status	Case Rejected
Party Name	MEDREICH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ File Number	HQRNORM APPLY 00006691AM24
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was observed thatthe firm<br>had neither attended the Personal Hearing nor intimated to the Committee. Hence, it was decided toreject<br>the application of the firm.

Case No.	2 / NC/3/MEET/May/202425/3
Case Status	Case Approved
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ File Number	HQRNORM APPLY 00005925AM24
RA File Number	NA
Licence No and<br>Date	0910065335/08/08/2017
Norms Committee Decision:<br>Shri A Suresh, Plant In-charge of the firm attended the Personal Hearing and explained the case. The Committee<br>heard the explanation of the Representative of the firm and after due deliberation, the committee has decided to fix ad-<br>hoc norms on the basis of information provided by the firm as under, or as applied whichever is less: -<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>**Qty.

ix ad- hoc norms on the basis of information provided by the firm as under, or as applied whichever is less: - Export Product Qty. Sl. No. Import Items Qty. allowed. Tiemonium Methyl Sulfate 1 kg. 1 2-Acetyl thiophene 0.75 kg. Note: The above norms are for regularization and closure purposes only. RA concerned may take further necessary action as per the above decision of NC||

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Case No.	3 / NC/3/MEET/May/202425/3
Case Status	Case Deferred
Party Name	CONCORD BIOTECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ File Number	HQRNORM REVIW00008666AM24
RA File Number	082404000101 AM20
Licence No and<br>Date	0810145581/27/06/2019
Norms Committee Decision:<br>Shri Mayur Kansara, Manager (Finance) and Shri Anand Dhiman representative of the firm attended<br>the Personal Hearing and explained the case. The Committee heard the explanation of the<br>Representative of the firm and after due deliberation,it was directed to the firm to furnish the following<br>information/documents for further consideration:-<br>Molecular weight of input and output products.<br>1.<br>Percentage yield on the molar basis with technical justification.<br>2.<br>Revised GST certificate to account for the entire balanced quantity.<br>3.

nput and output products.** 1. Percentage yield on the molar basis with technical justification. 2. Revised GST certificate to account for the entire balanced quantity. 3.||

Case No.	4 / NC/3/MEET/May/202425/3
Case Status	Case Deferred
Party Name	ARENE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ File Number	HQRNORM REVIW00006628AM24
RA File Number	092404000024 AM21
Licence No and<br>Date	0910068681/28/04/2020
Norms Committee Decision:<br>The Committee considered the case as per the agenda and it has been observed that the firm could not attend<br>the PH and this was the first opportunity only. Therefore, the committee has decided to grant one more<br>opportunity to the firm for aPersonal Hearingwith relevant documents/information.

Case No.	5 / NC/3/MEET/May/202425/3
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED

4 This document has been digitally signed by Raman Kumar, Deputy DGFT on 11-06-2024 10:22:59.

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4 This document has been digitally signed by Raman Kumar, Deputy DGFT on 11-06-2024 10:22:59.

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Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ File Number<br>HQRNORM APPLY 00192148AM22
RA File Number<br>03AA04091496 AM22
Licence No and<br>Date<br>0311007180/23/09/2021
Norms Committee Decision:
Dr. Anand Kumar Pandey, Sr. GM (R&D) and Shri P. Edward, Sr. Manager (Licensing) of the firm
attended the Personal Hearing and explained the case. The Committee heard the explanation of the
Representative of the firm and after due deliberation,it was directed to the firm to furnish the following
information/documents for further consideration:-
Complete batch chemical reaction showing the description of export and import items along<br>1.
with percentage yield on a molar basis.
Certificate of Analysis (CoA) of import item to explain the complete description of import item<br>2.
No.1

and import items along** 1.| |with percentage yield on a molar basis.| |Certificate of Analysis (CoA) of import item to explain the complete description of import item 2.| |No.1|

Case No.<br>6 / NC/3/MEET/May/202425/3	Case No.<br>6 / NC/3/MEET/May/202425/3
Case Status<br>Case Approved
Party Name<br>KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number and Date NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ File Number<br>HQRNORM REVIW00000165AM24
RA File Number<br>03AX04000308 AM22
Licence No and Date<br>0311009920/30/12/2021
Norms Committee Decision:
Dr. Anand Kumar Pandey, Sr. GM (R&D) and Shri P. Edward, Sr. Manager (Licensing) of the firm
attended the Personal Hearing and explained the case. The Committee heard the explanation of the
Representative of the firm and after due deliberation, the Committee considered the case as per agenda
and took a cue from the earlier decision for	the same export product/import item		in meeting No.
NC/3/MEET/Jan/202324/20 dated 18/01/2024 against		Advance Authorisation No. 0311004745 dated
19/06/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.1 as per details given below
or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl.	Import Items		Qty. allowed.
	No.
MEROPENEM FOR INJECTION<br>1 kg.	1	MEROPENEM NON STERILE		0.8968 kg.
(MEROPENEM<br>BUFFERED		MEROPENEM TRIHYDRATE
STERILE)		NON STERILE

