IN FORCE Advance Authorisation

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Government of India / भारत सरकार

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

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

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Jun/202324/6 DATED: 14/06/2023

Please Note

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

Meeting No. NC/3/MEET/Jun/202324/6 dated 14/06/2023 of Norms Committee - III for the year 2023-24 was held on 14/06/2023 under the Chairmanship of Rajiv Soni ,Joint DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

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

The following members were present in the meeting:-

	Name and Designation of Representatives
1	T SONGZALIAN,Deputy DGFT	DGFT(HQ)
2	UTTAM SARKAR,Assistant Section Officer	DGFT(HQ)
3	NAND Lal,Technical Consultant	DPIIT
4	SHAISH KUMAR,Technical Consultant	DGFT
5	DINESHNARAIN MATHUR,Technical<br>Consultant	DGFT
6	Nand Lal,Technical Consultant	DGFT

This document has been digitally signed by T SONGZALIAN, Deputy DGFT on 19-07-2023 17:59:03.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Jun/202324/6
Case Status	Case Rejected
Party Name	AQUILA ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00005454AM23
RA File Number	NA
Licence No and<br>Date	0310830783/null
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,<br>the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	2 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	ADCOCK INGRAM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00005419AM23
RA File Number	NA
Licence No and<br>Date	0710104124/15/05/2014
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the application of the firm had already been<br>approved in meetingNo.6/82/ALC-4/2014 dated 29/08/2014. Hence, the Committee decided towithdraw the application

and it was observed that the application of the firm had already been approved in meetingNo.6/82/ALC-4/2014 dated 29/08/2014. Hence, the Committee decided towithdraw the application||

Case No.	3 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	REYAANSH HEALTHCARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM REVIW00004873AM23
RA File Number	039504000872 AM18
Licence No and<br>Date	0310818545/16/01/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less: -

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Export Product	Qty.	Sl. No.	Import Items	Qty.
SELAMECTIN 6% SPOT on 0.25 ML TUBE	42600.000	1	SELAMECTIN	7.375 kg.
(Pack Size 3 Tubes x 0.25ML) (NT.WT.0.63
KGS 14200 CARTONS (For Veterinary Use	Number
only)
SELAMECTIN 6% SPOT on 0.50 ML TUBE	63600.000 Number
(Pack Size 3 Tubes x 0.50 ML) (NT.WT.1.90
KGS 21200 CARTONS (For Veterinary Use
only)
SELAMECTIN 6% SPOT on 0.75 ML TUBE	69600.000
(Pack Size 3 Tubes x 0.75 ML) (NT.WT.3.13
KGS 23200 CARTONS (For Veterinary Use	Number
only)
SELAMECTIN 6% SPOT on 1 ML TUBE	7425.000 Number
(Pack Size 3 Tubes x 1 ML) (NT.WT.0.44 KGS
2475 CARTONS (For Veterinary Use only)
SELAMECTIN 6% SPOT on 2 ML TUBE	9465.000 Number
(Pack Size 3 Tubes x 2 ML) (NT.WT.1.13 KGS

||| |(Pack Size 3 Tubes x 1 ML) (NT.WT.0.44 KGS||||| |2475 CARTONS (For Veterinary Use only)||||| |SELAMECTIN 6% SPOT on 2 ML TUBE|9465.000 Number|||| |(Pack Size 3 Tubes x 2 ML) (NT.WT.1.13 KGS||||| |3155 CARTONS (For Veterinary Use only)|||||

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

Case No.	4 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	CROPNOSYS (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM REVIW00005535AM23
RA File Number	039404000527 AM19
Licence No and<br>Date	0310823957/24/09/2018
Norms Committee Decision:
The case is under	consideration for want for comments from TE.

Case No.	5 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved

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Party Name	REYAANSH HEALTHCARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM REVIW00005644AM23
RA File Number	018205000964 AM20
Licence No and<br>Date	0310833938/06/01/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.

tion of ad-hoc norms and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. SELAMECTIN SIX PERCENT SPOT ON 0.25ML TUBE NET QUANTITY OF SELAMECTIN 1.980 KGS (SELAMECTIN 60 MG/ML) 120000.0 CARTON 1 SELAMECTIN 1.836 kg. SELAMECTIN SIX PERCENT SPOT ON 0.50ML TUBE NET QUANTITY OF SELAMECTIN 6.60 KGS (SELAMECTIN 60 MG/ML) 200000.0 CARTON 2 SELAMECTIN 6.120 kg. SELAMECTIN SIX PERCENT SPOT ON 0.75ML TUBE NET QUANTITY OF SELAMECTIN 7.425 KGS (SELAMECTIN 60 MG/ML) 150000.0 CARTON 3 SELAMECTIN 6.885 kg. SELAMECTIN SIX PERCENT SPOT ON 1 ML TUBE NET QUANTITY OF SELAMECTIN 5.940 KGS (SELAMECTIN 60 MG/ML) 90000.0 CARTON 4 SELAMECTIN 5.508 kg. SELAMECTIN SIX PERCENT SPOT ON 4ML TUBE NET QUANTITY OF SELAMECTIN 2.376 KGS (SELAMECTIN 60 MG/ML) 9000.0 CARTON 5 SELAMECTIN 2.203 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	6 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	DELTA FINOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM REVIW00003546AM23
RA File Number	039404000112 AM21
Licence No and	0310836419/29/05/2020

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Date

Norms Committee Decision:

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

Manufacturing process indicating stage wise with justification of 75% yield.
Start the reaction with liquid Bromine and Hexamine and Iso Propyle Alcohol giving molecular height of reactants and products.
Also submit one shipping bill of the export product along with export and import product statement of the said Authorization.

Case No.<br>7 / NC/3/MEET/Jun/202324/6
Case Status<br>Case Approved
Party Name<br>DELTA FINOCHEM PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202324/ 6 and	14/06/2023
HQ File Number<br>HQRNORM APPLY 00000298AM23
RA File Number<br>03AX04002053 AM22
Licence No and<br>Date<br>0311013980/19/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para			4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items		Qty.
N-Cetyl<br>Bromide<br>(1-<br>Bromo<br>1 kg.	1	Ecorol 16/99P (Cetyl Alcohol)		0.835 kg.
Hexadecane)
	2	Liquid Bromine		0.276 kg.
RA concerned may take further necessary action as per above decision of NC.

br>Bromo 1 kg.|1|Ecorol 16/99P (Cetyl Alcohol)||0.835 kg.|| |Hexadecane)|||||| ||2|Liquid Bromine||0.276 kg.|| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	8 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	REYAANSH HEALTHCARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00001972AM23
RA File Number	03AX04002163 AM23
Licence No and<br>Date	0311016269/11/07/2022

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Norms Committee Decision:

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

Export Product	Qty.	Sl. No.	Import Items	Qty.(in gm)
IMPACT SOLUTION FOR CATS 0.40 ML.(Packing 3 Tubes X<br>0.40 ml) (IMPACT SOLUTION FOR CATS 0.40 ML. Each ml<br>contains Imidacloprid 100 mg + Moxidectin 10 mg. Moxidectin<br>consumed including wastages & overages :- 0.224 Kgs)	51000.0<br>Number	1	Moxidectin	208.08
IMPACT SOLUTION FOR CATS 0.80 ML.(Packing 3 Tubes X<br>0.80 ml)(IMPACT SOLUTION FOR CATS 0.80 ML.<br>Each ml contains Imidacloprid 100 mg + Moxidectin 10 mg.<br>Moxidectin consumed including wastages & overages :- 0.528<br>Kgs.)	60000.0<br>Number	2	Moxidectin	489.60
IMPACT SOLUTION FOR DOGS 0.40 ML.(Packing 3 Tubes X<br>0.40 ml )(IMPACT SOLUTION FOR DOGS 0.40 ML. Each ml<br>contains Imidacloprid 100 mg + Moxidectin 25 mg. Moxidectin<br>consumed including wastages & overages :- 0.594 Kgs)	54000.0<br>Number	3	Moxidectin	550.80
IMPACT SOLUTION FOR DOGS 1 ML.(Packing 3 Tubes X 1 ml<br>)(IMPACT SOLUTION FOR DOGS 1 ML. Each ml<br>contains Imidacloprid 100 mg + Moxidectin 25 mg. Moxidectin<br>consumed including wastages & overages :- 1.650 Kgs)	60000.0<br>Number	4	Moxidectin	1530.00
IMPACT SOLUTION FOR DOGS 4 ML.(Packing 3 Tubes X 4 ml<br>)(IMPACT SOLUTION FOR DOGS 4 ML. Each ml<br>contains Imidacloprid 100 mg + Moxidectin 25 mg.

650 Kgs)|60000.0 Number|4|Moxidectin|1530.00| |IMPACT SOLUTION FOR DOGS 4 ML.(Packing 3 Tubes X 4 ml )(IMPACT SOLUTION FOR DOGS 4 ML. Each ml contains Imidacloprid 100 mg + Moxidectin 25 mg. Moxidectin consumed including wastages & overages :- 1.980 Kgs)|18000.0 Number|5|Moxidectin|1836.00| |IMPACT SOLUTION FOR DOGS 2.5 ML.(Packing 3 Tubes X 2.5 ML )(IMPACT SOLUTION FOR DOGS 2.5 ML. Each ml contains Imidacloprid 100 mgs + Moxidectin 25 mg. Moxidectin consumed including wastages & overage 1.031 Kgs)| 15000.0 Number|6|Moxidectin|956.33|

Case No.	9 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved

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Party Name	Party Name	REYAANSH HEALTHCARE	REYAANSH HEALTHCARE	REYAANSH HEALTHCARE	REYAANSH HEALTHCARE	REYAANSH HEALTHCARE
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00004021AM23
RA File Number		03AX04003763 AM23
Licence No and<br>Date		0311018994/02/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>(in kg.)<br>Selamectin 6% Spot On 0.25 ml Tube.

HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. (in kg.) Selamectin 6% Spot On 0.25 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 1.299 Kg.(Net Content of Selamectin is 1.181 kg).) 78720.0 Number 1 SELAMECTIN 1.299 Selamectin 6% Spot On 0.50 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 5.271 Kg. (Net Content of Selamectin is 4.792 kg.)) 159720.0 Number 2 SELAMECTIN 5.271 Selamectin 6% Spot On 0.75 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 10.247 Kg. (Net Content of Selamectin is 9.315 kg).) 207000.0 Number 3 SELAMECTIN 10.247 Selamectin 6% Spot On 1 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 5.306 Kg. (Net Content of Selamectin is 4.824 kg).) 80400.0 Number 4 SELAMECTIN 5.306 Selamectin 6% Spot On 2 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 4.435 Kg. (Net Content of Selamectin is 4.032 kg).) 33600.0 Number 5 SELAMECTIN 4.113 Selamectin 6% Spot On 4 ml Tube.

y of Selamectin Consumed Including Wastages & Overages : 4.435 Kg. (Net Content of Selamectin is 4.032 kg).) 33600.0 Number 5 SELAMECTIN 4.113 Selamectin 6% Spot On 4 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 3.453 Kg.(Net Content of Selamectin is 3.139 kg.)) 13080.0 Number 6 SELAMECTIN 3.453||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. (in kg.)| ||Selamectin 6% Spot On 0.25 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 1.299 Kg.(Net Content of Selamectin is 1.181 kg).)|| 78720.0 Number|1|SELAMECTIN|1.299| ||Selamectin 6% Spot On 0.50 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 5.271 Kg. (Net Content of Selamectin is 4.792 kg.))|| 159720.0 Number|2|SELAMECTIN|5.271| ||Selamectin 6% Spot On 0.75 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 10.247 Kg. (Net Content of Selamectin is 9.315 kg).)|| 207000.0 Number|3|SELAMECTIN|10.247| ||Selamectin 6% Spot On 1 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 5.306 Kg. (Net Content of Selamectin is 4.824 kg).)||80400.0 Number|4|SELAMECTIN|5.306| ||Selamectin 6% Spot On 2 ml Tube.

Net Quantity of Selamectin Consumed Including Wastages & Overages : 5.306 Kg. (Net Content of Selamectin is 4.824 kg).)||80400.0 Number|4|SELAMECTIN|5.306| ||Selamectin 6% Spot On 2 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 4.435 Kg. (Net Content of Selamectin is 4.032 kg).)||33600.0 Number|5|SELAMECTIN|4.113| ||Selamectin 6% Spot On 4 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 3.453 Kg.(Net Content of Selamectin is 3.139 kg.))||13080.0 Number|6|SELAMECTIN|3.453|

Party Name	Party Name	REYAANSH HEALTHCARE	REYAANSH HEALTHCARE	REYAANSH HEALTHCARE	REYAANSH HEALTHCARE	REYAANSH HEALTHCARE
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00004021AM23
RA File Number		03AX04003763 AM23
Licence No and<br>Date		0311018994/02/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>(in kg.)<br>Selamectin 6% Spot On 0.25 ml Tube. Each ml Contains<br>Selamectin 60 mg(Net Quantity of Selamectin Consumed<br>Including Wastages & Overages : 1.299 Kg.(Net Content of<br>Selamectin is 1.181 kg).)<br> 78720.0<br>Number<br>1<br>SELAMECTIN<br>1.299<br>Selamectin 6% Spot On 0.50 ml Tube.

f Selamectin Consumed Including Wastages & Overages : 1.299 Kg.(Net Content of Selamectin is 1.181 kg).) 78720.0 Number 1 SELAMECTIN 1.299 Selamectin 6% Spot On 0.50 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 5.271 Kg. (Net Content of Selamectin is 4.792 kg.)) 159720.0 Number 2 SELAMECTIN 5.271 Selamectin 6% Spot On 0.75 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 10.247 Kg. (Net Content of Selamectin is 9.315 kg).) 207000.0 Number 3 SELAMECTIN 10.247 Selamectin 6% Spot On 1 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 5.306 Kg. (Net Content of Selamectin is 4.824 kg).) 80400.0 Number 4 SELAMECTIN 5.306 Selamectin 6% Spot On 2 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 4.435 Kg. (Net Content of Selamectin is 4.032 kg).) 33600.0 Number 5 SELAMECTIN 4.113 Selamectin 6% Spot On 4 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 3.453 Kg.(Net Content of Selamectin is 3.139 kg.)) 13080.0 Number 6 SELAMECTIN 3.453||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. (in kg.)| ||Selamectin 6% Spot On 0.25 ml Tube.

Net Content of Selamectin is 3.139 kg.)) 13080.0 Number 6 SELAMECTIN 3.453||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. (in kg.)| ||Selamectin 6% Spot On 0.25 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 1.299 Kg.(Net Content of Selamectin is 1.181 kg).)|| 78720.0 Number|1|SELAMECTIN|1.299| ||Selamectin 6% Spot On 0.50 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 5.271 Kg. (Net Content of Selamectin is 4.792 kg.))|| 159720.0 Number|2|SELAMECTIN|5.271| ||Selamectin 6% Spot On 0.75 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 10.247 Kg. (Net Content of Selamectin is 9.315 kg).)|| 207000.0 Number|3|SELAMECTIN|10.247| ||Selamectin 6% Spot On 1 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 5.306 Kg. (Net Content of Selamectin is 4.824 kg).)||80400.0 Number|4|SELAMECTIN|5.306| ||Selamectin 6% Spot On 2 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 4.435 Kg. (Net Content of Selamectin is 4.032 kg).)||33600.0 Number|5|SELAMECTIN|4.113| ||Selamectin 6% Spot On 4 ml Tube.

Net Quantity of Selamectin Consumed Including Wastages & Overages : 4.435 Kg. (Net Content of Selamectin is 4.032 kg).)||33600.0 Number|5|SELAMECTIN|4.113| ||Selamectin 6% Spot On 4 ml Tube. Each ml Contains Selamectin 60 mg(Net Quantity of Selamectin Consumed Including Wastages & Overages : 3.453 Kg.(Net Content of Selamectin is 3.139 kg.))||13080.0 Number|6|SELAMECTIN|3.453|

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Case No.	10 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	REYAANSH HEALTHCARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00004769AM23
RA File Number	03AX04004317 AM23
Licence No and<br>Date	0311019713/02/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<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.<br>Maropitant Injection 10 mg / ml(Each ml contains:<br>Maropitant Citrate 14.484 mg. Equivalent to<br>Maropitant 10 mg. Pack Size: 20 ml. Total<br>Maropitant Citrate Consumed along with wastages &<br>overages - 1 Kg.)<br>1 Number<br>1<br>Maropitant Citrate<br>Monohydrate<br>304.135 mg.<br>RA concerned may take further necessary action as per above decision of NC.

med along with wastages & overages - 1 Kg.) 1 Number 1 Maropitant Citrate Monohydrate 304.135 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	11 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	EMCURE PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006566AM23
RA File Number	NA
Licence No and<br>Date	3111001908/23/12/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. 15/82-ALC4/2018dated22/03/2019against advance authorization<br>No.3110067194dated10/10/2018, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details

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gi<br>RA	ven below or as applied by the firm, whichever is less:-	ven below or as applied by the firm, whichever is less:-	ven below or as applied by the firm, whichever is less:-	ven below or as applied by the firm, whichever is less:-	ven below or as applied by the firm, whichever is less:-
	Export Product	Qty.	Sl. No.	Import Items	Qty.
	CIPROBIOTIC FORTE TAB 500MG<br>(CIPROFLOXACIN TABLETS<br>500MG)(EACH FILM COATED<br>TABLET CONTAIN :<br>CIPROFLOXACIN<br>HYDROCHLORIDE USP<br>EQUIVALENT TO CIPROFLOXACIN<br>500 MG [NET WEIGHT 4300 KG])	One 500 mg.<br>tablet	1	CIPROFLOXACIN HCL USP	555.0 mg./ 500<br>mg.

