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 / व्यापार महकमा Directorate General of Foreign Trade / िवदेश व्यापार महािनदेशालय Directorate General of Foreign Trade, Delhi / िवदेश व्यापार महािनदेशालय, िदल्ली VANIJYA BHAWAN, AKBAR ROAD,NEW DELHI / 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/Oct/202223/11 DATED: 31/10/2022

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/Oct/202223/11 dated 31/10/2022 of Norms Committee - III for the year 2022-23 was held on 31/10/2022 under the Chairmanship of Rajiv Soni ,Joint DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

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

The following members were present in the meeting:-

S.No.	Name and Designation of Representatives	Name and Designation of Representatives	Department
1	AJAY KUMAR,Deputy Director	AJAY KUMAR,Deputy Director	Directorate General of Foreign Trade, Delhi
2	NAND Lal,Technical Authority		Technical Consultant,DGFT
3	SHAISH KUMAR,Technical Authority		Technical Consultant,DGFT
4	DINESHNARAIN MATHUR,Technical<br>Authority		Technical Consultant,DGFT
Case Details and Decision(s):
Case No.		1 / NC/3/MEET/Oct/202223/11

Case Details and Decision(s):

This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-11-2022 15:21:42.

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Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00001942AM23
RA File Number	NA
Licence No and<br>Date	0910067796/null
Norms Committee Decision:
The Committee considered the request of the firm for enhancement of norms and it was observed that the firm had
earlier represented its case for enhancement of norms and was called to attend Personal Hearing. The firm had
attended the Personal Hearing in Meeting No.NC/3/MEET/Apr/202223/2 dated 20.04.2022and after hearing the
explanation of the Representatives of firm, it was observed that the export description given in this Advance
Authorization is not from non- infringing process. Moreover, it was also noted by the committee that the firm is a
regular exporter of these pharma items but have not taken any licence under non- infringing clause directly from RA ,
as per the policy provision given under para 4.18 of HBP Vol. I. The Representative of firm also agreed with
observation of the	committee that the exports are being made under buy back arrangement. Accordingly, the request
of firm wasrejected.
Now, the firm has again requested for enhancement in the quantity of import items.

that the exports are being made under buy back arrangement. Accordingly, the request| |of firm wasrejected.|| |Now, the firm has again requested for enhancement in the quantity of import items. In view of above,|| |the Committee decided torejectthe case maintaining the status quo.|| |RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>2 / NC/3/MEET/Oct/202223/11
Case Status<br>Case Rejected
Party Name<br>SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number<br>HQRNORM REVIW00000951AM23
RA File Number<br>092404000017 AM14
Licence No and<br>Date<br>0910055800/19/04/2013
Norms Committee Decision:
The Committee considered the request of the firm for enhancement of norms and it was observed that the firm had
earlier represented its case for enhancement of norms and was called to attend Personal Hearing. The firm had
attended the Personal Hearing in Meeting No.NC/3/MEET/Apr/202223/2 dated 20.04.2022and after hearing the
explanation of the Representatives of firm, it was observed that the export description given in this Advance
Authorization is not from non- infringing process. Moreover, it was also noted by the committee that the firm is a
regular exporter of these pharma items but have not taken any licence under non- infringing clause directly from RA ,
as per the policy provision given under para 4.18 of HBP Vol. I.

e firm is a| |regular exporter of these pharma items but have not taken any licence under non- infringing clause directly from RA ,| |as per the policy provision given under para 4.18 of HBP Vol. I. The Representative of firm also agreed with| |observation of the committee that the exports are being made under buy back arrangement. Accordingly, the request| |of firm wasrejected.|

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Now, the firm has again requested for enhancement in the quantity of import items. In view of above, the Committee decided to reject the case maintaining the status quo.

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

Case No.	3 / NC/3/MEET/Oct/202223/11
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00000972AM23
RA File Number	092404000139 AM15
Licence No and<br>Date	0910060467/17/06/2014
Norms Committee Decision:<br>The Committee considered the request of the firm for enhancement of norms and it was observed that the firm had<br>earlier represented its case for enhancement of norms and was called to attend Personal Hearing. The firm had<br>attended the Personal Hearing in Meeting No.NC/3/MEET/Apr/202223/2 dated 20.04.2022and after hearing the<br>explanation of the Representatives of firm, it was observed that the export description given in this Advance<br>Authorization is not from non- infringing process.

0.04.2022and after hearing the explanation of the Representatives of firm, it was observed that the export description given in this Advance Authorization is not from non- infringing process. Moreover, it was also noted by the committee that the firm is a regular exporter of these pharma items but have not taken any licence under non- infringing clause directly from RA , as per the policy provision given under para 4.18 of HBP Vol. I. The Representative of firm also agreed with observation of the committee that the exports are being made under buy back arrangement. Accordingly, the request of firm wasrejected**. Now, the firm has again requested for enhancement in the quantity of import items. In view of above, the Committee decided torejectthe case maintaining the status quo. RA concerned may take further necessary action as per above decision of NC.||

Case No.	4 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00002557AM23
RA File Number	039404000494 AM15
Licence No and<br>Date	0310788620/02/09/2014
Norms Committee Decision:

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The Committee considered the request of firm for fixation of adhoc norms for Export Product No. 6 and 7 and after deliberation, it was decided to fix adhoc norms for Export Product No. 6 and 7 as under:

- Adhoc norms for Export Product No. 6 Ozonol antibiotic 15 gm

Export Product	Qty.	Sl. No.	Import Items	Qty.
Ozonol antibiotic 15 gm	1 Number	1	WHITE PROTOPET	14.2584 gram
		2	LIDOCAINE<br>HYDROCHLORIDE	0.612 gram
		3	BACITRACIN NON STERILE<br>MICRONIZED	107.667 mg
		4	POLYMYXIN<br>B<br>SULPHATE<br>(NON STER. MICRO)	0.02205 gram
		5	Alluminium collapsible tune 15<br>gms whether printed or out	Relevant, as per<br>packing policy

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- Adhoc norms for Export Product No. 7 Ozonol antibiotic 30 gm

Export Product	Qty.	Sl. No.	Import Items	Qty.
Ozonol antibiotic 30 gm	1 Number	1	WHITE PROTOPET	28.5168 gram
		2	LIDOCAINE<br>HYDROCHLORIDE	1.224 gram
		3	BACITRACIN NON STERILE<br>MICRONIZED	212.75 mg
		4	POLYMYXIN B SULPHATE<br>(NON STER MICRO)	0.0441 gram
		5	Alluminium collapsible tune 30<br>gms whether printed or out	Relevant, as per<br>packing policy

Rest of the earlier Minutes would remain the same.

Case No.	5 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00002556AM23
RA File Number	039404000590 AM16
Licence No and<br>Date	0310799952/02/11/2015
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to revise adhoc norms as<br>under:

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Export Product	Qty.	Sl.<br>No.	Import Items	Qty.
Fusidic Acid Cream 15<br>Gm. Tube(Tech. Spec:<br>Labelled content Fusidic<br>Acid 2% W/W; Brand<br>Amigermol Crema or<br>any other.)	<br> <br> <br> <br>1 Number	1	Fusidic Acid Micronized	0.306 gram
		2	White Soft Paraffin (Petrolatium Jelly)	0.840 gram
		3	Liquid Paraffin (Mineral Oil Kyadol)	1.665 gram
		4	Empty Aluminium Tube 15 Gm. Printed	Relevant as per<br>packing policy

06 gram| |||2|White Soft Paraffin (Petrolatium Jelly)|0.840 gram| |||3|Liquid Paraffin (Mineral Oil Kyadol)|1.665 gram| |||4|Empty Aluminium Tube 15 Gm. Printed|Relevant as per packing policy|

Case No.	Case No.	Case No.	6 / NC/3/MEET/Oct/202223/11	6 / NC/3/MEET/Oct/202223/11	6 / NC/3/MEET/Oct/202223/11	6 / NC/3/MEET/Oct/202223/11	6 / NC/3/MEET/Oct/202223/11
Case Status			Case Approved
Party Name			GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number			HQRNORM REVIW00002220AM23
RA File Number			072404000386 AM16
Licence No and<br>Date			0710109429/23/02/2016
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to revise adhoc norms as<br>under:<br>Sl. No. EXPORT PRODUCT<br>QTY.<br>Sl. No. IMPORT ITEMS<br>QTY.<br>1<br>CITRIC ACID<br>1.001 kg<br>1<br>MAGNESIUM CITRATE<br>1 kg<br>2<br>MAGNESIUM CARBONATE<br>0.730 kg<br>1<br>CITRIC ACID<br>0.816 kg<br>2<br>CALCIUM CITRATE<br>1 kg
	Sl. No.	EXPORT PRODUCT		QTY.	Sl. No.	IMPORT ITEMS	QTY.
	1	MAGNESIUM CITRATE		1 kg	1	CITRIC ACID	1.001 kg
					2	MAGNESIUM CARBONATE	0.730 kg
	2	CALCIUM CITRATE		1 kg	1	CITRIC ACID	0.816 kg

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|QTY.|Sl. No.|IMPORT ITEMS|QTY.| ||1|MAGNESIUM CITRATE||1 kg|1|CITRIC ACID|1.001 kg| ||||||2|MAGNESIUM CARBONATE|0.730 kg| ||2|CALCIUM CITRATE||1 kg|1|CITRIC ACID|0.816 kg|

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3<br>CALCIUM CARBONATE<br>0.660 kg<br>3<br>ZINC CITRATE<br>1 kg<br>1<br>CITRIC ACID<br>0.880 kg<br>4<br>POTASSIUM CITRATE<br>1 kg<br>1<br>CITRIC ACID<br>0.859 kg<br>RA concerned may take further necessary action as per above decision of NC.				3	CALCIUM CARBONATE	0.660 kg
	3	ZINC CITRATE	1 kg	1	CITRIC ACID	0.880 kg
	4	POTASSIUM CITRATE	1 kg	1	CITRIC ACID	0.859 kg

Case No.	7 / NC/3/MEET/Oct/202223/11
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00001940AM23
RA File Number	092404000348 AM17
Licence No and<br>Date	0910064196/28/09/2016
Norms Committee Decision:<br>The Committee considered the request of the firm for enhancement of norms and it was observed that the firm had<br>earlier represented its case for enhancement of norms and was called to attend Personal Hearing. The firm had<br>attended the Personal Hearing in Meeting No.NC/3/MEET/Apr/202223/2 dated 20.04.2022and after hearing the<br>explanation of the Representatives of firm, it was observed that the export description given in this Advance<br>Authorization is not from non- infringing process.

Case No.	8 / NC/3/MEET/Oct/202223/11
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00001941AM23
RA File Number	092404000649 AM17

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Licence No and 0910064785/09/03/2017 Date Norms Committee Decision: The Committee considered the request of the firm for enhancement of norms and it was observed that the firm had earlier represented its case for enhancement of norms and was called to attend Personal Hearing. The firm had attended the Personal Hearing in Meeting No. NC/3/MEET/Apr/202223/2 dated 20.04.2022 and after hearing the explanation of the Representatives of firm, it was observed that the export description given in this Advance Authorization is not from non- infringing process. Moreover, it was also noted by the committee that the firm is a regular exporter of these pharma items but have not taken any licence under non- infringing clause directly from RA , as per the policy provision given under para 4.18 of HBP Vol. I. The Representative of firm also agreed with observation of the committee that the exports are being made under buy back arrangement. Accordingly, the request of firm was rejected . Now, the firm has again requested for enhancement in the quantity of import items. In view of above, the Committee decided to reject the case maintaining the status quo. RA concerned may take further necessary action as per above decision of NC.

the quantity of import items. In view of above, the Committee decided to reject the case maintaining the status quo. RA concerned may take further necessary action as per above decision of NC.

Case No.	9 / NC/3/MEET/Oct/202223/11
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00000968AM23
RA File Number	092404000309 AM18
Licence No and<br>Date	0910065528/29/09/2017
Norms Committee Decision:
The Committee considered the request of the firm for enhancement of norms and it was observed that the firm had
earlier represented its case for enhancement of norms and was called to attend Personal Hearing. The firm had
attended the Personal Hearing in Meeting No.NC/3/MEET/Apr/202223/2 dated 20.04.2022and after hearing the
explanation of the Representatives of firm, it was observed that the export description given in this Advance
Authorization is not from non- infringing process. Moreover, it was also noted by the committee that the firm is a
regular exporter of these pharma items but have not taken any licence under non- infringing clause directly from RA ,
as per the policy provision given under para 4.18 of HBP Vol. I. The Representative of firm also agreed with
observation of the	committee that the exports are being made under buy back arrangement. Accordingly, the request
of firm wasrejected.
Now, the firm has again requested for enhancement in the quantity of import items.

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Case No.	10 / NC/3/MEET/Oct/202223/11
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00001945AM23
RA File Number	092404000430 AM18
Licence No and<br>Date	0910065723/07/12/2017
Norms Committee Decision:<br>T<br>The Committee considered the request of the firm for enhancement of norms and it was observed that the firm had<br>earlier represented its case for enhancement of norms and was called to attend Personal Hearing. The firm had<br>attended the Personal Hearing in Meeting No.NC/3/MEET/Apr/202223/2 dated 20.04.2022and after hearing the<br>explanation of the Representatives of firm, it was observed that the export description given in this Advance<br>Authorization is not from non- infringing process. Moreover, it was also noted by the committee that the firm is a<br>regular exporter of these pharma items but have not taken any licence under non- infringing clause directly from RA ,<br>as per the policy provision given under para 4.18 of HBP Vol. I.

firm is a regular exporter of these pharma items but have not taken any licence under non- infringing clause directly from RA , as per the policy provision given under para 4.18 of HBP Vol. I. The Representative of firm also agreed with observation of the committee that the exports are being made under buy back arrangement. Accordingly, the request of firm wasrejected. Now, the firm has again requested for enhancement in the quantity of import items. In view of above, the Committee decided torejectthe case maintaining the status quo. RA concerned may take further necessary action as per above decision of NC.||

Case No.	11 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00001131AM23
RA File Number	052304000334 AM18
Licence No and<br>Date	0510404915/13/12/2017
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for<br>same export product / import item in Meeting No.NC/3/MEET/Dec/202122/12 dated 17.12.2021against advance<br>authorization No.0510409477 dated 25.01.2019 and 0510411049 dated 25.06.2019, it was decided to revise adhoc<br>norms as under:

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dated 17.12.2021**against advance authorization No.0510409477 dated 25.01.2019 and 0510411049 dated 25.06.2019, it was decided to revise adhoc norms as under:||

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	Export product	Qty.	Sl. No.	Import items	Qty.
	DI-BUTYL PHTHALATE (GRADE-<br>M) (DBP-M) ((PACKED IN 2554	<br>1 kg	1	PHTHALIC ANHYDRIDE	0.56 kg
	NOS. OF HM-HDPE DRUMS MADE
	OF HDPE GRANULES (21,709.000<br>KGS.<br>WITHOUT<br>WASTAGE))	<br>	2	SABUTOL	0.595 kg
	(EACH DRUM SHALL WEIGHT 8.5<br>KG AND STORAGE CAPACITY<br>235.000 KGS.))	<br>	3	HDPE GRANULES	Relevant as per packing<br>policy
<br>	<br>A concerned may take further necessary	action as per above decision of NC.

