IN FORCE Advance Authorisation

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Government of India / भारत सरकार

Ministry of Commerce and Industry / वािणज्य और उद्योग मंत्रालय

Department of Commerce / वािणज्य िवभाग

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

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Mar/202223/24 DATED: 13/04/2023

Please Note

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

Meeting No. NC/3/MEET/Mar/202223/24 dated 13/04/2023 of Norms Committee - III for the year 2023-24 was held on 13/04/2023 under the Chairmanship of Rajiv Soni ,Joint DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

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

The following members were present in the meeting:-

	Name and Designation of Representatives	Department
1	T SONGZALIAN,Deputy DGFT	DGFT(HQ)
2	NAND Lal,Technical Consultant	DPIIT
3	SHAISH KUMAR,Technical Consultant	DGFT
4	DINESHNARAIN MATHUR,Technical<br>Consultant	DGFT
5	T SONGZALIAN,Deputy DGFT	Directorate General of Foreign Trade, Delhi

This document has been digitally signed by T SONGZALIAN, Deputy DGFT on 16-05-2023 11:53:52.

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Mar/202223/24
Case Status	Case Rejected
Party Name	BIO-GEN EXTRACTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00003010AM23
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:
"The firm had claimed that import item is not dispersible in cold water."The committee requested the applicant to submit
the documents to show whether the import item is dispersible in cold water or not but failed to do show. Further, the committee
had given an opportunity to the applicant a personal hearing through email dated01.02.2023. During the personal hearing on
07.02.2023, it was requested by the technical team to the applicant to submit specific documents i.e., CoA (Certificate of analysis)
to the import item. However, the firm has still failed to furnish the same, hence, the committee has decided to reject the case. The
applicant has the right to file a review before the committee along with corroborated documents within 90 days in terms of para
4.17 of HBP-2023.

mittee has decided to reject the case. The|| |applicant has the right to file a review before the committee along with corroborated documents within 90 days in terms of para|| |4.17 of HBP-2023.||

Case No.	2 / NC/3/MEET/Mar/202223/24
Case Status	Case Rejected
Party Name	BIO-GEN EXTRACTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00003011AM23
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:
"The firm had claimed that import item is not dispersible in cold water."The committee requested the applicant to submit
the documents to show whether the import item is dispersible in cold water or not but failed to do show. Further, the committee
had given an opportunity to the applicant a personal hearing through email dated01.02.2023. During the personal hearing on
07.02.2023, it was requested by the technical team to the applicant to submit specific documents i.e., CoA (Certificate of analysis)
to the import item. However, the firm has still failed to furnish the same, hence, the committee has decided to reject the case. The
applicant has the right to file a review before the committee along with corroborated documents within 90 days in terms of para
4.17 of HBP-2023.

mittee has decided to reject the case. The|| |applicant has the right to file a review before the committee along with corroborated documents within 90 days in terms of para|| |4.17 of HBP-2023.||

Case No.	3 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	SUDEEP NUTRITION PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00004919AM23
RA File Number	NA
Licence No and	NA

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Date

Norms Committee Decision:

The Committee considered the request of firm for fixation of adhoc norms to enable them to obtain Advance Authorization from concerned RA and it was decided to fix adhoc norms as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items		Qty.
Vitamin A Palmitate 250CWS	7500 kg.	1	Vitamin A Palmitate 1.7	MIU	1125 kg.
(Each gram of export item will contain
2,50,000 IU of Vitamin A Palmitate)

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

A Palmitate 1.7|MIU|1125 kg.| |(Each gram of export item will contain|||||| |2,50,000 IU of Vitamin A Palmitate)||||||

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

Case No.	4 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	SUDEEP NUTRITION PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00004920AM23
RA File Number	NA
Licence No and<br>Date	NA
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 calculation sheet certified by GST/CA.<br>1.

Case No.	5 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	SUDEEP NUTRITION PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00004921AM23
RA File Number	NA
Licence No and<br>Date	NA
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

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information/documents from the firm:-

Complete calculation sheet certified by GST/CA.

review/fixation of ad-hoc norms and it was decided to call for following||

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information/documents from the firm:-

Complete calculation sheet certified by GST/CA.

Case No.	6 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	AQUILA ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00005454AM23
RA File Number	NA
Licence No and<br>Date	0310830783/null
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Chemistry with calculation giving molecular weight of reactant & product with efficiency of the reaction.<br>i.<br>Justification of yield and the commercial value of by product, if any.<br>ii.

Case No.	Case No.	7 / NC/3/MEET/Mar/202223/24	7 / NC/3/MEET/Mar/202223/24	7 / NC/3/MEET/Mar/202223/24	7 / NC/3/MEET/Mar/202223/24	7 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		HQRNORM APPLY 00006697AM23
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 against Advance Authorization No. 0910062138 dated<br>05.06.2015 having RA F. No.

te||NA||||| |Norms Committee Decision: The Committee considered the request of firm for fixation of ad-hoc norms against Advance Authorization No. 0910062138 dated 05.06.2015 having RA F. No. 09/24/040/00105/AM16 and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as ||||||| |per details given below or as applied by the firm, whichever is less:-||||||| |||||||| |||||||| ||E Pd|||Sl N|I I|| ||xport rouc|t|Qty.|. o.|mport tems|Qty.| |||||||| ||Sofosbuvir||1 kg|1|2-Deoxy-2-fluoro-2-C-methyluridine (or) 1-[(2R 3R 4R| 0.87 kg| ||||||5R)-3-fluoro-4-hydroxy-5-(hydroxymethyl)-3-methyl || ||||||tetrahydrofuran-2-yl]pyrimidine-2 4(1H 3H)-dione (2- deoxy-2-fluoro-2-C-methyluridine)|| |||||||| ||||||||

Case No.	Case No.	7 / NC/3/MEET/Mar/202223/24	7 / NC/3/MEET/Mar/202223/24	7 / NC/3/MEET/Mar/202223/24	7 / NC/3/MEET/Mar/202223/24	7 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		HQRNORM APPLY 00006697AM23
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 against Advance Authorization No. 0910062138 dated<br>05.06.2015 having RA F. No. 09/24/040/00105/AM16 and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.

fixation of ad-hoc norms against Advance Authorization No. 0910062138 dated 05.06.2015 having RA F. No. 09/24/040/00105/AM16 and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as ||||||| |per details given below or as applied by the firm, whichever is less:-||||||| |||||||| |||||||| ||E Pd|||Sl N|I I|| ||xport rouc|t|Qty.|. o.|mport tems|Qty.| |||||||| ||Sofosbuvir||1 kg|1|2-Deoxy-2-fluoro-2-C-methyluridine (or) 1-[(2R 3R 4R| 0.87 kg| ||||||5R)-3-fluoro-4-hydroxy-5-(hydroxymethyl)-3-methyl || ||||||tetrahydrofuran-2-yl]pyrimidine-2 4(1H 3H)-dione (2- deoxy-2-fluoro-2-C-methyluridine)|| |||||||| ||||||||

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	2	L-Alanine Isopropyl Ester Hydro Chloride	1.80 kg.
	3	Phenyl Diclorophosphate	1.58 kg.
	4	Penta Fluorophenol	1.16 kg.

A bove proposed norms are for regularization and closure only. No repeat license will be issued on the basis of above decision of Norms Committee.

.58 kg.| ||4|Penta Fluorophenol|1.16 kg.|

A bove proposed norms are for regularization and closure only. No repeat license will be issued on the basis of above decision of Norms Committee.

	2<br>L-Alanine Isopropyl Ester Hydro Chloride<br>1.80 kg.<br>3<br>Phenyl Diclorophosphate<br>1.58 kg.<br>4<br>Penta Fluorophenol<br>1.16 kg.	2<br>L-Alanine Isopropyl Ester Hydro Chloride<br>1.80 kg.<br>3<br>Phenyl Diclorophosphate<br>1.58 kg.<br>4<br>Penta Fluorophenol<br>1.16 kg.	2<br>L-Alanine Isopropyl Ester Hydro Chloride<br>1.80 kg.<br>3<br>Phenyl Diclorophosphate<br>1.58 kg.<br>4<br>Penta Fluorophenol<br>1.16 kg.
Abo<br>deci<br>RA c	2<br>3<br>4	L-Alanine Isopropyl Ester Hydro Chloride	1.80 kg.
		Phenyl Diclorophosphate	1.58 kg.
		Penta Fluorophenol	1.16 kg.

---|---|---| |Abo deci RA c||||2 3 4|L-Alanine Isopropyl Ester Hydro Chloride||1.80 kg.|| ||||||Phenyl Diclorophosphate||1.58 kg.|| ||||||Penta Fluorophenol||1.16 kg.|| |||||||||| ||ve proposed norms ||are for regularization and closure only. No repeat license will be issued on the basis of above |||||| ||sion of Norms Com||mittee.|||||| ||oncerned may take fu||rther necessary action as per above decision of NC.|||||| |||||||||| |||||||||| |Case||||||||| ||No.|8 / N|C/3/MEET/Mar/202223/24|||||| |Case||||||||| ||Status|Case|Approved|||||| |Part|y Name|OPT|IMUS DRUGS PRIVATE LIMITED|||||| |Mee and|ting Number|NC/|3/ MEET/ Mar/ 202223/ 24 and 13/04/2023|||||| ||Date|||||||| |HQ|File Number|HQR|NORM APPLY 00007002AM23|||||| |RA|File Number|NA||||||| |Lice Date|nce No and|NA||||||| |||||||||| |Norms Committee Decision: The Committee considered the request of firm for fixation of ad-hoc norms against Advance Authorization No. 0910062516 dated 18.08.2015 having RA F. No. 09/24/040/00231/AM16 and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl.

/24/040/00231/AM16 and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 2-Deoxy-2-fluoro-2-C-methyluridine (or) 1-[(2R 3R 4R 5R)-3-fluoro-4-hydroxy-5-(hydroxymethyl)-3-methyl tetrahydrofuran-2-yl]pyrimidine-2 4(1H 3H)-dione (2- deoxy-2-fluoro-2-C-methyluridine) 0.87 kg 2 L-Alanine Isopropyl Ester Hydro Chloride 1.80 kg. 3 Phenyl Diclorophosphate 1.58 kg. Sofosbuvir 1 kg 4 Penta Fluorophenol 1.16 kg. Above proposed norms are for regularization and closure only. No repeat license will be issued on the basis of above|ms Committee Decis Committee considered 8.2015 having RA F. etails given below or||ion: the request of firm for fixation of ad-hoc norms against Advance Authorization No. 0910062516 dated No. 09/24/040/00231/AM16 and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as as applied by the firm, whichever is less:-||||| | ||Export Product||Qty.|Sl. No.|Import Items|Qty.||| |||||||||| ||Sofosbuvir||1 kg|1|2-Deoxy-2-fluoro-2-C-methyluridine (or) 1-[(2R 3R 4R 5R)-3-fluoro-4-hydroxy-5-(hydroxymethyl)-3-methyl tetrahydrofuran-2-yl]pyrimidine-2 4(1H 3H)-dione (2- deoxy-2-fluoro-2-C-methyluridine)| 0.87 kg||| |||||2|L-Alanine Isopropyl Ester Hydro Chloride|1.80 kg.||| |||||3|Phenyl Diclorophosphate|1.58 kg.||| |||||4|Penta Fluorophenol|1.16 kg.|||

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decision of Norms Committee.

Case No.	Case No.	9 / NC/3/MEET/Mar/202223/24	9 / NC/3/MEET/Mar/202223/24	9 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		GLAND PHARMA LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		HQRNORM REVIW00006484AM23
RA File Number		092404000497 AM13
Licence No and<br>Date		0910054771/11/01/2013
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and taking cue from the earlier decision for same<br>export product/import product in meeting No.NC/3/MEET/Mar/202223dated24/03/2023against advance authorization no.<br>0910058787dated31/12/2013, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per earlier decision/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>Nadroparin Calcium<br>52.25 mg<br>2<br>Barrel Syringes<br>1.0534 Nos.<br>3<br>Needle Shield<br>1.0451 Nos.<br>4<br>Plunger Stoppers<br>1.1091 Nos.<br>5<br>Plunger Rods<br>1.0294 Nos.<br>6<br>Preventis<br>1.05 Nos.<br>7<br>Anti Factor Xa Test Kits<br>Not admissible<br>8<br>Anti Factor IIa Test Kits<br>Not admissible<br>9<br>Analytical Columns<br>Not admissible<br>Nadroparin Calcium Injection<br>(Low Molecular Weight Heparin)<br>5700 IU/0.6ml in a PFS<br>1 Number
	Export product		Qty.	Sl.

r>Not admissible 9 Analytical Columns Not admissible Nadroparin Calcium Injection (Low Molecular Weight Heparin) 5700 IU/0.6ml in a PFS 1 Number||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Nadroparin Calcium Injection (Low Molecular Weight Heparin) 5700 IU/0.6ml in a PFS|| 1 Number|1|Nadroparin Calcium|52.25 mg| |||||2|Barrel Syringes|1.0534 Nos.| |||||3|Needle Shield|1.0451 Nos.| |||||4|Plunger Stoppers|1.1091 Nos.| |||||5|Plunger Rods|1.0294 Nos.| |||||6|Preventis|1.05 Nos.| |||||7|Anti Factor Xa Test Kits|Not admissible| |||||8|Anti Factor IIa Test Kits|Not admissible| |||||9|Analytical Columns|Not admissible|

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

cal Grade Paper|0.9 gram| ||12|Tubing|0.020 cms| ||13|Anti Factor Xa|Not admissible| ||14|Anti Factor IIa|Not admissible| ||15|N.M.R. Standard|Not admissible| ||16|Mol.Wt.Standard|Not admissible|

Case No.<br>10 / NC/3/MEET/Mar/202223/24	Case No.<br>10 / NC/3/MEET/Mar/202223/24
Case Status<br>Case Approved
Party Name<br>GLAND PHARMA LTD
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number<br>HQRNORM REVIW00006483AM23
RA File Number<br>092404000294 AM14
Licence No and<br>Date<br>0910057628/19/09/2013
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.08/82-ALC4/2015 dated 16/09/2015against advance authorizationNo.0910061096 dated
15/10/2014, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per earlier decision/details given below or
as applied by the firm, whichever is less: -
Export Product	Qty.	Sl. No.	Import Items	Qty.
Adenosine Injection USP Prefilled	1 Number	1	Adenosine	0.0132 gm./vial
Syringe 3mg/ml, 4ml in a PFS		2	Barrel Syringes	1.1095 numbers

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3	V-OVS 10.6 Tip Caps	1.03 numbers
4	Plunger Stoppers	1.1481 numbers
5	Plunger Rods	1.03 numbers
6	Filters (Plastic)	Consumable on Net
		to Net basis.
7	Tubing (Plastic)
8	Reference Standards

| |---|---|---|---| ||4|Plunger Stoppers|1.1481 numbers| ||5|Plunger Rods|1.03 numbers| ||6|Filters (Plastic)|Consumable on Net| ||||to Net basis.| ||7|Tubing (Plastic)|| ||8|Reference Standards||

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

Case No.<br>11 / NC/3/MEET/Mar/202223/24
Case Status<br>Case Approved
Party Name<br>GLAND PHARMA LTD
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number<br>HQRNORM REVIW00006315AM23
RA File Number<br>092404000174 AM15
Licence No and<br>Date<br>0910060614/08/07/2014
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and taking cue from the earlier decision for			same export
product/import product in meeting no.NC/3/MEET/Mar/202223/22dated24.03.2023against advance authorization no.
0910064221dated30/09/2016, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per earlier decision/details
given below or as applied by the firm, whichever is less:
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty.
1<br>Adenosine Injection Prefilled<br>Syringe 3 mg/ ml, 2ml in a<br>1 Number	Adenosine	0.0066 grams
2<br>3<br>PFS	Barrel Syringes<br>V-OVS 10.6 Tip Caps	Relevant<br>as<br>packing policy		per

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Prefilled Syringe 3 mg/ ml, 2ml in a 1 Number|Adenosine|0.0066 grams|||| |2 3 PFS|Barrel Syringes V-OVS 10.6 Tip Caps|Relevant as packing policy||per||

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4	Plunger Stoppers
5	Plunger Rods
6	Filters (Plastic)	Consumable on Net to<br>Net basis.
7	Tubing (Plastic)
8	Reference Standards

Case No.	Case No.	Case No.	12 / NC/3/MEET/Mar/202223/24	12 / NC/3/MEET/Mar/202223/24	12 / NC/3/MEET/Mar/202223/24	12 / NC/3/MEET/Mar/202223/24	12 / NC/3/MEET/Mar/202223/24
Case Status			Case Approved
Party Name			GLAND PHARMA LTD
Meeting Number<br>and Date			NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number			HQRNORM REVIW00006316AM23
RA File Number			092404000350 AM15
Licence No and<br>Date			0910061069/09/10/2014
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Mar/202223dated24/03/2023against advance authorization no.<br>0910058787dated31/12/2013, it was decided to fix adhoc norms under Para 4.07 of HBP Vol.

t product in meetingNo.NC/3/MEET/Mar/202223dated24/03/2023against advance authorization no. 0910058787dated31/12/2013, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per earlier decision/details given below or as applied by the firm, whichever is less: Sl. No. Export product Qty. Sl. No. Import items Qty. 1 Nadroparin Calcium 26.125 mg 2 Barrel Syringes 1.0534 Nos. 3 Needle Shield 1.0451 Nos. 4 Plunger Stoppers 1.1091 Nos. 1 Nadroparin Calcium ( Nadroparin Calcium Injection 2850 IU/0.3ml) PFS(IU) 1 Number|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Nadroparin Calcium ( Nadroparin Calcium Injection 2850 IU/0.3ml) PFS(IU)|| 1 Number|1|Nadroparin Calcium|26.125 mg| ||||||2|Barrel Syringes|1.0534 Nos.| ||||||3|Needle Shield|1.0451 Nos.| ||||||4|Plunger Stoppers|1.1091 Nos.|

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U/0.3ml) PFS(IU)|| 1 Number|1|Nadroparin Calcium|26.125 mg| ||||||2|Barrel Syringes|1.0534 Nos.| ||||||3|Needle Shield|1.0451 Nos.| ||||||4|Plunger Stoppers|1.1091 Nos.|

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5	Plunger Rods	1.0294 Nos.
6	Preventis	1.05 Nos.
7	Anti Factor Xa Test Kits	Not admissible
8	Anti Factor IIa Test Kits	Not admissible
9	Analytical Columns	Not admissible
10	Analytical Guard Columns	Not admissible
11	Medical Grade Paper	0.9 gram
12	Tubing	0.020 cms
13	Anti Factor Xa	Not admissible
14	Anti Factor IIa	Not admissible
15	N.M.R. Standard	Not admissible
16	Mol.Wt.Standard	Not admissible

|0.9 gram| |||||12|Tubing|0.020 cms| |||||13|Anti Factor Xa|Not admissible| |||||14|Anti Factor IIa|Not admissible| |||||15|N.M.R. Standard|Not admissible| |||||16|Mol.Wt.Standard|Not admissible|

Case No.	13 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM REVIW00003288AM23
RA File Number	318304000178 AM16
Licence No and<br>Date	3110066046/14/03/2016
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and based on informationGST Range-II<br>(Chiplun) certified production and consumption dataprovided by the firm, it was decided to revise adhoc norms

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as under:

Export Product	Qty.	Sl. No.	Import Items	Qty.
2,3,6-Trimethyl Phenol (TMP)	1 kg.	1	Meta Cresol (MC99)	0.9882 kg.
		2	Methanol	0.575 kg.
		3	Catalyst	0.027 kg.

der:

Export Product	Qty.	Sl. No.	Import Items	Qty.
2,3,6-Trimethyl Phenol (TMP)	1 kg.	1	Meta Cresol (MC99)	0.9882 kg.
		2	Methanol	0.575 kg.
		3	Catalyst	0.027 kg.

