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/Mar/202223/22 DATED: 24/03/2023

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/Mar/202223/22 dated 24/03/2023 of Norms Committee - III for the year 2022-23 was held on 24/03/2023 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:-

S.No.	Name and Designation of Representatives	Department
1	AJAY KUMAR,Deputy Director	DGFT(HQ)
2	NAND Lal,Technical Consultant	DPIIT
3	SHAISH KUMAR,Technical Consultant	DGFT
4	DINESHNARAIN MATHUR,Technical<br>Consultant	DGFT

ent**| |---|---|---| |1|AJAY KUMAR,Deputy Director|DGFT(HQ)| |2|NAND Lal,Technical Consultant|DPIIT| |3|SHAISH KUMAR,Technical Consultant|DGFT| |4|DINESHNARAIN MATHUR,Technical Consultant|DGFT|

This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-04-2023 18:26:04.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00004181AM23
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/documents from the
firm:-
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.
Stoichiometric balance between import and export on molar basis.<br>iv.
Details of indigenous input with quantity.<br>v.

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

ndigenous input with quantity.** v.||

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

Case No.<br>2 / NC/3/MEET/Mar/202223/22	Case No.<br>2 / NC/3/MEET/Mar/202223/22	Case No.<br>2 / NC/3/MEET/Mar/202223/22
Case Status<br>Case Approved
Party Name<br>GLAND PHARMA LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number<br>HQRNORM REVIW00006334AM23
RA File Number<br>092404000481 AM14
Licence No and<br>Date<br>0910058788/31/12/2013
Norms Committee Decision:
The Committee considered the request of firm for inclusion of Export Product No. 1, which was left					over by NC
while ratifying adhoc norms of subject Advance Authorization and after deliberation, it was decided to					ratify adhoc
norms for Export Product No. 1 as under:
Export Product	Qty.	Sl. No.	Import Items	Qty.
Adenosine Injection Prefilled<br>Syringe 3 mg/ ml, 2ml in a	<br> <br>1 Number	1	Adenosine	0.0066 grams
PFS		2	Barrel Syringes	Relevant	as	per

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==> picture [464 x 211] intentionally omitted <==

----- Start of picture text ----- 3 V-OVS 10.6 Tip Caps packing policy 4 Plunger Stoppers 5 Plunger Rods 6 Filters (Plastic) Consumable on Net to Net basis. 7 Tubing (Plastic) 8 Reference Standards ----- End of picture text -----

ng policy 4 Plunger Stoppers 5 Plunger Rods 6 Filters (Plastic) Consumable on Net to Net basis. 7 Tubing (Plastic) 8 Reference Standards ----- End of picture text -----

Rest of the earlier Minutes will remain the same.

RA may take appropriate action as per the decision of Norms Committee.

Case No.	Case No.	Case No.	3 / NC/3/MEET/Mar/202223/22	3 / NC/3/MEET/Mar/202223/22	3 / NC/3/MEET/Mar/202223/22
Case Status			Case Approved
Party Name			GLAND PHARMA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number			HQRNORM REVIW00006489AM23
RA File Number			092404000485 AM14
Licence No and<br>Date			0910058787/31/12/2013
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms andit was decided to ratify adhoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Nadroparin Calcium<br>26.125 mg<br>2<br>Barrel Syringes<br>1.0534 Nos.<br>3<br>Needle Shield<br>1.0451 Nos.<br>4<br>Plunger Stoppers<br>1.1091 Nos.<br>1<br>Low molecular weight Heparin,<br>Nadroparin Calcium Injection<br>2,850 anti - Xa IU/0.3ml<br>PFS(IU)<br>1 Number
	Sl. No.	Export product		Qty.	Sl.

Plunger Stoppers 1.1091 Nos. 1 Low molecular weight Heparin, Nadroparin Calcium Injection 2,850 anti - Xa IU/0.3ml PFS(IU) 1 Number|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Low molecular weight Heparin, Nadroparin Calcium Injection 2,850 anti - Xa IU/0.3ml PFS(IU)|| 1 Number|1|Nadroparin Calcium|26.125 mg| ||||||2|Barrel Syringes|1.0534 Nos.| ||||||3|Needle Shield|1.0451 Nos.| ||||||4|Plunger Stoppers|1.1091 Nos.|

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			5	Plunger Rods	1.0294 Nos.
			6	Preventis	1.05 Nos.
			7	Anti Factor Xa Test Kits	Not admissible
			8	Anti Factor IIa Test Kits	Not admissible
			9	Analytical Columns	Not admissible
			10	Analytical Guard Columns	Not admissible
			11	Medical Grade Paper	0.9 gram
			12	Tubing	0.020 cms
			13	Anti Factor Xa	Not admissible
			14	Anti Factor IIa	Not admissible
			15	N.M.R. Standard	Not admissible
			16	Mol.Wt.Standard	Not admissible
2	Low molecular weight Heparin,<br>Nadroparin Calcium Injection<br>5,700 anti - Xa IU/0.6ml<br>PFS(IU)	<br> <br> <br>1 Number	1	Nadroparin Calcium	52.25 mg
			2	Barrel Syringes	1.0534 Nos.
			3	Needle Shield	1.0451 Nos.
			4	Plunger Stoppers	1.1091 Nos.
			5	Plunger Rods	1.0294 Nos.
			6	Preventis	1.05 Nos.
			7	Anti Factor Xa Test Kits	Not admissible

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Needle Shield|1.0451 Nos.| |||||4|Plunger Stoppers|1.1091 Nos.| |||||5|Plunger Rods|1.0294 Nos.| |||||6|Preventis|1.05 Nos.| |||||7|Anti Factor Xa Test Kits|Not admissible|

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8	Anti Factor IIa Test Kits	Not admissible
9	Analytical Columns	Not admissible
10	Analytical Guard Columns	Not admissible
11	Medical Grade Paper	0.9 gram
12	Tubing	0.020 cms
13	Anti Factor Xa	Not admissible
14	Anti Factor IIa	Not admissible
15	N.M.R. Standard	Not admissible
16	Mol.Wt.Standard	Not admissible

Case No.<br>4 / NC/3/MEET/Mar/202223/22	Case No.<br>4 / NC/3/MEET/Mar/202223/22	Case No.<br>4 / NC/3/MEET/Mar/202223/22
Case Status<br>Case Approved
Party Name<br>GLAND PHARMA LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number<br>HQRNORM REVIW00006335AM23
RA File Number<br>092404000344 AM15
Licence No and<br>Date<br>0910061096/15/10/2014
Norms Committee Decision:
The Committee considered the request of firm for inclusion of Export Product No. 1, which was left			over by NC
while ratifying adhoc norms of subject Advance Authorization and after deliberation, it was decided to			ratify adhoc
norms for Export Product No. 1 as under:
Export Product	Qty.	Sl.

|while ratifying adhoc norms of subject Advance Authorization and after deliberation, it was decided to|||||ratify adhoc||| |norms for Export Product No. 1 as under:|||||||| |Export Product|Qty.|Sl. No.|Import Items|Qty.|||| |Adenosine Injection Prefilled Syringe 3 mg/ ml, 2ml in a| 1 Number|1|Adenosine|0.0066 grams|||| |PFS||2|Barrel Syringes|Relevant|as|per||

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==> picture [464 x 211] intentionally omitted <==

Rest of the earlier Minutes will remain the same. RA may take appropriate action as per the decision of Norms Committee.

Case No.	Case No.	5 / NC/3/MEET/Mar/202223/22	5 / NC/3/MEET/Mar/202223/22	5 / NC/3/MEET/Mar/202223/22	5 / NC/3/MEET/Mar/202223/22	5 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		GLAND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00006348AM23
RA File Number		092404000709 AM15
Licence No and<br>Date		0910062070/26/05/2015
Norms Committee Decision:<br>The Committee considered the request of firm for inclusion of Export Product No.

File Number||092404000709 AM15||||| |Licence No and Date||0910062070/26/05/2015||||| |Norms Committee Decision: The Committee considered the request of firm for inclusion of Export Product No. 1, which was left over by NC while ratifying adhoc norms of subject Advance Authorization and after deliberation, it was decided to ratify adhoc norms for Export Product No. 1 as under: Export Product Qty. Sl. No. Import Items Qty. 1 Heparin Sodium Powder 0.0634 gm 2 Barrel Syringes 1.1172 Nos. 3 Needle Shield 1.164 Nos. Enoxaparin PFS 20 mg 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Enoxaparin PFS 20 mg||1 Number|1|Heparin Sodium Powder|0.0634 gm| |||||2|Barrel Syringes|1.1172 Nos.| |||||3|Needle Shield|1.164 Nos.|

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	4	Plunger Stoppers	1.1292 Nos.
	5	Plunger Rods	1.0279 Nos.
	6	Preventis Rubber	1.0361 Nos.

Rest of the earlier Minutes will remain the same. RA may take appropriate action as per the decision of Norms Committee.

|---|---| ||5|Plunger Rods|1.0279 Nos.| ||6|Preventis Rubber|1.0361 Nos.|

Rest of the earlier Minutes will remain the same. RA may take appropriate action as per the decision of Norms Committee.

Case No.	Case No.	6 / NC/3/MEET/Mar/202223/22	6 / NC/3/MEET/Mar/202223/22	6 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		GLAND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00006350AM23
RA File Number		092404000712 AM15
Licence No and<br>Date		0910062071/26/05/2015
Norms Committee Decision:<br>The Committee considered the request of firm for inclusion of Export Product No. 1, which was left over by NC<br>while ratifying adhoc norms of subject Advance Authorization and after deliberation, it was decided to ratify adhoc<br>norms for Export Product No. 1 as under:<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>Heparin Sodium Powder<br>0.0634 gm<br>2<br>Barrel Syringes<br>1.1172 Nos.<br>3<br>Needle Shield<br>1.164 Nos.<br>4<br>Plunger Stoppers<br>1.1292 Nos.<br>5<br>Plunger Rods<br>1.0279 Nos.<br>Enoxaparin PFS 20 mg<br>1 Number<br>6<br>Preventis Rubber<br>1.0361 Nos.
	Export Product		Qty.	Sl.

br>1.164 Nos. 4 Plunger Stoppers 1.1292 Nos. 5 Plunger Rods 1.0279 Nos. Enoxaparin PFS 20 mg 1 Number 6 Preventis Rubber 1.0361 Nos.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Enoxaparin PFS 20 mg||1 Number|1|Heparin Sodium Powder|0.0634 gm| |||||2|Barrel Syringes|1.1172 Nos.| |||||3|Needle Shield|1.164 Nos.| |||||4|Plunger Stoppers|1.1292 Nos.| |||||5|Plunger Rods|1.0279 Nos.| |||||6|Preventis Rubber|1.0361 Nos.|

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Rest of the earlier Minutes will remain the same.

Case No.	7 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00005997AM23
RA File Number	039404000859 AM16
Licence No and<br>Date	0310802380/09/02/2016
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to call for following information/documents
from the firm:-
Copy of Shipping Bill indicating percentage purity of export product.<br>i.
Copy of Bill of Entry indicating percentage purity of import product.<br>ii.

ocuments|| |from the firm:-|| |Copy of Shipping Bill indicating percentage purity of export product. i.|| |Copy of Bill of Entry indicating percentage purity of import product. ii.||

Case No.<br>8 / NC/3/MEET/Mar/202223/22	Case No.<br>8 / NC/3/MEET/Mar/202223/22	Case No.<br>8 / NC/3/MEET/Mar/202223/22
Case Status<br>Case Approved
Party Name<br>GLAND PHARMA LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number<br>HQRNORM REVIW00006339AM23
RA File Number<br>092404000357 AM17
Licence No and<br>Date<br>0910064221/30/09/2016
Norms Committee Decision:
The Committee considered the request of firm for inclusion of Export Product No. 1, which was left					over by NC
while ratifying adhoc norms of subject Advance Authorization and after deliberation, it was decided to					ratify adhoc
norms for Export Product No. 1 as under:
Export Product	Qty.	Sl. No.	Import Items	Qty.
Adenosine Injection Prefilled<br>Syringe 3 mg/ ml, 2ml in a	<br> <br>1 Number	1	Adenosine	0.0066 grams
PFS		2	Barrel Syringes	Relevant	as	per

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|Import Items|Qty.|||| |Adenosine Injection Prefilled Syringe 3 mg/ ml, 2ml in a| 1 Number|1|Adenosine|0.0066 grams|||| |PFS||2|Barrel Syringes|Relevant|as|per||

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3	V-OVS 10.6 Tip Caps	packing policy
4	Plunger Stoppers
5	Plunger Rods
6	Filters (Plastic)	Consumable on Net to<br>Net basis.
7	Tubing (Plastic)
8	Reference Standards

Rest of the earlier Minutes will remain the same.

Case No.	9 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00005839AM23
RA File Number	039404000733 AM18
Licence No and<br>Date	0310817950/20/12/2017
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to call for following information/documents<br>from the firm:-<br>Copy of Shipping Bill indicating percentage purity of export product.<br>i.<br>Copy of Bill of Entry indicating percentage purity of import product.<br>ii.

ocuments from the firm:- Copy of Shipping Bill indicating percentage purity of export product. i. Copy of Bill of Entry indicating percentage purity of import product. ii.||

Case No.	10 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	REYAANSH HEALTHCARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00004873AM23
RA File Number	039504000872 AM18
Licence No and<br>Date	0310818545/16/01/2018

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Norms Committee Decision:

Deferred for comments of TE.

Case No.<br>11 / NC/3/MEET/Mar/202223/22	Case No.<br>11 / NC/3/MEET/Mar/202223/22
Case Status<br>Case Approved
Party Name<br>ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number<br>HQRNORM REVIW00005945AM23
RA File Number<br>039404000963 AM18
Licence No and<br>Date<br>0310819402/23/02/2018
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms
under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
	Export product<br>Qty.	Sl.

adhoc norms and it was decided to ratify adhoc norms|||||| |under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:|||||| ||Export product Qty.|Sl. No.|Import items|Qty.|| ||PAXIFLAS TRAMADOL 1 Number|1|PEARLITOL 50 C (35)|276.46 mg|| ||HYDROCHLORIDE 37.5 mg AND||||| ||PARACETAMOL 325mg ORODISPERSIBLE TABLETS|2|PEARLITOL 400 DC|276.46 mg|| |RA may take appropriate action as per the decision of Norms Committee.||||||

Case No.	12 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	SIDDHARTH CARBOCHEM PRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00004691AM23
RA File Number	039504000992 AM18
Licence No and<br>Date	0310819448/28/02/2018
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and taking cue from earlier decision for
same export product / import item in Meeting No.1/82-ALC4/2019 dated 03.06.2019 against advance authorization
No.0310828654 dt. 26.04.2019, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:

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Export product	Qty.	Sl. No. Import items	Qty.
METHYL SALICYLATE (MIN. 99%)	1 kg	1<br>METHANOL	1.1715 kg.

pplied by the firm, whichever is less:||

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Export product	Qty.	Sl. No. Import items	Qty.
METHYL SALICYLATE (MIN. 99%)	1 kg	1<br>METHANOL	1.1715 kg.

Case No.	13 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00005781AM23
RA File Number	039404000015 AM19
Licence No and<br>Date	0310820585/23/04/2018
Norms Committee Decision:
Decision:The Committee considered the case as per agenda and it was decided to call for following information/documents
from the firm:-
Copy of Shipping Bill indicating percentage purity of export product.<br>i.
Copy of Bill of Entry indicating percentage purity of import product.<br>ii.

Case No.<br>14 / NC/3/MEET/Mar/202223/22	Case No.<br>14 / NC/3/MEET/Mar/202223/22	Case No.<br>14 / NC/3/MEET/Mar/202223/22
Case Status<br>Case Approved
Party Name<br>ARCH PHARMALABS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number<br>HQRNORM REVIW00006595AM23
RA File Number<br>039404000142 AM19
Licence No and<br>Date<br>0310822704/30/07/2018
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms andit was decided to ratify adhoc norms under
Para 4.07 of HBP Vol.

/30/07/2018|||||| |Norms Committee Decision:|||||| |The Committee considered the request of firm for fixation of adhoc norms andit was decided to ratify adhoc norms under|||||| |Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:|||||| ||Export product Qty.|Sl. No.|Import items|Qty.|| ||3a-Hydroxy-7-keto-5b-cholan- 1 kg|1|Cholic Acid|1.32 kg|| ||24-oic acid (IP-5)||||| |||2|Hydrazine Hydrate ( 80% solution)|1.403 kg||

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3	Acetone	2.00 kg
4	IEP OX 239 Spray Dried Enzyme Powder	0.0283 kg
5	IEP OX 152 Spray Dried Enzyme Powder	0.050 kg
6	IEP OX 243 Spray Dried Enzyme Powder	0.034 kg
7	(B-NAD)<br>B-Nicotinamide-adenine<br>dinucleotide(Coenzyme-1)	<br>0.0075 kg

83 kg| ||||5|IEP OX 152 Spray Dried Enzyme Powder|0.050 kg| ||||6|IEP OX 243 Spray Dried Enzyme Powder|0.034 kg| ||||7|(B-NAD) B-Nicotinamide-adenine dinucleotide(Coenzyme-1)| 0.0075 kg|

Case No.	15 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	NATURAL REMEDIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00000342AM23
RA File Number	072404000170 AM19
Licence No and<br>Date	0710113897/25/09/2018
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was observed that the firm still has not<br>furnished its reply. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	16 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	PAYAL POLYPLAST PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00005229AM23
RA File Number	052404000392 AM19
Licence No and<br>Date	0510408318/02/11/2018
Norms Committee Decision:

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The Committee considered the request of firm for review of adhoc norms and it was observed that the firm has not provided any technical justification / information for enhancement. Hence, it was decided to reject the case maintaining the status quo.