Case No.	12 / NC/3/MEET/Oct/202223/11
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00000970AM23
RA File Number	092404000459 AM18
Licence No and<br>Date	0910065758/19/12/2017
Norms Committee Decision:
The Committee considered the request of the firm for enhancement of norms and it was observed that the firm had
earlier represented its case for enhancement of norms and was called to attend Personal Hearing.

e considered the request of the firm for enhancement of norms and it was observed that the firm had|| |earlier represented its case for enhancement of norms and was called to attend Personal Hearing. The firm had|| |attended the Personal Hearing in Meeting No.NC/3/MEET/Apr/202223/2 dated 20.04.2022and after hearing the|| |explanation of the Representatives of firm, it was observed that the export description given in this Advance|| |Authorization is not from non- infringing process. Moreover, it was also noted by the committee that the firm is a|| |regular exporter of these pharma items but have not taken any licence under non- infringing clause directly from RA ,|| |as per the policy provision given under para 4.18 of HBP Vol. I. The Representative of firm also agreed with|| |observation of the|committee that the exports are being made under buy back arrangement. Accordingly, the request| |of firm wasrejected.|| |Now, the firm has again requested for enhancement in the quantity of import items. In view of above,|| |the Committee decided torejectthe case maintaining the status quo.|| |RA concerned may take further necessary action as per above decision of NC.||

Case No.	13 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	SHREE GANESH REMEDIES LIMITED

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necessary action as per above decision of NC.||

Case No.	13 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	SHREE GANESH REMEDIES LIMITED

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Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00002092AM23
RA File Number	342404000340 AM18
Licence No and<br>Date	3410043947/09/03/2018
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was decided to call for following
information/documents from the firm:
Complete set of 4.07 application.<br>i.
Complete technical details as per Annexure to Appendix 4E.<br>ii.
Stoichiometric balance.<br>iii.

Case No.	14 / NC/3/MEET/Oct/202223/11
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00000969AM23
RA File Number	092404000036 AM19
Licence No and<br>Date	0910066244/18/05/2018
Norms Committee Decision:
The Committee considered the request of the firm for enhancement of norms and it was observed that the firm had
earlier represented its case for enhancement of norms and was called to attend Personal Hearing.

Case No.	15 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	ZYDUS LIFESCIENCES LIMITED

11 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-11-2022 15:21:42.

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---|---| |Case Status|Case Deferred| |Party Name|ZYDUS LIFESCIENCES LIMITED|

11 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-11-2022 15:21:42.

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Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00002046AM23
RA File Number	082404000264 AM19
Licence No and<br>Date	0810143988/29/11/2018
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was observed that the firm was earlier given<br>PH through Video Conferencing in Meeting No.NC/3/MEET/Apr/202223/2on 21.04.2022 for the reasonability of import<br>item Nos. 2 and 3, i.e., Gelatin NF and Glycerine USP for export of Soft Gelatin Capsules. During PH, the firm could not<br>be able to explain the technical issues, hence import item No. 2 and 3 were not recommended.<br>Now, the firm has again requested and furnished some technical documents like Batch Formula, Batch Record<br>and copies of confidential documents submitted to ANDA.<br>Going through the documents now, it was felt that the firm may be given another chancefor attending<br>Personal Hearing<br> before Norms Committee to explain its case.

submitted to ANDA. Going through the documents now, it was felt that the firm may be given another chancefor attending Personal Hearing before Norms Committee to explain its case.||

Case No.	16 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	MALLADI DRUGS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00001752AM23
RA File Number	042404000218 AM19
Licence No and<br>Date	0410165065/04/01/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc normsand it was observed that the norms applied by<br>the firm are higher than supported by the chemistry and material balance. Also, the Export Product is a new<br>molecule.<br>Hence, it was decided to call the firm for attendingPersonal Hearing<br> before Norms Committee to<br>explain its case.

Case No.	17 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	SHREE GANESH REMEDIES LIMITED
Meeting Number	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022

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17 / NC/3/MEET/Oct/202223/11| |---|---| |Case Status|Case Deferred| |Party Name|SHREE GANESH REMEDIES LIMITED| |Meeting Number|NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022|

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and Date
HQ File Number	HQRNORM REVIW00002113AM23
RA File Number	342404000399 AM19
Licence No and<br>Date	3410045006/28/03/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to call for following<br>information/documents from the firm:<br>Complete set of 4.07 application.<br>i.<br>Complete technical details as per Annexure to Appendix 4E.<br>ii.<br>Stoichiometric balance.<br>iii.

Case No.	18 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	SYMBIOSIS PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00000804AM23
RA File Number	332404000002 AM20
Licence No and<br>Date	3310030527/16/04/2019
Norms Committee Decision:<br>Deferred for comments of TE.

1/10/2022| |HQ File Number|HQRNORM REVIW00000804AM23| |RA File Number|332404000002 AM20| |Licence No and Date|3310030527/16/04/2019| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	19 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00002204AM23
RA File Number	052304000048 AM20
Licence No and<br>Date	0510410475/03/05/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc normsand it was decided to call the firm for attending<br>Personal Hearing<br> before Norms Committee to explain its case alongwith following documents / information:<br>DML.<br>i.<br>COA of import item from foreign supplier.<br>ii.<br>Master Batch Formula.<br>iii.

UDIN00256516AM23

Case No.	20 / NC/3/MEET/Oct/202223/11
Case Status	Case Rejected
Party Name	SRINI PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00000971AM23
RA File Number	092404000269 AM20
Licence No and<br>Date	0910067906/20/08/2019
Norms Committee Decision:<br>The Committee considered the request of the firm for enhancement of norms and it was observed that the firm had<br>earlier represented its case for enhancement of norms and was called to attend Personal Hearing.

e considered the request of the firm for enhancement of norms and it was observed that the firm had earlier represented its case for enhancement of norms and was called to attend Personal Hearing. The firm had attended the Personal Hearing in Meeting No.NC/3/MEET/Apr/202223/2 dated 20.04.2022and after hearing the explanation of the Representatives of firm, it was observed that the export description given in this Advance Authorization is not from non- infringing process. Moreover, it was also noted by the committee that the firm is a regular exporter of these pharma items but have not taken any licence under non- infringing clause directly from RA , as per the policy provision given under para 4.18 of HBP Vol. I. The Representative of firm also agreed with observation of the committee that the exports are being made under buy back arrangement. Accordingly, the request of firm wasrejected. Now, the firm has again requested for enhancement in the quantity of import items. In view of above, the Committee decided torejectthe case maintaining the status quo. RA concerned may take further necessary action as per above decision of NC.||

tity of import items. In view of above, the Committee decided torejectthe case maintaining the status quo. RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	Case No.<br>	21 / NC/3/MEET/Oct/202223/11	21 / NC/3/MEET/Oct/202223/11	21 / NC/3/MEET/Oct/202223/11	21 / NC/3/MEET/Oct/202223/11	21 / NC/3/MEET/Oct/202223/11
Case Status<br>		Case Approved
Party Name<br>		GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date<br>		NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number<br>		HQRNORM REVIW00002537AM23
RA File Number<br>		072404000107 AM20
Licence No and<br>Date<br>		0710115314/21/08/2019
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.
	Export product		Qty.	Sl. No.	Import items	Qty.

Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.|

Case No.<br>	Case No.<br>	21 / NC/3/MEET/Oct/202223/11	21 / NC/3/MEET/Oct/202223/11	21 / NC/3/MEET/Oct/202223/11	21 / NC/3/MEET/Oct/202223/11	21 / NC/3/MEET/Oct/202223/11
Case Status<br>		Case Approved
Party Name<br>		GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date<br>		NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number<br>		HQRNORM REVIW00002537AM23
RA File Number<br>		072404000107 AM20
Licence No and<br>Date<br>		0710115314/21/08/2019
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.
	Export product		Qty.	Sl. No.	Import items	Qty.

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MINOXIDIL (USP / Ph.Eur / IP) 1 kg 1 2,4 DIAMINO-6-CHLOROPYRIMIDINE 0.95 kg

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

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MINOXIDIL (USP / Ph.Eur / IP) 1 kg 1 2,4 DIAMINO-6-CHLOROPYRIMIDINE 0.95 kg

Case No.	22 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00002536AM23
RA File Number	072404000117 AM20
Licence No and<br>Date	0710115318/22/08/2019
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>1<br>MINOXIDIL (IP/USP/Ph.Eur.)<br>2.500 MT<br>2<br>MINOXIDIL SULPHATE<br>2.00 MT<br>Sl. No.<br>Import items<br>Qty.<br>1<br>2,4 DIAMINO-6-CHLOROPYRIMIDINE<br>4.275 MT<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	23 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	MALLADI DRUGS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022

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3/11| |---|---| |Case Status|Case Deferred| |Party Name|MALLADI DRUGS AND PHARMACEUTICALS LIMITED| |Meeting Number and Date|NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022|

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HQ File Number	HQRNORM REVIW00001751AM23
RA File Number	042404000089 AM20
Licence No and<br>Date	0410166026/29/08/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc normsand it was observed that the norms applied by<br>the firm are higher than supported by the chemistry and material balance. Also, the Export Product is a new<br>molecule.<br>Hence, it was decided to call the firm for attendingPersonal Hearing<br> before Norms Committee to<br>explain its case.

Case No.	24 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	MENTHA AND ALLIED PRODUCTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	018205000763AM20
RA File Number	052404000375 AM20
Licence No and<br>Date	0510412231/23/10/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda andit was observed that the reply furnished by the firm was not clear.<br>Hence, it was decided to call the firm for attendingPersonal Hearing<br> before Norms Committee to explain its case<br>alongwith following document / information:<br>Exact specification of Export and to link it with import item with COA of both import and export, to justify the<br>same.

plain its case alongwith following document / information: Exact specification of Export and to link it with import item with COA of both import and export, to justify the same.||

Case No.	25 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	THINQ PHARMA-CRO LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00002242AM23
RA File Number	039504000967 AM20
Licence No and<br>Date	0310833909/06/01/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and taking 1.20 mole of side-chain

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against 1 mole of export product, it was decided to revise adhoc norms as under:

Export product	Qty.	Sl. No.	Import items	Qty.
G-101 (All Trans Retinoic Acid,<br>1-Hydroxy-3,3-dimethyl-2-<br>Butanone Ester)	<br>1 kg	1	Tretinoin (All Trans Retinoic Acid)	1.00 kg
		2	1-Chloro Pinacolone	0.600 kg
		3	Cesium Carbonate	1.135 kg

Trans Retinoic Acid, 1-Hydroxy-3,3-dimethyl-2- Butanone Ester)| 1 kg|1|Tretinoin (All Trans Retinoic Acid)|1.00 kg| |||2|1-Chloro Pinacolone|0.600 kg| |||3|Cesium Carbonate|1.135 kg|

Case No.	26 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	LACTOSE (INDIA) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00002116AM23
RA File Number	039504001033 AM20
Licence No and<br>Date	0310834414/23/01/2020
Norms Committee Decision:<br>The Committee considered the request of the firm for fixation of adhoc normsand it was observed that the<br>Representation received from the firm was incomplete and highly confusing due to various grades mentioned in their<br>export and import items.<br>In view of above, the Committee decided to visit Firm’s Factory to gather requisite information for<br>fixation of norms.

Case No.	27 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00002535AM23
RA File Number	072404000008 AM21
Licence No and<br>Date	0710116344/17/04/2020

UDIN00256516AM23

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:

Sl. No.	Export product	Qty.
1	MINOXIDIL (USP/Ph.EUR/IP)	3.500 MT
2	MINOXIDIL SULPHATE	7.500 MT

Sl. No.	Import items	Qty.
1	2,4 DIAMINO-6-CHLOROPYRIMIDINE	10.450 MT

Case No.	Case No.	Case No.	28 / NC/3/MEET/Oct/202223/11	28 / NC/3/MEET/Oct/202223/11	28 / NC/3/MEET/Oct/202223/11	28 / NC/3/MEET/Oct/202223/11	28 / NC/3/MEET/Oct/202223/11
Case Status			Case Approved
Party Name			GLENMARK PHARMACEUTICALS LIMITED
Meeting Number and Date			NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number			HQRNORM REVIW00002013AM23
RA File Number			039404000022 AM21
Licence No and Date			0310835878/25/04/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to revise adhoc norms as<br>under:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>FLUOCINOLONE ACE EAR DROPS<br>0.01% 20ML (Fluocinolone Acetonide<br>0.01%) (Net Wt. of FLUOCINOLONE<br>ACETONIDE BP in1100 Gms.)<br>500000<br>Number<br>1<br>FLUOCINOLONE<br>ACETONIDE BP<br>1020 grams
	Sl.<br>No.	Export product		Qty.	Sl. No.	Import items	Qty.
	1	FLUOCINOLONE ACE EAR DROPS<br>0.01% 20ML (Fluocinolone Acetonide<br>0.01%) (Net Wt.

INOLONE ACETONIDE BP 1020 grams|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|FLUOCINOLONE ACE EAR DROPS 0.01% 20ML (Fluocinolone Acetonide 0.01%) (Net Wt. of FLUOCINOLONE ACETONIDE BP in1100 Gms.)|| 500000 Number|1|FLUOCINOLONE ACETONIDE BP|1020 grams|

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2	FLUOCINOLONE	<br>ACE<br>SCALP<br>OIL	<br>500000	1	FLUOCINOLONE	6078 grams
	0.01% 118ML (Fluocinolone Acetonide				ACETONIDE BP
	0.01%<br>Topical	Oil)<br>(Net<br>Wt.<br>of	<br>Number
	FLUOCINOLONE	ACETONIDE BP in
	6490 Gms.)
3	FLUOCINOLONE	<br>ACE<br>BODY<br>OIL	<br>100000	1	FLUOCINOLONE	1203.6 grams
	0.01% 118ML (Fluocinolone Acetonide				ACETONIDE BP
	0.01%<br>Topical	Oil)<br>(Net<br>Wt.<br>of	<br>Number
	FLUOCINOLONE	ACETONIDE BP in
	1298 Gms.)