Case No.	14 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	SWATI MENTHOL AND ALLIED CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM REVIW00006223AM23
RA File Number	292404000002 AM17
Licence No and<br>Date	2910025262/23/09/2016
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/documents from the
firm: -
Justification for enhancement the quantity of import<br>i.
Step wise manufacturing process.<br>ii.
Complete chemical reaction with molecular and structural formula and molecular weights alongwith stage wise<br>iii.
percentage yields on molar basis.
Also provide the shipping bills as well as bill of entry of the import and export products.<br>iv.
At the time of obtaining license please provide the following information/documents:-
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>i.
Stoichiometric balance between import and export on molar basis.<br>ii.
Details of indigenous input with quantity<br>iii.

UDIN00067928AM24

Appendix 4E for chemical products. i.|| |Stoichiometric balance between import and export on molar basis. ii.|| |Details of indigenous input with quantity iii.||

UDIN00067928AM24

Case No.	15 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	SWATI MENTHOL AND ALLIED CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM REVIW00006224AM23
RA File Number	292404000009 AM17
Licence No and<br>Date	2910025281/23/02/2017
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents from the<br>firm:-<br>Justification for enhancement the quantity of import<br>i.<br>Step wise manufacturing process.<br>ii.<br>Complete chemical reaction with molecular and structural formula and molecular weights alongwith stage wise<br>percentage yields on molar basis.<br>iii.<br>Also provide the shipping bills as well as bill of entry of the import and export products.<br>iv.<br>At the time of obtaining license please provide the following information/documents:-<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>v.<br>Stoichiometric balance between import and export on molar basis.<br>vi.<br>Details of indigenous input with quantity<br>vii.

etails as per Annexure to Appendix 4E for chemical products. v. Stoichiometric balance between import and export on molar basis. vi. Details of indigenous input with quantity vii.||

Case No.<br>	16 / NC/3/MEET/Mar/202223/24
Case Status<br>	Case Deferred
Party Name<br>	SWATI MENTHOL AND ALLIED CHEMICALS LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number<br>	HQRNORM REVIW00006225AM23
RA File Number<br>	292404000006 AM18
Licence No and<br>Date<br>	2910025308/30/10/2017
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents from the<br>firm: -<br>Justification for enhancement the quantity of import<br>i.<br>Step wise manufacturing process.<br>ii.

UDIN00067928AM24

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

iv. Also provide the shipping bills as well as bill of entry of the import and export products.

At the time of obtaining license please provide the following information/documents:-

v. Complete technical details as per Annexure to Appendix 4E for chemical products.
vi. Stoichiometric balance between import and export on molar basis.
vii. Details of indigenous input with quantity

e technical details as per Annexure to Appendix 4E for chemical products.

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

Case No.	17 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM REVIW00003287AM23
RA File Number	318304000129 AM18
Licence No and<br>Date	3110066979/13/02/2018
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and on the basis of information provided<br>by the firm; it was decided to revise adhoc norms as under.<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>DNOVO BP838<br>[Tetra<br>Methyl<br>Bisphenol<br>A<br>(TMBPA)]<br>1 kg.<br>1<br>2,6 xylenol<br>1.507 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	18 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023

UDIN00067928AM24

/ NC/3/MEET/Mar/202223/24| |---|---| |Case Status|Case Deferred| |Party Name|AUROBINDO PHARMA LTD| |Meeting Number and Date|NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023|

UDIN00067928AM24

HQ File Number<br>HQRNORM REVIW00006188AM23
RA File Number<br>092404000168 AM19
Licence No and<br>Date<br>0910066418/04/07/2018
Norms Committee Decision:
The Committee considered the case as per agenda and it has been observed that“Description and content of API in the
export does not match with the approved composition in the DML.
The Committee has advised to the firm to come forPersonal Hearingalongwith Shipping Bill, bill of entry and COA of
import and export.

Case No.		19 / NC/3/MEET/Mar/202223/24
Case Status		Case Deferred
Party Name		CROPNOSYS (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		HQRNORM REVIW00005535AM23
RA File Number		039404000527 AM19
Licence No and<br>Date		0310823957/24/09/2018
Norms Committee	Decision:
The Committee considered the case as per agenda and it was decided to call for following justification from the firm:-
Why the firm has		shown the export product as (FI) and what is the meaning of (FI) in export description given in
their application.	Please clarify.Also provide the shipping bills as well as bill of entry of the import and export products.

at is the meaning of (FI) in export description given in**| |their application.|**Please clarify.**Also provide the shipping bills as well as bill of entry of the import and export products.||

Case No.	20 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM REVIW00006120AM23
RA File Number	092404000345 AM19
Licence No and<br>Date	0910066762/25/10/2018
Norms Committee Decision:
The Committee considered the case as per agenda and it has been observed that“Description and content of API in the
export does not match with the approved composition in the DML.
The Committee has advised to the firm to come forPersonal Hearingalongwith Shipping Bill, bill of entry and COA of
import and export.

UDIN00067928AM24

Case No.	21 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM REVIW00006118AM23
RA File Number	092404000386 AM19
Licence No and<br>Date	0910066874/20/11/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed that“Description and content of API in the<br>export does not match with the approved composition in the DML.<br>The Committee has advised to the firm to come forPersonal Hearingalongwith Shipping Bill, bill of entry and COA of<br>import and export.

match with the approved composition in the DML. The Committee has advised to the firm to come forPersonal Hearing**alongwith Shipping Bill, bill of entry and COA of import and export.||

Case No.	Case No.	22 / NC/3/MEET/Mar/202223/24	22 / NC/3/MEET/Mar/202223/24	22 / NC/3/MEET/Mar/202223/24	22 / NC/3/MEET/Mar/202223/24	22 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		018205000672AM20
RA File Number		039504000625 AM20
Licence No and<br>Date		0310831873/27/09/2019
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms andit was decided to fix adhoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>LEVULINIC ACID<br>3.0 kg.<br>2<br>HYDRAZINE HYDRATE 100%<br>2.35 kg.<br>3-METHYL PYRIDAZINE (3-<br>MP)<br>1 kg.<br>3<br>5% PALLADIUM ON CARBON<br>PASTE TYPE 487,5R 487 (Pd/C) on<br>Dry Basis (IMPORT ON FREE OF<br>COST BASIS<br>0.1348 kg.<br>(Free of cost)
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	3-METHYL PYRIDAZINE (3-<br>MP)		1 kg.	1	LEVULINIC ACID	3.0 kg.
				2	HYDRAZINE HYDRATE 100%	2.35 kg.
				3	5% PALLADIUM ON CARBON<br>PASTE TYPE 487,5R 487 (Pd/C) on<br>Dry Basis (IMPORT ON FREE OF<br>COST BASIS	0.1348 kg.<br>(Free of cost)

UDIN00067928AM24

DRAZINE HYDRATE 100%|2.35 kg.| |||||3|5% PALLADIUM ON CARBON PASTE TYPE 487,5R 487 (Pd/C) on Dry Basis (IMPORT ON FREE OF COST BASIS|0.1348 kg. (Free of cost)|

UDIN00067928AM24

PALLADIUM	METAL	<br>1 kg.	4	Nil (Since it is made from residual of	Nil
SPONGE (EXPORT	ON FREE			import item no. 3 above)
OF COST BASIS)

Case No.	Case No.	23 / NC/3/MEET/Mar/202223/24	23 / NC/3/MEET/Mar/202223/24	23 / NC/3/MEET/Mar/202223/24	23 / NC/3/MEET/Mar/202223/24	23 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		018205001022AM20
RA File Number		052404000669 AM20
Licence No and<br>Date		0510413373/17/01/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP 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.

t was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less. Export Product Qty. Sl. No. Import Items Qty. (in Kg.) 1 Noroxymorphone 1.20 2 5% palladium carbon(50% wet) Not required in relevant process steps. 3 Cyclopropyl methanol 1.35 4 Methane Sulfonyl Chloride 2.00 5 Lithium Bromide 1.65 6 Hydrochloric Acid Not importable item 7 Acetic Acid Not required in relevant process steps. Not required in relevant Naltrexone Hydrochloride (Bulk Drug/ Pharmacopeial Grade) 1 kg. 8 Ammonia Liquor||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. (in Kg.)| ||Naltrexone Hydrochloride (Bulk Drug/ Pharmacopeial Grade)|| 1 kg.|1|Noroxymorphone|1.20| |||||2|5% palladium carbon(50% wet)|Not required in relevant process steps.| |||||3|Cyclopropyl methanol|1.35| |||||4|Methane Sulfonyl Chloride|2.00| |||||5|Lithium Bromide|1.65| |||||6|Hydrochloric Acid|Not importable item| |||||7|Acetic Acid|Not required in relevant process steps.| |||||8|Ammonia Liquor|Not required in relevant|

UDIN00067928AM24

Bromide|1.65| |||||6|Hydrochloric Acid|Not importable item| |||||7|Acetic Acid|Not required in relevant process steps.| |||||8|Ammonia Liquor|Not required in relevant|

UDIN00067928AM24

			process steps.
	9	Dimethyl Formamide	2.57
	10	Cyclohexene	3.60
	11	Ethyl Acetate	8.00
	12	Triethyl Amine	3.77
	13	Eno carbon / Activated<br>Carbon	0.100
Forexportitem no.2, it was decided to ratify ad-hoc norms as per SIONA-412.

Case No.	24 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM REVIW00005896AM23
RA File Number	039504001151 AM20
Licence No and<br>Date	0310835305/09/03/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and based on information provided by the firm, it was<br>decided to revise the description of importitemno.3asIsopropyl Alcoholinstead of Iso Propanol.<br>RA concerned may take further necessary action as per above decision of NC.

m, it was decided to revise the description of importitemno.3asIsopropyl Alcoholinstead of Iso Propanol. RA concerned may take further necessary action as per above decision of NC.||

Case No.	25 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	018205001136AM20
RA File Number	052404000749 AM20

UDIN00067928AM24

Licence No and 0510413850/12/03/2020 Date

Deferred for comments of TE.Also provide the shipping bills as well as bill of entry of the import and export products.

Case No.	Case No.	26 / NC/3/MEET/Mar/202223/24	26 / NC/3/MEET/Mar/202223/24	26 / NC/3/MEET/Mar/202223/24	26 / NC/3/MEET/Mar/202223/24	26 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		RECKITT BENCKISER HEALTHCARE INDIA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		HQRNORM REVIW00004155AM23
RA File Number		052404000026 AM21
Licence No and<br>Date		0510414109/06/05/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and on the basis of information provided by the firm, it<br>was decided to revise adhoc norms as under.<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>ISOMALT ST-M<br>2429 mg/tablet<br>2<br>D&C YELLOW NO. 10<br>0.44 mg/tablet<br>3<br>FD&C YELLOW NO.

s as under. Export Product Qty. Sl. No. Import Items Qty. 1 ISOMALT ST-M 2429 mg/tablet 2 D&C YELLOW NO. 10 0.44 mg/tablet 3 FD&C YELLOW NO. 6 0.007 mg/tablet 4 BENZOCAINE USP 15.30 mg/tablet 5 HONEY & LEMON FLAVOUR TAK 042202 6.444 mg/tablet 6 INTENSATE COOL FLAV TAK 052848 4.70 mg/tablet Cepacol Extra Strength Lozenges- Honey Lemon (2350 mg per tablet) 1 Number Tablet (Lozenges) 7 MOUTHFEEL ENHANCER TAK 053628 2.30 mg/tablet RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Cepacol Extra Strength Lozenges- Honey Lemon (2350 mg per tablet)||1 Number Tablet (Lozenges)|1|ISOMALT ST-M|2429 mg/tablet| |||||2|D&C YELLOW NO. 10|0.44 mg/tablet| |||||3|FD&C YELLOW NO. 6|0.007 mg/tablet| |||||4|BENZOCAINE USP|15.30 mg/tablet| |||||5|HONEY & LEMON FLAVOUR TAK 042202|6.444 mg/tablet| |||||6|INTENSATE COOL FLAV TAK 052848|4.70 mg/tablet| |||||7|MOUTHFEEL ENHANCER TAK 053628|2.30 mg/tablet| ||concerned may take further necessary action as per above decision of NC.||||||

UDIN00067928AM24

FLAV TAK 052848|4.70 mg/tablet| |||||7|MOUTHFEEL ENHANCER TAK 053628|2.30 mg/tablet| ||concerned may take further necessary action as per above decision of NC.||||||

UDIN00067928AM24

Case No.<br>27 / NC/3/MEET/Mar/202223/24
Case Status<br>Case Approved
Party Name<br>BALAJI AMINES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number<br>HQRNORM REVIW00005238AM23
RA File Number<br>318304000007 AM21
Licence No and<br>Date<br>3110067740/19/05/2020
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms under Para
4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less.
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty.
1<br>N-METHYL-2-PYRROLIDONE<br>1 kg.	METHANOL	0.37 kg.
2	AMMONIA ANHYDROUS	0.16 kg.
3	GAMMA BUTYROLACTONE	0.90 kg.
RA concerned may take further necessary action as per above decision of NC.

METHYL-2-PYRROLIDONE 1 kg.|METHANOL|0.37 kg.|| |2|AMMONIA ANHYDROUS|0.16 kg.|| |3|GAMMA BUTYROLACTONE|0.90 kg.|| |RA concerned may take further necessary action as per above decision of NC.||||

Case No.<br>28 / NC/3/MEET/Mar/202223/24
Case Status<br>Case Approved
Party Name<br>SONGWON SPECIALTY CHEMICALS - INDIA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number<br>HQRNORM REVIW00006226AM23
RA File Number<br>342404000060 AM21
Licence No and<br>Date<br>3410046173/23/06/2020
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import
product inmeeting no. NC/3/MEET/Mar/202122/15 dated 17/03/2022against advance authorization no.	3411000191 dated
04/02/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the
firm, whichever is less.
Export Product<br>Qty.<br>Sl. No.<br>Import Items	Qty. (in Kg.)

UDIN00067928AM24

Para 4.07 of HBP Vol. I as per details given below or as applied by the||| |firm, whichever is less.||| |Export Product Qty. Sl. No. Import Items|Qty. (in Kg.)||

UDIN00067928AM24

1	Dimethyl Oxalate	1.25
2	Sodium Methoxide Powder	0.856
3	Sodium Methoxide Solution (30%) /<br>Sodium Methylate Solution (30%)	1.52
4	Dimethylformamide	0.55
5	1,2-Dichloroethane / Ethylene<br>Dichloride	1.835
6	Sulfolane	0.26
7	Sodium Sulphide (60 % min.) / Sodium<br>Sulfide (60% min)	1.458
8	Methyl Monochloro Acetate	2.454

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

ane|0.26| ||||7|Sodium Sulphide (60 % min.) / Sodium Sulfide (60% min)|1.458| ||||8|Methyl Monochloro Acetate|2.454|

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

Case No.	Case No.	29 / NC/3/MEET/Mar/202223/24	29 / NC/3/MEET/Mar/202223/24	29 / NC/3/MEET/Mar/202223/24	29 / NC/3/MEET/Mar/202223/24	29 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		BALAJI AMINES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		HQRNORM REVIW00005260AM23
RA File Number		018205001623 AM21
Licence No and<br>Date		3110067847/08/09/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and on the basis of information provided by the firm, it<br>was decided to revise adhoc norms as under.<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>METHANOL<br>0.37 kg.<br>N-METHYL-2-PYRROLIDONE<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	N-METHYL-2-PYRROLIDONE		1 kg.	1	METHANOL	0.37 kg.

UDIN00067928AM24

	2	AMMONIA ANHYDROUS	0.16 kg.
	3	GAMMA BUTYROLACTONE	0.90 kg.

ty.|Sl. No.|Import Items|Qty.| ||N-METHYL-2-PYRROLIDONE||1 kg.|1|METHANOL|0.37 kg.|

UDIN00067928AM24

	2	AMMONIA ANHYDROUS	0.16 kg.
	3	GAMMA BUTYROLACTONE	0.90 kg.

Case No.	Case No.	30 / NC/3/MEET/Mar/202223/24	30 / NC/3/MEET/Mar/202223/24	30 / NC/3/MEET/Mar/202223/24	30 / NC/3/MEET/Mar/202223/24	30 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		018205001832AM21
RA File Number		052404000405 AM21
Licence No and<br>Date		0510415761/06/11/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP 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. (in Kg.)<br>1<br>Noroxymorphone<br>1.20<br>2<br>5% palladium carbon(50%<br>wet)<br>Not required in relevant<br>process steps.<br>3<br>Cyclopropyl methanol<br>1.35<br>4<br>Methane Sulfonyl Chloride<br>2.00<br>5<br>Lithium Bromide<br>1.65<br>6<br>Hydrochloric Acid<br>Not importable item.<br>7<br>Acetic Acid<br>Not required in relevant<br>process steps.<br>Naltrexone<br>Hydrochloride<br>(Bulk<br>Drug/ Pharmacopeal Grade)<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

br>7 Acetic Acid Not required in relevant process steps. Naltrexone Hydrochloride (Bulk Drug/ Pharmacopeal Grade) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. (in Kg.)| ||Naltrexone Hydrochloride (Bulk Drug/ Pharmacopeal Grade)|| 1 kg.|1|Noroxymorphone|1.20| |||||2|5% palladium carbon(50% wet)|Not required in relevant process steps.| |||||3|Cyclopropyl methanol|1.35| |||||4|Methane Sulfonyl Chloride|2.00| |||||5|Lithium Bromide|1.65| |||||6|Hydrochloric Acid|Not importable item.| |||||7|Acetic Acid|Not required in relevant process steps.|

UDIN00067928AM24

	8	Ammonia Liquor	Not required in relevant<br>process steps.
	9	Dimethyl Formamide	2.57
	10	Cyclohexene	3.60
	11	Ethyl Acetate	8.00
	12	Triethyl Amine	3.77
	13	Eno carbon / Activated<br>Carbon	0.100
Forexportitem no.2, it was decided to ratify ad-hoc norms as per SIONA-412.