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

l justification / information for enhancement. Hence, it was decided to reject the case maintaining the status quo.

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

Case No.	17 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00005574AM23
RA File Number	039404000682 AM19
Licence No and<br>Date	0310824972/12/11/2018
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms andit was decided to ratify adhoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3- Cyclopropylamino-2-(2,4-Dichloro-5-<br>Fluorobenzoyl)Acrylate<br>1.307 kg.<br>2<br>N-Ethyl / Piperazine<br>0.490 kg.<br>3<br>Methanol<br>0.334 kg.<br>Enrofloxacin<br>1 kg<br>4<br>Caustic Soda Flakes<br>0.360 kg.<br>RA may take appropriate action as per the decision of Norms Committee.

Case No.	18 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	DINAKARA LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00005704AM23
RA File Number	092404000571 AM19

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Licence No and 0910067285/18/03/2019 Date Norms Committee Decision:

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Licence No and 0910067285/18/03/2019 Date Norms Committee Decision:

The Committee considered the request of firm for fixation of adhoc norms and taking cue from earlier decision for same export product / import item in Meeting No. 6/82-ALC4/2019 dated 16.08.2019 against advance authorization No. 0910067692 dt. 25.06.2019 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product			Qty.	Sl. No.	Import items	Qty.
1-(2,4-Difluoro	Phenyl)-2-(1H-1,2,4-		1 kg	1	1,3-Difluoro Benzene	0.60 kg
triazole-1-yl)	Ethanone	(Ethanone
Derivative)

Case No.	Case No.		19 / NC/3/MEET/Mar/202223/22	19 / NC/3/MEET/Mar/202223/22
Case Status			Case Approved
Party Name			HEMA DYECHEM PRIVATE LIMITED
Meeting Number and Date			NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number			HQRNORM REVIW00001544AM23
RA File Number			039404001141 AM19
Licence No and Date			0310828400/16/04/2019
Norms Committee Decision:
The Committee considered the request of firm for review of				adhoc norms and on the basis of information provided by
the firm, it was decided to revise adhoc norms as under:
	Export product		Qty.<br>Sl.	Import items	Qty.
			No.
	1,3	DIMETHOXY<br>1 kg<br>1		RESORCINOL/1,3DIHYDROXYBENZENE	1.19 kg

| |the firm, it was decided to revise adhoc norms as under:||||||| ||Export product||Qty. Sl.|Import items|Qty.|| ||||No.|||| ||1,3|DIMETHOXY 1 kg 1||RESORCINOL/1,3DIHYDROXYBENZENE|1.19 kg|| ||BENZENE/RESORCINOL|||||| ||DIMETHYL||ETHER/M-|||| ||DIMETHOXYBEZENE|||||| ||Note: The above norms are only for regularization purpose and no repeat licences will be issued||||on the|| ||basis of these norms.|||||| ||||||||

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

Case No.	Case No.	Case No.	20 / NC/3/MEET/Mar/202223/22	20 / NC/3/MEET/Mar/202223/22	20 / NC/3/MEET/Mar/202223/22	20 / NC/3/MEET/Mar/202223/22	20 / NC/3/MEET/Mar/202223/22
Case Status			Case Approved
Party Name			REYAANSH HEALTHCARE
Meeting Number<br>and Date			NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number			HQRNORM REVIW00005643AM23
RA File Number			018205000836 AM20
Licence No and<br>Date			0310832850/18/11/2019
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.

ided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Sl. No. Export product Qty. Sl. No. Import items Qty. (in grams) 1 IMPACT SOLUTION FOR CATS(0.40 ML EACH ML CONTAINS IMIDACLOPRID 100MG MOXIDECTIN 10 MG) 60000 Numbers 1 MOXIDECTIN 244.80 2 IMPACT SOLUTION FOR CATS .(0.80ML EACH ML CONTAINS IMIDACLOPRID 100 MG MOXIDECTIN 10 MG) 60000 Numbers 2 MOXIDECTIN 489.60 3 IMPACT SOLUTION FOR DOGS(0.40 ML EACH ML CONTAINS IMIDACLOPRID 100MG MOXIDECTIN 25 MG) 60000 Numbers 3 MOXIDECTIN 612.00 4 IMPACT SOLUTION FOR DOGS(1ML EACH ML CONTAINS IMIDACLOPRID 100 MG MOXIDECTIN 25 MG) 38721 Numbers 4 MOXIDECTIN 987.38 5 IMPACT SOLUTION FOR DOGS(2.50 ML EACH ML CONTAINS IMIDACLOPRID 100MG MOXIDECTIN 25 MG) 60000 Numbers 5 MOXIDECTIN 3825.30 6 IMPACT SOLUTION FOR DOGS(4ML EACH ML CONTAINS IMIDACLOPRID 100MG MOXIDECTIN 25 MG) 9381 Numbers 6 MOXIDECTIN 956.86|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.

IMPACT SOLUTION FOR DOGS(4ML EACH ML CONTAINS IMIDACLOPRID 100MG MOXIDECTIN 25 MG) 9381 Numbers 6 MOXIDECTIN 956.86|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty. (in grams)| ||1|IMPACT SOLUTION FOR CATS(0.40 ML EACH ML CONTAINS IMIDACLOPRID 100MG MOXIDECTIN 10 MG)|| 60000 Numbers|1|MOXIDECTIN|244.80| ||2|IMPACT SOLUTION FOR CATS .(0.80ML EACH ML CONTAINS IMIDACLOPRID 100 MG MOXIDECTIN 10 MG)|| 60000 Numbers|2|MOXIDECTIN|489.60| ||3|IMPACT SOLUTION FOR DOGS(0.40 ML EACH ML CONTAINS IMIDACLOPRID 100MG MOXIDECTIN 25 MG)|| 60000 Numbers|3|MOXIDECTIN|612.00| ||4|IMPACT SOLUTION FOR DOGS(1ML EACH ML CONTAINS IMIDACLOPRID 100 MG MOXIDECTIN 25 MG)|| 38721 Numbers|4|MOXIDECTIN|987.38| ||5|IMPACT SOLUTION FOR DOGS(2.50 ML EACH ML CONTAINS IMIDACLOPRID 100MG MOXIDECTIN 25 MG)|| 60000 Numbers|5|MOXIDECTIN|3825.30| ||6|IMPACT SOLUTION FOR DOGS(4ML EACH ML CONTAINS IMIDACLOPRID 100MG MOXIDECTIN 25 MG)|| 9381 Numbers|6|MOXIDECTIN|956.86| |||||||||

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Case No.	21 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	REYAANSH HEALTHCARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00005644AM23
RA File Number	018205000964 AM20
Licence No and<br>Date	0310833938/06/01/2020
Norms Committee Decision:<br>Deferred for comments of TE.

4/03/2023| |HQ File Number|HQRNORM REVIW00005644AM23| |RA File Number|018205000964 AM20| |Licence No and Date|0310833938/06/01/2020| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	Case No.	22 / NC/3/MEET/Mar/202223/22	22 / NC/3/MEET/Mar/202223/22	22 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00006630AM23
RA File Number		018205001104 AM20
Licence No and<br>Date		0310835027/24/02/2020
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04.02.2023 under the Chairmanship of Shri Rajiv Kumar<br>Soni, Jt. DGFT to ascertain the exact wastage of import items in their licences.<br>The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc<br>norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl<br>3<br>Cyclopropylamino-2(2,4<br>Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.294 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl.

chloride BP/EP/USP (Ciprofloxacin) 1 kg 2 Piperazine Anhydrous 0.390 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin)|| 1 kg|1|Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate|1.294 kg| |||||2|Piperazine Anhydrous|0.390 kg| ||RA concerned may take further necessary action as per above decision of NC.||||||

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Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.

Case No.	Case No.	23 / NC/3/MEET/Mar/202223/22	23 / NC/3/MEET/Mar/202223/22	23 / NC/3/MEET/Mar/202223/22	23 / NC/3/MEET/Mar/202223/22	23 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00006631AM23
RA File Number		018205001105 AM20
Licence No and<br>Date		0310835028/24/02/2020
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04.02.2023 under the Chairmanship of Shri Rajiv Kumar<br>Soni, Jt.

ee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the factory visit of M/s Aarti Drugs Limited was carried out on 04.02.2023 under the Chairmanship of Shri Rajiv Kumar Soni, Jt. DGFT to ascertain the exact wastage of import items in their licences. The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc norms as under: Export product Qty. Sl. No. Import items Qty. 1 Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate 1.294 kg Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin) 1 kg 2 Piperazine Anhydrous 0.390 kg RA concerned may take further necessary action as per above decision of NC. Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin)|| 1 kg|1|Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate|1.294 kg| |||||2|Piperazine Anhydrous|0.390 kg| ||RA concerned may take further necessary action as per above decision of NC.|||||| ||Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.||||||

essary action as per above decision of NC.|||||| ||Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.||||||

Case No.	Case No.	23 / NC/3/MEET/Mar/202223/22	23 / NC/3/MEET/Mar/202223/22	23 / NC/3/MEET/Mar/202223/22	23 / NC/3/MEET/Mar/202223/22	23 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00006631AM23
RA File Number		018205001105 AM20
Licence No and<br>Date		0310835028/24/02/2020
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04.02.2023 under the Chairmanship of Shri Rajiv Kumar<br>Soni, Jt. DGFT to ascertain the exact wastage of import items in their licences.<br>The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc<br>norms as under:<br>Export product<br>Qty.<br>Sl. No.

ge of import items in their licences. The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc norms as under: Export product Qty. Sl. No. Import items Qty. 1 Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate 1.294 kg Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin) 1 kg 2 Piperazine Anhydrous 0.390 kg RA concerned may take further necessary action as per above decision of NC. Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin)|| 1 kg|1|Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate|1.294 kg| |||||2|Piperazine Anhydrous|0.390 kg| ||RA concerned may take further necessary action as per above decision of NC.|||||| ||Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.||||||

Case No.	24 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00006632AM23
RA File Number	018205001106 AM20

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Licence No and 0310835029/24/02/2020 Date Norms Committee Decision:

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Licence No and 0310835029/24/02/2020 Date Norms Committee Decision:

As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the factory visit of M/s Aarti Drugs Limited was carried out on 04.02.2023 under the Chairmanship of Shri Rajiv Kumar Soni, Jt. DGFT to ascertain the exact wastage of import items in their licences.

The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc norms as under:

orms as under:
Export product	Qty.<br>Sl. No. Import items		Qty.
Ciprofloxacin<br>Hydrochloride	1<br>Ethyl<br>3<br>Cyclopropylamino-2(2,4<br> <br>1 kg	Dichloro-	1.294 kg
BP/EP/USP (Ciprofloxacin)	5Fluorobenzoyl) Acrylate
	2<br>Piperazine Anhydrous		0.390 kg
RA concerned may take further necessary action as per above decision of NC.
Note: The above norms are only for regularization purpose and no repeat licences will be			issued on the
basis of these norms.

essary action as per above decision of NC.|||| |Note: The above norms are only for regularization purpose and no repeat licences will be|||issued on the| |basis of these norms.||||

Case No.	Case No.	Case No.	25 / NC/3/MEET/Mar/202223/22	25 / NC/3/MEET/Mar/202223/22
Case Status			Case Approved
Party Name			VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number			HQRNORM REVIW00004314AM23
RA File Number			318304000161 AM20
Licence No and<br>Date			3110067716/17/03/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>1<br>Assurity plus Spot on Imidacloprid 10% w/v Moxidectin BP 1% w/v(0.4 ml x 6<br>pipettes ( 12 GM))<br>500 Numbers
	Sl. No.	Export product		Qty.
	1	Assurity plus Spot on Imidacloprid 10% w/v Moxidectin BP 1% w/v(0.4 ml x 6<br>pipettes ( 12 GM))		<br>500 Numbers

x 6 pipettes ( 12 GM)) 500 Numbers||||| ||Sl. No.|Export product||Qty.| ||1|Assurity plus Spot on Imidacloprid 10% w/v Moxidectin BP 1% w/v(0.4 ml x 6 pipettes ( 12 GM))|| 500 Numbers|

Case No.	Case No.	Case No.	25 / NC/3/MEET/Mar/202223/22	25 / NC/3/MEET/Mar/202223/22
Case Status			Case Approved
Party Name			VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number			HQRNORM REVIW00004314AM23
RA File Number			318304000161 AM20
Licence No and<br>Date			3110067716/17/03/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>1<br>Assurity plus Spot on Imidacloprid 10% w/v Moxidectin BP 1% w/v(0.4 ml x 6<br>pipettes ( 12 GM))<br>500 Numbers
	Sl. No.	Export product		Qty.
	1	Assurity plus Spot on Imidacloprid 10% w/v Moxidectin BP 1% w/v(0.4 ml x 6<br>pipettes ( 12 GM))		<br>500 Numbers

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500 Numbers||||| ||Sl. No.|Export product||Qty.| ||1|Assurity plus Spot on Imidacloprid 10% w/v Moxidectin BP 1% w/v(0.4 ml x 6 pipettes ( 12 GM))|| 500 Numbers|

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2	Assurity plus Spot on Imidacloprid 10% w/v Moxidectin BP 1% w/v(0.8 ml x 6	<br>1200 Numbers
	pipettes ( 58 GM))
3	Assurity plus Spot on Imidacloprid 10% w/v Moxidectin BP 2.5% w/v(1 ml x 6	<br>800 Numbers
	pipettes (120 GM))
4	Assurity plus Spot on Imidacloprid 10% w/v Moxidectin BP 2.5% w/v(2.5 ml x 6	<br>900 Numbers
	pipettes ( 337.50 GM))
5	Assurity plus Spot on Imidacloprid 10% w/v Moxidectin BP 2.5% w/v(4 ml x 6	<br>2450 Numbers
	pipettes ( 1410 GM ))
6	Radicate Spot on Selamectin 6%(0.75 ml x 6 pipettes w/v( 1890 GM))	5000 Numbers

Sl. No.	Import Items	Qty.
1	Moxidectin-EP	1993.132 gram
2	Selamectin-EP	1377.00 gram

Case No.	26 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00006633AM23
RA File Number	018205001156 AM20
Licence No and<br>Date	0310835503/19/03/2020
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04.02.2023 under the Chairmanship of Shri Rajiv Kumar<br>Soni, Jt. DGFT to ascertain the exact wastage of import items in their licences.

ory visit of M/s Aarti Drugs Limited was carried out on 04.02.2023 under the Chairmanship of Shri Rajiv Kumar Soni, Jt. DGFT to ascertain the exact wastage of import items in their licences.||

19 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-04-2023 18:26:04.