tems**||Qty. allowed.|| ||No.||||| |MEROPENEM FOR INJECTION 1 kg.|1|MEROPENEM NON STERILE||0.8968 kg.|| |(MEROPENEM BUFFERED||MEROPENEM TRIHYDRATE|||| |STERILE)||NON STERILE||||

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==> picture [467 x 207] intentionally omitted <==

----- Start of picture text ----- (Containing NLT 84% Sterile 2 Packing Materials: Relevant, as per Meropenem) ALUMINIUM Packing Policy CANISTER(5KG) and General /ALUMINIUM BOTTLE Notes. ANODIZED 2M(20L000T.8020XY)(ONE SET CONTAINS ONE CANISTER / RA concerned may take further necessary action as per above decision of NC ----- End of picture text -----

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

	(Containing<br>NLT<br>84%<br> <br>Meropenem)	Packing Materials:<br>ALUMINIUM	Relevant, as per<br>Packing Policy
		CANISTER(5KG)<br>/ALUMINIUM BOTTLE<br>ANODIZED<br>2M(20L000T.8020XY)(ONE<br>SET CONTAINS ONE<br>CANISTER /	<br>and General<br>Notes.
RA concerned may take further necessary action as per above decision of NC





Case No	7 / NC/3/MEET/Ma/202425/3
.	y
Case Status	Case Approved

Part Name	ALEMBIC PHARMACEUTICALS LIMITED
y

|||||||||| |Case No||7 / NC/3/MEET/Ma/202425/3||||||||||| |.||y||||||||||| |Case Status||Case Approved||||||||||| |||||||||||||| |Part Name||ALEMBIC PHARMACEUTICALS LIMITED||||||||||| |y||||||||||||| |Meeting Number and Date||NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024||||||||||| |||||||||||||| |HQ File Number||HQRNORM APPLY 00346268AM22||||||||||| |RA File Number||34AX04000204 AM22||||||||||| |Licence No and||3411001767/07/02/2022||||||||||| |Date||||||||||||| |Norms Committee Decision: Shri Saibal Mukherjee, General Manager and Ms. G. Sherly, Manager of the firm attended the Personal Hearing and explained the case. The Committee heard the explanation of the Representative of the firm and after due deliberation||||||||||||| | the committee has|| decided to fix ad-hoc norm||||, s on the basis of information provided by the firm, as under, or as||||||| | applied whichever|| is less: -||||||||||| |||||||||||||| |||||||||||||| |||||||||||||| ||Export|Product|Qty.|||Sl. No.||Import Items|||Qty. allowed.|| |||||||||||||| |||||||||||||| ||Azithromycin | Tablets | 1 Number|||1||Erythromycin Thiocyanate|||587.92 mg|| ||USP 250 mg tab|||||||(ON 100% ACTIVITY )||||| |||||||2||Hydroxylamine HCL|||269.91 mg.|| |||||||3||Methanol|||801.72 mg.|| ||||||||||||||

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omycin Thiocyanate|||587.92 mg|| ||USP 250 mg tab|||||||(ON 100% ACTIVITY )||||| |||||||2||Hydroxylamine HCL|||269.91 mg.|| |||||||3||Methanol|||801.72 mg.|| ||||||||||||||

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		4	Methylene Chloride	828.44 mg.
		5	Platinum Metal	0.563 mg.
		6	Acetone	1897.00 mg.
Azithromycin<br>Tablets<br>USP 500 mg tab	<br>1 Number	7	Erythromycin Thiocyanate<br>( ON 100% ACTIVITY )	1175.85 mg.
		8	Hydroxylamine HCL	539.82 mg.
		9	Methanol	1603.44 mg.
		10	Methylene Chloride	1656.88 mg.
		11	Platinum Metal	1.127 mg.
		12	Acetone	3794.8 mg.

br>( ON 100% ACTIVITY )|1175.85 mg.| ||||8|Hydroxylamine HCL|539.82 mg.| ||||9|Methanol|1603.44 mg.| ||||10|Methylene Chloride|1656.88 mg.| ||||11|Platinum Metal|1.127 mg.| ||||12|Acetone|3794.8 mg.| ||Azithromycin Tablets USP 600 mg tab| 1 Number|13|Erythromycin Thiocyanate ( ON 100% ACTIVITY )|1411.00 mg.| ||||14|Hydroxylamine HCL|647.80 mg.| ||||15|Methanol|1924.14 mg.| ||||16|Methylene Chloride|1988.28 mg.| ||||17|Platinum Metal|1.353 mg.| ||||18|Acetone|4553.80 mg.|

Note: (i) The ad-hoc norms is fixed as per existing SION A-2440. (ii) No repeat Advance Authorisation to be issued on the existing norms.

