IN FORCE Advance Authorisation

DGFT Minutes

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Government of India / भारत सरकार

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

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

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Dec/202324/17 DATED: 20/12/2023

Please Note

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

Meeting No. NC/3/MEET/Dec/202324/17 dated 20/12/2023 of Norms Committee - III for the year 2023-24 was held on 20/12/2023 under the Chairmanship of Rajiv Soni ,Joint DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

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

The following members were present in the meeting:-

S.No.	Name and Designation of Representatives	Department
1	UTTAM SARKAR,Assistant Section Officer	DGFT(HQ)
2	Raman Kumar,Deputy DGFT	DGFT(HQ)
3	NAND Lal,Technical Consultant	DPIIT
4	SHAISH KUMAR,Technical Consultant	DGFT
5	DINESHNARAIN MATHUR,Technical<br>Consultant	DGFT
6	Nand Lal,Technical Consultant	DGFT

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Case Details and Decision(s):

Case No.<br>1 / NC/3/MEET/Dec/202324/17
Case Status<br>Case Deferred
Party Name<br>KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number<br>HQRNORM APPLY 00004206AM24
RA File Number<br>NA
Licence No and<br>Date<br>NA
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal
Hearingbefore Norms Committee to explain its case alongwith following information / documents from the firm :-
Molar Weight of each input and output item of each stage.<br>i.
Percentage yield on molar basis for each step.<br>ii.
CA certified Production/Consumption data.<br>iii.
Sample of Shipping Bills and Bill of Entry of the export products along with statement of Input-output<br>iv.
as per export documents of the said authorization.

Case No.	2 / NC/3/MEET/Dec/202324/17
Case Status	Case Rejected
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00004197AM24
RA File Number	092404000413 AM12
Licence No and<br>Date	0910050238/15/12/2011
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm had neither
attended thePersonal Hearingnor intimated to committee. Hence, it was decided torejectthe case maintaining the
status quo.

c norms and it was observed that the firm had neither|| |attended thePersonal Hearingnor intimated to committee. Hence, it was decided torejectthe case maintaining the|| |status quo.||

Case No.	3 / NC/3/MEET/Dec/202324/17
Case Status	Case Rejected
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00003005AM24
RA File Number	092404000287 AM14
Licence No and	0910057785/01/10/2013

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Date

Norms Committee Decision:

The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm had neither attended the Personal Hearing nor intimated to committee. Hence, it was decided to reject the case maintaining the status quo.

Case No.	4 / NC/3/MEET/Dec/202324/17
Case Status	Case Rejected
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00003009AM24
RA File Number	092404000044 AM15
Licence No and<br>Date	0910059969/01/05/2014
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm had neither
attended the Personal Hearing nor intimated to committee. Hence, it was decided torejectthe case maintaining the
status quo.

hoc norms and it was observed that the firm had neither|| |attended the Personal Hearing nor intimated to committee. Hence, it was decided torejectthe case maintaining the|| |status quo.||

Case No.	5 / NC/3/MEET/Dec/202324/17
Case Status	Case Rejected
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00003004AM24
RA File Number	092404000421 AM15
Licence No and<br>Date	0910061287/21/11/2014
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm had neither
attended the Personal Hearing nor intimated to committee. Hence, it was decided torejectthe case maintaining the
status quo.

Case No.	6 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	CLARION ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00005834AM24
RA File Number	502404000002 AM16
Licence No and<br>Date	5010002211/29/06/2015

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Norms Committee Decision:

Shri Vivek Tiwari, Director, and Shri Gyanesh Jadoa, Production (Head) of the firm had attended the Personal Hearing and explained firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has considered for review of ad-hoc norms on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under, or as applied whichever is lower: -

Export Product	Qty	S.No.	Import Item	Qty. allowed
3-Hydroxy Acetophenone (99%	1 Kg.	1	Acetophenone	2.04 kg
Assy. Value)
			(99.50% Assy. Value)

Note: The above norms are for regularization and closure purpose only.

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

Case No.<br>7 / NC/3/MEET/Dec/202324/17	Case No.<br>7 / NC/3/MEET/Dec/202324/17
Case Status<br>Case Approved
Party Name<br>MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number<br>HQRNORM REVIW00006372AM24
RA File Number<br>039504000304 AM17
Licence No and<br>Date<br>0310806238/14/07/2016
Norms Committee Decision:
Shri Kunal Sikchi, Director and Shri Nitin Vyas, Sr. Executive of the firm had attended the Personal Hearing and
explained firm’s case. The Committee	heard the explanation of Representative of the firm and after due deliberation
the committee has considered for review of ad-hoc		norms on	the basis of information provided	by the firm, it was
decided to revise ad-hoc norms as under, or as applied whichever is less:-
Export Product	Qty	S.No.	Import Item	Qty. allowed
D Alpha Tocopherol having Net	1 Kg.	1	Fatty Acid Distillate Deoderised	30.00 kg
content of Fatty Acid			Distillate
Distillate/Deoderised Distillate
727000.00 kgs. Methenol 99 Percent		2	Methenol 99%	9.18 kg

This document has been digitally signed by Raman Kumar, Deputy DGFT on 31-01-2024 15:53:42.

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Distillate|||||| |727000.00 kgs. Methenol 99 Percent||2|Methenol 99%|9.18 kg||

This document has been digitally signed by Raman Kumar, Deputy DGFT on 31-01-2024 15:53:42.

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222400.00 kg. S Heptane 71200.00		3	S-Heptane	2.94 kg
kg. Acetone 29000.00 kg.
		4	Acetone	1.20 kg

Note: The above norms are for regularization and closure purpose only. No repeat Licence may be allowed by RA on above norms.

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

Case No.	8 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00000261AM24
RA File Number	039404000617 AM17
Licence No and<br>Date	0310808312/06/10/2016
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	9 / NC/3/MEET/Dec/202324/17	9 / NC/3/MEET/Dec/202324/17	9 / NC/3/MEET/Dec/202324/17	9 / NC/3/MEET/Dec/202324/17	9 / NC/3/MEET/Dec/202324/17
Case Status		Case Approved
Party Name		CLARION ORGANICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number		HQRNORM REVIW00005838AM24
RA File Number		502404000013 AM17
Licence No and<br>Date		5010002312/16/12/2016

and Date||NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023||||| |HQ File Number||HQRNORM REVIW00005838AM24||||| |RA File Number||502404000013 AM17||||| |Licence No and Date||5010002312/16/12/2016||||| |Norms Committee Decision: Shri Vivek Tiwari, Director, and Shri Gyanesh Jadoa, Production (Head) of the firm had attended the Personal Hearing and explained firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has considered for review of ad-hoc norms on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under, or as applied whichever is lower: - Export Product Qty S.No. Import Item Qty. allowed||||||| ||Export Product||Qty|S.No.|Import Item|Qty. allowed|

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3-Hydroxy Acetophenone (99%	1 Kg.	1	Acetophenone	2.04 kg
Assy. Value)
			(99.50% Assy. Value)

Note: The above norms are for regularization and closure purpose only.

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

Case No.	10 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00000263AM24
RA File Number	039404001181 AM17
Licence No and<br>Date	0310812323/03/04/2017
Norms Committee Decision:
The case is under	consideration for want of comments of TE.

Case No.	Case No.	11 / NC/3/MEET/Dec/202324/17
Case Status		Case Approved
Party Name		MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number		HQRNORM REVIW00006373AM24
RA File Number		039504000999 AM17
Licence No and<br>Date		0310812435/11/04/2017
Norms Committee Decision:
Shri Kunal Sikchi, Director and Shri Nitin Vyas, Sr. Executive of the firm had attended the Personal Hearing and
explained firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation
the committee has considered for review of ad-hoc norms on the basis of information provided			by the firm, it was
decided to revise		ad-hoc norms as under, or as applied whichever is less:-
	Export Product<br>Qty<br>S.No.<br>Import Item		Qty. allowed
	D Alpha Tocopherol having Net<br>Fatty Acid Distillate Deoderised<br>1 Kg.<br>1		30.00 kg

hever is less:-||| ||Export Product Qty S.No. Import Item||Qty. allowed|| ||D Alpha Tocopherol having Net Fatty Acid Distillate Deoderised 1 Kg. 1||30.00 kg||

Case No.	Case No.	11 / NC/3/MEET/Dec/202324/17
Case Status		Case Approved
Party Name		MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number		HQRNORM REVIW00006373AM24
RA File Number		039504000999 AM17
Licence No and<br>Date		0310812435/11/04/2017
Norms Committee Decision:
Shri Kunal Sikchi, Director and Shri Nitin Vyas, Sr. Executive of the firm had attended the Personal Hearing and
explained firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation
the committee has considered for review of ad-hoc norms on the basis of information provided			by the firm, it was
decided to revise		ad-hoc norms as under, or as applied whichever is less:-
	Export Product<br>Qty<br>S.No.<br>Import Item		Qty. allowed
	D Alpha Tocopherol having Net<br>Fatty Acid Distillate Deoderised<br>1 Kg.<br>1		30.00 kg

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content of Fatty Acid		Distillate
Distillate/Deoderised Distillate
727000.00 kgs. Methenol 99 Percent<br>222400.00 kg. S Heptane 71200.00	2	Methenol 99%	9.18 kg
kg. Acetone 29000.00 kg.
	3	S-Heptane	2.94 kg
	4	Acetone	1.20 kg

erised Distillate||||| |727000.00 kgs. Methenol 99 Percent 222400.00 kg. S Heptane 71200.00||2|Methenol 99%|9.18 kg| |kg. Acetone 29000.00 kg.||||| |||3|S-Heptane|2.94 kg| |||4|Acetone|1.20 kg|

Note:The above norms are for regularization and closure purpose only. No repeat Licence may be allowed by RA on above norms.

Case No.	Case No.	12 / NC/3/MEET/Dec/202324/17	12 / NC/3/MEET/Dec/202324/17	12 / NC/3/MEET/Dec/202324/17	12 / NC/3/MEET/Dec/202324/17	12 / NC/3/MEET/Dec/202324/17
Case Status		Case Approved
Party Name		MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number		HQRNORM REVIW00006374AM24
RA File Number		039504000267 AM18
Licence No and<br>Date		0310814547/11/07/2017
Norms Committee Decision:<br>Shri Kunal Sikchi, Director and Shri Nitin Vyas,Sr. Executive of the firm had attended the Personal Hearing and<br>explained firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation<br>the committee has considered for review of ad-hoc norms on the basis of information provided by the firm, it was<br>decided to revise ad-hoc norms as under, or as applied whichever is less:-<br>Export Product<br>Qty<br>S.No.<br>Import Item<br>**Qty.

is of information provided by the firm, it was decided to revise ad-hoc norms as under, or as applied whichever is less:- Export Product Qty S.No. Import Item Qty. allowed 1 Fatty Acid Distillate Deoderised Distillate 30.00 kg 2 Methenol 99% 9.18 kg 3 S-Heptane 2.94 kg D Alpha Tocopherol having Net content of Fatty Acid Distillate/Deoderised Distillate 727000.00 kgs. Methenol 99 Percent 222400.00 kg. S Heptane 71200.00 kg. Acetone 29000.00 kg. 1 Kg.||||||| ||Export Product||Qty|S.No.|Import Item|Qty. allowed| ||D Alpha Tocopherol having Net content of Fatty Acid Distillate/Deoderised Distillate 727000.00 kgs. Methenol 99 Percent 222400.00 kg. S Heptane 71200.00 kg. Acetone 29000.00 kg.||1 Kg.|1|Fatty Acid Distillate Deoderised Distillate|30.00 kg| |||||2|Methenol 99%|9.18 kg| |||||3|S-Heptane|2.94 kg|

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4 Acetone 1.20 kg

Note:The above norms are for regularization and closure purpose only. No repeat Licence may be allowed by RA on above norms.

Case No.	13 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00000262AM24
RA File Number	039404000295 AM18
Licence No and<br>Date	0310814908/31/07/2017
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00000262AM24| |RA File Number|039404000295 AM18| |Licence No and Date|0310814908/31/07/2017| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	14 / NC/3/MEET/Dec/202324/17	14 / NC/3/MEET/Dec/202324/17	14 / NC/3/MEET/Dec/202324/17	14 / NC/3/MEET/Dec/202324/17	14 / NC/3/MEET/Dec/202324/17
Case Status		Case Approved
Party Name		MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number		HQRNORM REVIW00006375AM24
RA File Number		039504000651 AM18
Licence No and<br>Date		0310817413/29/11/2017
Norms Committee Decision:<br>Shri Kunal Sikchi, Director and Shri Nitin Vyas,Sr. Executive of the firm had attended the Personal Hearing and explained<br>firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has<br>considered for review of ad-hoc norms on the basis of information provided by the firm, it was decided to revise ad-hoc<br>norms as under, or as applied whichever is less:-<br>Export Product<br>Qty<br>S.No.<br>Import Item<br>Qty. allowed<br>1<br>Fatty Acid Distillate Deoderised<br>Distillate<br>30.00 kg<br>D Alpha Tocopherol having Net<br>content of Fatty Acid<br>1 Kg.
	Export Product		Qty	S.No.	Import Item	Qty. allowed
	D Alpha Tocopherol having Net<br>content of Fatty Acid		1 Kg.	1	Fatty Acid Distillate Deoderised<br>Distillate	30.00 kg

||Export Product||Qty|S.No.|Import Item|Qty. allowed| ||D Alpha Tocopherol having Net content of Fatty Acid||1 Kg.|1|Fatty Acid Distillate Deoderised Distillate|30.00 kg|

Case No.	Case No.	14 / NC/3/MEET/Dec/202324/17	14 / NC/3/MEET/Dec/202324/17	14 / NC/3/MEET/Dec/202324/17	14 / NC/3/MEET/Dec/202324/17	14 / NC/3/MEET/Dec/202324/17
Case Status		Case Approved
Party Name		MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number		HQRNORM REVIW00006375AM24
RA File Number		039504000651 AM18
Licence No and<br>Date		0310817413/29/11/2017
Norms Committee Decision:<br>Shri Kunal Sikchi, Director and Shri Nitin Vyas,Sr. Executive of the firm had attended the Personal Hearing and explained<br>firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has<br>considered for review of ad-hoc norms on the basis of information provided by the firm, it was decided to revise ad-hoc<br>norms as under, or as applied whichever is less:-<br>Export Product<br>Qty<br>S.No.<br>Import Item<br>Qty. allowed<br>1<br>Fatty Acid Distillate Deoderised<br>Distillate<br>30.00 kg<br>D Alpha Tocopherol having Net<br>content of Fatty Acid<br>1 Kg.
	Export Product		Qty	S.No.	Import Item	Qty. allowed
	D Alpha Tocopherol having Net<br>content of Fatty Acid		1 Kg.	1	Fatty Acid Distillate Deoderised<br>Distillate	30.00 kg

xport Product**||Qty|S.No.|Import Item|Qty. allowed| ||D Alpha Tocopherol having Net content of Fatty Acid||1 Kg.|1|Fatty Acid Distillate Deoderised Distillate|30.00 kg|

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Distillate/Deoderised Distillate	2	Methenol 99%	9.18 kg
727000.00 kgs. Methenol 99 Percent
222400.00 kg. S Heptane 71200.00<br>kg. Acetone 29000.00 kg.	3	S-Heptane	2.94 kg
	4	Acetone	1.20 kg

Note:The above norms are for regularization and closure purpose only. No repeat Licence may be allowed by RA on above norms.

Case No.	15 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00000265AM24
RA File Number	039404000822 AM18
Licence No and<br>Date	0310818765/30/01/2018
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	16 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00006289AM24
RA File Number	039404000911 AM18
Licence No and<br>Date	0310819230/19/02/2018
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	17 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023

.**||

Case No.	17 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023

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and Date
HQ File Number	HQRNORM REVIW00006376AM24
RA File Number	039504000037 AM19
Licence No and<br>Date	0310820676/26/04/2018
Norms Committee Decision:<br>Shri Kunal Sikchi, Director and Shri Nitin Vyas,Sr. Executive of the firm had attended the Personal Hearing and<br>explained firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation<br>the committee has considered for review of ad-hoc norms on the basis of information provided by the firm, it was<br>decided to revise ad-hoc norms as under, or as applied whichever is less:-<br>Export Product<br>Qty<br>S.No.<br>Import Item<br>Qty. allowed<br>1<br>Fatty Acid Distillate Deoderised<br>Distillate<br>30.00 kg<br>2<br>Methenol 99%<br>9.18 kg<br>3<br>S-Heptane<br>2.94 kg<br>D Alpha Tocopherol having Net<br>content of Fatty Acid<br>Distillate/Deoderised Distillate<br>727000.00 kgs. Methenol 99 Percent<br>222400.00 kg. S Heptane 71200.00<br>kg. Acetone 29000.00 kg.<br>1 Kg.<br>4<br>Acetone<br>1.20 kg<br>Note:The above norms are for regularization and closure purpose only. No repeat Licence may be allowed by<br>RA on above norms.<br>RA concerned may take further necessary action as per above decision of NC.

ms are for regularization and closure purpose only. No repeat Licence may be allowed by** RA on above norms. RA concerned may take further necessary action as per above decision of NC.||

Case No.	18 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00006968AM23
RA File Number	039404000258 AM19
Licence No and<br>Date	0310821966/27/06/2018
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

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Case No.	19 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00006377AM24
RA File Number	039504000488 AM19
Licence No and<br>Date	0310824019/26/09/2018
Norms Committee Decision:<br>Shri Kunal Sikchi, Director and Shri Nitin Vyas,Sr. Executive of the firm had attended the Personal Hearing and<br>explained firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation<br>the committee has considered for review of ad-hoc norms on the basis of information provided by the firm, it was<br>decided to revise ad-hoc norms as under, or as applied whichever is less:-<br>Export Product<br>Qty<br>S.No.<br>Import Item<br>**Qty.

is of information provided by the firm, it was decided to revise ad-hoc norms as under, or as applied whichever is less:- Export Product Qty S.No. Import Item Qty. allowed 1 Fatty Acid Distillate Deoderised Distillate 30.00 kg 2 Methenol 99% 9.18 kg 3 S-Heptane 2.94 kg D Alpha Tocopherol having Net content of Fatty Acid Distillate/Deoderised Distillate 727000.00 kgs. Methenol 99 Percent 222400.00 kg. S Heptane 71200.00 kg. Acetone 29000.00 kg. 1 Kg. 4 Acetone 1.20 kg Note:The above norms are for regularization and closure purpose only. No repeat Licence may be allowed by RA on above norms. RA concerned may take further necessary action as per above decision of NC.||

Case No.	20 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00000260AM24
RA File Number	039404000753 AM19

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Licence No and 0310825758/18/12/2018 Date Norms Committee Decision: The case is under consideration for want of comments of TE.

4| |RA File Number|039404000753 AM19|

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Licence No and 0310825758/18/12/2018 Date Norms Committee Decision: The case is under consideration for want of comments of TE.

