IN FORCE Advance Authorisation

DGFT Minutes

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Government of India / भारत सरकार

Ministry of Commerce and Industry / वािणज्य और उद्योग मंत्रालय

Department of Commerce / वािणज्य िवभाग

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

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Nov/202324/16 DATED: 17/11/2023

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/Nov/202324/16 dated 17/11/2023 of Norms Committee - III for the year 2023-24 was held on 17/11/2023 under the Chairmanship of Rajiv Soni ,Joint DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

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

The following members were present in the meeting:-

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

This document has been digitally signed by UTTAM DEY SARKAR, Assistant Section Officer on 08-12-2023 15:01:49.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	INNOVASSYNTH TECHNOLOGIES (INDIA ) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00004451AM24
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>To indicate name of reactants and products in the chemical reaction.<br>1.<br>Certificate of Analysis (CoA) report of import and export of the items.<br>2.<br>Complete<br>justification<br>for<br>the<br>low<br>yield<br>of<br>the<br>reaction<br>(at<br>each<br>stage),<br>indicating<br>the<br>impurities/isomers/precipitation formed during the reaction.<br>3.<br>Production/Consumption data duly endorsed by GST.<br>4.

* each stage), indicating the impurities/isomers/precipitation formed during the reaction. 3. Production/Consumption data duly endorsed by GST. 4.||

Case No.	2 / NC/3/MEET/Nov/202324/16
Case Status	Case Rejected
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00004198AM24
RA File Number	092404000579 AM12
Licence No and<br>Date	0910051360/21/02/2012
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm had neither<br>attended the Personal Hearing nor intimated to committee. Hence, it was decided torejectthe case maintaining the<br>status quo.

Case No.	3 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	MYLAN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00003162AM23
RA File Number	092404000288 AM13
Licence No and<br>Date	0910053905/26/09/2012

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Norms Committee Decision:

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
SAXAGLIPTIN<br>HYDROCHLORIDE	1 kg.	1	(S)-N-Boc -3 -Hydroxyadmantyl-D-glycine (or)<br>KSM- I.	<br>2.64 kg.
		2	[1S-(1alpha,3alpha,5alpha)]-3-(aminocarbonyl)-2-<br>azabicyclo[3,1,0]hexane-2-carboxylic<br>acid<br>,1,1-<br>dimethylethylester	1.80 kg.
		3	Isopropyl alcohol	8.37 kg.
		4	n- Heptane	1.00 kg.
		5	Dry Tetrahydrofuron	2.93 kg.
		6	Methane sulfonyl chloride	1.186 kg.
		7	Triethyl amine	3.492 kg.
		8	Cyclohexane	Not required
		9	Tetramethyl ethylene diamine	1.741 kg.
		10	Methanol	2.98 kg.
		11	Pottsium Carbonate	2.318 kg.
		12	Dichloromethane	17.08 kg.
		13	Methane Sulfonic Acid	1.486 kg.

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

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

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egularization and closure purpose only. No repeat Licence may be allowed by RA on above norms.**

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

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Case No.	4 / NC/3/MEET/Nov/202324/16
Case Status	Case Rejected
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00003010AM24
RA File Number	092404000374 AM15
Licence No and<br>Date	0910061119/17/10/2014
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm had neither<br>attended the Personal Hearing nor intimated to committee. Hence, it was decided torejectthe case maintaining thestatus<br>quo.

Case No.	5 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00004184AM23
RA File Number	522404000042 AM17
Licence No and<br>Date	5210042032/30/09/2016
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>To provide technical justification indicating material balance on molar basis.<br>1.<br>Yield of the reaction.<br>2.

ded to call for following information/documents from the firm:- To provide technical justification indicating material balance on molar basis. 1. Yield of the reaction. 2.||

Case No.	6 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00002204AM23
RA File Number	052304000048 AM20
Licence No and<br>Date	0510410475/03/05/2019
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-

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No justification for enhancement in view of import item description and approved composition in DML.

Case No.	7 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	NOVEL NUTRIENTSS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00001063AM24
RA File Number	072404000056 AM20
Licence No and<br>Date	0710115041/11/06/2019
Norms Committee Decision:<br>The committee considered the case as per agenda and it was observed that the firm vide email dated 03/11/2023 has<br>informed that they have surrendered the license. Therefore, the committee decided towithdrawthe application of the<br>firm.

d it was observed that the firm vide email dated 03/11/2023 has informed that they have surrendered the license. Therefore, the committee decided towithdrawthe application of the firm.||

Case No.	8 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00006311AM23
RA File Number	039504000760 AM20
Licence No and<br>Date	0310832692/11/11/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>HYDROQUINONE<br>0.735 kg.<br>YAPOX CL 30/10" HYDROQUINONE BIS" (<br>2 HYDROXY ETHYL ETHER)<br>1 kg.<br>2<br>ETHYLENE CARBONATE<br>1.232 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 9 / NC/3/MEET/Nov/202324/16

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ER) 1 kg. 2 ETHYLENE CARBONATE 1.232 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No. 9 / NC/3/MEET/Nov/202324/16

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Case Status	Case Status	Case Approved	Case Approved	Case Approved	Case Approved	Case Approved
Party Name		ARCH PHARMALABS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM REVIW00000303AM24
RA File Number		039404000888 AM20
Licence No and<br>Date		0310834332/20/01/2020
Norms Committee Decision:<br>Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less with following conditions:-<br>Against 100 kg of export obligation of ‘URSODEOXYCHOLIOC ACID (UDCA’, the export of 85 kg of “3a-<br>Hydroxy-7-keto-5b-cholan-24-oic acid (IP-5)” may be endorsed based on the main raw material Cholic Acid.<br>i.<br>Import of input item No. 4 and 6 are not allowed for export of “3a-Hydroxy-7-keto-5b-cholan-24-oic acid (IP-<br>5)”. Custom duty plus interest etc. will be paid for such import, as per policy.<br>ii.<br>For any excess of other inputs imported in each license, the firm will pay custom duty + interest as applicable<br>under the Policy.<br>iii.<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>CHOLIC ACID<br>1.

orted in each license, the firm will pay custom duty + interest as applicable under the Policy. iii. Export Product Qty. Sl. No. Import Items Qty. allowed. 1 CHOLIC ACID 1. 65kg 2 HYDRAZINE HYDRATE (80% SOLUTION) 1.65 kg 3 IEP OX 239 SPRAY DRIED ENZYME POWDER 0.033 kg 4 IEP OX 235 SPRAY DRIED ENZYME POWDER Not required 5 IEP OX 152 SPRAY DRIED ENZYME POWDER 0.050 kg 6 IEP SP 41 SPRAY DRIED ENZYME POWDER Not required 3a-Hydroxy-7- keto-5b-cholan- 24-oic acid (IP-5) [7-Ketolithocholic acid (3α-Hydroxy- 7-oxo-5β-cholanic acid), Minimum 99.75%. No single related or unrelated impurity should be more than 0.05%] 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||3a-Hydroxy-7- keto-5b-cholan- 24-oic acid (IP-5) [7-Ketolithocholic acid (3α-Hydroxy- 7-oxo-5β-cholanic acid), Minimum 99.75%. No single related or unrelated impurity should be more than 0.05%]||1 kg.|1|CHOLIC ACID |1. 65kg| |||||2|HYDRAZINE HYDRATE (80% SOLUTION) |1.65 kg| |||||3|IEP OX 239 SPRAY DRIED ENZYME POWDER | 0.033 kg| |||||4|IEP OX 235 SPRAY DRIED ENZYME POWDER | Not required| |||||5|IEP OX 152 SPRAY DRIED ENZYME POWDER | 0.050 kg| |||||6|IEP SP 41 SPRAY DRIED ENZYME POWDER | Not required|

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OWDER | Not required| |||||5|IEP OX 152 SPRAY DRIED ENZYME POWDER | 0.050 kg| |||||6|IEP SP 41 SPRAY DRIED ENZYME POWDER | Not required|

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7	IEP<br>OX<br>243<br>SPRAY	DRIED<br>0.040 kg
	ENZYME POWDER
8	(B-NAD)B-NICOTINAMIDE-	0.008 kg
	ADENINE DINUCLEOTIDE
	( COENZYME-1)

Note: Above norms are for regularization and closure purpose only. No fresh license will be issued on above said ad-hoc norms.

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

Case No.	10 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	AURA LIFECARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00001012AM24
RA File Number	342404000323 AM20
Licence No and<br>Date	3410045804/23/01/2020
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and it was decided that RA may work-out<br>the import entitlement of*Dextrosein line withSION A-325*on pro-rata basis or as applied whichever is lower.

of firm for review of ad-hoc norms and it was decided that RA may work-out the import entitlement of**Dextrosein line withSION A-325**on pro-rata basis or as applied whichever is lower.||

Case No.	11 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	NOVEL NUTRIENTSS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00001058AM24
RA File Number	072404000038 AM21
Licence No and<br>Date	0710116503/26/05/2020
Norms Committee Decision:<br>The committee considered the case as per agenda and it was observed that the firm vide email stated that they surrender the<br>above licence. Hence , the committee decided towithdrawthe case.

Case No. 12 / NC/3/MEET/Nov/202324/16

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Case Status	Case Approved
Party Name	CLARIANT INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	018205001343AM21
RA File Number	039404000110 AM21
Licence No and<br>Date	0310836469/01/06/2020
Norms Committee Decision:<br>Ms. Meghana Abhijit Karpe, Logistic Head and Shri Prashant Wadaskar, Plant Manager of the firm had<br>attended the Personal Hearing and explained the case.

9/01/06/2020| |Norms Committee Decision: Ms. Meghana Abhijit Karpe, Logistic Head and Shri Prashant Wadaskar, Plant Manager of the firm had attended the Personal Hearing and explained the case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has considered for review of ad-hoc norms on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under, or as applied whichever is lower: - Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Dimethyl acrylic acid ester 0.84 kg. 2 Hydroxyl amine hydrochloride 1.54 kg. PIROCTONE OLAMINE OR VIPIROX (Octopirox plus) 1 kg. 3 Isononyl acid chloride 1.667 kg. RA concerned may take further necessary action as per above decision of NC||

Case No.	Case No.	13 / NC/3/MEET/Nov/202324/16	13 / NC/3/MEET/Nov/202324/16	13 / NC/3/MEET/Nov/202324/16	13 / NC/3/MEET/Nov/202324/16	13 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		BROOKS LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM REVIW00004249AM24
RA File Number		302404000010 AM21
Licence No and<br>Date		3010105213/02/06/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol.

010105213/02/06/2020||||| |Norms Committee Decision: The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.|

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|Meropenem Injection USP1000 mg.Each vial contains Sterile Meropenem Trihydrate USP equ to Anhydrous Meropenem1000mg (SterileSodium Carbonate USP equ to Sodium 90.2mg with Pre-Import condition in terms of Para 4.13(iii) of FTP 2015-20 import should be made 1st &EO shall be fulfilled within 12 months from the dt. of import of each consignment in terms of Appdix-4J) 1 Number 1 MEROPENEM WITH SODIUM CARBONATE USP 1.29 gm. Export Item Name: Meropenem Injection 500 mg USPEach vial contains Sterile Meropenem Trihydrate USP equ to Anhydrous Meropenem 500mg (SterileSodium Carbonate USP equ to Sodium 90.2mg with Pre-Import condition in terms of Para 4.13(iii) of FTP 2015-20 import shud be made 1st &EO shall be fulfilled within 12 months from the dt.

Sodium Carbonate USP equ to<br>Sodium 90.2mg with Pre-Import condition<br>in terms of Para 4.13(iii) of FTP 2015-20<br>import shud be made 1st &EO shall be<br>fulfilled within 12 months from the dt. of<br>import of each consignment in terms of<br>Appdix-4J)<br>1 Number<br>2<br>MEROPENEM WITH SODIUM<br>CARBONATE USP<br>0.645 gm.<br>RA concerned may take further necessary action as per above decision of NC.	Meropenem Injection USP1000 mg.Each<br>vial contains Sterile Meropenem Trihydrate<br>USP equ to Anhydrous Meropenem1000mg<br>(SterileSodium Carbonate USP equ to<br>Sodium 90.2mg with Pre-Import condition<br>in terms of Para 4.13(iii) of FTP 2015-20<br>import should be made 1st &EO shall be<br>fulfilled within 12 months from the dt. of<br>import of each consignment in terms of<br>Appdix-4J)	1 Number	1	MEROPENEM WITH SODIUM<br>CARBONATE USP	1.29 gm.
	Export Item Name: Meropenem Injection<br>500 mg USPEach vial contains Sterile<br>Meropenem Trihydrate USP equ to<br>Anhydrous Meropenem 500mg<br>(SterileSodium Carbonate USP equ to<br>Sodium 90.2mg with Pre-Import condition<br>in terms of Para 4.13(iii) of FTP 2015-20<br>import shud be made 1st &EO shall be<br>fulfilled within 12 months from the dt. of<br>import of each consignment in terms of<br>Appdix-4J)	1 Number	2	MEROPENEM WITH SODIUM<br>CARBONATE USP	0.645 gm.

Case No.	14 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	AURA LIFECARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00001123AM24
RA File Number	342404000133 AM21
Licence No and<br>Date	3410046298/18/08/2020
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and it was decided that RA may work-out<br>the import entitlement of**Dextrose in line withSION A-325**on pro-rata basis or as applied whichever is lower.

Case No.	15 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00005055AM23
RA File Number	092404000282 AM21

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Licence No and 0910069242/22/09/2020 Date Norms Committee Decision:

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

s Committee Decision:

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Tobramycin for Inhalation solution 60 mg / ml<br>( 300 mg / 5 ml ) Net quantity of export<br>product 35.04 Kgs(Each mL contains<br>Tobramycin sulfate equivalent to Tobramycin-<br>60mg. Excipients q.s.)	1 Number	1	Tobramycin Sulfate	466.49 mg.
Tobramycin for Inhalation solution 75 mg / ml<br>( 300 mg / 4 ml ) Net quantity of export<br>product 23.36 Kgs(Each mL contains<br>Tobramycin sulfate equivalent to Tobramycin-<br>75mg. Excipients q.s.)	1 Number	2	Tobramycin Sulfate	466.49 mg.

Case No.	16 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00004153AM23
RA File Number	039404000571 AM21
Licence No and<br>Date	0310839148/27/10/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case alongwith relevant information / documents.		Personal Hearing<br>before

sidered the case as per agenda and it was decided to call the firm for attending Norms Committee to explain its case alongwith relevant information / documents.||Personal Hearing before|

Case No.	17 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	018205001869AM21
RA File Number	052404000441 AM21

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Licence No and 0510415972/24/11/2020 Date Norms Committee Decision:

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

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

s input with quantity.**

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

Case No.	18 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	REFLUX PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001513AM24
RA File Number	NA
Licence No and<br>Date	0311001445/03/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>3<br>CHLORO<br>2<br>METHYLANILINE<br>99<br>PERCENT MIN<br>0.67 kg.<br>2<br>ORTHO<br>CHLORO<br>BENZOIC<br>ACID<br>99<br>PERCENT MIN<br>0.75 kg.<br>TOLFENAMIC ACID<br>1 kg.<br>3<br>DIMETHYL FORMAMIDE 99 POINT 9<br>PERCENT<br>2.13 kg.<br>RA concerned may take further necessary action as per above decision of NC.

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. TOLFENAMIC ACID 1 kg. 3 DIMETHYL FORMAMIDE 99 POINT 9 PERCENT 2.13 kg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	19 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	INDOCO REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00004407AM24
RA File Number	03AA04023340 AM21
Licence No and<br>Date	0311001698/16/02/2021
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Copy of Bill of Entry of import item.<br>1.<br>CoA of import item from foreign supplier.<br>2.

Case No.	20 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00101696AM21
RA File Number	09AA04005325 AM21
Licence No and<br>Date	0911000494/11/03/2021
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Drug Manufacturing Licence (DML) with approved composition.<br>1.<br>Master Batch Formula.<br>2.

orms and it was decided to call for following information/documents from the firm:- Drug Manufacturing Licence (DML) with approved composition. 1. Master Batch Formula. 2.||

Case No.	21 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	BROOKS LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00004240AM24
RA File Number	30AA04005114 AM21
Licence No and<br>Date	3011000438/25/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP

UDIN00391140AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Meropenem Injection USP 1000<br>mg each v	<br>1 Number	1	MEROPENEM<br>WITH<br>SODIUM<br>CAARBONATE USP	<br>1.29 gm

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Meropenem Injection USP 1000<br>mg each v	<br>1 Number	1	MEROPENEM<br>WITH<br>SODIUM<br>CAARBONATE USP	<br>1.29 gm

Case No.	22 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	CLARIANT INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00004498AM24
RA File Number	03AA04009823 AM22
Licence No and<br>Date	0311003530/04/05/2021
Norms Committee Decision:<br>Ms. Meghana Abhijit Karpe, Logistic Head and Shri Prashant Wadaskar, Plant Manager of the firm had<br>attended the Personal Hearing and explained the case. The Committee heard the explanation of<br>Representative of the firm and after due deliberation the committee has considered for review of ad-hoc<br>norms on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under,<br>or as applied whichever is lower: -<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Dimethyl acrylic acid ester<br>0.84 kg.<br>2<br>Hydroxyl amine hydrochloride<br>1.54 kg.<br>PIROCTONE OLAMINE OR VIPIROX<br>(Octopirox plus)<br>1 kg.<br>3<br>Isononyl acid chloride<br>1.667 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	23 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	NAPROD LIFE SCIENCES PRIVATE LIMITED

UDIN00391140AM24

ry action as per above decision of NC.||

Case No.	23 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	NAPROD LIFE SCIENCES PRIVATE LIMITED

UDIN00391140AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00004760AM24
RA File Number	03AA04021964 AM22
Licence No and<br>Date	0311004323/04/06/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>Bleomycin For Injection USP 15 Units<br>(Lyophilised)(Bleomycin For Injection<br>USP 15 Units (Lyophilised) (Net Content<br>of Bleomycin Sulfate, Non Sterile - 115<br>Grams (10 mg in each vial))<br>1 Number<br>1<br>Bleomycin Sulfate, Non Sterile<br>10 mg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	24 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	SWISS PARENTERALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00003403AM23
RA File Number	08AA04007143 AM22
Licence No and<br>Date	0811001742/15/06/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

REVIW00003403AM23| |RA File Number|08AA04007143 AM22| |Licence No and Date|0811001742/15/06/2021| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	25 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00138116AM22
RA File Number	26AA04002063 AM22
Licence No and<br>Date	2611000198/13/07/2021

UDIN00391140AM24

Norms Committee Decision:

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

Complete and balanced chemical reactions for each step, as given in process details, alongwith molar weight and percentage yield on molar basis.
Justification for molar excess shown for various inputs.
End-use of intermediate.