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(iii) The committee decided to examine the SION for Azithromycin Dihydrate for revision.

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

Case No.	8 / NC/3/MEET/May/202425/3
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ File Number	HQRNORM APPLY 00380949AM22
RA File Number	34AX04000157 AM22
Licence No and<br>Date	3411001935/09/03/2022
Norms Committee Decision:
Shri Saibal Mukherjee, General Manager and Ms. G. Sherly, Manager of the firm attended the Personal
Hearing and explained the case. The Committee heard the explanation of the Representative of the firm and
after due deliberation, the Committee decided to defer the case till revised data is analyzed for revision of
SION.

Case No.<br>9 / NC/3/MEET/May/202425/3
Case Status<br>Case Deferred
Party Name<br>KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ File Number<br>HQRNORM APPLY 00001959AM23
RA File Number<br>03AX04002151 AM23
Licence No and<br>Date<br>0311016241/11/07/2022
Norms Committee Decision:
Dr. Anand Kumar Pandey, Sr. GM (R&D) and Shri P. Edward, Sr. Manager (Licensing) of the firm
attended the Personal Hearing and explained the case.

311016241/11/07/2022| |Norms Committee Decision:| |Dr. Anand Kumar Pandey, Sr. GM (R&D) and Shri P. Edward, Sr. Manager (Licensing) of the firm| |attended the Personal Hearing and explained the case. The Committee heard the explanation of the| |Representative of the firm and after due deliberation, it was directed to the firm to furnish the following| |information/documents for further consideration:-| |Complete batch chemical reaction showing the description of export and import items along i.| |with percentage yield on a molar basis.|

8 This document has been digitally signed by Raman Kumar, Deputy DGFT on 11-06-2024 10:22:59.

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Case No.	Case No.	10 / NC/3/MEET/May/202425/3
Case Status		Case Approved

Party Name		MACLEODS PHARMACEUTICALS LTD
Mi b	d
eetng Numer a<br>Date		NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024

HQ File Number		HQRNORM REVIW00008151AM24

RA File Number		03AX04002952 AM23
Li d D		0311017587/08/09/2022
cence No an a	e
Ci	ii
Norms ommttee	ecson:
Shri Mohit Agraw<br>Committee heard	al, GM (IL) and others of the firm attended the Personal Hearing and explained the case.

nce No an a||e||||||||| |Ci||ii||||||||| |Norms ommttee||ecson:||||||||| |Shri Mohit Agraw Committee heard||al, GM (IL) and others of the firm attended the Personal Hearing and explained the case. The the explanation of the Representative of the firm and after due deliberation, the committee has||||||||| |decided to fix ad-hoc norms on the basis of information provided by the firm as under, or as applied whichever is less: - Export Product Qty. Sl. No. Import Items Qty. allowed. 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) 1 Number 5 LAMIVUDINE Indigenously||||||||||| ||Export Product|||Qty.||Sl.|Import Items|||**Qty.

ofovir disoproxil Fumarate 300mg + Dolutegravir Sodium 50mg tablets) 1 Number 5 LAMIVUDINE Indigenously||||||||||| ||Export Product|||Qty.||Sl.|Import Items|||Qty. allowed.| |||||||No.||||| |||||||||||| ||Lamivudine 300mg + Tenofovir disoproxil Fumarate 300mg + Dolutegravir Sodium 50mg tablets (Lamivudine 300mg + Tenofovir disoproxil Fumarate 300mg + Dolutegravir Sodium 50mg tablets)|||1|Number|1|(R|)-3-AMINO-1-BUTANOL||19.635 mg.| |||||||||||| |||||||2|1-( me 4-|2,2-dimethoxyethyl)-5- thoxy-6(methoxycarbonyl) oxo-14-dihydropyridine-3-||Indigenously procured| |||||||3|ca|, rboxylic acid||| ||||||||Lit|hium bromide anhydrous||Indigenously | |||||||||||procured| |||||||||||| |||||||4 5|(R)-9-(2-phosphonomethoxy propyl)-adenine|||205.02 mg.| ||||||||LAMIVUDINE|||Indigenously| |||||||||||procured| |||||||||||| |RA concerned m||ay take further necessary action as per above decision of NC||||||||| |||||||||||| |||||||||||| ||||||||||||