UDIN00018757AM24

|The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc norms as under: Export product Qty. Sl. No. Import items Qty. 1 Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate 1.294 kg Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin) 1 kg 2 Piperazine Anhydrous 0.390 kg RA concerned may take further necessary action as per above decision of NC. Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.|The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc norms as under: Export product Qty. Sl. No.

ed on the<br>basis of these norms.**	The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc<br>norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl<br>3<br>Cyclopropylamino-2(2,4<br>Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.294 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.<br>Note: The above norms are only for regularization purpose and no repeat licences will be issued on the<br>basis of these norms.	The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc<br>norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl<br>3<br>Cyclopropylamino-2(2,4<br>Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.294 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.<br>Note: The above norms are only for regularization purpose and no repeat licences will be issued on the<br>basis of these norms.	Visit Report and after deliberation, it was decided to revise adhoc	Visit Report and after deliberation, it was decided to revise adhoc	Visit Report and after deliberation, it was decided to revise adhoc
	Export product<br>Qty.<br>Sl. No.

|Visit Report and after deliberation, it was decided to revise adhoc|Visit Report and after deliberation, it was decided to revise adhoc| |---|---|---|---|---|---| ||Export product Qty. Sl. No. Import items Qty. 1 Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate 1.294 kg Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin) 1 kg 2 Piperazine Anhydrous 0.390 kg RA concerned may take further necessary action as per above decision of NC. Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.|Qty.|Sl. No.|Import items|Qty.| ||| 1 kg|1|Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate|1.294 kg| ||||2|Piperazine Anhydrous|0.390 kg|

Case No.	Case No.	27 / NC/3/MEET/Mar/202223/22	27 / NC/3/MEET/Mar/202223/22	27 / NC/3/MEET/Mar/202223/22	27 / NC/3/MEET/Mar/202223/22	27 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		RECKITT BENCKISER HEALTHCARE INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00004127AM23
RA File Number		052404000025 AM21
Licence No and<br>Date		0510414108/06/05/2020

and Date||NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023||||| |HQ File Number||HQRNORM REVIW00004127AM23||||| |RA File Number||052404000025 AM21||||| |Licence No and Date||0510414108/06/05/2020||||| |Norms Committee Decision: The Committee considered the request of firm for fixation of adhoc norms and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Jul/202122/4 dated 15.07.2021 against advance authorization No.0510409206 dt. 07.01.2019, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. for 1 number Lozenges 1 ISOMALT ST-M 1913.10 mg 2 LYCASIN 80/55 (MALTOTOL) (Water content 25%) 570.00 mg 3 D&C red no. 33 0.055 mg Cepacol Extra Strength Lozenges Cherry 1 Number Lozenges||||||| ||Export product||Qty.|Sl. No.|Import items|Qty. for 1 number Lozenges| ||Cepacol Extra Strength Lozenges Cherry|| 1 Number Lozenges|1|ISOMALT ST-M|1913.10 mg| |||||2|LYCASIN 80/55 (MALTOTOL) (Water content 25%)| 570.00 mg| |||||3|D&C red no. 33|0.055 mg|

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zenges Cherry|| 1 Number Lozenges|1|ISOMALT ST-M|1913.10 mg| |||||2|LYCASIN 80/55 (MALTOTOL) (Water content 25%)| 570.00 mg| |||||3|D&C red no. 33|0.055 mg|

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4	FD&C Red no. 40	0.073 mg
5	Benzocaine USP	15.30 mg
6	Wild Cherry Flavour TAK 040489	12.71 mg
7	Cherry Bark FL NAT TAK 054757	4.90 mg
8	Intensate Cool Flavour TAK052848	4.70 mg

Case No.	Case No.	28 / NC/3/MEET/Mar/202223/22	28 / NC/3/MEET/Mar/202223/22	28 / NC/3/MEET/Mar/202223/22	28 / NC/3/MEET/Mar/202223/22	28 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00006634AM23
RA File Number		018205001376 AM21
Licence No and<br>Date		0310836635/11/06/2020
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04.02.2023 under the Chairmanship of Shri Rajiv Kumar<br>Soni, Jt.

ee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the factory visit of M/s Aarti Drugs Limited was carried out on 04.02.2023 under the Chairmanship of Shri Rajiv Kumar Soni, Jt. DGFT to ascertain the exact wastage of import items in their licences. The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc norms as under: Export product Qty. Sl. No. Import items Qty. 1 Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate 1.294 kg Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin) 1 kg 2 Piperazine Anhydrous 0.390 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product Qty. Sl. No. Import items Qty. 1 Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate 1.294 kg Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin) 1 kg 2 Piperazine Anhydrous 0.390 kg RA concerned may take further necessary action as per above decision of NC.||Qty.|Sl. No.|Import items|Qty.| |||| 1 kg|1|Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate|1.294 kg| |||||2|Piperazine Anhydrous|0.390 kg|

above decision of NC.||Qty.|Sl. No.|Import items|Qty.| |||| 1 kg|1|Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate|1.294 kg| |||||2|Piperazine Anhydrous|0.390 kg|

Case No.	Case No.	28 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00006634AM23
RA File Number		018205001376 AM21
Licence No and<br>Date		0310836635/11/06/2020
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04.02.2023 under the Chairmanship of Shri Rajiv Kumar<br>Soni, Jt. DGFT to ascertain the exact wastage of import items in their licences.<br>The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc<br>norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl<br>3<br>Cyclopropylamino-2(2,4<br>Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.294 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product<br>Qty.<br>Sl. No.

br>BP/EP/USP (Ciprofloxacin) 1 kg 2 Piperazine Anhydrous 0.390 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product Qty. Sl. No. Import items Qty. 1 Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate 1.294 kg Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin) 1 kg 2 Piperazine Anhydrous 0.390 kg RA concerned may take further necessary action as per above decision of NC.||Qty.|Sl. No.|Import items|Qty.| |||| 1 kg|1|Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate|1.294 kg| |||||2|Piperazine Anhydrous|0.390 kg|

UDIN00018757AM24

Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.

Case No.	Case No.	29 / NC/3/MEET/Mar/202223/22	29 / NC/3/MEET/Mar/202223/22	29 / NC/3/MEET/Mar/202223/22	29 / NC/3/MEET/Mar/202223/22	29 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00006635AM23
RA File Number		018205001440 AM21
Licence No and<br>Date		0310836986/01/07/2020
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No.

006635AM23||||| |RA File Number||018205001440 AM21||||| |Licence No and Date||0310836986/01/07/2020||||| |Norms Committee Decision: As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the factory visit of M/s Aarti Drugs Limited was carried out on 04.02.2023 under the Chairmanship of Shri Rajiv Kumar Soni, Jt. DGFT to ascertain the exact wastage of import items in their licences. The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc norms as under: Export product Qty. Sl. No. Import items Qty. 1 Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate 1.294 kg Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin) 1 kg 2 Piperazine Anhydrous 0.390 kg RA concerned may take further necessary action as per above decision of NC. Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin)|| 1 kg|1|Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate|1.294 kg| |||||2|Piperazine Anhydrous|0.390 kg| ||RA concerned may take further necessary action as per above decision of NC.|||||| ||Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.||||||

essary action as per above decision of NC.|||||| ||Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.||||||

Case No.	30 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00006636AM23
RA File Number	018205001441 AM21
Licence No and<br>Date	0310836987/01/07/2020

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Norms Committee Decision:

The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc norms as under:

orms as under:
Export product	Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)	<br>1 kg	1	Ethyl<br>3<br>Cyclopropylamino-2(2,4<br>Dichloro-<br>5Fluorobenzoyl) Acrylate	1.294 kg
		2	Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.
Note: The above norms are only for regularization purpose and no repeat licences will be issued on the<br>basis of these norms.

necessary action as per above decision of NC.||||| |Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.|||||

Case No.	31 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00006637AM23
RA File Number	018205001442 AM21
Licence No and<br>Date	0310836988/01/07/2020
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04.02.2023 under the Chairmanship of Shri Rajiv Kumar<br>Soni, Jt. DGFT to ascertain the exact wastage of import items in their licences.<br>The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc<br>norms as under:

UDIN00018757AM24

Export product	Qty.	Sl. No.	Import items	Qty.
Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)	<br>1 kg	1	Ethyl<br>3<br>Cyclopropylamino-2(2,4<br>Dichloro-<br>5Fluorobenzoyl) Acrylate	1.294 kg
		2	Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.
Note: The above norms are only for regularization purpose and no repeat licences will be issued on the<br>basis of these norms.

ecessary action as per above decision of NC.||||| ||Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.|||||

Case No.	Case No.	32 / NC/3/MEET/Mar/202223/22	32 / NC/3/MEET/Mar/202223/22	32 / NC/3/MEET/Mar/202223/22	32 / NC/3/MEET/Mar/202223/22	32 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00006638AM23
RA File Number		018205001443 AM21
Licence No and<br>Date		0310836990/01/07/2020
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04.02.2023 under the Chairmanship of Shri Rajiv Kumar<br>Soni, Jt. DGFT to ascertain the exact wastage of import items in their licences.<br>The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc<br>norms as under:<br>Export product<br>Qty.<br>Sl. No.

ge of import items in their licences. The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc norms as under: Export product Qty. Sl. No. Import items Qty. 1 Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate 1.294 kg Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin) 1 kg 2 Piperazine Anhydrous 0.390 kg RA concerned may take further necessary action as per above decision of NC. Note: The above norms are only for regularization purpose and no repeat licences will be issued on the||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin)|| 1 kg|1|Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate|1.294 kg| |||||2|Piperazine Anhydrous|0.390 kg| ||RA concerned may take further necessary action as per above decision of NC.|||||| ||Note: The above norms are only for regularization purpose and no repeat licences will be issued on the||||||

UDIN00018757AM24

basis of these norms.

Case No.	Case No.	33 / NC/3/MEET/Mar/202223/22	33 / NC/3/MEET/Mar/202223/22	33 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00006639AM23
RA File Number		018205001444 AM21
Licence No and<br>Date		0310836991/01/07/2020
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04.02.2023 under the Chairmanship of Shri Rajiv Kumar<br>Soni, Jt. DGFT to ascertain the exact wastage of import items in their licences.<br>The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc<br>norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl<br>3<br>Cyclopropylamino-2(2,4<br>Dichloro-<br>5Fluorobenzoyl) Acrylate<br>1.294 kg<br>Ciprofloxacin<br>Hydrochloride<br>BP/EP/USP (Ciprofloxacin)<br>1 kg<br>2<br>Piperazine Anhydrous<br>0.390 kg<br>RA concerned may take further necessary action as per above decision of NC.<br>Note: The above norms are only for regularization purpose and no repeat licences will be issued on the<br>basis of these norms.
	Export product		Qty.	Sl.

above decision of NC. Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin)|| 1 kg|1|Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate|1.294 kg| |||||2|Piperazine Anhydrous|0.390 kg| ||RA concerned may take further necessary action as per above decision of NC.|||||| ||Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.||||||

Case No.	34 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00006640AM23
RA File Number	018205001446 AM21
Licence No and<br>Date	0310837001/01/07/2020
Norms Committee Decision:

UDIN00018757AM24

2 and 24/03/2023| |HQ File Number|HQRNORM REVIW00006640AM23| |RA File Number|018205001446 AM21| |Licence No and Date|0310837001/01/07/2020| |Norms Committee Decision:||

UDIN00018757AM24

|As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the factory visit of M/s Aarti Drugs Limited was carried out on 04.02.2023 under the Chairmanship of Shri Rajiv Kumar Soni, Jt. DGFT to ascertain the exact wastage of import items in their licences. The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc norms as under: Export product Qty. Sl. No. Import items Qty. 1 Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate 1.294 kg Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin) 1 kg 2 Piperazine Anhydrous 0.390 kg RA concerned may take further necessary action as per above decision of NC. Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.|As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the factory visit of M/s Aarti Drugs Limited was carried out on 04.02.2023 under the Chairmanship of Shri Rajiv Kumar Soni, Jt. DGFT to ascertain the exact wastage of import items in their licences. The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc norms as under: Export product Qty. Sl. No.

ge of import items in their licences. The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc norms as under: Export product Qty. Sl. No. Import items Qty. 1 Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate 1.294 kg Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin) 1 kg 2 Piperazine Anhydrous 0.390 kg RA concerned may take further necessary action as per above decision of NC. Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.|As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the factory visit of M/s Aarti Drugs Limited was carried out on 04.02.2023 under the Chairmanship of Shri Rajiv Kumar Soni, Jt. DGFT to ascertain the exact wastage of import items in their licences. The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc norms as under: Export product Qty. Sl. No.

ge of import items in their licences. The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc norms as under: Export product Qty. Sl. No. Import items Qty. 1 Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate 1.294 kg Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin) 1 kg 2 Piperazine Anhydrous 0.390 kg RA concerned may take further necessary action as per above decision of NC. Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.| |---|---|---|---|---|---| ||Export product|Qty.|Sl. No.|Import items|Qty.| ||Ciprofloxacin Hydrochloride BP/EP/USP (Ciprofloxacin)| 1 kg|1|Ethyl 3 Cyclopropylamino-2(2,4 Dichloro- 5Fluorobenzoyl) Acrylate|1.294 kg| ||||2|Piperazine Anhydrous|0.390 kg| ||RA concerned may take further necessary action as per above decision of NC.||||| ||Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.|||||

ecessary action as per above decision of NC.||||| ||Note: The above norms are only for regularization purpose and no repeat licences will be issued on the basis of these norms.|||||

Case No.	Case No.	35 / NC/3/MEET/Mar/202223/22	35 / NC/3/MEET/Mar/202223/22	35 / NC/3/MEET/Mar/202223/22	35 / NC/3/MEET/Mar/202223/22	35 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00006641AM23
RA File Number		018205001453 AM21
Licence No and<br>Date		0310837056/07/07/2020
Norms Committee Decision:<br>As per the decision taken by the Committee in its Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022, the<br>factory visit of M/s Aarti Drugs Limited was carried out on 04.02.2023 under the Chairmanship of Shri Rajiv Kumar<br>Soni, Jt. DGFT to ascertain the exact wastage of import items in their licences.<br>The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc<br>norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Ciprofloxacin<br>Hydrochloride<br>Ethyl<br>3<br>Cyclopropylamino-2(2,4<br>Dichloro-<br>1 kg<br>1<br>1.294 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Ciprofloxacin<br>Hydrochloride		<br>1 kg	1	Ethyl<br>3<br>Cyclopropylamino-2(2,4<br>Dichloro-	1.294 kg

UDIN00018757AM24

1.294 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Ciprofloxacin Hydrochloride|| 1 kg|1|Ethyl 3 Cyclopropylamino-2(2,4 Dichloro-|1.294 kg|

UDIN00018757AM24

BP/EP/USP (Ciprofloxacin)		5Fluorobenzoyl) Acrylate
	2	Piperazine Anhydrous	0.390 kg
RA concerned may take further necessary action as per above decision of NC.
Note: The above norms are only for regularization purpose and no repeat licences will be issued on the<br>basis of these norms.

Case No.	36 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	SHIVA BIO CHEM INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00004344AM23
RA File Number	502404000009 AM21
Licence No and<br>Date	5010002703/07/08/2020

| |Meeting Number and Date|NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023| |HQ File Number|HQRNORM REVIW00004344AM23| |RA File Number|502404000009 AM21| |Licence No and Date|5010002703/07/08/2020| |Norms Committee Decision: The Committee considered the request of firm for fixation of adhoc norms andit was observed that the firm still has not provided following information / documents, due to non-receipt of which, its case was earlier rejected too: COA of import item from foreign supplier indication percentage moisture content. i. Complete specification of export item. ii. Process of manufacturing indicating wastage at each stage of manufacturing. iii. Hence, it was decided torejectthe case maintaining the status quo. RA concerned may take further necessary action as per above decision of NC.||

Case No.	37 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	SRI CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00002991AM23
RA File Number	042404000109 AM21
Licence No and<br>Date	0410167147/07/10/2020

UDIN00018757AM24

Norms Committee Decision:

The Committee considered the request of firm for fixation of adhoc norms and it was observed that the firm still has not furnished its reply. Hence, the Committee decided to reject the case.

Case No.	38 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	018205001756AM21
RA File Number	039404000825 AM20
Licence No and<br>Date	0310838959/16/10/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms andit was decided to ratify adhoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ethyl 3- Cyclopropylamino-2-(2,4-Dichloro-5-<br>Fluorobenzoyl)Acrylate<br>1.307 kg.<br>2<br>N-Ethyl / Piperazine<br>0.490 kg.<br>3<br>Methanol<br>0.334 kg.<br>Enrofloxacin<br>1 kg<br>4<br>Caustic Soda Flakes<br>0.360 kg.<br>RA may take appropriate action as per the decision of Norms Committee.

Case No.	39 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00004724AM23
RA File Number	018205001755 AM21

UDIN00018757AM24

Licence No and 0310838958/16/10/2020 Date Norms Committee Decision:

UDIN00018757AM24

Licence No and 0310838958/16/10/2020 Date Norms Committee Decision:

The Committee examined the Factory Visit Report and after deliberation, it was decided to revise adhoc norms as under:

orms as under:
Export product	Qty.<br>Sl. No. Import items		Qty.
Ciprofloxacin<br>Hydrochloride	1<br>Ethyl<br>3<br>Cyclopropylamino-2(2,4<br> <br>1 kg	Dichloro-	1.294 kg
BP/EP/USP (Ciprofloxacin)	5Fluorobenzoyl) Acrylate
	2<br>Piperazine Anhydrous		0.390 kg
RA concerned may take further necessary action as per above decision of NC.
Note: The above norms are only for regularization purpose and no repeat licences will be			issued on the
basis of these norms.

essary action as per above decision of NC.|||| |Note: The above norms are only for regularization purpose and no repeat licences will be|||issued on the| |basis of these norms.||||

Case No.	Case No.	40 / NC/3/MEET/Mar/202223/22	40 / NC/3/MEET/Mar/202223/22	40 / NC/3/MEET/Mar/202223/22	40 / NC/3/MEET/Mar/202223/22	40 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00005153AM23
RA File Number		018205001788 AM21
Licence No and<br>Date		0310839173/28/10/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms andit was decided to ratify adhoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2,4 Dichloro-5-Fluoro Acetophenone(DCFA)<br>1.123 kg.<br>Norfloxacin<br>1 kg.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Norfloxacin		1 kg.	1	2,4 Dichloro-5-Fluoro Acetophenone(DCFA)	1.123 kg.

5-Fluoro Acetophenone(DCFA) 1.123 kg. Norfloxacin 1 kg.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Norfloxacin||1 kg.|1|2,4 Dichloro-5-Fluoro Acetophenone(DCFA)|1.123 kg.|

Case No.	Case No.	40 / NC/3/MEET/Mar/202223/22	40 / NC/3/MEET/Mar/202223/22	40 / NC/3/MEET/Mar/202223/22	40 / NC/3/MEET/Mar/202223/22	40 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00005153AM23
RA File Number		018205001788 AM21
Licence No and<br>Date		0310839173/28/10/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms andit was decided to ratify adhoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2,4 Dichloro-5-Fluoro Acetophenone(DCFA)<br>1.123 kg.<br>Norfloxacin<br>1 kg.
	Export product		Qty.	Sl. No.	Import items	Qty.
	Norfloxacin		1 kg.	1	2,4 Dichloro-5-Fluoro Acetophenone(DCFA)	1.123 kg.

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A) 1.123 kg. Norfloxacin 1 kg.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Norfloxacin||1 kg.|1|2,4 Dichloro-5-Fluoro Acetophenone(DCFA)|1.123 kg.|

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2	Dimethyl Carbonate	1.01 kg.
3	Dimethyl Formamide	0.50 kg.
4	Mono Ethyl Amine(70%)	0.557 kg.
5	Piperazine Anhydrous	0.665 kg.
6	Methanol	1.20 kg.