ILM COATED TABLET CONTAIN : CIPROFLOXACIN HYDROCHLORIDE USP EQUIVALENT TO CIPROFLOXACIN 500 MG [NET WEIGHT 4300 KG])|One 500 mg. tablet|1|CIPROFLOXACIN HCL USP|555.0 mg./ 500 mg. Tablet| ||concerned may take further necessary action as per above decision of NC.|||||

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

Case No.	Case No.	12 / NC/3/MEET/Jun/202324/6	12 / NC/3/MEET/Jun/202324/6	12 / NC/3/MEET/Jun/202324/6	12 / NC/3/MEET/Jun/202324/6	12 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		MERIDIAN ENTERPRISES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00005783AM23
RA File Number		03AX04004956 AM23
Licence No and<br>Date		0311020765/17/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>in meeting No.NC/3/MEET/Nov/202223/12dated18/11/2022against advance authorization No.0311013150dated21/03/2022,<br>it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever<br>is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Dequalinium Chloride Oral Spray (Dequadin Oral<br>Spray) 25 ML Bottle. (Each ml contains: Dequalinium<br>Chloride 0.5 percent(Dequalinium Chloride Oral<br>Spray (Dequadin Oral Spray) 25 ML Bottle.

br>Dequalinium Chloride Oral Spray (Dequadin Oral Spray) 25 ML Bottle. (Each ml contains: Dequalinium Chloride 0.5 percent(Dequalinium Chloride Oral Spray (Dequadin Oral Spray) 25 ML Bottle. (Each ml contains: Dequalinium Chloride 0.5 percent (net content of Input per ml=5mg,Net content per 25ml bottle = 125mg Total net content = 3.2353 kgs)) 1 Number 1 Dequalinium Chloride 127.50 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Dequalinium Chloride Oral Spray (Dequadin Oral Spray) 25 ML Bottle. (Each ml contains: Dequalinium Chloride 0.5 percent(Dequalinium Chloride Oral Spray (Dequadin Oral Spray) 25 ML Bottle. (Each ml contains: Dequalinium Chloride 0.5 percent (net content of Input per ml=5mg,Net content per 25ml bottle = 125mg Total net content = 3.2353 kgs))|| 1 Number|1|Dequalinium Chloride|127.50 mg.|

UDIN00181221AM24

Case No.	13 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	SHARON BIO-MEDICINE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00005790AM23
RA File Number	03AX04005196 AM23
Licence No and<br>Date	0311020778/18/01/2023
Norms Committee Decision:<br>Submit one shipping bill complete set of the export product along with export and import product statement of<br>the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this<br>case.

product along with export and import product statement of** the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.||

Case No.	Case No.	14 / NC/3/MEET/Jun/202324/6	14 / NC/3/MEET/Jun/202324/6	14 / NC/3/MEET/Jun/202324/6	14 / NC/3/MEET/Jun/202324/6	14 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		MERIDIAN ENTERPRISES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00005789AM23
RA File Number		03AX04004961 AM23
Licence No and<br>Date		0311020771/18/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Dequalinium Chloride Oral Spray (Dequadin Oral<br>Spray) 25 ML Bottle. (Each ml contains: Dequalinium<br>Chloride 0.5 percent(Dequalinium Chloride Oral<br>Spray (Dequadin Oral Spray) 25 ML Bottle. (Each ml<br>contains: Dequalinium Chloride 0.5 percent (net<br>content of Input per ml=5mg,Net content per 25ml<br>bottle = 125mg Total net content = 3.2353 kgs))<br>1 Number<br>1<br>Dequalinium Chloride<br>126.90 mg. per<br>Bottle
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Dequalinium Chloride Oral Spray (Dequadin Oral<br>Spray) 25 ML Bottle.

1 Number 1 Dequalinium Chloride 126.90 mg. per Bottle||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Dequalinium Chloride Oral Spray (Dequadin Oral Spray) 25 ML Bottle. (Each ml contains: Dequalinium Chloride 0.5 percent(Dequalinium Chloride Oral Spray (Dequadin Oral Spray) 25 ML Bottle. (Each ml contains: Dequalinium Chloride 0.5 percent (net content of Input per ml=5mg,Net content per 25ml bottle = 125mg Total net content = 3.2353 kgs))|| 1 Number|1|Dequalinium Chloride|126.90 mg. per Bottle| ||||||||

UDIN00181221AM24

Case No.	Case No.	15 / NC/3/MEET/Jun/202324/6	15 / NC/3/MEET/Jun/202324/6	15 / NC/3/MEET/Jun/202324/6	15 / NC/3/MEET/Jun/202324/6	15 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		ROYAL PHARMA
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00005811AM23
RA File Number		03AX04005198 AM23
Licence No and<br>Date		0311020795/19/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>in meetingNo.NC/3/MEET/Dec/202223/15dated29/12/2022against advance authorizationNo.0311015473 dated 13/06/2022,<br>it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever<br>is less:-<br>Export Product<br>Qty.<br>Sl.

3 dated 13/06/2022**, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 N - [4-CYANO-3- (TRIFLUORO METHYL) PHENYL] METHACRYLAMIDE 0.709 kg. BICALUTAMIDE SULFIDE(CHEMICAL NAME: N-[4-CYANO-3-(TRIFLUORO METHYL)PHENYL]-3-[(4- FLUOROPHENYL THIO)] -2-HYDROXY-2-METHYL PROPIONALIDE) 1 kg. 2 4- FLUOROTHIOPHENOL 0.30 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||BICALUTAMIDE SULFIDE(CHEMICAL NAME: N-[4-CYANO-3-(TRIFLUORO METHYL)PHENYL]-3-[(4- FLUOROPHENYL THIO)] -2-HYDROXY-2-METHYL PROPIONALIDE)||1 kg.|1|N - [4-CYANO-3- (TRIFLUORO METHYL) PHENYL] METHACRYLAMIDE|0.709 kg.| |||||2|4- FLUOROTHIOPHENOL|0.30 kg.| ||concerned may take further necessary action as per above decision of NC.||||||

.|1|N - [4-CYANO-3- (TRIFLUORO METHYL) PHENYL] METHACRYLAMIDE|0.709 kg.| |||||2|4- FLUOROTHIOPHENOL|0.30 kg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	16 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	SUVEN PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006169AM23
RA File Number	09AX04000957 AM23
Licence No and<br>Date	0911004428/08/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Mar/202223/24 dated 13/04/2023against advance<br>authorizationNo.0911002860dated19/04/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I

UDIN00181221AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
1,2,3,5-Tetra-O-acetyl-B-L-<br>Ribofuranose<br>(POWDER)	<br>1 kg.	1	METHYL ISO BUTYL KETONE	1.840 kg.
		2	L RIBOSE	0.842 kg.

port Product	Qty.	Sl. No.	Import Items	Qty.
1,2,3,5-Tetra-O-acetyl-B-L-<br>Ribofuranose<br>(POWDER)	<br>1 kg.	1	METHYL ISO BUTYL KETONE	1.840 kg.
		2	L RIBOSE	0.842 kg.

Case No.	17 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	ALTA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006166AM23
RA File Number	03AX04005444 AM23
Licence No and<br>Date	0311021244/08/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>in meetingNo.NC/3/MEET/Nov/202223/12dated18/11/2022against advance authorizationNo. 5211002509dated19/05/2022,<br>it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever<br>is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>PARAHYDROXY BENZOIC ACID<br>0.97 kg.<br>METHYL PARABEN(METHYL PARABEN)<br>1 kg.<br>2<br>METHANOL<br>0.50 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	18 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
PartyName	REYAANSH HEALTHCARE

UDIN00181221AM24

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

Case No.	18 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
PartyName	REYAANSH HEALTHCARE

UDIN00181221AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006176AM23
RA File Number	03AX04005439 AM23
Licence No and<br>Date	0311021258/08/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>in meetingNo. NC/3/MEET/Sep/202223/9dated07/10/2022against advance authorizationNo. 0311011529dated18/02/2022<br>, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever<br>is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>SELAMECTIN 6% SPOT ON 0.25 ML TUBE(Each ml<br>Contains Selamectin 60 mg Net Quantity of Selamectin<br>Consumed Including Wastages & Overages : 1.100 Kg.<br>(Net Content of Selamectin is 1 kg))<br>100 Numbers<br>1<br>SELAMECTIN<br>1.53 gram<br>SELAMECTIN 6% SPOT ON 0.75 ML TUBE(Each ml<br>Contains Selamectin 60 mg Net Quantity of Selamectin<br>Consumed Including Wastages & Overages : 1 Kg. (Net<br>content of Selamectin is 0.9099 kg))<br>100 Numbers<br>1<br>SELAMECTIN<br>4.59 gram<br>RA concerned may take further necessary action as per above decision of NC.

ages & Overages : 1 Kg. (Net content of Selamectin is 0.9099 kg)) 100 Numbers 1 SELAMECTIN 4.59 gram RA concerned may take further necessary action as per above decision of NC.||

Case No.	19 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006206AM23
RA File Number	09AX04001006 AM23
Licence No and<br>Date	0911004437/09/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>in meetingNo. NC/3/MEET/Jan/202223/18dated23/01/2023against advance authorizationNo. 0911003684dated23/09/2022<br>, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever<br>is less:-

UDIN00181221AM24

4dated23/09/2022** , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||

UDIN00181221AM24

Export product	Qty.	Sl. No.	Import items	Qty.
sodium<br>(S)-4-oxo-4,6,7,8-tetrahydropyrrolo<br>[1,2-<br>a]pyrimidine-6-carboxylate((Pyrimidinone<br>acid,<br>sodium<br>salt))	<br>1 kg	1	L Pyroglutamic Acid	2.70 kg
		2	Triethyl Amine	2.27 kg
		3	2,5-Norbornadiene	1.73 kg
		4	Chloro Sulfonyl Isocyanate	2.778 kg
		5	Isopropyl Alcohol	4.02 kg
		6	Methyl Tert Butyl Ether	5.91 kg
		7	Toluene	5.72 Litre
		8	Ethyl Acetate	2.95 Litre
		9	N-Heptane	1.82 kg
		10	Ethyl Benzene	1.00 kg
		11	Methanol	1.50 kg
		12	Methylene Chloride	3.25 Litre

utyl Ether|5.91 kg| ||||7|Toluene|5.72 Litre| ||||8|Ethyl Acetate|2.95 Litre| ||||9|N-Heptane|1.82 kg| ||||10|Ethyl Benzene|1.00 kg| ||||11|Methanol|1.50 kg| ||||12|Methylene Chloride|3.25 Litre|

Case No.	20 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006211AM23
RA File Number	05AX04003224 AM23
Licence No and<br>Date	0511017283/09/02/2023
Norms Committee Decision:

UDIN00181221AM24

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/May/202324/5 dated 08/06/2023 against advance authorization No.0511013507 dated 30/06/2022 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.
Choline Chloride 60% Aqueous	1 kg.	1	Ethylene Oxide	0.197 kg.
		2	Trimethyl Amine	0.261 kg.

e firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.
Choline Chloride 60% Aqueous	1 kg.	1	Ethylene Oxide	0.197 kg.
		2	Trimethyl Amine	0.261 kg.

Case No.	21 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006186AM23
RA File Number	03AX04005398 AM23
Licence No and<br>Date	0311021275/09/02/2023
Norms Committee Decision:
Submit one shipping bill complete set of the export product along with export and import product statement of the said
Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.

Case No.<br>22 / NC/3/MEET/Jun/202324/6
Case Status<br>Case Approved
Party Name<br>ADCOCK INGRAM LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number<br>HQRNORM APPLY 00006192AM23
RA File Number<br>07AX04001687 AM23
Licence No and Date<br>0711006394/09/02/2023
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00181221AM24

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

UDIN00181221AM24

Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>PYRIDOSTIGMINE BROMIDE<br>PH.EUR<br>10.2 mg.<br>1(PYRIDOSTIGMINE BROMIDE<br>10mg+LACTOSE MONOHYDRATE-<br>30mg Tablets (MESTINON 10mg Tablets,<br>PYRIDOSTIGMINE 30.00<br>KGS+LACTOSE 90.00 KGS, No of Tabs<br>3000000) PH.EUR)<br>1<br>NumberTablet<br>2<br>LACTOSE MONOHYDRATE-<br>PHARMATOSE 350M PH.EUR<br>30.00 mg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty.
	1(PYRIDOSTIGMINE BROMIDE<br>10mg+LACTOSE MONOHYDRATE-<br>30mg Tablets (MESTINON 10mg Tablets,<br>PYRIDOSTIGMINE 30.00<br>KGS+LACTOSE 90.00 KGS, No of Tabs<br>3000000) PH.EUR)	<br>1<br>NumberTablet	1<br>	PYRIDOSTIGMINE BROMIDE<br>PH.EUR	<br>10.2 mg.
			2	LACTOSE MONOHYDRATE-<br>PHARMATOSE 350M PH.EUR	30.00 mg.

br>KGS+LACTOSE 90.00 KGS, No of Tabs 3000000) PH.EUR)| 1 NumberTablet|1 |PYRIDOSTIGMINE BROMIDE PH.EUR| 10.2 mg.| ||||2|LACTOSE MONOHYDRATE- PHARMATOSE 350M PH.EUR|30.00 mg.|

Case No.	Case No.	23 / NC/3/MEET/Jun/202324/6	23 / NC/3/MEET/Jun/202324/6	23 / NC/3/MEET/Jun/202324/6	23 / NC/3/MEET/Jun/202324/6	23 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006204AM23
RA File Number		05AX04003209 AM23
Licence No and<br>Date		0511017281/09/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import<br>product in meeting No.NC/3/MEET/Apr/202324/1dated28/04/2023against advance authorizationNo.0511016533dated<br>26/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. (in kg.)<br>1<br>Pencillin<br>G<br>Potassium<br>First<br>Crystal<br>8.515<br>2<br>METHYLENE<br>CHLORIDE<br>/Dichloromethane<br>76.165<br>3<br>Triethylamine<br>3.214<br>4<br>Methanol<br>41.137<br>CEFTIBUTEN JP(POWDER)<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

METHYLENE CHLORIDE /Dichloromethane 76.165 3 Triethylamine 3.214 4 Methanol 41.137 CEFTIBUTEN JP(POWDER) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. (in kg.)| ||CEFTIBUTEN JP(POWDER)||1 kg.|1|Pencillin G Potassium First Crystal| 8.515| |||||2|METHYLENE CHLORIDE /Dichloromethane| 76.165| |||||3|Triethylamine|3.214| |||||4|Methanol|41.137|

UDIN00181221AM24

==> picture [464 x 326] intentionally omitted <==

----- Start of picture text ----- 5 Ethyl-4-chloroacetoacetate 1.82 6 Methyl-3-methoxy acrylate 1.62 7 Prenol 3.114 8 N,N-Dimethyl Formamide 12.16 9 Acetonitrile 7.50 10 Activated carbon 0.200 11 Acetone 1.20 12 Toluene 23.00 13 Acetic acid 5.50 ----- End of picture text -----

Case No.	Case No.	24 / NC/3/MEET/Jun/202324/6	24 / NC/3/MEET/Jun/202324/6	24 / NC/3/MEET/Jun/202324/6	24 / NC/3/MEET/Jun/202324/6	24 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		MANKIND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006194AM23
RA File Number		05AX04003232 AM23
Licence No and<br>Date		0511017272/09/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.

se as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 6400000.0 DOXEPIN HYDROCHLORIDE CAPSULES USP 10 MG 1 DOXEPIN HCL 72.66 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||DOXEPIN HYDROCHLORIDE CAPSULES USP 10 MG||6400000.0|1|DOXEPIN HCL|72.66 kg.|

UDIN00181221AM24

	Numbers
DOXEPIN HYDROCHLORIDE CAPSULES USP 25 MG	3200000.0<br>Numbers	2	DOXEPIN HCL	90.83 kg.
DOXEPIN HYDROCHLORIDE CAPSULES USP 50 MG	1500000.0<br>Numbers	3	DOXEPIN HCL	85.15 kg.
DOXEPIN HYDROCHLORIDE CAPSULES USP 75 MG	1300000.0<br>Numbers	4	DOXEPIN HCL	110.7 kg.
DOXEPIN HYDROCHLORIDE CAPSULES USP 100 MG	1300000.0<br>Numbers	5	DOXEPIN HCL	147.6 kg.

N HCL|85.15 kg.| ||DOXEPIN HYDROCHLORIDE CAPSULES USP 75 MG|1300000.0 Numbers|4|DOXEPIN HCL|110.7 kg.| ||DOXEPIN HYDROCHLORIDE CAPSULES USP 100 MG|1300000.0 Numbers|5|DOXEPIN HCL|147.6 kg.|

Case No.	Case No.	25 / NC/3/MEET/Jun/202324/6	25 / NC/3/MEET/Jun/202324/6	25 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006238AM23
RA File Number		08AX04001875 AM23
Licence No and<br>Date		0811007267/10/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>in meetingNo. 4/82-ALC4/2019dated19/07/2019against advance authorizationNo.0810142125 dated 08/03/2018, it was<br>decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>SPIRONOLACTONE TABLETS BP 25<br>MG(EACH FILM COATED TABLET<br>CONTAINS: SPIRONOLACTONE<br>PH.EUR. 25 MG)<br>1 Number<br>1<br>SPIRONOLACTONE EP / BP / IP /<br>USP / PH. EUR.<br>25.50 mg per<br>Tablet<br>SPIRONOLACTONE TABLETS BP 50<br>MG(EACH FILM COATED TABLET<br>CONTAINS: SPIRONOLACTONE<br>1 Number<br>2<br>SPIRONOLACTONE EP / BP / IP /<br>USP / PH. EUR.<br>51.00 mg per<br>Tablet
	Export Product		Qty.	Sl.