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ndigenously| |||||||||||procured| |||||||||||| |RA concerned m||ay take further necessary action as per above decision of NC||||||||| |||||||||||| |||||||||||| ||||||||||||

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Cas	e No.	11 / NC/3/MEET/May/202425/3
Cas	e Status	Case Approved

Par	ty Name	KOPRAN RESEARCH LABORATORIES LIMITED
Me	eting Number and Date	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ	File Number	HQRNORM APPLY 00003283AM23
RA	File Number	03AX04003060 AM23
Lic	ence No and Date	0311018071/22/09/2022
No<br>D<br>a<br>R<br>a<br>N<br>1<br>o
	ms Committee Decision:<br>r. Anand Kumar Pandey, Sr. GM<br>ttended the Personal Hearing and e<br>		(R&D) and S<br>xplained the<br>			hri P.<br>case.<br>		Edward, Sr. Manager (Licensi<br>The Committee heard the exp<br>	ng) of the firm<br>lanation of the<br>
	epresentative of the firm and after<br>nd taking cue from the earlier de<br>C/3/MEET/Jan/202324/20 dated 18<br>9/06/2021, it was decided to fix ad-h<br>r as applied by the firm, whichever is		ue deliberati<br>cision for the<br>/01/2024 aga<br>oc norms und<br>less:-			on, the<br>same<br>inst A<br>er Para		committee considered the case<br>export product/import item i<br>dvance Authorisation No. 031<br>4.07 of HBP Vol.1 as per deta	as per agenda<br>n meeting No.<br>1004745 dated<br>ils given below

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

No. 031 4.07 of HBP Vol.1 as per deta|as per agenda n meeting No. 1004745 dated ils given below| |||||||||||| ||Export Product||||Qty.|Sl. No.||Import Items||Qty. allowed.| |||||||||||| ||MEROPENEM FOR INJECTION (MEROPENEM BUFFERED STERILE|||| 1 kg.|1||MEROPENEM NON STERILE MEROPENEM TRIHYDRATE NON STERILE||0.8968 kg.| ||)|||||||||| ||(Containing|NLT 84% Sterile||||||||| ||Meropenem)|||||2||Packing Materials:||Relevant, as per| |||||||||ALUMINIUM CANISTER(5KG)||Packing Policy and General| |||||||||/ALUMINIUM BOTTLE||Notes.| |||||||||ANODIZED||| |||||||||2M(20L000T.8020XY)(ONE ||| |||||||||SET CONTAINS ONE CANISTER /||| |||||||||||| |R|A concerned may take further necessary action|||||as per above decision of NC|||||




Cas	e No.	11 / NC/3/MEET/May/202425/3
Cas	e Status	Case Approved

Par	ty Name	KOPRAN RESEARCH LABORATORIES LIMITED
Me	eting Number and Date	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ	File Number	HQRNORM APPLY 00003283AM23
RA	File Number	03AX04003060 AM23
Lic	ence No and Date	0311018071/22/09/2022
No<br>D<br>a<br>R<br>a<br>N<br>1<br>o
	ms Committee Decision:<br>r. Anand Kumar Pandey, Sr. GM<br>ttended the Personal Hearing and e<br>		(R&D) and S<br>xplained the<br>	hri P.<br>case.<br>	Edward, Sr.

br>a N 1 o||||||||||| ||ms Committee Decision: r. Anand Kumar Pandey, Sr. GM ttended the Personal Hearing and e |||(R&D) and S xplained the |||hri P. case. ||Edward, Sr. Manager (Licensi The Committee heard the exp |ng) of the firm lanation of the | ||epresentative of the firm and after nd taking cue from the earlier de C/3/MEET/Jan/202324/20 dated 18 9/06/2021, it was decided to fix ad-h r as applied by the firm, whichever is|||ue deliberati cision for the /01/2024 aga oc norms und less:-|||on, the same inst A er Para||committee considered the case export product/import item i dvance Authorisation No. 031 4.07 of HBP Vol.1 as per deta|as per agenda n meeting No. 1004745 dated ils given below| |||||||||||| ||Export Product||||Qty.|Sl. No.||Import Items||Qty. allowed.| |||||||||||| ||MEROPENEM FOR INJECTION (MEROPENEM BUFFERED STERILE|||| 1 kg.|1||MEROPENEM NON STERILE MEROPENEM TRIHYDRATE NON STERILE||0.8968 kg.| ||)|||||||||| ||(Containing|NLT 84% Sterile||||||||| ||Meropenem)|||||2||Packing Materials:||Relevant, as per| |||||||||ALUMINIUM CANISTER(5KG)||Packing Policy and General| |||||||||/ALUMINIUM BOTTLE||Notes.| |||||||||ANODIZED||| |||||||||2M(20L000T.8020XY)(ONE ||| |||||||||SET CONTAINS ONE CANISTER /||| |||||||||||| |R|A concerned may take further necessary action|||||as per above decision of NC|||||