Case No.	29 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00002534AM23
RA File Number	072404000046 AM21
Licence No and<br>Date	0710116483/22/05/2020
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was decided to call for following
information/documents from the firm:
As per manufacturing details, there is blending as such the details (such as name and quantity) of items which<br>i.
are blended.

for following|| |information/documents from the firm:|| |As per manufacturing details, there is blending as such the details (such as name and quantity) of items which i.|| |are blended.|| |Complete technical details as per Annexure to Appendix 4E. ii.||

Case No.	30 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00002538AM23
RA File Number	072404000053 AM21
Licence No and<br>Date	0710116510/27/05/2020
Norms Committee Decision:

UDIN00256516AM23

The Committee considered the request of firm for fixation of adhoc norms and it was decided to call for following information/documents from the firm:

i. Complete technical details as per Annexure to Appendix 4E clearly indicating indigenous items.
ii. As per manufacturing details, there id blending as such the details (such as name and quantity) of items which are blended.
iii. Purity with moisture content of both import and export items. iv. Production / Consumption data for three year duly certified by CA.

ame and quantity) of items which are blended.**

iii. Purity with moisture content of both import and export items. iv. Production / Consumption data for three year duly certified by CA.

Case No.	Case No.	31 / NC/3/MEET/Oct/202223/11	31 / NC/3/MEET/Oct/202223/11	31 / NC/3/MEET/Oct/202223/11	31 / NC/3/MEET/Oct/202223/11	31 / NC/3/MEET/Oct/202223/11
Case Status		Case Approved
Party Name		KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number		HQRNORM REVIW00001816AM23
RA File Number		052304000071 AM21
Licence No and<br>Date		0510414611/13/07/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for<br>same export product / import item in Meeting No.NC/3/MEET/Dec/202122/12 dated 17.12.2021against advance<br>authorization No.0510409477 dated 25.01.2019 and 0510411049 dated 25.06.2019it was decided to revise adhoc<br>norms as under:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>PHTHALIC ANHYDRIDE<br>0.56 kg<br>2<br>SABUTOL<br>0.595 kg<br>DI-BUTYL PHTHALATE (GRADE-<br>M) (DBP-M)((PACKED IN 2554<br>NOS.

er: Export product Qty. Sl. No. Import items Qty. 1 PHTHALIC ANHYDRIDE 0.56 kg 2 SABUTOL 0.595 kg DI-BUTYL PHTHALATE (GRADE- M) (DBP-M)((PACKED IN 2554 NOS. OF HM-HDPE DRUMS MADE OF HDPE GRANULES (21,709.000 KGS. WITHOUT WASTAGE)) (EACH DRUM SHALL WEIGHT 8.5 KG AND STORAGE CAPACITY 235.000 KGS.)) 1 kg 3 HDPE GRANULES Relevant as per packing policy RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||DI-BUTYL PHTHALATE (GRADE- M) (DBP-M)((PACKED IN 2554 NOS. OF HM-HDPE DRUMS MADE OF HDPE GRANULES (21,709.000 KGS. WITHOUT WASTAGE)) (EACH DRUM SHALL WEIGHT 8.5 KG AND STORAGE CAPACITY 235.000 KGS.))|| 1 kg|1|PHTHALIC ANHYDRIDE|0.56 kg| |||||2|SABUTOL|0.595 kg| |||||3|HDPE GRANULES|Relevant as per packing policy| |||||per above decision of NC.|||

Case No.	32 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED

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er above decision of NC.|||

Case No.	32 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED

UDIN00256516AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00002084AM23
RA File Number	039404000232 AM21
Licence No and<br>Date	0310837216/15/07/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc normsand it was decided to call for following<br>information / documents from the firm:<br>Description of Export Product does not match with the DML. Please clarify.<br>i.

Case No.	Case No.	33 / NC/3/MEET/Oct/202223/11	33 / NC/3/MEET/Oct/202223/11	33 / NC/3/MEET/Oct/202223/11	33 / NC/3/MEET/Oct/202223/11	33 / NC/3/MEET/Oct/202223/11
Case Status		Case Approved
Party Name		AMINES AND PLASTICIZERS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number		018205001625AM21
RA File Number		039404000370 AM21
Licence No and<br>Date		0310838163/08/09/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.

as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 Ethylene Oxide 0.313 kg N-BENZYLETHANOLAMINE 1 kg 2 Benzyl Amine 0.7611 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||N-BENZYLETHANOLAMINE||1 kg|1|Ethylene Oxide|0.313 kg| |||||2|Benzyl Amine|0.7611 kg| |||||per above decision of NC.|||

Case No.	34 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	VIBRANT PHARMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022

UDIN00256516AM23

HQ File Number	018205001663AM21
RA File Number	072404000163 AM21
Licence No and<br>Date	0710117014/15/09/2020
Norms Committee Decision:
Deferred for comments of TE.

516AM23

HQ File Number	018205001663AM21
RA File Number	072404000163 AM21
Licence No and<br>Date	0710117014/15/09/2020
Norms Committee Decision:
Deferred for comments of TE.

HQ File Number	HQ File Number	018205001663AM21	018205001663AM21	018205001663AM21	018205001663AM21	018205001663AM21
RA File Number		072404000163 AM21
Licence No and		0710117014/15/09/2020
Date
Norms Committee<br>		Decision:<br>
Deferred for comme		nts of TE.


Case No.		35 / NC/3/MEET/Oct/202223/11
Case Status		Case Approved

Party Name		BELCHEM INDUSTRIES (INDIA) PVT LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number		018205001738AM21
RA File Number		039404000504 AM21
L<br>D	icence No and<br>ate	0310838842/13/10/2020
N<br>T<br>i<br>0<br>d
	orms Committee Decision:<br>he Committee considered the case as per agenda<br>		and taki<br>	ng cue f<br>	rom earlier decision for same ex<br>	port product /<br>
	mport item in Meeting No.NC/3/MEET/Sep/2<br>311008190 dated 02.11.2021, it was decided to<br>etails given below or as applied by the firm, which		02223/8<br>ratify adh<br>ever is les	dated<br>oc norm<br>s:	3.09.2022against advance auth<br>s under Para 4.07 of HBP	orization No.<br>Vol.

en below or as applied by the firm, which|||02223/8 ratify adh ever is les||dated oc norm s:||3.09.2022against advance auth s under Para 4.07 of HBP||orization No. Vol. I as per| |||||||||||| ||Export product||Qty.||Sl. No.||Import items||Qty.|| |||| |||| || || ||1,3 DIMETHY HYDANTOIN|OL -5,5- DIMETHYL DMDM HYDANTOIN| 1 kg||1||5,5 DIMETHYL HYDANTOIN ASSAY 99% MIN COLOUR PURE|| 0.382 kg|| || 52%-55%) A| SSAY 55% MAX| |||| WHITE|||| || BELGUARD D| MDMH||||||||| |||||||||||| |||||||||||| |||||||||||| |RA concerned may||take further necessary action as per above decision of NC.||||||||| |||||||||||| |||||||||||| |Case No.||36 / NC/3/MEET/Oct/202223/11||||||||| |Case Status||Case Approved||||||||| |Party Name||SYNNAT PHARMA PRIVATE LIMITED||||||||| |Meeting Number and Date||NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022||||||||| |HQ File Number||018205001771AM21||||||||| |RA File Number||022404000094 AM21||||||||| |Licence No and Date||0210210167/20/10/2020|||||||||

Case No.	36 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	018205001771AM21
RA File Number	022404000094 AM21
Licence No and<br>Date	0210210167/20/10/2020

UDIN00256516AM23

Norms Committee Decision:

The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Aug/202223/6 dated 09.09.2022 against advance authorization No. 0210208260 dated 07.03.2018 , it was decided to revise adhoc norms as under:

Export product	Qty.	Sl. No.	Import items	Qty.
Noscapine BP USP Ph.Eur JP CP / Noscapine<br>Hydrochloride BP Ph.Eur	<br>1 kg	1	Noscapine Crude Content 95%	1.158 kg

Case No.	37 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	018205001853AM21
RA File Number	342404000223 AM21
Licence No and<br>Date	3410046549/13/11/2020
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	38 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	THINQ PHARMA-CRO LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00002241AM23
RA File Number	03AA04013380 AM21
Licence No and<br>Date	0311000264/24/12/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and taking 1.20 mole of side-chain<br>against 1 mole of export product, it was decided to revise adhoc norms as under:

UDIN00256516AM23

uest of firm for review of adhoc norms and taking 1.20 mole of side-chain against 1 mole of export product, it was decided to revise adhoc norms as under:||

UDIN00256516AM23

Export product	Qty.	Sl. No.	Import items	Qty.
G-101 (All Trans Retinoic Acid, 1-<br>Hydroxy-3,3-dimethyl-2-Butanone<br>Ester)	1 kg	1	Tretinoin (All Trans Retinoic Acid)	1.00 kg
		2	1-Chloro Pinacolone	0.600 kg
		3	Cesium Carbonate	1.135 kg

Case No.	39 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00002081AM23
RA File Number	03AA04016798 AM21
Licence No and<br>Date	0311000935/14/01/2021

| |Meeting Number and Date|NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022| |HQ File Number|HQRNORM REVIW00002081AM23| |RA File Number|03AA04016798 AM21| |Licence No and Date|0311000935/14/01/2021| |Norms Committee Decision: The Committee considered the request of firm for fixation of adhoc norms and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Sep/202223/9 dated 07.10.2022against advance authorization No.0311012331 dated 07.03.2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 PROPIOPHENONE 0.922 kg 2-AMINO-2-PHENYLBUTYRIC ACID SODIUM SALT (SATURATED ACYCLIC MONOCARBOXYLIC ACIDS & THEIR SALTS) 1 kg 2 SODIUM CYANIDE 0.337 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	40 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED

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cessary action as per above decision of NC.||

Case No.	40 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED

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Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00002205AM23
RA File Number	03AA04021752 AM21
Licence No and<br>Date	0311001487/04/02/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc normsand following things were observed:<br>Firm has revised the import quantity.<br>i.<br>Wastage applied 8% for Topical Solution involving 5-6% overfilling.<br>ii.<br>Firm has given Batch Record to Show API requirement and Excipients.<br>iii.<br>Hence, it was decided to call the firm for attendingPersonal Hearing<br> before Norms Committee to<br>explain its case.

Case No.	41 / NC/3/MEET/Oct/202223/11
Case Status	Case Rejected
Party Name	MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00002258AM23
RA File Number	07AA04009852 AM21
Licence No and<br>Date	0711000657/15/03/2021
Norms Committee Decision:<br>The Committee considered the request of firm for enhancement of norms andit was observedRubber Stopper is already<br>allowed as per General Policy for Packing Material mentioned in Handbook of Procedure Vol. II (SION Book).

the request of firm for enhancement of norms andit was observedRubber Stopper is already allowed as per General Policy for Packing Material mentioned in Handbook of Procedure Vol. II (SION Book). Hence, it was decided torejectthe case maintaining the status quo. RA concerned may take further necessary action as per above decision of NC.||

Case No.	42 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	VIBRANT PHARMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00000295AM22
RA File Number	07AA04011201 AM21
Licence No and<br>Date	0711000825/01/04/2021
Norms Committee Decision:

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Deferred for comments of TE.

Case No.	43 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	SAURAV CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00000680AM22
RA File Number	30AA04006198 AM21
Licence No and<br>Date	3011000463/01/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents from the<br>firm:<br>Percentage yield on molar basis for each step of manufacturing process.<br>i.<br>ii Stepwise material balance sheet based on the recent batch record.

tion/documents from the firm: Percentage yield on molar basis for each step of manufacturing process. i. ii Stepwise material balance sheet based on the recent batch record.||

Case No.	44 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00023689AM22
RA File Number	07AA04002023 AM22
Licence No and<br>Date	0711000922/21/04/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	45 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00027802AM22
RA File Number	07AA04002553 AM22
Licence No and<br>Date	0711000992/27/04/2021
Norms Committee Decision:

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Deferred for comments of TE.

Case No.	46 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00027804AM22
RA File Number	07AA04002549 AM22
Licence No and<br>Date	0711000993/27/04/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/10/2022| |HQ File Number|HQRNORM APPLY 00027804AM22| |RA File Number|07AA04002549 AM22| |Licence No and Date|0711000993/27/04/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	47 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00027780AM22
RA File Number	07AA04000758 AM22
Licence No and<br>Date	0711000991/27/04/2021
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>Production / Consumption data of export product MAGNESIUM BISGLYCINATE / MAGNESIUM<br>GLYCINE<br>COMPLEX(MAGNESIUM<br>BISGLYCINATE<br>/<br>MAGNESIUM<br>GLYCINE<br>COMPLEX)MAGNESIUM GLYCINE COMPLEX) for the years 2018-19 and 2019-20 duly certified by<br>GST.<br>i.<br>ii COA report of Magnesium Oxide.

i. Production / Consumption data of export product MAGNESIUM BISGLYCINATE / MAGNESIUM GLYCINE COMPLEX(MAGNESIUM BISGLYCINATE / MAGNESIUM GLYCINE COMPLEX)MAGNESIUM GLYCINE COMPLEX) for the years 2018-19 and 2019-20 duly certified by GST.

Case No.	48 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00028506AM22
RA File Number	07AA04002556 AM22
Licence No and<br>Date	0711001000/28/04/2021

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Norms Committee Decision:

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

Export product	Qty.	Sl. No.	Import items	Qty.
ALPRAZOLAM (IP/BP/EP/USP)	1 kg	1	TRIETHYL ORTHO ACETATE	1.108 kg
		2	ACETONE	1.50 kg

Case No.	49 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00029824AM22
RA File Number	03AA04003827 AM22
Licence No and<br>Date	0311003447/30/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda andit was observed that the reply furnished by the firm was not clear.<br>Hence, it was decided to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.