Case No.	Case No.	41 / NC/3/MEET/Mar/202223/22	41 / NC/3/MEET/Mar/202223/22	41 / NC/3/MEET/Mar/202223/22	41 / NC/3/MEET/Mar/202223/22	41 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00005154AM23
RA File Number		018205001818 AM21
Licence No and<br>Date		0310839307/04/11/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms andit was decided to ratify adhoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.

of adhoc norms andit was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 2,4 Dichloro-5-Fluoro Acetophenone(DCFA) 1.123 kg. 2 Dimethyl Carbonate 1.01 kg. 3 Dimethyl Formamide 0.50 kg. 4 Mono Ethyl Amine(70%) 0.557 kg. 5 Piperazine Anhydrous 0.665 kg. Norfloxacin 1 kg.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Norfloxacin||1 kg.|1|2,4 Dichloro-5-Fluoro Acetophenone(DCFA)|1.123 kg.| |||||2|Dimethyl Carbonate|1.01 kg.| |||||3|Dimethyl Formamide|0.50 kg.| |||||4|Mono Ethyl Amine(70%)|0.557 kg.| |||||5|Piperazine Anhydrous|0.665 kg.|

Case No.	Case No.	41 / NC/3/MEET/Mar/202223/22	41 / NC/3/MEET/Mar/202223/22	41 / NC/3/MEET/Mar/202223/22	41 / NC/3/MEET/Mar/202223/22	41 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		AARTI DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00005154AM23
RA File Number		018205001818 AM21
Licence No and<br>Date		0310839307/04/11/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms andit was decided to ratify adhoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.

UDIN00018757AM24

6 Methanol RA may take appropriate action as per the decision of Norms Committee.

1.20 kg.

Case No.	42 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00049028AM21
RA File Number	07AA04006399 AM21
Licence No and<br>Date	0711000171/28/12/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

as observed that the firm still has not furnished its reply. Hence,|| |the Committee decided torejectthe case.|| |RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>43 / NC/3/MEET/Mar/202223/22	Case No.<br>43 / NC/3/MEET/Mar/202223/22
Case Status<br>Case Approved
Party Name<br>GRANULES INDIA LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number<br>HQRNORM REVIW00006413AM23
RA File Number<br>09AA04004807 AM21
Licence No and<br>Date<br>0911000371/17/02/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
	Export product<br>Qty.<br>Sl. No.	Import items	Qty.
	1<br>AZATHIOPRINE 25 mg<br>1 Number	Azathioprine	25.00 mg
	2	Cellulose Microcristalline	25.00 mg

by the firm, whichever is less:||||| ||Export product Qty. Sl. No.|Import items|Qty.|| ||1 AZATHIOPRINE 25 mg 1 Number|Azathioprine|25.00 mg|| ||2|Cellulose Microcristalline|25.00 mg||

Case No.<br>43 / NC/3/MEET/Mar/202223/22	Case No.<br>43 / NC/3/MEET/Mar/202223/22
Case Status<br>Case Approved
Party Name<br>GRANULES INDIA LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number<br>HQRNORM REVIW00006413AM23
RA File Number<br>09AA04004807 AM21
Licence No and<br>Date<br>0911000371/17/02/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
	Export product<br>Qty.<br>Sl. No.	Import items	Qty.
	1<br>AZATHIOPRINE 25 mg<br>1 Number	Azathioprine	25.00 mg
	2	Cellulose Microcristalline	25.00 mg

UDIN00018757AM24

3	Mannitol	25.00 mg
4	Corn Starch	7.00 mg
5	Croscarmellose Sodium	2.75 mg
6	Povidone K	4.00 mg
7	Sodium Stearyl Fumarate	1.25 mg
8	Hypromellose	1.15 mg
9	Macrogol	0.20 mg

-|---|---|---| ||||4|Corn Starch|7.00 mg| ||||5|Croscarmellose Sodium|2.75 mg| ||||6|Povidone K|4.00 mg| ||||7|Sodium Stearyl Fumarate|1.25 mg| ||||8|Hypromellose|1.15 mg| ||||9|Macrogol|0.20 mg|

Case No.	Case No.	44 / NC/3/MEET/Mar/202223/22	44 / NC/3/MEET/Mar/202223/22	44 / NC/3/MEET/Mar/202223/22	44 / NC/3/MEET/Mar/202223/22	44 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		GRANULES INDIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00006416AM23
RA File Number		09AA04004799 AM21
Licence No and<br>Date		0911000378/17/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Methotrexate<br>2.50 mg<br>2<br>Anhydrous<br>Calcium<br>hydrogen<br>phosphate<br>6.375 mg<br>Methotrexate 2.5 mg<br>1 Number
	Export product		Qty.	Sl. No.	Import items	Qty.
	Methotrexate 2.5 mg		1 Number	1	Methotrexate	2.50 mg
				2	Anhydrous<br>Calcium<br>hydrogen<br>phosphate	<br>6.375 mg

UDIN00018757AM24

|Export product||Qty.|Sl. No.|Import items|Qty.| ||Methotrexate 2.5 mg||1 Number|1|Methotrexate|2.50 mg| |||||2|Anhydrous Calcium hydrogen phosphate| 6.375 mg|

UDIN00018757AM24

3	Lactose Monohydrate (Tablettose 80)	12.50 mg
4	Sodium starch glycollate	1.80 mg
5	Microcrystalline Cellulose	21.075 mg
6	Purified Talc	0.375 mg
7	Magnesium Stearate	0.375 mg

Case No.	Case No.	45 / NC/3/MEET/Mar/202223/22	45 / NC/3/MEET/Mar/202223/22	45 / NC/3/MEET/Mar/202223/22	45 / NC/3/MEET/Mar/202223/22	45 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		GRANULES INDIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00006420AM23
RA File Number		09AA04004798 AM21
Licence No and<br>Date		0911000395/20/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.

as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 Hydroxyurea USP 500.00 mg 2 Colloidal Silicon Dioxide NF 1.50 mg 3 Magnesium Stearate 0.50 mg HYDROXYUREA CAPSULES 500 mg 1 Number 4 Capsule size1 Relevant as per packing policy||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||HYDROXYUREA CAPSULES 500 mg||1 Number|1|Hydroxyurea USP|500.00 mg| |||||2|Colloidal Silicon Dioxide NF|1.50 mg| |||||3|Magnesium Stearate|0.50 mg| |||||4|Capsule size1|Relevant as per packing policy|

UDIN00018757AM24

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

Case No.		46 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved

rned may take further necessary action as per above decision of NC.| |---|---|---|---|---|---|---|---|---| |||||||||| |Case No.||46 / NC/3/MEET/Mar/202223/22||||||| |Case Status||Case Approved||||||| |Party Name||GRANULES INDIA LIMITED||||||| |Meeting Number||||||||| |and Date||NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023||||||| |HQ File Number||HQRNORM REVIW00006473AM23||||||| |RA File Number||09AA04005468 AM21||||||| |Licence No and||||||||| |Date||0911000463/05/03/2021||||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP||||||||| | Vol. I as per details given below or as applied by the firm, whichever is less:||||||||| |||||||||| ||Export product||Qty.|Sl. No.|Import items|||Qty.| |||||||||| |||||||||| ||Tamoxifen citrat|e 20 m|1 Number|1|Tamoxifen citrate|||3040 m| |||g||||||. g| |||||||||| |||||2|Calcium hydrogen phosphate dihydrate|||281.60 mg| |||||||||| |||||||||| |||||3|Povidone K 25|||8.00 mg| |R||||4|Sodium starch glycolate|||20.00 mg| |||||5|mangnesium stearate|||5.00 mg| |||||||||| |||||6|Ce|llulose||33.00 mg| |||||||||| |||||7|Sil|ica, collo|idal anhydrous|2.00 mg| ||A concerned may take further necessary action|||as per abov||||| |||||||e decisio|n of NC.|| |||||||||| |||||||||| |Case No.||47 / NC/3/MEET/Mar/202223/22||||||| |Case Status||Case Rejected|||||||

Case No.	47 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected

UDIN00018757AM24

|||||||| |Case No.||47 / NC/3/MEET/Mar/202223/22||||||| |Case Status||Case Rejected|||||||

Case No.	47 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected

UDIN00018757AM24

Party Name	NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00109027AM21
RA File Number	03AA04031482 AM21
Licence No and<br>Date	0311002729/22/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Party Name	Party Name	NAVIN FLUORINE INTERNATIONAL LIMITED	NAVIN FLUORINE INTERNATIONAL LIMITED	NAVIN FLUORINE INTERNATIONAL LIMITED	NAVIN FLUORINE INTERNATIONAL LIMITED	NAVIN FLUORINE INTERNATIONAL LIMITED	NAVIN FLUORINE INTERNATIONAL LIMITED	NAVIN FLUORINE INTERNATIONAL LIMITED	NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM APPLY 00109027AM21
RA File Number		03AA04031482 AM21
Licence No and		0311002729/22/03/2021
Date

Norms Committee<br>The Committee con		Decision:<br>sidered the case as per agenda and it was observed that the firm still has not furnished its repl Hence
<br>the Committee deci		y.

|||||| |Norms Committee The Committee con||Decision: sidered the case as per agenda and it was observed that the firm still has not furnished its repl Hence|||||||| | the Committee deci||y. , ded torejectthe case.|||||||| ||||||||||| |RA c||oncerned may take further necessary action as per above decision of NC|||||||| |.|||||||||| ||||||||||| |Case No.||48 / NC/3/MEET/Mar/202223/22|||||||| |C|ase Status|Case Approved|||||||| |P|arty Name|AARTI DRUGS LIMITED|||||||| |M a|eeting Number||||||||| || nd Date|NC/ 3/ MEET/ Mar/ 202223/ 2|||2 and 24/0||3/2023||| |H|Q File Number|HQRNORM APPLY 0010478|||5AM22||||| |R|A File Number|039404000639 AM21|||||||| |L D|icence No and ate|0311002735/01/06/2021|||||||| ||||||||||| |N T P|orms Committee Decision: he Committee considered the request of firm for fi ara 4.07 of HBP Vol. I as per details given belo||||xation of a w or as ap||||| ||||||||hoc nor plied by|ms andit was decided to ratify adh the firm, whichever is less:|oc norms under| ||||||||||| ||Export product||Qty.|Sl. No.||Import items|||Qty.| ||Enrofloxacin||1 kg|1||Ethyl 3- Cyclopropylamino-2-(2,4-Dichloro-5- Fluorobenzoyl)Acrylate|||1.307 kg.| ||||||||||| |||||2||N-Ethyl / Piperazine|||0.490 kg.| ||||||||||| ||||||||||| |||||3||Methanol|||0.334 kg.| ||||||||||| ||||||||||| |||||4||Caustic Soda Flakes|||0.360 kg.| ||||||||||| ||||||||||| |RA may take approp||riate action as per the decision of Norms Committee.|||||||| ||||||||||| ||||||||||| ||||||||||| |Case No.||49 / NC/3/MEET/Mar/202223/22||||||||

0 kg.| ||||||||||| ||||||||||| |RA may take approp||riate action as per the decision of Norms Committee.|||||||| ||||||||||| ||||||||||| ||||||||||| |Case No.||49 / NC/3/MEET/Mar/202223/22||||||||

Case No. 49 / NC/3/MEET/Mar/202223/22

UDIN00018757AM24

Case Status	Case Rejected
Party Name	SWISS PARENTERALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00003402AM23
RA File Number	08AA04005392 AM22
Licence No and<br>Date	0811001628/01/06/2021
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was observed that the firm still has not
furnished its reply.	Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	50 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	ANTILA LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00165364AM22
RA File Number	08AA04018980 AM22
Licence No and<br>Date	0811002348/18/08/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

as observed that the firm still has not furnished its reply. Hence,|| |the Committee decided torejectthe case.|| |RA concerned may take further necessary action as per above decision of NC.||

Case No.	51 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	FDC LIMITED
Meeting Number	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
and Date
HQ File Number	HQRNORM REVIW00005815AM23
RA File Number	03AA040106163 AM22
Licence No and	0311007214/25/09/2021
Date
Norms Committee	Decision:
The Committee con<br>before Norms Com	sidered the case as per agenda and it was decided to callthe firm for attendingPersonal Hearing<br>mittee to explain its case alongwithfollowing information / documents from the firm:

36 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-04-2023 18:26:04.

UDIN00018757AM24

“The firm may be advised to get their license amended for the export description as given in their Drug Manufacturing License and Batch Manufacturing Record.”

023 18:26:04.

UDIN00018757AM24

“The firm may be advised to get their license amended for the export description as given in their Drug Manufacturing License and Batch Manufacturing Record.”

“The firm may be advised to get their license amended for the export description as given in their Drug<br>Manufacturing License and Batch Manufacturing Record.”	“The firm may be advised to get their license amended for the export description as given in their Drug<br>Manufacturing License and Batch Manufacturing Record.”	“The firm may be advised to get their license amended for the export description as given in their Drug<br>Manufacturing License and Batch Manufacturing Record.”	“The firm may be advised to get their license amended for the export description as given in their Drug<br>Manufacturing License and Batch Manufacturing Record.”	“The firm may be advised to get their license amended for the export description as given in their Drug<br>Manufacturing License and Batch Manufacturing Record.”

Case No.		52 / NC/3/MEET/Mar/202223/22
	.
C	ase Status	Case Deferred
P	arty Name	ENCUBE ETHICALS PRIVA	TE LIMITE	D

ufacturing Record.”| |---|---|---|---|---|---|---| |||||||| |Case No.||52 / NC/3/MEET/Mar/202223/22||||| ||.|||||| |C|ase Status|Case Deferred||||| |P|arty Name|ENCUBE ETHICALS PRIVA|TE LIMITE|D||| |M a|eeting Number nd Date|NC/ 3/ MEET/ Mar/ 202223/ 2|2 and 24/03|/2023||| |H|Q File Number|HQRNORM APPLY 0019549|7AM22|||| |||||||| |R|A File Number|03AA040105795 AM22||||| |Licence No and Date|icence No and|||||| |||0311007265/27/09/2021||||| |Norms Committee Decision: The Committee considered the case as per agenda and decided tovisit** factoryas there are large number of other similar ||||||| |cases of the company pending for ratification. Hence, the Committee decided to defer the case.|||||||

Case No.	53 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00005837AM23
RA File Number	03AA040106642 AM22
Licence No and<br>Date	0311007268/28/09/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to callthe firm for attendingPersonal Hearing
before Norms Committee to explain its case alongwithfollowing information / documents from the firm:
“The firm may be advised to get their license amended for the export description as given in their Drug
Manufacturing License and Batch Manufacturing Record.”

uments from the firm:|| |“The firm may be advised to get their license amended for the export description as given in their Drug|| |Manufacturing License and Batch Manufacturing Record.”||

Case No.	54 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00002321AM23
RA File Number	03AA040118606 AM22
Licence No and<br>Date	0311008613/16/11/2021
Norms Committee Decision:

37 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-04-2023 18:26:04.

UDIN00018757AM24

The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence, the Committee decided to reject the case.

Case No.	55 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00303629AM22
RA File Number	03AX04000191 AM22
Licence No and<br>Date	0311009972/31/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

as observed that the firm still has not furnished its reply. Hence,|| |the Committee decided torejectthe case.|| |RA concerned may take further necessary action as per above decision of NC.||

Case No.	56 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	SCITECH SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00311328AM22
RA File Number	03AA040131440 AM22
Licence No and<br>Date	0311010245/07/01/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	57 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	PORUS LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023

38 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-04-2023 18:26:04.

UDIN00018757AM24

HQ File Number	HQRNORM APPLY 00315693AM22
RA File Number	09AX04000098 AM22
Licence No and<br>Date	0911002275/12/01/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

as observed that the firm still has not furnished its reply. Hence,|| |the Committee decided torejectthe case.|| |RA concerned may take further necessary action as per above decision of NC.||

Case No.	58 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00318349AM22
RA File Number	31AX04000040 AM22
Licence No and<br>Date	3111000876/14/01/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	59 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00321040AM22
RA File Number	03AX04000043 AM22
Licence No and<br>Date	0311010585/17/01/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

39 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-04-2023 18:26:04.

UDIN00018757AM24

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

39 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-04-2023 18:26:04.