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2M(20L000T.8020XY)(ONE ||| |||||||||SET CONTAINS ONE CANISTER /||| |||||||||||| |R|A concerned may take further necessary action|||||as per above decision of NC|||||

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Case No.	12 / NC/3/MEET/May/202425/3
Case Status	Case Approved
Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number and<br>Date	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ File Number	HQRNORM REVIW00008388AM24
RA File Number	03AX04004899 AM23
Licence No and Date	0311020446/03/01/2023
Norms Committee Decision:<br>Shri Mohit Agrawal, GM (IL) and others of the firm attended the Personal Hearing and explained the case. The<br>Committee heard the explanation of the Representative of the firm and after due deliberation, the committee has<br>decided to fix ad-hoc norms on the basis of information provided by the firm as under, or as applied whichever is less:<br>-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.<br>1<br>(R)-3-AMINO-1-BUTANOL<br>19.635 mg.<br>2<br>1-(2,2-dimethoxyethyl)-5-<br>methoxy-6(methoxycarbonyl)<br>4-oxo-1,4-dihydropyridine-3-<br>carboxylic acid<br>Indigenously<br>procured.<br>3<br>(R)-9-(2-phosphonomethoxy<br>propyl)-adenine<br>205.02 mg.<br>Lamivudine 300mg + Tenofovir<br>disoproxil Fumarate 300mg +<br>Dolutegravir Sodium 50mg<br>tablets (Lamivudine 300mg<br>+Tenofovir disoproxil Fumarate<br>300mg + Dolutegravir Sodium<br>50mg tablets)<br>1 Number<br>4<br>LAMIVUDINE<br>Indigenously<br>procured.<br>RA concerned may take further necessary action as per above decision of NC

Fumarate 300mg + Dolutegravir Sodium 50mg tablets) 1 Number 4 LAMIVUDINE Indigenously procured. RA concerned may take further necessary action as per above decision of NC||

Case No.	13 / NC/3/MEET/May/202425/3
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024

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and Date	and Date
HQ File Number		HQRNORM APPLY 00005568AM23
RA File Number		34AX04000926 AM23
Licence No and<br>Date		3411003231/05/01/2023
Norms Committee Decision:<br>Shri Saibal Mukherjee, General Manager and Ms. G. Sherly, Manager of the firm had attended the Personal Hearing<br>and explained the case. The Committee heard the explanation of the Representative of the firm and after due<br>deliberation, the committee has decided to fix ad-hoc norms on the basis of information provided by the firm as under,<br>or as applied whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ed to fix ad-hoc norms on the basis of information provided by the firm as under, or as applied whichever is less: - Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Erythromycin Thiocyanate (ON 100% ACTIVITY ) 587.92 mg 2 Hydroxylamine HCL 269.91 mg. 3 Methanol 801.72 mg. 4 Methylene Chloride 828.44 mg. 5 Platinum Metal 0.563 mg. Azithromycin Tablets USP 250 mg tab 1 Number 6 Acetone 1897.00 mg. 7 Erythromycin Thiocyanate ( ON 100% ACTIVITY ) 1175.85 mg. 8 Hydroxylamine HCL 539.82 mg. 9 Methanol 1603.44 mg. 10 Methylene Chloride 1656.88 mg. 11 Platinum Metal 1.127 mg. Azithromycin Tablets USP 500 mg tab 1 Number 12 Acetone 3794.8 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Azithromycin Tablets USP 250 mg tab|| 1 Number|1|Erythromycin Thiocyanate (ON 100% ACTIVITY )|587.92 mg| |||||2|Hydroxylamine HCL|269.91 mg.| |||||3|Methanol|801.72 mg.| |||||4|Methylene Chloride|828.44 mg.| |||||5|Platinum Metal|0.563 mg.| |||||6|Acetone|1897.00 mg.| ||Azithromycin Tablets USP 500 mg tab|| 1 Number|7|Erythromycin Thiocyanate ( ON 100% ACTIVITY )|1175.85 mg.| |||||8|Hydroxylamine HCL|539.82 mg.| |||||9|Methanol|1603.44 mg.| |||||10|Methylene Chloride|1656.88 mg.| |||||11|Platinum Metal|1.127 mg.| |||||12|Acetone|3794.8 mg.|