Case No.	50 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	CLARIANT INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00032203AM22
RA File Number	03AA04009823 AM22
Licence No and<br>Date	0311003530/04/05/2021
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:

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i. Reason for not indicating indigenous items in Appendix 4E.

case as per agenda and it was decided to call for following information/documents from the firm:||

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i. Reason for not indicating indigenous items in Appendix 4E.
ii. Large difference in individual yield and actual output, therefore complete justification for low yield.

iii Reason for non-recovery of methanol in the process.

Case No.	51 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00033515AM22
RA File Number	05AA04007697 AM22
Licence No and<br>Date	0511002442/05/05/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking into consideration 83% yield, it was decided to ratify<br>adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>BENZOTRIFLUORIDE (BTF)<br>0.16 kg<br>2,2-difluoro-1,3-benzodioxole(DFBD)<br>1 kg<br>2<br>1,3-BENZODIOXOLE<br>0.9306 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	52 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	ASTEC LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00036355AM22
RA File Number	03AA04007493 AM22
Licence No and<br>Date	0311003675/09/05/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/10/2022| |HQ File Number|HQRNORM APPLY 00036355AM22| |RA File Number|03AA04007493 AM22| |Licence No and Date|0311003675/09/05/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No. 53 / NC/3/MEET/Oct/202223/11

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Case Status	Case Deferred
Party Name	SHREE GANESH REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00002093AM23
RA File Number	34AA04000586 AM22
Licence No and<br>Date	3411000551/11/05/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to call for following<br>information/documents from the firm:<br>Complete set of 4.07 application.<br>i.<br>Complete technical details as per Annexure to Appendix 4E.<br>ii.<br>Stoichiometric balance<br>iii.

Case No.	54 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00038818AM22
RA File Number	03AA04005126 AM22
Licence No and<br>Date	0311003736/12/05/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/10/2022| |HQ File Number|HQRNORM APPLY 00038818AM22| |RA File Number|03AA04005126 AM22| |Licence No and Date|0311003736/12/05/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	55 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	SAURAV CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00045345AM22
RA File Number	30AA04001247 AM22
Licence No and<br>Date	3011000633/18/05/2021
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:

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i. Percentage yield on molar basis for each step of manufacturing process.

ii Stepwise material balance based on the recent batch record.

Case No.	56 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	UNITED MUD-CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00103082AM22

RA File Number	03AA04017853 AM22
Licence No and<br>Date	0311004136/30/05/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that only mixing process is involved, hence, it<br>was decided to ratify adhoc norms under Para 4.07 of HBP Vol.

ittee Decision: The Committee considered the case as per agenda and it was observed that only mixing process is involved, hence, 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. RHEOLOGY MODIFIER (containing 79.61% Dimer Acid) 60 MT 1 Dimer Acid 48.24 MT RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	57 / NC/3/MEET/Oct/202223/11
Case Status		Case Approved
Party Name		TIDE INDUSTRIES

Meeting Nu<br>and Date	mber	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022

HQ File Nu	mber	HQRNORM APPLY 00107290AM22

RA File Nu	mber	34AA04002205 AM22
Licence No	and
Date		3411000694/04/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and after offsetting the price of By-Product, it was decided to ratify
<br>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:

UDIN00256516AM23

as decided to ratify|||| | adhoc norms under|| Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:|| ||||| ||||| |||||

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Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Acrylic Acid<br>83843.00 kg<br>Gamma - Decalactone<br>100000 kg<br>2<br>Di tert Butyl Peroxide<br>31000.00 kg<br>RA concerned may take further necessary action as per above decision of NC.	Export product	Qty.	Sl. No.	Import items	Qty.
	Gamma - Decalactone	100000 kg	1	Acrylic Acid	83843.00 kg
			2	Di tert Butyl Peroxide	31000.00 kg

Case No.	Case No.	58 / NC/3/MEET/Oct/202223/11	58 / NC/3/MEET/Oct/202223/11	58 / NC/3/MEET/Oct/202223/11	58 / NC/3/MEET/Oct/202223/11	58 / NC/3/MEET/Oct/202223/11
Case Status		Case Approved
Party Name		TIDE INDUSTRIES
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number		HQRNORM APPLY 00107366AM22
RA File Number		34AA04002212 AM22
Licence No and<br>Date		3411000697/04/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis of information provided by the firm and taking<br>commercial value of By-Product, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.

e of By-Product, 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 Acrylic Acid 84285.00 kg Gamma Undecalactone (Aldehyde C14) 100000 kg 2 Di tert Butyl Peroxide 25000.00 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Gamma Undecalactone (Aldehyde C14)||100000 kg|1|Acrylic Acid|84285.00 kg| |||||2|Di tert Butyl Peroxide|25000.00 kg| |||||above decision of NC.|||

Case No.	59 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00108212AM22

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RA File Number	05AA04019922 AM22
Licence No and<br>Date	0511002989/05/06/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Y 00108212AM22|

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RA File Number	05AA04019922 AM22
Licence No and<br>Date	0511002989/05/06/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	Case No.	Case No.	60 / NC/3/MEET/Oct/202223/11	60 / NC/3/MEET/Oct/202223/11	60 / NC/3/MEET/Oct/202223/11	60 / NC/3/MEET/Oct/202223/11	60 / NC/3/MEET/Oct/202223/11
Case Status			Case Approved
Party Name			GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number			HQRNORM APPLY 00109187AM22
RA File Number			03AA04022509 AM22
Licence No and<br>Date			0311004402/07/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Aug/202223/6 dated 09.09.2022against advance authorization No.<br>0210208260 dated 07.03.2018, it was decided to revise adhoc norms as under:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>Sl. No.

Aug/202223/6 dated 09.09.2022**against advance authorization No. 0210208260 dated 07.03.2018, it was decided to revise adhoc norms as under: Sl. No. Export Product Qty. Sl. No. Import items Qty. 1 OFLOMIL LAK NAIL 5 Percent (Pack size 2.5ml) (Oflomil Lacquer/Amorolfine Hydrochloride Nail Lacquer)((Each 1 ml contains Amorolfine hydrochloride 50 mg) (Net wt of Amorolfine Hydrochloride is 12.50 Kgs)) 100000 Number 1 Amorolfine Hydrochloride 12.75 kg 2 OFLOMIL LAK NAIL 5 Percent (Pack size 5ml) (Oflomil Lacquer/Amorolfine Hydrochloride Nail Lacquer)((Each 1 ml contains Amorolfine hydrochloride 50 mg) (Net wt of Amorolfine Hydrochloride is 25.00 Kgs)) 100000 Number 2 Amorolfine Hydrochloride 25.50 kg RA concerned may take further necessary action as per above decision of NC.|||||||| ||Sl. No.|Export Product||Qty.|Sl. No.|Import items|Qty.| ||1|OFLOMIL LAK NAIL 5 Percent (Pack size 2.5ml) (Oflomil Lacquer/Amorolfine Hydrochloride Nail Lacquer)((Each 1 ml contains Amorolfine hydrochloride 50 mg) (Net wt of Amorolfine Hydrochloride is 12.50 Kgs))|| 100000 Number|1|Amorolfine Hydrochloride|12.75 kg|

1 ml contains Amorolfine hydrochloride 50 mg) (Net wt of Amorolfine Hydrochloride is 12.50 Kgs))|| 100000 Number|1|Amorolfine Hydrochloride|12.75 kg| ||2|OFLOMIL LAK NAIL 5 Percent (Pack size 5ml) (Oflomil Lacquer/Amorolfine Hydrochloride Nail Lacquer)((Each 1 ml contains Amorolfine hydrochloride 50 mg) (Net wt of Amorolfine Hydrochloride is 25.00 Kgs))|| 100000 Number|2|Amorolfine Hydrochloride|25.50 kg| ||RA concerned may take further necessary action as per above decision of NC.|||||||

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Case No.	61 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00109628AM22
RA File Number	03AA04019238 AM22
Licence No and<br>Date	0311004420/08/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda andit was observed that it was not possible to correlate import item<br>Nos. 2 to 8 with the export product. Hence, it was decided to call the firm for attendingPersonal Hearing<br> before<br>Norms Committee to explain its case aongwith sample of import items.

Nos. 2 to 8 with the export product. Hence, it was decided to call the firm for attendingPersonal Hearing before Norms Committee to explain its case aongwith sample of import items.||

Case No.	62 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00109428AM22
RA File Number	34AA04002141 AM22
Licence No and<br>Date	3411000701/08/06/2021
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> Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>ii.<br>Stoichiometric balance between import and export on molar basis.<br>iii.<br>Complete justification of wastage of raw materials for the manufacturing of export product.<br>iv.

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

Case No.	63 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	ALPHAMED FORMULATIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00109478AM22
RA File Number	09AA04003622 AM22
Licence No and<br>Date	0911001018/08/06/2021
Norms Committee Decision:

C/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022| |HQ File Number|HQRNORM APPLY 00109478AM22| |RA File Number|09AA04003622 AM22| |Licence No and Date|0911001018/08/06/2021| |Norms Committee Decision:||

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The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Jun/202223/5 dated 08.07.2022 against advance authorization No. 0910069429 dated 03.11.2020 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export Product				Qty.	Sl. No.	Import items	Qty.
Ashton<br>&	Parson		Infant	<br>1 Number	1	Tincture Matricaria Duplex	4.136 mg
Powders((Each	Sachet	Contains<br>-		<br>Sachet
4.055 Mg of<br>Duplex))	Tincture		Matricaria		2	Lactose Monohydrate modified	259.62 mg

nt| 1 Number|1|Tincture Matricaria Duplex|4.136 mg| |Powders((Each|Sachet|Contains -|| Sachet|||| |4.055 Mg of Duplex))|Tincture||Matricaria||2|Lactose Monohydrate modified|259.62 mg|

Case No.	Case No.	64 / NC/3/MEET/Oct/202223/11	64 / NC/3/MEET/Oct/202223/11
Case Status		Case Approved
Party Name		THINQ PHARMA-CRO LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number		HQRNORM REVIW00002243AM23
RA File Number		03AA04053651 AM22
Licence No and<br>Date		0311005719/29/07/2021
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and as per GST given for 1.28 kg/kg
during 2020-21 and averaging the earlier ratified norms with GST data, it was decided to revise adhoc norms as
under:
	Export product	Qty.	Sl. No.	Import items	Qty.
	Dimethyl Isosorbide<br>1 kg		1	Isosorbide	1.10 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	65 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred

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

Case No.	65 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred

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Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM REVIW00002321AM23
RA File Number	03AA040118606 AM22
Licence No and<br>Date	0311008613/16/11/2021
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was decided to call for following
information/documents from the firm:
Copy of DML for export.<br>i.
Composition of export product showing percentage content of API and Buffering Agent.<br>ii.
iii COA of export product.

Party N	ame	KOPR	AN RE	SEARCH	LABORATORIES LIMITED
Meetin<br>and Da	g Number<br>te	NC/ 3	/ MEET/	Oct/ 202	223/ 11 and 31/10/2022
HQ Fil	e Number	HQR	NORM R	EVIW00	002321AM23
RA Fil	e Number	03AA	0401186	06 AM2	2
Licenc<br>Date	e No and	03110	08613/1	6/11/202	1
Norms<br>The C<br>inform<br>i.<br>ii.<br>iii	Committee Decisi<br>ommittee consider<br>ation/documents fro<br>Copy of DML fo<br> <br>Composition of e<br> <br>COA of export p		on:<br>ed the re<br>m the fir<br>r export<br>xport p<br>roduct.

tee consider ation/documents fro Copy of DML fo Composition of e COA of export p||on: ed the re m the fir r export xport p roduct.|||||||| ||||||quest of m:|firm for review of adhoc norms and it was decided to call|||||for following| ||||||.||||||| |||||| roduct s|howing percentage content of API and Buffering Agent.|||||| ||||||||||||| ||||||||||||| |Case N||o.|66 / N|C/3/ME|||||||| ||||||ET/Oct/2|02223/11|||||| |Case St||atus|Case|Approve|d||||||| |Party N||ame|ELIX|IR PHAR|MA||||||| ||||||||||||| |Meetin and Da||g Number te|NC/ 3|/ MEET/|Oct/ 202|223/ 11 and 31/10/2022|||||| |HQ File Number|||HQRNORM APPLY 00262257AM22||||||||| |RA File Number|||08AA04034885 AM22||||||||| |Licence No and Date|||0811003200/23/11/2021||||||||| |Norms Committee Decision:|||||||||||| |The Committee c|||nsidered the case as er aenda and takin cue from earlier decision for same exort roduct /||||||||| | import item in M|||p g g p p eeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022against advance authorization No.||||||||| | 0811002031 dated||| 19.07.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per||||||||| |details given below||| or as applied by the firm, whichever is less:||||||||| ||||||||||||| ||||||||||||| ||||||||||||| ||Export product||||||Qty.|Sl.

.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.|| ||3-ISOBUTYL GLUTARIC ACID (CMH DIACID)||||||1 kg|1|ISOVALERALDEHYDE|0.6068 kg|| |||||||||2|ETHYL CYANOACETATE|0.7814 kg|| |||||||||3|DIETHYL MALONATE|0.90 kg|| ||||||||||||| |||||||||||||

UDIN00256516AM23

Case No.	67 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	DEEPAK NITRITE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00262416AM22
RA File Number	34AA04008408 AM22
Licence No and<br>Date	3411001440/23/11/2021
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>By-Product obtained during the reaction for manufacturing of export item giving its value with invoices.<br>i.

Case No.	68 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00262423AM22
RA File Number	05AA04098088 AM22
Licence No and<br>Date	0511006367/23/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/10/2022| |HQ File Number|HQRNORM APPLY 00262423AM22| |RA File Number|05AA04098088 AM22| |Licence No and Date|0511006367/23/11/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	69 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00263483AM22
RA File Number	03AA04003343 AM22
Licence No and<br>Date	0311008815/24/11/2021
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:

37 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-11-2022 15:21:42.

UDIN00256516AM23

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.

hnical 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.

Case No.	70 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00263486AM22
RA File Number	03AA04009051 AM22
Licence No and<br>Date	0311008816/24/11/2021
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>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.<br>Details of indigenous input with quantity.<br>v.

er 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.||

Case No.	71 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00263488AM22
RA File Number	03AA04014060 AM22
Licence No and<br>Date	0311008817/24/11/2021
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:

38 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-11-2022 15:21:42.

UDIN00256516AM23

Step wise manufacturing process.