UDIN00018757AM24

C	ase No.	60 / NC/3/MEET/Mar/202223/22	60 / NC/3/MEET/Mar/202223/22	60 / NC/3/MEET/Mar/202223/22	60 / NC/3/MEET/Mar/202223/22	60 / NC/3/MEET/Mar/202223/22
C	ase Status	Case Approved
P	arty Name	SWATI MENTHOL AND ALLIED CHEMICALS LIMITED
M<br>a	eeting Number<br>nd Date	NC/ 3/ MEET/ Mar/ 20		2223/ 22 and 24/03/2023
H	Q File Number	HQRNORM APPLY 0		0321275AM22
R	A File Number	05AX04000573 AM22

L<br>D	icence No and<br>ate	0511007997/	17/01/202	2
N<br>.<br>T<br>is<br>a<br>H<br>R
	orms Committee Decision:<br>he Committee considered the c<br>no blending of any other item<br>scertain purity of 99.5% - 99.7<br>BP Vol. I as per details given b		ase as per<br>involve<br>% from 9<br>elow or a
				agenda an<br>d, hence, t	d as per the process given by the fi<br>he case was examined only after	rm, it was observed that there<br>taking distillation process to
				9%.

r a|||||||||| |||||||agenda an d, hence, t|||d as per the process given by the fi he case was examined only after||rm, it was observed that there taking distillation process to|| |||||||9%. Acco s applied b|||rdingly, it was decided to ratify ad y the firm, whichever is less:||hoc norms under Para 4.07 of|| |||||||||||||| ||Export product 1,8 Cineole 99.5% - 99.7%||||Q|||||||| |||||||ty.||Sl|. No.|Import items||Qty.| ||||||1|kg||1||Eucalyptol||1.01 kg| |||||||||||(Containing 1,8 Cineole 99%|)|| ||A concerned may take further n||ecessary|||||||||| |||||||action as p|||er above decision of NC.|||| |||||||||||||| |C|ase No. |61 / NC/3/ME|ET/Mar/2|||02223/22||||||| |C|ase Status |Case Approve|d|||||||||| |P|arty Name |AARTI DRU|GS LIMIT|||||||||| |||||||ED||||||| |M a|eeting Number nd Date |NC/ 3/ MEET|/ Mar/ 20|||2223/ 22 an|||d 24/03/2023|||| |H|Q File Number |HQRNORM R|EVIW00|||005155AM|||23|||| |R|A File Number |03AA0404473|5 AM22|||||||||| |L D|icence No and ate |0311010626/1|8/01/202|||2||||||| |N T P|orms Committee Decision: he Committee considered the req ara 4.07 of HBP Vol. I as per d||uest of fir etails giv|||||||||| |||||||m for fixati n below o|||on of adhoc norms andit was decide r as alied b the firm whichever||d to ratify adhoc norms under is less:|| ||||||||||pp y ,|||| |||||||||||||| ||Export product|||Qty.|||Sl. No.||Import items|||Qty.| ||||||||||||||

s decide r as alied b the firm whichever||d to ratify adhoc norms under is less:|| ||||||||||pp y ,|||| |||||||||||||| ||Export product|||Qty.|||Sl. No.||Import items|||Qty.| ||||||||||||||

Case No.<br>61 / NC/3/MEET/Mar/202223/22	Case No.<br>61 / NC/3/MEET/Mar/202223/22	Case No.<br>61 / NC/3/MEET/Mar/202223/22
Case Status<br>Case Approved
Party Name<br>AARTI DRUGS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number<br>HQRNORM REVIW00005155AM23
RA File Number<br>03AA04044735 AM22
Licence No and<br>Date<br>0311010626/18/01/2022
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms andit was decided to ratify adhoc norms under
Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
	Export product<br>Qty.	Sl. No.	Import items	Qty.

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s 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.||

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1	2,4 Dichloro-5-Fluoro Acetophenone(DCFA)	1.123 kg.
2	Dimethyl Carbonate	1.01 kg.
3	Dimethyl Formamide	0.50 kg.
4	Mono Ethyl Amine(70%)	0.557 kg.
5	Piperazine Anhydrous	0.665 kg.
6	Methanol	1.20 kg.

Case No.	62 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00005521AM23
RA File Number	03AX04000818 AM22
Licence No and<br>Date	0311010921/27/01/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and as per the justification provided by the<br>firm, it was observed that there is other compound present in the import and also yield is low because of 10% residue<br>remaining, hence it was decided to revise adhoc norms as under:<br>Export product<br>Qty.<br>Sl. No.

that there is other compound present in the import and also yield is low because of 10% residue remaining, hence it was decided to revise adhoc norms as under: Export product Qty. Sl. No. Import items Qty. Dimethyl-2-methyl glutarate 1 kg 1 2-methyl glutaronitrile (Purity 86-87%) 0.85 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	63 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected

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Party Name	BALAJI AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	NORM APPLY 00343126AM22
RA File Number	31AX04000059 AM22
Licence No and<br>Date	3111000968/04/02/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

as observed that the firm still has not furnished its reply. Hence,|| |the Committee decided torejectthe case.|| |RA concerned may take further necessary action as per above decision of NC.||

Case No.	64 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00359473AM22
RA File Number	03AX04001229 AM22
Licence No and<br>Date	0311011469/18/02/2022
Norms Committee Decision:
The Committee considered the case as per agenda and decided tovisit factoryas there are large number of other similar
cases of the company pending for ratification. Hence, the Committee decided to defer the case.

Case No.	65 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	GUPTA AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00381776AM22
RA File Number	05AX04001230 AM22
Licence No and<br>Date	0511010862/10/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

42 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-04-2023 18:26:04.

UDIN00018757AM24

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

42 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-04-2023 18:26:04.

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Case No.	66 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	AASHA BIOCHEM
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00383526AM22
RA File Number	10AX04000077 AM22
Licence No and<br>Date	1011000943/11/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	67 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	GUPTA AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00386306AM22
RA File Number	05AX04001267 AM22
Licence No and<br>Date	0511010970/14/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

as observed that the firm still has not furnished its reply. Hence,|| |the Committee decided torejectthe case.|| |RA concerned may take further necessary action as per above decision of NC.||

Case No.	68 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	PROEC ENERGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00386396AM22
RA File Number	05AX04001262 AM22
Licence No and<br>Date	0511010975/14/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,

43 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-04-2023 18:26:04.

UDIN00018757AM24

the Committee decided to reject the case.

Case No.	69 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	DPB ANTIBIOTICS
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00387310AM22
RA File Number	03AX04001617 AM22
Licence No and<br>Date	0311012908/15/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

as observed that the firm still has not furnished its reply. Hence,|| |the Committee decided torejectthe case.|| |RA concerned may take further necessary action as per above decision of NC.||

Case No.	70 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00409264AM22
RA File Number	03AX04002067 AM22
Licence No and<br>Date	0311013503/31/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	71 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00409265AM22

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RA File Number	03AX04002070 AM22
Licence No and<br>Date	0311013504/31/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

as observed that the firm still has not furnished its reply. Hence,|| |the Committee decided torejectthe case.|| |RA concerned may take further necessary action as per above decision of NC.||

Case No.	72 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00409266AM22
RA File Number	03AX04002071 AM22
Licence No and<br>Date	0311013505/31/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	73 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM REVIW00006096AM23
RA File Number	03AX04000111 AM23
Licence No and<br>Date	0311013749/10/04/2022
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for
same export product / import item in Meeting No.NC/3/MEET/Dec/202223/17dated13/01/2023 against advance
authorization No.0311004509dt.10/06/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as
per details given below or as applied by the firm, whichever is less:

ce|| |authorization No.0311004509dt.10/06/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as|| |per details given below or as applied by the firm, whichever is less:||

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Export product	Qty.	Sl. No.	Import items	Qty.
DI-NONYLATED DIPHENYLAMINE<br>(YALUB DND)	1 kg	1	DIPHENYLAMINE	0.4134 kg
		2	NONENE	0.800 kg
		3	ACTIVATED CLAY	0.05 kg

Case No.	Case No.	74 / NC/3/MEET/Mar/202223/22	74 / NC/3/MEET/Mar/202223/22	74 / NC/3/MEET/Mar/202223/22	74 / NC/3/MEET/Mar/202223/22	74 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM REVIW00006097AM23
RA File Number		03AX04000094 AM23
Licence No and<br>Date		0311013750/10/04/2022

and Date||NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023||||| |HQ File Number||HQRNORM REVIW00006097AM23||||| |RA File Number||03AX04000094 AM23||||| |Licence No and Date||0311013750/10/04/2022||||| |Norms Committee Decision: The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Dec/202223/17dated13/01/2023 against advance authorization No.0311004509dt.10/06/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 DIPHENYLAMINE 0.4134 kg 2 NONENE 0.800 kg DI-NONYLATED DIPHENYLAMINE (YALUB DND) 1 kg 3 ACTIVATED CLAY 0.05 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||DI-NONYLATED DIPHENYLAMINE (YALUB DND)||1 kg|1|DIPHENYLAMINE|0.4134 kg| |||||2|NONENE|0.800 kg| |||||3|ACTIVATED CLAY|0.05 kg| |||||above decision of NC.|||

UDIN00018757AM24

ems|Qty.| ||DI-NONYLATED DIPHENYLAMINE (YALUB DND)||1 kg|1|DIPHENYLAMINE|0.4134 kg| |||||2|NONENE|0.800 kg| |||||3|ACTIVATED CLAY|0.05 kg| |||||above decision of NC.|||

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Case No.	Case No.	75 / NC/3/MEET/Mar/2022	23/22	23/22
Case Status		Case Approved
Party Name
		YASHO INDUSTRIES LIM	ITED
Meeting Number
and Date		NC/ 3/ MEET/ Mar/ 202223	/ 22 and 24/03/		023
HQ File Number		HQRNORM REVIW00006	099AM23
RA File Number		03AX04000163 AM23

Licence No and<br>Date		0311013879/17/04/2022
Norms Committee Decision:<br>The Committee considered the request of firm<br>same export product / import item in Meetin<br>authorization No.0311004509dt.10/06/2021, i<br>per details given below or as applied by the firm<br>Export product<br>Q<br>DI-NONYLATED DIPHENYLAMINE<br>(YALUB DND)<br>1
	he Committee considered the request of firm<br>me export product / import item in Meetin<br>		for review of<br>g No.NC/3/M<br>		adhoc no<br>EET/Dec/<br>		rms and taking cue from earlier<br>202223/17dated13/01/2023 agai<br>			decision for<br>nst advance<br>
	uthorization No.0311004509dt.10/06/2021, i<br>er details given below or as applied by the firm		t was de<br>, which	cided t<br>ever is	o r<br>les	atify a<br>s:	dh	oc norms under Para 4.07 o	f H	BP Vol. I as



	Export product		ty.	Sl.

by the firm|||t was de , which|cided t ever is|o r les||atify a s:|dh|oc norms under Para 4.07 o|f H|BP Vol. I as| |||||||||||||| |||||||||||||| |||||||||||||| ||Export product|||ty.|Sl. No.||I|port i|te|ms|Qty|.| ||DI-NONYLATED DIPHENYLAMINE (YALUB DND)||1|kg|1||DIPHE||NYLAMINE||0.4|134 kg| ||||||2||NONEN||E||0.8|00 kg| |||||||||||||| ||||||3||ACTIV||ATED CLAY||0.0|5 kg| |||||||||||||| |||||||||||||| |||||||||||||| |||||||||||||| |RA concerned may||take further necessary action as per above decision of NC.||||||||||| |||||||||||||| |||||||||||||| |||||||||||||| |Case No||76 / NC/3/MEET/Mar/202223/22||||||||||| |.||||||||||||| |Case Status||Case Rejected||||||||||| |||||||||||||| |Party Name||AVID ORGANICS PRIVATE LIMITED||||||||||| |||||||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023||||||||||| |||||||||||||| |HQ File Number||HQRNORM APPLY 00000351AM23||||||||||| |RA File Number||34AX04000065 AM23||||||||||| |Licence No and||||||||||||| |Date||3411002146/20/04/2022||||||||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence, the Committee decided torejectthe case||||||||||||| |||.||||||||||| |||||||||||||| |||||||||||||| ||||||||||||||

and it was observed that the firm still has not furnished its reply. Hence, the Committee decided torejectthe case||||||||||||| |||.||||||||||| |||||||||||||| |||||||||||||| ||||||||||||||

Case No.	76 / NC/3/MEET/Mar/202223/22
Case Status	Case Rejected
Party Name	AVID ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00000351AM23
RA File Number	34AX04000065 AM23
Licence No and<br>Date	3411002146/20/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.

UDIN00018757AM24

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

Case No.	Case No.	77 / NC/3/MEET/Mar/202223/22	77 / NC/3/MEET/Mar/202223/22	77 / NC/3/MEET/Mar/202223/22	77 / NC/3/MEET/Mar/202223/22	77 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM APPLY 00000535AM23
RA File Number		31AX04000023 AM23
Licence No and<br>Date		3111001324/02/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.

case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 Tylosin Tartrate EP 0.101 kg. TYLODOX GOLD Powder (Pack size 1 Kgs Jar)(Each gram powder contains: Tylosin Tartrate BP (Vet) equivalent to Tylosin base 100 mg Doxycycline Hyclate BP Equivalent to Doxycycline 200 mg) 1number 3 Doxycycline Hyclate BP/EP/USP 0.202 kg. 2 Tylosin Tartrate EP 10.1 gm. TYLODOX GOLD Powder (Pack size 100 Gms sachet)(Each gram powder contains: Tylosin Tartrate BP (Vet) equivalent to Tylosin base 100 mg Doxycycline Hyclate BP Equivalent to Doxycycline 200 mg) 1 number 4 Doxycycline Hyclate BP/EP/USP 20.2 gm GENTADOX GOLD Powder ( pack Size 1 Kgs Jar)(Each gram powder contains: Doxycycline Hyclate 200mg, Gentamycin Sulphate 100mg) 1 number 5 Doxycycline Hyclate BP/EP/USP 0.202 kg GENTADOX GOLD Powder ( pack Size 100 Gms Sachet)(Each gram powder contains: Doxycycline Hyclate 200mg, Gentamycin Sulphate 100mg) 1 number 6 Doxycycline Hyclate BP/EP/USP 20.2 gm NEODOX -GOLD Powder ( pack Size 1 Kgs Jar)(Each gram powder contains: Each gram powder contains: Doxycycline Hyclate BP Equivalent to Doxycycline 100 mg Neomycin Sulfate BP 100 mg) 1 number 7 Doxycycline Hyclate BP/EP/USP 0.101 kg. NEODOX -GOLD Powder ( pack Size 100 Gms Sachet)(Each gram powder contains: Doxycycline Hyclate BP Equivalent to Doxycy

e BP 100 mg) 1 number 7 Doxycycline Hyclate BP/EP/USP 0.101 kg. NEODOX -GOLD Powder ( pack Size 100 Gms Sachet)(Each gram powder contains: Doxycycline Hyclate BP Equivalent to Doxycycline 100 mg Neomycin Sulfate BP 100 mg) 1 number 8 Doxycycline Hyclate BP/EP/USP 10.1 gm||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||TYLODOX GOLD Powder (Pack size 1 Kgs Jar)(Each gram powder contains: Tylosin Tartrate BP (Vet) equivalent to Tylosin base 100 mg Doxycycline Hyclate BP Equivalent to Doxycycline 200 mg)|| 1number|1|Tylosin Tartrate EP|0.101 kg.| |||||3|Doxycycline Hyclate BP/EP/USP|0.202 kg.| ||TYLODOX GOLD Powder (Pack size 100 Gms sachet)(Each gram powder contains: Tylosin Tartrate BP (Vet) equivalent to Tylosin base 100 mg Doxycycline Hyclate BP Equivalent to Doxycycline 200 mg)|| 1 number|2|Tylosin Tartrate EP|10.1 gm.| |||||4|Doxycycline Hyclate BP/EP/USP|20.2 gm| ||GENTADOX GOLD Powder ( pack Size 1 Kgs Jar)(Each gram powder contains: Doxycycline Hyclate 200mg, Gentamycin Sulphate 100mg)|| 1 number|5|Doxycycline Hyclate BP/EP/USP|0.202 kg| ||GENTADOX GOLD Powder ( pack Size 100 Gms Sachet)(Each gram powder contains: Doxycycline Hyclate 200mg, Gentamycin Sulphate 100mg)|| 1 number|6|Doxycycline Hyclate BP/EP/USP|20.2 gm|

| ||GENTADOX GOLD Powder ( pack Size 100 Gms Sachet)(Each gram powder contains: Doxycycline Hyclate 200mg, Gentamycin Sulphate 100mg)|| 1 number|6|Doxycycline Hyclate BP/EP/USP|20.2 gm| ||NEODOX -GOLD Powder ( pack Size 1 Kgs Jar)(Each gram powder contains: Each gram powder contains: Doxycycline Hyclate BP Equivalent to Doxycycline 100 mg Neomycin Sulfate BP 100 mg)|| 1 number|7|Doxycycline Hyclate BP/EP/USP|0.101 kg.| ||NEODOX -GOLD Powder ( pack Size 100 Gms Sachet)(Each gram powder contains: Doxycycline Hyclate BP Equivalent to Doxycycline 100 mg Neomycin Sulfate BP 100 mg)|| 1 number|8|Doxycycline Hyclate BP/EP/USP|10.1 gm|

UDIN00018757AM24

AmitraXX 12.5% EC / Amitraz 12.5% EC (pack Size	<br>1 number	9	Amitraz IP/BP	12.75 gm
1 Litre Bottle), Each ml contains Amitraz IP/BP
12.5%
AmitraXX 12.5% EC / Amitraz 12.5% EC (pack Size	<br>1 number	10	Amitraz IP/BP	1.275 gm.
100 ml Bottle), Each ml contains Amitraz IP/ BP
12.5%
RA concerned may take further necessary action as per above decision of NC.

|| ||3||Amoxycilli|n Trihydrate and Clavulanate|||1 Nb|||5||Amoxycillin Trihydrate|||315000||| |||| Potassium | + Silicon Dioxide (1:1) Suspension |||umer||||||||. mg.||| ||||312.5mg/5 Amoxycilli|ml((60ml Bottle, Each 5 ml co n Trihydrate equivalent|ntains to||||||||||||| |||| Amoxycilli Silicon Di| n 250mg & Clavulanate Potassi oxide (1:1) equivalent to Clavu|um + lanic|||||6||Clavulanate Potassium + Silicon Dioxide (1:1)|||186||0.078 mg.| ||||acid 625|m) (Euivalent to 105000K|of||||||||||||| ||||. Amoxycilli|g q . n Trihydrate & 26.250Kg|g of||||||||||||| ||||Clavulanat|)|||||||||||||| ||||||||||||||||||| |||||||||||||||||||

UDIN00018757AM24

Amoxycillin<br>Trihydrate<br>and<br>Clavulanate	<br>1 Number	7	Amoxycillin Trihydrate	5880.00 mg.
Potassium + Silicon Dioxide (1:1) Suspension
457.00mg/5ml((70ml Bottle, Each 5 ml contains
Amoxycillin Trihydrate equivalent to Amoxycillin<br>400mg & Clavulanate Potassium + Silicon<br>Dioxide (1:1) equivalent to Clavulanic acid 57mg)	<br> <br>	8	Clavulanate Potassium + Silicon<br>Dioxide (1:1)	1979.87 mg.
(Equivalent<br>to<br>196.000Kg<br>of<br>Amoxycillin
Trihydrate & 27.930Kg of Clavulanate)

ulanic acid 57mg)| |8|Clavulanate Potassium + Silicon Dioxide (1:1)|1979.87 mg.| ||(Equivalent to 196.000Kg of Amoxycillin||||| ||Trihydrate & 27.930Kg of Clavulanate)|||||

Case No.	97 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003648AM23
RA File Number	05AX04001858 AM23
Licence No and<br>Date	0511015244/11/10/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	98 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003663AM23
RA File Number	09AX04000574 AM23
Licence No and<br>Date	0911003782/12/10/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	99 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	SMILAX LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003666AM23
RA File Number	09AX04000263 AM22
Licence No and	0911003783/12/10/2022

UDIN00018757AM24

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/Jun/202223/5 dated 08/07/2022 against advance authorization No. 0911001113 dated 24/06/2021 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
CLOPIDOGREL	1 kg	1	Thiophene-2-Ethylamine	0.53 kg
CAMPHORSULFONATE
		2	L-Camphor Sulfonic Acid	0.455 kg
		3	Isopropyl Acetate	1.82 kg

Case No.	100 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	VINEET LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003691AM23
RA File Number	09AX04000567 AM23
Licence No and<br>Date	0911003791/13/10/2022
Norms Committee Decision:
Deferred for comments of TE.