Case No.	26 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	DIAMINES AND CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00145203AM22
RA File Number	34AA04005573 AM22
Licence No and<br>Date	3411000885/22/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>PIPERAZINE ANHYDROUS<br>1 kg.<br>1<br>PIPERAZINE CRUDE OR PIPERAZINE<br>MIXTURE<br>(Percentage purity not more than 48.1%)<br>2.047 kg.<br>RA concerned may take further necessary action as per above decision of NC.

1 kg. 1 PIPERAZINE CRUDE OR PIPERAZINE MIXTURE (Percentage purity not more than 48.1%) 2.047 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	27 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	SYNOKEM PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00147457AM22
RA File Number	05AA04059070 AM22
Licence No and<br>Date	0511003826/26/07/2021
Norms Committee Decision:

UDIN00391140AM24

Shri Krishan Khemka, Consultant and Shri Deepak Nagar, Manager of the firm had attended the Personal Hearing and explained the case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has advised to the firm to amend the license from concerned RA with correct export product and import item.

Case No.	28 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	SUNDYOTA NUMANDIS PROBIOCEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00004161AM24
RA File Number	08AA04021121 AM22
Licence No and<br>Date	0811002324/16/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case toDeptt. of Bio-Technologyfor<br>obtaining their comments.

2324/16/08/2021| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to refer the case toDeptt. of Bio-Technologyfor obtaining their comments.||

Case No.	29 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00164102AM22
RA File Number	03AA04065031 AM22
Licence No and<br>Date	0311006216/17/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case alongwith Relevent information / documents.		Personal Hearing

Case No.	30 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00005936AM23
RA File Number	34AA04006527 AM22
Licence No and<br>Date	3411000984/17/08/2021
Norms Committee Decision:<br>Decision:Dr. Dhaval Patel, Technical Expert, Shri Dhruval Parmar (Exim) of the firm had attended the Personal

UDIN00391140AM24

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

beration the committee has considered for review of ad-hoc norms on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under, or as applied whichever is less: -

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Limbunile(3,7-Dimethyl-2(3),<br>6-nonadienonitrile))	1 kg.	1	Ethyl Heptenone	1.145 kg.
		2	Cyano Acetic acid (70%)	1.75 kg.

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

Case No.	31 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00006174AM23
RA File Number	NA
Licence No and<br>Date	3411000984/17/08/2021
Norms Committee Decision:<br>Decision:Dr. Dhaval Patel, Technical Expert, Shri Dhruval Parmar (Exim) of the firm had attended the Personal<br>Hearing and explained the case. The Committee heard the explanation of Representative of the firm and after due<br>deliberation the committee has considered for review of ad-hoc norms on the basis of information provided by the<br>firm, it was decided to revise ad-hoc norms as under, or as applied whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

information provided by the firm, it was decided to revise ad-hoc norms as under, or as applied whichever is less: - Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Ethyl Heptenone 1.145 kg. Limbunile(3,7-Dimethyl-2(3), 6-nonadienonitrile)) 1 kg. 2 Cyano Acetic acid (70%) 1.75 kg. Note: The above norms are for regularization and closure purpose only. No repeat Licence may be allowed by RA on above norms. RA concerned may take further necessary action as per above decision of NC.||

Case No. 32 / NC/3/MEET/Nov/202324/16

UDIN00391140AM24

Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00170502AM22
RA File Number	08AA04022482 AM22
Licence No and<br>Date	0811002393/25/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Oct/202324/15 dated 13/10/2023against advance<br>authorizationNo.0811002958 dated 22/10/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>VINORELBINE CONCENTRATE FOR<br>SOLUTION FOR INFUSION 10MG/ML,<br>1ML VIAL(EACH ML CONTAINS:<br>VINORELBINE TARTRATE PH.EUR<br>EQ.

Export Product Qty. Sl. No. Import Items Qty. allowed. VINORELBINE CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML, 1ML VIAL(EACH ML CONTAINS: VINORELBINE TARTRATE PH.EUR EQ. TO VINORELBINE 10 MG) 1 Number 1 VINORELBINE TARTRATE EP / BP / IP / USP / PH. EUR (Water content 2.3%) 14.33 mg. VINORELBINE CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML, 5ML VIAL(EACH ML CONTAINS: VINORELBINE TARTRATE PH.EUR EQ. TO VINORELBINE 10 MG [IN WHICH ACTIVE INGREDIENT VINORELBINE TARTRATE USED IS 183.000 GRAMS]) 1 Number 2 VINORELBINE TARTRATE EP / BP / IP / USP / PH. EUR (Water content 2.3%) 71.66 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	33 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	DIAMINES AND CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00184161AM22
RA File Number	34AA04007354 AM22
Licence No and<br>Date	3411001111/15/09/2021

UDIN00391140AM24

Norms Committee Decision:

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
PIPERAZINE ANHYDROUS	1 kg.	1	PIPERAZINE CRUDE OR PIPERAZINE<br>MIXTURE<br>(Percentage purity not more than 48.1%)	2.047 kg.

Case No.	34 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	CUCKOS PHARMACEUTICAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00184568AM22
RA File Number	33AA04006480 AM22
Licence No and<br>Date	3311000430/15/09/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	35 / NC/3/MEET/Nov/202324/16	35 / NC/3/MEET/Nov/202324/16	35 / NC/3/MEET/Nov/202324/16	35 / NC/3/MEET/Nov/202324/16	35 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		ASOJ SOFT CAPS PVT LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00190578AM22
RA File Number		34AA04007816 AM22
Licence No and<br>Date		3411001148/22/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol.

|Licence No and Date||3411001148/22/09/2021||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

Case No.	Case No.	35 / NC/3/MEET/Nov/202324/16	35 / NC/3/MEET/Nov/202324/16	35 / NC/3/MEET/Nov/202324/16	35 / NC/3/MEET/Nov/202324/16	35 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		ASOJ SOFT CAPS PVT LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00190578AM22
RA File Number		34AA04007816 AM22
Licence No and<br>Date		3411001148/22/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00391140AM24

NERVERON	1 Number	1	ALPHA LIPOIC ACID	204.00 mg
(each capsule containing 200 mg of
Alpha Lipoic Acid)

.|Import Items|Qty. allowed.|

UDIN00391140AM24

NERVERON	1 Number	1	ALPHA LIPOIC ACID	204.00 mg
(each capsule containing 200 mg of
Alpha Lipoic Acid)

Case No.	36 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00195372AM22
RA File Number	34AA04006808 AM22
Licence No and<br>Date	3411001180/27/09/2021
Norms Committee Decision:<br>Dr. Dhaval Patel, Technical Expert, Shri Dhruval Parmar (Exim) of the firm had attended the Personal Hearing and<br>explained the case. The Committee heard the explanation of Representative of the firm and after due deliberation<br>the committee has considered for review of ad-hoc norms on the basis of information provided by the firm, it was<br>decided to revise ad-hoc norms as under, or as applied whichever is less: -<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>2-Methyl-3-butene-2- ol<br>0.616 kg.<br>2<br>Tri Methyl Ortho formate<br>0.71 kg.<br>POMELO<br>ACETAL<br>((6,6-Dimethoxy-<br>2,5,5-trimethylhex- 2-ene))<br>1 kg.<br>3<br>Iso Butyraldehyde<br>1.105 kg.<br>Note: The above norms are for regularization and closure purpose only. No repeat Licence may be allowed by<br>RA on above norms.<br>RA concerned may take further necessary action as per above decision of NC.

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

Case No.	37 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00212058AM22

UDIN00391140AM24

RA File Number	03AA040109332 AM22
Licence No and<br>Date	0311007711/14/10/2021
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	38 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	TOJO VIKAS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00226905AM22
RA File Number	05AA04094141 AM22
Licence No and<br>Date	0511005704/26/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case toDeptt. of Bio-Technologyfor<br>obtaining their comments.

5704/26/10/2021| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to refer the case toDeptt. of Bio-Technologyfor obtaining their comments.||

Case No.	Case No.	39 / NC/3/MEET/Nov/202324/16	39 / NC/3/MEET/Nov/202324/16	39 / NC/3/MEET/Nov/202324/16	39 / NC/3/MEET/Nov/202324/16	39 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		BHARAT PARENTERALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00239596AM22
RA File Number		34AA04008748 AM22
Licence No and<br>Date		3411001363/02/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>CEFACLOR CAPSULES USP 500MG(( EACH<br>HARD GELATIN CAPSULE CONTAIN<br>CEFACLOR USP EQ TO ANHYDROUS<br>CEFACLOR 500MG) (TOTAL CONTENT:<br>CEFACLOR IP/BP/USP 85.1256 KGS)151200<br>Capsules)<br>1 Number<br>1<br>CEFACLOR<br>(Average water content 4.3%)<br>531.93 mg<br>CEFACLOR EXTENDED-RELEASE TABLETS<br>USP 750 MG(( EACH FILM COATED<br>EXTENDED RELEASE TABLET CONTAINS<br>1 Number<br>2<br>CEFACLOR<br>(Average water content 4.3%)<br>797.90 mg
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

ACH FILM COATED EXTENDED RELEASE TABLET CONTAINS 1 Number 2 CEFACLOR (Average water content 4.3%) 797.90 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||CEFACLOR CAPSULES USP 500MG(( EACH HARD GELATIN CAPSULE CONTAIN CEFACLOR USP EQ TO ANHYDROUS CEFACLOR 500MG) (TOTAL CONTENT: CEFACLOR IP/BP/USP 85.1256 KGS)151200 Capsules)||1 Number|1|CEFACLOR (Average water content 4.3%)|531.93 mg| ||CEFACLOR EXTENDED-RELEASE TABLETS USP 750 MG(( EACH FILM COATED EXTENDED RELEASE TABLET CONTAINS||1 Number|2|CEFACLOR (Average water content 4.3%)|797.90 mg|

Case No.	Case No.	39 / NC/3/MEET/Nov/202324/16	39 / NC/3/MEET/Nov/202324/16	39 / NC/3/MEET/Nov/202324/16	39 / NC/3/MEET/Nov/202324/16	39 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		BHARAT PARENTERALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00239596AM22
RA File Number		34AA04008748 AM22
Licence No and<br>Date		3411001363/02/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. CEFACLOR CAPSULES USP 500MG(( EACH HARD GELATIN CAPSULE CONTAIN CEFACLOR USP EQ TO ANHYDROUS CEFACLOR 500MG) (TOTAL CONTENT: CEFACLOR IP/BP/USP 85.1256 KGS)151200 Capsules) 1 Number 1 CEFACLOR (Average water content 4.3%) 531.93 mg CEFACLOR EXTENDED-RELEASE TABLETS USP 750 MG(( EACH FILM COATED EXTENDED RELEASE TABLET CONTAINS 1 Number 2 CEFACLOR (Average water content 4.3%) 797.90 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||CEFACLOR CAPSULES USP 500MG(( EACH HARD GELATIN CAPSULE CONTAIN CEFACLOR USP EQ TO ANHYDROUS CEFACLOR 500MG) (TOTAL CONTENT: CEFACLOR IP/BP/USP 85.1256 KGS)151200 Capsules)||1 Number|1|CEFACLOR (Average water content 4.3%)|531.93 mg| ||CEFACLOR EXTENDED-RELEASE TABLETS USP 750 MG(( EACH FILM COATED EXTENDED RELEASE TABLET CONTAINS||1 Number|2|CEFACLOR (Average water content 4.3%)|797.90 mg|

UDIN00391140AM24

g| ||CEFACLOR EXTENDED-RELEASE TABLETS USP 750 MG(( EACH FILM COATED EXTENDED RELEASE TABLET CONTAINS||1 Number|2|CEFACLOR (Average water content 4.3%)|797.90 mg|

UDIN00391140AM24

CEFACLOR USP EQ TO ANHYDROUS<br>CEFACLOR 750MG)(TOTAL CONTENT:<br>CEFACLOR IP/BP/USP 85.176 KGS ) 100800<br>Tabletss)<br>CEFACLOR FOR ORAL SUSPENSION USP 125<br>MG /5ML IN 75ML BOTTLE((EACH 5ML OF<br>RECONSTITUTED SUSPENSION CONTAINS<br>CEFACLOR USP EQ TO ANHYDROUS<br>CEFACLOR 125 MG)(TOTAL<br>CONTENT:CEFACLOR IP/BP/USP 31.65<br>KGS)15000 Bottles)<br>1 Number<br>3<br>CEFACLOR<br>(Average water content 4.3%)<br>2053.40 mg<br>CEFACLOR FOR ORAL SUSPENSION USP 250<br>MG /5ML IN 75ML BOTTLE((EACH 5ML OF<br>RECONSTITUTED SUSPENSION CONTAINS<br>CEFACLOR USP EQ TO ANHYDROUS<br>CEFACLOR 250 MG)(TOTAL<br>CONTENT:CEFACLOR IP/BP/USP 46.431 KGS<br>)11000 Bottles)<br>1 Number<br>4<br>CEFACLOR<br>(Average water content 4.3%)<br>4106.80 mg.<br>RA concerned may take further necessary action as per above decision of NC.	CEFACLOR USP EQ TO ANHYDROUS<br>CEFACLOR 750MG)(TOTAL CONTENT:<br>CEFACLOR IP/BP/USP 85.176 KGS ) 100800<br>Tabletss)
	CEFACLOR FOR ORAL SUSPENSION USP 125<br>MG /5ML IN 75ML BOTTLE((EACH 5ML OF<br>RECONSTITUTED SUSPENSION CONTAINS<br>CEFACLOR USP EQ TO ANHYDROUS<br>CEFACLOR 125 MG)(TOTAL<br>CONTENT:CEFACLOR IP/BP/USP 31.65<br>KGS)15000 Bottles)	1 Number	3	CEFACLOR<br>(Average water content 4.3%)	2053.40 mg

SUSPENSION CONTAINS CEFACLOR USP EQ TO ANHYDROUS CEFACLOR 125 MG)(TOTAL CONTENT:CEFACLOR IP/BP/USP 31.65 KGS)15000 Bottles)|1 Number|3|CEFACLOR (Average water content 4.3%)|2053.40 mg| ||CEFACLOR FOR ORAL SUSPENSION USP 250 MG /5ML IN 75ML BOTTLE((EACH 5ML OF RECONSTITUTED SUSPENSION CONTAINS CEFACLOR USP EQ TO ANHYDROUS CEFACLOR 250 MG)(TOTAL CONTENT:CEFACLOR IP/BP/USP 46.431 KGS )11000 Bottles)|1 Number|4|CEFACLOR (Average water content 4.3%)|4106.80 mg.|

Case No.	40 / NC/3/MEET/Nov/202324/16
Case Status	Case Rejected
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00261092AM22
RA File Number	09AA04016734 AM22
Licence No and<br>Date	0911001888/22/11/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was observed that the firm had neither<br>attended the Personal Hearing nor intimated to committee. Hence, it was decided torejectthe case maintaining the<br>status quo.

Case No.	41 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	LAZERHEAD LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00266328AM22
RA File Number	09AA04012424 AM22

UDIN00391140AM24

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Licence No and 0911001950/26/11/2021 Date Norms Committee Decision: The Committee considered the case as per agenda and it was decided to refer the case to Deptt. of Bio-Technology for obtaining their comments.

Case No.	42 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00272724AM22
RA File Number	03AA040127775 AM22
Licence No and<br>Date	0311009114/02/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.NC/3/MEET/Oct/202324/15 dated 13/10/2023against advance authorization<br>No.0311008170 dated 02/11/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>HYDRAZINE HYDRATE<br>(Min. 80% purity)<br>0.4125 kg.<br>2<br>CAUSTIC SODA<br>0.266 kg.<br>2,5-DIMERCAPTO-1,3,4-<br>THIADIAZOLE (YALUB DMTD)<br>1 kg.<br>3<br>CARBON DISULPHIDE<br>0.048 kg.<br>RA concerned may take further necessary action as per above decision of NC.

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

Case No.	43 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00004710AM24
RA File Number	03AA040124486 AM22
Licence No and<br>Date	0311009090/02/12/2021

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Norms Committee Decision:

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
DIISOPROPYL ETHER<br>(Purity more than 99.21%) (Moisture<br>less than 1000 PPM)	1 kg.	1	CRUDE DIISOPROPYL ETHER<br>(Purity not more than 95%)	1.25 kg.

Case No.	44 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00277912AM22
RA File Number	05AA040108247 AM22
Licence No and<br>Date	0511006681/07/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<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>allowed.<br>CEFEPIME POWDER FOR SOLUTION FOR<br>INJECTION, WEIGHT 1 GMS/VIAL<br>(CEFEPIME HCL+L- ARGININE STERILE USP)<br>1 Number<br>1<br>CEFEPIME<br>HCL+L-<br>ARGININE<br>STERILE<br>USP<br>1.05 gm.<br>CEFEPIME POWDER FOR SOLUTION FOR<br>INJECTION,WEIGHT 2 GMS/VIAL<br>(CEFEPIME HCL+L- ARGININE STERILE USP)<br>1 Number<br>2<br>CEFEPIME<br>HCL+L-<br>ARGININE<br>STERILE<br>USP<br>2.10 gm.<br>RA concerned may take further necessary action as per above decision of NC.