0| ||||11|Ethyl Acetate|8.00| ||||12|Triethyl Amine|3.77| ||||13|Eno carbon / Activated Carbon|0.100| ||Forexportitem no.2, it was decided to ratify ad-hoc norms as per SIONA-412.|||||

Case No.	Case No.	31 / NC/3/MEET/Mar/202223/24	31 / NC/3/MEET/Mar/202223/24	31 / NC/3/MEET/Mar/202223/24	31 / NC/3/MEET/Mar/202223/24	31 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		GRANULES INDIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		HQRNORM REVIW00006417AM23
RA File Number		09AA04004810 AM21
Licence No and<br>Date		0911000379/17/02/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms with prorate basis as per NC3meet/March/2022-23/22<br>dated 24.03.2023 and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied<br>by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Azathioprine<br>50.00 mg.<br>2<br>Cellulose Microcristalline<br>50.00 mg.<br>Azathioprine 50mg (Azathioprine 50mg)<br>1 number
	Export Product<br>		Qty.	Sl. No.	Import Items	Qty.
	Azathioprine 50mg (Azathioprine 50mg)<br>		1 number	1	Azathioprine	50.00 mg.
				2	Cellulose Microcristalline	50.00 mg.

UDIN00067928AM24

t Product ||Qty.|Sl. No.|Import Items|Qty.| ||Azathioprine 50mg (Azathioprine 50mg) ||1 number|1|Azathioprine|50.00 mg.| |||||2|Cellulose Microcristalline|50.00 mg.|

UDIN00067928AM24

3	Mannitol	50.00 mg.
4	Corn Starch	14.00 mg.
5	Croscarmellose Sodium	5.50 mg.
6	Povidone K	8.00 mg.
7	Sodium Stearyl Fumarate	2.50 mg.
8	Hypromellose	2.30 mg.
9	Macrogol	0.40 mg.

Case No.	Case No.	32 / NC/3/MEET/Mar/202223/24	32 / NC/3/MEET/Mar/202223/24	32 / NC/3/MEET/Mar/202223/24	32 / NC/3/MEET/Mar/202223/24	32 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		GRANULES INDIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		HQRNORM REVIW00006414AM23
RA File Number		09AA04004805 AM21
Licence No and<br>Date		0911000376/18/02/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms and it was decided to ratify ad-hoc norms under Para<br>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.

n of ad-hoc norms and it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. 1 Tamoxifen citrate 45.60 mg. 2 calcium hydrogen phosphate dihydrate 258.40 mg. 3 povidone K 25 6.00 mg. Tamoxifen citrate 30 mg (Tamoxifen citrate 30 mg) 1 number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Tamoxifen citrate 30 mg (Tamoxifen citrate 30 mg)||1 number|1|Tamoxifen citrate|45.60 mg.| |||||2|calcium hydrogen phosphate dihydrate| 258.40 mg.| |||||3|povidone K 25|6.00 mg.|

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4	sodium starch glycolate	30.00 mg.
5	mangnesium stearate	5.00 mg.
6	cellulose	33.00 mg.
7	silica	2.00 mg.

4	sodium starch glycolate	30.00 mg.
5	mangnesium stearate	5.00 mg.
6	cellulose	33.00 mg.
7	silica	2.00 mg.

Case No.	Case No.	33 / NC/3/MEET/Mar/202223/24	33 / NC/3/MEET/Mar/202223/24	33 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		GRANULES INDIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		HQRNORM REVIW00006415AM23
RA File Number		09AA04004802 AM21
Licence No and<br>Date		0911000377/18/02/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms as per NC # Meet/March 2022-23/22 dated 24.03.2023<br>and it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Tamoxifen citrate<br>30.40 mg.<br>2<br>calcium hydrogen phosphate<br>dihydrate<br>281.60 mg.<br>3<br>povidone K 25<br>8.00 mg.<br>4<br>sodium starch glycolate<br>20.00 mg.<br>5<br>mangnesium stearate<br>5.00 mg.<br>6<br>cellulose<br>33.00 mg.<br>Tamoxifen citrate 20 mg(Tamoxifen citrate 20<br>mg)<br>1 Number
	Export Product		Qty.	Sl.

arch glycolate 20.00 mg. 5 mangnesium stearate 5.00 mg. 6 cellulose 33.00 mg. Tamoxifen citrate 20 mg(Tamoxifen citrate 20 mg) 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Tamoxifen citrate 20 mg(Tamoxifen citrate 20 mg)|| 1 Number|1|Tamoxifen citrate|30.40 mg.| |||||2|calcium hydrogen phosphate dihydrate|281.60 mg.| |||||3|povidone K 25|8.00 mg.| |||||4|sodium starch glycolate|20.00 mg.| |||||5|mangnesium stearate|5.00 mg.| |||||6|cellulose|33.00 mg.|

UDIN00067928AM24

7 silica 2.00 mg. RA concerned may take further necessary action as per above decision of NC.

Case No.	34 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	GRANULES INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM REVIW00006418AM23
RA File Number	09AA04005473 AM21
Licence No and<br>Date	0911000464/05/03/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of ad-hoc norms as per NC # Meet/March 2022-23/22 dated 24.03.2023<br>and it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less: -<br>Export Product<br>Qty.<br>Sl.

ed 24.03.2023 and it was decided to ratify ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: - Export Product Qty. Sl. No. Import Items Qty. 1 Tamoxifen citrate 45.60 mg. 2 Calcium hydrogen phosphate dihydrate 258.40 mg. 3 Povidone K 25 6.00 mg. 4 Sodium starch glycolate 30.00 mg. 5 Mangnesium stearate 5.00 mg. 6 Cellulose, microcrystalline 33.00 mg. Tamoxifen citrate 30 mg (Tamoxifen citrate 30 mg) 1 number 7 Silica colloidal anhydrous 2.00 mg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00067928AM24

Cas	e No.	35 / NC/3/MEET/Mar/202223/	24
Cas	e Status	Case Approved
Par	ty Name	GRANULES INDIA LIMITED

Me<br>and	eting Number<br>Date	NC/ 3/ MEET/ Mar/ 202223/ 2	4 and 13/04/202	3
HQ	File Number	HQRNORM REVIW00006419	AM23
RA	File Number	09AA04005498 AM21
Lic<br>Dat	ence No and<br>e	0911000487/10/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import<br>product in meeting No.NC/3/MEET/Mar/20202223/22 dated 24/03/2023against advance authorizationno.0911000378<br>dated 17/02/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.

ct in meeting No.NC/3/MEET/Mar/20202223/22 dated 24/03/2023against advance authorizationno.0911000378 dated 17/02/2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as lid b th fi hih i l|ms Committee Decision:||||||||||| |appe y e rm, wcever s ess:-|||||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||Export Pro|duct||Qty.||Sl. No.|Import Items||||Qty.| ||||||||||||| ||||||||||||| ||Methotrexate 2.|mg||1 Number||1|Methotrexate||||2.50 mg.| ||(Methotrexate 2.|5mg)|||||||||| ||||||||||||| |||||||2|Anhydrous Calcium hydrogen phosphate||||6.375.mg.| ||||||||||||| |||||||3|Lactose Monohydrate (Tablettose 80)||||12.50 mg.| ||||||||||||| |||||||4|Sodium starch glycollate||||1.80 mg.| ||||||||||||| ||||||||||||| |||||||5|Microcrystalline Cellulose||||21.075 mg.| ||||||||||||| ||||||||||||| |||||||6|Purified Talc||||0.375 mg.| ||||||||||||| ||||||||||||| |||||||7|Magnesium Stearate||||0.375 mg.| |RA|||||||||||| ||concerned may take further necessary action as per above decision of NC.||||||||||| ||||||||||||| |Cas|e No.|36 / NC/3/MEET/Mar/202223/24|||||||||| |Cas|e Status|Case Deferred|||||||||| |Par||RECKITT BECKISER HEALTHCARE IDIA PRIATE LIMITED|||||||||| ||y Name|N||||N|||||| |Me and|eting Number Date|NC/ 3/ MEET/ Mar/ 202223/ 24 an||||d 13/04/202||3|||| |HQ|File Number|HQRNORM APPLY 00103707AM||||21||||||

HCARE IDIA PRIATE LIMITED|||||||||| ||y Name|N||||N|||||| |Me and|eting Number Date|NC/ 3/ MEET/ Mar/ 202223/ 24 an||||d 13/04/202||3|||| |HQ|File Number|HQRNORM APPLY 00103707AM||||21||||||

Case No.	36 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	RECKITT BENCKISER HEALTHCARE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00103707AM21

UDIN00067928AM24

RA File Number	05AA04039234 AM21
Licence No and<br>Date	0511001736/15/03/2021
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Complete calculation sheet approved by the GST/CA.<br>1.<br>Also provide the shipping bills as well as bill of entry of the import and export products.<br>2.

Case No.	Case No.	37 / NC/3/MEET/Mar/202223/24	37 / NC/3/MEET/Mar/202223/24	37 / NC/3/MEET/Mar/202223/24	37 / NC/3/MEET/Mar/202223/24	37 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		HQRNORM APPLY 00004824AM22
RA File Number		05AA04000952 AM22
Licence No and<br>Date		0511002092/06/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.

||| |Licence No and Date||0511002092/06/04/2021||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less. Export Product Qty. Sl. No. Import Items Qty. (in Kg.) 1 Noroxymorphone 1.20 2 5% palladium carbon(50% wet) Not required in relevant process steps. 3 Cyclopropyl methanol 1.35 4 Methane Sulfonyl Chloride 2.00 5 Lithium Bromide 1.65 6 Hydrochloric Acid Not importable item 7 Acetic Acid Not required in relevant process steps. Naltrexone Hydrochloride (Bulk Drug/ Pharmacopeal Grade) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. (in Kg.)| ||Naltrexone Hydrochloride (Bulk Drug/ Pharmacopeal Grade)|| 1 kg.|1|Noroxymorphone|1.20| |||||2|5% palladium carbon(50% wet)|Not required in relevant process steps.| |||||3|Cyclopropyl methanol|1.35| |||||4|Methane Sulfonyl Chloride|2.00| |||||5|Lithium Bromide|1.65| |||||6|Hydrochloric Acid|Not importable item| |||||7|Acetic Acid|Not required in relevant process steps.|

UDIN00067928AM24

4|Methane Sulfonyl Chloride|2.00| |||||5|Lithium Bromide|1.65| |||||6|Hydrochloric Acid|Not importable item| |||||7|Acetic Acid|Not required in relevant process steps.|

UDIN00067928AM24

	8	Ammonia Liquor	Not required in relevant<br>process steps.
	9	Dimethyl Formamide	2.57
	10	Cyclohexene	3.60
	11	Ethyl Acetate	8.00
	12	Triethyl Amine	3.77
	13	Eno carbon / Activated<br>Carbon	0.100
Forexportitem no.2, it was decided to ratify ad-hoc norms as per SIONA-412.

Case No.	38 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	CLARIANT INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00032203AM22
RA File Number	03AA04009823 AM22
Licence No and<br>Date	0311003530/04/05/2021
Norms Committee Decision:<br>Deferred for comments of TE. Also submit shipping bills and bill of entry of the export and import products.

23 AM22| |Licence No and Date|0311003530/04/05/2021| |Norms Committee Decision: Deferred for comments of TE. Also submit shipping bills and bill of entry of the export and import products.||

Case No.	39 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	SAKAR HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM REVIW00005812AM23
RA File Number	08AA04004104 AM22
Licence No and<br>Date	0811001574/25/05/2021

UDIN00067928AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
BARI<br>NYSTATIN<br>DROPS<br>(NYSTATIN<br>ORAL<br>SUSPENSION 1,00,000 IU/5ML, 30 ML.<br>(IN GLASS BOTTLE))	<br>1 Number	1	NYSTATIN<br>(EP/BP/USP)	97.056 mg.
NYSTATIN ORAL SUSPENSION (NYSTATIN ORAL<br>SUSPENSION 1,00,000 IU/ ML, 30 ML.<br>( IN GLASSBOTTLE))	1 Number	2	NYSTATIN<br>(EP/BP/USP)	485.28 mg.

1 Number|1|NYSTATIN (EP/BP/USP)|97.056 mg.| |NYSTATIN ORAL SUSPENSION (NYSTATIN ORAL SUSPENSION 1,00,000 IU/ ML, 30 ML. ( IN GLASSBOTTLE))|1 Number|2|NYSTATIN (EP/BP/USP)|485.28 mg.|

Case No.	40 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	U. K. AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM REVIW00005651AM23
RA File Number	03AA04019445 AM22
Licence No and<br>Date	0311004281/03/06/2021
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>As per information given low & high Boiler is 30% of Crude Product.<br>i.<br>What is the commercial value of Crude Product with proof of sale documents.<br>ii.<br>Shipping bill and Bill of entry of the export and import products.<br>iii.

Case No.	41 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM REVIW00004186AM23
RA File Number	03AA04019330 AM22

UDIN00067928AM24

Licence No and 0311004745/19/06/2021 Date

Deferred for comments of TE. Also submit shipping bill and bill of entry of the export products.

e Number|03AA04019330 AM22|

UDIN00067928AM24

Licence No and 0311004745/19/06/2021 Date

Deferred for comments of TE. Also submit shipping bill and bill of entry of the export products.

Case No.<br>42 / NC/3/MEET/Mar/202223/24
Case Status<br>Case Approved
Party Name<br>AMI ORGANICS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number<br>HQRNORM APPLY 00148387AM22
RA File Number<br>52AA04010429 AM22
Licence No and<br>Date<br>5211001058/27/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less.
Export Product<br>Qty.	Sl. No.	Import Items	Qty.
Methyl Paraben(Methyl Paraben)<br>1 kg.	1	Phenol	0.7725 kg.
RA concerned may take further necessary action as per above decision of NC.

|Export Product Qty.|Sl. No.|Import Items|Qty.|| |Methyl Paraben(Methyl Paraben) 1 kg.|1|Phenol|0.7725 kg.|| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No.	43 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00148419AM22
RA File Number	31AA04021097 AM22
Licence No and<br>Date	3111000476/27/07/2021
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-
Copy of DML with approved composition for each export item.<br>i.
Also call shipping bill and bill of entry.<br>ii.

UDIN00067928AM24

Case No.	44 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM REVIW00004845AM23
RA File Number	31AA04001432 AM22
Licence No and Date	3111000494/30/07/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and on the basis of information provided<br>by the firm, it was decided to revise adhoc norms as under:-<br>Export Product<br>Qty.<br>Sl.

ttee considered the request of firm for review of adhoc norms and on the basis of information provided by the firm, it was decided to revise adhoc norms as under:- Export Product Qty. Sl. No. Import Items Qty. 1 MONOETHANOLAMINE 1.06 kg. ETHYLENEDIAMINE(ORGANIC CHEMICAL) 1 kg. 2 AMMONIA ANHYDROUS 0.294 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	45 / NC/3/MEET/Mar/202223/24	45 / NC/3/MEET/Mar/202223/24	45 / NC/3/MEET/Mar/202223/24	45 / NC/3/MEET/Mar/202223/24	45 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		AMI ORGANICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		HQRNORM APPLY 00161263AM22
RA File Number		52AA04010591 AM22
Licence No and<br>Date		5211001166/12/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less.<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Butyl Paraben(Butyl Paraben)<br>1 kg.<br>1<br>Para Hydroxy Benzoic Acid<br>0.8368 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.
	Butyl Paraben(Butyl Paraben)		1 kg.	1	Para Hydroxy Benzoic Acid	0.8368 kg.

UDIN00067928AM24

Benzoic Acid 0.8368 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Butyl Paraben(Butyl Paraben)||1 kg.|1|Para Hydroxy Benzoic Acid|0.8368 kg.| ||||||||

UDIN00067928AM24

Case No.	46 / NC/3/MEET/Mar/202223/24
Case Status	Case Rejected
Party Name	SUNDYOTA NUMANDIS PROBIOCEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM REVIW00005645AM23
RA File Number	08AA04021121 AM22
Licence No and<br>Date	0811002324/16/08/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence,
the Committee decided torejectthe case.

Case No.<br>47 / NC/3/MEET/Mar/202223/24
Case Status<br>Case Approved
Party Name<br>DORF-KETAL CHEMICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number<br>HQRNORM APPLY 00178330AM22
RA File Number<br>03AA04067379 AM22
Licence No and<br>Date<br>0311006748/07/09/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para		4.07 of HBP Vol.
I as per details given below or as applied by the firm, whichever is less.
Export Product<br>Qty.<br>Sl.

ase as per agenda and it was decided to fix adhoc norms under Para||4.07 of HBP Vol.||| |I as per details given below or as applied by the firm, whichever is less.||||| |Export Product Qty. Sl. No.|Import Items||Qty.|| |1 Tetra isopropyl titanate - 1 kg.|Titanium Tetrachloride / Ticl4||0.69 kg.|| |TyzorTPT(Chemical Name ? Tetra||||| |2 isopropyl titanate - Tyzor TPT)|Iso-Propyl Alcohol.||0.90 kg.|| |3|Heptane / Heptanes||0.06 kg.|| |RA concerned may take further necessary action as per above decision of NC.|||||

UDIN00067928AM24

Case No.	48 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	SANOFI INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00185047AM22
RA File Number	03AA04082679 AM22
Licence No and<br>Date	0311007007/16/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import<br>product in meetingno. NC/3/MEET/Mar/202223/22dated24/03/2023against advance authorization no.0311018608<br>dated 17/10/2022, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less.<br>Export product<br>Qty.<br>Sl. No.

dated 17/10/2022, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less. Export product Qty. Sl. No. Import items Qty. 1 Sodium Valproate 135.864 mg. EPILIM CR 200MG TABS 100'S(EPILIM CR SODIUM VALPROATE- 133.2 &VALPROIC ACID-58MG TAB CR)((Total net content of Sodium Valproate 4129.20 Kgs &Valproic Acid 1798 Kgs)) 1 number 2 Valproic Acid 59.16 mg. 3 Sodium Valproate 203.796 mg. EPILIM CR 300MG TABS 100'S(EPILIM CR SODIUM VALPROATE- 199.8 &VALPROICACID-87MG TABCR)((Total net content of Sodium Valproate 9990 Kgs &Valproic Acid 4350 Kgs)) 1 number 4 Valproic Acid 88.74 mg. 5 Sodium Valproate 339.66 mg. EPILIM CR 500MG TABS 100'S(EPILIM CR SODIUM VALPROATE- 333 &VALPROIC ACID- 145MG TABCR)((Total net content of Sodium Valproate 16650 Kgs &Valproic Acid 7250 Kgs)) 1 number 6 Valproic Acid 147.90 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	49 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM REVIW00004846AM23
RA File Number	31AA04026965 AM22
Licence No and Date	3111000573/16/09/2021
Norms Committee Decision:

UDIN00067928AM24

/ 24 and 13/04/2023| |HQ File Number|HQRNORM REVIW00004846AM23| |RA File Number|31AA04026965 AM22| |Licence No and Date|3111000573/16/09/2021| |Norms Committee Decision:||

UDIN00067928AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
ETHYLENEDIAMINE(ORGANIC	1 kg.	1	MONOETHANOLAMINE	1.06 kg.
CHEMICAL)
		2	AMMONIA ANHYDROUS	0.294 kg.