Case No.	101 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	VINS BIOPRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003701AM23
RA File Number	09AX04000630 AM23
Licence No and<br>Date	0911003795/13/10/2022
Norms Committee Decision:

UDIN00018757AM24

The Committee considered the case as per agenda and it was decided to refer the case to Department of Bio Technology (DBT) for obtaining their comments.

ttee Decision:||

UDIN00018757AM24

The Committee considered the case as per agenda and it was decided to refer the case to Department of Bio Technology (DBT) for obtaining their comments.

Case No.<br>102 / NC/3/MEET/Mar/202223/22
Case Status<br>Case Approved
Party Name<br>DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number<br>HQRNORM APPLY 00003702AM23
RA File Number<br>34AX04000674 AM23
Licence No and<br>Date<br>3411002906/13/10/2022
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/202223/18	dated23/01/2023 against advance		authorization No.
3411002686dated26/08/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:
Export product<br>Qty.<br>Sl. No.		Import items	Qty.
Phenol<br>1 MT<br>1		Cumene	0.84466 MT
RA concerned may take further necessary action as per above		decision of NC.

ver is less:||||| |Export product Qty. Sl. No.||Import items|Qty.|| |Phenol 1 MT 1||Cumene|0.84466 MT|| |RA concerned may take further necessary action as per above||decision of NC.|||

Case No.	103 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003705AM23
RA File Number	03AX04003633 AM23
Licence No and<br>Date	0311018563/14/10/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms as perSION A-412.
RA concerned may take further necessary action as per above decision of NC.

Case No. 104 / NC/3/MEET/Mar/202223/22

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Case Status	Case Status	Case Approved	Case Approved	Case Approved	Case Approved	Case Approved
Party Name		AUROBINDO PHARMA LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM APPLY 00003712AM23
RA File Number		09AX04000518 AM23
Licence No and<br>Date		0911003801/14/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol.

icence No and Date||0911003801/14/10/2022||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. (in Kg.) 1 6-Amino Penicillanic Acid (6-APA) 0.5139 2 4-Ethyl-2, 3 Dioxo Piperazine (EDP) 0.4113 3 Triethylamine 0.577 4 Trimethyl Chlorosilane 0.3778 5 Triphosgene 0.3154 6 Pivaloyl Chloride 0.3058 7 Carbon Enoanticromos (Activated carbon) 0.063 8 D(-) Alpha Phenyl Glycine Base 0.4015 9 Potassium Carbonate (Anhydrous) 0.1838 10 Methanol (Methyl Alcohol) 0.2778 11 Methylene Chloride 2.810 Piperacillin USP/Ph.Eur/BP(Piperacillin Monohydrate) 1 kg. 12 Isopropyl Alcohol 0.320||||||| ||Export product||Qty.|Sl. No.|Import items|Qty. (in Kg.)| ||Piperacillin USP/Ph.Eur/BP(Piperacillin Monohydrate)||1 kg.|1|6-Amino Penicillanic Acid (6-APA)|0.5139| |||||2|4-Ethyl-2, 3 Dioxo Piperazine (EDP)|0.4113| |||||3|Triethylamine|0.577| |||||4|Trimethyl Chlorosilane|0.3778| |||||5|Triphosgene|0.3154| |||||6|Pivaloyl Chloride|0.3058| |||||7|Carbon Enoanticromos (Activated carbon)|0.063| |||||8|D(-) Alpha Phenyl Glycine Base|0.4015| |||||9|Potassium Carbonate (Anhydrous)|0.1838| |||||10|Methanol (Methyl Alcohol)|0.2778| |||||11|Methylene Chloride|2.810| |||||12|Isopropyl Alcohol|0.320|

UDIN00018757AM24

e Base|0.4015| |||||9|Potassium Carbonate (Anhydrous)|0.1838| |||||10|Methanol (Methyl Alcohol)|0.2778| |||||11|Methylene Chloride|2.810| |||||12|Isopropyl Alcohol|0.320|

UDIN00018757AM24

Case No.	105 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	HETERO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003713AM23
RA File Number	09AX04000603 AM23
Licence No and<br>Date	0911003803/14/10/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	106 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	RUMIT LIFE CARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003723AM23
RA File Number	03AX04003613 AM23
Licence No and<br>Date	0311018575/14/10/2022
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/Nov/202223/12 dated18/11/2022 against advance authorization No.<br>0311013605 dated04/04/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Betamethasone<br>Dipropionate<br>IP/BP/EP/USP<br>1 kg<br>1<br>Betamethasone IP/BP/EP/USP<br>0.868 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 107 / NC/3/MEET/Mar/202223/22

te IP/BP/EP/USP 1 kg 1 Betamethasone IP/BP/EP/USP 0.868 kg RA concerned may take further necessary action as per above decision of NC.||

Case No. 107 / NC/3/MEET/Mar/202223/22

UDIN00018757AM24

Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003742AM23
RA File Number	05AX04001751 AM23
Licence No and<br>Date	0511015334/14/10/2022
Norms Committee Decision:
Deferred for comments of TE.

Case Status	Case Status	Case Status	Case Deferred	Case Deferred	Case Deferred	Case Deferred
Party Name			SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number			HQRNORM APPLY 00003742AM23
RA File Number			05AX04001751 AM23
Licence No and<br>Date			0511015334/14/10/2022
Norms Committee Decision:<br>Deferred for comments of TE.
	<br>eferred f	<br>or comments of TE.


C	ase No.		108 / NC/3/MEET/Mar/202223/	22
C	ase Statu	s	Case Deferred
P	arty Nam	e	NAVIN FLUORINE ADVANC	ED SCIEN	CES LI	MITED
M<br>a	eeting N<br>nd Date	umber	NC/ 3/ MEET/ Mar/ 202223/ 22	and 24/03/	2023
H	Q File N	umber	HQRNORM APPLY 00003759	AM23
R	A File N	umber	03AX04003669 AM23
L<br>D
	icence N<br>ate	o and	0311018602/16/10/2022

/ Mar/ 202223/ 22|and 24/03/|2023|||| |H|Q File N|umber|HQRNORM APPLY 00003759|AM23||||| |R|A File N|umber|03AX04003669 AM23|||||| |L D||||||||| ||icence N ate|o and|0311018602/16/10/2022|||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call for following information/documents from the firm: Function of Acetaldoxime in chemical reaction. i. Percentage yield at every stage of reaction. ii. Justification for low yield of 44%. iii. Commercial value of By-Product High Boiler iv. Production Consumption data for last year duly certified by GST. v.|orms Co he Com rm: i.|mmittee Decision: mittee considered the case as per agenda an Function of Acetaldoxime in chemical||d it was de reaction.|cided to|call for following information/documen||ts from the| |||||||||| |||||||||| |||||||||| |Case No.|||109 / NC/3/MEET/Mar/202223/22|||||| |||||||||| |Case Status|||Case Deferred|||||| |||||||||| |Party Name|||ORIENTAL AROMATICS LIMITED|||||| |||||||||| |Meeting Number and Date|||NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023|||||| |||||||||| |HQ File Number|||HQRNORM APPLY 00003761AM23|||||| |||||||||| |RA File Number|||03AX04003660 AM23|||||| |||||||||| |Licence No and Date|||0311018607/17/10/2022|||||| |||||||||| |Norms Committee Decision: Deferred for comments of TE.||||||||| |||||||||| |||||||||| |Case No.|||110 / NC/3/MEET/Mar/202223/22||||||

ce No and Date|||0311018607/17/10/2022|||||| |||||||||| |Norms Committee Decision: Deferred for comments of TE.||||||||| |||||||||| |||||||||| |Case No.|||110 / NC/3/MEET/Mar/202223/22||||||

64 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-04-2023 18:26:04.

UDIN00018757AM24

Case Status	Case Status	Case Approved	Case Approved	Case Approved	Case Approved	Case Approved
Party Name		SANOFI INDIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM APPLY 00003762AM23
RA File Number		03AX04003648 AM23
Licence No and<br>Date		0311018608/17/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>Sodium Valproate<br>135.864 mg.<br>EPILIM CR 200MG TABS 100'S(EPILIM CR SODIUM<br>VALPROATE- 133.2 &VALPROIC ACID-58MG TAB<br>CR)((Total net content of Sodium Valproate 4129.20 Kgs<br>&Valproic Acid 1798 Kgs))<br>1 number<br>2<br>Valproic Acid<br>59.16 mg.<br>3<br>Sodium Valproate<br>203.796 mg.<br>EPILIM CR 300MG TABS 100'S(EPILIM CR SODIUM<br>VALPROATE-<br>199.8<br>&VALPROICACID-87MG<br>TABCR)((Total net content of Sodium Valproate 9990 Kgs<br>&Valproic Acid 4350 Kgs))<br>1 number<br>4<br>Valproic Acid<br>88.74 mg.<br>5<br>Sodium Valproate<br>339.66 mg.<br>EPILIM CR 500MG TABS 100'S(EPILIM

((Total net content of Sodium Valproate 9990 Kgs &Valproic Acid 4350 Kgs)) 1 number 4 Valproic Acid 88.74 mg. 5 Sodium Valproate 339.66 mg. EPILIM CR 500MG TABS 100'S(EPILIM CR SODIUM VALPROATE- 333 &VALPROIC ACID- 145MG TAB CR)((Total net content of Sodium Valproate 16650 Kgs &Valproic Acid 7250 Kgs)) 1 number 6 Valproic Acid 147.90 mg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||EPILIM CR 200MG TABS 100'S(EPILIM CR SODIUM VALPROATE- 133.2 &VALPROIC ACID-58MG TAB CR)((Total net content of Sodium Valproate 4129.20 Kgs &Valproic Acid 1798 Kgs))|| 1 number|1|Sodium Valproate|135.864 mg.| |||||2|Valproic Acid|59.16 mg.| ||EPILIM CR 300MG TABS 100'S(EPILIM CR SODIUM VALPROATE- 199.8 &VALPROICACID-87MG TABCR)((Total net content of Sodium Valproate 9990 Kgs &Valproic Acid 4350 Kgs))|| 1 number|3|Sodium Valproate|203.796 mg.| |||||4|Valproic Acid|88.74 mg.| ||EPILIM CR 500MG TABS 100'S(EPILIM CR SODIUM VALPROATE- 333 &VALPROIC ACID- 145MG TAB CR)((Total net content of Sodium Valproate 16650 Kgs &Valproic Acid 7250 Kgs))|| 1 number|5|Sodium Valproate|339.66 mg.| |||||6|Valproic Acid|147.90 mg.| |||||decision of NC.|||

br>CR)((Total net content of Sodium Valproate 16650 Kgs &Valproic Acid 7250 Kgs))|| 1 number|5|Sodium Valproate|339.66 mg.| |||||6|Valproic Acid|147.90 mg.| |||||decision of NC.|||

Case No.	111 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003765AM23
RA File Number	08AX04001180 AM23
Licence No and<br>Date	0811006263/17/10/2022
Norms Committee Decision:

UDIN00018757AM24

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

Export product	Qty.	Sl. No.	Import items	Qty.
DOXEPIN HYDROCHLORIDE	1 Number	1	DOXEPIN HYDROCHLORIDE USP	2.295 gm.
CREAM 5% , 45G TUBE US (EACH
TUBE CONTAINS : DOXEPIN
HYDROCHLORIDE CREAM
5%)(EACH CONTAINS: DOXEPIN
HYDROCHLORIDE, USP, 5%
(EQUIVALENT TO 4.4% DOXEPIN)
NET CONTENT OF DOXEPIN BP
SHOULD NOT BE LESS THAN
100.035 KGS. IN EXPORT ITEM)

| |5%)(EACH CONTAINS: DOXEPIN||||| |HYDROCHLORIDE, USP, 5%||||| |(EQUIVALENT TO 4.4% DOXEPIN)||||| |NET CONTENT OF DOXEPIN BP||||| |SHOULD NOT BE LESS THAN||||| |100.035 KGS. IN EXPORT ITEM)|||||

Case No.<br>112 / NC/3/MEET/Mar/202223/22	Case No.<br>112 / NC/3/MEET/Mar/202223/22
Case Status<br>Case Approved
Party Name<br>FDC LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number<br>HQRNORM APPLY 00003767AM23
RA File Number<br>03AX04003664 AM23
Licence No and<br>Date<br>0311018619/17/10/2022
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/Oct/202122/10dated 12/11/2021 against advance authorization No.
0311000293dated 22-12-2020, it was decided to ratify		adhoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:
Export product	Qty.	Sl. No.	Import items	Qty.
Loxoptic<br>Ophthalmic<br>Solution	<br>1 Vial	1	Betaxolol Hydrochloride	28.56 mg
5mg/ml((Each vial contains 5mg of
Betaxolol Hydrochloride Net Wt of bulk
drug is 4.50 kgs))

UDIN00018757AM24

Solution| 1 Vial|1|Betaxolol Hydrochloride|28.56 mg|| |5mg/ml((Each vial contains 5mg of|||||| |Betaxolol Hydrochloride Net Wt of bulk|||||| |drug is 4.50 kgs))||||||

UDIN00018757AM24

RA concerned may take further necessary action as per above decision of NC.	RA concerned may take further necessary action as per above decision of NC.	RA concerned may take further necessary action as per above decision of NC.	RA concerned may take further necessary action as per above decision of NC.	RA concerned may take further necessary action as per above decision of NC.	RA concerned may take further necessary action as per above decision of NC.	RA concerned may take further necessary action as per above decision of NC.
	A conce	rned may take further necessar		y action as p	er above	decision of NC.