TABLETS BP 50 MG(EACH FILM COATED TABLET CONTAINS: SPIRONOLACTONE 1 Number 2 SPIRONOLACTONE EP / BP / IP / USP / PH. EUR. 51.00 mg per Tablet||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||SPIRONOLACTONE TABLETS BP 25 MG(EACH FILM COATED TABLET CONTAINS: SPIRONOLACTONE PH.EUR. 25 MG)||1 Number|1|SPIRONOLACTONE EP / BP / IP / USP / PH. EUR.|25.50 mg per Tablet| ||SPIRONOLACTONE TABLETS BP 50 MG(EACH FILM COATED TABLET CONTAINS: SPIRONOLACTONE||1 Number|2|SPIRONOLACTONE EP / BP / IP / USP / PH. EUR.|51.00 mg per Tablet|

UDIN00181221AM24

PH.EUR. 50 MG)<br>SPIRONOLACTONE TABLETS BP 100<br>MG(EACH FILM COATED TABLET<br>CONTAINS: SPIRONOLACTONE<br>PH.EUR. 100 MG [IN WHICH ACTIVE<br>INGREDIENT SPIRONOLACTONE<br>USED IS 116.250 KGS.])<br>1 Number<br>3<br>SPIRONOLACTONE EP / BP / IP /<br>USP / PH. EUR.<br>102.00 mg per<br>tablet<br>RA concerned may take further necessary action as per above decision of NC.	PH.EUR. 50 MG)
	SPIRONOLACTONE TABLETS BP 100<br>MG(EACH FILM COATED TABLET<br>CONTAINS: SPIRONOLACTONE<br>PH.EUR. 100 MG [IN WHICH ACTIVE<br>INGREDIENT SPIRONOLACTONE<br>USED IS 116.250 KGS.])	1 Number	3	SPIRONOLACTONE EP / BP / IP /<br>USP / PH. EUR.	102.00 mg per<br>tablet

Case No.	Case No.	26 / NC/3/MEET/Jun/202324/6	26 / NC/3/MEET/Jun/202324/6	26 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		CLAROID PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006241AM23
RA File Number		08AX04001837 AM23
Licence No and<br>Date		0811007268/10/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>THEOPHYLLINE ANHYDROUS BP<br>120 MG TABLET (THEOPHYLLINE<br>ANHYDROUS BP 120 MG TABLET<br>CONTENT THEOPHYLLINE<br>ANHYDROUS BP 122.4 MG AND<br>SALBUTAMOL (as salbutamol sulphate<br>) BP 2 MG)<br>1 Number<br>1<br>THEOPHYLLINE ANHYDROUS BP<br>122.40 mg per<br>Tablet<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl.

br>) BP 2 MG) 1 Number 1 THEOPHYLLINE ANHYDROUS BP 122.40 mg per Tablet RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||THEOPHYLLINE ANHYDROUS BP 120 MG TABLET (THEOPHYLLINE ANHYDROUS BP 120 MG TABLET CONTENT THEOPHYLLINE ANHYDROUS BP 122.4 MG AND SALBUTAMOL (as salbutamol sulphate ) BP 2 MG)||1 Number|1|THEOPHYLLINE ANHYDROUS BP|122.40 mg per Tablet| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	27 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED

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Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006243AM23
RA File Number		08AX04001877 AM23
Licence No and<br>Date		0811007279/10/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>in meetingNo. 4/82-ALC4/2019dated19/07/2019against advance authorizationNo.0810142125 dated 08/03/2018, it was<br>decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

rt product in meetingNo. 4/82-ALC4/2019dated19/07/2019against advance authorizationNo.0810142125 dated 08/03/2018, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. SPIRONOLACTONE TABLETS BP 25 MG(EACH FILM COATED TABLET CONTAINS: SPIRONOLACTONE PH.EUR. 25 MG) 1 Number 1 SPIRONOLACTONE EP / BP / IP / USP / PH. EUR. 25.50 mg per Tablet SPIRONOLACTONE TABLETS BP 50 MG(EACH FILM COATED TABLET CONTAINS: SPIRONOLACTONE PH.EUR. 50 MG) 1 Number 2 SPIRONOLACTONE EP / BP / IP / USP / PH. EUR. 51.00 mg per Tablet SPIRONOLACTONE TABLETS BP 100 MG(EACH FILM COATED TABLET CONTAINS: SPIRONOLACTONE PH.EUR. 100 MG [IN WHICH ACTIVE INGREDIENT SPIRONOLACTONE USED IS 116.250 KGS.]) 1 Number 3 SPIRONOLACTONE EP / BP / IP / USP / PH. EUR. 102.00 mg per tablet RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||SPIRONOLACTONE TABLETS BP 25 MG(EACH FILM COATED TABLET CONTAINS: SPIRONOLACTONE PH.EUR. 25 MG)||1 Number|1|SPIRONOLACTONE EP / BP / IP / USP / PH. EUR.|25.50 mg per Tablet| ||SPIRONOLACTONE TABLETS BP 50 MG(EACH FILM COATED TABLET CONTAINS: SPIRONOLACTONE PH.EUR. 50 MG)||1 Number|2|SPIRONOLACTONE EP / BP / IP / USP / PH.

SP / PH. EUR.|25.50 mg per Tablet| ||SPIRONOLACTONE TABLETS BP 50 MG(EACH FILM COATED TABLET CONTAINS: SPIRONOLACTONE PH.EUR. 50 MG)||1 Number|2|SPIRONOLACTONE EP / BP / IP / USP / PH. EUR.|51.00 mg per Tablet| ||SPIRONOLACTONE TABLETS BP 100 MG(EACH FILM COATED TABLET CONTAINS: SPIRONOLACTONE PH.EUR. 100 MG [IN WHICH ACTIVE INGREDIENT SPIRONOLACTONE USED IS 116.250 KGS.])||1 Number|3|SPIRONOLACTONE EP / BP / IP / USP / PH. EUR.|102.00 mg per tablet| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	28 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006244AM23
RA File Number	08AX04001874 AM23
Licence No and Date	0811007285/10/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per

UDIN00181221AM24

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

d the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per||

UDIN00181221AM24

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

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


Export Pro	duct		Qty.		Sl. No.	Import Items		Qty.

HYDROXYCHLOROQUINE SULFATE<br>TABLETS USP 100 MG(EACH FILM<br>COATED TABLET CONTAINS:<br>HYDROXYCHLOROQUINE SULFATE USP<br>100MG EQ. TO HYDROXYCHLOROQUINE			<br> <br>1 Number		1	HYDROXYCHLOROQUINE<br>SULFATE EP / BP / IP / USP / PH.<br>EUR.		102.00 mg.
<br>77.5 MG)

HYDROXYCHLOROQUINE SULFA<br>TABLETS USP 200 MG(EACH FILM<br>COATED TABLET CONTAINS:		TE<br>	1 Num	ber	2	HYDROXYCHLOROQUINE<br>SULFATE EP / BP / IP / USP<br>EUR.	<br>/ PH.	204.00 mg.
HYDROXYCHLOROQUINE SULFATE USP<br>200MG EQ. TO HYDROXYCHLOROQUINE<br>155 MG)			<br>

HYDROXYCH<br>	LOROQUINE SULFATE<br>		1 Number		3	HYDROXYCHLOROQUINE<br>		306.00 mg.
TABLETS USP<br>COATED TAB	300 MG(EACH FILM<br>LET CONTAINS:					SULFATE EP / BP / IP / USP / PH.<br>EUR.

HYDROXYCH<br>300MG EQ.

br>||1 Number||3|HYDROXYCHLOROQUINE ||306.00 mg.| ||TABLETS USP COATED TAB|300 MG(EACH FILM LET CONTAINS:|||||SULFATE EP / BP / IP / USP / PH. EUR.||| ||||||||||| ||HYDROXYCH 300MG EQ. T 23250|LOROQUINE SULFATE USP O HYDROXYCHLOROQUINE|| |||||| ||. mg)||||||||| ||||||||||| ||HYDROXYCH TABLETS USP COATED TAB|LOROQUINE SULFATE 400 MG(EACH FILM ET CONTAINS||1 Number||4|HYDROXYCHLOROQUINE SULFATE EP / BP / IP / USP / PH. EUR||408.00 mg.| |RA|: HYDROXYCHLOROQUINE SULFATE USP 400MG EQ. TO HYDROXYCHLOROQUINE 310 MG [IN WHICH ACTIVE INGREDIENT||| |||.||| ||||||||||| ||concerned may take further necessary ac||tion as per above||decision of NC.||||| ||||||||||| |Cas|e No.|29 / NC/3/MEET/Jun|/202324/6||||||| |Cas|||||||||| ||e Status|Case Deferred|||||||| |Par|ty Name|AURORE LIFE SCIENCES PRIVATE LIMITED|||||||| |Me and|eting Number Date|NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023|||||||| |HQ File Number||HQRNORM APPLY 00006267AM23|||||||| |RA File Number||09AX04000893 AM23||||||||

Case No.	29 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006267AM23
RA File Number	09AX04000893 AM23

UDIN00181221AM24

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Licence No and 0911004453/13/02/2023 Date Norms Committee Decision: Submit one shipping bill complete set of the export product along with export and import product statement of the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.

Case No.	30 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006286AM23
RA File Number	03AX04005525 AM23
Licence No and<br>Date	0311021390/13/02/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm: -<br>No import quantity is available on Portal.<br>1.<br>Firm is advised to furnish hard copy of application along with Advance Authorisation.<br>2.<br>Submit one shipping bill complete set of the export product along with export and import product statement of the said<br>Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.

f the export product along with export and import product statement of the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.||

Case No.	Case No.	31 / NC/3/MEET/Jun/202324/6	31 / NC/3/MEET/Jun/202324/6	31 / NC/3/MEET/Jun/202324/6	31 / NC/3/MEET/Jun/202324/6	31 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		GLAND PHARMA LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006277AM23
RA File Number		09AX04000920 AM23
Licence No and<br>Date		0911004455/13/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<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.<br>Dorzolamide Hydrochloride Ophthalmic<br>Solution USP 20mg/ml, (2%) 10ml<br>1 Number<br>1<br>Dorzolamide<br>Hydrochloride<br>234.19 mg. per<br>bottle
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Dorzolamide Hydrochloride Ophthalmic<br>Solution USP 20mg/ml, (2%) 10ml		1 Number	1	Dorzolamide<br>Hydrochloride	234.19 mg. per<br>bottle

||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Dorzolamide Hydrochloride Ophthalmic Solution USP 20mg/ml, (2%) 10ml||1 Number|1|Dorzolamide Hydrochloride|234.19 mg. per bottle|

Case No.	Case No.	31 / NC/3/MEET/Jun/202324/6	31 / NC/3/MEET/Jun/202324/6	31 / NC/3/MEET/Jun/202324/6	31 / NC/3/MEET/Jun/202324/6	31 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		GLAND PHARMA LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006277AM23
RA File Number		09AX04000920 AM23
Licence No and<br>Date		0911004455/13/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<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.<br>Dorzolamide Hydrochloride Ophthalmic<br>Solution USP 20mg/ml, (2%) 10ml<br>1 Number<br>1<br>Dorzolamide<br>Hydrochloride<br>234.19 mg. per<br>bottle
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Dorzolamide Hydrochloride Ophthalmic<br>Solution USP 20mg/ml, (2%) 10ml		1 Number	1	Dorzolamide<br>Hydrochloride	234.19 mg. per<br>bottle

UDIN00181221AM24

Bottle(USP Condition: The firm should account for 6.00 Kgs of input at SL No.1 of the import list in the resultant product which should be reflected in SBs.)

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

account for 6.00 Kgs of input at SL No.1 of the import list in the resultant product which should be reflected in SBs.)

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


	Bottle(USP Condition: The firm should<br>account for 6.00 Kgs of input at SL No.1<br>of the import list in the resultant product<br>which should be reflected in SBs.)


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


Case No.		32 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		GLAND PHARMA LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006276AM23
RA File Number		09AX04000967 AM23
Licence No and<br>Date		0911004454/13/02/2023

Norms Committee Decision:
The Committee c		onsidered 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 detai		<br>ls given below or as applied by the firm, whichever is less:-



	Export Pr	oduct	Qty.	Sl.

under Para 4.07 of HBP||||||||| | Vol. I as per detai|| ls given below or as applied by the firm, whichever is less:-||||||||| |||||||||||| |||||||||||| |||||||||||| ||Export Pr|oduct|Qty.||Sl. No.||Import Items||Qty.|| |||||||||||| ||Diazepam Inj fill i 225l|ection USP, 5mg/ml 2ml Pfilld Si USP| 208350.0 Nb||1||Diazepam||2.292 kg.|| ||n .m re-e yrnge ( Condition: The firm should account for 2.084 Kgs of input at SL No.1 and 208,350 Nos each of input at SL No. 2,3,4 of the import list in the resultant || umer|||||||| ||||||2||Barrel Syringes||219476.0 Number|| ||||||3||Plunger Stoppers||231081.1 Number|| ||product should be reflected in SBs.)|||||||||| |||||||||||| ||||||4||Plunger Rods||214475.0 Number|| |||||||||||| |||||||||||| |||||||||||| |RA concerned may||take further necessary action as per above decision of NC.||||||||| |||||||||||| |||||||||||| |Case No.||33 / NC/3/MEET/Jun/202324/6||||||||| |Case Status||Case Deferred||||||||| |||||||||||| |Party Name||KOPRAN LIMITED||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023|||||||||

Case No.	33 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	KOPRAN LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023

UDIN00181221AM24

No.	33 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	KOPRAN LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023

UDIN00181221AM24

HQ File Number	HQRNORM APPLY 00006275AM23
RA File Number	03AX04005476 AM23
Licence No and<br>Date	0311021384/13/02/2023
Norms Committee Decision:
Submit one shipping bill complete set of the export product along with export and import product statement of the said
Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.

HQ File Number	HQ File Number	HQRNORM APPLY 00006275AM23	HQRNORM APPLY 00006275AM23	HQRNORM APPLY 00006275AM23	HQRNORM APPLY 00006275AM23	HQRNORM APPLY 00006275AM23	HQRNORM APPLY 00006275AM23	HQRNORM APPLY 00006275AM23
RA File Number		03AX04005476 AM23

Licence No and<br>		0311021384/13/02/2023
Date

Norms Committee		ecision:
Submit one shippin		g bill complete set of the export product along with export and import product statement of the said
Authorization.

||||||||| |||||||||| |Norms Committee||ecision:||||||| |Submit one shippin||g bill complete set of the export product along with export and import product statement of the said||||||| |Authorization. Als||o, it is directed to technical expert to give their comments before next agenda of this case.||||||| |||||||||| |||||||||| |Case No.||34 / NC/3/MEET/Jun/202324/6||||||| |||||||||| |Case Status||Case Approved||||||| |Party Name||HETERO LABS LIMITED||||||| |Meeting Number and Date||NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023||||||| |HQ File Number||HQRNORM APPLY 00006266AM23||||||| |RA File Number||09AX04000928 AM23||||||| |Lic Dat|ence No and e|0911004452/13/02/2023||||||| |Nor Th det RA|ms Committee Decision: e Committee considered the case as per agenda ails given below or as applied by the firm, which||and it was deci ever is less:-||ded to fix|ad-hoc norms under Para 4.07 o|f HBP Vol. I as per|| |||||||||| ||Export Product|||Qty.||||| ||||||Sl. No.|Import Items||Qty. (in kg.)| ||( R)-9-[2-phosphonomethoxy)propyl] Adenine (?Compounds containing a pyrimidine ring (wh or not hydrogenated) or piperazine ring in the structure)||ether|1 kg.||||| ||||||1|ADENINE||1.06| |||||||||| ||||||2|N,N-DIMETHYLFORMAMIDE||2.00| |||||||||| ||||||3|(R)-1,2-PROPYLENE CARBONATE||0.98| ||||||4|N-METHYL-2-PYRROLIDONE||0.21| |||||||||| ||||||5|Diethyl Para Toluene Sulfonyl Methyl Phosphonate|Oxy| 1.00| ||||||6|Magnesium Tert. Butoxide||1.00| ||concerned may take further necessary action as p||er above decisi|||||| ||||||on of NC.|||| ||||||||||

luene Sulfonyl Methyl Phosphonate|Oxy| 1.00| ||||||6|Magnesium Tert. Butoxide||1.00| ||concerned may take further necessary action as p||er above decisi|||||| ||||||on of NC.|||| ||||||||||

UDIN00181221AM24

Case No.	Case No.	35 / NC/3/MEET/Jun/202324/6	35 / NC/3/MEET/Jun/202324/6	35 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		KOPRAN LIMITED
Meeting Number
<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006261AM23
RA File Number		03AX04005485 AM23
Licence No and		0311021362/13/02/2023
Date
Norms Committee		Decision:

The Committee con<br>in meetingNo. NC/		sidered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>3/MEET/Apr/202324/1dated28/04/2023against advance authorizationNo.0311020258dated26/12/2022it
<br>was decided to fix a<br>less:-		,<br>d-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is
RA
	Export Product		Qty.	Sl.

| | was decided to fix a less:-||, d-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is||||||| |RA||||||||| ||Export Product||Qty.|Sl. No. |Import Items||Qty.|| |||||||||| ||CEFEPIME FOR INJECTION||1 kg.|1 |CEFEPIM|E HCL (NON-STERILE)|0.6|5 kg.| |||||2 |L-ARGIN|INE|0.3|70 kg.| |||||||||| |||||3 |PACKING|MATERIAL|Rel pac|evant as per king policy.| |||||||||| ||concerned may take further necessary action as per|||above decisi||||| ||||||on of NC.|||| |||||||||| |||||||||| |Cas|e No.|36 / NC/3/MEET/Jun/202324/||6||||| |Cas|e Status|Case Deferred||||||| |||||||||| |Par|ty Name|KOPRAN LIMITED||||||| |Me and|eting Number Date|NC/ 3/ MEET/ Jun/ 202324/ 6||and 14/06/2|023|||| |HQ|File Number|HQRNORM APPLY 0000626||0AM23||||| |RA|File Number|03AX04005475 AM23||||||| |Lic Dat|ence No and e|0311021361/13/02/2023||||||| |||||||||| |Nor The for Hen|ms Committee Decision: committee considered the request of firm for fix same export item against the Advance Authorisa ce, the committee decided to defer the case till t|||ation of ad- tion No. 031 he finalizatio|hoc norms|and it was observed that review||case of the firm| ||||||1004745 n of revie|dated 19/06/2021 is already unde w case.||r consideration.| |||||||||| |Case No.||37 / NC/3/MEET/Jun/202324/6|||||||

d it was observed that review||case of the firm| ||||||1004745 n of revie|dated 19/06/2021 is already unde w case.||r consideration.| |||||||||| |Case No.||37 / NC/3/MEET/Jun/202324/6|||||||

Case No.	36 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	KOPRAN LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006260AM23
RA File Number	03AX04005475 AM23
Licence No and<br>Date	0311021361/13/02/2023
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and it was observed that review case of the firm
for same export item against the Advance Authorisation No. 0311004745 dated 19/06/2021 is already under consideration.
Hence, the committee decided to defer the case till the finalization of review case.