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

Case No.<br>72 / NC/3/MEET/Oct/202223/11
Case Status<br>Case Approved
Party Name<br>SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number<br>HQRNORM APPLY 00265259AM22
RA File Number<br>05AA040104139 AM22
Licence No and<br>Date<br>0511006448/25/11/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/May/202223/4 dated 17.06.2022against advance authorization No.
0511002009 dated 31.03.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP				Vol. I as per
details given below or as applied by the firm, whichever is less:
Export product	Qty.	Sl. No.	Import items	Qty.
Brimonidine Tartrate 0.1 Percent Eye Drops	<br>166667	1	Brimonidine Tartrate	0.85 kg
Solution 5ml Santabrim	Vials
<br>RA concerned may take further necessary action as per above decision of			NC.

Tartrate 0.1 Percent Eye Drops| 166667|1|Brimonidine Tartrate|0.85 kg|| |Solution 5ml Santabrim|Vials||||| | RA concerned may take further necessary action as per above decision of|||NC.|||

Case No.	73 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00264884AM22
RA File Number	03AA040120003 AM22
Licence No and<br>Date	0311008832/25/11/2021
Norms Committee Decision:

UDIN00256516AM23

The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Aug/202223/6 dated 09.09.2022 against advance authorization No. 0310822175 dated 06.07.2018 , 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:

ance authorization No. 0310822175 dated 06.07.2018 , 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:

|The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Aug/202223/6 dated 09.09.2022against advance authorization No.0310822175 dated 06.07.2018, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Sl. No. Export product Qty. Sl. No. Import items Qty. 1 OXYBUTYNIN CHLORIDE USP 5.10 mg 2 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 38.88 mg 3 SENTRY POLYOX WSR N80 FP NF 80.52 mg 1 OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB USP 5 MG. Each tablet contains (i) Oxybutynin Chloride USP- 5 mg (ii) Eastman((TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.52 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg.

Chloride USP- 5 mg (ii) Eastman((TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.52 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 68.808 Kgs (ii) 535.05 Kgs (iii) 1108.08 Kgs (iv) 565.60 Kgs.) 1 Number 4 SENTRY POLYOX WSR 303 NF 41.10 mg 5 OXYBUTYNIN CHLORIDE USP 10.20 mg 6 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 38.88 mg 7 SENTRY POLYOX WSR N80 FP NF 80.77 mg 2 OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 10 MG. Each tablet contains (i) Oxybutynin Chloride USP- 10mg (ii) Eastman((TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.77 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 68.807 Kgs (ii) 267.52 Kgs (iii) 555.754 Kgs (iv) 282.80 Kgs.) 1 Number 8 SENTRY POLYOX WSR 303 NF 41.10 mg 9 OXYBUTYNIN CHLORIDE USP 15.30 mg OXYBUTYNIN CHLORIDE 3 1 Number|The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Aug/202223/6 dated 09.09.2022against advance authorization No.0310822175 dated 06.07.2018, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Sl. No. Export product Qty. Sl. No.

8**, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Sl. No. Export product Qty. Sl. No. Import items Qty. 1 OXYBUTYNIN CHLORIDE USP 5.10 mg 2 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 38.88 mg 3 SENTRY POLYOX WSR N80 FP NF 80.52 mg 1 OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB USP 5 MG. Each tablet contains (i) Oxybutynin Chloride USP- 5 mg (ii) Eastman((TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.52 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 68.808 Kgs (ii) 535.05 Kgs (iii) 1108.08 Kgs (iv) 565.60 Kgs.) 1 Number 4 SENTRY POLYOX WSR 303 NF 41.10 mg 5 OXYBUTYNIN CHLORIDE USP 10.20 mg 6 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 38.88 mg 7 SENTRY POLYOX WSR N80 FP NF 80.77 mg 2 OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 10 MG. Each tablet contains (i) Oxybutynin Chloride USP- 10mg (ii) Eastman((TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.77 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg.

utynin Chloride USP- 10mg (ii) Eastman((TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.77 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 68.807 Kgs (ii) 267.52 Kgs (iii) 555.754 Kgs (iv) 282.80 Kgs.) 1 Number 8 SENTRY POLYOX WSR 303 NF 41.10 mg 9 OXYBUTYNIN CHLORIDE USP 15.30 mg OXYBUTYNIN CHLORIDE 3 1 Number|The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Aug/202223/6 dated 09.09.2022against advance authorization No.0310822175 dated 06.07.2018, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Sl. No. Export product Qty. Sl. No. Import items Qty. 1 OXYBUTYNIN CHLORIDE USP 5.10 mg 2 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 38.88 mg 3 SENTRY POLYOX WSR N80 FP NF 80.52 mg 1 OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB USP 5 MG. Each tablet contains (i) Oxybutynin Chloride USP- 5 mg (ii) Eastman((TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.52 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg.

Chloride USP- 5 mg (ii) Eastman((TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.52 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 68.808 Kgs (ii) 535.05 Kgs (iii) 1108.08 Kgs (iv) 565.60 Kgs.) 1 Number 4 SENTRY POLYOX WSR 303 NF 41.10 mg 5 OXYBUTYNIN CHLORIDE USP 10.20 mg 6 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 38.88 mg 7 SENTRY POLYOX WSR N80 FP NF 80.77 mg 2 OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 10 MG. Each tablet contains (i) Oxybutynin Chloride USP- 10mg (ii) Eastman((TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.77 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 68.807 Kgs (ii) 267.52 Kgs (iii) 555.754 Kgs (iv) 282.80 Kgs.) 1 Number 8 SENTRY POLYOX WSR 303 NF 41.10 mg 9 OXYBUTYNIN CHLORIDE USP 15.30 mg OXYBUTYNIN CHLORIDE 3 1 Number| |---|---|---|---|---|---|---| ||Sl. No.|Export product|Qty.|Sl. No.|Import items|Qty.| ||1|OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB USP 5 MG. Each tablet contains (i) Oxybutynin Chloride USP- 5 mg (ii) Eastman((TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.52 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg.

Chloride USP- 5 mg (ii) Eastman((TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.52 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 68.808 Kgs (ii) 535.05 Kgs (iii) 1108.08 Kgs (iv) 565.60 Kgs.)|1 Number|1|OXYBUTYNIN CHLORIDE USP|5.10 mg| |||||2|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)| 38.88 mg| |||||3|SENTRY POLYOX WSR N80 FP NF|80.52 mg| |||||4|SENTRY POLYOX WSR 303 NF|41.10 mg| ||2|OXYBUTYNIN CHLORIDE EXTENDED RELEASE TAB. USP 10 MG. Each tablet contains (i) Oxybutynin Chloride USP- 10mg (ii) Eastman((TM Cellulose Acetate (CA 398-10NF/EP)- 38.88 mg (iii) Sentry Polyox WSR N80 FP NF- 80.77 mg (iv) Sentry Polyox WSR 303 NF- 41.10 mg. Net content (i) 68.807 Kgs (ii) 267.52 Kgs (iii) 555.754 Kgs (iv) 282.80 Kgs.)| 1 Number|5|OXYBUTYNIN CHLORIDE USP|10.20 mg| |||||6|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)| 38.88 mg| |||||7|SENTRY POLYOX WSR N80 FP NF|80.77 mg| |||||8|SENTRY POLYOX WSR 303 NF|41.10 mg| ||3|OXYBUTYNIN CHLORIDE| 1 Number|9|OXYBUTYNIN CHLORIDE USP|15.30 mg|

UDIN00256516AM23

8.88 mg| |||||7|SENTRY POLYOX WSR N80 FP NF|80.77 mg| |||||8|SENTRY POLYOX WSR 303 NF|41.10 mg| ||3|OXYBUTYNIN CHLORIDE| 1 Number|9|OXYBUTYNIN CHLORIDE USP|15.30 mg|

UDIN00256516AM23

EXTENDED RELEASE TAB.		10	EASTMAN	(TM)	<br>38.88 mg
USP<br>15<br>MG.<br>Each<br>tablet			ACETATE (CA	398-10NF/EP)
contains<br>(i)<br>Oxybutynin
Chloride USP - 15 mg((ii)<br>Eastman (TM Cellulose Acetate	<br>	11	SENTRY POLYOX WSR N80 FP NF		81.02 mg
(CA 398-10NF/EP)- 38.88 mg
(iii) Sentry Polyox WSR N80 FP<br>NF- 81.02 mg (iv) Sentry Polyox	<br>	12	SENTRY POLYOX WSR 303 NF		41.10 mg
WSR 303 NF- 41.10 mg. Net
content (i) 91.743 Kgs (ii)
237.798 Kgs (iii) 495.535 Kgs
(iv) 251.376 Kgs.)

Case No.	74 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00266181AM22
RA File Number	08AA04035102 AM22
Licence No and<br>Date	0811003242/26/11/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	75 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	LAZERHEAD LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00266328AM22
RA File Number	09AA04012424 AM22
Licence No and<br>Date	0911001950/26/11/2021
Norms Committee Decision:
Deferred for comments of TE.

/10/2022| |HQ File Number|HQRNORM APPLY 00266328AM22| |RA File Number|09AA04012424 AM22| |Licence No and Date|0911001950/26/11/2021| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No. 76 / NC/3/MEET/Oct/202223/11

UDIN00256516AM23

Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00268778AM22
RA File Number	09AA04017927 AM22
Licence No and<br>Date	0911001956/29/11/2021
Norms Committee Decision:
Deferred for comments of TE.

C	ase Status	Case Deferre	d
P	arty Name	AUROBIND	O PHARM	A LTD
M<br>a	eeting Number<br>nd Date	NC/ 3/ MEET	/ Oct/ 202	223/ 11 a	nd 31/10/2022

H	Q File Number	HQRNORM	APPLY 00	268778A	M22
R	A File Number	09AA040179	27 AM22
L<br>D	icence No and<br>ate	0911001956/	29/11/2021

N<br>D	orms Committee Decision:<br>eferred for comments of TE.


C	ase No.	77 / NC/3/M	EET/Oct/20
				2223/11
C	ase Status	Case Approv	ed
P	arty Name	USV PRIVA	TE LIMITE	D
Meeting Number<br>and Date	ti Nb
		NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number		HQRNORM APPLY 00268952AM22
RA File Number		03AA040120475 AM22
Li N d
cence o an<br>Date		0311009010/29/11/2021

Norms Committee		Decision:

00268952AM22|||||||| |RA File Number|||03AA040120475 AM22|||||||| |Li N d||||||||||| |cence o an Date|||0311009010/29/11/2021|||||||| |||||||||||| |Norms Committee|||Decision:|||||||| |||||||||||| |The Committee co |||nsidered the case as per agenda and taking cue from earlier decision for same export product / |||||||| |import item in M 0311009726 dated |||eeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022against advance authorization No. 23.12.2021, 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:|||||||| |||||||||||| |||||||||||| |||||||||||| ||Sl. No.|Export product||||Qty.|Sl. No.|Import items||Qty.| ||1|Doxycycline Hyclate DR Tablets USP 75 mg , 100'S US((1,450 Bottles X 100 Per Bottles = 1,45,000 Tablets) (Total Weight of Export Product = 10.88 Kgs) (Net Content weight of Import Product = 12.88 kgs))|||| 145000 Tablets|1|Doxycycline Hyclate USP||12.55 kg| ||2|Export Item Name: Doxycycline Hyclate DR Tablets USP 100 mg , 100'S US((9,900 Bottles X 100 Per Bottles = 990000 Tablets) (Total Weight of|||| 990000 Tablets|2|Doxycycline Hyclate USP||114.25 kg| ||||||| ||||| |||,, Export Product = 99.00 Kgs) (Net Content weight of Import Product = 117.28 kgs))|||| |||||

UDIN00256516AM23

cline Hyclate USP||114.25 kg| ||||||| ||||| |||,, Export Product = 99.00 Kgs) (Net Content weight of Import Product = 117.28 kgs))|||| |||||

UDIN00256516AM23

Case No.	78 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00270155AM22
RA File Number	342404000285 AM20
Licence No and<br>Date	3411001477/30/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents from the<br>firm:<br>Copy of DML for export item.<br>i.<br>ii Complete chemistry, molecular weight, percentage yield on molar basis etc. as per Annexure to Appendix 4E.

Case No.	79 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00271471AM22
RA File Number	342404000079 AM21
Licence No and<br>Date	3411001482/01/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information/documents from the<br>firm:<br>Copy of DML for export item.<br>i.<br>ii Complete chemistry, molecular weight, percentage yield on molar basis etc. as per Annexure to Appendix 4E.

mation/documents from the firm: Copy of DML for export item. i. ii Complete chemistry, molecular weight, percentage yield on molar basis etc. as per Annexure to Appendix 4E.||

Case No.	80 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022

UDIN00256516AM23

and Date
HQ File Number	HQRNORM APPLY 00271583AM22
RA File Number	342404000002 AM21
Licence No and<br>Date	3411001484/01/12/2021
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>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.<br>Details of indigenous input with quantity.<br>v.

er 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.||

Case No.	81 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00271633AM22
RA File Number	342404000080 AM21
Licence No and<br>Date	3411001485/01/12/2021
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>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.<br>Details of indigenous input with quantity.<br>v.

Case No.	82 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	UPL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00271160AM22
RA File Number	03AA040125862 AM22

44 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-11-2022 15:21:42.

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Licence No and 0311009068/01/12/2021 Date Norms Committee Decision:

AM22|

44 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-11-2022 15:21:42.

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Licence No and 0311009068/01/12/2021 Date Norms Committee Decision:

Deferred for comments of TE.

Case No.	83 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	NEXUS PHARMA CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00271316AM22
RA File Number	08AA04035774 AM22
Licence No and<br>Date	0811003272/01/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Aug/202223/6 dated 09.09.2022against advance authorization No.<br>0811003688 dated 06.01.2022, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Clobetasol Propionate USP<br>1 kg<br>1<br>Betamethasone base<br>1.00 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

br>Sl. No. Import items Qty. Clobetasol Propionate USP 1 kg 1 Betamethasone base 1.00 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	84 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00272097AM22
RA File Number	07AA04040799 AM22
Licence No and<br>Date	0711002516/02/12/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

UDIN00256516AM23

Sl. No.	Export product	Qty.
1	MINOXIDIL (USP/Ph.EUR/IP)	9.00 MT
2	MINOXIDIL SULPHATE	7.00 MT

Sl. No.	Import items	Qty.
1	2,4 DIAMINO -6-CHLOROPYRIMIDINE	15.66855 MT

xport product|Qty.| |---|---|---| |1|MINOXIDIL (USP/Ph.EUR/IP)|9.00 MT| |2|MINOXIDIL SULPHATE|7.00 MT|

Sl. No.	Import items	Qty.
1	2,4 DIAMINO -6-CHLOROPYRIMIDINE	15.66855 MT

Case No.	85 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00272098AM22
RA File Number	07AA04040797 AM22
Licence No and<br>Date	0711002517/02/12/2021
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>Production / Consumption data of export product MAGNESIUM BISGLYCINATE / MAGNESIUM<br>GLYCINE<br>COMPLEX(MAGNESIUM<br>BISGLYCINATE<br>/<br>MAGNESIUM<br>GLYCINE<br>COMPLEX)MAGNESIUM GLYCINE COMPLEX) for the years 2018-19 and 2019-20 duly certified by<br>GST.<br>i.<br>ii COA report of Magnesium Oxide.

i. Production / Consumption data of export product MAGNESIUM BISGLYCINATE / MAGNESIUM GLYCINE COMPLEX(MAGNESIUM BISGLYCINATE / MAGNESIUM GLYCINE COMPLEX)MAGNESIUM GLYCINE COMPLEX) for the years 2018-19 and 2019-20 duly certified by GST.