Case No.<br>50 / NC/3/MEET/Mar/202223/24
Case Status<br>Case Approved
Party Name<br>TADIMETY AROMATICS PRIVATE	LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number<br>HQRNORM APPLY 00187990AM22
RA File Number<br>07AA04024759 AM22
Licence No and<br>Date<br>0711001935/20/09/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as
per details given below or as applied by the firm, whichever	is less:-
Export Product	Qty.	Sl. No.	Import Items	Qty.
Rosecrystals Ex Benzaldehyde	1 kg.	1	Benzaldehyde	0.465 kg.
(Trichloro-Phenyl Methyl Corbinyl Acetate)
RA concerned may take further necessary action as per above decision of NC.

|Rosecrystals Ex Benzaldehyde|1 kg.|1|Benzaldehyde|0.465 kg.|| |(Trichloro-Phenyl Methyl Corbinyl Acetate)|||||| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	51 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	CHEMPLAST SANMAR LIMITED
Meeting Number	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023

UDIN00067928AM24

and Date
HQ File Number	HQRNORM REVIW00006805AM23
RA File Number	04AA04015436 AM22
Licence No and<br>Date	0411001511/22/09/2021
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>i.<br>Production/consumption data duly certify with GST/CA.<br>ii.<br>Justification for enhancement in the quantity of import.<br>iii.<br>Shipping bill and bill of entry<br>iv.

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

hipping bill and bill of entry** iv.||

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

Case No.	52 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	INDO AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00191007AM22
RA File Number	03AA040103017 AM22
Licence No and<br>Date	0311007156/23/09/2021
Norms Committee Decision:<br>The firm vide e-mail dated07.02.2023has informed that they have surrender their above licence. In view of e-mail<br>of firm, the Committee decided towithdrawthe case.

Case No.	53 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00192148AM22
RA File Number	03AA04091496 AM22
Licence No and<br>Date	0311007180/23/09/2021
Norms Committee Decision:<br>Deferred for comments of TE. Shipping bill and bill of entry of the export products.

Case No.	54 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved

UDIN00067928AM24

Deferred for comments of TE. Shipping bill and bill of entry of the export products.||

Case No.	54 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved

UDIN00067928AM24

Party Name	INDO AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00194032AM22
RA File Number	03AA04083866 AM22
Licence No and<br>Date	0311007213/25/09/2021
Norms Committee Decision:
The firm vide e-mail dated07.02.2023has informed that they have surrender their above licence. In view of e-mail
of firm, the Committee decided towithdrawthe case.

Case No.	55 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	CHEMPLAST SANMAR LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and	13/04/2023
HQ File Number	HQRNORM APPLY 00206478AM22
RA File Number	04AA04028427 AM22
Licence No and Date	0411001606/08/10/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para			4.07 of HBP Vol.
I as per details given below or as applied by the firm, whichever is less.
Export Product	Qty.<br>Sl. No.	Import Items		Qty.
2-TRIFLUORO	1 kg.<br>1	2-AMINOBENZOTRIFLUORIDE		0.832 kg.
METHYLBENZENE
SULFONAMIDE(2-TRIFLUORO
METHYLBENZENE
SULFONAMIDE)
RA concerned may take further necessary action as per above decision of NC

IDE||0.832 kg.|| |METHYLBENZENE||||||| |SULFONAMIDE(2-TRIFLUORO||||||| |METHYLBENZENE||||||| |SULFONAMIDE)||||||| |RA concerned may take further necessary action as per above decision of NC|||||||

Case No.	56 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	GLAND PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00206565AM22
RA File Number	09AA04010507 AM22

UDIN00067928AM24

Licence No and 0911001380/08/10/2021 Date

Deferred for comments of TE. Also call shipping bill and bill of entry.

Case No.	Case No.	57 / NC/3/MEET/Mar/202223/24	57 / NC/3/MEET/Mar/202223/24	57 / NC/3/MEET/Mar/202223/24	57 / NC/3/MEET/Mar/202223/24	57 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		HQRNORM APPLY 00208798AM22
RA File Number		05AA04089568 AM22
Licence No and<br>Date		0511005321/11/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP 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.

t was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less. Export Product Qty. Sl. No. Import Items Qty. (in Kg.) 1 Noroxymorphone 1.20 2 5% palladium carbon(50% wet) Not required in relevant process steps. 3 Cyclopropyl methanol 1.35 4 Methane Sulfonyl Chloride 2.00 5 Lithium Bromide 1.65 6 Hydrochloric Acid Not importable item. 7 Acetic Acid Not required in relevant process steps. 8 Ammonia Liquor Not required in relevant process steps. 9 Dimethyl Formamide 2.57 Naltrexone Hydrochloride (Bulk Drug/ Pharmacopeal Grade) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. (in Kg.)| ||Naltrexone Hydrochloride (Bulk Drug/ Pharmacopeal Grade)|| 1 kg.|1|Noroxymorphone|1.20| |||||2|5% palladium carbon(50% wet)|Not required in relevant process steps.| |||||3|Cyclopropyl methanol|1.35| |||||4|Methane Sulfonyl Chloride|2.00| |||||5|Lithium Bromide|1.65| |||||6|Hydrochloric Acid|Not importable item.| |||||7|Acetic Acid|Not required in relevant process steps.| |||||8|Ammonia Liquor|Not required in relevant process steps.| |||||9|Dimethyl Formamide|2.57|

ochloric Acid|Not importable item.| |||||7|Acetic Acid|Not required in relevant process steps.| |||||8|Ammonia Liquor|Not required in relevant process steps.| |||||9|Dimethyl Formamide|2.57|

Case No.	Case No.	57 / NC/3/MEET/Mar/202223/24	57 / NC/3/MEET/Mar/202223/24	57 / NC/3/MEET/Mar/202223/24	57 / NC/3/MEET/Mar/202223/24	57 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		HQRNORM APPLY 00208798AM22
RA File Number		05AA04089568 AM22
Licence No and<br>Date		0511005321/11/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP 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. (in Kg.)<br>1<br>Noroxymorphone<br>1.20<br>2<br>5% palladium carbon(50%<br>wet)<br>Not required in relevant<br>process steps.<br>3<br>Cyclopropyl methanol<br>1.35<br>4<br>Methane Sulfonyl Chloride<br>2.00<br>5<br>Lithium Bromide<br>1.65<br>6<br>Hydrochloric Acid<br>Not importable item.<br>7<br>Acetic Acid<br>Not required in relevant<br>process steps.<br>8<br>Ammonia Liquor<br>Not required in relevant<br>process steps.<br>9<br>Dimethyl Formamide<br>2.57<br>Naltrexone<br>Hydrochloride<br>(Bulk<br>Drug/ Pharmacopeal Grade)<br>1 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty.

in relevant process steps. 9 Dimethyl Formamide 2.57 Naltrexone Hydrochloride (Bulk Drug/ Pharmacopeal Grade) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. (in Kg.)| ||Naltrexone Hydrochloride (Bulk Drug/ Pharmacopeal Grade)|| 1 kg.|1|Noroxymorphone|1.20| |||||2|5% palladium carbon(50% wet)|Not required in relevant process steps.| |||||3|Cyclopropyl methanol|1.35| |||||4|Methane Sulfonyl Chloride|2.00| |||||5|Lithium Bromide|1.65| |||||6|Hydrochloric Acid|Not importable item.| |||||7|Acetic Acid|Not required in relevant process steps.| |||||8|Ammonia Liquor|Not required in relevant process steps.| |||||9|Dimethyl Formamide|2.57|

UDIN00067928AM24

	10	Cyclohexene	3.60
	11	Ethyl Acetate	8.00
	12	Triethyl Amine	3.77
	13	Eno carbon / Activated<br>Carbon	0.100
Forexportitem no.2, it was decided to ratify ad-hoc norms as per SIONA-412.

-| ||||11|Ethyl Acetate|8.00| ||||12|Triethyl Amine|3.77| ||||13|Eno carbon / Activated Carbon|0.100| ||Forexportitem no.2, it was decided to ratify ad-hoc norms as per SIONA-412.|||||

Case No.	58 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	NEON LABORATORIES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00210390AM22
RA File Number	03AA040106734 AM22
Licence No and Date	0311007655/12/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Drug Formulation Injection(ampoules/vials<br>upto10ML)-ESTEN FORTE-Essential<br>Phospholipids(250Mg/5ML Solution<br>for I V Injection. NETT QTY. OF<br>EXPORTS = 132.625 KGS)<br>1 number<br>1<br>Phosphatidylcholine from Soya<br>bean<br>275.00 mg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00067928AM24

RTS = 132.625 KGS) 1 number 1 Phosphatidylcholine from Soya bean 275.00 mg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00067928AM24


Case No.				59 / NC/3/MEET/Mar/202223/24
Case Status				Case Approved
Party Name				GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date				NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number				HQRNORM REVIW00003807AM23
RA File Number				03AA040110385 AM22
Licence No and<br>Date
		e		0311007732/17/10/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and on the basis of information provided by the<br>firm, it was decided to revise adhoc norms as under:-<br>Sl. No. Export Product<br>Qty.<br>1<br>Mometasone Furoate Ointment 0.10 Percent (Pack 10gms) (Net Wt. of Mometasone<br>Furoate Micronized 0.200 Kgs.)<br>20000 Numbers		ms Committee Decision:
		e Committee considered the request of firm for revie<br>m, it was decided to revise adhoc norms as under:-			w of adh	oc norms	and on the basis of information pro		vided by the
	Sl. No.
			Export Product					Qty.
	1		Mometasone Furoate Ointment 0.10 Percent (Pack 10gms) (Net Wt. of Mometasone<br>Furoate Micronized 0.200 Kgs.)					<br>20000 Numbers


	2		Mometa	sone Furoate Ointment 010 Percent (Pack 15gms) (Net Wt of Mometasone
			<br>Furoate	.

f Mometasone Furoate Micronized 0.200 Kgs.)||||| 20000 Numbers|| ||||||||||| ||||||||||| ||2||Mometa|sone Furoate Ointment 010 Percent (Pack 15gms) (Net Wt of Mometasone|||||| |||| Furoate|. . Micronized 0.300 Kgs.)|||| 20000 Numbers|| ||||||||||| ||3||Mometa |sone Furoate Ointment 0.10 Percent /Momate Ointment 0.10 Percent (Pack |||| 20000 Numbers|| ||||20gms)|(Net Wt. of Mometasone Furoate Micro 0.400 Kgs.)|||||| ||||||||||| ||||||||||| ||4||Mometa Furoate|sone Furoate Ointment 0.10 Percent (Pack 30gms) (Net Wt. of Mometasone Micronized 3.000 Kgs.)|||| 100000Numbers|| ||||||||||| ||5||Mometasone Furoate Ointment 0.10 Percent (pack 45gms) (Net Wt. of Mometasone Furoate Micronized 4.50 Kgs.)||||| 100000 Numbers|| ||6||Mometasone Furoate Ointment 0.10 Percent (Pack 50gms) (Net Wt. of Mometasone Furoate Micronized 1.00 Kgs.)||||| 20000 Numbers|| ||7||||||||| ||||Mometasone Furoate Ointment 0.10 Perce Furoate Micronized 1.800 Kgs.)||nt (pack|60gms) (|Net Wt. of Mometasone| 30000 N|umbers| ||8||Mometasone Furoate Ointment 0.10 Percen Furoate Micronized 2.000 Kgs.)||t (pack 1|00gms)|(Net Wt. of Mometasone| 20000 N|umbers| ||9||Mometasone Furoate Tropical Solution U||SP 0.1 P|ercent (L|otion) (Pack 30ml) (Net| 30000 N|umbers| |||||||||||

UDIN00067928AM24

1|00gms)|(Net Wt. of Mometasone| 20000 N|umbers| ||9||Mometasone Furoate Tropical Solution U||SP 0.1 P|ercent (L|otion) (Pack 30ml) (Net| 30000 N|umbers| |||||||||||

UDIN00067928AM24

|Wt. of Mometasone Furoate Micronized 0.900 Kgs.) 10 Mometasone Furoate Tropical Solution USP 0.1 Percent (Lotion) (Pack 60ml) (Net Wt. of Mometasone Furoate Micronized 1.800 Kgs.) 30000 Numbers 11 Mometasone Furoate Cream 0.1 Percent (Pack 10gms) (Net Wt. of Mometasone Furoate Micronized 0.700 Kgs.) 70000 Numbers 12 Mometasone Furoate Cream 0.1 Percent (Pack 15gms) (Net Wt. of Mometasone Furoate Micronized 1.050 Kgs.) 70000 Numbers 13 Mometasone Furoate Cream 0.1 Percent (Pack 20gms) (Net Wt. of Mometasone Furoate Micronized 1.40 Kgs.) 70000 Numbers 14 Mometasone Furoate Cream 0.1 Percent /Metactiv Cream 0.10 Percent (Pack 30gms) (Net Wt. of Mometasone Furoate Micronized 2.40 Kgs.) 80000 Numbers 15 Mometasone Furoate Cream 0.1 Percent (Pack 45gms) (Net Wt. of Mometasone Furoate Micronized 3.600 Kgs.) 80000 Numbers 16 Mometasone Furoate Cream 0.1 Percent (Pack 50gms) (Net Wt. of Mometasone Furoate Micronized 7.500 Kgs.) 150000Numbers 17 Mometasone Furoate Cream 0.1 Percent (Pack 60gms) (Net Wt. of Mometasone Furoate Micronized 17.400 Kgs.) 290000Numbers 18 Mometasone Furoate Cream 0.1 Percent (Pack 100gms) (Net Wt. of Mometasone Furoate Micronized 29.000 Kgs.) 290000Numbers Sl.

	Wt. of Mometasone Furoate Micronized 0.900 Kgs.)
10	Mometasone Furoate Tropical Solution USP 0.1 Percent (Lotion) (Pack 60ml) (Net<br>Wt. of Mometasone Furoate Micronized 1.800 Kgs.)	<br>30000 Numbers
11	Mometasone Furoate Cream 0.1 Percent (Pack 10gms) (Net Wt. of Mometasone<br>Furoate Micronized 0.700 Kgs.)	<br>70000 Numbers
12	Mometasone Furoate Cream 0.1 Percent (Pack 15gms) (Net Wt. of Mometasone<br>Furoate Micronized 1.050 Kgs.)	<br>70000 Numbers
13	Mometasone Furoate Cream 0.1 Percent (Pack 20gms) (Net Wt. of Mometasone<br>Furoate Micronized 1.40 Kgs.)	<br>70000 Numbers
14	Mometasone Furoate Cream 0.1 Percent /Metactiv Cream 0.10 Percent (Pack<br>30gms) (Net Wt. of Mometasone Furoate Micronized 2.40 Kgs.)	<br>80000 Numbers
15	Mometasone Furoate Cream 0.1 Percent (Pack 45gms) (Net Wt. of Mometasone<br>Furoate Micronized 3.600 Kgs.)	<br>80000 Numbers
16	Mometasone Furoate Cream 0.1 Percent (Pack 50gms) (Net Wt. of Mometasone<br>Furoate Micronized 7.500 Kgs.)	<br>150000Numbers
17	Mometasone Furoate Cream 0.1 Percent (Pack 60gms) (Net Wt.

s| ||16|Mometasone Furoate Cream 0.1 Percent (Pack 50gms) (Net Wt. of Mometasone Furoate Micronized 7.500 Kgs.)||| 150000Numbers| ||17|Mometasone Furoate Cream 0.1 Percent (Pack 60gms) (Net Wt. of Mometasone Furoate Micronized 17.400 Kgs.)||| 290000Numbers| ||18|Mometasone Furoate Cream 0.1 Percent (Pack 100gms) (Net Wt. of Mometasone Furoate Micronized 29.000 Kgs.)||| 290000Numbers| ||||||| ||Sl. No.||Import Items|Qty|| ||1||Mometasone Furoate Micronized|79.897 kg.||

Case No.	60 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved

UDIN00067928AM24

Party Name<br>KREATIVE ORGANICS PRIVATE LIMITED	Party Name<br>KREATIVE ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and	13/04/2023
HQ File Number<br>HQRNORM APPLY 00229743AM22
RA File Number<br>09AA04016534 AM22
Licence No and<br>Date<br>0911001791/28/10/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as
per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.	Sl. No.	Import Items	Qty.
ETODOLAC METHYL ESTER<br>1 Kg.	1	7-Ethyl Tryptophol	0.655 kg.
	2	Methyl 3-Oxo-Pentanoate	0.455 kg.
RA concerned may take further necessary action as per above decision of NC.

ms|Qty.|| |ETODOLAC METHYL ESTER 1 Kg.|1|7-Ethyl Tryptophol|0.655 kg.|| ||2|Methyl 3-Oxo-Pentanoate|0.455 kg.|| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No.	61 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM REVIW00006964AM23
RA File Number	09AA04016788 AM22
Licence No and<br>Date	0911001796/29/10/2021
Norms Committee Decision:
Deferred for comments of TE. Shipping bill and bill of entry of the export products

Case No.	62 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM REVIW00003766AM23
RA File Number	03AA040116810 AM22
Licence No and<br>Date	0311008170/02/11/2021

UDIN00067928AM24

Norms Committee Decision:

The Committee considered the case as per agenda and following have been observed by the technical authority:-

i. In the revised Statement applied have not given yield at first stage of reaction.
ii. As per chemistry & Stoichiometric balance quantity of carbon disulphide is much less as per Stoichiometric required on moler basis.
iii. Shipping bill and bill of entry of the export products.

The Committee has advised to the firm to come for Personal Hearing with well accredited technical representative.

Case No.<br>63 / NC/3/MEET/Mar/202223/24
Case Status<br>Case Approved
Party Name<br>NITIKA PHARMACEUTICAL SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number<br>HQRNORM APPLY 00245623AM22
RA File Number<br>50AA04003867 AM22
Licence No and<br>Date<br>5011000294/09/11/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as
per details given below or as applied by the firm, whichever is less.
Export Product	Qty.	Sl. No.	Import Items	Qty.
Magnesium<br>Stearate<br>Fatty<br>Acid<br>of<br>Salt	<br>1 kg.	1	Stearic Acid	0.910 kg.
Magnesium(Magnesium Stearate Fatty Acid of Salt
Magnesium)
RA concerned may take further necessary action as per above	decision of NC.

Salt| 1 kg.|1|Stearic Acid|0.910 kg.|| |Magnesium(Magnesium Stearate Fatty Acid of Salt|||||| |Magnesium)|||||| |RA concerned may take further necessary action as per above|decision of NC.|||||

Case No.	64 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	AARTI INDUSTRIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00246187AM22
RA File Number	03AA04078980 AM22
Licence No and	0311008372/09/11/2021

UDIN00067928AM24

Date

Deferred for comments of TE also call shipping bill and bill of entry.

Case No.	65 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	FREESIA CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00249915AM22
RA File Number	03AA040117893 AM22
Licence No and<br>Date	0311008508/12/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Cyclopentanone(CAS No. 120-92-3)<br>1 kg.<br>1<br>Adipic Acid<br>1.93 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	66 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00253270AM22
RA File Number	05AA04099135 AM22
Licence No and<br>Date	0511006147/15/11/2021
Norms Committee Decision:<br>Deferred for comments of TE and call shipping bill and bill of entry.