Case No.	21 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00000752AM24
RA File Number	052404000438 AM19
Licence No and<br>Date	0510410372/25/04/2019
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	22 / NC/3/MEET/Dec/202324/17	22 / NC/3/MEET/Dec/202324/17	22 / NC/3/MEET/Dec/202324/17	22 / NC/3/MEET/Dec/202324/17	22 / NC/3/MEET/Dec/202324/17
Case Status		Case Approved
Party Name		ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number		HQRNORM REVIW00000818AM24
RA File Number		082404000026 AM20
Licence No and<br>Date		0810145127/30/04/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms as under.<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

f firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under. Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Imidazole 0.712 kg. 2 SODIUM METHOXIDE POWDER 1.00 kg. N-(3-AMINOPROPYL) IMIDAZOLE WHITE OR OFF WHITE CRYSTAL 1 kg. 3 ACRYLONITRILE 0.500 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||N-(3-AMINOPROPYL) IMIDAZOLE WHITE OR OFF WHITE CRYSTAL||1 kg.|1|Imidazole|0.712 kg.| |||||2|SODIUM METHOXIDE POWDER|1.00 kg.| |||||3|ACRYLONITRILE|0.500 kg.| |||||as per above decision of NC.|||

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Case No.	23 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	INDO AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00005846AM24
RA File Number	039404000179 AM20
Licence No and<br>Date	0310829884/25/06/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the<br>firm, it was decided to revise ad-hoc norms as under:-<br>S.No<br>Export Product<br>Qty<br>S.No.<br>Import Item<br>**Qty.

norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:- S.No Export Product Qty S.No. Import Item Qty. allowed 1 C 16 18 Fatty Acid 1.57 kg 1 Tallow Amine (IAL TA) 1 Kg 2 Ni Catalyst 0.001 kg OR 2 Stearyl Amines 100 (IAL SA 100) 1Kg 1 C 16 18 Fatty Acid 1.80 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	24 / NC/3/MEET/Dec/202324/17
Case Status<br>	Case Deferred
Party Name<br>	CONCORD BIOTECH LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number<br>	HQRNORM REVIW00001262AM24
RA File Number<br>	082404000101 AM20
Licence No and<br>Date<br>	0810145581/27/06/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearingbefore<br>Norms Committee to explain its case alongwith relevent information / documents.

Case No.	25 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	AETHER INDUSTRIES LIMITED

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case alongwith relevent information / documents.||

Case No.	25 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	AETHER INDUSTRIES LIMITED

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Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00005919AM24
RA File Number	522104000086 AM20
Licence No and Date	5210043147/14/08/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc 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 Item<br>Qty. allowed<br>1<br>2,6-DICHLOROTOLUENE<br>1.90 kg<br>2<br>TETRAHYDROFURAN<br>1.50 kg<br>3-METHOXY-2-METHYLLENZOYL<br>CHLORIDE.<br>1 Kg<br>3<br>DIMETHYLSULFOXIDE<br>1.37 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	Case No.	26 / NC/3/MEET/Dec/202324/17	26 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00004761AM23
RA File Number			039404000395 AM20
Licence No and<br>Date			0310831546/13/09/2019

umber and Date|||NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023|| |HQ File Number|||HQRNORM REVIW00004761AM23|| |RA File Number|||039404000395 AM20|| |Licence No and Date|||0310831546/13/09/2019|| |Norms Committee Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms for export to US only are as under:- S.No Export Product Quantity 1 SECURA PROTECTIVE CREAM 2.75 Oz 78 Gms Tube 1 Number 2 SECURA PROTECTIVE CREAM 40 GM TUBES 1 Number||||| ||S.No|Export Product||Quantity| ||1|SECURA PROTECTIVE CREAM 2.75 Oz 78 Gms Tube||1 Number| ||2|SECURA PROTECTIVE CREAM 40 GM TUBES||1 Number|

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3	SECURA PROTECTIVE CREAM 1.75 OZ 50 Gms TUBE	1 Number
4	SECURA PROTECTIVE OINTMENT 2.47 Oz 70 GM TUBE	1 Number
5	SECURA PROTECTIVE OINTMENT 5.6 Oz 159 GM TUBE	1 Number
6	SECURA MOISTURIZING CREAM 3 Oz 85 GM TUBE	1 Number
7	SECURA MOSITURIZING CREAM 6.5 Oz 184 GM Tube	1 Number
8	SECURA EXTRA PROTECTIVE CREAM 3.25 Oz 92 GMS TUBE	1 Number
9	SECURA EXTRA PROTECTIVE CREAM 7.75 Oz 219.70 GM TUBE	1 Number
10	SECURA ANTIFUNGAL EXTRA THICK PROTECTIVE CREAM 92 GMS TUBE	1 Number
11	UNICARE MOISTURIZING LOTION 8 Oz 236 ML	1 Number
12	UNICARE MOISTURIZING LOTION 2 Oz 60 ML	1 Number
13	UNI DERM MOISTURIZING CREAM 3 Oz 85 Gms Tube	1 Number
14	UNI DERM MOISTURIZING CREAM 80 GMS TUBE	1 Number
15	SECURA EXTRA PROTECTIVE CREAM 90 GMS TUBE	1 Number

LOTION 2 Oz 60 ML|1 Number| ||13|UNI DERM MOISTURIZING CREAM 3 Oz 85 Gms Tube|1 Number| ||14|UNI DERM MOISTURIZING CREAM 80 GMS TUBE|1 Number| ||15|SECURA EXTRA PROTECTIVE CREAM 90 GMS TUBE|1 Number| ||16|SECURA ANTI FUNGAL GREASELESS 2 Oz 57 GM TUBE|1 Number| ||17|SOLOSITE WOUND GEL 3 Oz 85 Gm TUBE|1 Number| ||18|SOLOSITE WOUND GEL 20 GM TUBE|1 Number| ||19|SOLOSITE SOOTHING, HYDRATING, HEALING GEL 50 GM TUBE|1 Number| ||20|SECURA MOISTURIZING LOTION 8 Oz 236 ML|1 Number| ||21|SECURA MOISTURIZING LOTION 60 ML|1 Number|

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22	SOLOSITE SOOTHING,HYDRATING HEALING GEL	20 GM TUBE	1 Number
23	SOLOSITE SOOTHING,HYDRATING HEALING GEL	100 GM TUBE	1 Number

S.No	Import Product	Quantity
1	Relevant Bulk Drugs	Net content in the export product plus 3% wastage.
2	Relevant Excipients	Net content in the export product plus 3% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy

Note:

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

Case No.	27 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	OPES HEALTH CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00006304AM24
RA File Number	082404000202 AM20
Licence No and<br>Date	0810146231/25/09/2019
Norms Committee Decision:

16 This document has been digitally signed by Raman Kumar, Deputy DGFT on 31-01-2024 15:53:42.

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The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Jan/202223/18 dated 23.01.2023 against advance authorization No. 0811006083 dated 22.09.2022 , 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: -

authorization No. 0811006083 dated 22.09.2022 , 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: -

Sl. No.	Export product	Qty.	Sl. No.	Import items	Qty.
1	Metamizaole Magnesium 300 mg and<br>Pargeverine Hydrochloride 6mg Oral<br>Drop((Considering the loss on drying<br>@14.50% of Bulkdrug for 300MG we<br>need to poor 350.88 Mg. So net content of<br>the raw material is :- 72000 Bottles * 5<br>ML * 350.88 MG = 126.32 Kgs.))	<br>72000.0<br>Numbers	1	Metamizole Magnesium	114.923 Kg
2	Metamizaole Magnesium 300 mg and<br>Pargeverine Hydrochloride 6mg Oral<br>Drop((Considering the loss on drying<br>@14.50% of Bulkdrug for 300MG we<br>need to poor 350.88 Mg. So net content of<br>the raw material is :- 376000 Bottles * 15<br>ML * 350.88 MG = 1978.96 Kgs.))	<br>376000.0<br>Numbers	2	Metamizole Magnesium	1776.60 Kg

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

Case No.	28 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00006429AM24
RA File Number	092404000365 AM20
Licence No and<br>Date	0910068207/20/11/2019
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00006429AM24| |RA File Number|092404000365 AM20| |Licence No and Date|0910068207/20/11/2019| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	29 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023

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and Date
HQ File Number	HQRNORM REVIW00002001AM24
RA File Number	092404000540 AM20
Licence No and<br>Date	0910068421/28/01/2020
Norms Committee Decision:<br>Dr. Suresh Reddy Childipudi, R&D Head, and Shri T. Ram Prasad of the firm had attended the Personal Hearing<br>and explained firm’s case. The Committee heard the explanation of Representative of the firm and after due<br>deliberation the committee has considered for fixation of ad-hoc norms on the basis of information provided by the<br>firm, it was decided to fix ad-hoc norms as under, or as applied whichever is lower: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed<br>(1R,2R)-2-amino-6-(4-nitrophenyl)-1-<br>phenylhex-5-yn-1-ol hydrochloride<br>1 kg.<br>1<br>CDX-034<br>LYOPHILIZED<br>ENZYME POWDER<br>0.014 kg<br>RA concerned may take further necessary action as per above decision of Norms Committee.

phenylhex-5-yn-1-ol hydrochloride 1 kg. 1 CDX-034 LYOPHILIZED ENZYME POWDER 0.014 kg RA concerned may take further necessary action as per above decision of Norms Committee.||

Case No.	30 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00005893AM24
RA File Number	039504000017 AM21
Licence No and<br>Date	0310835789/21/04/2020
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	31 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00007119AM23
RA File Number	052404000024 AM21
Licence No and<br>Date	0510414104/04/05/2020
Norms Committee Decision:

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The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:-

Export Product<br>	Qty.	Sl. No.	Import Items<br>	Qty. allowed.
Broxinac Eye Drops 0.09% 2.5 ml /<br>Bromfenac Eye Drops 0.09% 2.5ml<br>	<br>100 Vials	1	Bromfenac Sodium Hydrate	263.925 mg.
Broxinac Eye Drops 0.09% 1.7 ml /<br>Bromfenac Eye Drops 0.09% 1.7ml<br>	<br>100 Vials	2	Bromfenac Sodium Hydrate	179.469 mg

.09% 2.5ml | 100 Vials|1|Bromfenac Sodium Hydrate|263.925 mg.| |Broxinac Eye Drops 0.09% 1.7 ml / Bromfenac Eye Drops 0.09% 1.7ml | 100 Vials|2|Bromfenac Sodium Hydrate|179.469 mg|

Case No.	Case No.	Case No.	32 / NC/3/MEET/Dec/202324/17	32 / NC/3/MEET/Dec/202324/17	32 / NC/3/MEET/Dec/202324/17	32 / NC/3/MEET/Dec/202324/17	32 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			OLIVE HEALTH CARE
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00007206AM23
RA File Number			039504000069 AM21
Licence No and<br>Date			0310836213/15/05/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less :-<br>Sl.<br>No.<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Item<br>Qty. allowed<br>1<br>TEMAZEPAM TEVA 10 MG<br>CAPSULES (TEMAZEPAM<br>CAPSULES 10MG)(( TOTAL NO OF<br>CAPSULES IS 10725000 AND NET<br>WT OF EXEMPT MATERIALS<br>CONTAIN IN RESULTANT<br>PRODUCT IS 107 KG))<br>1 Number<br>1<br>TEMAZEPAM Ph.Eur.<br>10.20 mg<br>TEMAZEPAM TEVA 20 MG<br>CAPSULES (TEMAZEPAM<br>2<br>1 Number<br>2<br>TEMAZEPAM Ph.Eur.<br>20.40 mg
	Sl.<br>No.	Export Product		Qty.	Sl.<br>No.<br>	Import Item	**Qty.

AZEPAM TEVA 20 MG CAPSULES (TEMAZEPAM 2 1 Number 2 TEMAZEPAM Ph.Eur. 20.40 mg|||||||| ||Sl. No.|Export Product||Qty.|Sl. No. |Import Item|Qty. allowed| ||1|TEMAZEPAM TEVA 10 MG CAPSULES (TEMAZEPAM CAPSULES 10MG)(( TOTAL NO OF CAPSULES IS 10725000 AND NET WT OF EXEMPT MATERIALS CONTAIN IN RESULTANT PRODUCT IS 107 KG))||1 Number|1 |TEMAZEPAM Ph.Eur.|10.20 mg| ||2|TEMAZEPAM TEVA 20 MG CAPSULES (TEMAZEPAM||1 Number|2 |TEMAZEPAM Ph.Eur.|20.40 mg|

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CAPSULES 20 MG)((TOTAL NO OF CAPSULES IS 12187500 AND NET WT OF EXEMPT MATERIALS CONTAIN IN RESULTANT PRODUCT IS 244 KG))

Case No.	33 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	OPES HEALTH CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00006254AM24
RA File Number	082404000394 AM20
Licence No and<br>Date	0810147815/22/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jan/202223/18 dated 23.01.2023against advance authorization No.<br>0811006083 dated 22.09.2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>**Sl. No.

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: Sl. No. Export product Qty. Sl. No. Import items Qty. 1 Metamizaole Magnesium 300 mg and Pargeverine Hydrochloride 6mg per ML Oral Drop of 5 ML.(NET CONTENTS OF METAMIZOLE MAGNESIUM IS 324 KGS.) 216000 Numbers 1 Metamizole Magnesium 344.769 Kg 2 Metamizaole Magnesium 300 mg and Pargeverine Hydrochloride 6mg per ML Oral Drops of 15 ML.(NET CONTENTS OF METAMIZOLE MAGNESIUM IS 5076 KGS.) 1128000 Numbers 2 Metamizole Magnesium 5329.792 Kg RA concerned may take further necessary action as per above decision of NC||

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Case No.	34 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00000095AM24
RA File Number	522404000013 AM21
Licence No and<br>Date	5210043424/08/06/2020
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Complete chemical reactions with molecular and structural formula and molecular weight alongwith<br>stage wise percentage yield on molar basis.<br>i.<br>All technical details as per annexure to appendix 4E for chemical products.<br>ii.<br>Step wise manufacturing process.<br>iii.

br>stage wise percentage yield on molar basis. i. All technical details as per annexure to appendix 4E for chemical products. ii. Step wise manufacturing process. iii.||

Case No.	35 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00005894AM24
RA File Number	039504000137 AM21
Licence No and<br>Date	0310836741/18/06/2020
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	36 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00000121AM24
RA File Number	318304000020 AM21
Licence No and<br>Date	3110067788/08/07/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less :-

21 This document has been digitally signed by Raman Kumar, Deputy DGFT on 31-01-2024 15:53:42.

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

21 This document has been digitally signed by Raman Kumar, Deputy DGFT on 31-01-2024 15:53:42.

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	Sl.<br>No.	Export Product<br>		Qty.	Sl.<br>No.	Import Item	Qty. allowed
	1	Mono Methyl Ether of Hydroquinone - MEHQ<br>		1 Kg	1	Phenol	0.97 kg
					2	Methanol	0.38 kg
					3	Hydrogen Peroxide<br>PURITY 60%	0.75 kg
					4	Acetone (Solvent)	0.10 kg
	RA concerned may take further necessary action as per above decision of NC.

Case No.			37 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001550AM24
RA File Number			092404000185 AM21
Licence No and<br>Date			0910068991/22/07/2020
Norms Committee Decision:<br>Dr. Suresh Reddy Childipudi, R&D Head, and Shri T. Ram Prasad of the firm had attended the Personal Hearing<br>and explained firm’s case. The Committee heard the explanation of Representative of the firm and after due<br>deliberation the committee has considered for fixation of ad-hoc norms on the basis of information provided by the<br>firm, it was decided to fix ad-hoc norms as under, or as applied whichever is lower: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

of information provided by the firm, it was decided to fix ad-hoc norms as under, or as applied whichever is lower: - Export Product Qty. Sl. No. Import Items Qty. allowed (1R,2R)-2-amino-6-(4-nitrophenyl)-1- phenylhex-5-yn-1-ol hydrochloride 1 kg. 1 CDX-034 LYOPHILIZED ENZYME POWDER 0.014 kg||||||||

UDIN00462819AM24

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

Case No.	Case No.	Case No.	38 / NC/3/MEET/Dec/202324/17	38 / NC/3/MEET/Dec/202324/17	38 / NC/3/MEET/Dec/202324/17	38 / NC/3/MEET/Dec/202324/17	38 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			SHIVA BIO CHEM INDUSTRIES
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001904AM24
RA File Number			502404000009 AM21
Licence No and<br>Date			5010002703/07/08/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc 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>Sl. No.<br>Export product<br>Qty.<br>**Sl.

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 :- Sl. No. Export product Qty. Sl. No. Import items Qty. 1 Sunflower Lecithin Powder 1 MT 1 Crude Sunflower Lecithin Liquid 1.40 MT 2 Rapeseed Lecithin Powder 1MT 2 Crude Rapeseed Lecithin Liquid 1.40 MT RA concerned may take further necessary action as per above decision of NC.|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Sunflower Lecithin Powder||1 MT|1|Crude Sunflower Lecithin Liquid|1.40 MT| ||2|Rapeseed Lecithin Powder||1MT|2|Crude Rapeseed Lecithin Liquid|1.40 MT| ||RA concerned may take further necessary action as per above decision of NC.|||||||

Case No.	39 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00006169AM24
RA File Number	039404000421 AM21
Licence No and<br>Date	0310838377/21/09/2020
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.13/82-ALC4/2018 dated 14/01/2019against advance authorizationNo.<br>0310818881 dated 05/02/2018, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-

UDIN00462819AM24

881** dated 05/02/2018, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||

UDIN00462819AM24

Sl. No. Export product

Qty. Sl. No. Import items

Qty.