UDIN00245968AM25

g.| |||||8|Hydroxylamine HCL|539.82 mg.| |||||9|Methanol|1603.44 mg.| |||||10|Methylene Chloride|1656.88 mg.| |||||11|Platinum Metal|1.127 mg.| |||||12|Acetone|3794.8 mg.|

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13	Erythromycin Thiocyanate<br>( ON 100% ACTIVITY )	1411.00 mg.
14	Hydroxylamine HCL	647.80 mg.
15	Methanol	1924.14 mg.
16	Methylene Chloride	1988.28 mg.
17	Platinum Metal	1.353 mg.
18	Acetone	4553.80 mg.

Note: (i) The ad-hoc norms fixed as per existing SION A-2440.

(ii) No repeat Advance Authorisation to be issued on the existing norms.

(iii) SION for Azithromycin Dihydrate and their intermediates are pending for revision. RA concerned may take further necessary action as per the above decision of NC

Case No.	14 / NC/3/MEET/May/202425/3
Case Status	Case Approved
Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ File Number	HQRNORM REVIW00008389AM24
RA File Number	03AX04005022 AM23
Licence No and<br>Date	0311020561/09/01/2023
Norms Committee Decision:<br>Shri Mohit Agrawal, GM (IL) and others of the firm had attended the Personal Hearing and explained the case. The<br>Committee heard the explanation of the Representative of the firm and after due deliberation, the committee has<br>decided to fix ad-hoc norms on the basis of information provided by the firm as under, or as applied whichever is less:<br>-

UDIN00245968AM25

fter due deliberation, the committee has decided to fix ad-hoc norms on the basis of information provided by the firm as under, or as applied whichever is less: -||

UDIN00245968AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Lamivudine 300mg +	1 Number	1	(R)-3-AMINO-1-BUTANOL	19.635 mg.
Tenofovir disoproxil Fumarate
300mg + Dolutegravir Sodium<br>50mg tablets (Lamivudine<br>300mg + Tenofovir disoproxil<br>Fumarate 300mg + Dolutegravir<br>Sodium 50mg tablets)		2	1-(2,2-dimethoxyethyl)-5-<br>methoxy-6(methoxycarbonyl)<br>4-oxo-1,4-dihydropyridine-3-<br>carboxylic acid	70.125 mg.
		3	(R)-9-(2-phosphonomethoxy	205.02 mg.
			propyl)-adenine
		4	LAMIVUDINE	306.00 mg.

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

Case No.	15 / NC/3/MEET/May/202425/3	15 / NC/3/MEET/May/202425/3
Case Status	Case Approved
Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ File Number	HQRNORM REVIW00008390AM24
RA File Number	03AX04005710 AM23
Licence No and<br>Date	0311021583/24/02/2023
Norms Committee	Decision:
Shri Mohit Agrawal, GM (IL) and others of the firm had attended the Personal Hearing and explained the case.

|||| |Licence No and Date|0311021583/24/02/2023|||||| |Norms Committee|Decision:|||||| |Shri Mohit Agrawal, GM (IL) and others of the firm had attended the Personal Hearing and explained the case. The||||||| |Committee heard|the explanation of the Representative of the firm and after due deliberation, the committee has|||||| |decided to fix ad-hoc norms on the basis||of information provided by the firm as under, or as applied|||whichever is less:|| |-||||||| |Export|Product|Qty.|Sl.|Import Items|Qty. allowed.|| ||||No.|||| |Lamivudine|300mg + Tenofovir|1 Number|1|(R)-3-AMINO-1-BUTANOL|19.635 mg.||

UDIN00245968AM25

disoproxil Fumarate 300mg +	2	1-(2,2-dimethoxyethyl)-5-	70.125 mg.
Dolutegravir<br>Sodium<br>50mg		methoxy-6(methoxycarbonyl)
tablets (Lamivudine 300mg +		4-oxo-1,4-dihydropyridine-3-
Tenofovir disoproxil Fumarate		carboxylic acid
300mg + Dolutegravir Sodium
50mg tablets)	3	(R)-9-(2-phosphonomethoxy	205.02 mg.
		propyl)-adenine
	4	LAMIVUDINE	306.00 mg.