Case No. 37 / NC/3/MEET/Jun/202324/6

UDIN00181221AM24

Case Status<br>Case Approved
Party Name<br>YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number<br>HQRNORM APPLY 00006314AM23
RA File Number<br>03AX04005523 AM23
Licence No and<br>Date<br>0311021434/14/02/2023
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from	the earlier decision for same export product/import
product in meeting No.NC/3/MEET/Apr/202324/1dated28/04/2023	against advance authorization No.	0311019863

nd taking cue from||the earlier decision for same export product/import||||| |product in meeting No.NC/3/MEET/Apr/202324/1dated28/04/2023||against advance authorization No.||0311019863||| |dated08/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as||||||| |applied by the firm, whichever is less:-||||||| |Export Product|Qty.|Sl. No.|Import Items||Qty.|| |TETRA BENZYL THIURAM DISULFIDE (QUREACC TBZTD )|1 kg.|1|DIBENZYLAMINE||0.74 kg.|| |||2|CARBON DISULPHIDE||0.285 kg.|| |RA concerned may take further action as per above decision of NC.|||||||

Case No.<br>38 / NC/3/MEET/Jun/202324/6
Case Status<br>Case Approved
Party Name<br>SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number<br>HQRNORM APPLY 00006299AM23
RA File Number<br>05AX04003061 AM23
Licence No and<br>Date<br>0511017317/14/02/2023
Norms Committee Decision:
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/202223/18dated23/01/2023		against advance authorization No.
0511014706 dated 07/09/2022, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:
Export product<br>Qty.<br>Sl. No.	Import items		Qty.

UDIN00181221AM24

Inokain Eye Drops 0.4% 5ml 1 Vial 1 Benoxinate HCL 20.4 mg

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

UDIN00181221AM24

Inokain Eye Drops 0.4% 5ml 1 Vial 1 Benoxinate HCL 20.4 mg

Case No.	Case No.	39 / NC/3/MEET/Jun/202324/6	39 / NC/3/MEET/Jun/202324/6	39 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		AMNEAL INJECTABLES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006333AM23
RA File Number		08AX04001899 AM23
Licence No and<br>Date		0811007309/15/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>NOREPINEPHRINE BITARTRATE<br>INJECTION USP, 1 mg/ml (4ml)<br>(NOREPINEPHRINE BITARTRATE<br>INJECTION USP, 1 mg/ml (4ml)<br>(i.e.1.887 mg equal to Norepinephrine 1<br>mg))<br>100 Vials<br>1<br>NOREPINEPHRINE BITARTRATE<br>911.872 mg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl.

Norepinephrine 1 mg)) 100 Vials 1 NOREPINEPHRINE BITARTRATE 911.872 mg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||NOREPINEPHRINE BITARTRATE INJECTION USP, 1 mg/ml (4ml) (NOREPINEPHRINE BITARTRATE INJECTION USP, 1 mg/ml (4ml) (i.e.1.887 mg equal to Norepinephrine 1 mg))||100 Vials|1|NOREPINEPHRINE BITARTRATE|911.872 mg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	40 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	ARCH PROTECTION CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006341AM23
RA File Number	03AX04004385 AM23
Licence No and<br>Date	0311021465/15/02/2023
Norms Committee Decision:

UDIN00181221AM24

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

Chemistry giving molecular weight of reactant & product giving calculation as yield of the reaction with justification.

Production / Consumption data duly certified by CA.

The value of by product, if any, formed in the process.

Submit one shipping bill complete set of the export product along with export and import product statement of the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.

et of the export product along with export and import product statement of the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.**

Case No.	41 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	BELCHEM INDUSTRIES (INDIA) PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006352AM23
RA File Number	03AX04005586 AM23
Licence No and<br>Date	0311021482/16/02/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm: -
Justification for lower yield of 74%.<br>1.
Production/Consumption data duly certified by CA.<br>2.
Submit one shipping bill complete set of the export product along with export and import product statement of the
said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.

Case No.	42 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006351AM23
RA File Number	03AX04005363 AM23
Licence No and<br>Date	0311021477/16/02/2023
Norms Committee Decision:
Under consideration for physical verification.

Case No.	43 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved

UDIN00181221AM24

02/2023| |Norms Committee Decision:|| |Under consideration for physical verification.||

Case No.	43 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved

UDIN00181221AM24

Party Name	Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED	J B CHEMICALS AND PHARMACEUTICALS LIMITED	J B CHEMICALS AND PHARMACEUTICALS LIMITED	J B CHEMICALS AND PHARMACEUTICALS LIMITED	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006347AM23
RA File Number		03AX04005511 AM23
Licence No and<br>Date		0311021471/16/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<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 in<br>gm.<br>1<br>Benzydamine Hydrochloride 3.06<br>2<br>Cetylpyridinium Chloride<br>1.33<br>Benzydamine Hydrochloride And<br>Cetylpyridinium Chloride Anti-<br>Inflammatory And Antiseptic Lozenges<br>Sugar Free and (all other flavours. Each<br>lozenge contains (i) Benzydamine<br>Hydrochloride-3mg (ii) Cetylpyridinium<br>Chloride- 1.33mg (iii) Isomalt ST-M -<br>2586mg.

y And Antiseptic Lozenges Sugar Free and (all other flavours. Each lozenge contains (i) Benzydamine Hydrochloride-3mg (ii) Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M - 2586mg. Net content (i) 30.822 Kgs (ii) 13.664 Kgs (iii) 26568.481 Kgs.) 1000 Number 3 Isomalt ST-M 2586 4 Benzydamine Hydrochloride 3.06 Benzydamine Hydrochloride, 2,4- Dichlorobenzyl Alcohol And Lidocaine Hydrochloride Anaesthetic, Anti- Inflammatory, (Anti-Bacterial Lozenges Sugar Free. Each lozenge contains (i) Benzydamine Hydrochloride - 3mg (ii) Isomalt ST-M- 2586mg. Net content (i) 23.973 Kgs. (ii) 20664.374 Kgs.) 1000 Number 5 Isomalt ST-M 2586 6 Benzydamine Hydrochloride 3.06 Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours. (Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii) 3826.059 Kg.) 1000 Number 7 Isomalt ST-M 2586 8 Cetylpyridinium Chloride 1.00 Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic 1000 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed in gm.| ||Benzydamine Hydrochloride And Cetylpyridinium Chloride Anti- Inflammatory And Antiseptic Lozenges Sugar Free and (all other flavours. Each lozenge contains (i) Benzydamine Hydrochloride-3mg (ii) Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M - 2586mg.

y And Antiseptic Lozenges Sugar Free and (all other flavours. Each lozenge contains (i) Benzydamine Hydrochloride-3mg (ii) Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M - 2586mg. Net content (i) 30.822 Kgs (ii) 13.664 Kgs (iii) 26568.481 Kgs.)||1000 Number|1|Benzydamine Hydrochloride|3.06| |||||2|Cetylpyridinium Chloride|1.33| |||||3|Isomalt ST-M|2586| ||Benzydamine Hydrochloride, 2,4- Dichlorobenzyl Alcohol And Lidocaine Hydrochloride Anaesthetic, Anti- Inflammatory, (Anti-Bacterial Lozenges Sugar Free. Each lozenge contains (i) Benzydamine Hydrochloride - 3mg (ii) Isomalt ST-M- 2586mg. Net content (i) 23.973 Kgs. (ii) 20664.374 Kgs.)||1000 Number|4|Benzydamine Hydrochloride|3.06| |||||5|Isomalt ST-M|2586| ||Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours. (Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii) 3826.059 Kg.)|| 1000 Number|6 |Benzydamine Hydrochloride|3.06| |||||7|Isomalt ST-M|2586| ||Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic||1000 Number|8 |Cetylpyridinium Chloride|1.00| ||Lozenges Sugar Free and all other flavours.||||||

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

UDIN00181221AM24

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

UDIN00181221AM24

(Each lozenge contains (i) Cetylpyridinium<br>Chloride - 1.33mg (ii) lsomalt ST-M -<br>2586 mg. Net content (i) 1.968 Kg (ii)<br>3826.059 Kg.)<br>9<br>Isomalt ST-M<br>2586<br>10<br>Cetylpyridinium Chloride<br>1.00<br>Cetylpyridinium Chloride And<br>Benzydamine Hydrochloride Antiseptic<br>Lozenges Sugar Free. (Each lozenge<br>contains (i) Cetylpyridinium Chloride- 1<br>mg (ii) lsomalt ST-M - 2586mg. Net<br>content (i) 1.352 Kg (ii) 3496.272 Kg )<br>1000 Number<br>11<br>Isomalt ST-M<br>2586<br>RA concerned may take further necessary action as per above decision of NC.	(Each lozenge contains (i) Cetylpyridinium<br>Chloride - 1.33mg (ii) lsomalt ST-M -<br>2586 mg. Net content (i) 1.968 Kg (ii)<br>3826.059 Kg.)		9	Isomalt ST-M	2586
	Cetylpyridinium Chloride And<br>Benzydamine Hydrochloride Antiseptic<br>Lozenges Sugar Free. (Each lozenge<br>contains (i) Cetylpyridinium Chloride- 1<br>mg (ii) lsomalt ST-M - 2586mg. Net<br>content (i) 1.352 Kg (ii) 3496.272 Kg )	1000 Number	10	Cetylpyridinium Chloride	1.00
			11	Isomalt ST-M	2586

r>contains (i) Cetylpyridinium Chloride- 1 mg (ii) lsomalt ST-M - 2586mg. Net content (i) 1.352 Kg (ii) 3496.272 Kg )|1000 Number|10|Cetylpyridinium Chloride|1.00| ||||11|Isomalt ST-M|2586|

Case No.	44 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006391AM23
RA File Number	07AX04001706 AM23
Licence No and<br>Date	0711006466/17/02/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Complete technical details as per Annexure to appendix-4E.<br>1.<br>Submit one shipping bill complete set of the export product along with export and import product statement of the<br>said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case

Case No.	45 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	SALICYLATES & CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006402AM23
RA File Number	09AX04001018 AM23
Licence No and<br>Date	0911004488/17/02/2023
Norms Committee Decision:

UDIN00181221AM24

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

cision:||

UDIN00181221AM24

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

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

et of the export product along with export and import product statement of the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.**

|The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following information/documents from the firm:- Step wise manufacturing process. i. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis. ii. Complete technical details as per Annexure to Appendix 4E for chemical products. iii. Stoichiometric balance between import and export on molar basis. iv. Details of indigenous input with quantity. v. Sample of shipping bills and bill of entry of the import and export products along with statement of Input-Output as per export documents of said authorization. vi. Submit one shipping bill complete set of the export product along with export and import product statement of **the said Authorization.

per export documents of said authorization.** vi. Submit one shipping bill complete set of the export product along with export and import product statement of the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.|The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following information/documents from the firm:- Step wise manufacturing process. i. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis. ii. Complete technical details as per Annexure to Appendix 4E for chemical products. iii. Stoichiometric balance between import and export on molar basis. iv. Details of indigenous input with quantity. v. Sample of shipping bills and bill of entry of the import and export products along with statement of Input-Output as per export documents of said authorization. vi. Submit one shipping bill complete set of the export product along with export and import product statement of **the said Authorization.

per export documents of said authorization. vi. Submit one shipping bill complete set of the export product along with export and import product statement of the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.| |---|---|---|---|---|---|---|---|---|---|---| ||Step wise manufacturi i. Complete chemical rea ii.||ng process ctions wit|.** h molecular||and structural formula and m|||olecular weights along with|| || stage wise percentage y Complete technical det iii. Stoichiometric balance iv. Details of indigenous i v. Sample of shipping bi Input-Output as per ex vi. mit one shipping bill comp said Authorization. Also, i e.|| ields on m ails as per between nput with lls and bil port docu lete set of t is directe| olar basis. Annexure to || Appendix 4E for chemical pro i||| ducts.|| |||||mport and e quantity. l of entry of ments of said||xport on molar bass. the import and export produ authorization.|||cts along with statement of|| |||||the export p d to technica||roduct along with export and im l expert to give their comments|||port product statement of before next agenda of this|| |||||||||||| |||||||||||| |Cas|e No.|46 / NC/3/M|EET/Jun/2|2324/6||||||| ||||||||||||

d im** l expert to give their comments|||port product statement of before next agenda of this|| |||||||||||| |||||||||||| |Cas|e No.|46 / NC/3/M|EET/Jun/2|2324/6||||||| |||||||||||| |Cas|e Status|Case Approv|ed|||||||| |Par|ty Name|SUN PHAR|MACEUTI|CAL INDUST||RIES LIMITED||||| |Meeting Number and Date||NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023||||||||| |HQ File Number||HQRNORM APPLY 00006405AM23||||||||| |RA File Number||05AX04003274 AM23||||||||| |||||||||||| |Licence No and||||||||||| |Date||0511017389/17/02/2023||||||||| |Norms Committee||Decision:||||||||| |||||||||||| |The Committee co product in meetin dated14/11/2022||nsidered the case as per agenda and taking cue from the earlier decision for same export product/import gNo.NC/3/MEET Mar/202223/22dated24/03/2023against advance authorizationNo.0511015798 it was decided to fix ad-hoc norms under Para 407 of HBP Vol I as er details iven below or as||||||||| | applied by the firm||, . . p g , whichever is less:-||||||||| |||||||||||| |||||||||||| |||||||||||| ||Export Product||||Qty.||Sl.

Vol I as er details iven below or as||||||||| | applied by the firm||, . . p g , whichever is less:-||||||||| |||||||||||| |||||||||||| |||||||||||| ||Export Product||||Qty.||Sl. No.|Import Items||Qty.| |||||||||||| ||Amoxycillin Capsules 250 mg (Each capsule ||||1000000 ||1|Amoxycillin Trihydrate||292.68 kg.| ||contains Amoxy 250 m of Amo|cillin Trihydrate equivalent to cillin) ((Euivalent to|||Numbers|||||| ||g 250.000Kg of b|y q ulk drug))||||||||| |||||||||||| ||Amoxycillin Ca contains Amox|psules 500 mg (Each capsule cillin Trihdrate equivalent to|||1000000 Numbers||2|Amoxycillin Trihydrate||585.36 kg.| || 500 mg of Amo|y xycillin) ((Equivalent to||||||||| ||500.000 Kg of b|ulk drug))||||||||| |||||||||||| ||||||||||||

UDIN00181221AM24


Amoxycillin Tablets 1000 mg (Each tablet<br>contains Amoxycillin Trihydrate equivalent to<br>1000 mg of Amoxycillin) ((Equivalent to<br>1000.000Kg of bulk drug))	1000000<br>Numbers	3	Amoxycillin Trihydrate		1170.72 kg.

Amoxycillin Trihydrate & Clavulanate<br>Potassium + Microcrystalline Cellulose 1:1	8200000<br>Numbers	4	Amoxyci	llin Trihydrate	2399.64 kg.
<br>Tablets/Capsules 375 mg((Each Tablet/Capsule<br>contains Amoxycillin Trihydrate equivalent to<br>Amoxycillin 250mg andClavulanate Potassium<br>+ Microcrystalline Cellulose (1:1) equivalent to<br>Clli id 125 Eil 2050 K

t/Capsule contains Amoxycillin Trihydrate equivalent to Amoxycillin 250mg andClavulanate Potassium + Microcrystalline Cellulose (1:1) equivalent to Clli id 125 Eil 2050 K|||||||||||||||| |||||||||5|||Clavulan Microcry|ate Potassium + stallin e Cellulose|||2490.94 kg.|| |||||||||||| (1:1)|||||| ||avuanc ac mg) (quvaent to g of Amoxcillin Trihdrate and 1025 K|||||||||||||||| ||y Clavula)|y g||||||||||||||| |||||||||||||||||| |||||||||||||||||| ||Amoxycillin Tri|hydrate and Clavulanate||21000000||||6|||Amoxycillin Trihydrate||||1229086 kg|| || | || |||||||||||. .|| ||Potassium + Mi bll|crocrystalline Cellulose 1:1 625 h bll||Numbers||||||||||||| |||||||||||||||||| ||Taets/Capsue|s mg((Eac Taet/Capsue||||||||||||||| ||contains Amoxy|cillin Trihydrate equivalent to||||||7|||Clavulanate Potassium +||||6379.23 kg.|| || | ||||||||||||||| ||Amoxycillin 50|0mg and Clavulanate|||||||||Microcrystallin e Cellulose|||||| ||Potassium + Mi|rocrstalline Cellulose (1:1)|||||||||(1:1)|||||| |||y||||||||||||||| ||equivalent to Cl|avulanic acid 125mg)||||||||||||||| ||(Equivalent to 1|0500 Kg of Amoxycillin||||||||||||||| || Trihydrate and 2| 625 Kg Clav)||||||||||||||| |||||||||||||||||| |||||||||||||||||| ||Amoxycillin Tri Potassium + Mi|hydrate and Clavulanate crocrystalline Cellulose 1:1||23200000 Numbers||||8|||Amoxycillin Trihydrate||||23762.32 kg.|| |RA|Tablets/Capsules 1000 mg (Each|||||||||||||||| ||Tablet/(/Capsule contains Amoxycillin Trihydrate equi.

lline Cellulose 1:1||23200000 Numbers||||8|||Amoxycillin Trihydrate||||23762.32 kg.|| |RA|Tablets/Capsules 1000 mg (Each|||||||||||||||| ||Tablet/(/Capsule contains Amoxycillin Trihydrate equi. to Amoxycillin 875mg || & |||||9|||Clavulanate Potassium + Microcrystallin e Cellulose (1:1)||||7047.53 kg.|| ||Clavulanate Potassium + Microcrystall Cellulose (1:1) equi. to Clavulanic acid (Equi. to 20300.000Kg of Amoxycillin Trihydrate and 2900.000Kg of Clavula Potassium +)||ne 125mg) nate|||||||||||||| |||||||||||||||||| |||||||||||||||||| |||||||||||||||||| ||concerned may take further necessary action as p|||er above deci|||sion of NC|||.||||||| |||||||||||||||||| |||||||||||||||||| |Cas|e No.|47 / NC/3/MEET/Jun/202324||6||||||||||||| |||||||||||||||||| |Cas|e Status|Case Approved||||||||||||||| |||||||||||||||||| |Par|y Name|CIPLA LIMITED||||||||||||||| |||||||||||||||||| |Me d|etn umer|||||||||||||||| ||g Dt|NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023||||||||||||||| |an|ae|||||||||||||||| |HQ|File Number|HQRNORM APPLY 00006408AM23||||||||||||||| |||||||||||||||||| |RA File Number||03AX04005479 AM23||||||||||||||| |Li N d||0311021534/17/02/2023||||||||||||||| |cence o an||||||||||||||||| ||||||||||||||||||

Case No.	47 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006408AM23
RA File Number	03AX04005479 AM23
Licence No and	0311021534/17/02/2023

UDIN00181221AM24

Norms Committee Decision:

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
Testosterone Topical Solution 30 /<br>1.5mg / ml Pack Size 110ml(Each<br>Actuation delivers : Testosterone USP<br>30mg Also contains Alcohol USP ?.<br>Approx. 49.55% w/v (QS to 100%<br>w/v))	48000.0<br>Numbers	1	Testosterone USP	91.2 kg.
		2	Alcohol (Ethanol 95% v/v)	2616.0 kg.