1 SODIUM CROMOGLICATE EYE 1 Vial 1 SODIUM 0.2835 gm/13.5 ml DROPS 13.5 ML, 2% w/v CROMOGLYCATE pack
2 SODIUM CROMOGLICATE EYE 1 Vial 1 SODIUM 0.210 gm/10 ml pack DROPS 10 ML, 2% w/v CROMOGLYCATE
3 SODIUM CROMOGLICATE EYE 1 Vial 1 SODIUM 0.105 gm/5 ml pack DROPS 5 ML, 2% w/v CROMOGLYCATE

Case No.	Case No.	Case No.	40 / NC/3/MEET/Dec/202324/17	40 / NC/3/MEET/Dec/202324/17	40 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00004763AM23
RA File Number			039404000500 AM21
Licence No and<br>Date			0310839257/02/11/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the<br>firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>Sl.No<br>Export Product<br>Quantity<br>1<br>SECURA EXTRA PROTECTIVE CREAM 3.25 Oz 92 GM<br>1 Number<br>2<br>SECURA EXTRA PROTECTIVE CREAM 7.75 Oz 219.70 GM<br>1 Number<br>3<br>SECURA ANTIFUNGAL EXTRA THICK PROTECTIVE CREAM 3.25 Oz 92 GM<br>1 Number<br>S.No<br>Import Product<br>Quantity

r>SECURA EXTRA PROTECTIVE CREAM 7.75 Oz 219.70 GM 1 Number 3 SECURA ANTIFUNGAL EXTRA THICK PROTECTIVE CREAM 3.25 Oz 92 GM 1 Number S.No Import Product Quantity|||||| ||Sl.No|Export Product |||Quantity| ||1|SECURA EXTRA PROTECTIVE CREAM 3.25 Oz 92 GM |||1 Number| ||2|SECURA EXTRA PROTECTIVE CREAM 7.75 Oz 219.70 GM |||1 Number| ||3|SECURA ANTIFUNGAL EXTRA THICK PROTECTIVE CREAM 3.25 Oz 92 GM |||1 Number| ||||||| ||S.No|Import Product||Quantity||

Case No.	Case No.	Case No.	40 / NC/3/MEET/Dec/202324/17	40 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00004763AM23
RA File Number			039404000500 AM21
Licence No and<br>Date			0310839257/02/11/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the<br>firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>Sl.No<br>Export Product<br>Quantity<br>1<br>SECURA EXTRA PROTECTIVE CREAM 3.25 Oz 92 GM<br>1 Number<br>2<br>SECURA EXTRA PROTECTIVE CREAM 7.75 Oz 219.70 GM<br>1 Number<br>3<br>SECURA ANTIFUNGAL EXTRA THICK PROTECTIVE CREAM 3.25 Oz 92 GM<br>1 Number<br>S.No<br>Import Product<br>Quantity
	Sl.No	Export Product<br>		Quantity

r>1 Number 3 SECURA ANTIFUNGAL EXTRA THICK PROTECTIVE CREAM 3.25 Oz 92 GM 1 Number S.No Import Product Quantity|||||| ||Sl.No|Export Product |||Quantity| ||1|SECURA EXTRA PROTECTIVE CREAM 3.25 Oz 92 GM |||1 Number| ||2|SECURA EXTRA PROTECTIVE CREAM 7.75 Oz 219.70 GM |||1 Number| ||3|SECURA ANTIFUNGAL EXTRA THICK PROTECTIVE CREAM 3.25 Oz 92 GM |||1 Number| ||||||| ||S.No|Import Product||Quantity||

24 This document has been digitally signed by Raman Kumar, Deputy DGFT on 31-01-2024 15:53:42.

UDIN00462819AM24

1	Relevant Bulk Drugs	Net content in the export product plus 3% wastage.
2	Relevant Excipients	Net content in the export product plus 3% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy

Note:

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

Case No.	41 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00007267AM23
RA File Number	052404000395 AM21
Licence No and<br>Date	0510415782/09/11/2020
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	42 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00001504AM24
RA File Number	09AA04002748 AM21

UDIN00462819AM24

Licence No and Date 0911000023/15/12/2020 Norms Committee Decision:

UDIN00462819AM24

Licence No and Date 0911000023/15/12/2020 Norms Committee Decision:

Dr. Suresh Reddy Childipudi, R&D Head, and Shri T. Ram Prasad of the firm had attended the Personal Hearing and explained firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has considered for fixation of ad-hoc norms on the basis of information provided by the firm, it was decided to fix ad-hoc norms as under, or as applied whichever is lower: -

ower: -
Export Product	Qty.	Sl. No.	Import Items	Qty. allowed
Sodium<br>(S)-4-oxo-4,6,7,8-<br>tetrahydropyrrolo[1,2-a]<br>pyrimidine-6-carboxylate(drug<br>intermediate)	1 kg.	1	NORBORNADIENE TECH	2.00 kg.

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

Case No.	43 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00000254AM24
RA File Number	03AA04011698 AM21
Licence No and<br>Date	0311000235/21/12/2020
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00000254AM24| |RA File Number|03AA04011698 AM21| |Licence No and Date|0311000235/21/12/2020| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	44 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00001514AM24
RA File Number	09AA04003656 AM21
Licence No and<br>Date	0911000173/11/01/2021
Norms Committee Decision:<br>Dr. Suresh Reddy Childipudi, R&D Head, and Shri T. Ram Prasad of the firm had attended the Personal Hearing

UDIN00462819AM24

and explained firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has considered for fixation of ad-hoc norms on the basis of information provided by the firm, it was decided to fix ad-hoc norms as under, or as applied whichever is lower: -

Export Product<br>(1R,2R)-2-amino-6-(4-nitrophenyl)-1-<br>phenylhex-5-yn-1-ol hydrochloride	Qty.	Sl. No.	Import Items	Qty. allowed
	1 kg.	1	CDX-034<br>LYOPHILIZED<br>ENZYME POWDER	<br>0.014 kg

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

*|Qty. allowed| |---|---|---|---|---| ||1 kg.|1|CDX-034 LYOPHILIZED ENZYME POWDER| 0.014 kg|

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

Case No.	45 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00005982AM24
RA File Number	038504000144 AM21
Licence No and<br>Date	0311000450/25/02/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	Case No.	46 / NC/3/MEET/Dec/202324/17	46 / NC/3/MEET/Dec/202324/17	46 / NC/3/MEET/Dec/202324/17	46 / NC/3/MEET/Dec/202324/17	46 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001336AM24
RA File Number			31AA04007907 AM21
Licence No and<br>Date			3111000255/30/03/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less :-<br>Sl.<br>Sl. No. Export product<br>Qty.<br>Import items<br>Qty.
	Sl. No.	Export product		Qty.	Sl.	Import items	Qty.

UDIN00462819AM24

as applied by the firm, whichever is less :- Sl. Sl. No. Export product Qty. Import items Qty.|||||||| ||Sl. No.|Export product||Qty.|Sl.|Import items|Qty.|

UDIN00462819AM24

				No.
1	AMINO ETHYL PIPERAZINE	1	Kg	1	MONO ETHANOL AMINE	1.261	Kg

Case No.	Case No.	Case No.	47 / NC/3/MEET/Dec/202324/17	47 / NC/3/MEET/Dec/202324/17	47 / NC/3/MEET/Dec/202324/17	47 / NC/3/MEET/Dec/202324/17	47 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			OPES HEALTH CARE PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00006255AM24
RA File Number			08AA04005671 AM22
Licence No and<br>Date			0811001621/01/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import<br>item in Meeting No.NC/3/MEET/Jan/202223/18 dated 23.01.2023against advance authorization No.0811006083<br>dated 22.09.2022, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Metamizaole Magnesium 300 mg and<br>Pargeverine Hydrochloride 6mg Oral<br>Drop((Considering the loss on drying @14.50<br>PERCENT of Bulkdrug for 300MG we need<br>to poor 350.88 Mg.

ms Qty. 1 Metamizaole Magnesium 300 mg and Pargeverine Hydrochloride 6mg Oral Drop((Considering the loss on drying @14.50 PERCENT of Bulkdrug for 300MG we need to poor 350.88 Mg. So net content of the raw material is :- 32500 Bottles X 5 ML X 350.88 MG = 57.02 Kgs.)) 32500 Numbers 1 Metamizole Magnesium 51.875 Kg 2 Metamizaole Magnesium 300 mg and Pargeverine Hydrochloride 6mg Oral Drop((Considering the loss on drying @14.50 PERCENT of Bulkdrug for 300MG we need to poor 350.88 Mg. So net content of the raw material is :- 1074880 Bottles X 15 ML X 350.88 MG = 5657.31 Kgs.)) 1074880 Numbers 2 Metamizole Magnesium 5078.800 Kg|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Metamizaole Magnesium 300 mg and Pargeverine Hydrochloride 6mg Oral Drop((Considering the loss on drying @14.50 PERCENT of Bulkdrug for 300MG we need to poor 350.88 Mg. So net content of the raw material is :- 32500 Bottles X 5 ML X 350.88 MG = 57.02 Kgs.))||32500 Numbers|1|Metamizole Magnesium|51.875 Kg| ||2|Metamizaole Magnesium 300 mg and Pargeverine Hydrochloride 6mg Oral Drop((Considering the loss on drying @14.50 PERCENT of Bulkdrug for 300MG we need to poor 350.88 Mg. So net content of the raw material is :- 1074880 Bottles X 15 ML X 350.88 MG = 5657.31 Kgs.))||1074880 Numbers|2|Metamizole Magnesium|5078.800 Kg|

r 300MG we need to poor 350.88 Mg. So net content of the raw material is :- 1074880 Bottles X 15 ML X 350.88 MG = 5657.31 Kgs.))||1074880 Numbers|2|Metamizole Magnesium|5078.800 Kg|

Case No.	Case No.	Case No.	47 / NC/3/MEET/Dec/202324/17	47 / NC/3/MEET/Dec/202324/17	47 / NC/3/MEET/Dec/202324/17	47 / NC/3/MEET/Dec/202324/17	47 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			OPES HEALTH CARE PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00006255AM24
RA File Number			08AA04005671 AM22
Licence No and<br>Date			0811001621/01/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import<br>item in Meeting No.NC/3/MEET/Jan/202223/18 dated 23.01.2023against advance authorization No.0811006083<br>dated 22.09.2022, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Metamizaole Magnesium 300 mg and<br>Pargeverine Hydrochloride 6mg Oral<br>Drop((Considering the loss on drying @14.50<br>PERCENT of Bulkdrug for 300MG we need<br>to poor 350.88 Mg.

UDIN00462819AM24

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

15 ML X 350.88 MG = 5657.31 Kgs.))||1074880 Numbers|2|Metamizole Magnesium|5078.800 Kg|

UDIN00462819AM24

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

Case No.	48 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	RUMIT LIFE CARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00006332AM24
RA File Number	03AA04018136 AM22
Licence No and<br>Date	0311004214/01/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Aug/202324/11 dated 22/08/2023against advance<br>authorizationNo. 0311004279 dated 03/06/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>Betamethasone Dipropionate ( Net Content<br>Betamethasone 17 Propionate BP/EP/USP = 100<br>kgs)(Betamethasone Dipropionate ( Net Content<br>Betamethasone 17 Propionate BP/EP/USP = 100<br>kgs))<br>1 kg.<br>1<br>Betamethasone 17 Propionate<br>0.94 kg.<br>RA concerned may take further necessary action as per above decision of NC.

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

Case No.	49 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00001319AM24
RA File Number	03AA04017165 AM22
Licence No and<br>Date	0311004253/02/06/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the<br>firm, it was decided to revise ad-hoc norms for export to US only are as under:-

UDIN00462819AM24

Sl.<br>No	Export Product	Export Product	Export Product	Quantity
1	Medical Ointments/Creams(Hydrocortisone 1 Percentage OTC Cream 1 OZ/ 28 gm Tube<br>Total Wt.: 3998.79kg (Net Contents: Hydro39.99 kg, Glyc79.98, White wax119.97kg,<br>Stea39.99kg, Iso319.90kg, Cetyl119.97kg, Sorb119.97kg, Poly119.97kg, Anhy2.80kg,<br>Sod4.80kg, Sor2kg, Poly40 19.99))			1 Number
2	Medical Ointments/Creams(Hydrocortisone 1 Percentage OTC Ointment 1 OZ/ 28 gm Tube<br>Total Wt.: 3799.96kg (Net Contents: Hydro38 Kg, White Petrolatum: 3685.97 Kg))			1 Number

19.99))|||1 Number| |2|Medical Ointments/Creams(Hydrocortisone 1 Percentage OTC Ointment 1 OZ/ 28 gm Tube Total Wt.: 3799.96kg (Net Contents: Hydro38 Kg, White Petrolatum: 3685.97 Kg))|||1 Number| |3|Medical Ointments/Creams(Hydrocortisone Aloe 1 Percentage Cream 1 OZ/28 gm Tube Total Wt.: 2199.99kg (Net Contents: Hydro22kg, Glyc44kg, White wax66kg, Stea22kg, Iso176kg, Cetyl66kg, Sorb66kg, Poly66kg, Anhy1.54kg, Sod2.64kg, Sor1.10kg, Poly40 11kg, Aloe 2.20kg))|||1 Number| |||||| |S.No||Import Product|Quantity|| |1||Relevant Bulk Drugs|Net content in the export product plus 3% wastage.|| |2||Relevant Excipients|Net content in the export product plus 3% wastage.|| |3||Relevant Packaging Material|Relevant as per Packing Policy||

Note:

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

30 This document has been digitally signed by Raman Kumar, Deputy DGFT on 31-01-2024 15:53:42.

UDIN00462819AM24

Case No.	50 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	RUMIT LIFE CARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00006331AM24
RA File Number	03AA04021934 AM22
Licence No and<br>Date	0311004279/03/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Aug/202324/11dated22/08/2023against advance<br>authorizationNo. 0311004279 dated 03/06/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.

dated 03/06/2021*, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. Betamethasone Dipropionate ( Net Content Betamethasone 17 Propionate BP/EP/USP = 100 kgs)(Betamethasone Dipropionate ( Net Content Betamethasone 17 Propionate BP/EP/USP = 100 kgs)) 1 kg. 1 Betamethasone 17 Propionate 0.94 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	51 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00001333AM24
RA File Number	03AA04018281 AM22
Licence No and<br>Date	0311004321/04/06/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the<br>firm, it was decided to revise ad-hoc norms for export tgo US only are as under.

UDIN00462819AM24

st of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms for export tgo US only are as under.||

UDIN00462819AM24

S.No	Export Product	Quantity
1	Medical Creams & Ointments(Fusidic Acid and Betamethasone Valerate Cream 5 Gm Tube	<br>1 Number
	Total Wt: 146.34Kg, (Net Contents: Beta 0.18 Kg, Ceto 10.54 Kg, Fusidic 2.93 Kg, Macro
	2.63 Kg, Empty Aluminium Tubes 29268 Nos)
2	Medical Creams & Ointments(Fusidic Acid and Betamethasone Valerate Cream 15 Gm	<br>1 Number
	Tube Total Wt: 600 Kg, (Net Contents: Beta 0.73 Kg, Ceto 43.20 Kg, Fusidic 12 Kg, Macro
	10.80 Kg, Empty Aluminium Tubes 40000 Nos)
3	Medical Creams & Ointments(Fusidic Acid and Betamethasone Valerate Cream 30 Gm	<br>1 Number
	Tube Total Wt: 7185.30 Kg, (Net Contents: Beta 8.72 Kg, Ceto 517.34 Kg, Fusidic 143.71
	Kg, Macro 129.34 Kg, Empty Aluminium Tubes 239510 Nos)
4	Medical Creams & Ointments(Fusidic Acid and Betamethasone Valerate Cream 60 Gm	<br>1 Number
	Tube Total Wt: 3424.38 Kg, (Net Contents: Beta 4.41 Kg, Ceto 261.35 Kg, Fusidic 72.60
	Kg, Macro 65.34 Kg, Empty Aluminium Tubes 57643.73 Nos)

S.No	Import Product	Quantity
1	Relevant Bulk Drugs	Net content in the export product plus 3% wastage.
2	Relevant Excipients	Net content in the export product plus 3% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy

Note:

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

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

32 This document has been digitally signed by Raman Kumar, Deputy DGFT on 31-01-2024 15:53:42.

UDIN00462819AM24

Case No.	Case No.	Case No.	52 / NC/3/MEET/Dec/202324/17	52 / NC/3/MEET/Dec/202324/17	52 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001323AM24
RA File Number			03AA04015087 AM22
Licence No and<br>Date			0311004561/12/06/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the<br>firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>S.No<br>Export Product<br>Quantity<br>1<br>Medicinal Creams & Ointments(Permethrin Cream 5 Percentage (60 Gm ) Total Wt:<br>18000Kgs (Net Contents : Permethrin Ph.

only are as under:- S.No Export Product Quantity 1 Medicinal Creams & Ointments(Permethrin Cream 5 Percentage (60 Gm ) Total Wt: 18000Kgs (Net Contents : Permethrin Ph. Eur : 900Kg, Medium Chain : 1800Kg, Mono & DI- Glycerides : 900Kg, Isopropyl : 180Kg, Lanolin: 270Kg, Polyoxyethylene : 720Kg, Empty Tubes: 300000Nos)) 1 Number S.No Import Product Quantity 1 Relevant Bulk Drugs Net content in the export product plus 3% wastage. 2 Relevant Excipients Net content in the export product plus 3% wastage. 3 Relevant Packaging Material Relevant as per Packing Policy Note: 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointmentssolely for export to US. i. 1.02 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments for the export toother than US. ii.|||||| ||S.No|Export Product|||Quantity| ||1|Medicinal Creams & Ointments(Permethrin Cream 5 Percentage (60 Gm ) Total Wt: 18000Kgs (Net Contents : Permethrin Ph.

ther than US. ii.|||||| ||S.No|Export Product|||Quantity| ||1|Medicinal Creams & Ointments(Permethrin Cream 5 Percentage (60 Gm ) Total Wt: 18000Kgs (Net Contents : Permethrin Ph. Eur : 900Kg, Medium Chain : 1800Kg, Mono & DI- Glycerides : 900Kg, Isopropyl : 180Kg, Lanolin: 270Kg, Polyoxyethylene : 720Kg, Empty Tubes: 300000Nos))||| 1 Number| ||||||| ||S.No|Import Product||Quantity|| ||1|Relevant Bulk Drugs||Net content in the export product plus 3% wastage.|| ||2|Relevant Excipients||Net content in the export product plus 3% wastage.|| ||3|Relevant Packaging Material||Relevant as per Packing Policy|| ||Note: 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointmentssolely for export to US. i. 1.02 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments for the export toother than US.** ii.|||||

i. 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments solely for export to US.
ii. 1.02 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments for the export to other than US.

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in the export of Medicinal Cream/Ointments for the export to other than US.

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

Case No.	53 / NC/3/MEET/Dec/202324/17
Case Status	Case Rejected
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00006428AM24
RA File Number	09AA04003251 AM22
Licence No and<br>Date	0911001059/16/06/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm has not<br>provided any technical justification / information for enhancement. Hence, it was decided torejectthe case<br>maintaining thestatus quo.

Case No.	54 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM APPLY 00122419AM22
RA File Number	34AA04003768 AM22
Licence No and<br>Date	3411000762/23/06/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00122419AM22| |RA File Number|34AA04003768 AM22| |Licence No and Date|3411000762/23/06/2021| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	55 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00006410AM24
RA File Number	09AA04004589 AM22
Licence No and<br>Date	0911001093/23/06/2021
Norms Committee Decision:

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

Sl.<br>No.	Export Product<br>	Qty.	S.No.	Import Item	Qty. allowed
1	Tobramycin for Inhalation solution 60 mg<br>/ ml (300 mg / 5 ml)<br>1	<br>Number	1	Tobramycin Sulfate	466.49 mg /<br>vial
2	Tobramycin for Inhalation solution 75 mg<br>/ ml (300 mg / 4 ml)<br>1	<br>Number	2	Tobramycin Sulfate	466.49 mg /<br>vial

Case No.	56 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00005688AM23
RA File Number	08AA04009431 AM22
Licence No and<br>Date	0811001850/25/06/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Sl.<br>No.<br>Export Product<br>Qty.<br>Sl.No.<br>Import Item<br>Qty. allowed<br>1<br>O-CHLOROBENZYL CYANIDE<br>2.20 kg.<br>1<br>Indoline<br>1 Kg<br>2<br>TOLUENE<br>1.00 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 57 / NC/3/MEET/Dec/202324/17

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Case Status	Case Deferred
Party Name	HIKAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00004361AM24
RA File Number	34AA04002140 AM22
Licence No and<br>Date	3411000771/28/06/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00004361AM24| |RA File Number|34AA04002140 AM22| |Licence No and Date|3411000771/28/06/2021| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	Case No.	58 / NC/3/MEET/Dec/202324/17	58 / NC/3/MEET/Dec/202324/17	58 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001194AM24
RA File Number			03AA04024851 AM22
Licence No and<br>Date			0311004989/29/06/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>S.No<br>Export Product<br>Quantity<br>1<br>Medical Creams/ Ointments(FLUOCINONIDE TOPICAL SOLUTION 0.05<br>Percentage 60 ML Total Wt. 1799.82 Kgs (Net Content Fluocinonide Micronized USP<br>(Farmabios) 0.94 Kgs, Ethyl Alco 512.77 Kgs, DI- Isopropyl 126.35 Kgs, 2 OZ.

s(FLUOCINONIDE TOPICAL SOLUTION 0.05 Percentage 60 ML Total Wt. 1799.82 Kgs (Net Content Fluocinonide Micronized USP (Farmabios) 0.94 Kgs, Ethyl Alco 512.77 Kgs, DI- Isopropyl 126.35 Kgs, 2 OZ. Bottle 29997 Nos, Dropper Tip 29997 Nos, Needle 29997 Nos) 1 Number S.No Import Product Quantity 1 Relevant Bulk Drugs Net content in the export product plus 3% wastage. 2 Relevant Excipients Net content in the export product plus 3% wastage. 3 Relevant Packaging Material Relevant as per Packing Policy|||||| ||S.No|Export Product|||Quantity| ||1|Medical Creams/ Ointments(FLUOCINONIDE TOPICAL SOLUTION 0.05 Percentage 60 ML Total Wt. 1799.82 Kgs (Net Content Fluocinonide Micronized USP (Farmabios) 0.94 Kgs, Ethyl Alco 512.77 Kgs, DI- Isopropyl 126.35 Kgs, 2 OZ. Bottle 29997 Nos, Dropper Tip 29997 Nos, Needle 29997 Nos)|||1 Number| ||||||| ||S.No|Import Product||Quantity|| ||1|Relevant Bulk Drugs||Net content in the export product plus 3% wastage.|| ||2|Relevant Excipients||Net content in the export product plus 3% wastage.|| ||3|Relevant Packaging Material||Relevant as per Packing Policy||

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Note:

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

Case No.	Case No.	Case No.	59 / NC/3/MEET/Dec/202324/17	59 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001292AM24
RA File Number			03AA04035672 AM22
Licence No and<br>Date			0311005214/08/07/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the<br>firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>Sl.<br>No.<br>Export Product<br>Quantity<br>1<br>Medical Creams/Ointments(SECURA EXTRA PROTECTIVE CREAM 3.25 Oz 92 GM<br>Total Wt. 14296.70 (Net Wt. White Petr 5835.91 Kg, Cetostearyl 874.96Kg, Glucate 729.13<br>Kg, Akucell 437.48Kg, Karaya Gum 1020.78Kg, Diazolidinyl 28.59Kg))<br>1 Number<br>2<br>Medical Creams/Ointments(SECURA EXTRA PROTECTIVE CREAM 7.75 Oz 219.70<br>GM Total Wt. 5567.24 (Net Wt.