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

r Sodium||||| |50mg tablets)||3|(R)-9-(2-phosphonomethoxy|205.02 mg.| ||||propyl)-adenine|| |||4|LAMIVUDINE|306.00 mg.|

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

Case No.	Case No.	16 / NC/3/MEET/May/202425/3	16 / NC/3/MEET/May/202425/3	16 / NC/3/MEET/May/202425/3
Case Status		Case Deferred
Party Name		ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>		NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
and Date

HQ File Number		HQRNORM APPLY 00001008AM24

RA File Number		03AX04000694 AM24
Licence No and<br>		0311023767/22/05/2023
Date

Norms Committee		Decision:
Shri Kedar Pan<br>(Project) of the		dya, Sr. Manager (Logistics), Shri Chetan Moyal, Manager and Shri Anil Kumar, Head<br>firm attended the Personal Hearing and explained the case. The Committee heard the
<br>explanation of Representative of the firm and after due deliberation,it was directed to the firm to<br>furnish the following information/documents for further consideration:-<br>Master Batch Formula (MBF) for all export item showing the net content of import item in the<br>export without claiming any wastage or overages.<br>1.<br>Density of import items.<br>2.



Cas	e No.	17 / NC/3/MEET/May/2024	25/3
Cas	e Status	Case Rejected
Par	ty Name	REMEDIUM LIFECARE L	IMITED
Me	eting Number	NC/ 3/ MEET/ May/ 20242	5/ 3 and 16/05/20	24

| |||||||| |Cas|e No.|17 / NC/3/MEET/May/2024|25/3|||| |Cas|e Status|Case Rejected||||| |Par|ty Name|REMEDIUM LIFECARE L|IMITED|||| |Me|eting Number|NC/ 3/ MEET/ May/ 20242|5/ 3 and 16/05/20|24|||

Master Batch Formula (MBF) for all export item showing the net content of import item in the export without claiming any wastage or overages.

Case No.	17 / NC/3/MEET/May/202425/3
Case Status	Case Rejected
Party Name	REMEDIUM LIFECARE LIMITED
Meeting Number	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024

UDIN00245968AM25

and Date
HQ File Number<br>HQRNORM APPLY 00006031AM24
RA File Number<br>03AX04002475 AM24
Licence No and<br>Date<br>0311027606/04/10/2023
Norms Committee Decision:
The Committee considered the request of firm for fixation of ad-hoc norms and it was observed that the firm
had neither attended the Personal Hearing nor intimated to the Committee. Hence, it was decided toreject
the application of the firm.

The Committee considered the request of firm for fixation of ad-hoc norms and it was observed that the firm had neither attended the Personal Hearing nor intimated to the Committee. Hence, it was decided to reject the application of the firm.

fixation of ad-hoc norms and it was observed that the firm had neither attended the Personal Hearing nor intimated to the Committee. Hence, it was decided to reject the application of the firm.

Case No.	18 / NC/3/MEET/May/202425/3
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ File Number	HQRNORM APPLY 00006479AM24
RA File Number	03AX04003049 AM24
Licence No and<br>Date	0311028247/27/10/2023
Norms Committee Decision:
Shri Kedar Pandya, Sr. Manager (Logistics), Shri Chetan Moyal, Manager (CQA) and Shri Anil
Kumar, Head	(Project) of the firm attended the Personal Hearing and explained the case. The
Committee heard the explanation of the Representative of the firm and after due deliberation,it was
directed to the firm to furnish the following information/documents for further consideration:-
Master Batch Formula (MBF) for all export item showing the net content of import item in the<br>i.
export without claiming any wastage or overages.
Density of import items.<br>ii.

i. Master Batch Formula (MBF) for all export item showing the net content of import item in the export without claiming any wastage or overages.

**|| |Density of import items. ii.||

i. Master Batch Formula (MBF) for all export item showing the net content of import item in the export without claiming any wastage or overages.

Case No.	19 / NC/3/MEET/May/202425/3
Case Status	Case Deferred

Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED

Meeting Number
<br>and Date	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ File Number	HQRNORM APPLY 00006571AM24
RA File Number	03AX04003274 AM24

Licence No and
<br>Date	0311028380/01/11/2023

16 This document has been digitally signed by Raman Kumar, Deputy DGFT on 11-06-2024 10:22:59.

UDIN00245968AM25

Norms Committee Decision:

Shri Kedar Pandya, Sr. Manager (Logistics), Shri Chetan Moyal, Manager (CQA) and Shri Anil Kumar, Head (Project) of the firm attended the Personal Hearing and explained the case. The Committee heard the explanation of the Representative of the firm and after due deliberation,it was directed to the firm to furnish the following information/documents for further consideration:-

I. Master Batch Formula (MBF) for all export item showing the net content of import item in the export without claiming any wastage or overages.
II. Density of import items.

ation:-

I. Master Batch Formula (MBF) for all export item showing the net content of import item in the export without claiming any wastage or overages.
II. Density of import items.