Case No.	86 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	YASHO INDUSTRIES LIMITED

46 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-11-2022 15:21:42.

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|---|---| |Case Status|Case Deferred| |Party Name|YASHO INDUSTRIES LIMITED|

46 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-11-2022 15:21:42.

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Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00272724AM22
RA File Number	03AA040127775 AM22
Licence No and<br>Date	0311009114/02/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the reply furnished by the firm was incomplete.<br>Hence, it was decided to call for following information/documents from the firm:<br>Stoichiometric balance to arrive at the quantity of raw material asked for.<br>i.<br>ii Percentage yield of reaction in first stage.

Case No.	87 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00272084AM22
RA File Number	07AA04039101 AM22
Licence No and<br>Date	0711002507/02/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>ZINC GLUCONATE POWDER<br>1 kg<br>1<br>ZINC GLUCONATE GRANULAR<br>1.005 kg<br>RA concerned may take further necessary action as per above decision of NC.

r>Qty. Sl. No. Import items Qty. ZINC GLUCONATE POWDER 1 kg 1 ZINC GLUCONATE GRANULAR 1.005 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	88 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	AMARA LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00272745AM22

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RA File Number	RA File Number	09AA04018011 AM22	09AA04018011 AM22	09AA04018011 AM22	09AA04018011 AM22	09AA04018011 AM22
Licence No and<br>Date		0911001982/02/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Meta Chloro Benzyl Cyanide<br>1.37 kg<br>N<br>Methyl<br>Loratadine(N<br>Methyl<br>Loratadine)<br>1 kg<br>2<br>N N Dimethyl Carbomyl Chloride<br>0.68 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	N<br>Methyl<br>Loratadine(N<br>Methyl<br>Loratadine)		<br>1 kg	1	Meta Chloro Benzyl Cyanide	1.37 kg
				2	N N Dimethyl Carbomyl Chloride	0.68 kg
				s per above decision of NC.

tems|Qty.| ||N Methyl Loratadine(N Methyl Loratadine)|| 1 kg|1|Meta Chloro Benzyl Cyanide|1.37 kg| |||||2|N N Dimethyl Carbomyl Chloride|0.68 kg| |||||s per above decision of NC.|||

Case No.	Case No.	89 / NC/3/MEET/Oct/202223/11	89 / NC/3/MEET/Oct/202223/11	89 / NC/3/MEET/Oct/202223/11	89 / NC/3/MEET/Oct/202223/11	89 / NC/3/MEET/Oct/202223/11
Case Status		Case Approved
Party Name		GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number		HQRNORM APPLY 00272085AM22
RA File Number		07AA04039096 AM22
Licence No and<br>Date		0711002508/02/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.4/82-ALC4/2019 dated 19.07.2019against advance authorization No.0710109416 dated<br>18.02.2016, it was decided to ratify 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.<br>Import items<br>Qty.<br>1<br>CALCIUM LACTATE PENTAHYDRATE<br>0.490 kg<br>CALCIUM<br>LACTATE<br>GLUCONATE<br>1 kg<br>2<br>CALCIUM GLUCONATE<br>0.680 kg
	Export product<br>CALCIUM<br>LACTATE<br>GLUCONATE		Qty.	Sl. No.	Import items	Qty.
			<br>1 kg	1	CALCIUM LACTATE PENTAHYDRATE	0.490 kg
				2	CALCIUM GLUCONATE	0.680 kg

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xport product CALCIUM LACTATE GLUCONATE||Qty.|Sl. No.|Import items|Qty.| |||| 1 kg|1|CALCIUM LACTATE PENTAHYDRATE|0.490 kg| |||||2|CALCIUM GLUCONATE|0.680 kg|

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Case No.	90 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	PMC RUBBER CHEMICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00272783AM22
RA File Number	02AA04035173 AM22
Licence No and<br>Date	0211001583/02/12/2021
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>COA of catalogue of import and export item.<br>i.<br>ii Net content of import item in export product.

Case No.	91 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00272089AM22
RA File Number	07AA04039105 AM22
Licence No and<br>Date	0711002509/02/12/2021
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>Production / Consumption data of export product L-ORNITHINE-L-ASPARTATE (PURE-PHARMA)<br>for the years 2018-19 and 2019-20 duly certified by GST.<br>i.<br>ii Complete justification of wastage of raw materials for the manufacturing of export product.

RTATE (PURE-PHARMA)** for the years 2018-19 and 2019-20 duly certified by GST. i. ii Complete justification of wastage of raw materials for the manufacturing of export product.||

i. Production / Consumption data of export product L-ORNITHINE-L-ASPARTATE (PURE-PHARMA) for the years 2018-19 and 2019-20 duly certified by GST.

Case No.	92 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED

49 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-11-2022 15:21:42.

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Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00272834AM22
RA File Number	03AA04014502 AM22
Licence No and<br>Date	0311009117/02/12/2021
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>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis<br>iv.<br>Details of indigenous input with quantity.<br>v.

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.||

Case No.	Case No.	Case No.	93 / NC/3/MEET/Oct/202223/11	93 / NC/3/MEET/Oct/202223/11	93 / NC/3/MEET/Oct/202223/11	93 / NC/3/MEET/Oct/202223/11	93 / NC/3/MEET/Oct/202223/11
Case Status			Case Approved
Party Name			GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number			HQRNORM APPLY 00272093AM22
RA File Number			07AA04040783 AM22
Licence No and<br>Date			0711002512/02/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jun/202122/2 dated 02.07.2021against advance authorization No.<br>0711000943 dated 23.04.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Sl. No. Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>1<br>LACTOSE<br>0.3635 kg<br>1<br>CALCIUM LACTOBIONATE<br>1 kg<br>2<br>CALCIUM CARBONATE<br>0.052795 kg<br>1<br>LACTOSE<br>1.021 kg<br>CALCIUM BROMO<br>2<br>1 kg
	Sl. No.	Export Product		Qty.	Sl. No.	Import Items	Qty.
	1	CALCIUM LACTOBIONATE		1 kg	1	LACTOSE	0.3635 kg
					2	CALCIUM CARBONATE	0.052795 kg
	2	CALCIUM BROMO		1 kg	1	LACTOSE	1.021 kg

Sl. No.|Export Product||Qty.|Sl. No.|Import Items|Qty.| ||1|CALCIUM LACTOBIONATE||1 kg|1|LACTOSE|0.3635 kg| ||||||2|CALCIUM CARBONATE|0.052795 kg| ||2|CALCIUM BROMO||1 kg|1|LACTOSE|1.021 kg|

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	LACTOBIONATE		2	CALCIUM CARBONATE	0.360 kg
			3	HYDROBROMIC ACID	0.510 kg
3	CALCIUM GLUBIONATE	1 kg	1	LACTOSE	0.829 kg
			2	CALCIUM CARBONATE	0.140 kg
			3	CALCIUM GLUCONATE	0.42 kg
4	LACTOBIONIC ACID	1 kg	1	LACTOSE	0.5071 kg
			2	CALCIUM CARBONATE	0.0738 kg

Case No.	94 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00272951AM22
RA File Number	03AA04014150 AM22
Licence No and<br>Date	0311009127/02/12/2021

|Meeting Number and Date|NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022| |HQ File Number|HQRNORM APPLY 00272951AM22| |RA File Number|03AA04014150 AM22| |Licence No and Date|0311009127/02/12/2021| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm: Step wise manufacturing process. i. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis ii. Complete technical details as per Annexure to Appendix 4E for chemical products. iii. Stoichiometric balance between import and export on molar basis iv. Details of indigenous input with quantity. v.||

Case No.	95 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED

UDIN00256516AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00272095AM22
RA File Number	07AA04040782 AM22
Licence No and<br>Date	0711002513/02/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jun/202122/2 dated 02.07.2021against advance authorization No.<br>0711000943 dated 23.04.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol.

in Meeting No.NC/3/MEET/Jun/202122/2 dated 02.07.2021against advance authorization No. 0711000943 dated 23.04.2021, 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: Sl. No. Export Product Qty. Sl. No. Import Items Qty. 1 LACTOSE 1.16 kg 1 CALCIUM LACTOBIONATE 1 kg 2 CALCIUM CARBONATE 0.17 kg 1 LACTOSE 1.021 kg 2 CALCIUM CARBONATE 0.360 kg 2 CALCIUM BROMO LACTOBIONATE 1 kg 3 HYDROBROMIC ACID 0.510 kg 1 LACTOSE 0.829 kg 2 CALCIUM CARBONATE 0.140 kg 3 CALCIUM GLUBIONATE 1 kg 3 CALCIUM GLUCONATE 0.42 kg 1 LACTOSE 1.58 kg 4 LACTOBIONIC ACID 1 kg 2 CALCIUM CARBONATE 0.234 kg RA concerned may take further necessary action as per above decision of NC.||

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Case No.	96 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	PUNJAB CHEMICALS AND CROP PROTECTION LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00274052AM22
RA File Number	03AA040121338 AM22
Licence No and<br>Date	0311009169/03/12/2021

|Meeting Number and Date|NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022| |HQ File Number|HQRNORM APPLY 00274052AM22| |RA File Number|03AA040121338 AM22| |Licence No and Date|0311009169/03/12/2021| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Jun/202223/5 dated 08.07.2022against advance authorization No. 0311001236 dated 28.01.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 DIMETHYL SULFOXIDE 0.932 kg TRIMETHYL SULFOXONIUM BROMIDE 1 kg 2 TRIMETHYL ORTHOFORMATE 0.018 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	97 / NC/3/MEET/Oct/202223/11
Case Status<br>	Case Approved
Party Name<br>	PUNJAB CHEMICALS AND CROP PROTECTION LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number<br>	HQRNORM APPLY 00274069AM22
RA File Number<br>	03AA040121871 AM22
Licence No and<br>Date<br>	0311009171/03/12/2021

br>and Date |NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022| |HQ File Number |HQRNORM APPLY 00274069AM22| |RA File Number |03AA040121871 AM22| |Licence No and Date |0311009171/03/12/2021| |Norms Committee Decision: The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No.NC/3/MEET/Jun/202223/5 dated 08.07.2022against advance authorization No. 0311001236 dated 28.01.2021, 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:||

UDIN00256516AM23

Export product	Qty.	Sl.	Import items	Qty.
		No.
TRIMETHYL SULFOXONIUM	1 kg	1	DIMETHYL SULFOXIDE	0.932 kg
BROMIDE
		2	TRIMETHYL ORTHOFORMATE	0.018 kg

Case No.<br>98 / NC/3/MEET/Oct/202223/11
Case Status<br>Case Approved
Party Name<br>TIDE INDUSTRIES
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number<br>HQRNORM APPLY 00273476AM22
RA File Number<br>34AA04009751 AM22
Licence No and<br>Date<br>3411001491/03/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and on the	basis of information provided by the firm and taking
commercial value of By-Product, 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.

e of By-Product, 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 Gamma Undecalactone 200000 kg|Acrylic Acid|168570.00 kg|| |(Aldehyde C14)|||| |2|Di tert Butyl Peroxide|50000.00 kg|| |RA concerned may take further necessary action as per above decision of NC.||||

Case No.	99 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	RAKSHIT PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022

UDIN00256516AM23

HQ File Number	HQRNORM APPLY 00276086AM22
RA File Number	09AA04016769 AM22
Licence No and<br>Date	0911002001/06/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	100 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00276162AM22
RA File Number	03AA040123869 AM22
Licence No and<br>Date	0311009212/06/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information/documents from the
firm:
DML for each export product.<br>i.
Master Batch Formula for each export product.<br>ii.

per agenda and it was decided to call for following information/documents from the|| |firm:|| |DML for each export product. i.|| |Master Batch Formula for each export product. ii.||

Case No.<br>101 / NC/3/MEET/Oct/202223/11
Case Status<br>Case Approved
Party Name<br>SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number<br>HQRNORM APPLY 00276913AM22
RA File Number<br>05AA040105427 AM22
Licence No and<br>Date<br>0511006662/06/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify			adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
Sl. No. Export product	Qty.	Sl. No.	Import items	Qty.
Citicoline Tablets 500mg,(( Each Tablet<br>1	<br>1 Number	1	Citicoline Sodium	523.60 mg
contains Citicoline Sodium equivalent to

UDIN00256516AM23

Qty.|Sl. No.|Import items|Qty.|| |Citicoline Tablets 500mg,(( Each Tablet 1| 1 Number|1|Citicoline Sodium|523.60 mg|| |contains Citicoline Sodium equivalent to||||||

UDIN00256516AM23

Citicoline 500mg) (Equivalent to bulk<br>drug of 1190 Kg))<br>2<br>Export Item Name: Citicoline Injection<br>250mg/ml, 2 ml Ampoule((Each 2ml<br>Injection contains Citicoline Sodium<br>equivalent to Citicoline<br>1 Number<br>2<br>Citicoline Sodium<br>573.00 mg<br>3<br>Citicoline Injection 250mg/ml, 4 ml<br>Ampoule((Each 4ml Injection contains<br>Citicoline Sodium equivalent to Citicoline<br>1gm) (Equivalent to bulk drug of 10.000<br>Kg) Total Bulk Drug Qty. 1205.00Kg.)<br>1 Number<br>3<br>Citicoline Sodium<br>1146.00 mg<br>RA concerned may take further necessary action as per above decision of NC.		Citicoline 500mg) (Equivalent to bulk<br>drug of 1190 Kg))
	2	Export Item Name: Citicoline Injection<br>250mg/ml, 2 ml Ampoule((Each 2ml<br>Injection contains Citicoline Sodium<br>equivalent to Citicoline	<br> <br> <br>1 Number	2	Citicoline Sodium	573.00 mg
	3	Citicoline Injection 250mg/ml, 4 ml<br>Ampoule((Each 4ml Injection contains<br>Citicoline Sodium equivalent to Citicoline<br>1gm) (Equivalent to bulk drug of 10.000<br>Kg) Total Bulk Drug Qty. 1205.00Kg.)	<br> <br> <br> <br>1 Number	3	Citicoline Sodium	1146.00 mg

Case No.	102 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	VENUS REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00276997AM22
RA File Number	30AX04000001 AM22
Licence No and<br>Date	3011001471/06/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	103 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	AURA PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00277561AM22
RA File Number	03AA040123116 AM22
Licence No and<br>Date	0311009243/07/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No. 104 / NC/3/MEET/Oct/202223/11

UDIN00256516AM23

Case Status	Case Deferred
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00277912AM22
RA File Number	05AA040108247 AM22
Licence No and<br>Date	0511006681/07/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

10/2022| |HQ File Number|HQRNORM APPLY 00277912AM22| |RA File Number|05AA040108247 AM22| |Licence No and Date|0511006681/07/12/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	105 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00279887AM22
RA File Number	09AA04018537 AM22
Licence No and<br>Date	0911002024/08/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	Case No.	106 / NC/3/MEET/Oct/202223/11	106 / NC/3/MEET/Oct/202223/11	106 / NC/3/MEET/Oct/202223/11	106 / NC/3/MEET/Oct/202223/11	106 / NC/3/MEET/Oct/202223/11
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number		HQRNORM APPLY 00281870AM22
RA File Number		05AX04000039 AM22
Licence No and<br>Date		0511006799/10/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Jun/202223/5 dated 08.07.2022against advance authorization No.<br>0511001102 dated 04.02.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.