C	ase No.		113 / NC/3/MEET/M	ar/202223/22
C	ase Statu	s	Case Approved
P	arty Nam	e	VIRCHOW PETROC	HEMICAL P	RIVAT	E LIMITED
M<br>an	eeting N<br>d Date	umber	NC/ 3/ MEET/ Mar/	202223/ 22 an	d 24/03	/2023

H	Q File N	umber	HQRNORM APPLY	00003781AM	23

VIRCHOW PETROC|HEMICAL P||RIVAT|E LIMITED||||| |M an|eeting N d Date|umber|NC/ 3/ MEET/ Mar/|202223/ 22 an||d 24/03|/2023||||| ||||||||||||| |H|Q File N|umber|HQRNORM APPLY|00003781AM||23|||||| |R|A File N|umber|09AX04000392 AM2|3|||||||| ||||||||||||| |Li D|cence N ate|o and|0911003808/17/10/2|022|||||||| |N T V R|orms Co he Com ol. I as|mmittee Decision: mittee considered the case as per details given below or as a||per agenda a pplied by the|||||||| |||||||nd it wa firm, w|s decided to ratify adhoc norms under Para hichever is less:||||4.07 of HBP| ||||||||||||| ||Export|product||||Qty.||Sl. |Import items|Qty|.| |||||||||No.|||| ||GCLE(7 CEPHAL ESTER)|-PHENYLACETAMIDEO-3-CHLORO OSPORANIC ACID PARA METHOX (WHITE CRYSTALLINE)||METHYL Y BENZYL|1||||||| |||||||Kg.||1|PENICILLIN G POTASSIUM FIRST CRYSTAL|1.3|5 kg.| ||||||||||||| |||||||||2|ACETONE|1.9|71 kg.| ||||||||||||| |||||||||4|METHYLENE CHLORIDE MC|3.2|9 kg.| ||||||||||2 MERCAPTO BENZO THIAZOLE||| |||||||||5| MBT|0.5|1 kg.| |||||||||6|METHANOL|1.9|71 kg.| ||||||||||||| ||A conce|rned may take further necessar||y action as p|||||||| |||||||er above||decision of NC.|||| ||||||||||||| ||||||||||||| |C|ase No.||114 / NC/3/MEET/M|ar/202223/22|||||||| |Case Status|ase Statu|s|Case Deferred||||||||| ||||||||||||| |Party Name|||MATRIX LIFE SCIENCE PRIVATE LIMITED||||||||| |Meeting Number|||NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023|||||||||

|||| |Case Status|ase Statu|s|Case Deferred||||||||| ||||||||||||| |Party Name|||MATRIX LIFE SCIENCE PRIVATE LIMITED||||||||| |Meeting Number|||NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023|||||||||

Case No.	114 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023

UDIN00018757AM24

and Date
HQ File Number	HQRNORM APPLY 00003783AM23
RA File Number	03AX04003611 AM23
Licence No and<br>Date	0311018641/17/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/justification from the<br>firm:<br>Firm has applied norms for (i) Phytosterol Natural Refined Phytosterol 95% and (ii) Natural Mixed Tocopherol<br>70%, separately. Whereas, export item No.2 is the Byproduct of export item no. 1.<br>In view of above, no norms can be fixed in its present form.

d (ii) Natural Mixed Tocopherol** 70%, separately. Whereas, export item No.2 is the Byproduct of export item no. 1. In view of above, no norms can be fixed in its present form.||

Case No.	Case No.	Case No.	115 / NC/3/MEET/Mar/202223/22	115 / NC/3/MEET/Mar/202223/22	115 / NC/3/MEET/Mar/202223/22
Case Status			Case Approved
Party Name			ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number			HQRNORM APPLY 00003787AM23
RA File Number			34AX04000683 AM23
Licence No and<br>Date			3411002918/17/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>(in grams)<br>1<br>Diclofenac Sodium Topical Solution 2 % 112<br>gm(Diclofenac Sodium Topical Solution 2 % 112<br>gm )<br>1 number<br>1<br>Diclofenac Sodium USP 2.2838<br>2<br>Diclofenac Sodium Topical Gel 3 % 100 gm<br>(Diclofenac Sodium Topical Gel 3 % 100 gm )<br>1 number<br>2<br>Diclofenac Sodium USP 3.06
	Sl. No.	Export product		Qty.	Sl.

um USP 2.2838 2 Diclofenac Sodium Topical Gel 3 % 100 gm (Diclofenac Sodium Topical Gel 3 % 100 gm ) 1 number 2 Diclofenac Sodium USP 3.06|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty. (in grams)| ||1|Diclofenac Sodium Topical Solution 2 % 112 gm(Diclofenac Sodium Topical Solution 2 % 112 gm )|| 1 number|1|Diclofenac Sodium USP|2.2838| ||2|Diclofenac Sodium Topical Gel 3 % 100 gm (Diclofenac Sodium Topical Gel 3 % 100 gm )|| 1 number|2|Diclofenac Sodium USP|3.06| ||||||||| |Case No.|||116 / NC/3/MEET/Mar/202223/22||||| |Case Status|||Case Approved||||| |Party Name|||VIRCHOW PETROCHEMICAL PRIVATE LIMITED||||| |Meeting Number and Date|||NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023||||| |HQ File Number|||HQRNORM APPLY 00003788AM23||||| |RA File Number|||09AX04000393 AM23|||||

UDIN00018757AM24

Licence No and<br>Date<br>0911003815/17/10/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever			is less:
Export product	Qty.	Sl.

as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP||||||| |Vol. I as per details given below or as applied by the firm, whichever||||is less:||| |Export product|Qty.||Sl. No.|Import items|Qty.|| |GCLE(7-PHENYLACETAMIDEO-3-CHLOROMETHYL|1 Kg.||1|PENICILLIN G POTASSIUM FIRST|1.375 kg.|| |CEPHALOSPORANIC ACID PARA METHOXY||||CRYSTAL||| |BENZYL ESTER) (WHITE CRYSTALLINE)||||||| ||||2|ACETONE|1.971 kg.|| ||||4|METHYLENE CHLORIDE MC|3.29 kg.|| ||||5|2 MERCAPTO BENZO THIAZOLE|0.511 kg.|| |||||MBT||| ||||6|METHANOL|1.971 kg.|| |RA concerned may take further necessary action|as per above decision of NC.||||||

Case No.	Case No.		117 / NC/3/MEET/Mar/202223/22	117 / NC/3/MEET/Mar/202223/22
Case Status			Case Approved
Party Name			BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number			HQRNORM APPLY 00003797AM23
RA File Number			31AX04000194 AM23
Licence No and<br>Date			3111001751/18/10/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.

UDIN00018757AM24

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.||

UDIN00018757AM24

1	ETHYLENEDIAMINE<br>(ORGANIC CHEMICAL)	1 kg	1	MONO ETHANOL AMINE	1.03 kg
			2	AMMONIA ANHYDROUS	Not allowed
2	DI<br>ETHYLENE<br>TRIAMINE(ORGANIC CHEMICAL)	<br>1 kg	1	MONO ETHANOL AMINE	1.184 kg
			2	AMMONIA ANHYDROUS	Not allowed
3	AMINO<br>ETHYL<br>ETHANOL<br>AMINE(ORGANIC CHEMICAL)	<br>1 kg	1	MONO ETHANOL AMINE	1.1731 kg

E(ORGANIC CHEMICAL)| 1 kg|1|MONO ETHANOL AMINE|1.184 kg| |||||2|AMMONIA ANHYDROUS|Not allowed| ||3|AMINO ETHYL ETHANOL AMINE(ORGANIC CHEMICAL)| 1 kg|1|MONO ETHANOL AMINE|1.1731 kg|

Case No.	118 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	SALICYLATES & CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003801AM23
RA File Number	09AX04000575 AM23
Licence No and<br>Date	0911003827/18/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents from the<br>firm:<br>Percentage composition of Export Product.<br>i.<br>Step wise manufacturing process.<br>ii.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>iii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iv.<br>Stoichiometric balance between import and export on molar basis.<br>v.<br>Details of indigenous input with quantity.<br>vi.

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

Case No.	119 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	STYRAX LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003805AM23

UDIN00018757AM24

RA File Number<br>09AX04000612 AM23
Licence No and<br>Date<br>0911003830/18/10/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was		decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever			is less:
Export product	Qty.	Sl.	Import items	Qty.
		No.
				(in Kg.)
L-MENTHYL GLYOXYLATE HYDRATE (L-MGH)(L-	1 kg.	1	GLYOXALIC ACID 50PCT	0.752
MENTHYL GLYOXYLATE HYDRATE (L-MGH))
		2	CYCLOHEXANE	1.41
		3	L MENTHOL FRESH RECOVERY	0.45
RA concerned may take further necessary action as per above decision of NC.

Case No.<br>120 / NC/3/MEET/Mar/202223/22	Case No.<br>120 / NC/3/MEET/Mar/202223/22
Case Status<br>Case Approved
Party Name<br>AUROBINDO PHARMA LTD
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number<br>HQRNORM APPLY 00003808AM23
RA File Number<br>09AX04000551 AM23
Licence No and<br>Date<br>0911003834/18/10/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol.

nd Date 0911003834/18/10/2022|||||| |Norms Committee Decision:|||||| |The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP|||||| |Vol. I as per details given below or as applied by the firm, whichever is less:|||||| ||Export product Qty.|Sl. No.|Import items|Qty.|| ||Amoxicillin and Clavulanate Potassium 1 Number|1|6-Amino Penicillanic Acid (6-APA)|576.40 mg|| ||Tablets 1000 mg [875+125 mg]((Each Tablet||||| ||Tablet contains Amoxicillin trihydrate equivalent to Amoxicillin 875 mg and|2|D-(-)-4-hydroxyphenylglycine methyl ester [PHPG Ester]|496.38 mg||

Case No.<br>120 / NC/3/MEET/Mar/202223/22	Case No.<br>120 / NC/3/MEET/Mar/202223/22
Case Status<br>Case Approved
Party Name<br>AUROBINDO PHARMA LTD
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number<br>HQRNORM APPLY 00003808AM23
RA File Number<br>09AX04000551 AM23
Licence No and<br>Date<br>0911003834/18/10/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
	Export product<br>Qty.	Sl.

s per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP|||||| |Vol. I as per details given below or as applied by the firm, whichever is less:|||||| ||Export product Qty.|Sl. No.|Import items|Qty.|| ||Amoxicillin and Clavulanate Potassium 1 Number|1|6-Amino Penicillanic Acid (6-APA)|576.40 mg|| ||Tablets 1000 mg [875+125 mg]((Each Tablet||||| ||Tablet contains Amoxicillin trihydrate equivalent to Amoxicillin 875 mg and|2|D-(-)-4-hydroxyphenylglycine methyl ester [PHPG Ester]|496.38 mg||

UDIN00018757AM24

Clavulanate Potassium equivalent to	3	Penicillin G Amidase (Particle size	<br>2.25 mg
Clavulanic acid 125 mg))		250 - 500 micron, Creamish to
		Brown regularly shaped beads)
	4	Potassium Clavulanate Diluted with	<br>302.03 mg
		Microcrystalline Cellulose (1:1)

Case No.	121 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	MEDREICH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003824AM23
RA File Number	07AX04001015 AM23
Licence No and<br>Date	0711005482/19/10/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/documents from the
firm
(i) Copy of Master-Batch Formula showing net contents of inputs in Tablets.

nsidered the case as per agenda and it was decided to call for following information/documents from the|| |firm|| |(i) Copy of Master-Batch Formula showing net contents of inputs in Tablets.||

Case No.	Case No.		122 / NC/3/MEET/Mar/202223/22
Case Status			Case Approved
Party Name			VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ	File Number		HQRNORM APPLY 00003829AM23
RA File Number			03AX04003555 AM23
Licence No and<br>Date			0311018709/19/10/2022
Norms Committee Decision:
The	Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the				firm, whichever is less:
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.

UDIN00018757AM24

1	CLINDAMYCIN	HYDRCHLORIDE	<br>1 Number	1	Clindamycin	171.05 mg / 150 mg
	150MG CAPSULES				Hydrochloride	capsule
2	CLINDAMYCIN	HYDRCHLORIDE	<br>1 Number	1	Clindamycin	341.20 mg / 300 mg
	300MG CAPSULES				Hydrochloride	capsule

mg| |---|---|---|---|---|---|---| ||150MG CAPSULES||||Hydrochloride|capsule| |2|CLINDAMYCIN|HYDRCHLORIDE| 1 Number|1|Clindamycin|341.20 mg / 300 mg| ||300MG CAPSULES||||Hydrochloride|capsule|


	1	CLIND<br>	AMYCIN<br>HYDRCHLORIDE<br>	<br>1 Number	1	Clindamycin<br>	171.05 mg / 150 mg<br>
		150M	CAPSULES			Hydrochloride	capsule

	2	CLIND	AMYCIN<br>HYDRCHLORIDE	<br>1 Number	1	Clindamycin	341.20 mg / 300 mg
		300MG	CAPSULES			Hydrochloride	capsule



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

C N			123 / NC/3/MEET/M/202223/22
ase o.			ar

Case Status			Case Approved

Party Name			AETHER INDUSTRIES LIMITED

Meeting Number<br>and Date			NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023

HQ File Number			HQRNORM APPLY 00003858AM23

RA File Number			52AX04001677 AM23

Licence No and<br>Date			5211003490/20/10/2022

Norms Committee			Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.10/82-ALC4/2019 dated 29.11.2019against advance authorization No.5210043165<br>dated 30.08.2019, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.

rt item in Meeting No.10/82-ALC4/2019 dated 29.11.2019against advance authorization No.5210043165 dated 30.08.2019, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or lid b th fi hih i l||||||||||||| |a|s appe y e rm, wcever s ess:|||||||||||| |||||||||||||| |||||||||||||| |||||||||||||| ||Export product|||||Qt|Sl No||Import items|||Qt| |||||||y.|. .|||||y.| |||||||||||||| ||N-OCTYL D-GLU|||CAMINE||1 kg|1||N OCTYLAMINE|||0.825 kg| |||||||||||||| |||||||||||||| ||||||||2||DEXTROSE ANHYDROUS|||0.770 kg| |RA concerned may take further necessary action as per above decision of NC.||||||||||||| ||||||||||||||



Case No.	124 / NC/3/MEET/Mar/202223/22

Case Status	Case Approved

Party Name	TITAN LABORATORIES PRIVATE LIMITED
Meeting Number<br>	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
and Date

HQ File Number	HQRNORM APPLY 00003861AM23

UDIN00018757AM24

y Name|TITAN LABORATORIES PRIVATE LIMITED| |Meeting Number |NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023| |and Date|| ||| |HQ File Number|HQRNORM APPLY 00003861AM23| |||

UDIN00018757AM24

RA File Number

03AX04003762 AM23

Licence No and Date

0311018753/20/10/2022

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/Nov/202223/12 dated18/11/2022 against advance authorization No. 0311011408 dated 15/02/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. ORLISTAT PELLETS 50 % 1 kg 1 ORLISTAT 0.505 kg RA concerned may take further necessary action as per above decision of NC.

Case No.	125 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	HAFFKINE BIO PHARMACEUTICAL CORPORATION LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003863AM23
RA File Number	03AX04003507 AM23
Licence No and<br>Date	0311018754/20/10/2022

|Meeting Number and Date|NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023| |HQ File Number|HQRNORM APPLY 00003863AM23| |RA File Number|03AX04003507 AM23| |Licence No and Date|0311018754/20/10/2022| |Norms Committee Decision: The Committee considered the case as per agenda and on the basis of written comments furnished by Department of Biotechnology for similar case of the firm, it was decided to call for following information / documents from the firm: Technical process flow diagram of manufacturing of Bivalent (Type I & Type III) Oral Poliomyelitis Vaccine and wastage involved at each step. i. DML (Drug Manufacturing License). ii.||

Case No.	126 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003865AM23
RA File Number	08AX04001228 AM23

UDIN00018757AM24

Licence No and 0811006315/20/10/2022 Date Norms Committee Decision: The Committee considered the case as per agenda and it was decided to ratify adhoc norms as per SION A-412. RA concerned may take further necessary action as per above decision of NC.

Decision: The Committee considered the case as per agenda and it was decided to ratify adhoc norms as per SION A-412. RA concerned may take further necessary action as per above decision of NC.

Case No.	127 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	MISTAIR HEALTH AND HYGIENE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003866AM23
RA File Number	03AX04003730 AM23
Licence No and<br>Date	0311018761/21/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents from the<br>firm:-<br>Copy of DML for the composition shown in export item.<br>1.<br>Master-Batch Formula for above export.<br>2.

Case No.	128 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003867AM23
RA File Number	07AX04001068 AM23
Licence No and<br>Date	0711005519/21/10/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	129 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003884AM23

75 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-04-2023 18:26:04.

UDIN00018757AM24

Mar/ 202223/ 22 and 24/03/2023| |HQ File Number|HQRNORM APPLY 00003884AM23|

75 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-04-2023 18:26:04.

UDIN00018757AM24

RA File Number	RA File Number	05AX04001931 AM23	05AX04001931 AM23	05AX04001931 AM23	05AX04001931 AM23	05AX04001931 AM23
Licence No and<br>Date		0511015457/21/10/2022
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/202223/21 dated22/02/2023 against advance authorization No.<br>0511004616 dated08/09/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>PENICILLIN G POTASSIUM FIRST CRYSTAL<br>8.515 kg<br>2<br>METHYLENE CHLORIDE /Dichloromethane<br>76.165 kg<br>3<br>Triethylamine<br>3.214 kg<br>4<br>Methanol<br>41.137 kg<br>5<br>Ethyl 4 Chloroacetoacetate<br>1.82 kg<br>6<br>Methyl 3 Methoxy Acrylate<br>1.62 kg<br>7<br>Prenol<br>3.114 kg<br>8<br>N N Dimethyl Formamide<br>12.16 kg<br>9<br>Acetonitile<br>7.50 kg<br>10<br>Activated Carbon<br>0.200 kg<br>11<br>Acetone<br>1.20 kg<br>12<br>Toluene<br>23.00 kg<br>CEFTIBUTEN<br>USP/BP/EP/JP<br>(POWDER)<br>1 kg<br>13<br>Acetic Acid<br>5.50 kg
	Export product		Qty.	Sl.<br>No.	Import items	Qty.