Case No.	20 / NC/3/MEET/May/202425/3
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ File Number	HQRNORM APPLY 00006570AM24
RA File Number	03AX04003275 AM24
Licence No and<br>Date	0311028379/01/11/2023
Norms Committee Decision:
Shri Kedar Pandya, Sr. Manager (Logistics), Shri Chetan Moyal, Manager (CQA) and Shri Anil
Kumar, Head	(Project) of the firm attended the Personal Hearing and explained the case. The
Committee heard the explanation of the Representative of the firm and after due deliberation,it was
directed to the firm to furnish the following information/documents for further consideration:-
Master Batch Formula (MBF) for all export item showing the net content of import item in the<br>i.
export without claiming any wastage or overages.
Density of import items.<br>ii.

i. Master Batch Formula (MBF) for all export item showing the net content of import item in the export without claiming any wastage or overages.

**|| |Density of import items. ii.||

i. Master Batch Formula (MBF) for all export item showing the net content of import item in the export without claiming any wastage or overages.

Case No.	21 / NC/3/MEET/May/202425/3
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ File Number	HQRNORM APPLY 00006599AM24
RA File Number	03AX04003360 AM24
Licence No and	0311028414/02/11/2023

17 This document has been digitally signed by Raman Kumar, Deputy DGFT on 11-06-2024 10:22:59.

UDIN00245968AM25

Date

Norms Committee Decision:

i. Master Batch Formula (MBF) for all export item showing the net content of import item in the export without claiming any wastage or overages.
ii. Density of import items.

Case No.	22 / NC/3/MEET/May/202425/3
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ File Number	HQRNORM APPLY 00006592AM24
RA File Number	03AX04003362 AM24
Licence No and<br>Date	0311028404/02/11/2023
Norms Committee Decision:<br>Shri Kedar Pandya, Sr. Manager (Logistics), Shri Chetan Moyal, Manager (CQA) and Shri Anil Kumar,<br>Head (Project) of the firm attended the Personal Hearing and explained the case. The Committee heard the<br>explanation of the Representative of the firm and after due deliberation,it was directed to the firm to furnish<br>the following information/documents for further consideration:-<br>Master Batch Formula (MBF) for all export item showing the net content of import item in the<br>export without claiming any wastage or overages.<br>I.<br>Density of import items.<br>II.

I. Master Batch Formula (MBF) for all export item showing the net content of import item in the export without claiming any wastage or overages.

Case No.	23 / NC/3/MEET/May/202425/3
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024

18 This document has been digitally signed by Raman Kumar, Deputy DGFT on 11-06-2024 10:22:59.

UDIN00245968AM25

HQ File Number	HQRNORM APPLY 00006591AM24
RA File Number	03AX04003361 AM24
Licence No and<br>Date	0311028403/02/11/2023
Norms Committee Decision:<br>Shri Kedar Pandya, Sr. Manager (Logistics), Shri Chetan Moyal, Manager (CQA) and Shri Anil<br>Kumar, Head (Project) of the firm attended the Personal Hearing and explained the case. The<br>Committee heard the explanation of the Representative of the firm and after due deliberation,it was<br>directed to the firm to furnish the following information/documents for further consideration:-<br>Master Batch Formula (MBF) for all export item showing the net content of import item in the<br>export without claiming any wastage or overages.<br>I.<br>Density of import items.<br>II.

I. Master Batch Formula (MBF) for all export item showing the net content of import item in the export without claiming any wastage or overages.
II. Density of import items.

II.||

I. Master Batch Formula (MBF) for all export item showing the net content of import item in the export without claiming any wastage or overages.
II. Density of import items.

Case No.	24 / NC/3/MEET/May/202425/3
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202425/ 3 and 16/05/2024
HQ File Number	HQRNORM APPLY 00007599AM24
RA File Number	03AX04004373 AM24
Licence No and<br>Date	0311029682/27/12/2023
Norms Committee Decision:<br>Shri Kedar Pandya, Sr. Manager (Logistics), Shri Chetan Moyal, Manager (CQA) and Shri Anil<br>Kumar, Head (Project) of the firm attended the Personal Hearing and explained the case. The<br>Committee heard the explanation of the Representative of the firm and after due deliberation,it was<br>directed to the firm to furnish the following information/documents for further consideration:-<br>Master Batch Formula (MBF) for all export item showing the net content of import item in the<br>export without claiming any wastage or overages.<br>I.<br>Density of import items.<br>II.

I. Master Batch Formula (MBF) for all export item showing the net content of import item in the export without claiming any wastage or overages.

19 This document has been digitally signed by Raman Kumar, Deputy DGFT on 11-06-2024 10:22:59.

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