021**, 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 Ciprofloxacin 26.22 mg Ciprofloxacin and Dexamethasone 1 Number Bottle||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Ciprofloxacin and Dexamethasone||1 Number Bottle|1|Ciprofloxacin|26.22 mg|

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Sterile Otic Suspension 7.5ml((Each		2	Dexamethasone USP	7.87 mg
ml contains Ciprofloxacin 3mg. &
Dexamethasone 1mg (Equivalent to			(Micronised)
14.625 Kg. Ciprofloxacin and 4.875
Kg. Dexamethasone Bulk Drug))

Case No.	107 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	VINEET LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00283907AM22
RA File Number	09AX04000009 AM22
Licence No and<br>Date	0911002042/13/12/2021
Norms Committee Decision:
Deferred for comments of TE.

/10/2022| |HQ File Number|HQRNORM APPLY 00283907AM22| |RA File Number|09AX04000009 AM22| |Licence No and Date|0911002042/13/12/2021| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	108 / NC/3/MEET/Oct/202223/11	108 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00284396AM22
RA File Number	05AX04000058 AM22
Licence No and<br>Date	0511006831/13/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is				less:
Sl. No. Export product		Qty.	Sl. No.	Import items	Qty.
1<br>Meropenem Buffered (Meropenem Sod		<br>940 kg	1	(4R,5S,6S)-3-[[(3S,5S)-5-	778.132 kg
Carbonate Blend) Bulk Drug / Pharmacopeal				(Dimethylcarbamoyl)-3-
Grade (Relevant Bulk Drug) (Each 1208 mg				pyrrolidinyl]thio]-6-[(1R)-1-
Buffered	product contains NLT 1000 mg			hydroxyethyl]-4methyl-7-oxo-1-
Meropenem on Anhydrous basis)				azabicyclo

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Each 1208 mg||||pyrrolidinyl]thio]-6-[(1R)-1-||| |Buffered|product contains NLT 1000 mg|||hydroxyethyl]-4methyl-7-oxo-1-||| |Meropenem on Anhydrous basis)||||azabicyclo|||

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|2 Meropenem Injection 500mg ((Each vial contains Meropenem Sterile equivalent to anhydrous Meropenem Sodium Carbonate 500 mg (Equivalent to 990 Kg of bulk drug) Pharmaceutical Formulations / Standard Grade) (Each 1208 mg Buffered product contains NLT 1000 mg Meropenem on Anhydrous basis) 1800000 Numbers 2 (4R,5S,6S)-3-[[(3S,5S)-5- (Dimethylcarbamoyl)-3- pyrrolidinyl]thio]-6-[(1R)-1- hydroxyethyl]-4methyl-7-oxo-1- azabicyclo 819.522 kg 3 Meropenem Injection 1 Gm((Each vial contains Meropenem Sterile equivalent to anhydrous Meropenem Sodium Carbonate 1Gm (Equivalent to 1650Kg of bulk drug) Pharmaceutical Formulations / Standard Grade) (Each 1208 mg Buffered product contains NLT 1000 mg Meropenem on Anhydrous basis) 1500000 Numbers 3 (4R,5S,6S)-3-[[(3S,5S)-5- (Dimethylcarbamoyl)-3- pyrrolidinyl]thio]-6-[(1R)-1- hydroxyethyl]-4methyl-7-oxo-1- azabicyclo 1365.870 kg RA concerned may take further necessary action as per above decision of NC.|2|Meropenem Injection 500mg ((Each vial contains Meropenem Sterile equivalent to anhydrous Meropenem Sodium Carbonate 500 mg (Equivalent to 990 Kg of bulk drug) Pharmaceutical Formulations / Standard Grade) (Each 1208 mg Buffered product contains NLT 1000 mg Meropenem on Anhydrous basis)|

Equivalent to 990 Kg of bulk drug) Pharmaceutical Formulations / Standard Grade) (Each 1208 mg Buffered product contains NLT 1000 mg Meropenem on Anhydrous basis)| 1800000 Numbers|2|(4R,5S,6S)-3-[[(3S,5S)-5- (Dimethylcarbamoyl)-3- pyrrolidinyl]thio]-6-[(1R)-1- hydroxyethyl]-4methyl-7-oxo-1- azabicyclo|819.522 kg| |---|---|---|---|---|---|---| ||3|Meropenem Injection 1 Gm((Each vial contains Meropenem Sterile equivalent to anhydrous Meropenem Sodium Carbonate 1Gm (Equivalent to 1650Kg of bulk drug) Pharmaceutical Formulations / Standard Grade) (Each 1208 mg Buffered product contains NLT 1000 mg Meropenem on Anhydrous basis)| 1500000 Numbers|3|(4R,5S,6S)-3-[[(3S,5S)-5- (Dimethylcarbamoyl)-3- pyrrolidinyl]thio]-6-[(1R)-1- hydroxyethyl]-4methyl-7-oxo-1- azabicyclo|1365.870 kg|

Case No.	109 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00283711AM22
RA File Number	07AA04040751 AM22
Licence No and<br>Date	0711002615/13/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Please specify the Grades of import items.<br>i.

Committee Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm: Please specify the Grades of import items. i.||

Case No.	110 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00283764AM22
RA File Number	09AA04017426 AM22
Licence No and<br>Date	0911001978/13/12/2021

UDIN00256516AM23

Norms Committee Decision:

Deferred for comments of TE.

Case No.	Case No.	Case No.	111 / NC/3/MEET/Oct/202223/11	111 / NC/3/MEET/Oct/202223/11	111 / NC/3/MEET/Oct/202223/11	111 / NC/3/MEET/Oct/202223/11	111 / NC/3/MEET/Oct/202223/11
Case Status			Case Approved
Party Name			GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number			HQRNORM APPLY 00283775AM22
RA File Number			07AA04040754 AM22
Licence No and<br>Date			0711002620/13/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.7/82-ALC4/2019 dated 06.09.2019 against advance authorization No.0710114740 d<br>ated 02.04.2019, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or<br>as applied by the firm, whichever is less:<br>Sl. No.

710114740** d ated 02.04.2019, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Sl. No. Export Product Qty. Sl. No. Import Items Qty. 1 MAGNESIUM LACTATE GLUCONATE 1 kg 1 GLUCONO DELTA LACTONE 0.754 kg 2 ZINC GLUCONATE (Eur.Ph/USP) 1 kg 1 GLUCONO DELTA LACTONE 0.945 kg 3 MAGNESIUM GLUCONATE (Eur.Ph/USP) 1 kg 1 GLUCONO DELTA LACTONE 0.934 kg 4 POTASSIUM GLUCONATE (USP) 1 kg 1 GLUCONO DELTA LACTONE 0.930 kg 5 FERROUS GLUCONATE (BP/EP/USP) 1 kg 1 GLUCONO DELTA LACTONE 0.887 kg 6 MANGANESE GLUCONATE (Eur.Ph/USP) 1 kg 1 GLUCONO DELTA LACTONE 0.945 kg 7 CALCIUM MAGNESIUM LACTATE GLUCONATE 1 kg 1 GLUCONO DELTA LACTONE 0.830 kg|||||||| ||Sl. No.|Export Product||Qty.|Sl. No.|Import Items|Qty.| ||1|MAGNESIUM LACTATE GLUCONATE|| 1 kg|1|GLUCONO DELTA LACTONE|0.754 kg| ||2|ZINC GLUCONATE (Eur.Ph/USP)|| 1 kg|1|GLUCONO DELTA LACTONE|0.945 kg| ||3|MAGNESIUM GLUCONATE (Eur.Ph/USP)|| 1 kg|1|GLUCONO DELTA LACTONE|0.934 kg| ||4|POTASSIUM GLUCONATE (USP)|| 1 kg|1|GLUCONO DELTA LACTONE|0.930 kg| ||5|FERROUS GLUCONATE (BP/EP/USP)|| 1 kg|1|GLUCONO DELTA LACTONE|0.887 kg| ||6|MANGANESE GLUCONATE (Eur.Ph/USP)|| 1 kg|1|GLUCONO DELTA LACTONE|0.945 kg| ||7|CALCIUM MAGNESIUM LACTATE GLUCONATE|| 1 kg|1|GLUCONO DELTA LACTONE|0.830 kg|

ONE|0.887 kg| ||6|MANGANESE GLUCONATE (Eur.Ph/USP)|| 1 kg|1|GLUCONO DELTA LACTONE|0.945 kg| ||7|CALCIUM MAGNESIUM LACTATE GLUCONATE|| 1 kg|1|GLUCONO DELTA LACTONE|0.830 kg|

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Case No.	112 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00283847AM22
RA File Number	03AX04000077 AM22
Licence No and<br>Date	0311009414/13/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Maxigesic<br>cold<br>&<br>flu<br>Hot<br>Drink<br>500mg/150mg Sachets (Paracetamol &<br>Ibuprofen<br>Sachets<br>500<br>mg<br>&<br>150<br>mg)(Maxigesic cold & flu Hot Drink<br>500mg/150mg Sachets (Paracetamol &<br>Ibuprofen Sachets 500 mg & 150 mg) No.<br>of Sachets 300000.00 (Net content of<br>Ibuprofen Lysine Salt IH API 76.95 kg))<br>1 Number<br>1<br>Ibuprofen Lysine Salt<br>IH<br>258.88 mg<br>2<br>Maxigesic<br>cold<br>&flu<br>Hot<br>Drink<br>1000mg/300mg Sachets (Paracetamol &<br>Ibuprofen Sachets 1000 mg & 300<br>mg)(Maxigesic cold & flu Hot Drink<br>1000mg/300mg Sachets (Paracetamol &<br>Ibuprofen Sachets 1000 mg & 300 mg) No.<br>of Sachets 200000.00 (Net content of<br>Ibuprofen Lysine Salt IH API 102.60 kg))<br>1 Number<br>2<br>Ibuprofen Ly

k 1000mg/300mg Sachets (Paracetamol & Ibuprofen Sachets 1000 mg & 300 mg) No. of Sachets 200000.00 (Net content of Ibuprofen Lysine Salt IH API 102.60 kg)) 1 Number 2 Ibuprofen Lysine Salt IH 517.77 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	113 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred

UDIN00256516AM23

Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00283891AM22
RA File Number	09AA04018526 AM22
Licence No and<br>Date	0911002040/13/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	114 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00283899AM22
RA File Number	09AX04000002 AM22
Licence No and<br>Date	0911002041/13/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	115 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00285202AM22
RA File Number	09AA04017427 AM22
Licence No and<br>Date	0911002053/14/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/10/2022| |HQ File Number|HQRNORM APPLY 00285202AM22| |RA File Number|09AA04017427 AM22| |Licence No and Date|0911002053/14/12/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	116 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00286998AM22
RA File Number	31AX04000006 AM22
Licence No and<br>Date	3111000788/15/12/2021

62 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-11-2022 15:21:42.

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Norms Committee Decision:

Deferred for comments of TE.

Case No.	117 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00287478AM22
RA File Number	03AA040122138 AM22
Licence No and<br>Date	0311009510/16/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

10/2022| |HQ File Number|HQRNORM APPLY 00287478AM22| |RA File Number|03AA040122138 AM22| |Licence No and Date|0311009510/16/12/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	118 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	KusuMa PharMa
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00287868AM22
RA File Number	03AX04000216 AM22
Licence No and<br>Date	0311009541/16/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Mar/202122/15 dated 17/03/2022 against advance authorization No.<br>0311002428 dated 11-03-2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>ZINC CITRATE TRIHYDRATE<br>(PURE)<br>50000 kg<br>1<br>CITRIC ACID MONOHYDRATE<br>34109.5 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	119 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred

UDIN00256516AM23

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

Case No.	119 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred

UDIN00256516AM23

Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00289566AM22
RA File Number	34AX04000036 AM22
Licence No and<br>Date	3411001553/17/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
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.
Stoichiometric balance between import and export on molar basis.<br>iii.
Complete justification of wastage of raw materials for the manufacturing of export product.<br>iv.

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

ufacturing of export product.** iv.||

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

Case No.	120 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00289569AM22
RA File Number	34AX04000035 AM22
Licence No and<br>Date	3411001554/17/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
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.
Stoichiometric balance between import and export on molar basis.<br>iii.
Complete justification of wastage of raw materials for the manufacturing of export product.<br>iv.

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

Case No.	121 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00288929AM22
RA File Number	03AA040131485 AM22

64 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-11-2022 15:21:42.