Case No.	48 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006441AM23
RA File Number	03AX04005543 AM23
Licence No and<br>Date	0311021564/20/02/2023
Norms Committee Decision:<br>Submit one shipping bill complete set of the export product along with export and import product statement of<br>the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this<br>case.

Case No.	49 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	RUMIT LIFE CARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006465AM23
RA File Number	03AX04005602 AM23
Licence No and<br>Date	0311021579/20/02/2023
Norms Committee Decision:

UDIN00181221AM24

and 14/06/2023| |HQ File Number|HQRNORM APPLY 00006465AM23| |RA File Number|03AX04005602 AM23| |Licence No and Date|0311021579/20/02/2023| |Norms Committee Decision:||

UDIN00181221AM24

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Apr/202324/1 dated 28/04/2023 against advance authorization No. 0311020160 dated 20/12/2022 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

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

Case No.	Case No.	50 / NC/3/MEET/Jun/202324/6	50 / NC/3/MEET/Jun/202324/6	50 / NC/3/MEET/Jun/202324/6	50 / NC/3/MEET/Jun/202324/6	50 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006459AM23
RA File Number		04AX04000974 AM23
Licence No and<br>Date		0411004919/20/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>in meeting No.NC/3/MEET/Apr/202324/1 dated 28/04/2023against advance authorization**No.

d the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Apr/202324/1 dated 28/04/2023against advance authorizationNo. 0411004581 dated 07/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 Isobutyl Acetophenone 1.11 kg. 2 Sodium Metal 0.235 kg. 3 Monochloro Acetic Acid 0.919 kg. 4 Isopropyl Alcohol 0.50 kg. IBUPROFEN 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||IBUPROFEN||1 kg.|1|Isobutyl Acetophenone|1.11 kg.| |||||2|Sodium Metal|0.235 kg.| |||||3|Monochloro Acetic Acid|0.919 kg.| |||||4|Isopropyl Alcohol|0.50 kg.|

UDIN00181221AM24

5 Sodium Dichromate 0.630 kg.

Case No.	51 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006458AM23
RA File Number	04AX04001010 AM23
Licence No and<br>Date	0411004918/20/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>in meeting No.NC/3/MEET/Apr/202324/1 dated 28/04/2023against advance authorizationNo. 0411004581 dated 07/12/2022,<br>it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

roduct in meeting No.NC/3/MEET/Apr/202324/1 dated 28/04/2023against advance authorizationNo. 0411004581 dated 07/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 Isobutyl Acetophenone 1.11 kg. 2 Sodium Metal 0.235 kg. 3 Monochloro Acetic Acid 0.919 kg. 4 Isopropyl Alcohol 0.50 kg. IBUPROFEN 1 kg. 5 Sodium Dichromate 0.630 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	52 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023

UDIN00181221AM24

HQ	File Number		HQRN	ORM APPLY	00006428AM23
RA	File Number		03AX0	4005553 AM2	3
Licence No and Da
		e	0311021549/20/02/2023
Norms Committee		Decision:

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

s Committee||Decision:|||||||||||||||| ||||||||||||||||||| |The Committee con details given below||sidered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per or as applied by the firm, whichever is less:-|||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||Export Pro|duct||||||||||Qty.|Sl. |Import Items|||Qty. ll| ||||||||||||||No.||||aowed in gm.| ||||||||||||| |||||| ||Benzydamine H Ad Atiti|ydrochloride And Ce L S F|||tylpyridinium C d llth fl|||hloride Anti-Infl Eh l|||ammatory ti| 1000|1|Benz Hd|ydamine hlid||3.06| ||n nsepc|ozenges ugar ree a|||n (aoer av|||urs. ac ozeng|||conans| ||yr|core||| ||(i) Benzydamin Isomalt ST-M|e Hydrochloride-3mg - 2586mg. Net cont|||(ii) Cetylpyridin ent (i) 30.822|||ium Chloride- 1. Kgs (ii) 13.664|||33mg (iii) Kgs (iii)| Number|||||| ||||||||||||||||||| || 26568.481 Kgs.)||||||||||||2|Cetyl |pyridinium ||1.33| |||||||||||||||Chlor|ide||| ||||||||||||||||||| ||||||||||||||3|Isoma|lt ST-M||2586| ||Bdi Hdhlid 24D||||hlbl|||lhl Ad Li|||di|1000|4|B|di||306| ||enzyamne yrocore, ,-coroenzy Hydrochloride Anaesthetic, BtilLSFEhltiiB|||||||coo Anti-I d||n ocane nflammatory,(Anti- iHdhlid||Number||enzyamne Hydrochloride|||.| ||aceraozengesugarree.acozengeconan -3mg(ii)IsomaltST-M-2586mg.Netcontent(i) 23973 Ks (ii) 20664374 Ks)||||||()enzya|||neyro|ore||||||| ||||||||||||||5|Isomalt ST||-M|2586| ||. g. .

oride|||.| ||aceraozengesugarree.acozengeconan -3mg(ii)IsomaltST-M-2586mg.Netcontent(i) 23973 Ks (ii) 20664374 Ks)||||||()enzya|||neyro|ore||||||| ||||||||||||||5|Isomalt ST||-M|2586| ||. g. . g.||||||||||||||||| ||||||||||||||||||| ||Cetylpyridinium |Chloride And Bromhexine Hy |||||drochloride |||Antiseptic|Lozenges| 1000|6|Benzydami||ne|3.06| ||||||||||| | | || || || ||Sugar Free and Chloride - 133|all other flavours. (Each lozen mg (ii) lsomalt ST-M - 2586 m|||||ge contains g Net cont|||(i) Cetylp ent (i) 196|yridinium 8 Kg (ii)| Number||Hydrochlor||de|| ||. 3826.059 Kg.)||||||.|||.|||||||| ||||||||||||||||||| ||||||||||||||7|Isomalt ST-||M|2586| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours. (Each lozenge contains (i) Cetylpyridinium||||||||||| 1000 Number|8|Cetylpyridinium Chloride|||1.00| ||Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii)||||||||||||||||| || ||||||||||||||||| ||3826.059 Kg.)||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||9|Isomalt ST-M|||2586| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| |||||||||||||||||||

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|||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||9|Isomalt ST-M|||2586| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| |||||||||||||||||||

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10<br>Cetylpyridinium<br>Chloride<br>1.00<br>Cetylpyridinium Chloride And Benzydamine Hydrochloride Antiseptic Lozenges<br>Sugar Free. (Each lozenge contains (i) Cetylpyridinium Chloride- 1 mg (ii) lsomalt<br>ST-M - 2586mg. Net content (i) 1.352 Kg (ii) 3496.272 Kg )<br>1000<br>Number<br>11<br>Isomalt ST-M<br>2586<br>RA concerned may take further necessary action as per above decision of NC.	Cetylpyridinium Chloride And Benzydamine Hydrochloride Antiseptic Lozenges<br>Sugar Free. (Each lozenge contains (i) Cetylpyridinium Chloride- 1 mg (ii) lsomalt<br>ST-M - 2586mg. Net content (i) 1.352 Kg (ii) 3496.272 Kg )	<br> <br>1000<br>Number	10	Cetylpyridinium<br>Chloride	1.00
			11	Isomalt ST-M	2586

Case No.	Case No.	53 / NC/3/MEET/Jun/202324/6	53 / NC/3/MEET/Jun/202324/6	53 / NC/3/MEET/Jun/202324/6	53 / NC/3/MEET/Jun/202324/6	53 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006427AM23
RA File Number		03AX04005554 AM23
Licence No and Date		0311021548/20/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

||||| |Licence No and Date||0311021548/20/02/2023||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed in gm. 1 Benzydamine Hydrochloride 3.06 2 Cetylpyridinium Chloride 1.33 Benzydamine Hydrochloride And Cetylpyridinium Chloride Anti-Inflammatory And Antiseptic Lozenges Sugar Free and (allother flavours. Each lozenge contains (i) Benzydamine Hydrochloride-3mg (ii) Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M - 2586mg. Net content (i) 30.822 Kgs (ii) 13.664 Kgs (iii) 26568.481 Kgs.) 1000 Number 3 Isomalt ST-M 2586 4 Benzydamine Hydrochloride 3.06 Benzydamine Hydrochloride, 2,4-Dichlorobenzyl Alcohol And Lidocaine Hydrochloride Anaesthetic, Anti-Inflammatory,(Anti- BacterialLozengesSugarFree.Eachlozengecontains(i)BenzydamineHydrochloride -3mg(ii)IsomaltST-M-2586mg.Netcontent(i) 23.973 Kgs. (ii) 20664.374 Kgs.) 1000 Number 5 Isomalt ST-M 2586 6 Benzydamine Hydrochloride 3.06 Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours. (Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg.

pyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours. (Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii) 3826.059 Kg.) 1000 Number 7 Isomalt ST-M 2586||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed in gm.| ||Benzydamine Hydrochloride And Cetylpyridinium Chloride Anti-Inflammatory And Antiseptic Lozenges Sugar Free and (allother flavours. Each lozenge contains (i) Benzydamine Hydrochloride-3mg (ii) Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M - 2586mg. Net content (i) 30.822 Kgs (ii) 13.664 Kgs (iii) 26568.481 Kgs.)||1000 Number|1|Benzydamine Hydrochloride|3.06| |||||2|Cetylpyridinium Chloride|1.33| |||||3|Isomalt ST-M|2586| ||Benzydamine Hydrochloride, 2,4-Dichlorobenzyl Alcohol And Lidocaine Hydrochloride Anaesthetic, Anti-Inflammatory,(Anti- BacterialLozengesSugarFree.Eachlozengecontains(i)BenzydamineHydrochloride -3mg(ii)IsomaltST-M-2586mg.Netcontent(i) 23.973 Kgs. (ii) 20664.374 Kgs.)||1000 Number|4|Benzydamine Hydrochloride|3.06| |||||5|Isomalt ST-M|2586| ||Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours. (Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii) 3826.059 Kg.)||1000 Number|6|Benzydamine Hydrochloride|3.06| |||||7|Isomalt ST-M|2586|

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hloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii) 3826.059 Kg.)||1000 Number|6|Benzydamine Hydrochloride|3.06| |||||7|Isomalt ST-M|2586|

UDIN00181221AM24

Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges	1000	8	Cetylpyridinium	1.00
Sugar Free and all other flavours. (Each lozenge contains (i) Cetylpyridinium	Number		Chloride
Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii)
3826.059 Kg.)
		9	Isomalt ST-M	2586
Cetylpyridinium Chloride And Benzydamine Hydrochloride Antiseptic Lozenges	1000	10	Cetylpyridinium	1.00
Sugar Free. (Each lozenge contains (i) Cetylpyridinium Chloride- 1 mg (ii) lsomalt	Number		Chloride
ST-M - 2586mg. Net content (i) 1.352 Kg (ii) 3496.272 Kg )
		11	Isomalt ST-M	2586

||Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours. (Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii)|Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours. (Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii)|Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours. (Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg.

pyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours. (Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii)|Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours. (Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii)|Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours. (Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii)|Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours. (Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii)|1000 Number|8|Cetylpyridinium Chloride|Cetylpyridinium Chloride|1.00| |---|---|---|---|---|---|---|---|---|---|---|---| ||3826.059 Kg.)||||||||||| |||||||||9|Isomalt ST-M||2586| ||||||||||||| ||||||||||||| ||Cetylpyridinium ||Chloride And Benzydamine Hydrochloride Antiseptic Lozenges ||||1000 |10|Cetylpyridinium ||1.00| ||Sugar Free. (Ea ST-M - 2586mg||ch lozenge contains (i) Cetylpyridinium Chloride- 1 mg (ii) lsomalt .

enzydamine Hydrochloride Antiseptic Lozenges ||||1000 |10|Cetylpyridinium ||1.00| ||Sugar Free. (Ea ST-M - 2586mg||ch lozenge contains (i) Cetylpyridinium Chloride- 1 mg (ii) lsomalt . Net content (i) 1.352 Kg (ii) 3496.272 Kg )||||Number||Chloride||| ||||||||||||| |||||||||11|Isomalt ST-M||2586| ||||||||||||| ||||||||||||| ||||||||||||| |RA concerned may take further necessary action as per above decision of NC.|||||||||||| ||||||||||||| |Case No|||54 / NC/3/MEET/Jun/202324/6||||||||| |.|||||||||||| |C Stt|||C Ad||||||||| |ase aus|||ase pprove||||||||| |Part Name|||J B CHEMICALS AND PHARMACEUTICALS LIMITED||||||||| |y|||||||||||| |Meetin Number|||||||||||| |g and Date|||NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023||||||||| ||||||||||||| |HQ File Number|||HQRNORM APPLY 00006426AM23||||||||| |RA File Number|||03AX04005589 AM23||||||||| ||||||||||||| |Licence No and|||||||||||| | Date|||0311021547/20/02/2023||||||||| ||||||||||||| |Norms Committee|||Decision:||||||||| |The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in M eeting No.NC/3/MEET/Nov/20202223/12 dated 18/11/2022against advance authorization No.03110014993 dated 25/05/2022, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:|||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||Sl. No.|Export P|roduct|Qty|Sl.

4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:|||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||Sl. No.|Export P|roduct|Qty|Sl. No.|Import Items||||Qty|| ||||||||||||| ||1|Cetylpyri|dinium Chloride Benzydamine|1 Number|1|Pholcodine||||5.61 mg|| ||| Hydrochl|, oride and Pholcodine Lozenges||||||||| |||Sugar Fr |ee Blackcurrant/ Pineapple & ||||||||| |||Lime/(Ho Flavours. Pholcodi|ney, Lemon & Ginger/Other Each Lozenge contains (i) e 550m (ii) Benzdamine||2|Benzydamine Hydrochloride||||1.53mg|| ||||||||||||| |||.g y Hydrochloride 1.50 mg (iii) Cetylpyridinium Chloride 1.33 mg (iv)Isomalt ST-M 2583 mg. Net Content (i) 43.80 kg (ii) 11.94 kg (iii) 10.59 kg|||3|Cetylpyridinium Chloride||||1.357 mg|| ||||||4|Isomalt ST-M||||2583.0 mg|| ||| (iv) 20568 Kg)|||||||||| ||||||||||||| ||||||||||||| |||||||||||||

idinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii)|Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours. (Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii)|Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours. (Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii)|Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours. (Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii)|Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours. (Each lozenge contains (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii)|1000 Number|8|Cetylpyridinium Chloride|Cetylpyridinium Chloride|1.00| |---|---|---|---|---|---|---|---|---|---|---|---| ||3826.059 Kg.)||||||||||| |||||||||9|Isomalt ST-M||2586| ||||||||||||| ||||||||||||| ||Cetylpyridinium ||Chloride And Benzydamine Hydrochloride Antiseptic Lozenges ||||1000 |10|Cetylpyridinium ||1.00| ||Sugar Free. (Ea ST-M - 2586mg||ch lozenge contains (i) Cetylpyridinium Chloride- 1 mg (ii) lsomalt .