HCL+L- ARGININE STERILE USP) 1 Number 2 CEFEPIME HCL+L- ARGININE STERILE USP 2.10 gm. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	45 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00289566AM22
RA File Number	34AX04000036 AM22
Licence No and<br>Date	3411001553/17/12/2021
Norms Committee Decision:<br>Dr. Dhaval Patel, Technical Expert, Shri Dhruval Parmar (Exim) of the firm had attended the Personal Hearing and<br>explained the case. The Committee heard the explanation of Representative of the firm and after due deliberation<br>the committee has considered for review of ad-hoc norms on the basis of information provided by the firm, it was<br>decided to revise ad-hoc norms as under, or as applied whichever is less: -<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>PHENOXYETHYL<br>ISOBUTYRATE<br>(((Phenoxy) ethyl 2-methylpropanoate))<br>1 kg.<br>1<br>ISOBUTYRIC ACID<br>0.5633 kg.<br>Note: The above norms are for regularization and closure purpose only. No repeat Licence may be allowed by<br>RA on above norms.<br>RA concerned may take further necessary action as per above decision of NC.

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

Case No.	Case No.	46 / NC/3/MEET/Nov/202324/16	46 / NC/3/MEET/Nov/202324/16	46 / NC/3/MEET/Nov/202324/16	46 / NC/3/MEET/Nov/202324/16	46 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00289569AM22
RA File Number		34AX04000035 AM22
Licence No and<br>Date		3411001554/17/12/2021
Norms Committee Decision:<br>Dr. Dhaval Patel, Technical Expert, Shri Dhruval Parmar (Exim) of the firm had attended the Personal Hearing and<br>explained the case. The Committee heard the explanation of Representative of the firm and after due deliberation<br>the committee has considered for review of ad-hoc norms on the basis of information provided by the firm, it was<br>decided to revise ad-hoc norms as under, or as applied whichever is less: -<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

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EM PENTANOATE	1 kg.	1	Propionaldehyde	1.20 kg.
(ETHYL-2-METHYL PENTANOATE)

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

20 kg.| |---|---|---|---|---| |(ETHYL-2-METHYL PENTANOATE)|||||

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

Case No.	47 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	NATCO PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00004488AM24
RA File Number	09AX04000043 AM22
Licence No and<br>Date	0911002121/21/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case alongwith relevant information / documents.		Personal Hearing<br>before

Case No.	Case No.	48 / NC/3/MEET/Nov/202324/16	48 / NC/3/MEET/Nov/202324/16	48 / NC/3/MEET/Nov/202324/16	48 / NC/3/MEET/Nov/202324/16	48 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		CLARIANT INDIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM REVIW00004497AM24
RA File Number		03AX04000499 AM22
Licence No and<br>Date		0311009919/30/12/2021
Norms Committee Decision:<br>Ms. Meghana Abhijit Karpe, Logistic Head and Shri Prashant Wadaskar, Plant Manager of the firm had<br>attended the Personal Hearing and explained the case.

/12/2021||||| |Norms Committee Decision: Ms. Meghana Abhijit Karpe, Logistic Head and Shri Prashant Wadaskar, Plant Manager of the firm had attended the Personal Hearing and explained the case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has considered for review of ad-hoc norms on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under, or as applied whichever is lower: - Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Dimethyl acrylic acid ester 0.84 kg. PIROCTONE OLAMINE OR VIPIROX 1 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||PIROCTONE OLAMINE OR VIPIROX||1 kg.|1|Dimethyl acrylic acid ester|0.84 kg.|

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(Octopirox plus)		2	Hydroxyl amine hydrochloride	1.54 kg.
		3	Isononyl acid chloride	1.667 kg.

|1 kg.|1|Dimethyl acrylic acid ester|0.84 kg.|

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(Octopirox plus)		2	Hydroxyl amine hydrochloride	1.54 kg.
		3	Isononyl acid chloride	1.667 kg.

Case No.	49 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number and<br>Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00324009AM22
RA File Number	03AX04000495 AM22
Licence No and Date	0311010688/19/01/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>PHENOL<br>13770.0 kg.<br>2<br>YELLOW PHOSPHORUS<br>1471.5 kg.<br>3<br>BISPHENOL A<br>5562.0 kg.<br>POLY 4, 4 ISOPROPYLIDENEDIPHENOL<br>C12-C15 ALCOHOL PHOSPHITE<br>27000.0 kg.<br>4<br>C12 C15 ALCOHOL<br>19710.0 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	50 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00007005AM23
RA File Number	34AX04000212 AM22
Licence No and<br>Date	3411001750/04/02/2022

UDIN00391140AM24

Norms Committee Decision:

Decision: Dr. Dhaval Patel, Technical Expert, Shri Dhruval Parmar (Exim) of the firm had attended the Personal Hearing and explained the case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has considered for review of ad-hoc norms on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under, or as applied whichever is less: -

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Undecavertol (Kakdinol)<br>(4-Methyl-3-decen- 5-ol))	1 kg.	1	Propionaldehyde	0.947 kg.
		2	1-Pentanol / N Amyl Alcohol	0.709 kg.
		3	Magnesium Turning	0.182 kg.

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

Case No.	51 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00000257AM24
RA File Number	03AX04001590 AM22
Licence No and<br>Date	0311013222/22/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case alongwith relevant information / documents.		Personal Hearing<br>before

sidered the case as per agenda and it was decided to call the firm for attending Norms Committee to explain its case alongwith relevant information / documents.||Personal Hearing before|

Case No.	52 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00401252AM22
RA File Number	03AX04001906 AM22
Licence No and<br>Date	0311013320/25/03/2022
Norms Committee Decision:

UDIN00391140AM24

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.72/NC/3/MEET/Oct/202122/9 dated 15/10/2021 against advance authorization No. 0310837496 dated 30/07/2020 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Sl. No.	Export Product	Qty.
1	62/0- Phytosterol Natural Refined Phytosterol 95%	120000.000 kg.
2	62/0- Natural Mixed Tocopherol 70%	55000.000 kg.

Sl. No.	Import Item	Qty.
1	Fatty Acid Distillate / Deoderised Distillate	1842500 kg.
2	Acetone	88000 kg.
3	N-HEPTANE	188100 kg.

Tocopherol 70%|55000.000 kg.|

Sl. No.	Import Item	Qty.
1	Fatty Acid Distillate / Deoderised Distillate	1842500 kg.
2	Acetone	88000 kg.
3	N-HEPTANE	188100 kg.

Case No.	Case No.	53 / NC/3/MEET/Nov/202324/16	53 / NC/3/MEET/Nov/202324/16	53 / NC/3/MEET/Nov/202324/16	53 / NC/3/MEET/Nov/202324/16	53 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		KRITI NUTRIENTS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00408410AM22
RA File Number		56AX04000134 AM22
Licence No and<br>Date		5611000874/30/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00391140AM24

Soya Lecithin Liquid Food Grade	1MT	1	Soya Lecithin Liquid	1.01	MT
(Non GMO)

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

UDIN00391140AM24

Soya Lecithin Liquid Food Grade	1MT	1	Soya Lecithin Liquid	1.01	MT
(Non GMO)

Case No.	54 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00409480AM22
RA File Number	34AX04000458 AM22
Licence No and<br>Date	3411002061/31/03/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Copy of Master-Batch Formula for each export item.

Case No.	Case No.	55 / NC/3/MEET/Nov/202324/16	55 / NC/3/MEET/Nov/202324/16	55 / NC/3/MEET/Nov/202324/16	55 / NC/3/MEET/Nov/202324/16	55 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		AUROBINDO PHARMA LTD
Meeting Number and<br>Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00410013AM22
RA File Number		09AX04000193 AM22
Licence No and Date		0911002816/31/03/2022

and Date||NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023||||| |HQ File Number||HQRNORM APPLY 00410013AM22||||| |RA File Number||09AX04000193 AM22||||| |Licence No and Date||0911002816/31/03/2022||||| |Norms Committee Decision: . The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo.NC/3/MEET/Oct/202324/15 dated 13/10/2023against advance authorization No. 0910066762 dated 25/10/2018, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 6-APA (6-Amino Penicillanic Acid) 325.00 mg. AMOXYCILLIN AND CLAVULANATE POTASSIUM 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||AMOXYCILLIN AND CLAVULANATE POTASSIUM||1 Number|1|6-APA (6-Amino Penicillanic Acid)|325.00 mg.|

UDIN00391140AM24

*Qty.**|Sl. No.|Import Items|Qty. allowed.| ||AMOXYCILLIN AND CLAVULANATE POTASSIUM||1 Number|1|6-APA (6-Amino Penicillanic Acid)|325.00 mg.|

UDIN00391140AM24

2<br>D-(-)-4-hydroxyphenylglycine<br>methyl ester [PHPG Ester]<br>281.86 mg.<br>3<br>Penicillin G Amidase (Particle size<br>250 - 500 micron, Creamish to<br>Brown regularly shaped beads)<br>1.00 mg.<br>TABLETS 625 MG.<br>(Each film coated Tablet contains:<br>Amoxicillin Trihydrate equivalent<br>to Anhydrous Amoxicillin 500 mg<br>an<br>Clavulanate<br>Potassium<br>equivalent to Clavulanic Acid 125<br>mg.<br>4<br>Diluted<br>Clavulanate<br>Potassium<br>(1:1) / Potassium Clavulanate<br>Diluted<br>with<br>Microcrystalline<br>Cellulose (1:1)<br>297.825 mg.<br>RA concerned may take further necessary action as per above decision of NC.	TABLETS 625 MG.<br>(Each film coated Tablet contains:<br>Amoxicillin Trihydrate equivalent<br>to Anhydrous Amoxicillin 500 mg<br>an<br>Clavulanate<br>Potassium<br>equivalent to Clavulanic Acid 125<br>mg.		2	D-(-)-4-hydroxyphenylglycine<br>methyl ester [PHPG Ester]	281.86 mg.
			3	Penicillin G Amidase (Particle size<br>250 - 500 micron, Creamish to<br>Brown regularly shaped beads)	1.00 mg.
			4	Diluted<br>Clavulanate<br>Potassium<br>(1:1) / Potassium Clavulanate<br>Diluted<br>with<br>Microcrystalline<br>Cellulose (1:1)	297.825 mg.

ish to Brown regularly shaped beads)|1.00 mg.| ||||4|Diluted Clavulanate Potassium (1:1) / Potassium Clavulanate Diluted with Microcrystalline Cellulose (1:1)|297.825 mg.|

Case No.	Case No.	56 / NC/3/MEET/Nov/202324/16	56 / NC/3/MEET/Nov/202324/16	56 / NC/3/MEET/Nov/202324/16	56 / NC/3/MEET/Nov/202324/16	56 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00000168AM23
RA File Number		03AX04000080 AM23
Licence No and<br>Date		0311013777/11/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Tert-Butyl(E)-(6-(2-(4-(4-fluorophenyl)-6-<br>Isopropyl-2-(Methyl(Methyl<br>Sulfonyl)<br>Amino Pyrimidin-5-yl)Vinyl) (4R,6S)-2,2-<br>Dim<br>1.30 kg.<br>2<br>ETHYL ACETATE<br>0.674 kg.<br>3<br>METHANOL<br>1.874 kg.<br>ROSUVASTATIN CALCIUM<br>1 kg.<br>4<br>TOLUENE<br>0.772 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

r>2 ETHYL ACETATE 0.674 kg. 3 METHANOL 1.874 kg. ROSUVASTATIN CALCIUM 1 kg. 4 TOLUENE 0.772 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||ROSUVASTATIN CALCIUM||1 kg.|1|Tert-Butyl(E)-(6-(2-(4-(4-fluorophenyl)-6- Isopropyl-2-(Methyl(Methyl Sulfonyl) Amino Pyrimidin-5-yl)Vinyl) (4R,6S)-2,2- Dim| 1.30 kg.| |||||2|ETHYL ACETATE|0.674 kg.| |||||3|METHANOL|1.874 kg.| |||||4|TOLUENE|0.772 kg.|

UDIN00391140AM24

Case No.	Case No.	57 / NC/3/MEET/Nov/202324/16	57 / NC/3/MEET/Nov/202324/16	57 / NC/3/MEET/Nov/202324/16	57 / NC/3/MEET/Nov/202324/16	57 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00000220AM23
RA File Number		08AX04000742 AM22
Licence No and<br>Date		0811004640/13/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Aug/202324/11 dated 22/08/2023against advance<br>authorizationNo.0811002528 dated 07/09/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG) 1 Number Vial 1 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49 % in API) 61.87 mg/vial METHOTREXATE INJECTION BP 100MG/ML [5 ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100 MG) 1 Number Vial 2 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49 % in API) 618.70 mg/vial METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG) 1 Number Vial 3 METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49 % in API) 1237.39 mg/vial METHOTREXATE EP / BP / IP / USP / PH. EUR. METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG) 1 Number Vial 4 306.867 mg/vial||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)||1 Number Vial|1|METHOTREXATE EP / BP / IP / USP / PH.

.**|Import Items|Qty. allowed.| ||METHOTREXATE INJECTION BP 25MG/ML [2ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)||1 Number Vial|1|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49 % in API)|61.87 mg/vial| ||METHOTREXATE INJECTION BP 100MG/ML [5 ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100 MG)||1 Number Vial|2|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49 % in API)|618.70 mg/vial| ||METHOTREXATE INJECTION BP 100MG/ML [10ML VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR. 100MG)||1 Number Vial|3|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49 % in API)|1237.39 mg/vial| ||METHOTREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG)||1 Number Vial|4|METHOTREXATE EP / BP / IP / USP / PH. EUR.|306.867 mg/vial|

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TREXATE INJECTION USP 25MG/ML [10ML VIAL](EACH ML CONTAINS: METHOTREXATE USP 25MG)||1 Number Vial|4|METHOTREXATE EP / BP / IP / USP / PH. EUR.|306.867 mg/vial|

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(Moisture and Residual Solvents<br>content not less than 12.49 % in<br>API)<br>METHOTREXATE INJECTION BP 25MG/ML<br>[20ML VIAL](EACH ML CONTAINS:<br>METHOTREXATE PH. EUR. 25MG)<br>1 Number<br>Vial<br>5<br>METHOTREXATE<br>EP / BP / IP / USP / PH. EUR.<br>(Moisture and Residual Solvents<br>content not less than 12.49 % in<br>API)<br>590.57 mg/vial<br>METHOTREXATE INJECTION BP 25MG/ML<br>[40ML VIAL](EACH ML CONTAINS:<br>METHOTREXATE PH. EUR. 25MG)<br>1 Number<br>Vial<br>6<br>METHOTREXATE<br>EP / BP / IP / USP / PH. EUR.<br>(Moisture and Residual Solvents<br>content not less than 12.49 % in<br>API)<br>1181.15 mg/vial<br>METHOTREXATE INJECTION BP 100MG/ML<br>[50ML VIAL](EACH ML CONTAINS:<br>METHOTREXATE PH. EUR. 100MG [IN<br>WHICH ACTIVE INGREDIENT<br>METHOTREXATE USED IS 8.175 KGS.])<br>1 Number<br>Vial<br>7<br>METHOTREXATE<br>EP / BP / IP / USP / PH. EUR.<br>(Moisture and Residual Solvents<br>content not less than 12.49 % in<br>API)<br>5737.00 mg/vial<br>RA concerned may take further necessary action as per above decision of NC				(Moisture and Residual Solvents<br>content not less than 12.49 % in<br>API)
	METHOTREXATE INJECTION BP 25MG/ML<br>[20ML VIAL](EACH ML CONTAINS:<br>METHOTREXATE PH. EUR. 25MG)	1 Number<br>Vial	5	METHOTREXATE<br>EP / BP / IP / USP / PH.

in API)|| |---|---|---|---|---|---| ||METHOTREXATE INJECTION BP 25MG/ML [20ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)|1 Number Vial|5|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49 % in API)|590.57 mg/vial| ||METHOTREXATE INJECTION BP 25MG/ML [40ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 25MG)|1 Number Vial|6|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49 % in API)|1181.15 mg/vial| ||METHOTREXATE INJECTION BP 100MG/ML [50ML VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. 100MG [IN WHICH ACTIVE INGREDIENT METHOTREXATE USED IS 8.175 KGS.])|1 Number Vial|7|METHOTREXATE EP / BP / IP / USP / PH. EUR. (Moisture and Residual Solvents content not less than 12.49 % in API)|5737.00 mg/vial|

Case No.	58 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00000256AM23
RA File Number	09AX04000404 AM22
Licence No and<br>Date	0911002859/18/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Mar/202223/22 dated 24/03/2022against advance<br>authorizationNo.0911003834 dated 18/10/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

rt product in meetingNo. NC/3/MEET/Mar/202223/22 dated 24/03/2022against advance authorizationNo.0911003834 dated 18/10/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-||

UDIN00391140AM24

Export product	Qty.	Sl. No.	Import items	Qty.
Amoxicillin and Clavulanate<br>Potassium Tablets 1000 mg((Relevant<br>bulk drug content in the Export product<br>Amoxicillin trihydrate equivalent to<br>Amoxicillin 19687.50 kg and<br>Clavulanate Potassium equivalent to<br>Clavulanic acid 2812.5 kg))	<br>1 Number<br>Tablet	1	6-Amino Penicillanic Acid<br>(6-APA)	576.40 mg
		2	D-(-)-4-hydroxyphenylglycine<br>methyl ester [PHPG Ester]	496.38 mg
		3	Potassium Clavulanate Diluted with<br>Microcrystalline Cellulose (1:1)	<br>302.03 mg

c Acid (6-APA)|576.40 mg| ||||2|D-(-)-4-hydroxyphenylglycine methyl ester [PHPG Ester]|496.38 mg| ||||3|Potassium Clavulanate Diluted with Microcrystalline Cellulose (1:1)| 302.03 mg|

Case No.	Case No.	59 / NC/3/MEET/Nov/202324/16	59 / NC/3/MEET/Nov/202324/16	59 / NC/3/MEET/Nov/202324/16	59 / NC/3/MEET/Nov/202324/16	59 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00000389AM23
RA File Number		08AX04000767 AM22
Licence No and Date		0811004766/23/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Jun/202324/8dated30/06/2023against advance authorization<br>No.0811007534 dated 10.03.2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>NALTREXONE HYDROCHLORIDE<br>TABLETS 50 MG(EACH FILM<br>COATED TABLET CONTAINS:<br>NALTREXONE HYDROCHLORIDE<br>PH. EUR. 50 MG [IN WHICH ACTIVE<br>INGREDIENT NALTREXONE<br>HYDROCHLORIDE USED IS 114.000<br>KGS.])<br>1 Number<br>1<br>NALTREXONE<br>HYDROCHLORIDE EP /<br>BP / IP / USP / PH.