Case No.	67 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved

UDIN00067928AM24

ittee Decision: Deferred for comments of TE and call shipping bill and bill of entry.||

Case No.	67 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved

UDIN00067928AM24

Party Name	Party Name	AUROBINDO PHARMA LTD	AUROBINDO PHARMA LTD	AUROBINDO PHARMA LTD	AUROBINDO PHARMA LTD	AUROBINDO PHARMA LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		HQRNORM APPLY 00268778AM22
RA File Number		09AA04017927 AM22
Licence No and<br>Date		0911001956/29/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import<br>product in meetingno. NC/3/MEET/Mar/20202223/22 dated 24/03/2023against advance authorizationno. 0911003834<br>dated 18/10/2022, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less.<br>Export product<br>Qty.<br>Sl. No.

dated 18/10/2022, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less. Export product Qty. Sl. No. Import items Qty. 1 6-Amino Penicillanic Acid (6-APA) 576.40 mg 2 D-(-)-4-hydroxyphenylglycine methyl ester [PHPG Ester] 496.38 mg 3 Penicillin G Amidase (Particle size 250 - 500 micron, Creamish to Brown regularly shaped beads) 2.25 mg AMOXYCILLIN AND CLAVULANATE POTASSIUM TABLETS 1000mg((Each tablet contains Amoxicillin 875 mg and Potassium Clavulanate equivalent to Clavulanic acid 125 mg) [Relevant Bulk Drug content in the Export product is Amoxycillin Trihydrate is11812.50 Kgs and Clavulanate potassium is 1687.50 Kgs]) 1 Number Tablet 4 Potassium Clavulanate Diluted with Microcrystalline Cellulose (1:1) 302.03 mg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl.

br>Potassium Clavulanate Diluted with Microcrystalline Cellulose (1:1) 302.03 mg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||AMOXYCILLIN AND CLAVULANATE POTASSIUM TABLETS 1000mg((Each tablet contains Amoxicillin 875 mg and Potassium Clavulanate equivalent to Clavulanic acid 125 mg) [Relevant Bulk Drug content in the Export product is Amoxycillin Trihydrate is11812.50 Kgs and Clavulanate potassium is 1687.50 Kgs])|| 1 Number Tablet|1|6-Amino Penicillanic Acid (6-APA)|576.40 mg| |||||2|D-(-)-4-hydroxyphenylglycine methyl ester [PHPG Ester]|496.38 mg| |||||3|Penicillin G Amidase (Particle size 250 - 500 micron, Creamish to Brown regularly shaped beads)| 2.25 mg| |||||4|Potassium Clavulanate Diluted with Microcrystalline Cellulose (1:1)| 302.03 mg| ||RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	68 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00272724AM22
RA File Number	03AA040127775 AM22
Licence No and<br>Date	0311009114/02/12/2021
Norms Committee Decision:<br>Deferred for comments of TE also call shipping bill and bill of entry.

UDIN00067928AM24

r|03AA040127775 AM22| |Licence No and Date|0311009114/02/12/2021| |Norms Committee Decision: Deferred for comments of TE also call shipping bill and bill of entry.||

UDIN00067928AM24

Case No.	69 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	RAKSHIT PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00276086AM22
RA File Number	09AA04016769 AM22
Licence No and<br>Date	0911002001/06/12/2021
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Complete calculation sheet certified by GST/CA.<br>I.

Case No.	70 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM REVIW00006199AM23
RA File Number	09AX04000002 AM22
Licence No and<br>Date	0911002041/13/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed that“Description and content of API in the<br>export does not match with the approved composition in the DML.Call forPersonal Hearingalongwith Shipping Bill<br>and COA of import and export.

Description and content of API in the** export does not match with the approved composition in the DML.Call forPersonal Hearingalongwith Shipping Bill and COA of import and export.||

Case No.	71 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00286998AM22
RA File Number	31AX04000006 AM22
Licence No and<br>Date	3111000788/15/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less.

UDIN00067928AM24

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Gentadox<br>Gold<br>Powder<br>(1<br>Kg<br>Jar)(Gentadox Gold Powder (1 Kg Jar))<br>1 number<br>1<br>Doxycycline Hyclate<br>BP/EP/USP<br>0.202 kg.	Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Gentadox<br>Gold<br>Powder<br>(1<br>Kg<br>Jar)(Gentadox Gold Powder (1 Kg Jar))<br>1 number<br>1<br>Doxycycline Hyclate<br>BP/EP/USP<br>0.202 kg.
		Exort Product				Qt			Sl No	I	ort Item	s		Qt
	p					y.			.

br>1 Doxycycline Hyclate BP/EP/USP 0.202 kg.||||||||||||||| |---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---| |||Exort Product||||Qt|||Sl No|I|ort Item|s||Qt|| ||p|||||y.|||. .|p||||y.|| ||Gentadox Gold Powder (1 Kg Jar)(Gentadox Gold Powder (1 Kg Jar))||||| 1 number|||1|Doxycycline Hyclate BP/EP/USP||||0.202 kg.|| ||||||||||||||||| ||||||||||||||||| ||Gentadox Gold Powde|||r (100 Gm|| 1 number|||2|Doxycycline Hyclate||||20.2 gm.|| ||Sachet)(Gentadox Gold Po |||wder (100 Gm||||||BP/EP/USP|||||| ||Sachet))||||||||||||||| ||||||||||||||||| ||||||||||||||||| ||Neodox Gold Powder (1 K |||g Jar)(Neodox|| 1 number|||3|Doxycycline Hyclate||||0.101 kg.|| ||Gold Powder (1 Kg Jar))|||||||||BP/EP/USP|||||| ||||||||||||||||| ||||||||||||||||| ||Neodox Gold Powder (100 Gm Sachet)(Neodox Gold Powder (100 Gm Sachet))||||| 1 number|||4|Doxycycline Hyclate BP/EP/USP||||10.1 gm.|| ||Milbe Plus - S Tablets(Milbe Plus - S Tablets (14's Tablets)) (10 mg. tablet)||||| 1 number Tablet|||5|Milbemycin Oxime Usp||||10.2 mg.|| ||||||||||||||||| ||Milbe Plus - L Tablets(Milbe Tablets (14's Tablets)) (50 mg.||||Plus - L tablet)| 1 n|umber T|ablet|6|Milbemycin Oxime Usp||||51.0|0 mg.| ||||||||||||||||| ||PetOmitic ? 24(PetOmitic ? Tablets)) (24 mg. tablet)||||24 (14's| 1 n|umber T|ablet|7|Maropitant Citrate||||24.7|2 mg.| ||||||||||||||||| ||PetOmitic ? 60(PetOmitic ? 60 (14's Tablets)) (60 mg.

itic ? 24(PetOmitic ? Tablets)) (24 mg. tablet)||||24 (14's| 1 n|umber T|ablet|7|Maropitant Citrate||||24.7|2 mg.| ||||||||||||||||| ||PetOmitic ? 60(PetOmitic ? 60 (14's Tablets)) (60 mg. tablet)||||| 1 number Tablet|||8|Maropitant Citrate||||61.80 mg.|| ||PetOmitic ? 16(PetOmitic ? 16 (1*4's||||| 1 number Tablet|||9|Milbemycin Oxime Usp||||16.48 mg.|| ||Tablets)) (16 mg. tablet)||||||||||||||| ||||||||||||||||| ||||||||||||||||| ||||||||||||||||| ||||||||||||||||| |RA concerned may|||take further necessary action as per above decision of NC.||||||||||||| ||||||||||||||||| ||||||||||||||||| |C|||2 / C/3/MEET/M/202223/24||||||||||||| |ase No.|||7 Nar||||||||||||| |C S|||C Dfd||||||||||||| |ase tatus|||ase eerre||||||||||||| |Party Name|||MATRIX LIFE SCIENCE PRIVATE LIMITED||||||||||||| ||||||||||||||||| |Meeting Number and Date|||NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023||||||||||||| |HQ File Number|||HQRNORM APPLY 00287478AM22||||||||||||| |||||||||||||||||

Case No.	72 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00287478AM22

UDIN00067928AM24

UDIN00067928AM24

RA File Number<br>03AA040122138 AM22
Licence No and<br>Date<br>0311009510/16/12/2021
Norms Committee Decision:
Committee considered the case as per agenda and it was decided to call for following information/documents from the firm:
Firm has applied norms for (i) Phytosterol Natural Refined Phytosterol 95% and (ii) Natural Mixed Tocopherol
70%, separately.Whereas, export item No.2 is the Byproduct of export item no. 1.In view of above, no norms can be
fixed in its present form. Shipping bill and bill of entry.

Case No.	73 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	SUMAR BIOTECH LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00291905AM22
RA File Number	08AX04000034 AM22
Licence No and<br>Date	0811003488/20/12/2021
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-
Complete Technical details as per Annexure to Appendix 4E.<br>i.
Shipping bill and bill of entry.<br>ii.

was decided to call for following|| |information/documents from the firm:-|| |Complete Technical details as per Annexure to Appendix 4E. i.|| |Shipping bill and bill of entry. ii.||

Case No.	74 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00293142AM22
RA File Number	05AX04000189 AM22
Licence No and<br>Date	0511007079/21/12/2021
Norms Committee Decision:
Deferred for comments of TE also shipping bill and bill of entry.

Case No.	75 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00293146AM22
RA File Number	34AX04000029 AM22

UDIN00067928AM24

Licence No and 3411001569/21/12/2021 Date Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing before Norms Committee to explain its case regarding their export item and its end use. Also call shipping bill and bill of entry.

it was decided to call the firm for attending Personal Hearing before Norms Committee to explain its case regarding their export item and its end use. Also call shipping bill and bill of entry.

Case No.	Case No.	Case No.	76 / NC/3/MEET/Mar/202223/24	76 / NC/3/MEET/Mar/202223/24	76 / NC/3/MEET/Mar/202223/24
Case Status			Case Approved
Party Name			BALAJI SPECIALITY CHEMICALS LIMITED

Meeting Number an		d Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023

HQ File Number			HQRNORM REVIW00004848AM23

RA File Number			31AX04000017 AM22

Licence No and Da		te	3111000824/22/12/2021
Norms Committee		Decision:
The Committee co		nsidered the request of firm for review of adhoc norms and on the basis of information provided
<br>by	<br>the firm, it was	<br>decided to revise adhoc norms as			<br>under:-


	Export Product			Qty.	Sl.

review of adhoc norms and on the basis of information provided|||||| | by| the firm, it was| decided to revise adhoc norms as||| under:-||| ||||||||| ||||||||| ||Export Product|||Qty.|Sl. No.|Import Items|Qty.| ||||||||| ||ETHYLENEDIAMINE(ORGANIC CHEMICAL)|||1 kg.|1|MONOETHANOLAMINE|1.06 kg.| ||||||2|AMMONIA ANHYDROUS|0.294 kg.| ||||||||| ||||||||| ||||||||| |RA concerned ma||take further necessar action as e|||above decision of NC||| |||y p .|||||| ||||||||| |Case No.||77 / NC/3/MEET/Mar/202223/24|||||| |Case Status||Case Deferred|||||| |Party Name||LAURUS SYNTHESIS PRIVATE LIMITED|||||| |Meeting Number|||||||| | and Date||NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023|||||| |HQ File Number||HQRNORM APPLY 00295564AM22|||||| |RA File Number||09AX04000038 AM22|||||| |Licence No and Date||0911002144/23/12/2021|||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm:|||||||| |||||||||

Case No.	77 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00295564AM22
RA File Number	09AX04000038 AM22
Licence No and<br>Date	0911002144/23/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:

UDIN00067928AM24

12/2021| |Norms Committee Decision:|| |The Committee considered the case as per agenda and it was decided to call for following information / documents|| |from the firm:||

UDIN00067928AM24

I. Name of the API produced from the export item stated to be a Drug – Intermediate.
II. Technical justification for the difference in the applied norms for FMP in the two licences taken in January 2022 and February 2022.
III. Foreign collaborators’ Guaranteed Norms, if any, for the above export.
IV. Copy of Technical Literature in support of yields claimed.
V. Shipping bill and bill of entry.

Case No.	78 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00295569AM22
RA File Number	09AX04000039 AM22
Licence No and<br>Date	0911002145/23/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Name of the API produced from the export item stated to be a Drug – Intermediate.<br>I.<br>Technical justification for the difference in the applied norms for FMP in the two licences taken in<br>January 2022 and February 2022.<br>II.<br>Foreign collaborators’ Guaranteed Norms, if any, for the above export.<br>III.<br>Copy of Technical Literature in support of yields claimed.<br>IV.<br>Shipping bill and bill of entry.<br>V.

gn collaborators’ Guaranteed Norms, if any, for the above export.** III. Copy of Technical Literature in support of yields claimed. IV. Shipping bill and bill of entry. V.||

Case No.	79 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	LARK LABORATORIES (INDIA) LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00296972AM22
RA File Number	05AX04000299 AM22
Licence No and<br>Date	0511007234/24/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-

UDIN00067928AM24

Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>SITAGLIPTIN TABLETS BP 100 MG(NET<br>CONTENT SITAGLIPTIN PHOSPHATE<br>MONOHYDRATE BP-147.059(SITAGLIPTIN<br>TABLETS BP 100 MG(NET CONTENT<br>SITAGLIPTIN PHOSPHATE MONOHYDRATE<br>BP-147.059 KGS))<br>1 number<br>1<br>SITAGLIPTIN<br>PHOSPHATE<br>MONOHYDRATE BP<br>131.05 mg<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items<br>	Qty.
	SITAGLIPTIN TABLETS BP 100 MG(NET<br>CONTENT SITAGLIPTIN PHOSPHATE<br>MONOHYDRATE BP-147.059(SITAGLIPTIN<br>TABLETS BP 100 MG(NET CONTENT<br>SITAGLIPTIN PHOSPHATE MONOHYDRATE<br>BP-147.059 KGS))	1 number	1	SITAGLIPTIN<br>PHOSPHATE<br>MONOHYDRATE BP<br>	131.05 mg

Case No.	Case No.	80 / NC/3/MEET/Mar/202223/24	80 / NC/3/MEET/Mar/202223/24	80 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		SAVLA CHEMICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		HQRNORM APPLY 00298647AM22
RA File Number		03AX04000385 AM22
Licence No and<br>Date		0311009839/27/12/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and taking cue from earlier decision for<br>same export product / import item in Meeting No.NC/3/MEET/Sep/202223/8 dated 23.09.2022against advance<br>authorization No.0311005248 dt. 09/07/2021, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>HIGH PURITY METHYL TERTIARY<br>BUTYL ETHER 99.8%(HIGH PURITY<br>METHYL TERTIARY BUTYL<br>ETHER 99.8%)<br>1 kg.<br>1 Number<br>METHYL TERTIARY BUTYL ETHER<br>(MTBE)<br>1.00 kg.<br>RA concerend may take further necessary action as per above decision of Norms Committee.
	Export product		Qty.	Sl.

br>1 kg. 1 Number METHYL TERTIARY BUTYL ETHER (MTBE) 1.00 kg. RA concerend may take further necessary action as per above decision of Norms Committee.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||HIGH PURITY METHYL TERTIARY BUTYL ETHER 99.8%(HIGH PURITY METHYL TERTIARY BUTYL ETHER 99.8%)||1 kg.|1 Number|METHYL TERTIARY BUTYL ETHER (MTBE)| 1.00 kg.| ||RA concerend may take further necessary action as per above decision of Norms Committee.||||||

Case No.	81 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED

UDIN00067928AM24

Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00299344AM22
RA File Number	07AA04038998 AM22
Licence No and<br>Date	0711002737/28/12/2021
Norms Committee Decision:<br>Deferred for the comments of TE also call shipping bill and bill of entry.

Case No.	82 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM REVIW00006967AM23
RA File Number	09AX04000070 AM22
Licence No and<br>Date	0911002189/28/12/2021
Norms Committee Decision:<br>Deferred for the comments of TE also shipping bill and bill of entry.

967AM23| |RA File Number|09AX04000070 AM22| |Licence No and Date|0911002189/28/12/2021| |Norms Committee Decision: Deferred for the comments of TE also shipping bill and bill of entry.||

Case No.	83 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	CLARIANT INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00302256AM22
RA File Number	03AX04000499 AM22
Licence No and<br>Date	0311009919/30/12/2021
Norms Committee Decision:<br>Deferred for the comments of TE and shipping bill and bill of entry

Case No.	84 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00303552AM22
RA File Number	07AX04000082 AM22
Licence No and<br>Date	0711002772/31/12/2021
Norms Committee Decision:

UDIN00067928AM24

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:-

Complete calculation sheet certified by GST/CA.
COA and Process Flow Chart
shipping bill and bill of entry.

ed to call for following information/documents from the firm:-

Complete calculation sheet certified by GST/CA.
COA and Process Flow Chart
shipping bill and bill of entry.

Case No.	85 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00317040AM22
RA File Number	08AX04000199 AM22
Licence No and<br>Date	0811003776/13/01/2022
Norms Committee Decision:
Deferred for the comments of TE and shipping bill and bill of entry.