UDIN00181221AM24

g (iii) 10.59 kg|||3|Cetylpyridinium Chloride||||1.357 mg|| ||||||4|Isomalt ST-M||||2583.0 mg|| ||| (iv) 20568 Kg)|||||||||| ||||||||||||| ||||||||||||| |||||||||||||

UDIN00181221AM24

5<br>Pholcodine<br>5.61 mg<br>6<br>Cetylpyridinium Chloride<br>1.357 mg<br>2<br>Pholcodine and Cetylpyridinium Chloride<br>Lozenges Sugar Free Orange / Lemon and<br>Other Flavours. Each Lozenge contains ((i)<br>Pholcodine<br>5.50<br>mg<br>(ii)<br>Cetylpyridinium Chloride 1.33 mg (iii)<br>Isomalt ST-M 2579 mg. Net Content (i)<br>Pholcodine-30.77 kg (ii) Cetylpyridinium<br>Chloride-7.44 kg (iii) Isomalt ST-M-<br>14427.96 kg.)<br>1 Number<br>7<br>Isomalt ST-M<br>2579.0 mg<br> <br>RA concerned may take further necessary action as per above decision of NC.	2	Pholcodine and Cetylpyridinium Chloride<br>Lozenges Sugar Free Orange / Lemon and<br>Other Flavours. Each Lozenge contains ((i)<br>Pholcodine<br>5.50<br>mg<br>(ii)<br>Cetylpyridinium Chloride 1.33 mg (iii)<br>Isomalt ST-M 2579 mg. Net Content (i)<br>Pholcodine-30.77 kg (ii) Cetylpyridinium<br>Chloride-7.44 kg (iii) Isomalt ST-M-<br>14427.96 kg.)	<br> <br> <br> <br> <br> <br> <br>1 Number	5	Pholcodine	5.61 mg
				6	Cetylpyridinium Chloride	1.357 mg
				7	Isomalt ST-M	2579.0 mg

malt ST-M- 14427.96 kg.)| 1 Number|5|Pholcodine|5.61 mg| |---|---|---|---|---|---|---| |||||6|Cetylpyridinium Chloride|1.357 mg| |||||7|Isomalt ST-M|2579.0 mg|

Case No.	55 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006487AM23
RA File Number	09AX04001024 AM23
Licence No and<br>Date	0911004510/21/02/2023
Norms Committee Decision:<br>Submit one shipping bill complete set of the export product along with export and import product statement of<br>the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this<br>case.

Case No.	56 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006518AM23
RA File Number	34AX04001067 AM23
Licence No and<br>Date	3411003416/22/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00181221AM24

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

UDIN00181221AM24

Export Product		Qty.	Sl. No.	Import Items	Qty.
Fluorouracil Injection USP 2.5	gm 50	<br>1 Number	1	Fluorouracil USP	2.60 gm / 50 ml
ML(Fluorouracil Injection USP 2.5 gm 50					Injection
ML (Net content of active
ingredients 65.00 kgs )
Fluorouracil Injection USP 5	gm 100	<br>1 Number	2	Fluorouracil USP	5.20 gm / 100 ml
ML(Fluorouracil Injection USP 5 gm 100
ML<br>(Net<br>content<br>of	active				Injection
ingredients240.00 kgs)

Export Product<br>	Qty.	Sl. No.	Import Items	Qty.
Fluorouracil Injection USP 2.5 gm 50<br>ML(Fluorouracil Injection USP 25 m 50<br>	1 Number	1	Fluorouracil USP	2.60 gm / 50 ml<br>Injection
. g<br>ML (Net content of active<br>idi 6500 k
ngreents .

jection USP 2.5 gm 50 ML(Fluorouracil Injection USP 25 m 50 ||1 Number||1||Fluorouracil USP|2.60 gm / 50 ml Injection|| ||. g ML (Net content of active idi 6500 k||||||||| ||ngreents . gs )||||||||| ||Fluorouracil Injection USP 5 gm 100 ||1 Number||2||Fluorouracil USP|5.20 gm|/ 100 ml| ||ML(Fluorouracil Injection USP 5 gm 100 ML (Net content of active ingredients240.00 kgs)|||||||Injection|| ||||||||||| ||||||||||| |RA concerned ma||y take further necessary action as per above decision of NC.|||||||| ||||||||||| ||||||||||| ||||||||||| |Case No.||57 / NC/3/MEET/Jun/202324/6|||||||| |C Stt||C Ad|||||||| |ase aus||ase pprove|||||||| |Pt N||ALEMBIC PHARMACEUTICALS LIMITED|||||||| |ary ame|||||||||| |Mti Nb|||||||||| |eeng umer and Date||NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023|||||||| |H Fil Nb||HRNORM APPLY 00006517AM23|||||||| |Q e umer||Q|||||||| |RA File Number||34AX04001068 AM23|||||||| |Licence No and Date||3411003415/22/02/2023|||||||| |Norms Committee Decision:|||||||||| ||||||||||| |The Committee c ||onsidered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP |||||||| |Vol. I as per detai||ls given below or as applied by the firm, whichever is less: -|||||||| ||||||||||| ||||||||||| ||||||||||| ||Export Pr|oduct|Qty.||Sl.

c norms under Para 4.07 of HBP |||||||| |Vol. I as per detai||ls given below or as applied by the firm, whichever is less: -|||||||| ||||||||||| ||||||||||| ||||||||||| ||Export Pr|oduct|Qty.||Sl. No.||Import Items|Qty.|| ||||||||||| ||||||||||| ||Fluorouracil I (Fluorouracil I|njection USP 2.5 gm 50 ML njection USP 2.5 gm 50 ML| 1 Number||1||Fluorouracil USP|2.60 gm / 50 ml Injection|| ||(Net content of active ingredients 65.00 kgs)||||||||| |||| ||||||| ||Fluorouracil MLFl|Injection USP 5 gm 100 il Ii USP 5 100| 1 Number||2||Fluorouracil USP|5.20 gm / 100 ml|| ||(uoroura ML (Net conte|c njecton gm nt of active inredients24000| |||||Injection|| || kgs)|g.|||||||| |||||||||||

UDIN00181221AM24

Case No.	58 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006564AM23
RA File Number	08AX04001906 AM23
Licence No and<br>Date	0811007374/23/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<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.<br>CLOZAPINE TABLETS (CLOZAPYL 25MG)<br>(ZIPROC 25MG)(EACH UNCOATED TABLET<br>CONTAINS:CLOZAPINE<br>BP<br>25<br>MG<br>NET<br>CONTENT OF CLOZAPINE BP SHOULD NOT<br>BE LESS THAN 18.750 KGS.

ems Qty. CLOZAPINE TABLETS (CLOZAPYL 25MG) (ZIPROC 25MG)(EACH UNCOATED TABLET CONTAINS:CLOZAPINE BP 25 MG NET CONTENT OF CLOZAPINE BP SHOULD NOT BE LESS THAN 18.750 KGS. IN EXPORT ITEM) 1 Number 1 CLOZAPINE BP 25.50 mg / 25 mg. Tablet CLOZAPINE TABLETS (ZIPROC 100MG)(EACH UNCOATED TABLET CONTAINS: CLOZAPINE BP 100 MGNET CONTENT OF CLOZAPINE BP SHOULD NOT BE LESS THAN 520.000 KGS. IN EXPORT ITEM) 1 Number 2 CLOZAPINE BP 102.0 mg / 100 mg. tablet RA concerned may take further necessary action as per above decision of NC.||

Case No.	59 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006524AM23
RA File Number	08AX04001944 AM23
Licence No and Date	0811007355/23/02/2023

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Norms Committee Decision:

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

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



	Export Pro	duct	Qty.	Sl.

ms under Para 4.07 of HBP Vol. I as per| |---|---|---|---|---|---|---| |details given below or as applied by the firm, whichever is less:-||||||| |||||||| |||||||| |||||||| ||Export Pro|duct|Qty.|Sl. No.|Import Items|Qty.| |||||||| ||HYDROXYCH|LOROQUINE SULFATE| 1 Number|1|HYDROXYCHLOROQUINE|102.00 mg.| ||TABLETS U |SP 100 MG(EACH FILM |||SULFATE EP / BP / IP / USP / PH. || ||COATED TAB HYDROXYCH|LET CONTAINS: LOROQUINE SULFATE USP|||EUR.|| || 100MG EQ. TO HYDROXYCHLOROQUINE 77.5 MG)|| |||| ||HYDROXYCHLOROQUINE SULFATE TABLETS USP 200 MG(EACH FILM COATED TABLET CONTAINS:|| 1 Number|2|HYDROXYCHLOROQUINE SULFATE EP / BP / IP / USP / PH. EUR.|204.00 mg.| ||HYDROXYCHLOROQUINE SULFATE USP|||||| || 200MG EQ. T| O HYDROXYCHLOROQUINE| |||| ||155 MG)|||||| |||||||| |||||||| ||HYDROXYCH TABLETS U|LOROQUINE SULFATE SP 300 MG(EACH FILM| 1 Number|3|HYDROXYCHLOROQUINE SULFATE EP / BP / IP / USP / PH.|306.00 mg.| ||COATED TAB|LET CONTAINS:|||EUR.|| ||HYDROXYCH|LOROQUINE SULFATE USP||||| || 300MG EQ. T 232.50 mg)| O HYDROXYCHLOROQUINE| |||| |HYDROXYCHLOROQUINE SULFATE TABLETS USP 400 MG(EACH FILM COATED TABLET CONTAINS: HYDROXYCHLOROQUINE SULFATE USP 400MG EQ.

T 232.50 mg)| O HYDROXYCHLOROQUINE| |||| |HYDROXYCHLOROQUINE SULFATE TABLETS USP 400 MG(EACH FILM COATED TABLET CONTAINS: HYDROXYCHLOROQUINE SULFATE USP 400MG EQ. TO HYDROXYCHLOROQUINE 310 MG [IN WHICH ACTIVE INGREDIENT 1 Number 4 HYDROXYCHLOROQUINE SULFATE EP / BP / IP / USP / PH. EUR. 408.00 mg.||||||| ||HYDROXYCHLOROQUINE SULFATE TABLETS USP 400 MG(EACH FILM COATED TABLET CONTAINS: HYDROXYCHLOROQUINE SULFATE USP 400MG EQ. TO HYDROXYCHLOROQUINE 310 MG [IN WHICH ACTIVE INGREDIENT|| 1 Number|4|HYDROXYCHLOROQUINE SULFATE EP / BP / IP / USP / PH. EUR.|408.00 mg.| |||||||| |||||||| |RA concerned may||take further necessary action as per above decision of NC.||||| |||||||| |||||||| |Case No.||60 / NC/3/MEET/Jun/202324/6||||| |Case Status||Case Approved||||| |||||||| |Party Name||HONOUR LAB LIMITED||||| |||||||| |Meeting Number||||||| | and Date||NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023||||| |HQ File Number||HQRNORM APPLY 00006534AM23||||| ||||||||

Case No.	60 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	HONOUR LAB LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006534AM23

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UDIN00181221AM24

RA File Number

09AX04000902 AM23

Licence No and Date

0911004499/23/02/2023

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. (in kg.) 1 5-Hydroxy-1,3-oxathiolane-2- carboxylicacid(1R,2S,5R) menthyl ester 1.00 2 Dimethyl formamide 0.2632 3 Triphosgene 0.421 4 Cytosine 0.375 (2R-cis)-5-(4-amino-1,2-dihydro-2-oxo-1- pyrimidinyl)-1,3-oxathiolane-2-carboxylic acid(2S,5R)-methyl ester.(Otherheterocyclic compounds) 1 kg. 5 Hexamethyl disilazane 0.660 RA concerned may take further necessary action as per above decision of NC.

lic acid(2S,5R)-methyl ester.(Otherheterocyclic compounds) 1 kg. 5 Hexamethyl disilazane 0.660 RA concerned may take further necessary action as per above decision of NC.||

Case No.	61 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006526AM23
RA File Number	08AX04001943 AM23
Licence No and<br>Date	0811007356/23/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>in meetingNo.NC/3/MEET/Apr/20202324/1dated28/04/2023against advance authorizationNo.0811006675dated07/12/2022,<br>it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever<br>is less:-

UDIN00181221AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
NALTREXONE HYDROCHLORIDE	1 Number	1	NALTREXONE	51.93 mg/ tablet
TABLETS USP 50 MG(EACH			HYDROCHLORIDE EP / BP /
UNCOATED TABLET CONTAINS:			IP / USP / PH. EUR
NALTREXONE HYDROCHLORIDE USP
50 MG [IN WHICH ACTIVE
INGREDIENT NALTREXONE
HYDROCHLORIDE USED IS
308.505 KGS.])

/|| |UNCOATED TABLET CONTAINS:|||IP / USP / PH. EUR|| |NALTREXONE HYDROCHLORIDE USP||||| |50 MG [IN WHICH ACTIVE||||| |INGREDIENT NALTREXONE||||| |HYDROCHLORIDE USED IS||||| |308.505 KGS.])|||||

Case No.<br>62 / NC/3/MEET/Jun/202324/6	Case No.<br>62 / NC/3/MEET/Jun/202324/6
Case Status<br>Case Approved
Party Name<br>SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number<br>HQRNORM APPLY 00006587AM23
RA File Number<br>05AX04003315 AM23
Licence No and<br>Date<br>0511017491/24/02/2023
Norms Committee Decision:
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/Dec/202223/15 dated 29/12/2022against advance						authorization
No.0511014014dated 28/07/2022, it was decided to fix adhoc norms under Para 4.07 of HBP Vol.					I as per details
given below or as applied by the firm, whichever is		less:
	Sl. No. Export Product	Qty	Sl. No.	Import Items		Qty
	1<br>Visallergol Eye Drops 0.2 Percent 2.5ml	1 Number Vial	1	Olopatadine HCL		5.61 mg
RA concerned may take further necessary action as		per above decision of NC.

Case No.	63 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	SANOFI INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023

UDIN00181221AM24

3 / NC/3/MEET/Jun/202324/6| |---|---| |Case Status|Case Approved| |Party Name|SANOFI INDIA LIMITED| |Meeting Number and Date|NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023|

UDIN00181221AM24

HQ File Number	HQ File Number	HQ File Number	HQRNORM APPLY 00006589AM23	HQRNORM APPLY 00006589AM23	HQRNORM APPLY 00006589AM23
RA File Number			03AX04005778 AM23
Licence No and<br>Date			0311021689/24/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23/09/2022against advance authorization No.<br>0311007049 dated 17/09/2021, it was decided to fixadhoc norms under Para 4.07 of HBP Vol. I as per details given<br>below or as applied by the firm, whichever is less:-<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Festal<br>Dragees<br>(Tablets)<br>Enterosoluble<br>10x10s((Total net Weight, Pancreatin 76800.00<br>Kgs Strength of Pancreatin 192mg/Tablet))<br>1 Number<br>Tablet<br>1<br>Pancreatin<br>195.84 mg<br>2<br>Festal N Dragees (Tablets) 2x10s((Total net<br>Weight, Pancreatin 5312.5 Kgs Strength of<br>Pancreatin 212.50mg/Tablet))<br>1 Number<br>Tablet<br>2<br>Pancreatin<br>216.75 mg<br>RA concerned may take further necessary action as per above decision of NC.
	Sl. No.	Export product		Qty.	Sl.

eatin 212.50mg/Tablet)) 1 Number Tablet 2 Pancreatin 216.75 mg RA concerned may take further necessary action as per above decision of NC.|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Festal Dragees (Tablets) Enterosoluble 10x10s((Total net Weight, Pancreatin 76800.00 Kgs Strength of Pancreatin 192mg/Tablet))|| 1 Number Tablet|1|Pancreatin|195.84 mg| ||2|Festal N Dragees (Tablets) 2x10s((Total net Weight, Pancreatin 5312.5 Kgs Strength of Pancreatin 212.50mg/Tablet))|| 1 Number Tablet|2|Pancreatin|216.75 mg| ||RA concerned may take further necessary action as per above decision of NC.|||||||

Case No.	64 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	BRAWN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006591AM23
RA File Number	05AX04003295 AM23
Licence No and<br>Date	0511017494/24/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import<br>product in meeting No.NC/3/MEET/Dec/202223/15dated29/12/2022against advance authorization No.0511013337<br>dated21/06/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less:-

UDIN00181221AM24

7** dated21/06/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||

UDIN00181221AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
DOXYCYCLINE CAPSULES 100 MG((HARD GELATINE	1 Number	1	DOXYCYCLINE HYCLATE	117 mg.
CAPSULES CONTAINING YELLOW GRANULAR
POWDER))

Case No.	65 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006576AM23
RA File Number	03AX04005701 AM23
Licence No and<br>Date	0311021683/24/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>BRIMONIDINE EYE DROPS 5 ML ((EACH<br>VIAL CONTAINS BRIMONIDINE L<br>TARTRATE 0.01 GM NET WT OF BULK<br>DRUG IS 1.070 KGS))<br>1 Vial<br>1<br>BRIMONIDINE L<br>TARTRATE<br>10.2 mg / vial<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	66 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006579AM23
RA File Number	04AX04001001 AM23

UDIN00181221AM24

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Licence No and 0411004937/24/02/2023 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Apr/202324/1 dated 28/04/2023 against advance authorization No. 0411004581 dated 07/12/2022 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty.
IBUPROFEN	1 kg.	1	Isobutyl Acetophenone	1.11 kg.
		2	Sodium Metal	0.235 kg.
		3	Monochloro Acetic Acid	0.919 kg.
		4	Isopropyl Alcohol	0.50 kg.
		5	Sodium Dichromate	0.630 kg.

Case No.	67 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006580AM23
RA File Number	03AX04005710 AM23
Licence No and<br>Date	0311021583/24/02/2023

| |Meeting Number and Date|NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023| |HQ File Number|HQRNORM APPLY 00006580AM23| |RA File Number|03AX04005710 AM23| |Licence No and Date|0311021583/24/02/2023| |Norms Committee Decision: Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo.NC/3/MEET/Apr/20202324/1dated28/04/2023against advance authorization No.0311020446dated03/01/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||

UDIN00181221AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
Lamivudine 300mg + Tenofovir disoproxil	1 Number	1	(R)-3-AMINO-1-BUTANOL	19.635 mg.
Fumarate 300mg + Dolutegravir Sodium 50mg
tablets (Lamivudine 300mg + Tenofovir
disoproxil Fumarate 300mg + Dolutegravir		2	1-(2,2-dimethoxyethyl)-5-	Indigenously
Sodium 50mg tablets (Net content: 5400.000			methoxy-6(methoxycarbonyl) 4-	procured
kgs Dolutegravir Sodium + 32400.000 kgs			oxo-1,4-dihydropyridine-3-
Tenofovir Disoproxil Fumarate + 32400.000			carboxylic acid
kgs Lamivudine))
		3	(R)-9-(2-phosphonomethoxy	198.676 mg.
			propyl)-adenine
		4	LAMIVUDINE	Indigenously
				procured.

enofovir Disoproxil Fumarate + 32400.000|||carboxylic acid|| |kgs Lamivudine))||||| |||3|(R)-9-(2-phosphonomethoxy|198.676 mg.| ||||propyl)-adenine|| |||4|LAMIVUDINE|Indigenously| |||||procured.|

Case No.	Case No.	68 / NC/3/MEET/Jun/202324/6	68 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006601AM23
RA File Number		03AX04005798 AM23
Licence No and<br>Date		0311021713/26/02/2023
Norms Committee Decision:
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/Feb/202223/20dated24/02/2023against advance authorization No.
0311014080dt. 22/04/2022, it was decided to fix 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.
	HYDROQUINONE BIS(2 Hydroxy Ethyl		<br>1 kg.	1	HYDROQUINONE	0.579 kg.
	Ether) (YAPOX	LM 30/10)
				2	ETHYLENE CARBONATE	0.934 kg.