REXONE HYDROCHLORIDE PH. EUR. 50 MG [IN WHICH ACTIVE INGREDIENT NALTREXONE HYDROCHLORIDE USED IS 114.000 KGS.]) 1 Number 1 NALTREXONE HYDROCHLORIDE EP / BP / IP / USP / PH. EUR (All Alcoholic Solvents and water content NLT 1.86% as per COA of Import item). 51.93 mg/tablet||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||NALTREXONE HYDROCHLORIDE TABLETS 50 MG(EACH FILM COATED TABLET CONTAINS: NALTREXONE HYDROCHLORIDE PH. EUR. 50 MG [IN WHICH ACTIVE INGREDIENT NALTREXONE HYDROCHLORIDE USED IS 114.000 KGS.])||1 Number|1|NALTREXONE HYDROCHLORIDE EP / BP / IP / USP / PH. EUR (All Alcoholic Solvents and water content NLT 1.86% as per COA of Import item).|51.93 mg/tablet| ||||||||

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Case No.	Case No.	60 / NC/3/MEET/Nov/202324/16	60 / NC/3/MEET/Nov/202324/16	60 / NC/3/MEET/Nov/202324/16	60 / NC/3/MEET/Nov/202324/16	60 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00000438AM23
RA File Number		03AX04001990 AM22
Licence No and<br>Date		0311014190/26/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl.

per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 ARTEMISININ 1.04 kg. 2 SODIUM BOROHYDRIDE 0.188 kg. ARTEMETHER 1 kg. 3 TRIMETHYL ORTHO ACETATE 0.50 kg. RA concerned may take further necessary action as per above decision of NC.||||as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP applied by the firm, whichever is less:-||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||ARTEMETHER||1 kg.|1|ARTEMISININ|1.04 kg.| |||||2|SODIUM BOROHYDRIDE|0.188 kg.| |||||3|TRIMETHYL ORTHO ACETATE|0.50 kg.|

Case No.	Case No.	61 / NC/3/MEET/Nov/202324/16	61 / NC/3/MEET/Nov/202324/16	61 / NC/3/MEET/Nov/202324/16	61 / NC/3/MEET/Nov/202324/16	61 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		UNITED BIOCEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00000479AM23
RA File Number		05AX04000238 AM23
Licence No and<br>Date		0511012150/28/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.

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

UDIN00391140AM24

TRIMEBUTINE<br>MALEATE<br>TABLETS - 200MG<br>1 Number<br>1<br>TRIMEBUTINE MALEATE EP<br>203.95 mg<br>TRIMEBUTINE<br>MALEATE<br>TABLETS - 300 MG<br>1 Number<br>2<br>TRIMEBUTINE MALEATE EP<br>305.85 mg<br>RA concerned may take further necessary action as per above decision of NC	TRIMEBUTINE<br>MALEATE<br>TABLETS - 200MG	<br>1 Number	1	TRIMEBUTINE MALEATE EP	203.95 mg
	TRIMEBUTINE<br>MALEATE<br>TABLETS - 300 MG	<br>1 Number	2	TRIMEBUTINE MALEATE EP	305.85 mg

Case No.	62 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00000483AM23
RA File Number	03AX04000200 AM23
Licence No and<br>Date	0311014256/28/04/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under.<br>**Sl.

Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under. Sl. No. Export Product Quantity 1 Medical Creams & Ointments(Fusidic Acid and Betamethasone Valerate Cream 5 Gm Tube Tot Wt: 150 Kgs (Net Cont: Beta 0.18Kgs, Ceto 10.80Kgs, Fusi 3 Kgs, Macro 2.70 Kgs, Tubes 30000 Nos)) 1 Number 2 Medical Creams & Ointments(Fusidic Acid and Betamethasone Valerate Cream 15 Gm Tube Tot Wt: 2400 Kgs (Net Cont: Beta 2.91Kgs, Ceto 172.80Kgs, Fusi 48 Kgs, Macro 43.2 Kgs, Tubes 160000 Nos)) 1 Number 3 Medical Creams & Ointments(Fusidic Acid and Betamethasone Valerate Cream 30 Gm Tube Tot Wt: 3750 Kgs (Net Cont: Beta 4.55Kgs, Ceto 270Kgs, Fusi 75 Kgs, Macro 67.50 Kgs, Tubes 125000 Nos)) 1 Number 4 Medical Creams & Ointments(Fusidic Acid and Betamethasone Valerate Cream 60 Gm Tube Tot Wt: 2100 Kgs (Net Cont: Beta 2.55Kgs, Ceto 151.20Kgs, Fusi 42 Kgs, Macro 37.80 Kgs, Tubes 35000 Nos)) 1 Number 5 Medical Creams & Ointments(Fusidic Acid Cream 15 Gm Tube Tot Wt: 2400 Kgs (Net Cont: Fusi 48 Kgs, Tubes 160000 Nos)) 1 Number 6 Medical Creams &; Ointments(Fusidic Acid Cream 30 Gm Tube Tot Wt: 3000 Kgs (Net Cont: Fusi 60 Kgs, Tubes 100000 Nos)) 1 Number||

UDIN00391140AM24

bes 160000 Nos)) 1 Number 6 Medical Creams &; Ointments(Fusidic Acid Cream 30 Gm Tube Tot Wt: 3000 Kgs (Net Cont: Fusi 60 Kgs, Tubes 100000 Nos)) 1 Number||

UDIN00391140AM24

Sl. No.<br>Import Items<br>Quantity allowed.<br>1<br>Relevant Bulk Drugs<br>Net content in the export product plus 2% wastage.<br>2<br>Relevant Excipients<br>Net content in the export product plus 2% wastage.<br>3<br>Relevant Packaging Material<br>Relevant as per Packing Policy<br>Note: The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the<br>RA concerned for redemption.<br>RA concerned may take further necessary action as per above decision of NC.	Import Items	Quantity allowed.
	Relevant Bulk Drugs	Net content in the export product plus 2% wastage.
	Relevant Excipients	Net content in the export product plus 2% wastage.
	Relevant Packaging Material	Relevant as per Packing Policy

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

Case No.	Case No.	63 / NC/3/MEET/Nov/202324/16
Case Status
	e Status	Case Deferred
Par	ty Name	HARMAN FINOCHEM LIMITED

Me<br>and	eting Number	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
	Date
HQ	File Number	HQRNORM APPLY 00000485AM23

RA	File Number	03AX04000399 AM23
Lic<br>Dat	ence No and<br>e	0311014263/29/04/2022

Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>Norms Committee to explain its case alongwith Relevent information / documents.	rms Committee	Decision:
			Personal Hearing<br>before

Case No.	64 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	SAINOR LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00000500AM23
RA File Number	09AX04000372 AM22
Licence No and<br>Date	0911002924/29/04/2022
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-

UDIN00391140AM24

i. Justification of low yield i.e. 72%.

ii. Production/consumption data certified by GST for last one year.

lowing information/documents from the firm:-||

UDIN00391140AM24

i. Justification of low yield i.e. 72%.

ii. Production/consumption data certified by GST for last one year.

Case No.	65 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	SAINOR LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00000501AM23
RA File Number	09AX04000388 AM22
Licence No and<br>Date	0911002925/29/04/2022
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Justification of low yield i.e. 72%.<br>i.<br>Production/consumption data certified by GST for last one year.<br>ii.

Case No.	66 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	SAINOR LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00000502AM23
RA File Number	09AX04000389 AM22
Licence No and<br>Date	0911002926/29/04/2022
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Justification of low yield i.e. 72%.<br>i.<br>Production/consumption data certified by GST for last one year.<br>ii.

ded to call for following information/documents from the firm:- Justification of low yield i.e. 72%. i. Production/consumption data certified by GST for last one year. ii.||

Case No.	67 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00000506AM23

UDIN00391140AM24

RA File Number

09AX04000079 AM23

Licence No and Date

0911002928/29/04/2022

Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 1,2,6,7-TETRAHYDRO-8H-INDENO [5,4- B]FURAN-8-ONE 3.05 kg 2 CHLORO ACETONITRILE 2.25 kg RAMELTEON 1 Kg 3 S-IBUPROFEN 2.47 kg RA concerned may take further necessary action as per above decision of NC.

Case No.	68 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00000512AM23
RA File Number	08AX04000074 AM23
Licence No and<br>Date	0811004832/29/04/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00000512AM23| |RA File Number|08AX04000074 AM23| |Licence No and Date|0811004832/29/04/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	69 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00000513AM23
RA File Number	08AX04000823 AM22
Licence No and<br>Date	0811004833/29/04/2022
Norms Committee Decision:

UDIN00391140AM24

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No .NC/3/MEET/Oct/202324/15 dated 13/10/2023 against advance authorization No.0811002958 dated 22.10.2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

t advance authorization No.0811002958 dated 22.10.2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
VINORELBINE CONCENTRATE<br>FOR SOLUTION FOR INFUSION<br>10MG/ML, 1ML VIAL(EACH ML<br>CONTAINS:<br>VINORELBINE TARTRATE<br>PH.EUR EQ. TO VINORELBINE 10<br>MG)	1 Number	1	VINORELBINE TARTRATE<br>EP / BP / IP / USP / PH. EUR<br>(Water content 2.3 %)	14.33 mg
VINORELBINE CONCENTRATE<br>FOR SOLUTION FOR INFUSION<br>10MG/ML, 5ML VIAL(EACH ML<br>CONTAINS: VINORELBINE<br>TARTRATE PH.EUR EQ. TO<br>VINORELBINE 10 MG [IN WHICH<br>ACTIVE INGREDIENT<br>VINORELBINE TARTRATE<br>USED IS 1568.000 GRAMS])	1 Number	2	VINORELBINE TARTRATE<br>EP / BP / IP / USP / PH. EUR<br>(Water content 2.3 %)	71.66 mg

Case No.	70 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00000548AM23
RA File Number	03AX04000420 AM23
Licence No and<br>Date	0311014381/04/05/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-

UDIN00391140AM24

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

UDIN00391140AM24

Sl. No.	Export Product	Quantity
1	Medical Creams & Ointments(Bacitracin Zinc Ointment 0.5 OZ /14 GM Tube Tot Wt: 400.54Kgs<br>( Net Cont: Bacitracin 3.39 Kgs))	1 Number
2	Medical Creams & Ointments(Bacitracin Zinc Ointment 1 OZ / 28 GM Tube Tot Wt: 7597.464Kgs<br>( Net Cont: Bacitracin 64.27Kgs))	<br>1 Number
3	Medical Creams & Ointments(Double Antibiotic Ointment 0.5 OZ / 14 GM Tube Tot Wt:<br>199.78Kgs ( Net Cont: Bacitracin 1.69Kgs, Polymixin 0.37Kgs))	1 Number
4	Medical Creams & Ointments(Double Antibiotic Ointment 1 OZ / 28 GM tube Tot Wt: 1799.7Kgs<br>( Net Cont: Bacitracin 15.23Kgs, Polymixin 3.29Kgs))	1 Number
5	Medical Creams & Ointments(Triple Antibiotic Ointment W/ Pramoxine HCL 0.2 OZ / 14 GM<br>Tube Tot Wt: 2449.3Kgs (Net Cont: Baci 20.72Kgs, Poly 4.48Kgs, Neo 17.14Kgs, Pramo<br>24.98Kgs))	1 Number
6	Medical Creams & Ointments(Triple Antibiotic Ointment 0.5 OZ / 14 Gm Tube Tot Wt:<br>1213.59Kgs ( Net Cont: Baci 7.77Kgs, Poly 1.03Kgs, Neo 8.49Kgs))	1 Number
7	Medical Creams & Ointments(Triple Antibiotic Ointment 1 OZ / 28 Gm Tube Tot Wt: 785.82Kgs (<br>Net Cont: Baci 6.65Kgs, Poly 1.44Kgs, Neo 5.50Kgs))	<br>1 Number
8	Medical Creams & Ointments(Triple MS Antibiotic Ointment 1 OZ / 28 Gm Tube Tot Wt:<br>1260Kgs ( Net Cont: Baci 10.66Kgs, Poly 2.31Kgs, Neo 8.82Kgs))	1 Number

.44Kgs, Neo 5.50Kgs))|| 1 Number| |8|Medical Creams & Ointments(Triple MS Antibiotic Ointment 1 OZ / 28 Gm Tube Tot Wt: 1260Kgs ( Net Cont: Baci 10.66Kgs, Poly 2.31Kgs, Neo 8.82Kgs))||1 Number| |9|Medical Creams & Ointments(Triple MS Antibiotic Ointment 0.5 OZ / 14 Gm TubeTot Wt: 350Kgs ( Net Cont: Baci 2.96Kgs, Poly 0.64Kgs, Neo 2.45Kgs))||1 Number| |10|Medical Creams & Ointments(Triple MS Antibiotic Ointment 2 OZ / 56 Gm Tube Tot Wt: 392Kgs ( Net Cont: Baci 3.32Kgs, Poly 0.72Kgs, Neo 2.74Kgs))||1 Number| |11|Medical Creams & Ointments(Triple Antibiotic Ointment W/ Pramoxine HCL 1 OZ / 28 GM Tube Tot Wt: 560Kgs ( Net Cont: Baci 4.74Kgs, Poly 1.02Kgs, Neo 3.92Kgs, Pramo 5.71Kgs))||1 Number| |12|Medical Creams & Ointments(Triple Antibiotic Ointment W/ Pramoxine HCL 2 OZ / 56 GM Tube Tot Wt: 992.04Kgs (Net Cont: Baci 8.81Kgs, Poly 1.91Kgs, Neo 7.29Kgs, Pramo 10.62Kgs))||1 Number| ||||| |Sl. No.|Import Items|Quantity allowed.||

UDIN00391140AM24

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

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

Packaging Material|Relevant as per Packing Policy|

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

Case No.	71 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00000633AM23
RA File Number	07AX04000046 AM23
Licence No and<br>Date	0711003906/06/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>L-ORNITHINE-L-ASPARTATE<br>(Pure-pharma)<br>8.0 MT<br>1<br>L-ORNITHINE-L-ASPARTATE<br>(TECHNICAL GRADE)<br>8.08 MT<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	72 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00000635AM23
RA File Number	07AX04000115 AM23
Licence No and	0711003928/06/05/2022

UDIN00391140AM24

Date

Norms Committee Decision:

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

Complete Technical Details as per Annexure to Appendix-4E.

Case No.	73 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00000750AM23
RA File Number	34AX04000127 AM23
Licence No and<br>Date	3411002246/13/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>FOAM(MINOXIDIL TOPICAL AEROSOL<br>5% ( FOAM) 60 G CAN)<br>1Number<br>1<br>MINOXIDIL USP<br>3.06 gm.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	74 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	ANUH PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00000796AM23
RA File Number	03AX04000377 AM23
Licence No and<br>Date	0311014743/17/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00391140AM24

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

UDIN00391140AM24

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Erythromycin Thiocyanate<br>1.22 kgA<br>Erythromycin 11,12 Carbonate IP/BP/EP/USP 1 kg.<br>2<br>Ethylene Carbonate<br>0.975 kg.<br>RA concerned may take further necessary action as per above decision of NC	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	Erythromycin 11,12 Carbonate IP/BP/EP/USP	1 kg.	1	Erythromycin Thiocyanate	1.22 kgA
			2	Ethylene Carbonate	0.975 kg.

Case No.	75 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	SHIVA BIO CHEM INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00000856AM23
RA File Number	50AX04000018 AM23
Licence No and<br>Date	5011000486/18/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Soya Lecithin Powder<br>1 MT<br>1<br>Soya Lecithin Liquid<br>1.40 MT<br>RA concerned may take further necessary action as per above decision of NC.

y. Sl. No. Import Items Qty. allowed. Soya Lecithin Powder 1 MT 1 Soya Lecithin Liquid 1.40 MT RA concerned may take further necessary action as per above decision of NC.||

Case No.	76 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	VISION DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00000893AM23
RA File Number	09AX04000124 AM23
Licence No and<br>Date	0911003032/20/05/2022
Norms Committee Decision:

UDIN00391140AM24

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

Case No.	77 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	METROPOLITAN EXIMCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00000920AM23
RA File Number	03AX04000550 AM23
Licence No and<br>Date	0311014915/22/05/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	78 / NC/3/MEET/Nov/202324/16	78 / NC/3/MEET/Nov/202324/16	78 / NC/3/MEET/Nov/202324/16	78 / NC/3/MEET/Nov/202324/16	78 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00000944AM23
RA File Number		09AX04000145 AM23
Licence No and<br>Date		0911003039/23/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br> 2 6 DIFLUORO BENZYL BROMIDE<br>2BROMOMETHYL 1 3 DIFLUORO BENZENE<br>1.35 kg.<br>RUFINAMIDE<br>1 kg.<br>2<br>METHYL PROPIOLATE<br>0.66 kg.<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

kg. RUFINAMIDE 1 kg. 2 METHYL PROPIOLATE 0.66 kg. RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||RUFINAMIDE||1 kg.|1|2 6 DIFLUORO BENZYL BROMIDE 2BROMOMETHYL 1 3 DIFLUORO BENZENE|1.35 kg.| |||||2|METHYL PROPIOLATE|0.66 kg.| |||||necessary action as per above decision of NC.|||

Case No.	79 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	MAYA BIOTECH PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023

UDIN00391140AM24

and Date
HQ File Number	HQRNORM REVIW00003358AM24
RA File Number	30AX04000065 AM23
Licence No and<br>Date	3011002150/23/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case toDeptt. of Bio-Technologyfor<br>obtaining their comments.