729.13 Kg, Akucell 437.48Kg, Karaya Gum 1020.78Kg, Diazolidinyl 28.59Kg)) 1 Number 2 Medical Creams/Ointments(SECURA EXTRA PROTECTIVE CREAM 7.75 Oz 219.70 GM Total Wt. 5567.24 (Net Wt. White Petr 2272.55Kg, Cetostearyl 340.71Kg, Glucate 283.93Kg, Akucell 170.36Kg, Karaya Gum 397.50Kg, Diazolidinyl 11.13Kg)) 1 Number||||| ||Sl. No.|Export Product||Quantity| ||1|Medical Creams/Ointments(SECURA EXTRA PROTECTIVE CREAM 3.25 Oz 92 GM Total Wt. 14296.70 (Net Wt. White Petr 5835.91 Kg, Cetostearyl 874.96Kg, Glucate 729.13 Kg, Akucell 437.48Kg, Karaya Gum 1020.78Kg, Diazolidinyl 28.59Kg))||1 Number| ||2|Medical Creams/Ointments(SECURA EXTRA PROTECTIVE CREAM 7.75 Oz 219.70 GM Total Wt. 5567.24 (Net Wt. White Petr 2272.55Kg, Cetostearyl 340.71Kg, Glucate 283.93Kg, Akucell 170.36Kg, Karaya Gum 397.50Kg, Diazolidinyl 11.13Kg))||1 Number|

Case No.	Case No.	Case No.	59 / NC/3/MEET/Dec/202324/17	59 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001292AM24
RA File Number			03AA04035672 AM22
Licence No and<br>Date			0311005214/08/07/2021

umber and Date|||NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023|| |HQ File Number|||HQRNORM REVIW00001292AM24|| |RA File Number|||03AA04035672 AM22|| |Licence No and Date|||0311005214/08/07/2021|| |Norms Committee Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms for export to US only are as under:- Sl. No. Export Product Quantity 1 Medical Creams/Ointments(SECURA EXTRA PROTECTIVE CREAM 3.25 Oz 92 GM Total Wt. 14296.70 (Net Wt. White Petr 5835.91 Kg, Cetostearyl 874.96Kg, Glucate 729.13 Kg, Akucell 437.48Kg, Karaya Gum 1020.78Kg, Diazolidinyl 28.59Kg)) 1 Number 2 Medical Creams/Ointments(SECURA EXTRA PROTECTIVE CREAM 7.75 Oz 219.70 GM Total Wt. 5567.24 (Net Wt. White Petr 2272.55Kg, Cetostearyl 340.71Kg, Glucate 283.93Kg, Akucell 170.36Kg, Karaya Gum 397.50Kg, Diazolidinyl 11.13Kg)) 1 Number||||| ||Sl. No.|Export Product||Quantity| ||1|Medical Creams/Ointments(SECURA EXTRA PROTECTIVE CREAM 3.25 Oz 92 GM Total Wt. 14296.70 (Net Wt. White Petr 5835.91 Kg, Cetostearyl 874.96Kg, Glucate 729.13 Kg, Akucell 437.48Kg, Karaya Gum 1020.78Kg, Diazolidinyl 28.59Kg))||1 Number| ||2|Medical Creams/Ointments(SECURA EXTRA PROTECTIVE CREAM 7.75 Oz 219.70 GM Total Wt. 5567.24 (Net Wt. White Petr 2272.55Kg, Cetostearyl 340.71Kg, Glucate 283.93Kg, Akucell 170.36Kg, Karaya Gum 397.50Kg, Diazolidinyl 11.13Kg))||1 Number|

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GM Total Wt. 5567.24 (Net Wt. White Petr 2272.55Kg, Cetostearyl 340.71Kg, Glucate 283.93Kg, Akucell 170.36Kg, Karaya Gum 397.50Kg, Diazolidinyl 11.13Kg))||1 Number|

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3	Medical Creams/Ointments(SECURA ANTIFUNGAL EXTRA THICK PROTECTIVE	1 Number
	CREAM 3.25 Oz 92 GM Total Wt. 2000 (Net Wt. White Petr 800Kg, Cetostearyl 120Kg,
	Glucate 100Kg, Akucell 60Kg, Karaya Gum 140Kg, Diazolidinyl 4Kg))

S.No	Import Product	Quantity
1	Relevant Bulk Drugs	Net content in the export product plus 3% wastage.
2	Relevant Excipients	Net content in the export product plus 3% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy

Note:

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

Case No.	60 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM APPLY 00137048AM22
RA File Number	34AA04005105 AM22
Licence No and<br>Date	3411000838/12/07/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

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

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Case No.	Case No.	Case No.	Case No.	61 / NC/3/MEET/Dec/202324/17	61 / NC/3/MEET/Dec/202324/17	61 / NC/3/MEET/Dec/202324/17
Case Status				Case Approved
Party Name				ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date				NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number				HQRNORM REVIW00001310AM24
RA File Number				03AA04025361 AM22
Licence No and<br>Date				0311005326/12/07/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the<br>firm, it was decided to revise ad-hoc norms for export to US only are as under.<br>S.No<br>Export Product<br>Quantity<br>1<br>Medical Creams/Ointments(Ozonol Ointment 60 Gm Tube Total Wt. 1000.02 Kgs (Net<br>Content BEES WAX YELLOW (REFINED) USP 72 Kgs, PHARMALAN (LANOLIN)<br>USP 86.90 Kgs, ICHTHAMMOL USP 2.90 Kgs, ORIGANUM OIL RED IMITATION C<br>IN HOUSE 4.10 Kgs, Empty Aluminium Collap Tube 16667 Nos))<br>1 Number<br>S.No<br>Import Product<br>Quantity<br>1<br>Relevant Bulk Drugs<br>Net content in the export product plus 3% wastage.<br>2<br>Relevant Excipients<br>Net content in the export product plus 3% wastage.<br>3<br>Relevant Packaging Material<br>Relevant as per Packing Policy<br>Note:<br>1.03 kg.

oduct plus 3% wastage. 2 Relevant Excipients Net content in the export product plus 3% wastage. 3 Relevant Packaging Material Relevant as per Packing Policy Note: 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointmentssolely for export to US. i. 1.02 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments for the export toother than US. ii. The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption. iii.||||||| ||S.No||Export Product|||Quantity| ||1||Medical Creams/Ointments(Ozonol Ointment 60 Gm Tube Total Wt. 1000.02 Kgs (Net Content BEES WAX YELLOW (REFINED) USP 72 Kgs, PHARMALAN (LANOLIN) USP 86.90 Kgs, ICHTHAMMOL USP 2.90 Kgs, ORIGANUM OIL RED IMITATION C IN HOUSE 4.10 Kgs, Empty Aluminium Collap Tube 16667 Nos))||| 1 Number| |||||||| ||S.No|Import Product|||Quantity|| ||1|Relevant Bulk Drugs|||Net content in the export product plus 3% wastage.|| ||2|Relevant Excipients|||Net content in the export product plus 3% wastage.|| ||3|Relevant Packaging Material|||Relevant as per Packing Policy|| ||Note: 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointmentssolely for export to US. i. 1.02 kg.

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

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

39 This document has been digitally signed by Raman Kumar, Deputy DGFT on 31-01-2024 15:53:42.

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levant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

39 This document has been digitally signed by Raman Kumar, Deputy DGFT on 31-01-2024 15:53:42.

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Case No.	62 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00001518AM24
RA File Number	09AA04007265 AM22
Licence No and<br>Date	0911001194/12/07/2021
Norms Committee Decision:<br>Dr. Suresh Reddy Childipudi, R&D Head, and Shri T. Ram Prasad of the firm had attended the Personal Hearing<br>and explained firm’s case. The Committee heard the explanation of Representative of the firm and after due<br>deliberation the committee has considered for fixation of ad-hoc norms on the basis of information provided by the<br>firm, it was decided to fix ad-hoc norms as under, or as applied whichever is lower: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed<br>(1R,2R)-2-amino-6-(4-nitrophenyl)-1-<br>phenylhex-5-yn-1-ol hydrochloride<br>1 kg.<br>1<br>CDX-034<br>LYOPHILIZED<br>ENZYME POWDER<br>0.014 kg<br>RA concerned may take further necessary action as per above decision of Norms Committee.

phenylhex-5-yn-1-ol hydrochloride 1 kg. 1 CDX-034 LYOPHILIZED ENZYME POWDER 0.014 kg RA concerned may take further necessary action as per above decision of Norms Committee.||

Case No.	63 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00001313AM24
RA File Number	03AA04027532 AM22
Licence No and<br>Date	0311005407/15/07/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the<br>firm, it was decided to revise ad-hoc norms for export to US only are as under:-

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|S.No. Export Product Quantity 1 Medical Creams/ Ointments(Miconazole Nitrate 2 Percentage Antifungal Cream 0.5 Oz / 14 Gm Total Wt: 406 Kg (Net Cont: Benzoic 0.81Kg, Pegoxyl 81.20Kg, Oleoyl 12.18Kg, Miconazole 8.33 Kg)) 1 Number 2 Medical Creams/ Ointments(Miconazole Nitrate 2 Percentage Antifungal Cream 1 Oz / 28 Gm Total Wt: 2800 Kg (Net Cont: Benzoic 5.60Kg, Pegoxyl 560Kg, Oleoyl 84Kg, Miconazole 57.40Kg)) 1 Number 3 Medical Creams/ Ointments(Miconazole Nitrate 2 Percentage Antifungal Cream 1.5 Oz / 42.5 Gm Total Wt: 397.16 Kg (Net Cont: Benzoic 0.79Kg, Pegoxyl 79.43Kg, Oleoyl 11.91Kg, Miconazole 8.14 Kg)) 1 Number 4 Medical Creams/ Ointments(Miconazole Nitrate 2 Percentage Vaginal Cream USP 1.59 Oz / 45 Gm with 1 Applicator Pack

79Kg, Pegoxyl 79.43Kg, Oleoyl 11.91Kg, Miconazole 8.14 Kg)) 1 Number 4 Medical Creams/ Ointments(Miconazole Nitrate 2 Percentage Vaginal Cream USP 1.59 Oz / 45 Gm with 1 Applicator Pack Total Wt: 1200.11 Kg (Net Cont: Benzoic 2.40Kg, Pegoxyl 240.02Kg, Oleoyl 36Kg, Miconazole 24.60 Kg, Plastic app 26376 Nos)) 1 Number 5 Medical Creams/ Ointments(Miconazole Nitrate 2 Percentage Vaginal Cream USP 1.59 Oz / 45 Gm with 7 Applicator Pack Total Wt: 35200.48Kg (Net Cont: Benzoic 70.40Kg, Pegoxyl 7040.10Kg, Oleoyl 1056.01Kg, Miconazole 721.61Kg, Plastic app 773637Nos)) 1 Number S.No Import Product Quantity 1 Relevant Bulk Drugs Net content in the export product plus 3% wastage. 2 Relevant Excipients Net content in the export product plus 3% wastage. 3 Relevant Packaging Material Relevant as per Packing Policy Note: 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointmentssolely for export to US. i. 1.02 kg. of bulk drug and excipients may be allowed per kg.

S.No.	Export Product	Quantity
1	Medical Creams/ Ointments(Miconazole Nitrate 2 Percentage Antifungal Cream 0.5 Oz / 14<br>Gm Total Wt: 406 Kg (Net Cont: Benzoic 0.81Kg, Pegoxyl 81.20Kg, Oleoyl 12.18Kg,<br>Miconazole 8.33 Kg))	<br> <br>1 Number
2	Medical Creams/ Ointments(Miconazole Nitrate 2 Percentage Antifungal Cream 1 Oz / 28 Gm<br>Total Wt: 2800 Kg (Net Cont: Benzoic 5.60Kg, Pegoxyl 560Kg, Oleoyl 84Kg, Miconazole<br>57.40Kg))	<br> <br>1 Number
3	Medical Creams/ Ointments(Miconazole Nitrate 2 Percentage Antifungal Cream 1.5 Oz / 42.5<br>Gm Total Wt: 397.16 Kg (Net Cont: Benzoic 0.79Kg, Pegoxyl 79.43Kg, Oleoyl 11.91Kg,<br>Miconazole 8.14 Kg))	<br> <br>1 Number
4	Medical Creams/ Ointments(Miconazole Nitrate 2 Percentage Vaginal Cream USP 1.59 Oz / 45<br>Gm with 1 Applicator Pack Total Wt: 1200.11 Kg (Net Cont: Benzoic 2.40Kg, Pegoxyl<br>240.02Kg, Oleoyl 36Kg, Miconazole 24.60 Kg, Plastic app 26376 Nos))	<br> <br>1 Number

Cream USP 1.59 Oz / 45 Gm with 1 Applicator Pack Total Wt: 1200.11 Kg (Net Cont: Benzoic 2.40Kg, Pegoxyl 240.02Kg, Oleoyl 36Kg, Miconazole 24.60 Kg, Plastic app 26376 Nos))|| 1 Number| ||5|Medical Creams/ Ointments(Miconazole Nitrate 2 Percentage Vaginal Cream USP 1.59 Oz / 45 Gm with 7 Applicator Pack Total Wt: 35200.48Kg (Net Cont: Benzoic 70.40Kg, Pegoxyl 7040.10Kg, Oleoyl 1056.01Kg, Miconazole 721.61Kg, Plastic app 773637Nos))|| 1 Number| |||||| ||S.No|Import Product|Quantity|| ||1|Relevant Bulk Drugs|Net content in the export product plus 3% wastage.|| ||2|Relevant Excipients|Net content in the export product plus 3% wastage.|| ||3|Relevant Packaging Material|Relevant as per Packing Policy||

Note:

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

41 This document has been digitally signed by Raman Kumar, Deputy DGFT on 31-01-2024 15:53:42.

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Case No.	Case No.	Case No.	Case No.	64 / NC/3/MEET/Dec/202324/17	64 / NC/3/MEET/Dec/202324/17	64 / NC/3/MEET/Dec/202324/17
Case Status				Case Approved
Party Name				ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date				NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number				HQRNORM REVIW00001316AM24
RA File Number				03AA04060052 AM22
Licence No and<br>Date				0311006318/22/08/2021

and Date||||NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023||| |HQ File Number||||HQRNORM REVIW00001316AM24||| |RA File Number||||03AA04060052 AM22||| |Licence No and Date||||0311006318/22/08/2021||| |Norms Committee Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms for export to US only are as under:- Sl.No Export Product Quantity 1 Medical Creams/Ointments(Clobetasol Propionate Ointment 0.05 percentage 15Gm Net Wt: 2499.98 Kgs (Net Cont: Clobetasole 1.29 Kg, Sorbitan 12.5 Kg, White Petrolatum 2361.23 Kg, Empty Tubes 166665 Nos)) 1 Number 2 Medical Creams/Ointments(Clobetasol Propionate Ointment 0.05 percentage 30Gm Net Wt: 499.98 Kgs (Net Cont: Clobetasole 0.26 Kg, Sorbitan 2.5 Kg, White Petrolatum 472.23 Kg, Empty Tubes 16666 Nos)) 1 Number 3 Medical Creams/Ointments(Clobetasol Propionate Ointment 0.05 percentage 45Gm Net Wt: 999.99 Kgs (Net Cont: Clobetasole 0.52 Kg, Sorbitan 5 Kg, White Petrolatum 944.49Kg, Empty Tubes 22222 Nos)) 1 Number 4 Medical Creams/Ointments(Clobetasol Propionate Ointment 0.05 percentage 60Gm Net Wt: 10499.94 Kgs (Net Cont: Clobetasole 5.44 Kg, Sorbitan 52.5 Kg, White Petrolatum 9917.19 Kg, Empty Tubes 174999 Nos)) 1 Number S.No Import Product Quantity 1 Relevant Bulk Drugs Net content in the export product plus 3% wastage. 2 Relevant Excipients Net content in the export product plus 3% wastage.|||

Import Product** Quantity 1 Relevant Bulk Drugs Net content in the export product plus 3% wastage. 2 Relevant Excipients Net content in the export product plus 3% wastage.||||||| ||Sl.No||Export Product|||Quantity| ||1||Medical Creams/Ointments(Clobetasol Propionate Ointment 0.05 percentage 15Gm Net Wt: 2499.98 Kgs (Net Cont: Clobetasole 1.29 Kg, Sorbitan 12.5 Kg, White Petrolatum 2361.23 Kg, Empty Tubes 166665 Nos))|||1 Number| ||2||Medical Creams/Ointments(Clobetasol Propionate Ointment 0.05 percentage 30Gm Net Wt: 499.98 Kgs (Net Cont: Clobetasole 0.26 Kg, Sorbitan 2.5 Kg, White Petrolatum 472.23 Kg, Empty Tubes 16666 Nos))|||1 Number| ||3||Medical Creams/Ointments(Clobetasol Propionate Ointment 0.05 percentage 45Gm Net Wt: 999.99 Kgs (Net Cont: Clobetasole 0.52 Kg, Sorbitan 5 Kg, White Petrolatum 944.49Kg, Empty Tubes 22222 Nos))|||1 Number| ||4||Medical Creams/Ointments(Clobetasol Propionate Ointment 0.05 percentage 60Gm Net Wt: 10499.94 Kgs (Net Cont: Clobetasole 5.44 Kg, Sorbitan 52.5 Kg, White Petrolatum 9917.19 Kg, Empty Tubes 174999 Nos))|||1 Number| |||||||| ||S.No|Import Product|||Quantity|| ||1|Relevant Bulk Drugs|||Net content in the export product plus 3% wastage.|| ||2|Relevant Excipients|||Net content in the export product plus 3% wastage.||

42 This document has been digitally signed by Raman Kumar, Deputy DGFT on 31-01-2024 15:53:42.

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3 Relevant Packaging Material Relevant as per Packing Policy

Note:

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

Case No.	Case No.	Case No.	65 / NC/3/MEET/Dec/202324/17	65 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001363AM24
RA File Number			03AA04063825 AM22
Licence No and<br>Date			0311006317/22/08/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the<br>firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>Sl.No.<br>Export Product<br>Quantity<br>1<br>Medical Creams & Ointments (Clotrimazole Ointment 1 Percentage 20G Tot Wt:<br>6340Kg (Net Cont: Clotrimazole 67.62 Kg, SP Cetomacrogol 146.45 Kg, Cetostearyl<br>476.77 Kg))<br>1 Number<br>S.No<br>Import Product<br>Quantity
	Sl.No.	Export Product		Quantity

Cont: Clotrimazole 67.62 Kg, SP Cetomacrogol 146.45 Kg, Cetostearyl 476.77 Kg)) 1 Number S.No Import Product Quantity|||||| ||Sl.No.|Export Product|||Quantity| ||1|Medical Creams & Ointments (Clotrimazole Ointment 1 Percentage 20G Tot Wt: 6340Kg (Net Cont: Clotrimazole 67.62 Kg, SP Cetomacrogol 146.45 Kg, Cetostearyl 476.77 Kg))||| 1 Number| ||||||| ||S.No|Import Product||Quantity||

UDIN00462819AM24

1	Relevant Bulk Drugs	Net content in the export product plus 3% wastage.
2	Relevant Excipients	Net content in the export product plus 3% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy

Note:

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

Case No.	Case No.	Case No.	66 / NC/3/MEET/Dec/202324/17	66 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001317AM24
RA File Number			03AA04060785 AM22
Licence No and<br>Date			0311006386/24/08/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the<br>firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>Sl.<br>No<br>Export Product<br>Quantity<br>Medical Creams & Ointments(Clotrimazole 1 Percentage Cream 10 Gm tubeLabelled content<br>Clotrimazole 1 Percentage W/W Brand Canesten or any other. Tot Wt.