UDIN00181221AM24

port items|Qty.|| ||HYDROQUINONE BIS(2 Hydroxy Ethyl|| 1 kg.|1|HYDROQUINONE|0.579 kg.|| ||Ether) (YAPOX|LM 30/10)|||||| |||||2|ETHYLENE CARBONATE|0.934 kg.|| |||||||||

UDIN00181221AM24

Case No.	Case No.	69 / NC/3/MEET/Jun/202324/6	69 / NC/3/MEET/Jun/202324/6	69 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006602AM23
RA File Number		03AX04005806 AM23
Licence No and<br>Date		0311021714/26/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Feb/202223/20 dated 24/02/2023against advance authorization No.<br>0311014080dt. 22/04/2022, it was decided to fix norms under Para 4.07 of HBP Vol. I as per details given below or<br>as applied by the firm, whichever is less:-<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>HYDROQUINONE<br>0.579 kg.<br>HYDROQUINONE BIS(2 Hydroxy Ethyl<br>Ether) (YAPOX LM 30/10)<br>1 kg.<br>2<br>ETHYLENE CARBONATE<br>0.934 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl.

roxy Ethyl Ether) (YAPOX LM 30/10) 1 kg. 2 ETHYLENE CARBONATE 0.934 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||HYDROQUINONE BIS(2 Hydroxy Ethyl Ether) (YAPOX LM 30/10)|| 1 kg.|1|HYDROQUINONE|0.579 kg.| |||||2|ETHYLENE CARBONATE|0.934 kg.| ||RA concerned may take further necessary action as per|||above decision of NC.|||

Case No.	70 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006642AM23
RA File Number	08AX04001990 AM23
Licence No and<br>Date	0811007390/27/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>in meetingNo. 4/82-ALC4/2019dated19/07/2019against advance authorizationNo.0810142125 dated 08/03/2018, it was<br>decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00181221AM24

0142125 dated 08/03/2018**, 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:-||

UDIN00181221AM24

Export Product	Qty.	Sl. No.	Import Items	Qty.
SPIRONOLACTONE TABLETS BP 25<br>MG(EACH FILM COATED TABLET<br>CONTAINS: SPIRONOLACTONE<br>PH.EUR. 25 MG)	1 Number	1	SPIRONOLACTONE EP / BP / IP /<br>USP / PH. EUR.	25.50 mg per<br>Tablet
SPIRONOLACTONE TABLETS BP 50<br>MG(EACH FILM COATED TABLET<br>CONTAINS: SPIRONOLACTONE<br>PH.EUR. 50 MG)	1 Number	2	SPIRONOLACTONE EP / BP / IP /<br>USP / PH. EUR.	51.00 mg per<br>Tablet
SPIRONOLACTONE TABLETS BP 100<br>MG(EACH FILM COATED TABLET<br>CONTAINS: SPIRONOLACTONE<br>PH.EUR. 100 MG [IN WHICH ACTIVE<br>INGREDIENT SPIRONOLACTONE<br>USED IS 116.250 KGS.])	1 Number	3	SPIRONOLACTONE EP / BP / IP /<br>USP / PH. EUR.	102.00 mg per<br>tablet

Case No.	71 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	KOPRAN LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006649AM23
RA File Number	03AX04005732 AM23
Licence No and<br>Date	0311021773/27/02/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was observed that review case of the<br>firm for same export item against the Advance Authorisation No. 0311004745 dated 19/06/2021 is already under<br>consideration. Hence, the committee decided to defer the case till the finalization of review case.

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

Case No.	72 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	KOPRAN LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023

UDIN00181221AM24

HQ File Number	HQRNORM APPLY 00006648AM23
RA File Number	03AX04005729 AM23
Licence No and<br>Date	0311021772/27/02/2023
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and it was observed that review case of the
firm for same export item against the Advance Authorisation No. 0311004745 dated 19/06/2021 is already under
consideration. Hence, the committee decided to defer the case till the finalization of review case.

HQ File Number	HQ File Number	HQRNORM APPLY 00006648AM23	HQRNORM APPLY 00006648AM23	HQRNORM APPLY 00006648AM23	HQRNORM APPLY 00006648AM23	HQRNORM APPLY 00006648AM23	HQRNORM APPLY 00006648AM23	HQRNORM APPLY 00006648AM23	HQRNORM APPLY 00006648AM23	HQRNORM APPLY 00006648AM23
RA File Number		03AX04005729 AM23
Licence No and<br>Date		0311021772/27/02/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was observed that review case of the<br>**firm for same export item against the Advance Authorisation No.

sion: The committee considered the request of firm for fixation of ad-hoc norms and it was observed that review case of the firm for same export item against the Advance Authorisation No. 0311004745 dated 19/06/2021 is already under consideration. Hence, the committee decided to defer the case till the finalization of review case.||||||||||| ||||firm for fixation vance Authorisa||of ad-hoc norm tion No. 031100|||s and it was observed that re 4745 dated 19/06/2021 is alre||view case of the ady under| |||| ided to defer the|| case till the fina||| lization of review case.||| |||||||||||| |Case No.||73 / NC/3/MEET/Jun/202324/6||||||||| |Case Status||Case Approved||||||||| |Party Name||INTAS PHARMACEUTICALS LIMITED||||||||| |||||||||||| |Meeting Number ||NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023||||||||| |and Date||||||||||| |H Fil Nb||HRNORM APPLY 00006613AM23||||||||| |Q e umer||Q||||||||| |RA Fil Nb||08AX04002002 AM23||||||||| |e umer||||||||||| |Li N d||||||||||| |cence o an Date||0811007388/27/02/2023||||||||| |N Ci||ii||||||||| |orms ommttee||ecson:||||||||| |The Committee con||sidered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per||||||||| |details given below||or as applied by the firm, whichever is less:-||||||||| |||||||||||| ||Export Product|||Qty.||Sl.

t 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.|| |||||||||||| ||PROPAFENON |E HYDROCHLORIDE ||1 Tablet||1|PROPAFENONE ||153.00 mg/tablet|| ||TABLETS 150 TABLET CON|MG(EACH FILM COATED TAINS: PROPAFENONE|||||HYDROCHLORIDE EP / BP / IP / USP / PH. EUR.|||| || HYDROCHLO| RIDE PH. EUR. 150 MG)||||||||| |||||||||||| |||||l|||||l|| ||PROPAFENO TABLETS 300|E HYDROCHLORIDE MG(EACH FILM||1 Tabet||2|PROPAFENONE HYDROCHLORIDE EP / BP /||306.00 mg/ tabet|| || COATED TAB| LET CONTAINS:|||||IP / USP / PH. EUR.|||| ||PROPAFENON PH. EUR. 300 |E HYDROCHLORIDE MG [IN WHICH ACTIVE ||||||||| ||INGREDIENT PROPAFENONE HYDROCHLORIDE USED IS 283.500 KGS.])|||||||||| |||||||||||| |||||||||||| |||||||||||| |RA concerned ma||take necessar action as er above decision of NC||||||||| |y||y p .||||||||| |||||||||||| |Case No.||74 / NC/3/MEET/Jun/202324/6||||||||| |Case Status||Case Deferred|||||||||

Case No.	74 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred

UDIN00181221AM24

|||||| |Case No.||74 / NC/3/MEET/Jun/202324/6||||||||| |Case Status||Case Deferred|||||||||

Case No.	74 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred

UDIN00181221AM24

Party Name<br>INDO AMINES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number<br>HQRNORM APPLY 00006610AM23
RA File Number<br>03AX04005572 AM23
Licence No and<br>Date<br>0311021737/27/02/2023
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-
Reason for asking very high quantity of styrene comparing to theoretical yield.<br>I.
Yield of the reaction with justification.<br>II.
Submit one shipping bill complete set of the export product along with export and import product<br>III.
statement of the said Authorization. Also, it is directed to technical expert to give their comments before
next agenda of this case.

ct along with export and import product** III.| |statement of the said Authorization. Also, it is directed to technical expert to give their comments before| |next agenda of this case.|

Party Name	Party Name	INDO AMINES LIMITED	INDO AMINES LIMITED	INDO AMINES LIMITED	INDO AMINES LIMITED	INDO AMINES LIMITED	INDO AMINES LIMITED	INDO AMINES LIMITED	INDO AMINES LIMITED	INDO AMINES LIMITED	INDO AMINES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006610AM23
RA File Number		03AX04005572 AM23
Licence No and<br>		0311021737/27/02/2023
Date
Norms Committee		Decision:
The committee con		sidered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following
<br>information/docum		<br>ents from the firm:-
Reason for<br>I.<br>Yild f h<br>II		asking very high quantity of styrene comparing to theoretical yield.<br>i ih ifii
e o te<br>.<br>Submit on<br>III		reacton wt justcaton.<br>shipping bill complete set of the export product along with export and import product
<br>statement<br>.		<br>**of the said Authorization.

on** III||reacton wt justcaton. shipping bill complete set of the export product along with export and import product|||||||||| | statement .|| of the said Authorization. Also, it is directed to technical expert to give their comments before|||||||||| | next agend|| a of this case.|||||||||| ||||||||||||| |Case No.|||75 / NC/3/MEET/Jun/202324/6||||||||| |Case Status|||Case Approved||||||||| ||||||||||||| |Party Name|||AMOLI ORGANICS PRIVATE LIMITED||||||||| |Meeting Number an ||d|NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023||||||||| |Date|||||||||||| ||||||||||||| |HQ File Number|||HQRNORM APPLY 00006607AM23||||||||| ||||||||||||| |RA File Number|||03AX04005558 AM23||||||||| |Licence No and Da||te|0311021734/27/02/2023||||||||| ||||||||||||| |Norms Committee||Decision:|||||||||| |**:**The Committe||e considered the case as per agenda and taking cue from earlier decision for same export product /|||||||||| | import item in 0311015623dated|| Meeting No.NC/3/MEET/Dec/202223/15dated 29/12/2022against advance authorization No. 17/06/2022, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given|||||||||| |below or as applied by the firm, whichever is less: Export Product Qty. Sl. No.

17/06/2022**, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given|||||||||| |below or as applied by the firm, whichever is less: Export Product Qty. Sl. No. Import Items Qty. Rosuvastatin Calcium USP / BP / EP / IH 1 kg 1 Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4- fluorophenyl)-6-isopropyl-2-(N- methylmethylsulfonamido)pyrimidin-5- yl)vinyl)-2,2-di dimethyl-1,3-dioxan-4- yl)acetate 1.30 kg RA concerned may take further necessary action as per above decision of NC.|||||||||||| ||Export Product||||Qty.|S|l. No.|Import Items|||Qty.| ||Rosuvastatin Calcium USP / BP /|||| 1 kg|1||Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-|||1.30 kg| ||EP / IH|||||||fluor meth l)vi|ophenyl)-6-isopropyl-2-(N- ylmethylsulfonamido)pyrimidin-5- l)-22-di dimethl-13-dioxan-4|-|| |||||||||y yl)ac|y, y, etate||| ||||||||||||| ||||||||||||| ||concerned may take further necessary action as||||||per above decision of NC.||||| ||||||||||||| |Case No.||76 / NC/3/MEET/Jun/202324/6||||||||||

UDIN00181221AM24

||||||||| ||||||||||||| ||concerned may take further necessary action as||||||per above decision of NC.||||| ||||||||||||| |Case No.||76 / NC/3/MEET/Jun/202324/6||||||||||

UDIN00181221AM24

Case Status	Case Status	Case Approved	Case Approved	Case Approved	Case Approved	Case Approved
Party Name		ALTA LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006606AM23
RA File Number		03AX04005719 AM23
Licence No and<br>Date		0311021732/27/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Dec/202223/15 dated 29/12/2022against advance authorization No.<br>0311015468 dated 13/06/2022, it was decided to fix 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>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>SODIUM SALICYLATE<br>1 kg<br>1<br>SALICYLIC ACID<br>0.80 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	SODIUM SALICYLATE		1 kg	1	SALICYLIC ACID	0.80 kg
	RA concerned may take further necessary action as per above decision of NC.

NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||SODIUM SALICYLATE||1 kg|1|SALICYLIC ACID|0.80 kg| ||RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	Case No.	77 / NC/3/MEET/Jun/202324/6	77 / NC/3/MEET/Jun/202324/6	77 / NC/3/MEET/Jun/202324/6	77 / NC/3/MEET/Jun/202324/6	77 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006655AM23
RA File Number		04AX04001034 AM23
Licence No and<br>Date		0411004963/28/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Apr/202324/1 dated 28/04/2023against advance authorization<br>No. 0411004581 dated 07/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

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

Case No.	Case No.	77 / NC/3/MEET/Jun/202324/6	77 / NC/3/MEET/Jun/202324/6	77 / NC/3/MEET/Jun/202324/6	77 / NC/3/MEET/Jun/202324/6	77 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006655AM23
RA File Number		04AX04001034 AM23
Licence No and<br>Date		0411004963/28/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Apr/202324/1 dated 28/04/2023against advance authorization<br>No. 0411004581 dated 07/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

UDIN00181221AM24

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

UDIN00181221AM24

1	Isobutyl Acetophenone	1.11 kg.
2	Sodium Metal	0.235 kg.
3	Monochloro Acetic Acid	0.919 kg.
4	Isopropyl Alcohol	0.50 kg.
5	Sodium Dichromate	0.630 kg.

Case No.	Case No.	78 / NC/3/MEET/Jun/202324/6	78 / NC/3/MEET/Jun/202324/6	78 / NC/3/MEET/Jun/202324/6	78 / NC/3/MEET/Jun/202324/6	78 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		AUROBINDO PHARMA LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006657AM23
RA File Number		09AX04001022 AM23
Licence No and<br>Date		0911004550/28/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import<br>product in meetingno. NC/3/MEET/Mar/20202223/24 dated 13/04/2023against advance authorizationno. 0911001956<br>dated 29/11/2021, it was decided to fix adhoc norms under Para 4.07 of HBP Vol.

duct in meetingno. NC/3/MEET/Mar/20202223/24 dated 13/04/2023against advance authorizationno. 0911001956 dated 29/11/2021, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less. Export product Qty. Sl. No. Import items Qty. 1 6-Amino Penicillanic Acid (6-APA) 576.40 mg 2 D-(-)-4-hydroxyphenylglycine methyl ester [PHPG Ester] 496.38 mg 3 Penicillin G Amidase (Particle size 250 - 500 micron, Creamish to Brown regularly shaped beads) 2.25 mg AMOXYCILLIN AND CLAVULANATE POTASSIUM TABLETS 1000mg((Each tablet contains Amoxicillin 875 mg and Potassium Clavulanate equivalent to Clavulanic acid 125 mg) [Relevant Bulk Drug content in the Export product is Amoxycillin Trihydrate is11812.50 Kgs and Clavulanate ~~otassium is 168750 Ks])~~ 1 Number Tablet||||||| ||Export product||Qty.|Sl.

Bulk Drug content in the Export product is Amoxycillin Trihydrate is11812.50 Kgs and Clavulanate ~~otassium is 168750 Ks])~~ 1 Number Tablet||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||AMOXYCILLIN AND CLAVULANATE POTASSIUM TABLETS 1000mg((Each tablet contains Amoxicillin 875 mg and Potassium Clavulanate equivalent to Clavulanic acid 125 mg) [Relevant Bulk Drug content in the Export product is Amoxycillin Trihydrate is11812.50 Kgs and Clavulanate ~~otassium is 168750 Ks])~~|| 1 Number Tablet|1|6-Amino Penicillanic Acid (6-APA)|576.40 mg| |||||2|D-(-)-4-hydroxyphenylglycine methyl ester [PHPG Ester]|496.38 mg| |||||3|Penicillin G Amidase (Particle size 250 - 500 micron, Creamish to Brown regularly shaped beads)| 2.25 mg| ||~~p . g~~||||||

UDIN00181221AM24

4 Potassium Clavulanate Diluted with 302.03 mg Microcrystalline Cellulose (1:1)

icron, Creamish to Brown regularly shaped beads)| 2.25 mg| ||~~p . g~~||||||

UDIN00181221AM24

4 Potassium Clavulanate Diluted with 302.03 mg Microcrystalline Cellulose (1:1)

Case No.	79 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006668AM23
RA File Number	03AX04005749 AM23
Licence No and<br>Date	0311021795/28/02/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>GENTAMICIN EYE/EAR DROPS 10<br>ML((EACH VIAL CONTAINS<br>GENTAMICIN SULPHATE 0.030GM NET<br>WT OF BULK DRUG IS 4.110 KGS))<br>137000 Vials<br>1<br>GENTAMICIN SULPHATE<br>4.1922 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	80 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	VINYL PRODUCTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006693AM23
RA File Number	05AX04003380 AM23
Licence No and<br>Date	0511017572/01/03/2023
Norms Committee Decision:

UDIN00181221AM24

and 14/06/2023| |HQ File Number|HQRNORM APPLY 00006693AM23| |RA File Number|05AX04003380 AM23| |Licence No and Date|0511017572/01/03/2023| |Norms Committee Decision:||

UDIN00181221AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
PVC Plasticizer (Phthalic, Non-Polymeric)	1 kg.	1	Phthalic Anhydride	0.40 kg.
		2	2 Ethyl Hexanol	0.70 kg.