Case No.<br>86 / NC/3/MEET/Mar/202223/24
Case Status<br>Case Approved
Party Name<br>ADCOCK INGRAM LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number<br>HQRNORM APPLY 00320005AM22
RA File Number<br>07AX04000209 AM22
Licence No and<br>Date<br>0711002880/16/01/2022
Norms Committee Decision:
Committee considered the case as per agenda and taking cue from earlier decision for same export product/import
item in Meeting No.NC/3/MEET/Mar/20202223/22 dated 24/03/2023against advance authorization No.
0711005862dated 05/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I asper details given
below or asapplied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
Neulin 125mg Tablets -Theophylline 125 Mg	1	Theophylline BP / EP / USP /
+Guar gum 4.375 Mg(9142857 No.

d by the firm, whichever is less:||||| |Export product Qty.|Sl. No.|Import items|Qty.|| |Neulin 125mg Tablets -Theophylline 125 Mg|1|Theophylline BP / EP / USP /||| |+Guar gum 4.375 Mg(9142857 No. of||PH.EURAnhydrous Powder||| |Tabs)(Theop-1142.857 +GUAR.GUM 1 no. of Tablet|||127.5 mg|| |40.000KGS)||||| ||2|Guar Gum IH (BP / EP / USP /||| |||PH.EUR)|||

Case No.<br>86 / NC/3/MEET/Mar/202223/24
Case Status<br>Case Approved
Party Name<br>ADCOCK INGRAM LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number<br>HQRNORM APPLY 00320005AM22
RA File Number<br>07AX04000209 AM22
Licence No and<br>Date<br>0711002880/16/01/2022
Norms Committee Decision:
Committee considered the case as per agenda and taking cue from earlier decision for same export product/import
item in Meeting No.NC/3/MEET/Mar/20202223/22 dated 24/03/2023against advance authorization No.
0711005862dated 05/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I asper details given
below or asapplied by the firm, whichever is less:
Export product<br>Qty.	Sl. No.	Import items	Qty.
Neulin 125mg Tablets -Theophylline 125 Mg	1	Theophylline BP / EP / USP /
+Guar gum 4.375 Mg(9142857 No. of		PH.EURAnhydrous Powder
Tabs)(Theop-1142.857 +GUAR.GUM<br>1 no. of Tablet			127.5 mg
40.000KGS)
	2	Guar Gum IH (BP / EP / USP /
		PH.EUR)

UDIN00067928AM24

142857 No. of||PH.EURAnhydrous Powder||| |Tabs)(Theop-1142.857 +GUAR.GUM 1 no. of Tablet|||127.5 mg|| |40.000KGS)||||| ||2|Guar Gum IH (BP / EP / USP /||| |||PH.EUR)|||

UDIN00067928AM24

				4.375 mg
Neulin 200mg Tablets -Theophylline 200 Mg		1	Theophylline BP / EP / USP /
+Guar gum 7.00Mg(9142857 No. of			PH.EURAnhydrous Powder
	1 no. of Tablet			204.0 mg
Tabs)(Theop- 1828.571+GUAR.GUM
64.000 KGS		2	Guar Gum IH (BP / EP / USP /
			PH.EUR)
				7.00 mg
Neulin 250mg Tablets -Theophylline 250 Mg		1	Theophylline BP / EP / USP /
+Guar gum 8.750 Mg(9142857 No. of			PH.EURAnhydrous Powder
Tabs)(Theop-2285.714+GUAR.GUM	1 no. of Tablet			255.0 mg
80.000 KGS)
		2	Guar Gum IH (BP / EP / USP /
			PH.EUR)
				8.75 mg
Neulin 300mg Tablets -Theophylline 300 Mg		1	Theophylline BP / EP / USP /
+Guar gum 10.5 Mg(9142857 No. of Tabs)(Theop-			PH.EURAnhydrous Powder
2742.857+GUAR.GUM	1 no. of Tablet			306.0 mg
96.000 KGS)
		2	Guar Gum IH (BP / EP / USP /
			PH.EUR)
				10.5 mg

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

.857+GUAR.GUM|1 no. of Tablet|||306.0 mg| |96.000 KGS)||||| |||2|Guar Gum IH (BP / EP / USP /|| ||||PH.EUR)|| |||||10.5 mg|

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

Case No.	87 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00324009AM22
RA File Number	03AX04000495 AM22
Licence No and<br>Date	0311010688/19/01/2022
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-

UDIN00067928AM24

i. Material Balance & Stoichiometric requirement of quantity of Phenol against one kg. of export.
ii. Since Phenol is also produced as a by product in the last stage of reaction.
iii. Shipping bill and bill of entry

Case No.	88 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00332964AM22
RA File Number	09AX04000151 AM22
Licence No and<br>Date	0911002396/27/01/2022
Norms Committee Decision:
Deferred for the comments of TE and shipping bill and bill of entry.

2964AM22| |RA File Number|09AX04000151 AM22| |Licence No and Date|0911002396/27/01/2022| |Norms Committee Decision:|| |Deferred for the comments of TE and shipping bill and bill of entry.||

Case No.<br>89 / NC/3/MEET/Mar/202223/24	Case No.<br>89 / NC/3/MEET/Mar/202223/24
Case Status<br>Case Approved
Party Name<br>OLON ACTIVE PHARMACEUTICAL INGREDIENTS INDIA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number<br>HQRNORM APPLY 00345974AM22
RA File Number<br>03AX04001021 AM22
Licence No and<br>Date<br>0311010996/07/02/2022
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 meeting no. NC/3/MEET/Dec/2002223/17 dated 13/01/2023 against advance authorization No.0311007856 dated
22/10/2021, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as			applied by the
firm, whichever is less:-
	Export product<br>Qty.	Sl. No. Import items	Qty.
	Quetiapine Fumarate Micronised<br>1 kg	1<br>Dibenzo [b,f] [ 1,4 ] Thiazepine-11- [10	<br>0.580 kg
		Dibenzo-[b,f][1,4]-thiazepin-11(10H)-one
		(CAS 3159-07-7)
		2<br>1-[2-(2-Hydroxyethoxy) Ethyl Piperazine	<br>0.714 kg
		2-Hydroxy Ethyl Ethoxy Piperazine CAS
		13349-82-1

g|| |||Dibenzo-[b,f][1,4]-thiazepin-11(10H)-one||| |||(CAS 3159-07-7)||| |||2 1-[2-(2-Hydroxyethoxy) Ethyl Piperazine| 0.714 kg|| |||2-Hydroxy Ethyl Ethoxy Piperazine CAS||| |||13349-82-1|||

Case No.<br>89 / NC/3/MEET/Mar/202223/24	Case No.<br>89 / NC/3/MEET/Mar/202223/24
Case Status<br>Case Approved
Party Name<br>OLON ACTIVE PHARMACEUTICAL INGREDIENTS INDIA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number<br>HQRNORM APPLY 00345974AM22
RA File Number<br>03AX04001021 AM22
Licence No and<br>Date<br>0311010996/07/02/2022
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 meeting no. NC/3/MEET/Dec/2002223/17 dated 13/01/2023 against advance authorization No.0311007856 dated
22/10/2021, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as			applied by the
firm, whichever is less:-
	Export product<br>Qty.	Sl. No. Import items	Qty.
	Quetiapine Fumarate Micronised<br>1 kg	1<br>Dibenzo [b,f] [ 1,4 ] Thiazepine-11- [10	<br>0.580 kg
		Dibenzo-[b,f][1,4]-thiazepin-11(10H)-one
		(CAS 3159-07-7)
		2<br>1-[2-(2-Hydroxyethoxy) Ethyl Piperazine	<br>0.714 kg
		2-Hydroxy Ethyl Ethoxy Piperazine CAS
		13349-82-1

UDIN00067928AM24

thiazepin-11(10H)-one||| |||(CAS 3159-07-7)||| |||2 1-[2-(2-Hydroxyethoxy) Ethyl Piperazine| 0.714 kg|| |||2-Hydroxy Ethyl Ethoxy Piperazine CAS||| |||13349-82-1|||

UDIN00067928AM24

Case No.	90 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00346268AM22
RA File Number	34AX04000204 AM22
Licence No and<br>Date	3411001767/07/02/2022
Norms Committee Decision:<br>Deferred for the comments of TE and shipping bill and bill of entry.

Case No.	91 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	PUNISKA HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00347306AM22
RA File Number	08AX04000205 AM22
Licence No and<br>Date	0811003993/08/02/2022
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>Copy of DML showing approved composition of each export items.<br>I.<br>Wastage claimed in each export.<br>II.<br>and shipping bill and bill of entry.<br>III.

le ceftazidime USP and Sodium Carbonate equivalent to Anhydrous ceftazidime2 gm)| 95000 vials||CEFTAZIDIME WITH SODIUM CARBONATE USP| 200 kg|

Case No.	120 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00404671AM22
RA File Number	34AX04000254 AM22
Licence No and<br>Date	3411002035/28/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda andit was decided to call the firm for attending<br>before Norms Committee to explain its case.and shipping bill and bill of entry.		Personal Hearing

UDIN00067928AM24

Case No.<br>121 / NC/3/MEET/Mar/202223/24
Case Status<br>Case Approved
Party Name<br>MAHIMA LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number<br>HQRNORM APPLY 00405626AM22
RA File Number<br>05AX04001435 AM22
Licence No and<br>Date<br>0511011420/29/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as
per details given below or as applied by the firm, whichever is less.
Export Product<br>Qty.<br>Sl.

case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as|||| |per details given below or as applied by the firm, whichever is less.|||| |Export Product Qty. Sl. No.|Import Items|Qty.|| |TRIAMCINOLONE ACETONIDE 1 kg. 1|3,20-DIOXOPREGNA-1,4,9(11),16-|1.00 kg.|| ||TETRAEN-21-YLACETATE (3TR)||| |RA concerned may take further necessary action as per above decision of NC.||||

Case No.	122 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	KRITI NUTRIENTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00408410AM22
RA File Number	56AX04000134 AM22
Licence No and<br>Date	5611000874/30/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing<br>before
Norms Committee to explain its case alongwith following information / documents from the firm:-
Complete specification and COA of import item from Foreign Supplier.<br>i.
Point out the difference in specification of import and export.<br>ii.
Production/consumption data for last two years duly certified by GST.<br>iii.
and shipping bill and bill of entry.<br>iv.

Case No.	123 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved

UDIN00067928AM24

s duly certified by GST.** iii.||| |and shipping bill and bill of entry. iv.|||

Case No.	123 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved

UDIN00067928AM24

Party Name	PANACEA BIOTEC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00408439AM22
RA File Number	05AX04001517 AM22
Licence No and<br>Date	0511011486/30/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol.<br>I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Monovalent Bulk of<br>Poliomyelitis Type 1<br>14.23 Liters<br>2<br>Monovalent Bulk of<br>Poliomyelitis Type 3<br>8.98 Liters<br>3<br>Rubber Stopper<br>1,02,000 Numbers<br>BIVALENT (Type 1 & Type3)<br>ORAL POLIOMYELITIS VACCINE<br>(bOPV), 20 DOSE VIAL -(Live Oral<br>Sabin Strain,<br>Bivalent, Ready for use in vials of 20<br>doses with droppers, with vaccine vial<br>monitor (VVM) affixed on the<br>individual vial))<br>1,00,000 vials<br>4<br>VVM Dot for OPV<br>1,02,000 Numbers<br>RA concerned may take further necessary action as per above decision of NC.

br>monitor (VVM) affixed on the individual vial)) 1,00,000 vials 4 VVM Dot for OPV 1,02,000 Numbers RA concerned may take further necessary action as per above decision of NC.||

Case No.	124 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00408905AM22
RA File Number	34AX04000448 AM22
Licence No and<br>Date	3411002052/30/03/2022
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/Nov/202223/14 dated 07/12/2022against advance authorization<br>no.3411001662 dated 07/01/2022, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less.

UDIN00067928AM24

411001662 dated 07/01/2022**, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less.||

UDIN00067928AM24

Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.	Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.	Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.	Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.	Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.	Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.	Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.
Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.


1	Amantadi	ne<br>Hydrochloride	<br>1 Number	1	Amantadine Hydrochloride USP	102.00 mg
	capsules	<br>USP<br>100mg	<br> <br>Capsule
	(Amantad<br>	ine<br>Hydrochloride<br> <br> <br>	<br>	2	Mitlli lll (Ail PH301)	10600
	capsules<br>content<br>270.00 kg	USP<br>100mg<br>(Net<br>of active ingredients<br>s ) )	<br>		crocrysane ceuose vce	.

|ine Hydrochloride | |2|Mitlli lll (Ail PH301)||||10600| |||capsules content 270.00 kg|USP 100mg (Net of active ingredients s ) )| ||crocrysane ceuose vce||||. mg| |||||||||||| ||||||3|Hydroxypropyl Cellulose (Klucel LF)||||2.00 mg| |||||||||||| |||||||||||| ||||||4|Croscarmellose Sodium (Ac-Di-Sol)||||10.00 mg| ||||||5|Colloidal Silicon Dioxide (Aerosil 200 Pharma)||||1.00 mg| ||||||6|Magnesium Stearate (Vegetable Source)||||1.00 mg| ||||||7| |Empty Hard Gelatin Capsules Red Opaque / |||Relevant as per | ||||||| |ed Opa Cap in w|que Size 2 imprinted with A226 hite ink|on|packing policy| ||2|Amantadine Hydrochloride|| 1 Number|1||Amantad|ine Hydrochloride USP||10200 mg| ||| Tablets USP 100mg (Amantadine Hydrochloride Tablets USP 100mg (Net content of active ingredients 300.00 kgs ) )|| Tablet||||||.| ||||||2||Microcry|stalline Cellulose (Avicel PH 101|)|33.65 mg| |||||||||||| ||||||3||Povidone|(Kollidon 90F)||3.00 mg| |||||||||||| ||||||4| |Lake Pi t Y|gment HT 5285 FD&C Yellow ll FCF Ali Lk|6|0.300 mg| ||||||||unse|eow umnum ae||| ||||||5| |Sodium|Starch Glycolate (Type|A)|4.50 mg| ||||||||(EXPLO|TAB)||| |||||||||||| ||||||6||Povidone (K-30)|||3.00 mg| ||||||7| |Colloidal Silicon Dioxide (Aerosil 200 Pharma)|||0.75 mg| |||||||||||| |||||||||||| ||||||8|Magnesium Stearate||||0.80 mg| |||||||||||| |||||||||||| ||||||||||||

UDIN00067928AM24

| |Colloidal Silicon Dioxide (Aerosil 200 Pharma)|||0.75 mg| |||||||||||| |||||||||||| ||||||8|Magnesium Stearate||||0.80 mg| |||||||||||| |||||||||||| ||||||||||||

UDIN00067928AM24

Case No.	Case No.	Case No.	125 / NC/3/MEET/Mar/202223/24	125 / NC/3/MEET/Mar/202223/24	125 / NC/3/MEET/Mar/202223/24	125 / NC/3/MEET/Mar/202223/24	125 / NC/3/MEET/Mar/202223/24
Case Status			Case Approved
Party Name			ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number			HQRNORM APPLY 00409452AM22
RA File Number			34AX04000441 AM22
Licence No and<br>Date			3411002060/31/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import<br>product in meeting No.NC/3/MEET/Nov/20202223/14 dated 07/12/2022 against advance authorization No. 3411001604<br>dated 29/12/2021 , it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less:-<br>Sl. No. Export product<br>Qty.<br>Sl. No.

29/12/2021 , it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Sl. No. Export product Qty. Sl. No. Import items Qty. 1 Duloxetine Hydrochloride Ph,Eur. 22.88 mg 2 Sugar Spheres (30-35 PHARM-A- SPHERES) 20.33 mg 3 Hypromellose (Pharmacoat 606) 20.00 mg 4 Talc (Luzenac Pharma Ultra Micronised grade) 12.63 mg 5 Sucrose (Compressuc PS) 15.67 mg 6 Hypromellose Phthalate (HP 55) 12.07 mg 1 Duloxetine Caps.20 mg (Duloxetine Caps.20 mg (Net content of active ingredients 110.000 kgs )) 1 Number Capsule 7 Triethyl Citrate 1.21 mg 1 Duloxetine Hydrochloride Ph,Eur. 34.36 mg 2 Sugar Spheres (30-35 PHARM-A- SPHERES) 30.50 mg 2 Duloxetine Caps. 30 mg(Duloxetine Caps. 30 mg (Net content of active ingredients 225.00 kgs )) 1 Number Capsule|||||||| ||Sl. No.|Export product||Qty.|Sl.

.50 mg 2 Duloxetine Caps. 30 mg(Duloxetine Caps. 30 mg (Net content of active ingredients 225.00 kgs )) 1 Number Capsule|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Duloxetine Caps.20 mg (Duloxetine Caps.20 mg (Net content of active ingredients 110.000 kgs ))|| 1 Number Capsule|1|Duloxetine Hydrochloride Ph,Eur.|22.88 mg| ||||||2|Sugar Spheres (30-35 PHARM-A- SPHERES)|20.33 mg| ||||||3|Hypromellose (Pharmacoat 606)|20.00 mg| ||||||4|Talc (Luzenac Pharma Ultra Micronised grade)|12.63 mg| ||||||5|Sucrose (Compressuc PS)|15.67 mg| ||||||6|Hypromellose Phthalate (HP 55)|12.07 mg| ||||||7|Triethyl Citrate|1.21 mg| ||2|Duloxetine Caps. 30 mg(Duloxetine Caps. 30 mg (Net content of active ingredients 225.00 kgs ))|| 1 Number Capsule|1|Duloxetine Hydrochloride Ph,Eur.|34.36 mg| ||||||2|Sugar Spheres (30-35 PHARM-A- SPHERES)|30.50 mg|

UDIN00067928AM24

redients 225.00 kgs ))|| 1 Number Capsule|1|Duloxetine Hydrochloride Ph,Eur.|34.36 mg| ||||||2|Sugar Spheres (30-35 PHARM-A- SPHERES)|30.50 mg|

UDIN00067928AM24

			3	Hypromellose (Pharmacoat 606)	30.00 mg
			4	Talc (Luzenac Pharma Ultra Micronised<br>grade)	18.94 mg
			5	Sucrose (Compressuc PS)	23.50 mg
			6	Hypromellose Phthalate (HP 55)	18.10 mg
			7	Triethyl Citrate	1.81 mg
3	Duloxetine<br>Caps.<br>40<br>mg(Duloxetine Caps. 40 mg<br>(Net<br>content<br>of<br>active<br>ingredients 120.000 kgs ))	<br> <br> <br>1 Number<br>Capsule	1	Duloxetine Hydrochloride Ph,Eur.	45.76 mg
			2	Sugar<br>Spheres<br>(30-35<br>PHARM-A-<br>SPHERES)	40.67 mg
			3	Hypromellose (Pharmacoat 606)	40.00 mg
			4	Talc (Luzenac Pharma Ultra Micronised<br>grade)	25.26 mg
			5	Sucrose (Compressuc PS)	31.34 mg
			6	Hypromellose Phthalate (HP 55)	24.14 mg
			7	Triethyl Citrate	2.41 mg
4	Duloxetine<br>Caps.<br>60<br>mg(Duloxetine Caps. 60 mg<br>(Net<br>content<br>of<br>active<br>ingredients 450.00 kgs ))	<br> <br> <br>1 Number<br>Capsule	1	Duloxetine Hydrochloride Ph,Eur.	68.71 mg
			2	Sugar<br>Spheres<br>(30-35<br>PHARM-A-<br>SPHERES)	61.00 mg
			3	Hypromellose (Pharmacoat 606)	60.00 mg
			4	Talc (Luzenac Pharma Ultra Micronised<br>grade)	37.88 mg
			5	Sucrose (Compressuc PS)	47.00 mg
			6	Hypromellose Phthalate (HP 55)	36.20 mg

UDIN00067928AM24

7 Triethyl Citrate 3.62 mg

(Luzenac Pharma Ultra Micronised grade)|37.88 mg| |||||5|Sucrose (Compressuc PS)|47.00 mg| |||||6|Hypromellose Phthalate (HP 55)|36.20 mg|

UDIN00067928AM24

7 Triethyl Citrate 3.62 mg

Case No.<br>126 / NC/3/MEET/Mar/202223/24
Case Status<br>Case Approved
Party Name<br>BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and	13/04/2023
HQ File Number<br>HQRNORM REVIW00004847AM23
RA File Number<br>31AX04000100 AM22
Licence No and Date<br>3111001215/31/03/2022
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and on the basis of information provided
by the firm, it was decided to revise adhoc norms as under:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty.
1<br>ETHYLENEDIAMINE(ORGANIC<br>1 kg.	MONOETHANOLAMINE	1.06 kg.
CHEMICAL)
2	AMMONIA ANHYDROUS	0.294 kg.
RA concerned may take further necessary action as per above decision of NC.

br>ETHYLENEDIAMINE(ORGANIC 1 kg.||MONOETHANOLAMINE|1.06 kg.|| |CHEMICAL)||||| |2||AMMONIA ANHYDROUS|0.294 kg.|| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No.<br>127 / NC/3/MEET/Mar/202223/24
Case Status<br>Case Approved
Party Name<br>R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number<br>HQRNORM APPLY 00000086AM23
RA File Number<br>07AX04000582 AM22
Licence No and<br>Date<br>0711003633/06/04/2022
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 meeting no.NC/3/MEET/Nov/20202223/14 dated 07/12/2022against advance authorizationNo. 0711000345
dated 21/01/2021,it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as
applied by the firm, whichever is less.