11 Acetone 1.20 kg 12 Toluene 23.00 kg CEFTIBUTEN USP/BP/EP/JP (POWDER) 1 kg 13 Acetic Acid 5.50 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||CEFTIBUTEN USP/BP/EP/JP (POWDER)||1 kg|1|PENICILLIN G POTASSIUM FIRST CRYSTAL|8.515 kg| |||||2|METHYLENE CHLORIDE /Dichloromethane|76.165 kg| |||||3|Triethylamine|3.214 kg| |||||4|Methanol|41.137 kg| |||||5|Ethyl 4 Chloroacetoacetate|1.82 kg| |||||6|Methyl 3 Methoxy Acrylate|1.62 kg| |||||7|Prenol|3.114 kg| |||||8|N N Dimethyl Formamide|12.16 kg| |||||9|Acetonitile|7.50 kg| |||||10|Activated Carbon|0.200 kg| |||||11|Acetone|1.20 kg| |||||12|Toluene|23.00 kg| |||||13|Acetic Acid|5.50 kg|

RA File Number	RA File Number	05AX04001931 AM23	05AX04001931 AM23	05AX04001931 AM23	05AX04001931 AM23	05AX04001931 AM23
Licence No and<br>Date		0511015457/21/10/2022
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/202223/21 dated22/02/2023 against advance authorization No.<br>0511004616 dated08/09/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.

tem in Meeting No.NC/3/MEET/Feb/202223/21 dated22/02/2023 against advance authorization No. 0511004616 dated08/09/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 PENICILLIN G POTASSIUM FIRST CRYSTAL 8.515 kg 2 METHYLENE CHLORIDE /Dichloromethane 76.165 kg 3 Triethylamine 3.214 kg 4 Methanol 41.137 kg 5 Ethyl 4 Chloroacetoacetate 1.82 kg 6 Methyl 3 Methoxy Acrylate 1.62 kg 7 Prenol 3.114 kg 8 N N Dimethyl Formamide 12.16 kg 9 Acetonitile 7.50 kg 10 Activated Carbon 0.200 kg 11 Acetone 1.20 kg 12 Toluene 23.00 kg CEFTIBUTEN USP/BP/EP/JP (POWDER) 1 kg 13 Acetic Acid 5.50 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||CEFTIBUTEN USP/BP/EP/JP (POWDER)||1 kg|1|PENICILLIN G POTASSIUM FIRST CRYSTAL|8.515 kg| |||||2|METHYLENE CHLORIDE /Dichloromethane|76.165 kg| |||||3|Triethylamine|3.214 kg| |||||4|Methanol|41.137 kg| |||||5|Ethyl 4 Chloroacetoacetate|1.82 kg| |||||6|Methyl 3 Methoxy Acrylate|1.62 kg| |||||7|Prenol|3.114 kg| |||||8|N N Dimethyl Formamide|12.16 kg| |||||9|Acetonitile|7.50 kg| |||||10|Activated Carbon|0.200 kg| |||||11|Acetone|1.20 kg| |||||12|Toluene|23.00 kg| |||||13|Acetic Acid|5.50 kg|

UDIN00018757AM24

imethyl Formamide|12.16 kg| |||||9|Acetonitile|7.50 kg| |||||10|Activated Carbon|0.200 kg| |||||11|Acetone|1.20 kg| |||||12|Toluene|23.00 kg| |||||13|Acetic Acid|5.50 kg|

UDIN00018757AM24

Case No.	130 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003896AM23
RA File Number	07AX04001078 AM23
Licence No and<br>Date	0711005538/21/10/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	131 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003897AM23
RA File Number	07AX04001077 AM23
Licence No and<br>Date	0711005539/21/10/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/03/2023| |HQ File Number|HQRNORM APPLY 00003897AM23| |RA File Number|07AX04001077 AM23| |Licence No and Date|0711005539/21/10/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	132 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003898AM23
RA File Number	07AX04001085 AM23
Licence No and<br>Date	0711005540/21/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jan/202223/18 dated23/01/2023 against advance authorization No.<br>0711000991dated27/04/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:

77 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-04-2023 18:26:04.

UDIN00018757AM24

Export product	Qty.	Sl. No.	Import items	Qty.
MAGNESIUM<br>BISGLYCINATE<br>/<br>MAGNESIUM<br>GLYCINE COMPLEX	<br>1 kg	1	GLYCINE	0.97 kg
		2	MAGNESIUM OXIDE	0.26 kg

Export product	Qty.	Sl. No.	Import items	Qty.
MAGNESIUM<br>BISGLYCINATE<br>/<br>MAGNESIUM<br>GLYCINE COMPLEX	<br>1 kg	1	GLYCINE	0.97 kg
		2	MAGNESIUM OXIDE	0.26 kg

Case No.	133 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003899AM23
RA File Number	07AX04001086 AM23
Licence No and<br>Date	0711005541/21/10/2022
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	134 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003901AM23
RA File Number	03AX04003806 AM23
Licence No and<br>Date	0311018798/22/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents from the<br>firm:<br>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.

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

UDIN00018757AM24

ts.** iii.||

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

UDIN00018757AM24

iv. Stoichiometric balance between import and export on molar basis v. Details of indigenous input with quantity.

Case No.	135 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	MAYA BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003910AM23
RA File Number	30AX04000299 AM23
Licence No and<br>Date	3011002731/25/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis of written comments furnished by Department of<br>Biotechnology for similar case of the firm, it was decided to call for following information / documents from the firm:<br>Justification for claiming 20% wastage.<br>i.<br>Import input, that is, Urokinase in terms of IU/mg.<br>ii.<br>DML (Drug Manufacturing License).<br>iii.

/ documents from the firm: Justification for claiming 20% wastage. i. Import input, that is, Urokinase in terms of IU/mg. ii. DML (Drug Manufacturing License). iii.||

Case No.	Case No.	136 / NC/3/MEET/Mar/202223/22	136 / NC/3/MEET/Mar/202223/22	136 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		AUROBINDO PHARMA LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM APPLY 00003913AM23
RA File Number		09AX04000522 AM23
Licence No and<br>Date		0911003867/25/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>6-Amino Penicillanic Acid<br>576.40 mg.<br>2<br>D-(-)-4-hydroxyphenylglycine<br>methyl<br>ester<br>[PHPG Ester]<br>496.38 mg.<br>Penicillin G Amidase (Particle size 250 - 500<br>micron, Creamish to Brown regularly shaped<br>Amoxicillin Tablets 875 mg((Each Tablet<br>contains Amoxicillin Trihydrate equivalent<br>to Amoxicillin 875mg))<br>1 Number<br>3<br>2.25 mg.
	Export product		Qty.	Sl.

rown regularly shaped Amoxicillin Tablets 875 mg((Each Tablet contains Amoxicillin Trihydrate equivalent to Amoxicillin 875mg)) 1 Number 3 2.25 mg.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Amoxicillin Tablets 875 mg((Each Tablet contains Amoxicillin Trihydrate equivalent to Amoxicillin 875mg))|| 1 Number|1|6-Amino Penicillanic Acid|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| 2.25 mg.|

Case No.	Case No.	136 / NC/3/MEET/Mar/202223/22	136 / NC/3/MEET/Mar/202223/22	136 / NC/3/MEET/Mar/202223/22	136 / NC/3/MEET/Mar/202223/22	136 / NC/3/MEET/Mar/202223/22
Case Status		Case Approved
Party Name		AUROBINDO PHARMA LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number		HQRNORM APPLY 00003913AM23
RA File Number		09AX04000522 AM23
Licence No and<br>Date		0911003867/25/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.

as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 6-Amino Penicillanic Acid 576.40 mg. 2 D-(-)-4-hydroxyphenylglycine methyl ester [PHPG Ester] 496.38 mg. Penicillin G Amidase (Particle size 250 - 500 micron, Creamish to Brown regularly shaped Amoxicillin Tablets 875 mg((Each Tablet contains Amoxicillin Trihydrate equivalent to Amoxicillin 875mg)) 1 Number 3 2.25 mg.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Amoxicillin Tablets 875 mg((Each Tablet contains Amoxicillin Trihydrate equivalent to Amoxicillin 875mg))|| 1 Number|1|6-Amino Penicillanic Acid|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| 2.25 mg.|

UDIN00018757AM24

beads)

Case No.	137 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003914AM23
RA File Number	08AX04001242 AM23
Licence No and<br>Date	0811006339/25/10/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/03/2023| |HQ File Number|HQRNORM APPLY 00003914AM23| |RA File Number|08AX04001242 AM23| |Licence No and Date|0811006339/25/10/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	Case No.	Case No.	138 / NC/3/MEET/Mar/202223/22	138 / NC/3/MEET/Mar/202223/22	138 / NC/3/MEET/Mar/202223/22
Case Status			Case Approved
Party Name			GLAND PHARMA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number			HQRNORM APPLY 00003917AM23
RA File Number			09AX04000410 AM22
Licence No and<br>Date			0911002854/26/10/2022
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 dated29/12/2022 against advance authorization No.<br>0911003095 dated 02/06/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Nadroparin Calcium<br>26.125 mg<br>2<br>Barrel Syringes<br>1.05 Numbers<br>3<br>Plunger Stoppers<br>1.1085 Numbers<br>1<br>Nadroparin<br>Calcium<br>Injection (Low Molecular<br>Weight<br>Heparin)<br>2850<br>IU/0.3ml PFS(IU)<br>1 Number
	Sl. No.	Export product<br>		Qty.	Sl.

unger Stoppers 1.1085 Numbers 1 Nadroparin Calcium Injection (Low Molecular Weight Heparin) 2850 IU/0.3ml PFS(IU) 1 Number|||||||| ||Sl. No.|Export product ||Qty.|Sl. No.|Import items|Qty.| ||1|Nadroparin Calcium Injection (Low Molecular Weight Heparin) 2850 IU/0.3ml PFS(IU) || 1 Number|1|Nadroparin Calcium|26.125 mg| ||||||2|Barrel Syringes|1.05 Numbers| ||||||3|Plunger Stoppers|1.1085 Numbers|

UDIN00018757AM24

			4	Plunger Rods	1.0165 Numbers
			5	Preventis	1.05 Numbers
2	Nadroparin<br>Calcium<br>Injection (Low Molecular<br>Weight<br>Heparin)<br>5700<br>IU/0.6ml PFS(IU)	<br> <br> <br>1 Number	1	Nadroparin Calcium	52.25 mg
			2	Barrel Syringes	1.05 Numbers
			3	Plunger Stoppers	1.1085 Numbers
			4	Plunger Rods	1.0165 Numbers
			5	Preventis	1.05 Numbers

r> 1 Number|1|Nadroparin Calcium|52.25 mg| |||||2|Barrel Syringes|1.05 Numbers| |||||3|Plunger Stoppers|1.1085 Numbers| |||||4|Plunger Rods|1.0165 Numbers| |||||5|Preventis|1.05 Numbers|

Case No.	139 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	LYRUS LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003921AM23
RA File Number	07AX04001039 AM23
Licence No and<br>Date	0711005556/27/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>BEZAFIBRATE Tablet 400 mg<br>1 Number<br>1<br>BEZAFIBRATE<br>400.00 mg / Tablet<br>RA concerned may take further necessary action as per above decision of NC

UDIN00018757AM24

Case No.	140 / NC/3/MEET/Mar/202223/22
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003925AM23
RA File Number	09AX04000647 AM23
Licence No and<br>Date	0911003881/27/10/2022
Norms Committee Decision:<br>Deferred for comments of TE.

/03/2023| |HQ File Number|HQRNORM APPLY 00003925AM23| |RA File Number|09AX04000647 AM23| |Licence No and Date|0911003881/27/10/2022| |Norms Committee Decision: Deferred for comments of TE.||

Case No.<br>	Case No.<br>	Case No.<br>	141 / NC/3/MEET/Mar/202223/22	141 / NC/3/MEET/Mar/202223/22	141 / NC/3/MEET/Mar/202223/22	141 / NC/3/MEET/Mar/202223/22	141 / NC/3/MEET/Mar/202223/22
Case Status<br>			Case Approved
Party Name<br>			INDOCO REMEDIES LIMITED
Meeting Number<br>and Date<br>			NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number<br>			HQRNORM APPLY 00003935AM23
RA File Number<br>			03AX04003741 AM23
Licence No and<br>Date<br>			0311018893/27/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jan/202223/18 dated23/01/2023 against advance authorization No.<br>0311017259 dated 16/08/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>(A)<br>Sl. No. Export Product<br>Qty.<br>Sl. No.

**, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: (A) Sl. No. Export Product Qty. Sl. No. Import Items Qty. 1 ALLOPURINOL TABLETS 100MG (Each Allopurinol Tablet of 100mg contains Allopurinol 100mg)(Equivalent to:-Cyano Acetamide 0.0001mg,Triethyl Ortho formate 0.00021mg, Formamide 0.00015 mg, Morpholine 0.00013mg, Hydrazine Hydrate 0.00006 mg) Net wt of Allopurinol 15000 kgs (Cross Norms of Allopurinol SION No.A2321 & Tablets/Capsules A412)) 1 Number 1 Allopurinol 102.00 mg / 100 mg Tablet ALLOPURINOL TABLETS 300MG (Each 306.00 mg / 300 2 1 Number 2 Allopurinol|||||||| ||Sl. No.|Export Product||Qty.|Sl. No.|Import Items|Qty.| ||1|ALLOPURINOL TABLETS 100MG (Each Allopurinol Tablet of 100mg contains Allopurinol 100mg)(Equivalent to:-Cyano Acetamide 0.0001mg,Triethyl Ortho formate 0.00021mg, Formamide 0.00015 mg, Morpholine 0.00013mg, Hydrazine Hydrate 0.00006 mg) Net wt of Allopurinol 15000 kgs (Cross Norms of Allopurinol SION No.A2321 & Tablets/Capsules A412))||1 Number|1|Allopurinol|102.00 mg / 100 mg Tablet| ||2|ALLOPURINOL TABLETS 300MG (Each|| 1 Number|2|Allopurinol|306.00 mg / 300|

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o.A2321 & Tablets/Capsules A412))||1 Number|1|Allopurinol|102.00 mg / 100 mg Tablet| ||2|ALLOPURINOL TABLETS 300MG (Each|| 1 Number|2|Allopurinol|306.00 mg / 300|

UDIN00018757AM24

	Allopurinol<br>Tablet<br>of<br>300mg<br>contains				mg Tablet
	Allopurinol 300 mg)(Equivalent to:-Cyano
	Acetamide 0.0003mg ,Triethyl Ortho-formate
	0.00063mg,<br>Formamide<br>0.00045<br>mg,
	Morpholine 0.00039mg , Hydrazine Hydrate
	0.00018 mg) Net wt of Allopurinol 15000 kgs.
	(Cross Norms of Allopurinol SION No.A2321
	& Tablets/Capsules A412))

(B)

B)
Export product	Qty.	Sl. No.	Import items	Qty.
ALLOPURINOL	1 kg	1	Cyano Acetamide	1.00 kg
		2	Triethyl Ortho formate	2.10 kg
		3	Formamide	1.50 kg
		4	Morpholine	1.30 kg
		5	Hydrazine Hydrate	0.60 kg

Case No.	142 / NC/3/MEET/Mar/202223/22
Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 22 and 24/03/2023
HQ File Number	HQRNORM APPLY 00003936AM23
RA File Number	03AX04003679 AM23
Licence No and<br>Date	0311018894/27/10/2022

UDIN00018757AM24

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/202223/18 dated 23/01/2023 against advance authorization No. 0311018302 dated 30/09/2022 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

|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/202223/18 dated23/01/2023 against advance authorization No. 0311018302dated30/09/2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Sl. No. Export product Qty. Sl. No. Import items Qty. 1 Benzydamine Hydrochloride 3.06 gram 2 Cetylpyridinium Chloride 1.356 gram 1 Benzydamine Hydrochloride And Cetylpyridinium Chloride Anti- Inflammatory And Antiseptic Lozenges Sugar Free and(other flavours. Each lozenge contains (i) Benzydamine Hydrochloride-3mg (ii) Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M - 2586mg.

d Antiseptic Lozenges Sugar Free and(other flavours. Each lozenge contains (i) Benzydamine Hydrochloride-3mg (ii) Cetylpyridinium Chloride- 1.33mg (iii) Isomalt ST-M - 2586mg. Net content (i) 31.034 Kgs (ii) 13.759 Kgs (iii) 26751.736 Kgs.) 1000 Number 3 Isomalt ST-M 2586.00 gram 4 Benzydamine Hydrochloride 3.06 gram 2 Benzydamine Hydrochloride, 2,4- Dichlorobenzyl Alcohol And Lidocaine Hydrochloride Anaesthetic, Anti- Inflammatory,(Anti-Inflammatory, Anti- Bacterial Lozenges Sugar Free. Each lozenge contains (i) Benzydamine Hydrochloride - 3mg (ii) Isomalt ST-M- 2586mg. Net content (i) 25.926 Kgs. (ii) 22348.129 Kgs.) 1000 Number 5 Isomalt ST-M 2586.00 gram 6 Benzydamine Hydrochloride 3.06 gram 3 Benzydamine Hydrochloride Anti- Inflammatory Lozenges Sugar Free.(Each lozenge contains (i) Benzydamine Hydrochloride- 3mg (ii) Isomalt ST-M - 2586mg. Net content (i) 13.333 Kgs. (ii) 11493.343 Kgs.) 1000 Number 7 Isomalt ST-M 2586.00 gram 8 Cetylpyridinium Chloride 1.356 gram 4 Cetylpyridinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours.(Each (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg.

idinium Chloride And Bromhexine Hydrochloride Antiseptic Lozenges Sugar Free and all other flavours.(Each (i) Cetylpyridinium Chloride - 1.33mg (ii) lsomalt ST-M - 2586 mg. Net content (i) 1.968 Kg (ii) 3825.997 Kg.) 1000 Number 9 Isomalt ST-M 2586.00 gram|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/202223/18 dated23/01/2023 against adva

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