** Export Product Quantity Medical Creams & Ointments(Clotrimazole 1 Percentage Cream 10 Gm tubeLabelled content Clotrimazole 1 Percentage W/W Brand Canesten or any other. Tot Wt. 6060Kgs (Net Cont: Clotri 60.60Kgs, Oct 818.10Kgs, Cetyl 181.80Kgs, Ceto 606Kgs, Emp tubes 1 1 Number||||| ||Sl. No|Export Product||Quantity| ||1|Medical Creams & Ointments(Clotrimazole 1 Percentage Cream 10 Gm tubeLabelled content Clotrimazole 1 Percentage W/W Brand Canesten or any other. Tot Wt. 6060Kgs (Net Cont: Clotri 60.60Kgs, Oct 818.10Kgs, Cetyl 181.80Kgs, Ceto 606Kgs, Emp tubes|| 1 Number|

UDIN00462819AM24

==> picture [472 x 664] intentionally omitted <==

----- Start of picture text ----- 606000Nos) 2 Medical Creams & Ointments(Clotrimazole 1 Percentage Vaginal cream 35Gm Tube with 6 1 Number ApplicatorLabelled content Clotrimazole1 Percentage W/W Brand Canesten or any otherTot Wt.2999Kgs (Net Cont:Clotri30Kgs, Oct404.98Kgs, Cetyl90Kgs, Ceto299.99Kgs, Tubes 85710Nos, Plas 514260No)) 3 Medical Creams & Ointments(Clotrimazole1 PercentageCream 100 Gm Tube Labelled content 1 Number Clotrimazole1 Percentage W/W Brand Canesten or any other Tot Wt.2000Kgs (Net Cont:Clotri20Kgs, Oct270Kgs, Cetyl60Kgs, Ceto200Kgs, Tubes20000Nos)) 4 Medical Creams & Ointments(Clotrimazole 1 Percentage Cream 20Gm.Tube Labelled content 1 Number Clotrimazole1 PercentageW/W Brand Canesten or any otherTot Wt.9660Kgs (Net Cont:Clotri96.60Kgs, Oct1304.10Kgs, Cetyl289.80Kgs, Ceto966Kgs, Tubes483000Nos))<br

m.Tube Labelled content 1 Number Clotrimazole1 PercentageW/W Brand Canesten or any otherTot Wt.9660Kgs (Net Cont:Clotri96.60Kgs, Oct1304.10Kgs, Cetyl289.80Kgs, Ceto966Kgs, Tubes483000Nos)) 5 Medical Creams & Ointments(Clotrimazole 1 PercentageCream 50 Gm.Tube Labelled content 1 Number Clotrimazole1 PercentageW/W Brand Canesten or any other.Tot Wt.12910Kgs (Net Cont:Clotri129.10Kgs, Oct1742.85Kgs, Cetyl387.30Kgs, Ceto1291Kgs, Tubes 258200Nos)) 6 Medical Creams & Ointments(Clotrimazole 2 Percentage Vaginal Cream 20 Gm.Tube with 3 1 Number ApplicatorLabelled content Clotrimazole 2 PercentageW/W Brand Canesten or any other.Tot Wt.3000Kgs (Net Cont:Clotri60Kgs, Oct405Kgs, Cetyl90Kgs, Ceto300Kgs, Tubes 150000Nos, Plas 450000No) 7 Medical Creams & Ointments(Clotrimazole 1 Percentage Cream 5 Gm.Tube Labelled content 1 Number Clotrimazole 1 Percentage W/W Brand Canesten or any other.Tot Wt.1500Kgs (Net Cont:Clotri15Kgs, Oct202.50Kgs, Cetyl45Kgs, Ceto150Kgs, Tubes300000Nos)) 8 Medical Creams & Ointments(Clotrimazole 1 Percentage Cream 3 Gm. Tube Labelled content 1 Number Clotrimazole 1 Percentage W/W Brand Canesten or any otherTot Wt.1500Kgs (Net Cont:Clotri15Kgs, Oct202.50Kgs, Cetyl45Kgs, Ceto150Kgs, Tubes 500000Nos)) 9 Medical Creams & Ointments(Clotrimazole 1 Percentage cream 10 Gm.

W/W Brand Canesten or any otherTot Wt.1500Kgs (Net Cont:Clotri15Kgs, Oct202.50Kgs, Cetyl45Kgs, Ceto150Kgs, Tubes 500000Nos)) 9 Medical Creams & Ointments(Clotrimazole 1 Percentage cream 10 Gm. Tube with Fluconazole 1 Number Capsule Labelled content clotrimazole 1 Percentage W/W Brand Canesten or any otherTot Wt.370Kgs(Net Cont:Clotri3.70Kgs, Oct49.95Kgs,Cetyl11.1Kgs,Ceto37Kgs, Tubes 37000Nos)) S.No Import Product Quantity ----- End of picture text -----

UDIN00462819AM24

1	Relevant Bulk Drugs	Net content in the export product plus 3% wastage.
2	Relevant Excipients	Net content in the export product plus 3% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy

Note:

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

Case No.	Case No.	Case No.	67 / NC/3/MEET/Dec/202324/17	67 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001355AM24
RA File Number			03AA04068130 AM22
Licence No and<br>Date			0311006626/01/09/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the<br>firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>Sl.No<br>Export Product<br>Quantity<br>1<br>Medical Creams & Ointments(Ketoconazole Cream 2 percentage, 15 gm Total Wt: 5528.32<br>Kg (Net Cont: Sorb 110.57Kg, Poly 82.92Kg, Stearyl 414.62Kg, Isopropyl 55.28Kg, Tube:<br>368555Nos))<br>1 Number
	Sl.No	Export Product		Quantity

centage, 15 gm Total Wt: 5528.32 Kg (Net Cont: Sorb 110.57Kg, Poly 82.92Kg, Stearyl 414.62Kg, Isopropyl 55.28Kg, Tube: 368555Nos)) 1 Number||||| ||Sl.No|Export Product||Quantity| ||1|Medical Creams & Ointments(Ketoconazole Cream 2 percentage, 15 gm Total Wt: 5528.32 Kg (Net Cont: Sorb 110.57Kg, Poly 82.92Kg, Stearyl 414.62Kg, Isopropyl 55.28Kg, Tube: 368555Nos))||1 Number|

UDIN00462819AM24

2	Medical Creams & Ointments(Ketoconazole Cream 2 percentage, 30 gm Total Wt:	Medical Creams & Ointments(Ketoconazole Cream 2 percentage, 30 gm Total Wt:	1 Number
	12207.03Kg (Net Cont: Sorb 666.03Kg, Poly 499.52Kg, Stearyl 2497.60Kg, Isopropyl
	333.01Kg, Tube: 555023Nos))
3	Medical Creams & Ointments(Ketoconazole Cream 2 percentage, 60 gm Total Wt: 33301.37		1 Number
	Kg (Net Cont: Sorb 666.03Kg, Poly 499.52Kg, Stearyl 2497.60Kg, Isopropyl 333.01Kg,
	Tube: 555023Nos))

S.No	Import Product	Quantity
1	Relevant Bulk Drugs	Net content in the export product plus 3% wastage.
2	Relevant Excipients	Net content in the export product plus 3% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy

Note:

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

Case No.	68 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00001356AM24
RA File Number	03AA04074695 AM22
Licence No and<br>Date	0311006805/08/09/2021
Norms Committee Decision:

47 This document has been digitally signed by Raman Kumar, Deputy DGFT on 31-01-2024 15:53:42.

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The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-

Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-

Sl.No	Export Product	Quantity
1	Medicals Creams & Ointments(Desonide Ointment 0.05 Percenatge (15 Gm) Tot Wt. 990<br>Kg, (Net Cont: Desonide 0.508 Kg, White Petrolatum 989.51 Kg, Empty Tubes 66000 Nos))	1 Number
2	Medicals Creams & Ointments(Desonide Ointment 0.05 Percenatge (60 Gm) Tot Wt. 2220<br>Kg, (Net Cont: Desonide 1.14 Kg, White Petrolatum 2218.89 Kg, Empty Tubes 37000 Nos))	1 Number

S.No	Import Product	Quantity
1	Relevant Bulk Drugs	Net content in the export product plus 3% wastage.
2	Relevant Excipients	Net content in the export product plus 3% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy

Note:

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

Case No.	69 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED

48 This document has been digitally signed by Raman Kumar, Deputy DGFT on 31-01-2024 15:53:42.

UDIN00462819AM24

Meeting Number<br>and Date	Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001343AM24
RA File Number			03AA04010926 AM22
Licence No and<br>Date			0311006852/10/09/2021

EET/ Dec/ 202324/ 17 and 20/12/2023| |---|---|---|---|---|---| |HQ File Number|||HQRNORM REVIW00001343AM24||| |RA File Number|||03AA04010926 AM22||| |Licence No and Date|||0311006852/10/09/2021||| |Norms Committee Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms for export to US only are as under:- Sl.No Export Product Quantity 1 Medicals & Ointments(CLOTRIMAZOLE 1 Percentage (10MG/G) ANTI FUNGAL CREAM Total Contents: 1880 Kg (Net Contents Clotrimazole 19.18 Kg, Cetyl Esters Wax 75.20 Kg)) 1 Number 2 Medicals & Ointments(CLOTRIMAZOLE 1 PERCENTAGE (10MG/G) VAGINAL CREAM Total Contents: 3290 Kg (Net Contents Clotrimazole 33.56 Kg, Cetyl Esters Wax 131.60 Kg)) 1 Number S.No Import Product Quantity 1 Relevant Bulk Drugs Net content in the export product plus 3% wastage. 2 Relevant Excipients Net content in the export product plus 3% wastage. 3 Relevant Packaging Material Relevant as per Packing Policy Note: 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointmentssolely for export to US. i. 1.02 kg. of bulk drug and excipients may be allowed per kg.

y be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointmentssolely for export to US. i. 1.02 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments for the export toother than US. ii.|||||| ||Sl.No|Export Product|||Quantity| ||1|Medicals & Ointments(CLOTRIMAZOLE 1 Percentage (10MG/G) ANTI FUNGAL CREAM Total Contents: 1880 Kg (Net Contents Clotrimazole 19.18 Kg, Cetyl Esters Wax 75.20 Kg))|||1 Number| ||2|Medicals & Ointments(CLOTRIMAZOLE 1 PERCENTAGE (10MG/G) VAGINAL CREAM Total Contents: 3290 Kg (Net Contents Clotrimazole 33.56 Kg, Cetyl Esters Wax 131.60 Kg))|||1 Number| ||||||| ||S.No|Import Product||Quantity|| ||1|Relevant Bulk Drugs||Net content in the export product plus 3% wastage.|| ||2|Relevant Excipients||Net content in the export product plus 3% wastage.|| ||3|Relevant Packaging Material||Relevant as per Packing Policy|| ||Note: 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointmentssolely for export to US. i. 1.02 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments for the export toother than US. ii.|||||

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

han US.** ii.|||||

i. 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments solely for export to US.
ii. 1.02 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments for the export to other than US.

49 This document has been digitally signed by Raman Kumar, Deputy DGFT on 31-01-2024 15:53:42.

UDIN00462819AM24

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

Case No.	Case No.	70 / NC/3/MEET/Dec/202324/17	70 / NC/3/MEET/Dec/202324/17	70 / NC/3/MEET/Dec/202324/17	70 / NC/3/MEET/Dec/202324/17	70 / NC/3/MEET/Dec/202324/17
Case Status		Case Approved
Party Name		BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number		HQRNORM REVIW00001468AM24
RA File Number		34AA04006805 AM22
Licence No and<br>Date		3411001099/10/09/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of<br>by the firm, it was decided to revise ad-hoc norms as under.<br>Export Product<br>Qty.<br>Dimetol((2,6-Dimethylheptan-2-ol))<br>1 kg.<br>RA concerned may take further necessary action as per above				ad-hoc norms and on the basis of information provided
	Export Product<br>		Qty.	Sl. No.<br>	Import Items<br>	**Qty.

RA concerned may take further necessary action as per above||||ad-hoc norms and on the basis of information provided||| ||Export Product ||Qty.|Sl. No. |Import Items |Qty. allowed.| ||Dimetol((2,6-Dimethylheptan-2-ol)) ||1 kg.|1 |6 Methyl 2 heptanone |0.98 kg.| |||||2 |Acetic acid |0.18 kg.| |||||decision of NC.|||

Case No.	71 / NC/3/MEET/Dec/202324/17
Case Status	Case Rejected
Party Name	ASTEC LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM APPLY 00183041AM22
RA File Number	03AA04090257 AM22
Licence No and<br>Date	0311006909/13/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished the reply of<br>DL. Hence, the Committee decided torejectthe case.

UDIN00462819AM24

Case No.	72 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM APPLY 00193597AM22
RA File Number	03AA04097753 AM22
Licence No and<br>Date	0311007198/25/09/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00193597AM22| |RA File Number|03AA04097753 AM22| |Licence No and Date|0311007198/25/09/2021| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.<br>	73 / NC/3/MEET/Dec/202324/17
Case Status<br>	Case Approved
Party Name<br>	NATURAL AND ESSENTIAL OILS PRIVATE LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number<br>	HQRNORM APPLY 00196404AM22
RA File Number<br>	07AA04026654 AM22
Licence No and<br>Date<br>	0711002016/28/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Caffeine(Powder)<br>9450 kg.<br>1<br>Crude Caffeine decaffeination from green<br>coffee Purity 53.27%<br>17600 kg.<br>Coffee Extracts(Powder)<br>6250 kg.<br>2<br>Crude Caffeine decaffeination from green<br>coffee Purity 53.27%<br>17600 kg.<br>Caffeine(Powder)<br>9250 kg.<br>3<br>Crude Caffeine decaffeination from green<br>coffee Purity 52.12%<br>17600 kg.<br>Coffee Extracts(Powder)<br>6150 kg.<br>4<br>Crude Caffeine decaffeination from green<br>coffee Purity 52.12%<br>17600 kg.<br>RA concerned may take further necessary action as per above decision of NC.

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kg. 4 Crude Caffeine decaffeination from green coffee Purity 52.12% 17600 kg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	74 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00006071AM24
RA File Number	03AA040106642 AM22
Licence No and<br>Date	0311007268/28/09/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.<br>	Case No.<br>	Case No.<br>	75 / NC/3/MEET/Dec/202324/17	75 / NC/3/MEET/Dec/202324/17	75 / NC/3/MEET/Dec/202324/17
Case Status<br>			Case Approved
Party Name<br>			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number<br>			HQRNORM REVIW00001306AM24
RA File Number<br>			03AA040109530 AM22
Licence No and<br>Date<br>			0311007595/08/10/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by<br>the firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>S.No<br>Export Product<br>Quantity<br>1<br>Medical Creams & Ointments(Ozonol Ointment 30 Gm Tube Total Wt.

m, it was decided to revise ad-hoc norms for export to US only are as under:- S.No Export Product Quantity 1 Medical Creams & Ointments(Ozonol Ointment 30 Gm Tube Total Wt. 1399.98 Kgs (Net Cont: BEES WAX 100.80 Kgs, PHARMALAN 121.66 Kgs, ICHTHAMMOL 4.06 Kgs, ORIGANUM OIL 5.74 Kgs, Tube 46666 Nos)) 1 Number 2 Medical Creams & Ointments(Ozonol Ointment 60 Gm Tube Total Wt. 2000.04 Kgs (Net Cont: BEES WAX 144 Kgs, PHARMALAN 173.80 Kgs, ICHTHAMMOL 5.80 Kgs, ORIGANUM OIL 8.20 Kgs, Tube 33334 Nos)) 1 Number S.No Import Product Quantity|||||| ||S.No|Export Product|||Quantity| ||1|Medical Creams & Ointments(Ozonol Ointment 30 Gm Tube Total Wt. 1399.98 Kgs (Net Cont: BEES WAX 100.80 Kgs, PHARMALAN 121.66 Kgs, ICHTHAMMOL 4.06 Kgs, ORIGANUM OIL 5.74 Kgs, Tube 46666 Nos))||| 1 Number| ||2|Medical Creams & Ointments(Ozonol Ointment 60 Gm Tube Total Wt. 2000.04 Kgs (Net Cont: BEES WAX 144 Kgs, PHARMALAN 173.80 Kgs, ICHTHAMMOL 5.80 Kgs, ORIGANUM OIL 8.20 Kgs, Tube 33334 Nos))||| 1 Number| ||||||| ||S.No|Import Product||Quantity||

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1	Relevant Bulk Drugs	Net content in the export product plus 3% wastage.
2	Relevant Excipients	Net content in the export product plus 3% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy

Note:

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

Case No.	Case No.	Case No.	76 / NC/3/MEET/Dec/202324/17	76 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001328AM24
RA File Number			03AA040109754 AM22
Licence No and<br>Date			0311007605/10/10/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>S.No<br>Export Product<br>Quantity<br>1<br>Medical Creams & Ointments(Permethrin Cream 5 Percentage (60 Gm ) Tot Wt:<br>34998.72 Kgs (Net Cont: Medium Chain 3499.87 Kgs, Mono & DI-Glycerides<br>1749.94 Kgs, Isopropyl 349.99 Kgs, Lanolin 524.98 Kgs, Polyoxyethylene 1399.95<br>Kgs, Tubes 583312 Nos))<br>1 Number
	S.No	Export Product		Quantity