Case No.	Case No.	80 / NC/3/MEET/Nov/202324/16	80 / NC/3/MEET/Nov/202324/16	80 / NC/3/MEET/Nov/202324/16	80 / NC/3/MEET/Nov/202324/16	80 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		HETERO DRUGS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00000975AM23
RA File Number		09AX04000080 AM23
Licence No and<br>Date		0911003042/25/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol.

|Licence No and Date||0911003042/25/05/2022||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 4-FLUORO PHENOL 5.037 kg. NEBIVOLOL HYDROCHLORIDE 1 kg. 2 DIBAH 25 % IN TOLUENE 18.02 kg. RA concerned may take further necessary action as per above decision of NC.||||as decided to fix ad-hoc norms under Para 4.07 of HBP whichever is less:-||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||NEBIVOLOL HYDROCHLORIDE||1 kg.|1|4-FLUORO PHENOL|5.037 kg.| |||||2|DIBAH 25 % IN TOLUENE|18.02 kg.|

Case No.	81 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00000976AM23
RA File Number	09AX04000136 AM23
Licence No and<br>Date	0911003043/25/05/2022
Norms Committee Decision:

UDIN00391140AM24

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

AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
FLECAINIDE ACETATE	1 kg.	1	2,2,2- Trifluoroethanol	0.917 kg.
		2	2,5- Bis (2,2,2-trifluoro ethoxy) benzoic Acid	1.084 kg.
		3	2-(Aminomethyl ) piperidine	0.390 kg.

Case No.	Case No.	82 / NC/3/MEET/Nov/202324/16	82 / NC/3/MEET/Nov/202324/16	82 / NC/3/MEET/Nov/202324/16	82 / NC/3/MEET/Nov/202324/16	82 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00000978AM23
RA File Number		09AX04000133 AM23
Licence No and Date		0911003044/25/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>5 METHOXY 1 4 TRIFLUORO<br>METHYL<br>PHENYL<br>1<br>PENTANONE<br>0.99 kg<br>2<br>DIMETHYL FORMAMIDE<br>1.98 kg<br>3<br>2<br>CHLOROETHYLAMINE<br>HCL<br>0.48 kg<br>FLUVOXAMINE MALEATE<br>1 KG<br>4<br>SODIUM<br>HYDROXIDE<br>MICRO PEARLS<br>1.313 kg
	Export Product		Qty.	Sl. No.	Import Items	Qty.

1.98 kg 3 2 CHLOROETHYLAMINE HCL 0.48 kg FLUVOXAMINE MALEATE 1 KG 4 SODIUM HYDROXIDE MICRO PEARLS 1.313 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||FLUVOXAMINE MALEATE||1 KG|1|5 METHOXY 1 4 TRIFLUORO METHYL PHENYL 1 PENTANONE| 0.99 kg| |||||2|DIMETHYL FORMAMIDE|1.98 kg| |||||3|2 CHLOROETHYLAMINE HCL| 0.48 kg| |||||4|SODIUM HYDROXIDE MICRO PEARLS| 1.313 kg|

UDIN00391140AM24

Case No.	83 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	ALTA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00000980AM23
RA File Number	03AX04000822 AM23
Licence No and<br>Date	0311014992/25/05/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	84 / NC/3/MEET/Nov/202324/16	84 / NC/3/MEET/Nov/202324/16	84 / NC/3/MEET/Nov/202324/16	84 / NC/3/MEET/Nov/202324/16	84 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00000987AM23
RA File Number		05AX04000414 AM23
Licence No and<br>Date		0511012794/25/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol.

|Licence No and Date||0511012794/25/05/2022||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 2-n-propyl-4-methyl-6-(1- methylbenzimidazol-2-yl) 0.57 kg. 2 2-Cyano-4-Methyl Biphenyl (OTBN) 0.65 kg. 3 Acetic Acid 0.824 kg. 4 Toluene 1.57 kg. 5 Methylene Chloride 1.83 kg. TELMISARTAN CRUDE (POWDER) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||TELMISARTAN CRUDE (POWDER)||1 kg.|1|2-n-propyl-4-methyl-6-(1- methylbenzimidazol-2-yl)|0.57 kg.| |||||2|2-Cyano-4-Methyl Biphenyl (OTBN)|0.65 kg.| |||||3|Acetic Acid|0.824 kg.| |||||4|Toluene|1.57 kg.| |||||5|Methylene Chloride|1.83 kg.|

Case No.	Case No.	84 / NC/3/MEET/Nov/202324/16	84 / NC/3/MEET/Nov/202324/16	84 / NC/3/MEET/Nov/202324/16	84 / NC/3/MEET/Nov/202324/16	84 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00000987AM23
RA File Number		05AX04000414 AM23
Licence No and<br>Date		0511012794/25/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol.

UDIN00391140AM24

6 Methanol 1.83 kg.

57 kg.| |||||2|2-Cyano-4-Methyl Biphenyl (OTBN)|0.65 kg.| |||||3|Acetic Acid|0.824 kg.| |||||4|Toluene|1.57 kg.| |||||5|Methylene Chloride|1.83 kg.|

UDIN00391140AM24

6 Methanol 1.83 kg.

Case No.	85 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001002AM23
RA File Number	07AX04000209 AM23
Licence No and Date	0711004103/26/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>PHLOROGLUCINOL<br>VIATRIS<br>160<br>mg<br>ODT<br>(BP/EP/USP/IP 560 KG)<br>1 Number<br>1<br>PHLOROGLUCINOL DIHYDRATE<br>163.20 mg<br>RA concerned may take further necessary action as per above decision of NC

OL VIATRIS 160 mg ODT (BP/EP/USP/IP 560 KG) 1 Number 1 PHLOROGLUCINOL DIHYDRATE 163.20 mg RA concerned may take further necessary action as per above decision of NC||

Case No.	Case No.	86 / NC/3/MEET/Nov/202324/16	86 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00001061AM23
RA File Number		03AX04000415 AM23
Licence No and<br>Date		0311015092/30/05/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Sl. No.<br>Export Product<br>Quantity
	Export Product		Quantity

UDIN00391140AM24

1	Medical Creams & Ointments(Permethrin Cream 5 % (60 Gm ) Tot Wt: 37998.48 Kgs	1 Number
	(Net Cont: Medium chain 3799.85 Kgs, Mono 1899.93Kgs, Isopropyl 379.99Kgs, Lanolin
	569.98Kgs, Polyoxy 1519.94Kgs, Tubes 633308Nos))

Import Items	Quantity allowed.
Relevant Bulk Drugs	Net content in the export product plus 2% wastage.
Relevant Excipients	Net content in the export product plus 2% wastage.
Relevant Packaging Material	Relevant as per Packing Policy

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

Case No.	87 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00004512AM24
RA File Number	03AX04000506 AM23
Licence No and<br>Date	0311015097/30/05/2022
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Complete chemistry giving of both Acetic acid and Acetic Anhydride (indicating number moles in the<br>reaction).<br>1.

Case No.	88 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	ZENFOLD SUSTAINABLE TECHNOLOGIES PRIVATELIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023

UDIN00391140AM24

HQ File Number	HQRNORM APPLY 00001090AM23
RA File Number	09AX04000132 AM23
Licence No and<br>Date	0911003083/31/05/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

090AM23| |---|---| |RA File Number|09AX04000132 AM23| |Licence No and Date|0911003083/31/05/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	89 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001128AM23
RA File Number	52AX04000054 AM23
Licence No and<br>Date	5211002565/01/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>ParaHydroxy Benzoic Acid<br>0.934 kg.<br>Methyl Paraben Sodium<br>1 kg.<br>2<br>Methanol<br>0.99 kg.<br>RA concerned may take further necessary action as per above decision of NC

Case No.	90 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001173AM23
RA File Number	03AX04001017 AM23
Licence No and<br>Date	0311015227/03/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00391140AM24

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

UDIN00391140AM24

Export Product<br>	Qty.	Sl. No.	Import Items<br>	Qty. allowed.
2,3 DI CHLORO PYRIDINE<br>	240000.0 kg.	1	3 AMINO PYRIDINE<br>	240000.0 kg.
		2	HYDROGEN PEROXIDE<br>	152880.0 kg.
		3	SODIUM NITRITE<br>	164880.0 kg.
		4	CAUSTIC SODA LYE (SODIUM<br>HYDROXIDE LYE)<br>	<br>1519200.0 kg.

Case No.	91 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM REVIW00000271AM24
RA File Number	03AX04001018 AM23
Licence No and<br>Date	0311015240/03/06/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms as under.<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

f firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under. Export Product Qty. Sl. No. Import Items Qty. allowed. Dimethyl-2-methyl glutarate (MGDM) 1 kg. 1 2-methyl glutaronitrile Crude 0.95 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	92 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023

UDIN00391140AM24

HQ File Number	HQRNORM APPLY 00001229AM23
RA File Number	03AX04000530 AM23
Licence No and<br>Date	0311015288/07/06/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>**Sl.

Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:- Sl. No. Export Product Quantity 1 Medical Cream & Ointment(CLOTRIMAZOLE 1% (10MG/G) VAGINAL CREAM 35 Gm Tot Wt 1360.10Kgs (Net Cont Clotri 13.60 Kgs, Cetyl 54.40Kgs,Octy40.80Kgs,Ceto108.81 Kgs, Tubes38860 Nos.)) 1 Number 2 Medical Cream & Ointment(CLOTRIMAZOLE 1% (10MG/G) ANTI FUNGAL CREAM 50 Gm Tot Wt 5650 Kgs (Net Cont Clotri 56.50 Kgs, Cetyl 226Kgs,Octy169.50Kgs,Ceto452Kgs, Tubes 113000 Nos.)) 1 Number 3 Medical Cream & Ointment(CLOTRIMAZOLE 1% ANTIFUNGAL CREAM 20Gm DUO Tot Wt 3780 Kgs (Net Cont Clotri 37.80 Kgs, Cetyl 151.20Kgs,Octy113.40Kgs,Ceto302.40 Kgs, Tubes 189000Nos)) 1 Number Sl. No. Import Items Quantity allowed. 1 Relevant Bulk Drugs Net content in the export product plus 2% wastage. 2 Relevant Excipients Net content in the export product plus 2% wastage. 3 Relevant Packaging Material Relevant as per Packing Policy Note: The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption. RA concerned may take further necessary action as per above decision of NC.||

Case No.	93 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023

se No.	93 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023

UDIN00391140AM24

HQ File Number	HQ File Number	HQRNORM APPLY 00001238AM23	HQRNORM APPLY 00001238AM23	HQRNORM APPLY 00001238AM23	HQRNORM APPLY 00001238AM23	HQRNORM APPLY 00001238AM23
RA File Number		03AX04000996 AM23
Licence No and Date		0311015308/07/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Beclometasone Pressurised Inhalation BP<br>50mcg/Actuation ( 200 MD)(( Net Wt. of<br>Zephex 134a /Norflurane (1,1,1,2-<br>Tetrafluoroethane is Qty.983.98 kg ))<br>100000.0<br>Number<br>1<br>ZEPHEX<br>134A<br>/<br>NORFLURANE<br>(<br>1,1,1,2-<br>TETRAFLUOROETHANE)<br>1003.66 kg<br>Beclometasone Pressurised Inhalation<br>BP100mcg/Actuation (200 MD)(( Net<br>Wt. of Zephex 134a/ Norflurane (1,1,1,2-<br>Tetrafluoroethane is Qty.982.98 kg ))<br>100000.0<br>Number<br>2<br>ZEPHEX<br>134A<br>/<br>NORFLURANE<br>(<br>1,1,1,2-<br>TETRAFLUOROETHANE)<br>1002.64 kg<br>Beclometasone Pressurised Inhalation BP<br>200mcg/Actuation (200 MD)(( Net Wt.

100000.0 Number 2 ZEPHEX 134A / NORFLURANE ( 1,1,1,2- TETRAFLUOROETHANE) 1002.64 kg Beclometasone Pressurised Inhalation BP 200mcg/Actuation (200 MD)(( Net Wt. of Zephex 134a/ Norflurane (1,1,1,2- Tetrafluoroethane is Qty.969.48 kg )) 100000.0 Number 3 ZEPHEX 134A / NORFLURANE ( 1,1,1,2- TETRAFLUOROETHANE) 988.87 kg Beclometasone Pressurised Inhalation BP 250mcg/Actuation (200 MD)(( Net Wt. of Zephex 134a/ Norflurane (1,1,1,2- Tetrafluoroethane is Qty.956.97 kg )) 100000.0 Number 4 ZEPHEX 134A / NORFLURANE ( 1,1,1,2- TETRAFLUOROETHANE) 976.11 kg Ciclesonide Pressurised Inhalation Solution 80 mcg (120 MD)(( Net Wt. of Zephex 134a/ Norflurane (1,1,1,2- Tetrafluoroethane is Qty.903.76 kg )) 137200.0 Number 5 ZEPHEX 134A / NORFLURANE ( 1,1,1,2- TETRAFLUOROETHANE) 921.84 kg Ciclesonide Pressurised Inhalation Solution 160 mcg (120 MD)(( Net Wt. of Zephex 134a/ Norflurane (1,1,1,2- Tetrafluoroethane is Qty. 898.59 kg )) 137200.0 Number 6 ZEPHEX 134A / NORFLURANE ( 1,1,1,2- TETRAFLUOROETHANE) 916.56 kg Ciclesonide Pressurised Inhalation Solution 160 mcg (60 MD)(( Net Wt. of Zephex 134a/ Norflurane (1,1,1,2- 137200.0 Number 7 ZEPHEX 134A / NORFLURANE ( 1,1,1,2- TETRAFLUOROETHANE) 458.27 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.

134a/ Norflurane (1,1,1,2- 137200.0 Number 7 ZEPHEX 134A / NORFLURANE ( 1,1,1,2- TETRAFLUOROETHANE) 458.27 kg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Beclometasone Pressurised Inhalation BP 50mcg/Actuation ( 200 MD)(( Net Wt. of Zephex 134a /Norflurane (1,1,1,2- Tetrafluoroethane is Qty.983.98 kg ))||100000.0 Number|1|ZEPHEX 134A / NORFLURANE ( 1,1,1,2- TETRAFLUOROETHANE)| 1003.66 kg| ||Beclometasone Pressurised Inhalation BP100mcg/Actuation (200 MD)(( Net Wt. of Zephex 134a/ Norflurane (1,1,1,2- Tetrafluoroethane is Qty.982.98 kg ))||100000.0 Number|2|ZEPHEX 134A / NORFLURANE ( 1,1,1,2- TETRAFLUOROETHANE)| 1002.64 kg| ||Beclometasone Pressurised Inhalation BP 200mcg/Actuation (200 MD)(( Net Wt. of Zephex 134a/ Norflurane (1,1,1,2- Tetrafluoroethane is Qty.969.48 kg ))|| 100000.0 Number|3|ZEPHEX 134A / NORFLURANE ( 1,1,1,2- TETRAFLUOROETHANE)| 988.87 kg| ||Beclometasone Pressurised Inhalation BP 250mcg/Actuation (200 MD)(( Net Wt. of Zephex 134a/ Norflurane (1,1,1,2- Tetrafluoroethane is Qty.956.97 kg ))|| 100000.0 Number|4|ZEPHEX 134A / NORFLURANE ( 1,1,1,2- TETRAFLUOROETHANE)| 976.11 kg| ||Ciclesonide Pressurised Inhalation Solution 80 mcg (120 MD)(( Net Wt.