UDIN00067928AM24

Export product	Qty.	Sl. No.	Import items	Qty.
CLOMIPRAMINE HCL<br>(BP/EP/USP/JP)	1 kg	1	1 BROMO 3 CHLORO PROPANE	0.85 kg
		2	IMINODIBENZYL	1.00 kg
		3	METHANOL	1.20 kg
		4	IPA	0.50 kg
		5	TOLUENE	0.50 kg
		6	ACETONE	1.00 kg

|---| |CLOMIPRAMINE HCL (BP/EP/USP/JP)|1 kg|1|1 BROMO 3 CHLORO PROPANE|0.85 kg| |||2|IMINODIBENZYL|1.00 kg| |||3|METHANOL|1.20 kg| |||4|IPA|0.50 kg| |||5|TOLUENE|0.50 kg| |||6|ACETONE|1.00 kg|

Case No.	Case No.	128 / NC/3/MEET/Mar/202223/24	128 / NC/3/MEET/Mar/202223/24	128 / NC/3/MEET/Mar/202223/24	128 / NC/3/MEET/Mar/202223/24	128 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		HQRNORM APPLY 00000087AM23
RA File Number		07AX04000581 AM22
Licence No and<br>Date		0711003634/06/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import<br>product in meetingNo.NC/3/MEET/Sep/20202223/8 dated 23/09/2022against advance authorizationNo. 0711001451<br>dated 11/07/2021, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>ORTHO CHLORO TOLUENE<br>0.64 kg<br>ORPHENADRINE<br>1 kg
	Export product		Qty.	Sl.<br>No.	Import items	Qty.
	ORPHENADRINE		1 kg	1	ORTHO CHLORO TOLUENE	0.64 kg

UDIN00067928AM24

ORTHO CHLORO TOLUENE 0.64 kg ORPHENADRINE 1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||ORPHENADRINE||1 kg|1|ORTHO CHLORO TOLUENE|0.64 kg|

UDIN00067928AM24

2	TETRA HYDRO FURAN	0.43 kg
3	TOLUENE	1.06 kg
4	ACETONE	Not shown in<br>the process
5	METHANOL

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

Case No.	129 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000151AM23
RA File Number	09AX04000402 AM22
Licence No and<br>Date	0911002848/08/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import<br>product in meetingNo.NC/3/MEET/Jun/20202223/5 dated 08/07/2022against advance authorizationNo.0911001444<br>dated 30/08/2021, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as<br>applied by the firm, whichever is less:-<br>Sl. No. Export product<br>Qty.<br>Sl. No.

30/08/2021**, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Sl. No. Export product Qty. Sl. No. Import items Qty. 1 Ibuprofen 400mg and Paracetamol 325mg Powder for Oral Solution (Ibuclin Express) Pack Size :6's 1 Number 1 Ibuprofen Sodium Dihydrate 517.12 mg 2 Ibuprofen 400mg and Paracetamol 325mg Powder for Oral Solution (Ibuclin Express) Pack Size :9's 1 Number 2 Ibuprofen Sodium Dihydrate 517.12 mg RA concerned may take further necessary action as per above decision of NC.||

UDIN00067928AM24

Case No.	130 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000168AM23
RA File Number	03AX04000080 AM23
Licence No and<br>Date	0311013777/11/04/2022
Norms Committee Decision:<br>Deferred for comments of TEand shipping bill and bill of entry.

Case No.	131 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	ARENE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000197AM23
RA File Number	09AX04000016 AM23
Licence No and<br>Date	0911002850/12/04/2022
Norms Committee Decision:<br>Deferred for comments of TEand shipping bill and bill of entry.

00000197AM23| |RA File Number|09AX04000016 AM23| |Licence No and Date|0911002850/12/04/2022| |Norms Committee Decision: Deferred for comments of TEand shipping bill and bill of entry.||

Case No.	132 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	ENVEE DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000202AM23
RA File Number	34AX04000001 AM23
Licence No and<br>Date	3411002110/12/04/2022
Norms Committee Decision:<br>Deferred for comments of TEand shipping bill and bill of entry.

Case No.	133 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	SUVEN PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000293AM23
RA File Number	09AX04000008 AM23

UDIN00067928AM24

Licence No and<br>Date<br>0911002860/19/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para		4.07 of HBP Vol. I as
per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items		Qty.
1<br>1,2,3,5-TETRA-O-ACETYL-B-L-<br>1 kg.	METHYL ISO BUTYL KETONE		1.840 kg.
RIBOFURANOSE(POWDER)
2	L RIBOSE		0.842 kg.
RA concerned may take further necessary action as per above decision of NC.

RA-O-ACETYL-B-L- 1 kg.|METHYL ISO BUTYL KETONE||1.840 kg.|| |RIBOFURANOSE(POWDER)||||| |2|L RIBOSE||0.842 kg.|| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No.	Case No.	134 / NC/3/MEET/Mar/202223/24	134 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		ADCOCK INGRAM LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and		13/04/2023
HQ File Number		HQRNORM APPLY 00000333AM23
RA File Number		07AX04000044 AM23
Licence No and<br>Date		0711003752/20/04/2022
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/3/82-ALC4/2018 dated 05/06/2018					against advance authorizationNo.0710108351 dated
10/06/2015, 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.		Import items	Quantity allowed
				No.
	CAL - SUP TABLETS (CALCIUM		Numbers	1		GLYCINE USP/BP/EP	535.7 mg/tablet
	CARBONATE 1250 MG +
	GLYCINE 535.7 MG)
				2		CALCIUM CARBONATE	1275 mg/tablet
						DENSE BP/USP

UDIN00067928AM24

Numbers|1||GLYCINE USP/BP/EP|535.7 mg/tablet|| ||CARBONATE 1250 MG +|||||||| ||GLYCINE 535.7 MG)|||||||| |||||2||CALCIUM CARBONATE|1275 mg/tablet|| |||||||DENSE BP/USP|||

UDIN00067928AM24


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

Case No.			135 / NC/3/MEET/Mar/202223/24
Case Status			Case Approved
Party Name			INDOCO REMEDIES LIMITED

Meeting Number<br>			NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
and Date

HQ File Number			HQRNORM APPLY 00000337AM23

RA File Number			03AX04000169 AM23

Licence No and<br>Date			0311014011/20/04/2022

Norms Committee			Decision:
The Committee c			onsidered the case as per agenda and taking cue from the earlier decision for same export product/import
product in meetin<br>dated 04/07/2021<br>			gNo.NC/3/MEET/Nov/20202223/14 dated 07/12/2022against advance authorizationNo.0311005091<br> , it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as<br>
applied by the firm, whichever is less.<br>(A)<br>Sl. No.<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.
	Sl. No.	Export Product		Qty.	Sl.

r details given below or as ||||| |applied by the firm, whichever is less. (A) Sl. No. Export Product Qty. Sl. No. Import Items Qty.|||||||| ||Sl. No.|Export Product||Qty.|Sl. No.|Import Items|Qty.| ||||||||| ||||||||| ||1|ALL|OPURINOL TABLETS 100MG|1 Number|1|Allopurinol|102.00 mg / 100| |||(Eac|h Allopurinol Tablet of 100mg|||| mg Tablet| |||conta|ins Allopurinol||||| |||100m Acet |g)(Equivalent to:-Cyano amide 0.0001mg,Triethyl Ortho ||||| |||form |ate 0.00021mg, Formamide ||||| |||0.00 Hd|15 mg, Morpholine 0.00013mg, i Hd 000006 N||||| |||y wt o|azne yrate . mg) et f Allopurinol 15000 kgs (Cross||||| ||| Norms of Allopurinol SION No.A2321 & Tablets/Capsules A412))|||||| ||||||||| ||2|ALLOPURINOL TABLETS 300MG||1 Number|2|Allopurinol|306.00 mg / 300| |||(Eac|h Allopurinol Tablet of 300mg|||| mg Tablet| |||conta |ins Allopurinol 300 ||||| |||mg)( |Equivalent to:-Cyano Acetamide ||||| |||0.00 0.00 M|3mg ,Triethyl Ortho-formate 063mg, Formamide 0.00045 mg, hli 000039 Hdi||||| |||or|one .mg , yrazne|||||

UDIN00067928AM24

Hydrate 0.00018 mg) Net wt of Allopurinol 15000 kgs. (Cross Norms of Allopurinol SION No.A2321 & Tablets/Capsules A412))

(B)

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

items|Qty.| |---|---|---|---|---| |ALLOPURINOL|1 kg|1|Cyano Acetamide|1.00 kg| |||2|Triethyl Ortho formate|2.10 kg| |||3|Formamide|1.50 kg| |||4|Morpholine|1.30 kg| |||5|Cyano Acetamide|0.60 kg|

Case No.	136 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	RAVOO'S LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000343AM23
RA File Number	09AX04000225 AM22
Licence No and<br>Date	0911002468/20/04/2022
Norms Committee Decision:<br>Deferred for comments of TEand shipping bill and bill of entry.

Case No.	137 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved

UDIN00067928AM24

Party Name<br>ZYTEX BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number<br>HQRNORM APPLY 00000381AM23
RA File Number<br>03AX04000342 AM23
Licence No and<br>Date<br>0311014101/22/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty.
1<br>BACILLUS CEREUS<br>1000 kg.	FNI 103 PEPTONE	876 kg.
2	BIONIS YE MF	876 kg.
3	X SEED KAT PEPTONE	876 kg.
RA concerned may take further necessary action as per above decision	of NC.

1 BACILLUS CEREUS 1000 kg.|FNI 103 PEPTONE|876 kg.|| |2|BIONIS YE MF|876 kg.|| |3|X SEED KAT PEPTONE|876 kg.|| |RA concerned may take further necessary action as per above decision|of NC.|||

Case No.<br>138 / NC/3/MEET/Mar/202223/24
Case Status<br>Case Approved
Party Name<br>MICRO LABS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number<br>HQRNORM APPLY 00000411AM23
RA File Number<br>07AX04000019 AM23
Licence No and<br>Date<br>0711003862/26/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as
per details given below or as applied by the firm, whichever is less.
Export Product<br>Qty.	Sl. No.	Import Items	Qty.
LOSARTAN<br>POTASSIUM<br>25mg 1 Number	1	LOSARTAN POTASSIUM	25.50 mg.

Case No.<br>138 / NC/3/MEET/Mar/202223/24
Case Status<br>Case Approved
Party Name<br>MICRO LABS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number<br>HQRNORM APPLY 00000411AM23
RA File Number<br>07AX04000019 AM23
Licence No and<br>Date<br>0711003862/26/04/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as
per details given below or as applied by the firm, whichever is less.
Export Product<br>Qty.	Sl.

case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as||||| |per details given below or as applied by the firm, whichever is less.||||| |Export Product Qty.|Sl. No.|Import Items|Qty.|| |LOSARTAN POTASSIUM 25mg 1 Number|1|LOSARTAN POTASSIUM|25.50 mg.||

UDIN00067928AM24

TABLETS(BP/IP/EP/USP 3999996 Nos.)
LOSARTAN<br>POTASSIUM<br>50mg	<br>1 Number	2	LOSARTAN POTASSIUM	51.00 mg.
TABLETS(BP/IP/EP/USP 11999988 Nos.)


RA	TABLETS(BP/IP/EP/US			P 3999996	Nos.)
	LOSARTAN<br>POTA<br>TABLETS(BP/IP/EP/US			SSIUM<br>P 11999988	50mg<br>Nos.)	<br>1 N	umber	2	LOSARTAN POTASSIU	M	51.00 mg.

	concerned may take furth			er necessar
					y action as p		er above decision of NC.



Cas	e No.		13	/ NC/3/M	EET/Mar/2		2223/24
Cas	e Status		Ca	se Approve	d
Par	ty Name		IN	DOCO RE	MEDIES LI		MITED
Me<br>Dat	eting Number and<br>e		NC	/ 3/ MEET	/ Mar/ 2022		23/ 24 and 13/04/2023

HQ File Number			HQRNORM APPLY 00000445AM23

RA File Number			03AX04000383 AM23

Licence No and Da		te	0311014211/27/04/2022


Norms Committee		ecision:

3AX04000383 AM23||||||||||||||| |||||||||||||||||||| |Licence No and Da|||te|0311014211/27/04/2022||||||||||||||| |||||||||||||||||||| |||||||||||||||||||| |Norms Committee|||ecision:|||||||||||||||| |The Committee co|||nsidered the case as per agenda and taking cue from earlier decision for same export product /|||||||||||||||| |import item in M|||eeting No.NC/3/MEET/Jan/202223/18 dated 23/01/2023against advance authorization No.|||||||||||||||| |0311011780 dated |||25/02/2022, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details |||||||||||||||| |given below or as|||applied by the firm, whichever is less:|||||||||||||||| |||||||||||||||||||| |||||||||||||||||||| |||||||||||||||||||| ||Export product||||||Qty.|||||Sl. No.||Import items|||Qty.|| |||||||||||||||||||| ||Cirofloxacin and Dexamethasone||||||700000|||||1||Cirofloxacin HCL|||18113 k|| ||p Suspension USP ( 0.3% - 0.1 % ) 7.5 Bottle.((Each ml Contains:CIPROFLOXACIN HYDROCHLORIDE EQU TO CIPROFLOXACIN BASE 3mg and DEXAMETHASONE 1mg per bottle 7.5ml) (Each 7.5 ml Contains:|||||ml| N| umbers||||||p|||. g|| |||||||||||||2||Dexamethasone|||5513 k|| |||ontains:CIPROFLOXACIN YDROCHLORIDE EQU TO IPROFLOXACIN BASE 3mg and|||||||||||||||. g|| |||||||||||||3||Bottle|||Relevant as per|| |||EXAMETHASONE 1m .5ml) (Each 7.5 ml Conta|||g per bottle ins:|of||||||||||| packing policy|| |||||||||||||||||||| ||C 7 1|iprofloxacin 22.5mg & .5 mg) Net wt.

|||Relevant as per|| |||EXAMETHASONE 1m .5ml) (Each 7.5 ml Conta|||g per bottle ins:|of||||||||||| packing policy|| |||||||||||||||||||| ||C 7 1|iprofloxacin 22.5mg & .5 mg) Net wt. Cipr 5.750kgs & Dexamethaso|||Dexameth ofloxacin ne 5.250k|asone HCL gs)||||||4||Cap|||Relevant as per packing policy|| |||||||||||||5||D|||Rlt|| |||||||||||||||ropper|||eevan as per packing policy|| |||||||||||||||||||| |||||||||||||||||||| |||||||||||||||||||| |||||||||||||||||||| ||||||||||||||||||||

UDIN00067928AM24


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


Case No	140 / NC/3/MEET/Mar/202223/24
.
Case Status	Case Aroved
	pp
Part Name	SENTISS PHARMA PRIVATE LIMITED
y
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023

HQ File Number	HQRNORM APPLY 00000450AM23
RA File Number	05AX04000232 AM23
Licence No and<br>Date	0511012110/27/04/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import<br>product in meetingNo.5/82-ALC4/2019 dated 02/08/2019against advance authorization No.0510410568 dated<br>14/05/2019, it was decided to fix adhoc norms under Para 4.07 of HBP Vol.

roduct/import product in meetingNo.5/82-ALC4/2019 dated 02/08/2019against advance authorization No.0510410568 dated 14/05/2019, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less. Export product Qty. Sl. No. Import items Qty. |||||||||| |||agenda a 9 dated d|nd takin 02/08/2 P 4||g cue from the earlier decision for same expor 019against advance authorization No.05 07 f HBP Vl I dtil i bl||||t product/import 10410568 dated lid b| |||rms un|r ara||. o o. as per eas gven eow||||or as appe y| ||||||||||| |||||Qt||Sl|Imort items|Qt|| |||||y.||. No.|p|y.|| ||||||||||| |TIZOPTAN (BIMATOPROST 0.03% AND TIMOLOL 0.5% OPHTHALMIC SOLUTION) 3ML ||||1 No.||1|BIMATOPROST|0.90 mg/3 ml vial|| ||||||||||| |BIMATAN EYE OPHTHALMIC|DROPS (BIMATOPROST SOLUTION 003% 25ML|||1 No.||1|BIMATOPROST|0.75 mg/2.5 ml vial|| ||. .)||||||||| ||||||||||| |RA tk|it ti th dii f N Citt||||||||| |may ae appr|prae acon as per e ecson o orms ommee.||||||||| ||||||||||| |Case No.|141 / NC/3/MEET/Mar/202223/24||||||||| |Case Status|Case Approved||||||||| ||||||||||| |Party Name|MAKCUR LABORATORIES LIMITED||||||||| |Meeting Number and Date|NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023||||||||| |HQ File Number|HQRNORM APPLY 00000499AM23||||||||| |RA File Number|08AX04000097 AM23||||||||| |Licence No and Date|0811004820/29/04/2022||||||||| |Norms Committee Decision:|||||||||| |||||||||||

Q File Number|HQRNORM APPLY 00000499AM23||||||||| |RA File Number|08AX04000097 AM23||||||||| |Licence No and Date|0811004820/29/04/2022||||||||| |Norms Committee Decision:|||||||||| |||||||||||

Case No.	141 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000499AM23
RA File Number	08AX04000097 AM23
Licence No and<br>Date	0811004820/29/04/2022
Norms Committee Decision:

UDIN00067928AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
CEFOTAXIME SODIUM FOR	<br>1666667.0	1	CEFOTAXIME SODIUM	1798.33 kg.
INJECTION 1gm	numbers

Case No.	142 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	SAINOR LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000500AM23
RA File Number	09AX04000372 AM22
Licence No and<br>Date	0911002924/29/04/2022
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm:-
Step wise manufacturing process.<br>i.

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

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

Case No.	143 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	SAINOR LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000501AM23
RA File Number	09AX04000388 AM22
Licence No and<br>Date	0911002925/29/04/2022

UDIN00067928AM24

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:-

i. Step wise manufacturing process.
ii. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.
i. Step wise manufacturing process.
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.
v. Details of indigenous input with quantity
vi. and shipping bill and bill of entry.

Case No.	144 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	SAINOR LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000502AM23
RA File Number	09AX04000389 AM22
Licence No and<br>Date	0911002926/29/04/2022
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.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.
Stoichiometric balance between import and export on molar basis.<br>iv.
Details of indigenous input with quantity.<br>v.
and shipping bill and bill of entry.<br>vi.

iii.|| |Stoichiometric balance between import and export on molar basis. iv.|| |Details of indigenous input with quantity. v.|| |and shipping bill and bill of entry. vi.||

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

Case No.	145 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000601AM23
RA File Number	07AX04000602 AM22
Licence No and<br>Date	0711003913/05/05/2022
Norms Committee Decision:

UDIN00067928AM24

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:-

I. Complete calculation sheet certified by GST/CA.
II. COA and Process Flow Chart
III. shipping bill and bill of entry.

l for following information/documents from the firm:-

I. Complete calculation sheet certified by GST/CA.
II. COA and Process Flow Chart
III. shipping bill and bill of entry.

Case No.	146 / NC/3/MEET/Mar/202223/24	146 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	APTRA SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24	and 13/04/2023
HQ File Number	HQRNORM APPLY 00000622AM23
RA File Number	26AX04000005 AM23
Licence No and<br>Date	2611000572/06/05/2022
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/20202223/11 dated 31/10/2022against advance authorizationNo.0911001982
dated 02/12/2021, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as
applied by the firm, whichever is less.
Export product	Qty.	Sl. No.	Import items	Qty.
N<br>Methyl<br>Loratadine(N<br>Methyl<br>1 kg		1	Meta Chloro Benzyl Cyanide	1.37 kg
Loratadine)
		2	N N Dimethyl Carbomyl Chloride	0.68 kg
RA concerned may take further necessary action as per above decision of NC.