87 Kgs, Mono & DI-Glycerides 1749.94 Kgs, Isopropyl 349.99 Kgs, Lanolin 524.98 Kgs, Polyoxyethylene 1399.95 Kgs, Tubes 583312 Nos)) 1 Number||||| ||S.No|Export Product||Quantity| ||1|Medical Creams & Ointments(Permethrin Cream 5 Percentage (60 Gm ) Tot Wt: 34998.72 Kgs (Net Cont: Medium Chain 3499.87 Kgs, Mono & DI-Glycerides 1749.94 Kgs, Isopropyl 349.99 Kgs, Lanolin 524.98 Kgs, Polyoxyethylene 1399.95 Kgs, Tubes 583312 Nos))||1 Number|

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S.No	Import Product	Quantity
1	Relevant Bulk Drugs	Net content in the export product plus 3% wastage.
2	Relevant Excipients	Net content in the export product plus 3% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy

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

Case No. 96 / NC/3/MEET/Dec/202324/17

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Case Status	Case Status	Case Status	Case Approved	Case Approved	Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001345AM24
RA File Number			03AA040124200 AM22
Licence No and<br>Date			0311009326/09/12/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the<br>firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>S.No<br>Export Product<br>Quantity<br>1<br>Medical Creams & Ointments(Clobetasol Propionate Cream 0.05% 15 Gm tube Tot Wt: 1500<br>(Net Cont: Clob 0.78 Kg, Arlacel 67.50Kg, White Wax 15, Tubes 100000 Nos))<br>1 Number<br>2<br>Medical Creams & Ointments(Clobetasol Propionate Cream 0.05% 30 Gm tube Tot Wt: 2250<br>(Net Cont: Clob 1.17 Kg, Arlacel 101.25Kg, White Wax 22.50, Tubes 75000 Nos))<br>1 Number<br>3<br>Medical Creams & Ointments(Clobetasol Propionate Cream 0.05% 45 Gm tube Tot Wt: 1750.05<br>(Net Cont: Clob 0.91 Kg, Arlacel 78.75Kg, White Wax 17.50, Tubes 38890 Nos))<br>1 Number<br>4<br>Medical Creams & Ointments(Clobetasol Propionate Cream 0.05% 60 Gm tube Tot Wt: 2999.88<br>(Net Cont: Clob 1.56 Kg, Arlacel 135Kg, White Wax 30, Tubes 49998 Nos))<br>1 Number<br>**S

r>1 Number 4 Medical Creams & Ointments(Clobetasol Propionate Cream 0.05% 60 Gm tube Tot Wt: 2999.88 (Net Cont: Clob 1.56 Kg, Arlacel 135Kg, White Wax 30, Tubes 49998 Nos)) 1 Number S.No Import Product Quantity 1 Relevant Bulk Drugs Net content in the export product plus 3% wastage. 2 Relevant Excipients Net content in the export product plus 3% wastage. 3 Relevant Packaging Material Relevant as per Packing Policy Note: 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointmentssolely for export to US. i.|||||| ||S.No|Export Product|||Quantity| ||1|Medical Creams & Ointments(Clobetasol Propionate Cream 0.05% 15 Gm tube Tot Wt: 1500 (Net Cont: Clob 0.78 Kg, Arlacel 67.50Kg, White Wax 15, Tubes 100000 Nos))||| 1 Number| ||2|Medical Creams & Ointments(Clobetasol Propionate Cream 0.05% 30 Gm tube Tot Wt: 2250 (Net Cont: Clob 1.17 Kg, Arlacel 101.25Kg, White Wax 22.50, Tubes 75000 Nos))||| 1 Number| ||3|Medical Creams & Ointments(Clobetasol Propionate Cream 0.05% 45 Gm tube Tot Wt: 1750.05 (Net Cont: Clob 0.91 Kg, Arlacel 78.75Kg, White Wax 17.50, Tubes 38890 Nos))||| 1 Number| ||4|Medical Creams & Ointments(Clobetasol Propionate Cream 0.05% 60 Gm tube Tot Wt: 2999.88 (Net Cont: Clob 1.56 Kg, Arlacel 135Kg, White Wax 30, Tubes 49998 Nos))||| 1 Number| ||||||| ||S.No|Import Product||Quantity|| ||1|Relevant Bulk Drugs||Net content in the export product plus 3% wastage.||

Kg, Arlacel 135Kg, White Wax 30, Tubes 49998 Nos))||| 1 Number| ||||||| ||S.No|Import Product||Quantity|| ||1|Relevant Bulk Drugs||Net content in the export product plus 3% wastage.|| ||2|Relevant Excipients||Net content in the export product plus 3% wastage.|| ||3|Relevant Packaging Material||Relevant as per Packing Policy|| ||Note: 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointmentssolely for export to US. i.|||||

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

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

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

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

Case No.	97 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	VINEET LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM APPLY 00283907AM22
RA File Number	09AX04000009 AM22
Licence No and<br>Date	0911002042/13/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Carbonic<br>Acid<br>4-Nitrophenyl-5-<br>Thiazolylmethyl Ester<br>1 kg.<br>1<br>2-Chloro-5- (Chloromethyl)thiazole<br>1.25 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	98 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM APPLY 00287478AM22
RA File Number	03AA040122138 AM22
Licence No and<br>Date	0311009510/16/12/2021
Norms Committee Decision:

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and 20/12/2023| |HQ File Number|HQRNORM APPLY 00287478AM22| |RA File Number|03AA040122138 AM22| |Licence No and Date|0311009510/16/12/2021| |Norms Committee Decision:||

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Shri Kunal Sikchi, Director and Shri Nitin Vyas, Sr. Executive of the firm had attended the Personal Hearing and explained firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has considered for fixation of ad-hoc norms as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Oct/202122/9 dated 15/10/2021 against advance authorization No. 0310837496dated 30/07/2020 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Sl. No.<br>	Export Product	Qty.
1<br>	Phytosterol Natural Refined Phytosterol 95%	60,000.0 kg.
2<br>	Natural Mixed Tocopherol 50%	38,500.0kg.

Sl. No.	Import Item	Qty.
1	Fatty Acid Distillate / Deoderised Distillate	9,21,250 kg.
2	Acetone	44,000 kg.
3	N-HEPTANE	94,050 kg.

Note: The above norms are for regularization and closure purpose only. No repeat Licence may be allowed by RA on above norms.

Case No.	99 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00001321AM24
RA File Number	03AA040130524 AM22
Licence No and<br>Date	0311009529/16/12/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the<br>firm, it was decided to revise ad-hoc norms for export to US only are as under:-

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|S.No Export Product Quantity 1 Medical Creams & Ointments(Hydrocortisone 1% OTC Cream 1 OZ/ 28 gm Tube Tot Wt: 4191.66 Kgs Net Cont:(In KGs)Hydro: 41.92, Glyceryl 83.83,Wax 125.75,Stearyl41.92,Isopropyl 335.33,Cetyl125.75, Sorbitan125.75,Polysorb 125.75,Anhydrous2.93,Sodium5.03,Sorbic2.10, polyoxyl 20.96) 1 Number 2 Medical Creams & Ointments(Hydrocortisone 1 Percentage OTC Ointment 1 OZ/ 28 gm Tube (Net Cont: Hydrocortisone USP (Micronized) 20.00 Kgs)) 1 Number 3 Medical Creams & Ointments(Hydrocortisone Aloe 1% Cream 1 OZ/28 gm Tube Net Cont: (In KGs) Hydrocort 40, Glyceryl Stearate 80, White wax 120, Stearyl 40, Isopropyl 320, Cetyl 120, Sorbitan120, Polysorb 120, Anhydrous 2.8, Sodium 4.8, s

Aloe 1% Cream 1 OZ/28 gm Tube Net Cont: (In<br>KGs) Hydrocort 40, Glyceryl Stearate 80, White wax 120, Stearyl 40, Isopropyl 320, Cetyl 120,<br>Sorbitan120, Polysorb 120, Anhydrous 2.8, Sodium 4.8, sorbic acid<br>2, Polyoxyl 20, Aloe 4.)<br>1 Number<br>S.No<br>Import Product<br>Quantity<br>1<br>Relevant Bulk Drugs<br>Net content in the export product plus 3% wastage.<br>2<br>Relevant Excipients<br>Net content in the export product plus 3% wastage.<br>3<br>Relevant Packaging Material<br>Relevant as per Packing Policy<br>Note:<br>1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export<br>of Medicinal Cream/Ointmentssolely for export to US.<br>i.<br>1.02 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export<br>of Medicinal Cream/Ointments for the export toother than US.<br>ii.<br>The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA<br>concerned for redemption.<br>iii.<br>RA concerned may take further necessary action as per above decision of NC.	S.No	Export Product	Export Product	Quantity
	1	Medical Creams & Ointments(Hydrocortisone 1% OTC Cream 1 OZ/ 28 gm Tube Tot Wt:<br>4191.66<br>Kgs<br>Net<br>Cont:(In<br>KGs)Hydro:<br>41.92,<br>Glyceryl<br>83.83,Wax<br>125.75,Stearyl41.92,Isopropyl 335.33,Cetyl125.75, Sorbitan125.75,Polysorb<br>125.75,Anhydrous2.93,Sodium5.03,Sorbic2.10, polyoxyl 20.96)		<br> <br>1 Number

dro: 41.92, Glyceryl 83.83,Wax 125.75,Stearyl41.92,Isopropyl 335.33,Cetyl125.75, Sorbitan125.75,Polysorb 125.75,Anhydrous2.93,Sodium5.03,Sorbic2.10, polyoxyl 20.96)|| 1 Number| ||2|Medical Creams & Ointments(Hydrocortisone 1 Percentage OTC Ointment 1 OZ/ 28 gm Tube (Net Cont: Hydrocortisone USP (Micronized) 20.00 Kgs))|| 1 Number| ||3|Medical Creams & Ointments(Hydrocortisone Aloe 1% Cream 1 OZ/28 gm Tube Net Cont: (In KGs) Hydrocort 40, Glyceryl Stearate 80, White wax 120, Stearyl 40, Isopropyl 320, Cetyl 120 Sorbitan120, Polysorb 120, Anhydrous 2.8, Sodium 4.8, sorbic acid 2, Polyoxyl 20, Aloe 4.)|| , 1 Number| |||||| ||S.No |Import Product|Quantity|| ||1 |Relevant Bulk Drugs|Net content in the export product plus 3% wastage.|| ||2 |Relevant Excipients|Net content in the export product plus 3% wastage.|| ||3 |Relevant Packaging Material|Relevant as per Packing Policy||

Note:

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

Case No. 100 / NC/3/MEET/Dec/202324/17

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Case Status	Case Approved
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM APPLY 00293142AM22
RA File Number	05AX04000189 AM22
Licence No and<br>Date	0511007079/21/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product inmeeting No. NC/3/MEET/Nov/202324/16 dated 17/11/2023against advance<br>authorizationNo.0511006681 dated 07/12/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl. No.

12/2021**, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. CEFEPIME POWDER FOR SOLUTION FOR INJECTION, WEIGHT 1 GMS/VIAL (CEFEPIME HCL+LARGININE STERILE USP) 1 Number 1 CEFEPIME HCL+L- ARGININE STERILE USP 1.05 gm. EFEPIME POWDER FOR SOLUTION FOR INJECTION,WEIGHT 2 GMS/VIAL (CEFEPIME HCL+LARGININE STERILE USP) 1 Number 2 CEFEPIME HCL+L- ARGININE STERILE USP 2.10 gm. RA concerned may take further necessary action as per above decision of NC.||

Case No.	101 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM APPLY 00293146AM22
RA File Number	34AX04000029 AM22
Licence No and<br>Date	3411001569/21/12/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

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le Number|34AX04000029 AM22| |Licence No and Date|3411001569/21/12/2021| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

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Case No.	Case No.	Case No.	102 / NC/3/MEET/Dec/202324/17	102 / NC/3/MEET/Dec/202324/17	102 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001346AM24
RA File Number			03AA040123994 AM22
Licence No and<br>Date			0311009655/21/12/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>S.No<br>Export Product<br>Quantity<br>1<br>Medical Creams & Ointments(Fusidic Acid and Betamethasone Valerate Cream 15 Gm Tube)<br>1 Number<br>2<br>Medical Creams & Ointments(Fusidic Acid and Betamethasone Valerate Cream 30 Gm Tube)<br>1 Number<br>3<br>Medical Creams & Ointments(Fusidic Acid and Betamethasone Valerate Cream 60 Gm Tube)<br>1 Number<br>4<br>Medical Creams & Ointments(Fusidic Acid Cream 15 Gm Tube)<br>1 Number<br>5<br>Medical Creams & Ointments(Fusidic Acid Cream 30 Gm Tube)<br>1 Number<br>S.No<br>Import Product<br>Quantity<br>1<br>Relevant Bulk Drugs<br>Net content in the export product plus 3% wastage.<br>2<br>Relevant Excipients<br>Net content in the export product plus 3

S.No* Import Product Quantity 1 Relevant Bulk Drugs Net content in the export product plus 3% wastage. 2 Relevant Excipients Net content in the export product plus 3% wastage. 3 Relevant Packaging Material Relevant as per Packing Policy Note: 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointmentssolely for export to US. i.|||||| ||S.No|Export Product|||Quantity| ||1|Medical Creams & Ointments(Fusidic Acid and Betamethasone Valerate Cream 15 Gm Tube)|||1 Number| ||2|Medical Creams & Ointments(Fusidic Acid and Betamethasone Valerate Cream 30 Gm Tube)|||1 Number| ||3|Medical Creams & Ointments(Fusidic Acid and Betamethasone Valerate Cream 60 Gm Tube)|||1 Number| ||4|Medical Creams & Ointments(Fusidic Acid Cream 15 Gm Tube)|||1 Number| ||5|Medical Creams & Ointments(Fusidic Acid Cream 30 Gm Tube)|||1 Number| ||||||| ||S.No|Import Product||Quantity|| ||1|Relevant Bulk Drugs||Net content in the export product plus 3% wastage.|| ||2|Relevant Excipients||Net content in the export product plus 3% wastage.|| ||3|Relevant Packaging Material||Relevant as per Packing Policy|| ||Note: 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointmentssolely for export to US. i.|||||

||Note: 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointmentssolely for export to US. i.|||||

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

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

Case No.	Case No.	Case No.	103 / NC/3/MEET/Dec/202324/17	103 / NC/3/MEET/Dec/202324/17	103 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001357AM24
RA File Number			03AX04000252 AM22
Licence No and<br>Date			0311009654/21/12/2021

r and Date|||NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023||| |HQ File Number|||HQRNORM REVIW00001357AM24||| |RA File Number|||03AX04000252 AM22||| |Licence No and Date|||0311009654/21/12/2021||| |Norms Committee Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms for export to US only are as under:- S.No Export Product Quantity 1 Medical Creams & Ointments(Desonide Ointment 0.05 % (15 Gm) Tot Wt: 975Kgs (Net Cont: Desonide 0.5Kgs, White Petrolatum 974.51Kgs, Tubes: 65000Nos)) 1 Number 2 Medical Creams & Ointments(Desonide Ointment 0.05 % (60 Gm) Tot Wt: 1350Kgs (Net Cont: Desonide 0.69Kgs, White Petrolatum 1349.33Kgs, Tubes: 22500Nos)) 1 Number S.No Import Product Quantity 1 Relevant Bulk Drugs Net content in the export product plus 3% wastage. 2 Relevant Excipients Net content in the export product plus 3% wastage. 3 Relevant Packaging Material Relevant as per Packing Policy|||||| ||S.No|Export Product|||Quantity| ||1|Medical Creams & Ointments(Desonide Ointment 0.05 % (15 Gm) Tot Wt: 975Kgs (Net Cont: Desonide 0.5Kgs, White Petrolatum 974.51Kgs, Tubes: 65000Nos))|||1 Number| ||2|Medical Creams & Ointments(Desonide Ointment 0.05 % (60 Gm) Tot Wt: 1350Kgs (Net Cont: Desonide 0.69Kgs, White Petrolatum 1349.33Kgs, Tubes: 22500Nos))|||1 Number| ||||||| ||S.No|Import Product||Quantity||

ents(Desonide Ointment 0.05 % (60 Gm) Tot Wt: 1350Kgs (Net Cont: Desonide 0.69Kgs, White Petrolatum 1349.33Kgs, Tubes: 22500Nos))|||1 Number| ||||||| ||S.No|Import Product||Quantity|| ||1|Relevant Bulk Drugs||Net content in the export product plus 3% wastage.|| ||2|Relevant Excipients||Net content in the export product plus 3% wastage.|| ||3|Relevant Packaging Material||Relevant as per Packing Policy||

Case No.	Case No.	Case No.	103 / NC/3/MEET/Dec/202324/17	103 / NC/3/MEET/Dec/202324/17	103 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001357AM24
RA File Number			03AX04000252 AM22
Licence No and<br>Date			0311009654/21/12/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>S.No<br>Export Product<br>Quantity<br>1<br>Medical Creams & Ointments(Desonide Ointment 0.05 % (15 Gm) Tot Wt: 975Kgs (Net Cont:<br>Desonide 0.5Kgs, White Petrolatum 974.51Kgs, Tubes: 65000Nos))<br>1 Number<br>2<br>Medical Creams & Ointments(Desonide Ointment 0.05 % (60 Gm) Tot Wt: 1350Kgs (Net Cont:<br>Desonide 0.69Kgs, White Petrolatum 1349.33Kgs, Tubes: 22500Nos))<br>1 Number<br>S.No<br>Import Product<br>Quantity<br>1<br>Relevant Bulk Drugs<br>Net content in the exp

0Kgs (Net Cont: Desonide 0.69Kgs, White Petrolatum 1349.33Kgs, Tubes: 22500Nos)) 1 Number S.No Import Product Quantity 1 Relevant Bulk Drugs Net content in the export product plus 3% wastage. 2 Relevant Excipients Net content in the export product plus 3% wastage. 3 Relevant Packaging Material Relevant as per Packing Policy|||||| ||S.No|Export Product|||Quantity| ||1|Medical Creams & Ointments(Desonide Ointment 0.05 % (15 Gm) Tot Wt: 975Kgs (Net Cont: Desonide 0.5Kgs, White Petrolatum 974.51Kgs, Tubes: 65000Nos))|||1 Number| ||2|Medical Creams & Ointments(Desonide Ointment 0.05 % (60 Gm) Tot Wt: 1350Kgs (Net Cont: Desonide 0.69Kgs, White Petrolatum 1349.33Kgs, Tubes: 22500Nos))|||1 Number| ||||||| ||S.No|Import Product||Quantity|| ||1|Relevant Bulk Drugs||Net content in the export product plus 3% wastage.|| ||2|Relevant Excipients||Net content in the export product plus 3% wastage.|| ||3|Relevant Packaging Material||Relevant as per Packing Policy||

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Note:

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

Case No.	Case No.	Case No.	104 / NC/3/MEET/Dec/202324/17	104 / NC/3/MEET/Dec/202324/17	104 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001329AM24
RA File Number			03AX04000251 AM22
Licence No and<br>Date			0311009744/24/12/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the<br>firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>S.No.<br>Export Product<br>Quantity<br>1<br>Medical Creams & Ointments( Permethrin Cream 5 % (60 Gm ) Tot Wt: 35998.56Kgs<br>(Net Cont: Medium chain 3599.86Kgs, Mono 1799.93Kgs, Isopropyl 359.99Kgs, Lanolin<br>539.98Kgs, Polyoxy 1439.94Kgs, Tubes 599976Nos) )<br>1 Number<br>S.No<br>Import Product<br>Quantity<br>1<br>Relevant Bulk Drugs<br>Net content in the export product plus 3%

gs, Lanolin 539.98Kgs, Polyoxy 1439.94Kgs, Tubes 599976Nos) ) 1 Number S.No Import Product Quantity 1 Relevant Bulk Drugs Net content in the export product plus 3% wastage.|||||| ||S.No.|Export Product|||Quantity| ||1|Medical Creams & Ointments( Permethrin Cream 5 % (60 Gm ) Tot Wt: 35998.56Kgs (Net Cont: Medium chain 3599.86Kgs, Mono 1799.93Kgs, Isopropyl 359.99Kgs, Lanolin 539.98Kgs, Polyoxy 1439.94Kgs, Tubes 599976Nos) )|||1 Number| ||||||| ||S.No|Import Product||Quantity|| ||1|Relevant Bulk Drugs||Net content in the export product plus 3% wastage.||

Case No.	Case No.	Case No.	104 / NC/3/MEET/Dec/202324/17	104 / NC/3/MEET/Dec/202324/17	104 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001329AM24
RA File Number			03AX04000251 AM22
Licence No and<br>Date			0311009744/24/12/2021

r and Date|||NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023||| |HQ File Number|||HQRNORM REVIW00001329AM24||| |RA File Number|||03AX04000251 AM22||| |Licence No and Date|||0311009744/24/12/2021||| |Norms Committee Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms for export to US only are as under:- S.No. Export Product Quantity 1 Medical Creams & Ointments( Permethrin Cream 5 % (60 Gm ) Tot Wt: 35998.56Kgs (Net Cont: Medium chain 3599.86Kgs, Mono 1799.93Kgs, Isopropyl 359.99Kgs, Lanolin 539.98Kgs, Polyoxy 1439.94Kgs, Tubes 599976Nos) ) 1 Number S.No Import Product Quantity 1 Relevant Bulk Drugs Net content in the export product plus 3% wastage.|||||| ||S.No.|Export Product|||Quantity| ||1|Medical Creams & Ointments( Permethrin Cream 5 % (60 Gm ) Tot Wt: 35998.56Kgs (Net Cont: Medium chain 3599.86Kgs, Mono 1799.93Kgs, Isopropyl 359.99Kgs, Lanolin 539.98Kgs, Polyoxy 1439.94Kgs, Tubes 599976Nos) )|||1 Number| ||||||| ||S.No|Import Product||Quantity|| ||1|Relevant Bulk Drugs||Net content in the export product plus 3% wastage.||

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2	Relevant Excipients	Net content in the export product plus 3% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy

Note:

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

Case No.	Case No.	Case No.	105 / NC/3/MEET/Dec/202324/17	105 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00001354AM24
RA File Number			03AX04000229 AM22
Licence No and<br>Date			0311009746/24/12/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>S.No<br>Export Product<br>Quantity<br>1<br>Medical Creams & Ointments(Ketoconazole Cream 2 percentage, 15 gm Tot Wt:<br>4999.97Kgs (Net Cont: Sorbitan 100Kgs, Poly 75Kgs, Stearyl 375Kgs, Isopropyl 50Kgs,<br>Tubes 333331Nos))<br>1 Number<br>Medical Creams & Ointments(Ketoconazole Cream 2 percentage, 30 gm Tot Wt:<br>12999.87Kgs (Net Cont: Sorbitan 260Kgs, Poly 195Kgs, Stearyl 974.99Kgs, Isopropyl<br>2<br>1 Number

s)) 1 Number Medical Creams & Ointments(Ketoconazole Cream 2 percentage, 30 gm Tot Wt: 12999.87Kgs (Net Cont: Sorbitan 260Kgs, Poly 195Kgs, Stearyl 974.99Kgs, Isopropyl 2 1 Number||||| ||S.No|Export Product||Quantity| ||1|Medical Creams & Ointments(Ketoconazole Cream 2 percentage, 15 gm Tot Wt: 4999.97Kgs (Net Cont: Sorbitan 100Kgs, Poly 75Kgs, Stearyl 375Kgs, Isopropyl 50Kgs, Tubes 333331Nos))||1 Number| ||2|Medical Creams & Ointments(Ketoconazole Cream 2 percentage, 30 gm Tot Wt: 12999.87Kgs (Net Cont: Sorbitan 260Kgs, Poly 195Kgs, Stearyl 974.99Kgs, Isopropyl||1 Number|

UDIN00462819AM24

	130Kgs, Tubes 433329Nos))
3	Medical Creams & Ointments(Ketoconazole Cream 2 percentage, 60 gm Tot Wt:	1 Number
	37999.62Kgs (Net Cont: Sorbitan 759.99Kgs, Poly 569.99Kgs, Stearyl 2849.97Kgs,
	Isopropyl 380Kgs, Tubes 633327Nos))

S.No	Import Product	Quantity
1	Relevant Bulk Drugs	Net content in the export product plus 3% wastage.
2	Relevant Excipients	Net content in the export product plus 3% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy

Note:

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

Case No.	106 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00006188AM24
RA File Number	03AX04000256 AM22
Licence No and<br>Date	0311009818/27/12/2021
Norms Committee Decision:

75 This document has been digitally signed by Raman Kumar, Deputy DGFT on 31-01-2024 15:53:42.

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

Case No.	107 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM APPLY 00299896AM22
RA File Number	34AX04000090 AM22
Licence No and<br>Date	3411001598/28/12/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	108 / NC/3/MEET/Dec/202324/17	108 / NC/3/MEET/Dec/202324/17	108 / NC/3/MEET/Dec/202324/17	108 / NC/3/MEET/Dec/202324/17	108 / NC/3/MEET/Dec/202324/17
Case Status		Case Approved
Party Name		OPES HEALTH CARE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number		HQRNORM REVIW00006305AM24
RA File Number		08AX04000140 AM22
Licence No and<br>Date		0811003577/28/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product inmeeting No. NC/3/MEET/Jan/202223/18 dated 23/01/2023against advance<br>authorizationNo.0811006083 dated 22/09/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Metamizaole Magnesium 300 mg and Pargeverine Hydrochloride 6mg Oral Drop (Considering the loss on drying @14.50% of Bul (Metamizaole Magnesium 300 mg and Pargeverine Hydrochloride 6mg Oral Drop (Considering the loss on drying @14.50% of Bulkdrug for 300MG we need to poor 350.88 Mg. So net content of the raw material is :-90000 Bottles * 5 ML * 350.88 MG = 157.89 Kgs.)) 90000 Numbers 1 Metamizole Magnesium 143.654 kg. Metamizaole Magnesium 300 mg and 1150000 2 Metamizole Magnesium 5433.742 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Metamizaole Magnesium 300 mg and Pargeverine Hydrochloride 6mg Oral Drop (Considering the loss on drying @14.50% of Bul (Metamizaole Magnesium 300 mg and Pargeverine Hydrochloride 6mg Oral Drop (Considering the loss on drying @14.50% of Bulkdrug for 300MG we need to poor 350.88 Mg. So net content of the raw material is :-90000 Bottles * 5 ML * 350.88 MG = 157.89 Kgs.))|| 90000 Numbers|1 |Metamizole Magnesium|143.654 kg.| ||Metamizaole Magnesium 300 mg and||1150000|2 |Metamizole Magnesium|5433.742 kg.|

89 Kgs.))|| 90000 Numbers|1 |Metamizole Magnesium|143.654 kg.| ||Metamizaole Magnesium 300 mg and||1150000|2 |Metamizole Magnesium|5433.742 kg.|

Case No.	Case No.	108 / NC/3/MEET/Dec/202324/17	108 / NC/3/MEET/Dec/202324/17	108 / NC/3/MEET/Dec/202324/17	108 / NC/3/MEET/Dec/202324/17	108 / NC/3/MEET/Dec/202324/17
Case Status		Case Approved
Party Name		OPES HEALTH CARE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number		HQRNORM REVIW00006305AM24
RA File Number		08AX04000140 AM22
Licence No and<br>Date		0811003577/28/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product inmeeting No. NC/3/MEET/Jan/202223/18 dated 23/01/2023against advance<br>authorizationNo.0811006083 dated 22/09/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Metamizaole Magnesium 300 mg and<br>Pargeverine Hydrochloride 6mg Oral Drop<br>(Considering the loss on drying @14.50%<br>of Bul (Metamizaole Magnesium 300 mg<br>and Pargeverine Hydrochloride 6mg Oral<br>Drop (Considering the loss on drying<br>@14.50% of Bulkdrug for 300MG we need<br>to poor 350.88 Mg.

drying @14.50% of Bul (Metamizaole Magnesium 300 mg and Pargeverine Hydrochloride 6mg Oral Drop (Considering the loss on drying @14.50% of Bulkdrug for 300MG we need to poor 350.88 Mg. So net content of the raw material is :-90000 Bottles * 5 ML * 350.88 MG = 157.89 Kgs.)) 90000 Numbers 1 Metamizole Magnesium 143.654 kg. Metamizaole Magnesium 300 mg and 1150000 2 Metamizole Magnesium 5433.742 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Metamizaole Magnesium 300 mg and Pargeverine Hydrochloride 6mg Oral Drop (Considering the loss on drying @14.50% of Bul (Metamizaole Magnesium 300 mg and Pargeverine Hydrochloride 6mg Oral Drop (Considering the loss on drying @14.50% of Bulkdrug for 300MG we need to poor 350.88 Mg. So net content of the raw material is :-90000 Bottles * 5 ML * 350.88 MG = 157.89 Kgs.))|| 90000 Numbers|1 |Metamizole Magnesium|143.654 kg.| ||Metamizaole Magnesium 300 mg and||1150000|2 |Metamizole Magnesium|5433.742 kg.|

UDIN00462819AM24

Pargeverine Hydrochloride 6mg Oral Drop Numbers (Considering the loss on drying @14.50% of Bul(Metamizaole Magnesium 300 mg and Pargeverine Hydrochloride 6mg Oral Drop (Considering the loss on drying @14.50% of Bulkdrug for 300 MG we need to poor 350.88 Mg. So net content of the raw material is :-1150000 Bottles * 15 ML * 350.88 MG = 6052.68 K)

ide 6mg Oral Drop (Considering the loss on drying @14.50% of Bulkdrug for 300 MG we need to poor 350.88 Mg. So net content of the raw material is :-1150000 Bottles * 15 ML * 350.88 MG = 6052.68 K)

Case No.	109 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	KRUNAL INDUSTRIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM APPLY 00301989AM22
RA File Number	08AX04000162 AM22
Licence No and<br>Date	0811003592/30/12/2021
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Percentage yield of reaction.<br>1.<br>Stichometric balance on Molar basis plus percentage yield to arrive at the quantity of raw material<br>asked.<br>2.<br>Quantity and commercial value of By-product obtained.<br>3.

Case No.	110 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00000165AM24
RA File Number	03AX04000308 AM22
Licence No and<br>Date	0311009920/30/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal

UDIN00462819AM24

Hearing before Norms Committee to explain its case alongwith following information / documents from the firm :-

decided to call the firm for attendingPersonal||

UDIN00462819AM24

Hearing before Norms Committee to explain its case alongwith following information / documents from the firm :-

i. Molar Weight of each input and output item of each stage.
ii. Percentage yield on molar basis for each step.
iii. CA certified Production/Consumption data.
iv. Sample of Shipping Bills and Bill of Entry of the export products along with statement of Input-output as per export documents of the said authorization.

Case No.	111 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	PANACEA BIOTEC PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00005946AM24
RA File Number	05AX04000321 AM22
Licence No and<br>Date	0511007823/11/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case toDeptt. of Bio-Technologyfor<br>obtaining their comments.

7823/11/01/2022| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to refer the case toDeptt. of Bio-Technologyfor obtaining their comments.||

Case No.	Case No.	112 / NC/3/MEET/Dec/202324/17	112 / NC/3/MEET/Dec/202324/17	112 / NC/3/MEET/Dec/202324/17	112 / NC/3/MEET/Dec/202324/17	112 / NC/3/MEET/Dec/202324/17
Case Status		Case Approved
Party Name		ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number		HQRNORM APPLY 00317040AM22
RA File Number		08AX04000199 AM22
Licence No and<br>Date		0811003776/13/01/2022
Norms Committee Decision:<br>Shri Vimal Kaneria, General Manager, Shri Mahek Shah, Manager (Exim) & Logistics and Shri Devendra Mali,<br>Manager (Corporate Affairs)of the firm had attended the Personal Hearing and explained firm’s case. The<br>Committee heard the explanation of Representative of the firm and after due deliberation the committee has considered<br>for fixation of ad-hoc norms on the basis of information provided by the firm, it was decided to fix ad-hoc norms as<br>under, or as applied whichever is lower: -<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed<br>1<br>MEMANTINE HYDROCHLORIDE USP<br>7.14 mg.<br>MEMANTINE<br>HYDROCHLORIDE 1 Number
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed
	MEMANTINE<br>HYDROCHLORIDE		1 Number	1	MEMANTINE HYDROCHLORIDE USP	7.14 mg.

TINE HYDROCHLORIDE 1 Number||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed| ||MEMANTINE HYDROCHLORIDE||1 Number|1|MEMANTINE HYDROCHLORIDE USP|7.14 mg.|

Case No.	Case No.	112 / NC/3/MEET/Dec/202324/17	112 / NC/3/MEET/Dec/202324/17	112 / NC/3/MEET/Dec/202324/17	112 / NC/3/MEET/Dec/202324/17	112 / NC/3/MEET/Dec/202324/17
Case Status		Case Approved
Party Name		ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number		HQRNORM APPLY 00317040AM22
RA File Number		08AX04000199 AM22
Licence No and<br>Date		0811003776/13/01/2022
Norms Committee Decision:<br>Shri Vimal Kaneria, General Manager, Shri Mahek Shah, Manager (Exim) & Logistics and Shri Devendra Mali,<br>Manager (Corporate Affairs)of the firm had attended the Personal Hearing and explained firm’s case. The<br>Committee heard the explanation of Representative of the firm and after due deliberation the committee has considered<br>for fixation of ad-hoc norms on the basis of information provided by the firm, it was decided to fix ad-hoc norms as<br>under, or as applied whichever is lower: -<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed<br>1<br>MEMANTINE HYDROCHLORIDE USP<br>7.14 mg.<br>MEMANTINE<br>HYDROCHLORIDE 1 Number
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed
	MEMANTINE<br>HYDROCHLORIDE		1 Number	1	MEMANTINE HYDROCHLORIDE USP	7.14 mg.

UDIN00462819AM24

Number||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed| ||MEMANTINE HYDROCHLORIDE||1 Number|1|MEMANTINE HYDROCHLORIDE USP|7.14 mg.|

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EXTENDED RELEASE CAPSULES 7<br>MG ((ACTIVE INGREDIENT:<br>MEMANTINE HYDROCHLORIDE USP -<br>NET WT. 22.40 KGS.))	<br>	2	SUGAR SPHERES (NON-PAREIL) NF	30.60 mg.
		3	HYPROMELLOSE 5 CPS 2910 USP	3.824 mg.
		4	HYPROMELLOSE 3 CPS 2910 USP	3.06 mg.
		5	TRIETHYL CITRATE NF	0.829 mg.
		6	TALC PH EUR/USP	1.594 mg.
MEMANTINE<br>HYDROCHLORIDE<br>EXTENDED RELEASE CAPSULES 14<br>MG ((ACTIVE INGREDIENT:<br>MEMANTINE HYDROCHLORIDE USP<br>- NET WT. 72.78 KGS.))	<br> <br> <br>1 Number	7	MEMANTINE HYDROCHLORIDE USP	14.28 mg.
		8	SUGAR SPHERES (NON-PAREIL) NF	61.20 mg.
		9	HYPROMELLOSE 5 CPS 2910 USP	7.648 mg.
		10	HYPROMELLOSE 3 CPS 2910 USP	6.12 mg.
		11	TRIETHYL CITRATE NF	1.658 mg.
		12	TALC PH EUR/USP	3.188 mg.
MEMANTINE<br>HYDROCHLORIDE<br>EXTENDED RELEASE CAPSULES 21<br>MG ((ACTIVE INGREDIENT:<br>MEMANTINE HYDROCHLORIDE USP<br>- NET WT. 67.19 KGS.))	<br> <br> <br>1 Number	13	MEMANTINE HYDROCHLORIDE USP	21.42 mg.
		14	SUGAR SPHERES (NON-PAREIL) NF	91.80 mg.
		15	HYPROMELLOSE 5 CPS 2910 USP	11.472 mg.
		16	HYPROMELLOSE 3 CPS 2910 USP	9.18 mg.
		17	TRIETHYL CITRATE NF	2.487 mg.
		18	TALC PH EUR/USP	4.782 mg.
MEMANTINE<br>HYDROCHLORIDE<br>EXTENDED RELEASE CAPSULES 28<br>MG ((ACTIVE INGREDIENT:<br>MEMANTINE HYDROCHLORIDE USP<br>- NET WT.

17|TRIETHYL CITRATE NF|2.487 mg.| ||||18|TALC PH EUR/USP|4.782 mg.| ||MEMANTINE HYDROCHLORIDE EXTENDED RELEASE CAPSULES 28 MG ((ACTIVE INGREDIENT: MEMANTINE HYDROCHLORIDE USP - NET WT. 568.34 KGS.))| 1 Number|19|MEMANTINE HYDROCHLORIDE USP|28.56 mg.| ||||20|SUGAR SPHERES (NON-PAREIL) NF|122.40 mg.| ||||21|HYPROMELLOSE 5 CPS 2910 USP|15.296 mg.|

UDIN00462819AM24

|22 HYPROMELLOSE 3 CPS 2910 USP 12.24 mg. 23 TRIETHYL CITRATE NF 3.316 mg. 24 TALC PH EUR/USP 6.376 mg. 25 MEMANTINE HYDROCHLORIDE USP 5.10 mg. 26 TALC PH EUR/USP 1.02 mg. 27 CROSCARMELLOSE SODIUM NF 5.61 mg. 28 DIBASIC CALCIUM PHOSPHATE DIHYDRATE USP 73.95 mg. MEMANTINE HYDROCHLORIDE TABLETS 5 MG((ACTIVE INGREDIENT: MEMANTINE HYDROCHLORIDE USP - NET WT. 160.98 KGS.)) 1 Number 29 MAGNESIUM STEARATE PH.E/NF/JP 1.02 mg. 30 MEMANTINE HYDROCHLORIDE USP 10.20 mg. 31 TALC PH EUR/USP 2.04 mg. 32 CROSCARMELLOSE SODIUM NF 11.22 mg. 33 DIBASIC CALCIUM PHOSPHATE DIHYDRATE USP 147.90 mg. MEMANTINE HYDROCHLORIDE TABLETS 10 MG ((ACTIVE INGREDIENT: MEMANTINE HYDROCHLORIDE USP - NET WT.