6.97 kg ))|| 100000.0 Number|4|ZEPHEX 134A / NORFLURANE ( 1,1,1,2- TETRAFLUOROETHANE)| 976.11 kg| ||Ciclesonide Pressurised Inhalation Solution 80 mcg (120 MD)(( Net Wt. of Zephex 134a/ Norflurane (1,1,1,2- Tetrafluoroethane is Qty.903.76 kg ))||137200.0 Number|5|ZEPHEX 134A / NORFLURANE ( 1,1,1,2- TETRAFLUOROETHANE)| 921.84 kg| ||Ciclesonide Pressurised Inhalation Solution 160 mcg (120 MD)(( Net Wt. of Zephex 134a/ Norflurane (1,1,1,2- Tetrafluoroethane is Qty. 898.59 kg ))||137200.0 Number|6|ZEPHEX 134A / NORFLURANE ( 1,1,1,2- TETRAFLUOROETHANE)| 916.56 kg| ||Ciclesonide Pressurised Inhalation Solution 160 mcg (60 MD)(( Net Wt. of Zephex 134a/ Norflurane (1,1,1,2-||137200.0 Number|7|ZEPHEX 134A / NORFLURANE ( 1,1,1,2- TETRAFLUOROETHANE)| 458.27 kg|

UDIN00391140AM24

Tetrafluoroethane is Qty.449.29 kg ))

Case No.	94 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001260AM23
RA File Number	05AX04000587 AM23
Licence No and<br>Date	0511013087/08/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. NIPARIN INJECTION (HEPARIN INJECTION 5000IU/ML EACH VIAL OF 5ML) 51000 Pieces 1 Heparin Sodium IP 1300 MIU RA concerned may take further necessary action as per above decision of NC.||

Case No.	95 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001271AM23
RA File Number	09AX04000171 AM23
Licence No and<br>Date	0911003148/08/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00391140AM24

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>DIHYDRONOPOL<br>0.66 kg<br>4-(2-(2-(6,6-dimethylbicyclo<br>[3.1.1]<br>heptan-2-<br>yl)ethoxy)ethyl) morpholine<br>1 Kg<br>2<br>TOLUENE<br>1.915 kg<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	4-(2-(2-(6,6-dimethylbicyclo<br>[3.1.1]<br>heptan-2-<br>yl)ethoxy)ethyl) morpholine	1 Kg	1	DIHYDRONOPOL	0.66 kg
			2	TOLUENE	1.915 kg

||1 Number| |7|Medical Creams & Ointments(Clotrimazole10 PercentageVaginal cream 5 Gm Tube with 1 Applicator. Labelled content Clotrimazole 10 Percentage W/W;Brand Canesten or any other Tot Wt. 100Kgs (Net Cont: Clotri 10Kgs, Cetyl 3Kgs, Ceto 3.50Kgs, Emp tubes 20000Nos, Applicator 20000Nos))|| 1 Number| |8|Medical Creams & Ointments(Clotrimazole 1 Percentage Cream 5 Gm.Tube Labelled content Clotrimazole 1 Percentage W/W Brand Canesten or any other. Tot Wt. 1250Kgs (Net Cont: Clotri 12.500Kgs, Oct 236.25Kgs, Cetyl 52.50Kgs, Ceto 175Kgs, Emp tubes 350000Nos))||1 Number| |9|Medical Creams & Ointments(Clotrimazole 1 Percentage Cream 3 Gm. Tube Labelled content Clotrimazole 1 Percentage W/W Brand Canesten or any other Tot Wt. 1500Kgs (Net Cont: Clotri 15Kgs, Oct 202.50Kgs, Cetyl 45Kgs, Ceto 150Kgs, Emp tubes 500000Nos))||1 Number|

UDIN00391140AM24

Import Items	Quantity allowed.
Relevant Bulk Drugs	Net content in the export product plus 2% wastage.
Relevant Excipients	Net content in the export product plus 2% wastage.
Relevant Packaging Material	Relevant as per Packing Policy

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

Packaging Material|Relevant as per Packing Policy|

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

Case No.	Case No.	99 / NC/3/MEET/Nov/202324/16	99 / NC/3/MEET/Nov/202324/16	99 / NC/3/MEET/Nov/202324/16	99 / NC/3/MEET/Nov/202324/16	99 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		MANKIND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00001345AM23
RA File Number		05AX04000761 AM23
Licence No and<br>Date		0511013170/13/06/2022
Norms Committee Decision:<br>.<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Ofloxacin Otic Solution, 5ml(Having net<br>content of 5.83 kg of Bulk Drug), 0.3 % w/v<br>1 Number<br>1<br>OFLOXACIN USP<br>15.30 mg<br>Ofloxacin Otic Solution, 10ml(Having net<br>content of 4.01 kg of Bulk Drug), 0.3 % w/v<br>1 Number<br>2<br>OFLOXACIN USP<br>30.60 mg<br>Ofloxacin Ophthalmic Solution, USP,<br>5ml(Having net content of 13.22 kg of Bulk<br>1 Number<br>3<br>OFLOXACIN USP<br>15.30 mg
	Export Product		Qty.	Sl. No.	Import Items	Qty.

30.60 mg Ofloxacin Ophthalmic Solution, USP, 5ml(Having net content of 13.22 kg of Bulk 1 Number 3 OFLOXACIN USP 15.30 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Ofloxacin Otic Solution, 5ml(Having net content of 5.83 kg of Bulk Drug), 0.3 % w/v||1 Number|1|OFLOXACIN USP|15.30 mg| ||Ofloxacin Otic Solution, 10ml(Having net content of 4.01 kg of Bulk Drug), 0.3 % w/v||1 Number|2|OFLOXACIN USP|30.60 mg| ||Ofloxacin Ophthalmic Solution, USP, 5ml(Having net content of 13.22 kg of Bulk||1 Number|3|OFLOXACIN USP|15.30 mg|

UDIN00391140AM24

Drug), 0.3 % w/v

Case No.	100 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001346AM23
RA File Number	05AX04000760 AM23
Licence No and<br>Date	0511013171/13/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization<br>No.0511017985 dated 24/03/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.

was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Tobramycin Inhalation Solution, USP, 300mg/ 4ml(Having net content of 45.78 kg of Bulk drug) 1 Number 1 TOBRAMYCIN USP 306 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	101 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001347AM23
RA File Number	05AX04000669 AM23
Licence No and<br>Date	0511013173/13/06/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-

UDIN00391140AM24

Stoichiometric balance between import and export on molar basis.
Application/function of each Chemical in the process with justification.
Indigenous items to use in the process and accordingly to fill Appendix-4E Annexure. 4. Commercial value of the by-product, if any, and details of norms fined by Committee in past.

.**

Indigenous items to use in the process and accordingly to fill Appendix-4E Annexure. 4. Commercial value of the by-product, if any, and details of norms fined by Committee in past.

Case No.	102 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001358AM23
RA File Number	03AX04001122 AM23
Licence No and<br>Date	0311015470/13/06/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	103 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001399AM23
RA File Number	03AX04001167 AM23
Licence No and<br>Date	0311015523/15/06/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	104 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001459AM23
RA File Number	07AX04000281 AM23
Licence No and<br>Date	0711004347/17/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export

UDIN00391140AM24

and Date|0711004347/17/06/2022| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export||

UDIN00391140AM24

product/import product in meeting No.13/82-ALC4/2019 dated 31/01/2019 against advance authorization No. 0710114345 dated31/12/2018 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
MAGNESIUM ASPARTATE<br>(BP /DIHYDRATE Eur.Ph)	1 kg.	1	L-ASPARTIC ACID	1.05 kg.

Case No.	Case No.	105 / NC/3/MEET/Nov/202324/16	105 / NC/3/MEET/Nov/202324/16	105 / NC/3/MEET/Nov/202324/16	105 / NC/3/MEET/Nov/202324/16	105 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00001604AM23
RA File Number		08AX04000401 AM23
Licence No and<br>Date		0811005305/23/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Oct/202324/15 dated 13.10.2023against advance<br>authorizationNo. 0811002958 dated 22.10.2021,it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

product in meetingNo.NC/3/MEET/Oct/202324/15 dated 13.10.2023against advance authorizationNo. **0811002958 dated 22.10.2021,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. VINORELBINE CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML, 1ML VIAL(EACH ML CONTAINS: VINORELBINE TARTRATE PH.EUR EQ. TO VINORELBINE 10 MG) 1 Number 1 VINORELBINE TARTRATE EP / BP / IP / USP / PH. EUR (Water content 2.3 %) 14.33 mg VINORELBINE CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML, 5ML VIAL(EACH ML CONTAINS: VINORELBINE 1 Number 2 VINORELBINE TARTRATE EP / BP / IP / USP / PH. EUR (Water content 2.3 %) 71.66 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||VINORELBINE CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML, 1ML VIAL(EACH ML CONTAINS: VINORELBINE TARTRATE PH.EUR EQ. TO VINORELBINE 10 MG)||1 Number|1|VINORELBINE TARTRATE EP / BP / IP / USP / PH. EUR (Water content 2.3 %)|14.33 mg| ||VINORELBINE CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML, 5ML VIAL(EACH ML CONTAINS: VINORELBINE||1 Number|2|VINORELBINE TARTRATE EP / BP / IP / USP / PH. EUR (Water content 2.3 %)|71.66 mg|

UDIN00391140AM24

TARTRATE PH.EUR EQ. TO VINORELBINE 10 MG [IN WHICH ACTIVE INGREDIENT VINORELBINE TARTRATE USED IS 813.000 GRAMS])

IP / USP / PH. EUR (Water content 2.3 %)|71.66 mg|

UDIN00391140AM24

TARTRATE PH.EUR EQ. TO VINORELBINE 10 MG [IN WHICH ACTIVE INGREDIENT VINORELBINE TARTRATE USED IS 813.000 GRAMS])

Case No.	106 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001605AM23
RA File Number	08AX04000497 AM23
Licence No and<br>Date	0811005314/23/06/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	107 / NC/3/MEET/Nov/202324/16	107 / NC/3/MEET/Nov/202324/16	107 / NC/3/MEET/Nov/202324/16	107 / NC/3/MEET/Nov/202324/16	107 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00001745AM23
RA File Number		34AX04000259 AM23
Licence No and<br>Date		3411002449/29/06/2022
Norms Committee Decision:<br>Dr. Dhaval Patel, Technical Expert, Shri Dhruval Parmar (Exim) of the firm had attended the Personal Hearing and<br>explained the case.

Date||3411002449/29/06/2022||||| |Norms Committee Decision: Dr. Dhaval Patel, Technical Expert, Shri Dhruval Parmar (Exim) of the firm had attended the Personal Hearing and explained the case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has considered for review of ad-hoc norms on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under, or as applied whichever is less: - Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Propionaldehyde 0.947 kg. Undecavertol (Kakdinol) 1 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Undecavertol (Kakdinol)||1 kg.|1|Propionaldehyde|0.947 kg.|

UDIN00391140AM24

(4-Methyl-3-decen-	5-ol))		2	1-Pentanol / N Amyl Alcohol	0.709 kg.
			3	Magnesium Turning	0.182 kg.

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

.| |---|---|---|---|---|---| ||||3|Magnesium Turning|0.182 kg.|

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

Case No.	108 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001817AM23
RA File Number	03AX04001952 AM23
Licence No and<br>Date	0311016049/04/07/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Sl. No.<br>Export Product<br>Quantity<br>1<br>Medical Creams & Ointments(HYDROCORTISONE VALERATE CRM 0.2% 15GM Tot Wt:<br>225Kgs (Net Cont: Hyd 0.45Kgs, Carbo 1.13Kgs, Dibasic 0.14Kgs, Methyl 0.45Kgs, Sodium<br>0.27Kgs, Polyoxyl 9Kgs, Polyoxylethylene 0.72Kgs, Stearyl 6.75Kgs, Super 51.75Kgs, Proplylene<br>36Kgs, Tubes 15000Nos))<br>1 Number<br>2<br>Medical Creams & Ointments(HYDROCORTISONE VALERATE CRM 0.2% 45GM Tot Wt:<br>450Kgs (Net Cont: Hyd 0.90Kgs, Carbo 2.25Kgs, Dibasic 0.27Kgs, Methyl 0.90Kgs, Sodium<br>0.54Kgs, Polyoxyl 18Kgs, Polyoxylethylene 1.44Kgs, Stearyl 13.50Kgs, Super 103.5Kgs,<br>Proplylene 72Kgs, Tubes 10000Nos))<br>1 Number<br>3<br>Medical Creams & Ointments(HYDROCORTISONE VALERATE CRM 0.2% 60GM Tot Wt:<br>360Kgs (Net Cont: Hyd 0.72Kgs, Carbo 1.80Kgs, Dibasic 0.22Kgs, Methyl 0.72Kgs, Sodium<br>0.43Kgs, Polyoxyl 14Kgs, Poly

3 Medical Creams & Ointments(HYDROCORTISONE VALERATE CRM 0.2% 60GM Tot Wt: 360Kgs (Net Cont: Hyd 0.72Kgs, Carbo 1.80Kgs, Dibasic 0.22Kgs, Methyl 0.72Kgs, Sodium 0.43Kgs, Polyoxyl 14Kgs, Polyoxylethylene 1.15Kgs, Stearyl 10.80Kgs, Super82.80Kgs, Proplylene57.6Kgs, Tubes 6000Nos)) 1 Number||

UDIN00391140AM24

Sl. No.<br>Import Items<br>Quantity allowed.<br>1<br>Relevant Bulk Drugs<br>Net content in the export product plus 2% wastage.<br>2<br>Relevant Excipients<br>Net content in the export product plus 2% wastage.<br>3<br>Relevant Packaging Material<br>Relevant as per Packing Policy<br>Note: The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the<br>RA concerned for redemption.<br>RA concerned may take further necessary action as per above decision of NC.	Import Items	Quantity allowed.
	Relevant Bulk Drugs	Net content in the export product plus 2% wastage.
	Relevant Excipients	Net content in the export product plus 2% wastage.
	Relevant Packaging Material	Relevant as per Packing Policy

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

Case No.	Case No.	109 / NC/3/MEET/Nov/202324/16	109 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00001837AM23
RA File Number		03AX04001983 AM23
Licence No and<br>Date		0311016079/04/07/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Sl. No.<br>Export Product<br>Quantity<br>1<br>Medical Creams & Ointments(Miconazole Nitrate 2 % Antifungal Cream 0.5 Oz / 14 Gm Tot Wt:<br>394.8 Kgs (Net Cont: Benzoic 0.79 Kgs, Pegoxyl 78.99 Kgs, Oleoyl 11.87 Kgs, Miconazole 8.19<br>Kgs))<br>1 Number<br>2<br>Medical Creams & Ointments(Miconazole Nitrate 2 % Antifungal Cream 1 Oz / 28 Gm Tot Wt:<br>4809.7 Kgs (Net Cont: Benzoic 9.62 Kgs, Pegoxyl 962.28 Kgs, Oleoyl 144.64 Kgs, Miconazole<br>99.75 Kgs))<br>1 Number<br>3<br>Medical Creams & Ointments(Miconazole Nitrate 2 % Antifungal Cream 1.5 Oz / 42.5 Gm Tot<br>Wt: 794.33 Kgs (Net Cont: Benzoic 1.59 Kgs, Pegoxyl 158.92 Kgs, Oleoyl 23.89 Kgs,<br>Miconazole 16.47 Kgs))<br>1 Number<br>Medical Creams & Ointments(Miconazole Nitrate 2 % Vaginal Cream USP 1.59 Oz / 45 Gm<br>4<br>1 Number
	Export Product		Quantity

Oleoyl 23.89 Kgs, Miconazole 16.47 Kgs)) 1 Number Medical Creams & Ointments(Miconazole Nitrate 2 % Vaginal Cream USP 1.59 Oz / 45 Gm 4 1 Number|||| ||Export Product||Quantity| ||Medical Creams & Ointments(Miconazole Nitrate 2 % Antifungal Cream 0.5 Oz / 14 Gm Tot Wt: 394.8 Kgs (Net Cont: Benzoic 0.79 Kgs, Pegoxyl 78.99 Kgs, Oleoyl 11.87 Kgs, Miconazole 8.19 Kgs))|| 1 Number| ||Medical Creams & Ointments(Miconazole Nitrate 2 % Antifungal Cream 1 Oz / 28 Gm Tot Wt: 4809.7 Kgs (Net Cont: Benzoic 9.62 Kgs, Pegoxyl 962.28 Kgs, Oleoyl 144.64 Kgs, Miconazole 99.75 Kgs))||1 Number| ||Medical Creams & Ointments(Miconazole Nitrate 2 % Antifungal Cream 1.5 Oz / 42.5 Gm Tot Wt: 794.33 Kgs (Net Cont: Benzoic 1.59 Kgs, Pegoxyl 158.92 Kgs, Oleoyl 23.89 Kgs, Miconazole 16.47 Kgs))||1 Number| ||Medical Creams & Ointments(Miconazole Nitrate 2 % Vaginal Cream USP 1.59 Oz / 45 Gm||1 Number|

Case No.	Case No.	109 / NC/3/MEET/Nov/202324/16	109 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00001837AM23
RA File Number		03AX04001983 AM23
Licence No and<br>Date		0311016079/04/07/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>**Sl.