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

Case No.	81 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006678AM23
RA File Number	03AX04005502 AM23
Licence No and<br>Date	0311021802/01/03/2023
Norms Committee Decision:<br>Under consideration for physical verification.

ber|HQRNORM APPLY 00006678AM23| |RA File Number|03AX04005502 AM23| |Licence No and Date|0311021802/01/03/2023| |Norms Committee Decision: Under consideration for physical verification.||

Case No.	82 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	AARTI PHARMALABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006751AM23
RA File Number	03AX04005685 AM23
Licence No and<br>Date	0311021895/04/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Yield of reaction with justification of wastage at each stage.<br>1.<br>Function of sodium sulphate & urea in the reaction and also to give reason for indicating Ammonium<br>2.

UDIN00181221AM24

Sulphate in the process flow chart.

Submit one shipping bill complete set of the export product along with export and import product statement of the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.

et of the export product along with export and import product statement of the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.**

Case No.	83 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	BLUE JET HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006770AM23
RA File Number	03AX04005861 AM23
Licence No and<br>Date	0311021934/06/03/2023
Norms Committee Decision:<br>Submit one shipping bill complete set of the export product along with export and import product statement of<br>the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this<br>case.

Case No.	84 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	MEDREICH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006767AM23
RA File Number	07AX04001781 AM23
Licence No and<br>Date	0711006639/06/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Copy of Drug Manufacturing License (DML).<br>1.<br>Copy of Master Batch Formula<br>2.<br>Copy of Advance Authorisation<br>3.<br>Submit one shipping bill complete set of the export product along with export and import product<br>**statement of the said Authorization.

la** 2. Copy of Advance Authorisation 3. Submit one shipping bill complete set of the export product along with export and import product statement of the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case. 4.||

Submit one shipping bill complete set of the export product along with export and import product statement of the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.

Case No.	85 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	ANUH PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023

UDIN00181221AM24

HQ File Number	HQRNORM APPLY 00006763AM23
RA File Number	03AX04005850 AM23
Licence No and<br>Date	0311021914/06/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Stepwise complete chemistry, with molecular weight and percentage yield on molar basis.<br>1.<br>Copy of technical literature in support of yield envisaged in the process.<br>2.<br>Submit one shipping bill complete set of the export product along with export and import product<br>statement of the said Authorization. Also, it is directed to technical expert to give their comments before<br>next agenda of this case.<br>3.

t along with export and import product** statement of the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case. 3.||

Submit one shipping bill complete set of the export product along with export and import product statement of the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.

Case No.	86 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006779AM23
RA File Number	03AX04005915 AM23
Licence No and<br>Date	0311021940/07/03/2023
Norms Committee Decision:<br>Under consideration for physical verification.

Case No.	Case No.	87 / NC/3/MEET/Jun/202324/6	87 / NC/3/MEET/Jun/202324/6	87 / NC/3/MEET/Jun/202324/6	87 / NC/3/MEET/Jun/202324/6	87 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		LYRUS LIFE SCIENCES PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006780AM23
RA File Number		07AX04001780 AM23
Licence No and Date		0711006647/07/03/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.

e case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. NITROFURANTOIN ORAL SUSPENSION 1.5G/300ML 9333 Number 1 NITROFURANTOIN DIHYDRATE 14.28 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||NITROFURANTOIN ORAL SUSPENSION 1.5G/300ML||9333 Number|1|NITROFURANTOIN DIHYDRATE|14.28 kg.|

UDIN00181221AM24

NITROFURANTOIN ORAL	2000 Number	2	NITROFURANTOIN	6.12 kg.
SUSPENSION 3G/300ML			DIHYDRATE

NITROFURANTOIN ORAL<br>SUSPENSION 3G/300ML<br>2000 Number<br>2<br>NITROFURANTOIN<br>DIHYDRATE<br>6.12 kg.<br>RA concerned may take further necessary action as per above decision of NC.	NITROFURANTOIN ORAL<br>SUSPENSION 3G/300ML	NITROFURANTOIN ORAL<br>SUSPENSION 3G/300ML	2000 Number	2000 Number	2000 Number	2	2	2	2	NITROFURANTOIN<br>DIHYDRATE	NITROFURANTOIN<br>DIHYDRATE	6.12 kg.

Case No.		88 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		LYRUS LIFE SCIENCES PRIVATE LIMITED
Mti Nb
eeng umer<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023

HQ File Number		HQRNORM APPLY 00006781AM23

RA File Number		07AX04001758 AM23

Licence No and
<br>Date		0711006648/07/03/2023

File Number||HQRNORM APPLY 00006781AM23||||||||||| |||||||||||||| |RA File Number||07AX04001758 AM23||||||||||| |||||||||||||| |Licence No and||||||||||||| | Date||0711006648/07/03/2023||||||||||| |Norms Committee||Decision:||||||||||| |||||||||||||| |||||||||||||| |The Committee c Vol I as er detai||onsidered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP s iven below or as alied b the firm whichever is less:-||||||||||| ||. p g pp y ,|||||||||||| ||Export Product ||||Qty.|||Sl. No.|Import Items|||Qty.| |||||||||||||| ||ALVERINE CITRATE 60MG CAPSUL STOMACH PAIN & CRAMPS RELIEF(ALVERIN CITRATE 60MG|||ES |1 Number|||1|ALVERINE CITRATE|||60 mg per capsule| || CAPSULES NLS P - STOMACH PAIN CRAMPS RELIEF 100's)|||&||||||||| |||||||||||||| ||ALVERINE CITRATE 120MG CAPSU |||LES |1 Number|||2|ALVERINE CITRATE|||120 mg| ||STOMACH PAIN & CRAMPS RELIEF(ALVERIN CITRATE 120MG CAPSULES NLS P - STOMACH PAIN & CRAMPS RELIEF 60's)|||||||||||per capsule| |||||||||||||| |||||||||||||| |||||||||||||| |RA concerned ma||take further necessar action as er above decision of NC||||||||||| |||y p||||||||||| |||||||||||||| |Case No.||89 / NC/3/MEET/Jun/202324/6||||||||||| |Case Status||Case Deferred||||||||||| |Party Name||ZYDUS LIFESCIENCES LIMITED|||||||||||

Case No.	89 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	ZYDUS LIFESCIENCES LIMITED

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|Party Name||ZYDUS LIFESCIENCES LIMITED|||||||||||

Case No.	89 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	ZYDUS LIFESCIENCES LIMITED

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Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006783AM23
RA File Number	08AX04001767 AM23
Licence No and<br>Date	0811007464/07/03/2023
Norms Committee Decision:
Submit one shipping bill complete set of the export product along with export and import product statement of
the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this
case.

Meeting Number<br>and Date	Meeting Number<br>and Date
	Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and		14/06/2023
HQ	File Number	HQR	NORM APPLY 00006783AM23
RA	File Number	08A	X04001767 AM23
Lice<br>Date	nce No and	0811	007464/07/03/2023

Nor<br>Sub<br>the<br>case	ms Committee Decis<br>		ion:<br>
	mit one shipping b<br>		ill complete set of the export product along with export and import product statement of<br>
	said Authorization<br>		**.

s |||ion: |||||||||| ||mit one shipping b |||ill complete set of the export product along with export and import product statement of |||||||||| ||said Authorization |||. Also, it is dire|cted to technical||xpert to giv||e their comments before next ag|||enda of this|| ||.||||||||||||| ||||||||||||||| ||||||||||||||| |Case|No.||90 /|NC/3/MEET/Jun|/202324/6||||||||| |Case|Status||Case|Approved|||||||||| |Part|y Name||GLO|BAL CALCIU|M PRIVATE LIMI||TED||||||| ||||||||||||||| |Mee and|ting Number||NC/|3/ MEET/ J/ 202324/ 6 d 14/06/2023|||||||||| ||Date|||un an|||||||||| |HQ|File Number||HQR|NORM APPLY 00006785AM23|||||||||| |RA|File Number||04A|X04001029 AM23|||||||||| |Lice|nce No and||||||||||||| |Date|||0711|006656/07/03/2023|||||||||| |Nor|ms Committee||Decis|ion:|||||||||| ||||||||||||||| |Th imp 07|e Committee c t it i||onsid Mt|ered the case as per agenda and taking cue from earlier decision for same export product / NNC/3/MEET/D/202223/17dtd 13/01/2023it d thiti N|||||||||| ||or em n 100261||ee 1|ng o**.ecaeagans avance auorzaon o. i i fi h 4 f l il i|||||||||| | bel|5date ow or as alie||/** d b|2/2021, t was decded to x adoc norms under Para .07 o HBP Vo. I as per detas gven the firm whichever is less:|||||||||| ||pp||y|,|||||||||| ||||||||||||||| ||||||||||||||| ||Sl. No.|EXPORT P||RODUCT|||QTY.|Sl.

decded to x adoc norms under Para .07 o HBP Vo. I as per detas gven the firm whichever is less:|||||||||| ||pp||y|,|||||||||| ||||||||||||||| ||||||||||||||| ||Sl. No.|EXPORT P||RODUCT|||QTY.|Sl. No.|||IMPORT ITEMS|QTY.|| ||1|MAGNESI||UM CITRATE (USP/||| 1 k|1|||CITRIC ACID|1001 k|| ||| NONAHY|| DRATE Eur.Ph/ ANHYDROUS||| g|||||. g|| ||||||||||||||| |||Eur.Ph|/ DODECAHYDRATE||||||||||| |||||||||2|||MAGNESIUM |0.730 kg|| |||Eur.Ph|)||||||||CARBONATE||| ||||||||||||||| ||2|CALC|IUM CITRATE(USP)||||1 kg|1|||CITRIC ACID|0.816 kg|| ||||||||||||||| ||||||||||||||| |||||||||2|||CALCIUM CARBONATE|0.660 kg|| ||||||||||||||| ||3|ZINC CITRATE (USP)|||||1 kg|1|||CITRIC ACID|0.880 kg|| ||4|POTASSIUM CITRATE (BP/Eur.Ph/ USP)|||||1 kg|1|||CITRIC ACID|0.859 kg|| |||||||||||||||

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Case No.	91 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	ARORA AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006787AM23
RA File Number	05AX04003415 AM23
Licence No and<br>Date	0511017652/07/03/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/May/202324/4dated26/05/2023against advance authorization<br>No.0310835906dated25/04/2020, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

product in meetingNo.NC/3/MEET/May/202324/4dated26/05/2023against advance authorization No.0310835906dated25/04/2020, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. Menthol Crystals 1 kg. 1 L Menthol Molten 1.02 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	92 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	SCOTT EDIL PHARMACIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006790AM23
RA File Number	30AX04000539 AM23
Licence No and<br>Date	3011003243/07/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>CoA from Foreign Supplier showing potency of import item.<br>1.<br>Submit one shipping bill complete set of the export product along with export and import product<br>2.

Submit one shipping bill complete set of the export product along with export and import product

UDIN00181221AM24

statement of the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.

with export and import product**

UDIN00181221AM24

statement of the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.

Case No.	93 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006795AM23
RA File Number	05AX04003421 AM23
Licence No and<br>Date	0511017659/07/03/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23/09/2022against advance authorization No.<br>0511005004 dated 28/09/2021, it was decided to fixadhoc norms under Para 4.07 of HBP Vol. I as per details given<br>below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>TOBRISS<br>(TOBRAMYCIN<br>0.3<br>PERCENT) EYE DROPS 5 ML VIAL<br>1 Number Vial<br>1<br>Tobramycin Sulphate<br>19.057 mg<br>RA concerned may take further necessary action as per above decision of NC

RISS (TOBRAMYCIN 0.3 PERCENT) EYE DROPS 5 ML VIAL 1 Number Vial 1 Tobramycin Sulphate 19.057 mg RA concerned may take further necessary action as per above decision of NC||

Case No.	94 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006807AM23
RA File Number	09AX04001097 AM23
Licence No and<br>Date	0911004646/08/03/2023
Norms Committee Decision:<br>Submit one shipping bill complete set of the export product along with export and import product statement of<br>the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this<br>case..

UDIN00181221AM24

Case No.	95 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006808AM23
RA File Number	09AX04001078 AM23
Licence No and<br>Date	0911004655/08/03/2023
Norms Committee Decision:
Submit one shipping bill complete set of the export product along with export and import product statement of
the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this
case..

roduct along with export and import product statement of**|| |the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this|| |case..||

Case No.	96 / NC/3/MEET/Jun/202324/6	96 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006886AM23
RA File Number	03AX04005958 AM23
Licence No and<br>Date	0311022020/09/03/2023
Norms Committee Decision:
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/Feb/202223/20dated24/02/2023against advance authorization No.
0311014080dt. 22/04/2022, it was decided to fix 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.
HYDROQUINONE BIS(2 Hydroxy Ethyl		<br>1 kg.	1	HYDROQUINONE	0.579 kg.
Ether) (YAPOX	LM 30/10)
			2	ETHYLENE CARBONATE	0.934 kg.
RA concerned may take further necessary action as per above decision of NC.

Case No.	97 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED

UDIN00181221AM24

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

Case No.	97 / NC/3/MEET/Jun/202324/6
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED

UDIN00181221AM24

Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006885AM23
RA File Number		03AX04005936 AM23
Licence No and<br>Date		0311022019/09/03/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Feb/202223/20dated24/02/2023against advance authorization No.<br>0311014080dt. 22/04/2022, it was decided to fix norms under Para 4.07 of HBP Vol. I as per details given below or<br>as applied by the firm, whichever is less:-<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>HYDROQUINONE<br>0.579 kg.<br>HYDROQUINONE BIS(2 Hydroxy Ethyl<br>Ether) (YAPOX LM 30/10)<br>1 kg.<br>2<br>ETHYLENE CARBONATE<br>0.934 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl.

Case No.	Case No.	98 / NC/3/MEET/Jun/202324/6	98 / NC/3/MEET/Jun/202324/6	98 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006838AM23
RA File Number		05AX04003332 AM23
Licence No and<br>Date		0511017678/09/03/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>in meetingNo.NC/3/MEET/Jan/20202122/13dated21/01/2022against advance authorizationNo.0511004139dated<br>16/08/2021, 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,<br>whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>CITRIC ACID<br>0.726 kg.<br>TRI ETHYL CITRATE (TEC)(TRI ETHYL CITRATE<br>1 kg
	Export Product		Qty.	Sl.

hichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 CITRIC ACID 0.726 kg. TRI ETHYL CITRATE (TEC)(TRI ETHYL CITRATE 1 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||TRI ETHYL CITRATE (TEC)(TRI ETHYL CITRATE||1 kg|1|CITRIC ACID|0.726 kg.|

Case No.	Case No.	98 / NC/3/MEET/Jun/202324/6	98 / NC/3/MEET/Jun/202324/6	98 / NC/3/MEET/Jun/202324/6	98 / NC/3/MEET/Jun/202324/6	98 / NC/3/MEET/Jun/202324/6
Case Status		Case Approved
Party Name		KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number		HQRNORM APPLY 00006838AM23
RA File Number		05AX04003332 AM23
Licence No and<br>Date		0511017678/09/03/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product<br>in meetingNo.NC/3/MEET/Jan/20202122/13dated21/01/2022against advance authorizationNo.0511004139dated<br>16/08/2021, 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,<br>whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>CITRIC ACID<br>0.726 kg.<br>TRI ETHYL CITRATE (TEC)(TRI ETHYL CITRATE<br>1 kg
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	TRI ETHYL CITRATE (TEC)(TRI ETHYL CITRATE		1 kg	1	CITRIC ACID	0.726 kg.

UDIN00181221AM24

CITRATE (TEC)(TRI ETHYL CITRATE 1 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||TRI ETHYL CITRATE (TEC)(TRI ETHYL CITRATE||1 kg|1|CITRIC ACID|0.726 kg.|

UDIN00181221AM24

2<br>DENATURED ETHYL ALCOHOL<br>0.526 kg.<br>(TEC) (PACKED IN 400 NOS. OF HM-HDPE<br>DRUMS MADE OF HDPE GRANULES (3,400.000<br>KGS. WITHOUT WASTAGE)) (EACH DRUM<br>SHALL WEIGHT 8.5 KG AND STORAGE<br>CAPACITY<br>250.000 KGS.))<br>3<br>HDPE GRANULES<br>Relevant as per<br>paking policy<br>RA concerned may take further necessary action as per above decision of NC.	(TEC) (PACKED IN 400 NOS. OF HM-HDPE<br>DRUMS MADE OF HDPE GRANULES (3,400.000<br>KGS. WITHOUT WASTAGE)) (EACH DRUM<br>SHALL WEIGHT 8.5 KG AND STORAGE<br>CAPACITY<br>250.000 KGS.))		2	DENATURED ETHYL ALCOHOL	0.526 kg.
			3	HDPE GRANULES	Relevant as per<br>paking policy

Case No.	99 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00006898AM23
RA File Number	08AX04002105 AM23
Licence No and<br>Date	0811007519/10/03/2023
Norms Committee Decision:<br>Submit one shipping bill complete set of the export product along with export and import product statement of<br>the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this<br>case..

roduct along with export and import product statement of** the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case..||

Case No.	100 / NC/3/MEET/Jun/202324/6
Case Status	Case Deferred
Party Name	BLUE JET HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202324/ 6 and 14/06/2023
HQ File Number	HQRNORM APPLY 00000740AM24
RA File Number	03AX04000488 AM24
Licence No and<br>Date	0311023468/10/05/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>To give molecular weight of reactants & product of the chemical reaction with calculation sheet and<br>percentage yield.<br>1.<br>Justification for low yield of the reaction.<br>2.<br>End use of the product.<br>3.<br>Submit one shipping bill complete set of the export product along with export and import product<br>statement of the said Authorization. Also, it is directed to technical expert to give their comments before<br>next agenda of this case.<br>4.

Submit one shipping bill complete set of the export product along with export and import product statement of the said Authorization. Also, it is directed to technical expert to give their comments before next agenda of this case.

UDIN00181221AM24

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