		22	HYPROMELLOSE 3 CPS 2910 USP	12.24 mg.
		23	TRIETHYL CITRATE NF	3.316 mg.
		24	TALC PH EUR/USP	6.376 mg.
MEMANTINE<br>HYDROCHLORIDE<br>TABLETS<br>5<br>MG((ACTIVE<br>INGREDIENT:<br>MEMANTINE<br>HYDROCHLORIDE<br>USP - NET WT. 160.98 KGS.))	<br> <br> <br>1 Number	25	MEMANTINE HYDROCHLORIDE USP	5.10 mg.
		26	TALC PH EUR/USP	1.02 mg.
		27	CROSCARMELLOSE SODIUM NF	5.61 mg.
		28	DIBASIC<br>CALCIUM<br>PHOSPHATE<br>DIHYDRATE USP	<br>73.95 mg.
		29	MAGNESIUM STEARATE PH.E/NF/JP	1.02 mg.
MEMANTINE<br>HYDROCHLORIDE<br>TABLETS<br>10<br>MG<br>((ACTIVE<br>INGREDIENT:<br>MEMANTINE<br>HYDROCHLORIDE<br>USP - NET WT. 229.96 KGS.))	<br> <br> <br>1 Number	30	MEMANTINE HYDROCHLORIDE USP	10.20 mg.
		31	TALC PH EUR/USP	2.04 mg.
		32	CROSCARMELLOSE SODIUM NF	11.22 mg.
		33	DIBASIC<br>CALCIUM<br>PHOSPHATE<br>DIHYDRATE USP	<br>147.90 mg.
		34	MAGNESIUM STEARATE PH.E/NF/JP	2.04 mg.

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

C CALCIUM PHOSPHATE DIHYDRATE USP| 147.90 mg.| ||||34|MAGNESIUM STEARATE PH.E/NF/JP|2.04 mg.|

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

Case No.	113 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00001606AM24
RA File Number	31AX04000040 AM22
Licence No and<br>Date	3111000876/14/01/2022
Norms Committee Decision:

UDIN00462819AM24

The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
AMINO ETHYL PIPERAZINE<br>(ORGANIC CHEMICAL)	1 kg.	1	MONO ETHANOL AMINE	1.261 kg.
ETHYLENEDIAMINE<br>(ORGANIC CHEMICAL)	1 kg.	2	MONO ETHANOL AMINE	1.06 kg.
		3	AMMONIA ANHYDROUS	0.294 kg.
DI ETHYLENE TRI AMINE<br>(ORCGANIC CHEMICAL)	1 kg.	4	MONO ETHANOL AMINE	1.184 kg.
		5	AMMONIA ANHYDROUS	0.165 kg.
PIPERAZINE<br>(ORGANIC CHEMICAL)	1 kg.	6	MONO ETHANOL AMINE	1.481 kg.
AMINO ETHYL ETHANOL AMINE<br>(ORGANIC CHEMICAL)	1 kg.	7	MONO ETHANOL AMINE	1.173 kg.

.| |||5|AMMONIA ANHYDROUS|0.165 kg.| |PIPERAZINE (ORGANIC CHEMICAL)|1 kg.|6|MONO ETHANOL AMINE|1.481 kg.| |AMINO ETHYL ETHANOL AMINE (ORGANIC CHEMICAL)|1 kg.|7|MONO ETHANOL AMINE|1.173 kg.|

Case No.	114 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00005988AM24
RA File Number	03AX04000043 AM22
Licence No and<br>Date	0311010585/17/01/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

UDIN00462819AM24

Case No.	115 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00006478AM23
RA File Number	03AX04001106 AM22
Licence No and<br>Date	0311011140/06/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>HYDRAZINE HYDRATE<br>0.4125kg.<br>2<br>CAUSTIC SODA<br>0.266 kg.<br>2,5-DIMERCAPTO-1,3,4-<br>THIADIAZOLE(YALUB DMTD)<br>1 kg.<br>3<br>CARBON DISULPHIDE<br>0.048 kg.<br>RA concerned may take further necessary action as per above decision of NC.

DA 0.266 kg. 2,5-DIMERCAPTO-1,3,4- THIADIAZOLE(YALUB DMTD) 1 kg. 3 CARBON DISULPHIDE 0.048 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	116 / NC/3/MEET/Dec/202324/17	116 / NC/3/MEET/Dec/202324/17	116 / NC/3/MEET/Dec/202324/17	116 / NC/3/MEET/Dec/202324/17	116 / NC/3/MEET/Dec/202324/17
Case Status		Case Approved
Party Name		LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number		HQRNORM APPLY 00351303AM22
RA File Number		09AX04000191 AM22
Licence No and Date		0911002504/11/02/2022
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 item in meetingNo.NC/3/MEET/Oct/202324/15 dated 13/10/2023against advance authorization<br>No.0911001978 dated 13/12/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.
	Export Product		Qty.	Sl. No.	Import Items<br> <br>	Qty.<br>allowed.

UDIN00462819AM24

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

UDIN00462819AM24

1<br>Ethyl-3-amino-1-4-cyanotetrahydro-2H-<br>pyran-3-yl)-1H-Pyrazole-4-carboxylate<br>(Racemic ECPC)<br>5.120 kg.<br>2<br>2-Fluoro-4-Iodo-6-Methoxy Pyridine<br>(IFMP)<br>2.267 kg.<br>1-[(3R,4S)-4-Cyanotetrahydropyran-3-<br>yl]-3-[(2-fluoro-6-methoxy-4-pyridyl)<br>amino]pyrazole-4-carboxamide((L-<br>005251026-Form-I)<br>1 kg.<br>3<br>4,5-bis(Diphenylphosphino)-9,9-<br>dimethylxanthane (Xantphos)<br>0.153 kg.<br>RA concerned may take further necessary action as per above decision of NC.	1-[(3R,4S)-4-Cyanotetrahydropyran-3-<br>yl]-3-[(2-fluoro-6-methoxy-4-pyridyl)<br>amino]pyrazole-4-carboxamide((L-<br>005251026-Form-I)	1 kg.	1<br><br>p<br>(	Ethyl-3-amino-1-4-cyanotetrahydro-2H-<br>yran-3-yl)-1H-Pyrazole-4-carboxylate<br>Racemic ECPC)<br>	5.120 kg.
			2<br>2<br>(	-Fluoro-4-Iodo-6-Methoxy Pyridine<br>IFMP)<br>	2.267 kg.
			3<br>4<br>d	,5-bis(Diphenylphosphino)-9,9-<br>imethylxanthane (Xantphos)<br>	0.153 kg.

g.| |---|---|---|---|---|---| ||||2 2 (|-Fluoro-4-Iodo-6-Methoxy Pyridine IFMP) |2.267 kg.| ||||3 4 d|,5-bis(Diphenylphosphino)-9,9- imethylxanthane (Xantphos) |0.153 kg.|

Case No.	Case No.	117 / NC/3/MEET/Dec/202324/17	117 / NC/3/MEET/Dec/202324/17	117 / NC/3/MEET/Dec/202324/17	117 / NC/3/MEET/Dec/202324/17	117 / NC/3/MEET/Dec/202324/17
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number		HQRNORM APPLY 00356332AM22
RA File Number		08AX04000424 AM22
Licence No and<br>Date		0811004069/15/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>BUSPIRONE<br>HYDROCHLORIDE<br>TABLETS<br>USP<br>5<br>MG(EACH<br>UNCOATED TABLET CONTAINS:<br>BUSPIRONE<br>HYDROCHLORIDE USP 5 MG)<br>1 Number<br>1<br>BUSPIRONE HYDROCHLORID E EP<br>/ BP / IP / USP / PH. EUR.<br>5.1 mg / tablet<br>BUSPIRONE<br>HYDROCHLORIDE<br>TABLETS<br>USP<br>7.5<br>MG(EACH<br>UNCOATED TABLET CONTAINS:<br>BUSPIRONE<br>HYDROCHLORIDE USP 7.5 MG)<br>1 Number<br>2<br>BUSPIRONE HYDROCHLORID E EP<br>/ BP / IP / USP / PH.

NE HYDROCHLORIDE TABLETS USP 7.5 MG(EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 7.5 MG) 1 Number 2 BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR. 7.65 mg / tablet BUSPIRONE HYDROCHLORIDE TABLETS USP 10 MG(EACH 1 Number 3 BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR. 10.2 mg / tablet||||||| ||Export Product ||Qty.|Sl. No.|Import Items |Qty. allowed.| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 5 MG(EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 5 MG) || 1 Number|1|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR. |5.1 mg / tablet| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 7.5 MG(EACH UNCOATED TABLET CONTAINS: BUSPIRONE HYDROCHLORIDE USP 7.5 MG) || 1 Number|2|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR. |7.65 mg / tablet| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 10 MG(EACH || 1 Number|3|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR. |10.2 mg / tablet|

EUR. |7.65 mg / tablet| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 10 MG(EACH || 1 Number|3|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR. |10.2 mg / tablet|

Case No.	Case No.	117 / NC/3/MEET/Dec/202324/17	117 / NC/3/MEET/Dec/202324/17	117 / NC/3/MEET/Dec/202324/17	117 / NC/3/MEET/Dec/202324/17	117 / NC/3/MEET/Dec/202324/17
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number		HQRNORM APPLY 00356332AM22
RA File Number		08AX04000424 AM22
Licence No and<br>Date		0811004069/15/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>BUSPIRONE<br>HYDROCHLORIDE<br>TABLETS<br>USP<br>5<br>MG(EACH<br>UNCOATED TABLET CONTAINS:<br>BUSPIRONE<br>HYDROCHLORIDE USP 5 MG)<br>1 Number<br>1<br>BUSPIRONE HYDROCHLORID E EP<br>/ BP / IP / USP / PH. EUR.<br>5.1 mg / tablet<br>BUSPIRONE<br>HYDROCHLORIDE<br>TABLETS<br>USP<br>7.5<br>MG(EACH<br>UNCOATED TABLET CONTAINS:<br>BUSPIRONE<br>HYDROCHLORIDE USP 7.5 MG)<br>1 Number<br>2<br>BUSPIRONE HYDROCHLORID E EP<br>/ BP / IP / USP / PH.

UDIN00462819AM24

t| ||BUSPIRONE HYDROCHLORIDE TABLETS USP 10 MG(EACH || 1 Number|3|BUSPIRONE HYDROCHLORID E EP / BP / IP / USP / PH. EUR. |10.2 mg / tablet|

UDIN00462819AM24

UNCOATED TABLET CONTAINS:<br>BUSPIRONE<br>HYDROCHLORIDE USP 10 MG)<br>BUSPIRONE<br>HYDROCHLORIDE<br>TABLETS<br>USP<br>15<br>MG(EACH<br>UNCOATED TABLET CONTAINS:<br>BUSPIRONE<br>HYDROCHLORIDE USP 15 MG)<br>1 Number<br>4<br>BUSPIRONE HYDROCHLORID E EP<br>/ BP / IP / USP / PH. EUR.<br>15.3 mg / tablet<br>BUSPIRONE<br>HYDROCHLORIDE<br>TABLETS<br>USP<br>30<br>MG(EACH<br>UNCOATED TABLET CONTAINS:<br>BUSPIRONE<br>HYDROCHLORIDE USP 30 MG [IN<br>WHICH<br>ACTIVE<br>INGREDIENT<br>BUSPIRONE<br>HYDROCHLORIDE<br>USED IS 459.500 KGS.])<br>1 Number<br>5<br>BUSPIRONE HYDROCHLORID E EP<br>/ BP / IP / USP / PH. EUR.<br>30.6 mg / tablet<br>RA concerned may take further necessary action as per above decision of NC.	UNCOATED TABLET CONTAINS:<br>BUSPIRONE<br>HYDROCHLORIDE USP 10 MG)
	BUSPIRONE<br>HYDROCHLORIDE<br>TABLETS<br>USP<br>15<br>MG(EACH<br>UNCOATED TABLET CONTAINS:<br>BUSPIRONE<br>HYDROCHLORIDE USP 15 MG)<br>	<br> <br> <br>1 Number	4<br> <br>	BUSPIRONE HYDROCHLORID E EP<br>/ BP / IP / USP / PH. EUR.<br>	15.3 mg / tablet
	BUSPIRONE<br>HYDROCHLORIDE<br>TABLETS<br>USP<br>30<br>MG(EACH<br>UNCOATED TABLET CONTAINS:<br>BUSPIRONE<br>HYDROCHLORIDE USP 30 MG [IN<br>WHICH<br>ACTIVE<br>INGREDIENT<br>BUSPIRONE<br>HYDROCHLORIDE<br>USED IS 459.500 KGS.])<br>	<br> <br> <br> <br> <br> <br>1 Number	5<br> <br>	BUSPIRONE HYDROCHLORID E EP<br>/ BP / IP / USP / PH.

Case No.	Case No.	118 / NC/3/MEET/Dec/202324/17	118 / NC/3/MEET/Dec/202324/17	118 / NC/3/MEET/Dec/202324/17	118 / NC/3/MEET/Dec/202324/17	118 / NC/3/MEET/Dec/202324/17
Case Status		Case Approved
Party Name		EMCURE PHARMACEUTICALS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number		HQRNORM REVIW00001969AM24
RA File Number		31AX04000077 AM22
Licence No and Date		3111001114/02/03/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>CIPROBIOTIC FORT TAB 500MG<br>(CIPROFLOXACIN<br>TABLETS<br>500MG) (EACH FILM COATED<br>TABLET<br>1 Number<br>1<br>CIPROFLOXACIN<br>HYDROCHLORIDE USP<br>(Ciprofloxacin<br>Hydrochloride<br>Monohydrate)<br>582.21mg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	CIPROBIOTIC FORT TAB 500MG<br>(CIPROFLOXACIN<br>TABLETS<br>500MG) (EACH FILM COATED<br>TABLET		<br> <br> <br>1 Number	1	CIPROFLOXACIN<br>HYDROCHLORIDE USP<br>(Ciprofloxacin<br>Hydrochloride<br>Monohydrate)	<br>582.21mg.

MG (CIPROFLOXACIN TABLETS 500MG) (EACH FILM COATED TABLET|| 1 Number|1|CIPROFLOXACIN HYDROCHLORIDE USP (Ciprofloxacin Hydrochloride Monohydrate)| 582.21mg.|

Case No.	Case No.	118 / NC/3/MEET/Dec/202324/17	118 / NC/3/MEET/Dec/202324/17	118 / NC/3/MEET/Dec/202324/17	118 / NC/3/MEET/Dec/202324/17	118 / NC/3/MEET/Dec/202324/17
Case Status		Case Approved
Party Name		EMCURE PHARMACEUTICALS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number		HQRNORM REVIW00001969AM24
RA File Number		31AX04000077 AM22
Licence No and Date		3111001114/02/03/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>CIPROBIOTIC FORT TAB 500MG<br>(CIPROFLOXACIN<br>TABLETS<br>500MG) (EACH FILM COATED<br>TABLET<br>1 Number<br>1<br>CIPROFLOXACIN<br>HYDROCHLORIDE USP<br>(Ciprofloxacin<br>Hydrochloride<br>Monohydrate)<br>582.21mg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	CIPROBIOTIC FORT TAB 500MG<br>(CIPROFLOXACIN<br>TABLETS<br>500MG) (EACH FILM COATED<br>TABLET		<br> <br> <br>1 Number	1	CIPROFLOXACIN<br>HYDROCHLORIDE USP<br>(Ciprofloxacin<br>Hydrochloride<br>Monohydrate)	<br>582.21mg.

UDIN00462819AM24

ABLETS 500MG) (EACH FILM COATED TABLET|| 1 Number|1|CIPROFLOXACIN HYDROCHLORIDE USP (Ciprofloxacin Hydrochloride Monohydrate)| 582.21mg.|

UDIN00462819AM24

CONTAIN<br>:<br>CIPROFLOXACIN
HYDROCHLORIDE<br>USP
EQUIVALENT<br>TO
CIPROFLOXACIN 500 MG [NET
WEIGHT 2577.33 KG])

Case No.	119 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00006124AM24
RA File Number	08AX04000605 AM22
Licence No and<br>Date	0811004316/08/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case alongwith relevant documents.		Personal Hearing

Case No.	120 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	AARTI INDUSTRIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM APPLY 00386427AM22
RA File Number	03AX04001504 AM22
Licence No and<br>Date	0311012791/14/03/2022

|Meeting Number and Date|NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023| |HQ File Number|HQRNORM APPLY 00386427AM22| |RA File Number|03AX04001504 AM22| |Licence No and Date|0311012791/14/03/2022| |Norms Committee Decision: The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following information/documents from the firm:- End-Use of the export item. 1. Complete and Balanced chemical reactions with molar weight and pertentage yield on molar basis for each step. 2. Step-wise Material balance showing requirement and recovery of Tetra Hydro Furan (THF). 3.||

Complete and Balanced chemical reactions with molar weight and pertentage yield on molar basis for each step.

Case No.	121 / NC/3/MEET/Dec/202324/17
Case Status	Case Approved
Party Name	AETHER INDUSTRIES LIMITED

UDIN00462819AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM APPLY 00386506AM22
RA File Number	52AX04000090 AM22
Licence No and<br>Date	5211002165/14/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc 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>S.No.<br>Import Item<br>**Qty.

o fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty S.No. Import Item Qty. allowed 1 2,6-DICHLOROTOLUENE 1.90 kg 2 TETRAHYDROFURAN 1.50 kg 3-METHOXY-2-METHYLLENZOYL CHLORIDE. 1 Kg 3 DIMETHYLSULFOXIDE 1.37 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	122 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00006448AM24
RA File Number	03AX04000062 AM23
Licence No and<br>Date	0311013759/11/04/2022
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.<br>Details of indigenous input with quantity.<br>v.

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

UDIN00462819AM24

tity.** v.||

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

UDIN00462819AM24

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

Case No.	123 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM APPLY 00000912AM23
RA File Number	09AX04000058 AM23
Licence No and<br>Date	0911003033/20/05/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	124 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00000608AM24
RA File Number	05AX04000553 AM23
Licence No and<br>Date	0511012820/26/05/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00000608AM24| |RA File Number|05AX04000553 AM23| |Licence No and Date|0511012820/26/05/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	125 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00005924AM23
RA File Number	03AX04001050 AM23
Licence No and<br>Date	0311015297/07/06/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	126 / NC/3/MEET/Dec/202324/17
Case Status	Case Deferred
PartyName	BRAWN LABORATORIES LIMITED

87 This document has been digitally signed by Raman Kumar, Deputy DGFT on 31-01-2024 15:53:42.

UDIN00462819AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number	HQRNORM REVIW00006171AM23
RA File Number	05AX04000865 AM23
Licence No and<br>Date	0511013337/21/06/2022
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Justificaton for enhancement in the quantity of import item.<br>1.

est of firm for review of ad-hoc norms and it was decided to call for following information/documents from the firm:- Justificaton for enhancement in the quantity of import item. 1.||

Case No.	Case No.	Case No.	127 / NC/3/MEET/Dec/202324/17	127 / NC/3/MEET/Dec/202324/17	127 / NC/3/MEET/Dec/202324/17	127 / NC/3/MEET/Dec/202324/17	127 / NC/3/MEET/Dec/202324/17
Case Status			Case Approved
Party Name			CIPLA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202324/ 17 and 20/12/2023
HQ File Number			HQRNORM REVIW00000259AM24
RA File Number			03AX04001871 AM23
Licence No and<br>Date			0311015826/24/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jan/202122/13 dated 21/01/2022against advance<br>authorization**No.031100

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