Decision: The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided by the firm, it was decided to revise ad-hoc norms as under:- Sl. No. Export Product Quantity 1 Medical Creams & Ointments(Miconazole Nitrate 2 % Antifungal Cream 0.5 Oz / 14 Gm Tot Wt: 394.8 Kgs (Net Cont: Benzoic 0.79 Kgs, Pegoxyl 78.99 Kgs, Oleoyl 11.87 Kgs, Miconazole 8.19 Kgs)) 1 Number 2 Medical Creams & Ointments(Miconazole Nitrate 2 % Antifungal Cream 1 Oz / 28 Gm Tot Wt: 4809.7 Kgs (Net Cont: Benzoic 9.62 Kgs, Pegoxyl 962.28 Kgs, Oleoyl 144.64 Kgs, Miconazole 99.75 Kgs)) 1 Number 3 Medical Creams & Ointments(Miconazole Nitrate 2 % Antifungal Cream 1.5 Oz / 42.5 Gm Tot Wt: 794.33 Kgs (Net Cont: Benzoic 1.59 Kgs, Pegoxyl 158.92 Kgs, Oleoyl 23.89 Kgs, Miconazole 16.47 Kgs)) 1 Number Medical Creams & Ointments(Miconazole Nitrate 2 % Vaginal Cream USP 1.59 Oz / 45 Gm 4 1 Number|||| ||Export Product||Quantity| ||Medical Creams & Ointments(Miconazole Nitrate 2 % Antifungal Cream 0.5 Oz / 14 Gm Tot Wt: 394.8 Kgs (Net Cont: Benzoic 0.79 Kgs, Pegoxyl 78.99 Kgs, Oleoyl 11.87 Kgs, Miconazole 8.19 Kgs))|| 1 Number| ||Medical Creams & Ointments(Miconazole Nitrate 2 % Antifungal Cream 1 Oz / 28 Gm Tot Wt: 4809.7 Kgs (Net Cont: Benzoic 9.62 Kgs, Pegoxyl 962.28 Kgs, Oleoyl 144.64 Kgs, Miconazole 99.75 Kgs))||1 Number|

Creams & Ointments(Miconazole Nitrate 2 % Antifungal Cream 1 Oz / 28 Gm Tot Wt: 4809.7 Kgs (Net Cont: Benzoic 9.62 Kgs, Pegoxyl 962.28 Kgs, Oleoyl 144.64 Kgs, Miconazole 99.75 Kgs))||1 Number| ||Medical Creams & Ointments(Miconazole Nitrate 2 % Antifungal Cream 1.5 Oz / 42.5 Gm Tot Wt: 794.33 Kgs (Net Cont: Benzoic 1.59 Kgs, Pegoxyl 158.92 Kgs, Oleoyl 23.89 Kgs, Miconazole 16.47 Kgs))||1 Number| ||Medical Creams & Ointments(Miconazole Nitrate 2 % Vaginal Cream USP 1.59 Oz / 45 Gm||1 Number|

UDIN00391140AM24

	with 1 Applicator Pack Tot Wt: 3421.40 Kgs (Net Cont: Benzoic 6.84 Kgs, Pegoxyl 684.52 Kgs,
	Oleoyl 102.89 Kgs, Miconazole 70.96 Kgs, Plas App 76031 Nos))
5	Medical Creams & Ointments(Miconazole Nitrate 2 % Vaginal Cream USP 1.59 Oz / 45 Gm	1 Number
	with 7 Applicator Pack Tot Wt: 35599.59 Kgs (Net Cont: Benzoic 71.20 Kgs, Pegoxyl 7122.41
	Kgs, Oleoyl 1070.55 Kgs, Miconazole 738.34 Kgs, Plas App 791102 Nos))

Import Items	Quantity allowed.
Relevant Bulk Drugs	Net content in the export product plus 2% wastage.
Relevant Excipients	Net content in the export product plus 2% wastage.
Relevant Packaging Material	Relevant as per Packing Policy

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

Case No.	110 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001959AM23
RA File Number	03AX04002151 AM23
Licence No and<br>Date	0311016241/11/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	111 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001963AM23
RA File Number	05AX04001045 AM23

UDIN00391140AM24

Licence No and 0511013693/11/07/2022 Date Norms Committee Decision:

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

Case No.	112 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001993AM23
RA File Number	34AX04000353 AM23
Licence No and<br>Date	3411002522/12/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00001993AM23| |RA File Number|34AX04000353 AM23| |Licence No and Date|3411002522/12/07/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	Case No.	113 / NC/3/MEET/Nov/202324/16	113 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00001998AM23
RA File Number		03AX04002023 AM23
Licence No and<br>Date		0311016305/12/07/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Sl. No.<br>Export Product<br>Quantity<br>1<br>Medical creams & Ointment (TRETINOIN MICROSPHERE TOPICAL GEL 0.08%<br>50ML PUMP Tot Wt:2500 Kg Net cont:TRETI 2.20Kg PROP55 Kg BUTY0.25Kg<br>ACRY162.5Kg EDET0.25Kg CARB 974P22.50Kg GLYC312.5Kg SORB4.50Kg PPG20<br>118.75Kg CYCLO57.5Kg BENZ25Kg TROL10 Kg PROP 50Kg BOT50000 No PUM<br>5000No)<br>1 Number<br>Sl. No.<br>Import Items<br>Quantity allowed.
	Import Items		Quantity allowed.

UDIN00391140AM24

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

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

Case No.	Case No.	114 / NC/3/MEET/Nov/202324/16	114 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00001999AM23
RA File Number		03AX04002195 AM23
Licence No and<br>Date		0311016306/12/07/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Sl. No.<br>Export Product<br>Quantity<br>1<br>Medical creams & Ointment(Fluocinolone Acetonide Topical Solution USP 0.01 % (60<br>ML) Tot Wt: 12300 Kgs (Net Cont: Fluocinolone 1.23 Kgs, 2 Oz. White HDPE 205000<br>Nos, White PP dropper 205000 Nos, 20MM Natural LLDPE 205000Nos))<br>1 Number<br>Sl. No.<br>Import Items<br>Quantity allowed.<br>1<br>Relevant Bulk Drugs<br>Net content in the export product plus 2% wastage.<br>2<br>Relevant Excipients<br>Net content in the export product plus 2% wastage.<br>3<br>Relevant Packaging Material<br>Relevant as per Packing Policy
	Import Items		Quantity allowed.
	Relevant Bulk Drugs		Net content in the export product plus 2% wastage.
	Relevant Excipients		Net content in the export product plus 2% wastage.
	Relevant Packaging Material		Relevant as per Packing Policy

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

UDIN00391140AM24

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

Case No.	115 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002011AM23
RA File Number	52AX04001578 AM23
Licence No and<br>Date	5211002817/13/07/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Details of items/application Methylene chloride and Methanol in the process and justify the high<br>requirement of these two.<br>i.<br>Yield of the reaction and giving calculation for the requirement of all the chemicals.<br>ii.<br>Production/consumption data for the last three years duly endorsed by GST/CA.<br>iii.

Case No.	116 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002017AM23
RA File Number	09AX04000301 AM23
Licence No and<br>Date	0911003338/13/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00002017AM23| |RA File Number|09AX04000301 AM23| |Licence No and Date|0911003338/13/07/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	117 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002018AM23

UDIN00391140AM24

RA File Number	09AX04000333 AM23
Licence No and<br>Date	0911003339/13/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	118 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002019AM23
RA File Number	09AX04000338 AM23
Licence No and<br>Date	0911003340/13/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00002019AM23| |RA File Number|09AX04000338 AM23| |Licence No and Date|0911003340/13/07/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	119 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002039AM23
RA File Number	05AX04001046 AM23
Licence No and<br>Date	0511013764/14/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Aug/202324/11 dated 22.08.2023against advance authorization<br>No. 0511006367 dated 23.11.2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Taxus Baccatta Leaves<br>1340 kg<br>Docetaxel Trihydrate<br>(Anti cancer bulk drug)<br>1 kg<br>2<br>DSC -9 [4S,5R)-2-(4-methoxyphenyl)-N-t-boc-phenyl-<br>oxazolidine-5-carboxylic acid]<br>0.888 kg<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00391140AM24

[4S,5R)-2-(4-methoxyphenyl)-N-t-boc-phenyl- oxazolidine-5-carboxylic acid] 0.888 kg RA concerned may take further necessary action as per above decision of NC.||

UDIN00391140AM24

Case No.	120 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002067AM23
RA File Number	34AX04000361 AM23
Licence No and<br>Date	3411002535/15/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	121 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002087AM23
RA File Number	09AX04000341 AM23
Licence No and<br>Date	0911003356/15/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	122 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	SYMBIOTEC PHARMALAB PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002133AM23
RA File Number	56AX04000094 AM23
Licence No and<br>Date	5611001068/19/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00002133AM23| |RA File Number|56AX04000094 AM23| |Licence No and Date|5611001068/19/07/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	123 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	ADCOCK INGRAM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002158AM23

UDIN00391140AM24

RA File Number	07AX04000582 AM23
Licence No and<br>Date	0711004714/20/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	124 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	ASTEC LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002174AM23
RA File Number	03AX04002330 AM23
Licence No and<br>Date	0311016485/21/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00002174AM23| |RA File Number|03AX04002330 AM23| |Licence No and Date|0311016485/21/07/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	125 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002179AM23
RA File Number	05AX04001164 AM23
Licence No and<br>Date	0511013888/21/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Propionic Acid<br>1.41 kg.<br>Propionic Anhydride<br>1 kg.<br>2<br>Acetic Acid Glacial<br>0.50 kg.<br>RA concerned may take further necessary action as per above decision of NC

Case No. 126 / NC/3/MEET/Nov/202324/16

UDIN00391140AM24

e 1 kg. 2 Acetic Acid Glacial 0.50 kg. RA concerned may take further necessary action as per above decision of NC||

Case No. 126 / NC/3/MEET/Nov/202324/16

UDIN00391140AM24

Case Status	Case Deferred
Party Name	STYRAX LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002187AM23
RA File Number	09AX04000313 AM23
Licence No and<br>Date	0911003379/21/07/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Export product description in agenda and in the CA certificate and Appendix 4E is mismatch. Please clarify.<br>1.

Case No.	127 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002221AM23
RA File Number	07AX04000559 AM23
Licence No and<br>Date	0711004755/23/07/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>To give Chemistry of the reaction indicating molecular weight of both reactant band product.<br>1.<br>Yield of the reaction with end uses of the export item.<br>2.

nts from the firm:- To give Chemistry of the reaction indicating molecular weight of both reactant band product. 1. Yield of the reaction with end uses of the export item. 2.||

Case No.	128 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002228AM23
RA File Number	03AX04002208 AM23
Licence No and<br>Date	0311016558/25/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

UDIN00391140AM24

Case No.	129 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	ASMEE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002262AM23
RA File Number	03AX04002314 AM23
Licence No and<br>Date	0311016599/26/07/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>To give complete chemical reaction indicating molecular weight of each chemicals with chemical formula<br>(not using abbreviation)<br>1.<br>Yield of the reaction with justification.<br>2.<br>By-product, if any, with its commercial value.<br>3.

of each chemicals with chemical formula** (not using abbreviation) 1. Yield of the reaction with justification. 2. By-product, if any, with its commercial value. 3.||

Case No.	Case No.	130 / NC/3/MEET/Nov/202324/16	130 / NC/3/MEET/Nov/202324/16	130 / NC/3/MEET/Nov/202324/16	130 / NC/3/MEET/Nov/202324/16	130 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		FDC LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00002269AM23
RA File Number		03AX04002211 AM23
Licence No and<br>Date		0311016614/26/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>OFLOXACIN OTIC SOLUTION 5<br>ML((EACH VIAL CONTAINS<br>OFLOXACIN 0.015 GM NET WT OF<br>BULK DRUG IS 2.25 KGS))<br>1 Number<br>1<br>OFLOXACIN<br>15.30 mg<br>OFLOXACIN OTIC SOLUTION 10<br>ML((EACH VIAL CONTAINS<br>OFLOXACIN 0.03 GM NET WT OF<br>BULK DRUG IS 2.25 KGS))<br>1 Number<br>2<br>OFLOXACIN<br>30.00 mg
	Export Product		Qty.	Sl. No.	Import Items	Qty.

OTIC SOLUTION 10 ML((EACH VIAL CONTAINS OFLOXACIN 0.03 GM NET WT OF BULK DRUG IS 2.25 KGS)) 1 Number 2 OFLOXACIN 30.00 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||OFLOXACIN OTIC SOLUTION 5 ML((EACH VIAL CONTAINS OFLOXACIN 0.015 GM NET WT OF BULK DRUG IS 2.25 KGS))||1 Number|1|OFLOXACIN|15.30 mg| ||OFLOXACIN OTIC SOLUTION 10 ML((EACH VIAL CONTAINS OFLOXACIN 0.03 GM NET WT OF BULK DRUG IS 2.25 KGS))||1 Number|2|OFLOXACIN|30.00 mg|

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Case No.	Case No.	131 / NC/3/MEET/Nov/202324/16	131 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00002280AM23
RA File Number		03AX04002424 AM23
Licence No and<br>Date		0311016629/26/07/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Sl. No.<br>Export Product<br>Quantity<br>1<br>Medical Creams & Ointments(Clindamycin Phosphate Topical Solution USP 1 % ( 60<br>ML) Tot Wt: 19530 Kgs (Net Cont: CLINDA 249.98Kgs, 2 Oz. HDPE 350000Nos, 24-<br>400 WHITE PP 350000Nos, DAB-O-MATIC 350000Nos.))<br>1 Number<br>2<br>Medical Creams & Ointments(Clindamycin Phosphate Topical Solution USP 1 % ( 30<br>ML) Tot Wt: 3069 Kgs (Net Cont: CLINDA 39.28Kgs, 1 Oz.

ITE PP 350000Nos, DAB-O-MATIC 350000Nos.)) 1 Number 2 Medical Creams & Ointments(Clindamycin Phosphate Topical Solution USP 1 % ( 30 ML) Tot Wt: 3069 Kgs (Net Cont: CLINDA 39.28Kgs, 1 Oz. HDPE 110,000Nos, 24-400 WHITE PP 110,000Nos, DAB-O-MATIC 110,000Nos.)) 1 Number 3 Medical Creams & Ointments(Clindamycin Phosphate & Benzoyl Peroxide Gel, 1.2%/5% (45 Gm) Tot Wt: 7499.93 Kgs (Net Cont: CLINDA 90 Kgs, HYDROUS BENZ 375 Kgs.Tubes 166665Nos )) 1 Number 4 Medical Creams & Ointments(CLINDAMYCIN PHOSPHATE TOP. LOT. 1% 60ML Tot Wt: 26968.92 Kgs (Net Cont: CLINDA 320.40 Kgs, STEARIC ACID 539.39 Kgs, KOLLIWAX CSA674.23Kgs, LDPE BOTTLE483314 Nos)) 1 Number 5 Medical Creams & Ointments(CLINDAMYCIN(PHOSPHATE) GEL30 Gm Tot Wt: 3999.84 Kgs (Net Cont: CLINDA 47.60Kgs, Tubes 133328Nos.)) 1 Number 6 Medical Creams & Ointments(CLINDAMYCIN(PHOSPHATE) GEL60 Gm Tot Wt: 3999.84 Kgs (Net Cont: CLINDA 47.60Kgs, Tubes 66664 Nos.)) 1 Number Medical Creams & Ointments(Clindamycin 10mg/g + Benzoyl Peroxide 50mg/g Gel 7 1 Number|||| ||Export Product||Quantity| ||Medical Creams & Ointments(Clindamycin Phosphate Topical Solution USP 1 % ( 60 ML) Tot Wt: 19530 Kgs (Net Cont: CLINDA 249.98Kgs, 2 Oz. HDPE 350000Nos, 24- 400 WHITE PP 350000Nos, DAB-O-MATIC 350000Nos.))||1 Number| ||Medical Creams & Ointments(Clindamycin Phosphate Topical Solution USP 1 % ( 30 ML) Tot Wt: 3069 Kgs (Net Cont: CLINDA 39.28Kgs, 1 Oz.

400 WHITE PP 350000Nos, DAB-O-MATIC 350000Nos.))||1 Number| ||Medical Creams & Ointments(Clindamycin Phosphate Topical Solution USP 1 % ( 30 ML) Tot Wt: 3069 Kgs (Net Cont: CLINDA 39.28Kgs, 1 Oz. HDPE 110,000Nos, 24-400 WHITE PP 110,000Nos, DAB-O-MATIC 110,000Nos.))||1 Number| ||Medical Creams & Ointments(Clindamycin Phosphate & Benzoyl Peroxide Gel, 1.2%/5% (45 Gm) Tot Wt: 7499.93 Kgs (Net Cont: CLINDA 90 Kgs, HYDROUS BENZ 375 Kgs.Tubes 166665Nos ))|| 1 Number| ||Medical Creams & Ointments(CLINDAMYCIN PHOSPHATE TOP. LOT. 1% 60ML Tot Wt: 26968.92 Kgs (Net Cont: CLINDA 320.40 Kgs, STEARIC ACID 539.39 Kgs, KOLLIWAX CSA674.23Kgs, LDPE BOTTLE483314 Nos))||1 Number| ||Medical Creams & Ointments(CLINDAMYCIN(PHOSPHATE) GEL30 Gm Tot Wt: 3999.84 Kgs (Net Cont: CLINDA 47.60Kgs, Tubes 133328Nos.))||1 Number| ||Medical Creams & Ointments(CLINDAMYCIN(PHOSPHATE) GEL60 Gm Tot Wt: 3999.84 Kgs (Net Cont: CLINDA 47.60Kgs, Tubes 66664 Nos.))||1 Number| ||Medical Creams & Ointments(Clindamycin 10mg/g + Benzoyl Peroxide 50mg/g Gel||1 Number|

AMYCIN(PHOSPHATE) GEL60 Gm Tot Wt: 3999.84 Kgs (Net Cont: CLINDA 47.60Kgs, Tubes 66664 Nos.))||1 Number| ||Medical Creams & Ointments(Clindamycin 10mg/g + Benzoyl Peroxide 50mg/g Gel||1 Number|

Case No.	Case No.	131 / NC/3/MEET/Nov/202324/16	131 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00002280AM23
RA File Number		03AX04002424 AM23
Licence No and<br>Date		0311016629/26/07/2022
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Sl. No.<br>Export Product<br>Quantity<br>1<br>Medical Creams & Ointments(Clindamycin Phosphate Topical Solution USP 1 % ( 60<br>ML) Tot Wt: 19530 Kgs (Net Cont: CLINDA 249.98Kgs, 2 Oz. HDPE 350000Nos, 24-<br>400 WHITE PP 350000Nos, DAB-O-MATIC 350000Nos.))<br>1 Number<br>2<br>Medical Creams & Ointments(Clindamycin Phosphate Topical Solution USP 1 % ( 30<br>ML) Tot Wt: 3069 Kgs (Net Cont: CLINDA 39.28Kgs, 1 Oz. HDPE 110,000Nos, 24-400<br>WHITE PP 110,000Nos, DAB-O-MATIC 110,000Nos.))<br>1 Number<br>3<br>Medical Creams & Ointments(Clindamycin Phosphate & Benzoyl Peroxide Gel, 1.2%/5%<br>(45 Gm) Tot Wt: 7499.93 Kgs (Net Cont: CLINDA 90 Kgs, HYDROUS BENZ 375<br>Kgs.Tubes 166665Nos ))<br>1 Number<br>4<br>Medical Creams & Ointments(CLINDAMYCIN PHOSPHATE TOP. LOT.