1 kg||1|Meta Chloro Benzyl Cyanide|1.37 kg|| |Loratadine)|||||| |||2|N N Dimethyl Carbomyl Chloride|0.68 kg|| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No.	147 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000634AM23
RA File Number	07AX04000114 AM23
Licence No and<br>Date	0711003926/06/05/2022

UDIN00067928AM24

Deferred for comments of TE and shipping bill and bill of entry.

Case No.	148 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000635AM23
RA File Number	07AX04000115 AM23
Licence No and<br>Date	0711003928/06/05/2022
Norms Committee Decision:
Deferred for comments of TE and shipping bill and bill of entry.

Case No.	149 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	ADCOCK INGRAM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000741AM23
RA File Number	07AX04000110 AM23
Licence No and<br>Date	0711003978/13/05/2022
Norms Committee Decision:
Deferred for comments of TEand shipping bill and bill of entry.

Case No.	150 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	UNITED BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000757AM23
RA File Number	05AX04000267 AM23
Licence No and<br>Date	0511012548/13/05/2022
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:-
Import inputs i.e.Urokinase BP in terms of IU/mg.<br>i.

UDIN00067928AM24

tion of ad-hoc norms and it was decided to call for following|| |information/documents from the firm:-|| |**Import inputs i.**e.Urokinase BP in terms of IU/mg. i.||

UDIN00067928AM24

ii. DML (Drug Manufacturing License) iii. and shipping bill and bill of entry.

Case No.	151 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	ANUH PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000796AM23
RA File Number	03AX04000377 AM23
Licence No and<br>Date	0311014743/17/05/2022
Norms Committee Decision:<br>Deferred for comments of TEand shipping bill and bill of entry.

Case No.	152 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000815AM23
RA File Number	31AX04000039 AM23
Licence No and<br>Date	3111001366/17/05/2022
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>Name of import item no.4 of catalyst.<br>i.<br>Production/consumption data for the raw material indicating both catalyst for last three years duly certify by<br>GST/CA.<br>ii.<br>and shipping bill and bill of entry.<br>iii.

i. Production/consumption data for the raw material indicating both catalyst for last three years duly certify by GST/CA. ii. and shipping bill and bill of entry. iii.||

Case No.	153 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	SHIVA BIO CHEM INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000856AM23
RA File Number	50AX04000018 AM23
Licence No and<br>Date	5011000486/18/05/2022

UDIN00067928AM24

Norms Committee Decision:

The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing before Norms Committee to explain its case with the following information/documents:

i. COA of import and export item indicating percentage purity.
ii. If any, By-Product obtained, please furnish details of quantity and value of such By-Product.
iii. End use of Export Product.
iv. and shipping bill and bill of entry.

Case No.	154 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	VISION DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000893AM23
RA File Number	09AX04000124 AM23
Licence No and<br>Date	0911003032/20/05/2022
Norms Committee Decision:
Deferred for comments of TE.and shipping bill and bill of entry.

Case No.	155 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000918AM23
RA File Number	07AX04000117 AM23
Licence No and<br>Date	0711004046/21/05/2022
Norms Committee Decision:
Deferred for comments of TE.and shipping bill and bill of entry.

00000918AM23| |RA File Number|07AX04000117 AM23| |Licence No and Date|0711004046/21/05/2022| |Norms Committee Decision:|| |Deferred for comments of TE.and shipping bill and bill of entry.||

Case No.	156 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000939AM23
RA File Number	07AX04000122 AM23
Licence No and Date	0711004059/23/05/2022
Norms Committee Decision:

UDIN00067928AM24

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

Export Product	Qty.	Sl. No.	Import Items	Qty.
FLUCLOXACILLIN<br>CAPSULES<br>250<br>MG(FLUCLOXACILLIN CAPSULES 250<br>MG BP/EP/IP/USP 200.00 KG)	<br> <br>1 Number	1	FLUCLOXACILLIN<br>SODIUM	277.47 mg.
Export Item Name: FLUCLOXACILLIN<br>CAPSULES 500 MG(FLUCLOXACILLIN<br>CAPSULES<br>500<br>MG<br>BP/EP/IP/USP<br>16900.00 KG)	<br> <br> <br>1 Number	2	FLUCLOXACILLIN<br>SODIUM	554.94 mg.

.47 mg.| |Export Item Name: FLUCLOXACILLIN CAPSULES 500 MG(FLUCLOXACILLIN CAPSULES 500 MG BP/EP/IP/USP 16900.00 KG)| 1 Number|2|FLUCLOXACILLIN SODIUM|554.94 mg.|

Case No.	157 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000944AM23
RA File Number	09AX04000145 AM23
Licence No and<br>Date	0911003039/23/05/2022
Norms Committee Decision:<br>Deferred for comments of TEand shipping bill and bill of entry.

Case No.	158 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	HETERO DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000975AM23
RA File Number	09AX04000080 AM23
Licence No and<br>Date	0911003042/25/05/2022
Norms Committee Decision:<br>Deferred for comments of TEand shipping bill and bill of entry.

UDIN00067928AM24

Case No.	159 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000978AM23
RA File Number	09AX04000133 AM23
Licence No and<br>Date	0911003044/25/05/2022
Norms Committee Decision:<br>Deferred for comments of TEand shipping bill and bill of entry.

00000978AM23| |RA File Number|09AX04000133 AM23| |Licence No and Date|0911003044/25/05/2022| |Norms Committee Decision: Deferred for comments of TEand shipping bill and bill of entry.||

Case No.	160 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	ALTA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000980AM23
RA File Number	03AX04000822 AM23
Licence No and<br>Date	0311014992/25/05/2022
Norms Committee Decision:<br>Deferred for comments of TEand shipping bill and bill of entry.

Case No.	161 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00000987AM23
RA File Number	05AX04000414 AM23
Licence No and<br>Date	0511012794/25/05/2022
Norms Committee Decision:<br>Deferred for comments of TEand shipping bill and bill of entry..

Case No.	162 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00001002AM23

UDIN00067928AM24

RA File Number	07AX04000209 AM23
Licence No and<br>Date	0711004103/26/05/2022
Norms Committee Decision:<br>Deferred for comments of TEand shipping bill and bill of entry

M24

RA File Number	07AX04000209 AM23
Licence No and<br>Date	0711004103/26/05/2022
Norms Committee Decision:<br>Deferred for comments of TEand shipping bill and bill of entry

Case No.	Case No.	163 / NC/3/MEET/Mar/202223/24	163 / NC/3/MEET/Mar/202223/24	163 / NC/3/MEET/Mar/202223/24
Case Status		Case Approved
Party Name		SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number		HQRNORM APPLY 00001010AM23
RA File Number		04AX04000178 AM23
Licence No and<br>Date		0411003383/26/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Isobutyl Acetophenone<br>1.110 kg<br>2<br>Sodium Metal<br>0.235 kg<br>3<br>Monochloro Acetic Acid<br>0.919 kg<br>4<br>Iso Propyl Alcohol<br>0.500 kg<br>IBUPROFEN USP<br>1 Kg.<br>5<br>Sodium Dichromate<br>0.630 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl.

yl Alcohol 0.500 kg IBUPROFEN USP 1 Kg. 5 Sodium Dichromate 0.630 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||IBUPROFEN USP||1 Kg.|1|Isobutyl Acetophenone|1.110 kg| |||||2|Sodium Metal|0.235 kg| |||||3|Monochloro Acetic Acid|0.919 kg| |||||4|Iso Propyl Alcohol|0.500 kg| |||||5|Sodium Dichromate|0.630 kg| ||concerned may take further necessary action as per above decision of NC.||||||

Case No.	164 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQFile Number	HQRNORM APPLY 00001238AM23

UDIN00067928AM24

RA File Number	03AX04000996 AM23
Licence No and<br>Date	0311015308/07/06/2022
Norms Committee Decision:
Deferred for comments of TEand shipping bill and bill of entry.

RA File Number	03AX04000996 AM23
Licence No and<br>Date	0311015308/07/06/2022
Norms Committee Decision:
Deferred for comments of TEand shipping bill and bill of entry.

RA File Number	RA File Number	03AX04000996 AM23	03AX04000996 AM23	03AX04000996 AM23	03AX04000996 AM23
Licence No and<br>Date		0311015308/07/06/2022
Norms Committee Decision:<br>Deferred for comments of TEand shipping bill and bill of entry.


C	ase No.	165 / NC/3/MEET/Mar/202223	/24
C	ase Status	Case Deferred
P	arty Name	EAST AFRICAN INDIA OVE	RSEAS
M<br>a	eeting Number<br>nd Date	NC/ 3/ MEET/ Mar/ 202223/ 2	4 and 13/	04/2023

H	Q File Number	HQRNORM APPLY 00001260	AM23
R	A File Number	05AX04000587 AM23

L<br>D	icence No and<br>ate	0511013087/08/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda andit was decided to call the firm for attending<br>before Norms Committee to explain its caseand shipping bill and bill of entry.
					Personal Hearing

the case as per agenda andit was decided to call the firm for attending before Norms Committee to explain its caseand shipping bill and bill of entry.|||||||| |||||||Personal Hearing||

Case No.	Case No.	166 / NC/3/MEET/Mar/202223/24	166 / NC/3/MEET/Mar/202223/24
Case Status		Case Deferred
Party Name		NASENSE LABS PRIVATE LIMITED
Meeting Number<br>		NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
and Date

HQ File Number		HQRNORM APPLY 00001297AM23

RA File Number		09AX04000213 AM23
Licence No and<br>		0911003160/09/06/2022
Date

Norms Committee		Decision:
The committee con<br>information/docum		sidered the request of firm for review/fixation of ad-hoc norms and it was decided to call for following<br>ents from the firm:-
Percentage yield of reaction to arrive from theoretical consumption to practical consumption.<br>i.<br>and shipping bill and bill of entry.<br>ii.

C	ase No.	167 / NC/3/MEET/Mar/202223/24
C
	ase Status	Case Deferred
P	arty Name	RUMIT LIFE CARE
M<br>a	eeting Number
	<br>nd Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 1	/04/2023
H	Q File Number	HQRNORM APPLY 00001312AM23
R	A File Number	03AX04001057 AM23
L<br>	icence No and<br>	0311015409/10/06/2022
Date

/ MEET/ Mar/ 202223/ 24 and 1|/04/2023|||| |H|Q File Number|HQRNORM APPLY 00001312AM23||||| |R|A File Number|03AX04001057 AM23||||| |L |icence No and |0311015409/10/06/2022||||| |Date|||||||

Case No.	167 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	RUMIT LIFE CARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00001312AM23
RA File Number	03AX04001057 AM23
Licence No and<br>Date	0311015409/10/06/2022

UDIN00067928AM24

Deferred for comments of TEand shipping bill and bill of entry.

Case No.	168 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	AROCHEMA INGREDIENTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00001332AM23
RA File Number	26AX04000018 AM23
Licence No and<br>Date	2611000615/13/06/2022
Norms Committee Decision:
Deferred for comments of TEand shipping bill and bill of entry.

|Norms Committee Decision: Deferred for comments of TEand shipping bill and bill of entry.|Norms Committee Decision: Deferred for comments of TEand shipping bill and bill of entry.|Norms Committee Decision: Deferred for comments of TEand shipping bill and bill of entry.|Norms Committee Decision: Deferred for comments of TEand shipping bill and bill of entry.|Norms Committee Decision: Deferred for comments of TEand shipping bill and bill of entry.|Norms Committee Decision: Deferred for comments of TEand shipping bill and bill of entry.|Norms Committee Decision: Deferred for comments of TEand shipping bill and bill of entry.|Norms Committee Decision: Deferred for comments of TEand shipping bill and bill of entry.|Norms Committee Decision: Deferred for comments of TEand shipping bill and bill of entry.|Norms Committee Decision: Deferred for comments of TEand shipping bill and bill of entry.|Norms Committee Decision: Deferred for comments of TEand shipping bill and bill of entry.|Norms Committee Decision:<br

on: Deferred for comments of TEand shipping bill and bill of entry.|Norms Committee Decision: Deferred for comments of TEand shipping bill and bill of entry.|Norms Committee Decision: Deferred for comments of TEand shipping bill and bill of entry.| |---|---|---|---|---|---|---|---|---|---|---|---| ||||||||||||| |Case No.||168 / NC/3/MEET/Mar/202223/24|||||||||| |Case Status||Case Deferred|||||||||| |Party Name||AROCHEMA INGREDIENTS PRIVATE LIMITED|||||||||| |Meeting Number|||||||||||| | and Date||NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023|||||||||| |HQ File Number||HQRNORM APPLY 00001332AM23|||||||||| |RA File Number||26AX04000018 AM23|||||||||| |Licence No and Date||2611000615/13/06/2022|||||||||| |Norms Committee||Decision:|||||||||| ||||||||||||| |Deferred for com||ments of TEand shipping bill and bill of entry.|||||||||| ||||||||||||| ||||||||||||| |Case No.|||169 / NC/3/MEET/Mar/202223/24||||||||| |Case Status|||Case Approved||||||||| |Party Name|||ATUL LIMITED||||||||| |Meeting Number and Date|||NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023||||||||| |H|Q File Number||HQRNORM APPLY 00001338AM23||||||||| |R|A File Number||08AX04000229 AM23||||||||| |L|icence No and Date||0811005174/13/06/2022||||||||| |N |orms Committee Decision: The Committee considered the case as per age||||nda and t||aking cue||from earlier decision for same exp||ort product /|

11005174/13/06/2022||||||||| |N |orms Committee Decision: The Committee considered the case as per age||||nda and t||aking cue||from earlier decision for same exp||ort product /| ||import item in Meeting No.NC/3/MEET/No 0811000726dated 19/02/2021, it was decided to below or as applied by the firm, whichever is les||||v/202223/ fix adho s:||10dated c norms u||07/12/2022 against advance autho nder Para 4.07 of HBP Vol. I as per||rization No. details given| ||||||||||||| ||Export product|||Qty.||Sl. No.||Import items||Qty.|| ||||||||||||| ||Lapox ARD 55 (Triglycidyl ether of trimethylolpropane)(Chemicals)|||1 kg||1||Trimethylolpropane||0.42 kg|| |||||||2||Epichlorohydrin||0.995 kg|| ||||||||||||| ||||||||||||| |||||||3||Caustic Soda Lye 48 percentage||0.41 kg|| ||||||||||||| ||||||||||||| |||||||4||Toluene||Not allowed as no details shown|| ||||||||||| in the process.|| |||||||||||||

UDIN00067928AM24

ustic Soda Lye 48 percentage||0.41 kg|| ||||||||||||| ||||||||||||| |||||||4||Toluene||Not allowed as no details shown|| ||||||||||| in the process.|| |||||||||||||

UDIN00067928AM24


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

C	ase No.	170 / NC/3/MEET/Mar/202223/24
C	ase Status	Case Approved
P	arty Name	SATYADIVIS PHARMACEUTICALS P			RIVATE LIMITED

M<br>a	eeting Number<br>nd Date	NC/ 3/ MEET/ Mar/ 202223/ 2	4 and 13/0		4/2023
H	Q File Number	HQRNORM APPLY 0000134	3AM23
R	A File Number	09AX04000118 AM23
L<br>D	icence No and<br>ate	0911003170/13/06/2022

N<br> <br> <br> <br>	orms Committee Decision:
	The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import<br>product in meeting No.NC/3/MEET/Nov/20202223/14 dated 07/12/2022 against advance authorization No. 0911002190<br>dated 29/12/2021, it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied<br>by the firm, whichever is less.

	Export product		Qty.	Sl. No.		Import items	Qty.


	ALPHA-(2-MET	HYL<br>AMINE)<br>ETHYL	<br>1 k	1		BENZALDEHYDE	172 k
	<br>BENZENE MET	<br> <br> <br>HANOL	<br>g				.

||||| ||Export product||Qty.|Sl. No.||Import items||Qty.| |||||||||| |||||||||| ||ALPHA-(2-MET|HYL AMINE) ETHYL| 1 k|1||BENZALDEHYDE||172 k| || BENZENE MET| HANOL| g|||||. g| |||||2||PALLADIUM||0.0004 kg| |||||||||| |||||||||| |||||3||PARAFORMALDEHYDE||0.40 kg| |||||||||| |||||||||| |4 ACETOPHENONE 1.63 kg RA concerned may take further necessary action as per above decision of NC.||||4||ACETOPHENONE||1.63 kg| |||||||||| |Case No.||171 / NC/3/MEET/Mar/202223/24||||||| |Case Status||Case Approved||||||| |Party Name||HONOUR LAB LIMITED||||||| |||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023||||||| |HQ File Number||HQRNORM APPLY 00001344AM23||||||| |RA File Number||092404000405 AM21||||||| |Licence No and||1111222||||||| |Date||0900373/3/06/0|||||||

Case No.	171 / NC/3/MEET/Mar/202223/24
Case Status	Case Approved
Party Name	HONOUR LAB LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00001344AM23
RA File Number	092404000405 AM21
Licence No and	0911003173/13/06/2022
Date

UDIN00067928AM24

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. 15/82-ALC4/2018 dated 22.03.2019 against advance authorization No. 0910066731 dated 09/10/2018 , it was decided to fix adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less.

Export product	Qty.	Sl. No.	Import items	Qty.
(2R,5S)-5-(4-amino-5-fluoro-2-oxo-2H-pyrimidin--1-<br>yl)-[1,3]oxathiolane-2-carboxylic acid (1R,2S,5R)-<br>menthyl ester	1 kg	1	5-Fluoro Cytosine	0.44 kg
		2	Hexa Methyl Disilazane	0.53 kg
		3	Methane sulphonic acid	0.007 kg
		4	N,N-Dimethyl formamide	0.30 kg

Case No.	172 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00001345AM23
RA File Number	05AX04000761 AM23
Licence No and<br>Date	0511013170/13/06/2022
Norms Committee Decision:
Deferred for comments of TEand shipping bill and bill of entry.

Case No.	173 / NC/3/MEET/Mar/202223/24
Case Status	Case Deferred
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Mar/ 202223/ 24 and 13/04/2023
HQ File Number	HQRNORM APPLY 00001346AM23
RA File Number	05AX04000760 AM23
Licence No and<br>Date	0511013171/13/06/2022

UDIN00067928AM24

Deferred for comments of TEand shipping bill and bill of entry.

||Norms Committee Decision: Deferred for comments of TEand shipping bill and bill of entry.|Norms Commi

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