eroxide Gel, 1.2%/5% (45 Gm) Tot Wt: 7499.93 Kgs (Net Cont: CLINDA 90 Kgs, HYDROUS BENZ 375 Kgs.Tubes 166665Nos )) 1 Number 4 Medical Creams & Ointments(CLINDAMYCIN PHOSPHATE TOP. LOT. 1% 60ML Tot Wt: 26968.92 Kgs (Net Cont: CLINDA 320.40 Kgs, STEARIC ACID 539.39 Kgs, KOLLIWAX CSA674.23Kgs, LDPE BOTTLE483314 Nos)) 1 Number 5 Medical Creams & Ointments(CLINDAMYCIN(PHOSPHATE) GEL30 Gm Tot Wt: 3999.84 Kgs (Net Cont: CLINDA 47.60Kgs, Tubes 133328Nos.)) 1 Number 6 Medical Creams & Ointments(CLINDAMYCIN(PHOSPHATE) GEL60 Gm Tot Wt: 3999.84 Kgs (Net Cont: CLINDA 47.60Kgs, Tubes 66664 Nos.)) 1 Number Medical Creams & Ointments(Clindamycin 10mg/g + Benzoyl Peroxide 50mg/g Gel 7 1 Number|||| ||Export Product||Quantity| ||Medical Creams & Ointments(Clindamycin Phosphate Topical Solution USP 1 % ( 60 ML) Tot Wt: 19530 Kgs (Net Cont: CLINDA 249.98Kgs, 2 Oz. HDPE 350000Nos, 24- 400 WHITE PP 350000Nos, DAB-O-MATIC 350000Nos.))||1 Number| ||Medical Creams & Ointments(Clindamycin Phosphate Topical Solution USP 1 % ( 30 ML) Tot Wt: 3069 Kgs (Net Cont: CLINDA 39.28Kgs, 1 Oz. HDPE 110,000Nos, 24-400 WHITE PP 110,000Nos, DAB-O-MATIC 110,000Nos.))||1 Number| ||Medical Creams & Ointments(Clindamycin Phosphate & Benzoyl Peroxide Gel, 1.2%/5% (45 Gm) Tot Wt: 7499.93 Kgs (Net Cont: CLINDA 90 Kgs, HYDROUS BENZ 375 Kgs.Tubes 166665Nos ))|| 1 Number| ||Medical Creams & Ointments(CLINDAMYCIN PHOSPHATE TOP. LOT.

l Peroxide Gel, 1.2%/5% (45 Gm) Tot Wt: 7499.93 Kgs (Net Cont: CLINDA 90 Kgs, HYDROUS BENZ 375 Kgs.Tubes 166665Nos ))|| 1 Number| ||Medical Creams & Ointments(CLINDAMYCIN PHOSPHATE TOP. LOT. 1% 60ML Tot Wt: 26968.92 Kgs (Net Cont: CLINDA 320.40 Kgs, STEARIC ACID 539.39 Kgs, KOLLIWAX CSA674.23Kgs, LDPE BOTTLE483314 Nos))||1 Number| ||Medical Creams & Ointments(CLINDAMYCIN(PHOSPHATE) GEL30 Gm Tot Wt: 3999.84 Kgs (Net Cont: CLINDA 47.60Kgs, Tubes 133328Nos.))||1 Number| ||Medical Creams & Ointments(CLINDAMYCIN(PHOSPHATE) GEL60 Gm Tot Wt: 3999.84 Kgs (Net Cont: CLINDA 47.60Kgs, Tubes 66664 Nos.))||1 Number| ||Medical Creams & Ointments(Clindamycin 10mg/g + Benzoyl Peroxide 50mg/g Gel||1 Number|

UDIN00391140AM24

	30Gm Tot Wt: 1440 Kgs (Net Cont: CLINDA 14.40 Kgs, BENZOYL 72 Kgs, Tubes
	48000 Nos))
8	Medical Creams & Ointments(Clindamycin 10mg/g + Benzoyl Peroxide 50mg/g Gel 60	1 Number
	Gm Tot Wt: 1559.94 Kgs (Net Cont: CLINDA 15.60 Kgs, BENZOYL 111.38 Kgs, Tubes
	25999 Nos))

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

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

Case No.	Case No.	132 / NC/3/MEET/Nov/202324/16	132 / NC/3/MEET/Nov/202324/16	132 / NC/3/MEET/Nov/202324/16	132 / NC/3/MEET/Nov/202324/16	132 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		SOHAN HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00002282AM23
RA File Number		31AX04000121 AM23
Licence No and<br>Date		3111001587/26/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>METFORMIN HYDROCHLORIDE<br>DIRECT COMPRESSIBLE<br>GRANULES 86.66% W/W WHITE<br>1 kg.<br>1<br>DICYANDIAMIDE (DCDA)<br>WHITE POWDER<br>0.484 kg.
	Export Product		Qty.	Sl. No.	Import Items<br>	Qty. allowed.
	METFORMIN HYDROCHLORIDE<br>DIRECT COMPRESSIBLE<br>GRANULES 86.66% W/W WHITE		1 kg.	1	DICYANDIAMIDE (DCDA)<br>WHITE POWDER	0.484 kg.

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GRANULES POWDER

Case No.	133 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002284AM23
RA File Number	09AX04000361 AM23
Licence No and<br>Date	0911003407/26/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Sep/202324/14 dated 27.09.2023against advance authorization<br>No. 0911005558 dated 03.08.2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>Acetone<br>12.23 kg<br>2<br>BENZHYDRYL<br>6,6-<br>DIHYDROPENICILLANATE-1-<br>OXIDE<br>6.38 kg<br>3<br>Carbon Enoanticromos<br>0.200 kg<br>4<br>Dimethylformamide (D M F)<br>18.87 kg<br>5<br>Methanol (Methyl Alcohol)<br>3.09 kg<br>Tazobactam( Tazobactam Anhydrous)<br>1 kg<br>6<br>Methylene Chloride<br>10.76 kg<br>RA concerned may take further necessary action as per above decision of NC

UDIN00391140AM24

3.09 kg Tazobactam( Tazobactam Anhydrous) 1 kg 6 Methylene Chloride 10.76 kg RA concerned may take further necessary action as per above decision of NC||

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Case No.	134 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002294AM23
RA File Number	09AX04000377 AM23
Licence No and<br>Date	0911003411/27/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	135 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	SAINOR LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002317AM23
RA File Number	09AX04000364 AM23
Licence No and<br>Date	0911003412/28/07/2022
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>**Justification of low yield i.e.

on: The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following information/documents from the firm:- Justification of low yield i.e. 72%. i. Production/consumption data certified by GST for last one year. ii.|| ||| |Case No.|136 / NC/3/MEET/Nov/202324/16| |Case Status|Case Deferred| |Party Name|ALEMBIC PHARMACEUTICALS LIMITED| |Meeting Number and Date|NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023| |HQ File Number|HQRNORM APPLY 00002358AM23| |RA File Number|34AX04000398 AM23| |Licence No and Date|3411002586/29/07/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No. 137 / NC/3/MEET/Nov/202324/16

UDIN00391140AM24

Case Status	Case Deferred
Party Name	RA CHEM PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002388AM23
RA File Number	09AX04000378 AM23
Licence No and<br>Date	0911003424/01/08/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00002388AM23| |RA File Number|09AX04000378 AM23| |Licence No and Date|0911003424/01/08/2022| |Norms Committee Decision: The case is under consideration for want of comments of TE.||

Case No.	138 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	LEBEN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002393AM23
RA File Number	03AX04002517 AM23
Licence No and<br>Date	0311016775/01/08/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Apr/202223/1 dated 29/04/2021against advance authorization No.0311009732 dated<br>23.12.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>DOXYLEB CAPSULES (DOXYCYCLINE<br>HYCLATE CAPSULES BP)100MG(IN<br>PACKING OF 10sx10, 10sx100 &<br>1000s. QTY CONSUMED OF EXEMPT<br>MATERIAL DOXYCYCLINE HYCLATE<br>BP-117MG/CAPSULE)<br>7051282 Number<br>1<br>DOXYCYCLINE<br>HYCLATE BP<br>813.72 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	139 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	S.V.CHEM INTERMEDIATES PRIVATE LIMITED

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action as per above decision of NC.||

Case No.	139 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	S.V.CHEM INTERMEDIATES PRIVATE LIMITED

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Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002400AM23
RA File Number	04AX04000404 AM23
Licence No and<br>Date	0411003747/02/08/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meeting No.NC/3/MEET/Mar/202223/22dated24/03/2023against advance<br>authorizationNo. 0411004409 dated 07/11/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>CBZ-L-Valine(CBZ-L-Valine)<br>1 kg.<br>1<br>L - Valine<br>0.50 kg.<br>RA concerned may take further necessary action as per above decision of NC.

o.** Import Items Qty. allowed. CBZ-L-Valine(CBZ-L-Valine) 1 kg. 1 L - Valine 0.50 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	140 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	APTRA SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002435AM23
RA File Number	09AX04000268 AM23
Licence No and<br>Date	0911003430/03/08/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Chemical reaction of making export item indicating stages where solvent is used.<br>1.<br>Calculation for the requirement of solvent indicating quantity recycling to reuse.<br>2.<br>Production/Consumption data duly endorsed by GST.<br>3.

Case No.	141 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	NIFTY LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002449AM23

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RA File Number	09AX04000391 AM23
Licence No and<br>Date	0911003436/03/08/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

40AM24

RA File Number	09AX04000391 AM23
Licence No and<br>Date	0911003436/03/08/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	142 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00002474AM23
RA File Number	34AX04000434 AM23
Licence No and<br>Date	3411002610/04/08/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	143 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	NEULAND LABORATORIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001017AM24
RA File Number	09AX04000149 AM24
Licence No and<br>Date	0911005088/22/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization<br>No.0911004910 dated 28/04/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>IBREXAFUNGERP CITRATE<br>1 kg.<br>1<br>ENFUMAFUNGIN<br>4.55 kg.<br>RA concerned may take further necessary action as per above decision of NC

Qty. Sl. No. Import Items Qty. allowed. IBREXAFUNGERP CITRATE 1 kg. 1 ENFUMAFUNGIN 4.55 kg. RA concerned may take further necessary action as per above decision of NC||

Case No.	144 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved

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Party Name	NEULAND LABORATORIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001148AM24
RA File Number	09AX04000170 AM24
Licence No and<br>Date	0911005122/26/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization<br>No.0911004910 dated 28/04/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>IBREXAFUNGERP CITRATE<br>1 kg.<br>1<br>ENFUMAFUNGIN<br>4.55 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Qty. Sl. No. Import Items Qty. allowed. IBREXAFUNGERP CITRATE 1 kg. 1 ENFUMAFUNGIN 4.55 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	145 / NC/3/MEET/Nov/202324/16	145 / NC/3/MEET/Nov/202324/16	145 / NC/3/MEET/Nov/202324/16	145 / NC/3/MEET/Nov/202324/16	145 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		LEBEN LABORATORIES PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00001232AM24
RA File Number		03AX04000970 AM24
Licence No and Date		0311024107/01/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Apr/202223/1 dated 29/04/2022against advance<br>authorizationNo.0311009732 dated 23/12/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>DOXYLEB CAPSULE<br>(DOXYCYCLINE HYCLATE<br>CAPSULES BP) 100MG (IN PACKING<br>OF 10x10s, 10 x 100s &<br>1000s. QTY CONSUMED OF EXEMPT<br>9965338<br>Numbers<br>1<br>DOXYCYCLINE HYCLATE BP<br>1150 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.<br>allowed.
	DOXYLEB CAPSULE<br>(DOXYCYCLINE HYCLATE<br>CAPSULES BP) 100MG (IN PACKING<br>OF 10x10s, 10 x 100s &<br>1000s.

ATE BP 1150 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||DOXYLEB CAPSULE (DOXYCYCLINE HYCLATE CAPSULES BP) 100MG (IN PACKING OF 10x10s, 10 x 100s & 1000s. QTY CONSUMED OF EXEMPT||9965338 Numbers|1|DOXYCYCLINE HYCLATE BP|1150 kg.|

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MATERIAL DOXYCYCLINE HYCLATE BP-115.400MG/CAPSULE)

Case No.	146 / NC/3/MEET/Nov/202324/16
Case Status	Case Deferred
Party Name	LOZEN PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001379AM24
RA File Number	03AX04001008 AM24
Licence No and<br>Date	0311024330/07/06/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No.	Case No.	147 / NC/3/MEET/Nov/202324/16	147 / NC/3/MEET/Nov/202324/16	147 / NC/3/MEET/Nov/202324/16	147 / NC/3/MEET/Nov/202324/16	147 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00001436AM24
RA File Number		03AX04001014 AM24
Licence No and<br>Date		0311024400/09/06/2023

and Date||NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023||||| |HQ File Number||HQRNORM APPLY 00001436AM24||||| |RA File Number||03AX04001014 AM24||||| |Licence No and Date||0311024400/09/06/2023||||| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meetingNo.NC.3/MEET/Aug/202223/6 dated 09/09/2022against advance authorization No.0311009926 dated 30/12/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Fenofibrate Micronized IH/Ph.Eur 0.3155 kg. 2 Hypromellose (2910, 3 cps) Ph. Eur 0.0625 kg. 3 Docusate Sodium Ph.Eur 0.0062 kg. Fenofibrate Bulk Granulate 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Fenofibrate Bulk Granulate||1 kg.|1|Fenofibrate Micronized IH/Ph.Eur|0.3155 kg.| |||||2|Hypromellose (2910, 3 cps) Ph. Eur|0.0625 kg.| |||||3|Docusate Sodium Ph.Eur|0.0062 kg.|

UDIN00391140AM24

4<br>Sucrose Ph.Eur<br>0.3124 kg.<br>5<br>Sodium Lauril Sulfate Ph.Eur<br>0.0216 kg.<br>6<br>Lactose Monohydrate Ph.Eur<br>0.2804 kg.<br>RA concerned may take further necessary action as per above decision of NC.			4	Sucrose Ph.Eur	0.3124 kg.
			5	Sodium Lauril Sulfate Ph.Eur	0.0216 kg.
			6	Lactose Monohydrate Ph.Eur	0.2804 kg.

necessary action as per above decision of NC.			4	Sucrose Ph.Eur	0.3124 kg.
			5	Sodium Lauril Sulfate Ph.Eur	0.0216 kg.
			6	Lactose Monohydrate Ph.Eur	0.2804 kg.

Case No.	Case No.	148 / NC/3/MEET/Nov/202324/16	148 / NC/3/MEET/Nov/202324/16	148 / NC/3/MEET/Nov/202324/16	148 / NC/3/MEET/Nov/202324/16	148 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00001707AM24
RA File Number		03AX04001130 AM24
Licence No and<br>Date		0311024614/16/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/MEET/Mar/202122/15 dated 17/03/2022against advance authorization<br>No.0311001453 dated 12/02/2021, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Fenofibrate Micronized IH/Ph Eur 147.90 mg. Tablets/Capsules namely Fenofibrate 145mg tablets) (70200000 NOS)Nos)(Net Content:1)10298.340 KGS 2) 10219.014 KGS 3) (Indi):2073.708KGS 4) (Indi):202.878KGS 5) (Indi):705.510KGS 6) (Indi):9170.226KGS 7) (Indi):5977.530KGS 8) (Indi):5242.536KGS 9) (Indi):63.180KGS 10)(Indi): 2084.940KGS) 1 kg. 2 Sucrose PH.Eur (exepient) 143.575 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Tablets/Capsules namely Fenofibrate 145mg tablets) (70200000 NOS)Nos)(Net Content:1)10298.340 KGS 2) 10219.014 KGS 3) (Indi):2073.708KGS 4) (Indi):202.878KGS 5) (Indi):705.510KGS 6) (Indi):9170.226KGS 7) (Indi):5977.530KGS 8) (Indi):5242.536KGS 9) (Indi):63.180KGS 10)(Indi): 2084.940KGS)||1 kg.|1|Fenofibrate Micronized IH/Ph Eur|147.90 mg.| |||||2|Sucrose PH.Eur (exepient)|143.575 mg.| ||||||||

UDIN00391140AM24

5242.536KGS 9) (Indi):63.180KGS 10)(Indi): 2084.940KGS)||1 kg.|1|Fenofibrate Micronized IH/Ph Eur|147.90 mg.| |||||2|Sucrose PH.Eur (exepient)|143.575 mg.| ||||||||

UDIN00391140AM24

Case No.	149 / NC/3/MEET/Nov/202324/16
Case Status	Case Approved
Party Name	NEULAND LABORATORIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number	HQRNORM APPLY 00001908AM24
RA File Number	09AX04000226 AM24
Licence No and<br>Date	0911005228/19/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jun/202324/8 dated 30/06/2023against advance authorization<br>No.0911004910 dated 28/04/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>IBREXAFUNGERP CITRATE<br>1 kg.<br>1<br>ENFUMAFUNGIN<br>4.55 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Qty. Sl. No. Import Items Qty. allowed. IBREXAFUNGERP CITRATE 1 kg. 1 ENFUMAFUNGIN 4.55 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	150 / NC/3/MEET/Nov/202324/16	150 / NC/3/MEET/Nov/202324/16	150 / NC/3/MEET/Nov/202324/16	150 / NC/3/MEET/Nov/202324/16	150 / NC/3/MEET/Nov/202324/16
Case Status		Case Approved
Party Name		MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202324/ 16 and 17/11/2023
HQ File Number		HQRNORM APPLY 00002160AM24
RA File Number		03AX04001241 AM24
Licence No and<br>Date		0311024825/23/06/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Chloroquine Phosphate (CQP)<br>1 kg.<br>1<br>NOVALDIAMINE<br>0.411 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Chloroquine Phosphate (CQP)		1 kg.	1	NOVALDIAMINE	0.411 kg.

UDIN00391140AM24

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