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ence No and<br>e<br>0311009599/17/12/2021
rms Committee Decision:
Committee considered the case as per agenda and taking cue from earlier decision for same export product /
ort item in Meeting No.NC/3/MEET/Mar/2022122/16 dated 08.04.2022against advance		authorization No.
1008210 dated 03.11.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP		Vol. I as per
ails given below or as applied by the firm, whichever is less:
Export product<br>Qty.<br>Sl. No.	Import items	Qty.
1<br>CEFEPIME FOR INJECTION<br>1 kg	CEFEPIME HCL NON STERILE	0.655 kg
2	L ARGININE	0.370 kg
3	PACKING MATERIAL	Relevant as per
		packing policy
<br>concerned may take further necessary action as per above decision of NC.

Licence No and 0311009599/17/12/2021 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Mar/2022122/16 dated 08.04.2022 against advance authorization No. 0311008210 dated 03.11.2021 , 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:

ation No. 0311008210 dated 03.11.2021 , 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:

Case No.<br>122 / NC/3/MEET/Oct/202223/11
Case Status<br>Case Approved
Party Name<br>STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number<br>HQRNORM APPLY 00288969AM22
RA File Number<br>05AX04000134 AM22
Licence No and<br>Date<br>0511006992/17/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/May/202223/4 dated 17.06.2022against advance authorization No.
0510412070 dated 10.10.2019, it was decided to ratify adhoc norms under Para 4.07 of HBP		Vol. I as per
details given below or as applied by the firm, whichever is less:
Export product<br>Qty.<br>Sl. No.	Import items	Qty.
Deferoxamine Mesylate Sterile<br>1 kg<br>1	Deferoxamine Mesylate USP	1.02 kg

UDIN00256516AM23

Case No.	123 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00291953AM22
RA File Number	05AX04000176 AM22
Licence No and<br>Date	0511007040/20/12/2021
Norms Committee Decision:
Deferred for comments of TE.

/10/2022| |HQ File Number|HQRNORM APPLY 00291953AM22| |RA File Number|05AX04000176 AM22| |Licence No and Date|0511007040/20/12/2021| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	124 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	INFICHEM PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00291201AM22
RA File Number	52AX04000002 AM22
Licence No and<br>Date	5211001739/20/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	125 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00291474AM22
RA File Number	08AX04000083 AM22
Licence No and<br>Date	0811003487/20/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:

66 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-11-2022 15:21:42.

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Copy of COA of import item from foreign supplier showing Potency of Actual Import.


C	opy of COA of import item from foreign		supplier		showing		Potency of Actual Import.

C	ase No.	126 / NC/3/MEET/Oct/	202223/1		1
C	ase Status	Case Deferred

P	arty Name	ALEMBIC PHARMAC	EUTICA		LS LIMI		TED
M	eeting Number
a	nd Date	NC/ 3/ MEET/ Oct/ 20	223/ 11 a		nd 31/10		/2022
H	Q File Number	HQRNORM APPLY 00	291533A		M22
R	A File Number	34AX04000052 AM22
L	icence No and

D	ate	3411001560/20/12/202
N<br>	orms Committee<br>	Decision:<br>

D	eferred for comments of TE.

Case No.		127 / NC/3/MEET/Oct/202223/11
Case Status		Case Deferred
Party Name		DHANUKA LABORATORIES LIMITED
M	eeting Number
<br>a	<br>nd Date	NC/ 3/ MEET/ Oct/ 202223/ 11 an				d 31/10/2022
H
	Q File Number	HQRNORM APPLY 002		91684AM		22
R	A File Number	05AX04000180 AM22
L	icence No and

D	ate	0511007032/20/12/2021
N	orms Committee	Decision:

D	eferred for comme	nts of TE.


C	ase No	128 / NC/3/MEET/Oct/20		2223/11
	.

Committee|Decision:||||||||||||| |||||||||||||||| |D|eferred for comme|nts of TE.||||||||||||| |||||||||||||||| |||||||||||||||| |C|ase No|128 / NC/3/MEET/Oct/20|||||2223/11|||||||| ||.|||||||||||||| |C|ase Status|Case Deferred||||||||||||| |P|arty Name|SUMAR BIOTECH LLP||||||||||||| |M a|eeting Number nd Date|NC/ 3/ MEET/ Oct/ 2022|||||23/ 11 an|||||||| ||||||||||d 31/10/2||022|||| |H|Q File Number|HQRNO||RM APPLY 002|||91905AM||22|||||| |R||||||||||||||| ||A File Number|08|AX04|00034 A|M22|||||||||| |L D|icence No and |08|11003|488/20/1|2/2021|||||||||| ||ate|||||||||||||| |N D|orms Committee De eferred for comment||cision: s of TE| .||||||||||| |||||||||||||||| |||||||||||||||| |C|ase No.|12|9 / NC|||||||||||| |||||/3/MEE|/Oct/202223/11|||||||||| |C|ase Status|C|ase Def|erred||||||||||| |P|arty Name|M|ELZER|CHEM|ICALS PRIVATE LIMITED|||||||||| |MeetingNumber||NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022|||||||||||||

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|C|ase Status|C|ase Def|erred||||||||||| |P|arty Name|M|ELZER|CHEM|ICALS PRIVATE LIMITED|||||||||| |MeetingNumber||NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022|||||||||||||

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and Date
HQ File Number	HQRNORM APPLY 00291926AM22
RA File Number	31AA04030064 AM22
Licence No and<br>Date	3111000802/20/12/2021
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>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.<br>Details of indigenous input with quantity.<br>v.

Case No.	Case No.	130 / NC/3/MEET/Oct/202223/11	130 / NC/3/MEET/Oct/202223/11	130 / NC/3/MEET/Oct/202223/11	130 / NC/3/MEET/Oct/202223/11	130 / NC/3/MEET/Oct/202223/11
Case Status		Case Approved
Party Name		MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number		HQRNORM APPLY 00292436AM22
RA File Number		03AA040114422 AM22
Licence No and<br>Date		0311009656/21/12/2021

nd Date||NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022||||| |HQ File Number||HQRNORM APPLY 00292436AM22||||| |RA File Number||03AA040114422 AM22||||| |Licence No and Date||0311009656/21/12/2021||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 Ethoxy Methylene Malonic Acid Ester (EMME) 0.90 kg 2 METHANOL 0.57 kg 3 CAUSTIC SODA LYE 1.29 kg AMODIAQUINE HYDROCHLORIDE ( HCL ) 1 kg 4 Paracetamol 0.55 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||AMODIAQUINE HYDROCHLORIDE ( HCL )||1 kg|1|Ethoxy Methylene Malonic Acid Ester (EMME)|0.90 kg| |||||2|METHANOL|0.57 kg| |||||3|CAUSTIC SODA LYE|1.29 kg| |||||4|Paracetamol|0.55 kg|

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Case No.	131 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00292962AM22
RA File Number	09AA04017854 AM22
Licence No and<br>Date	0911002118/21/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/10/2022| |HQ File Number|HQRNORM APPLY 00292962AM22| |RA File Number|09AA04017854 AM22| |Licence No and Date|0911002118/21/12/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	132 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	NATCO PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00293027AM22
RA File Number	09AX04000043 AM22
Licence No and<br>Date	0911002121/21/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	133 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	ANANTA MEDICARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00293142AM22
RA File Number	05AX04000189 AM22
Licence No and<br>Date	0511007079/21/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	134 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred

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Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00293146AM22
RA File Number	34AX04000029 AM22
Licence No and<br>Date	3411001569/21/12/2021
Norms Committee Decision:
Deferred for comments of TE.

/10/2022| |HQ File Number|HQRNORM APPLY 00293146AM22| |RA File Number|34AX04000029 AM22| |Licence No and Date|3411001569/21/12/2021| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.<br>135 / NC/3/MEET/Oct/202223/11
Case Status<br>Case Approved
Party Name<br>DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number<br>HQRNORM APPLY 00293951AM22
RA File Number<br>34AX04000070 AM22
Licence No and<br>Date<br>3411001584/22/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Aug/202223/6 dated 09.09.2022 against advance		authorization No.
3411001756 dated 04.02.2022, it was decided to ratify adhoc norms under Para 4.07 of HBP		Vol. I as per
details given below or as applied by the firm, whichever is less:
Export Product<br>Qty.<br>Sl. No.	Import Items	Qty.
Phenol<br>7700 MT<br>1	Cumene	6503.883 MT
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	136 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	INDOCO REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00293646AM22
RA File Number	03AX04000320 AM22
Licence No and<br>Date	0311009690/22/12/2021

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Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Sep/202223/8 dated 23.09.2022 against advance authorization No. 0311008055 dated 31.10.2021 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl.	Import items	Qty.
		No.
Ketotifen Fumarate ophthalmic solution	<br>1 Number	1	Ketotifen Fumarate	1.785 mg
( 5ml Bottle )((Each ml. Contains:
Ketotifen (0.025 percentage)<br>Antihistamine )		2	Bottle	Relevant as per packing
				policy
(Equivalent to Ketotifen Fumarate<br>0.035 percentage ) = 1.750 mg per	<br>	3	Cap
bottle of 5ml ) (Net Weight in Export
Products is : 700 GRAMS))		4	Dropper

Case No.<br>137 / NC/3/MEET/Oct/202223/11	Case No.<br>137 / NC/3/MEET/Oct/202223/11	Case No.<br>137 / NC/3/MEET/Oct/202223/11
Case Status<br>Case Approved
Party Name<br>BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number<br>HQRNORM APPLY 00293897AM22
RA File Number<br>31AX04000017 AM22
Licence No and<br>Date<br>3111000824/22/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /

ce No and Date 3111000824/22/12/2021|||||| |Norms Committee Decision:|||||| |The Committee considered the case as per agenda and taking cue from earlier decision for same export product /|||||| |import item in Meeting No.**NC/3/MEET/Sep/202223/8 dated 23.09.2022 **against||||advance authorization No.|| |3111000494 dated 30.07.2021, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per|||||| |details given below or as applied by the firm, whichever|||is less:||| ||Export Product Qty.|Sl. No.|Import Items|Qty.||

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ETHYLENEDIAMINE	1	MONO ETHANOL AMINE	1.0374 kg
(ORGANIC CHEMICAL)
	2	AMMONIA ANHYDROUS	Not allowed, as it is shown
			indigenous

Case No.	138 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00295564AM22
RA File Number	09AX04000038 AM22
Licence No and<br>Date	0911002144/23/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	139 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00295569AM22
RA File Number	09AX04000039 AM22
Licence No and<br>Date	0911002145/23/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/10/2022| |HQ File Number|HQRNORM APPLY 00295569AM22| |RA File Number|09AX04000039 AM22| |Licence No and Date|0911002145/23/12/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	140 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	NEXUS PHARMA CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00296625AM22
RA File Number	08AX04000128 AM22
Licence No and<br>Date	0811003535/24/12/2021

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Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product / import item in Meeting No. NC/3/MEET/Aug/202223/6 dated 09.09.2022 against advance authorization No. 0811003688 dated 06.01.2022 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
Clobetasol Propionate USP	1 kg	1	Betamethasone base	1.00 kg

Case No.	141 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	LARK LABORATORIES (INDIA) LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00296972AM22
RA File Number	05AX04000299 AM22
Licence No and<br>Date	0511007234/24/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	142 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00298292AM22
RA File Number	08AX04000091 AM22
Licence No and<br>Date	0811003537/27/12/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	143 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	SRF LIMITED

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21| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	143 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	SRF LIMITED

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Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00298304AM22
RA File Number	05AX04000086 AM22
Licence No and<br>Date	0511007243/27/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
i Complete technical details as per Annexure to Appendix 4E.

Case No.<br>144 / NC/3/MEET/Oct/202223/11
Case Status<br>Case Deferred
Party Name<br>SAVLA CHEMICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number<br>HQRNORM APPLY 00298647AM22
RA File Number<br>03AX04000385 AM22
Licence No and<br>Date<br>0311009839/27/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Percentage purity of import item.<br>i.
COA of import item from foreign supplier.<br>ii.
Testing Report of import item from Foreign Accredited Institute.<br>iii.

|from the firm:| |Percentage purity of import item. i.| |COA of import item from foreign supplier. ii.| |Testing Report of import item from Foreign Accredited Institute. iii.|

Case No.	145 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00299344AM22
RA File Number	07AA04038998 AM22
Licence No and<br>Date	0711002737/28/12/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:

74 This document has been digitally signed by AJAY KUMAR, Deputy Director on 17-11-2022 15:21:42.

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Step wise manufacturing process.
i.
ii. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.
iii. Stoichiometric balance between import and export on molar basis.
iv. Complete justification of wastage of raw materials for the manufacturing of export product.

molar basis.**

iii. Stoichiometric balance between import and export on molar basis.
iv. Complete justification of wastage of raw materials for the manufacturing of export product.

Case No.	146 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	MAHARASHTRA ALDEHYDES AND CHEMICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00299560AM22
RA File Number	03AX04000272 AM22
Licence No and<br>Date	0311009857/28/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and on the basis of 95% yield, it was decided to ratify adhoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Butyric Acid<br>0.7984 kg<br>Ethyl Butyrate<br>1 kg<br>2<br>Ethanol<br>0.4168 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	147 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved
Party Name	MAHARASHTRA ALDEHYDES AND CHEMICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00299562AM22
RA File Number	03AX04000273 AM22
Licence No and<br>Date	0311009858/28/12/2021
Norms Committee Decision:

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and 31/10/2022| |HQ File Number|HQRNORM APPLY 00299562AM22| |RA File Number|03AX04000273 AM22| |Licence No and Date|0311009858/28/12/2021| |Norms Committee Decision:||

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The Committee considered the case as per agenda and on the basis of information given by the firm, 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.
TRIETHYL CITRATE	1 kg	1	Anhydrous Citric Acid	0.7322 kg
		2	ETHANOL	0.5263 kg

Case No.	148 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00299896AM22
RA File Number	34AX04000090 AM22
Licence No and<br>Date	3411001598/28/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	149 / NC/3/MEET/Oct/202223/11
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00299954AM22
RA File Number	09AX04000070 AM22
Licence No and<br>Date	0911002189/28/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	150 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved

UDIN00256516AM23

Date|0911002189/28/12/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	150 / NC/3/MEET/Oct/202223/11
Case Status	Case Approved

UDIN00256516AM23

Party Name	GLENFIN CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 11 and 31/10/2022
HQ File Number	HQRNORM APPLY 00356912AM22
RA File Number	03AX04001153 AM22
Licence No and<br>Date	0311011451/16/02/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and as per the clarification given by the firm and taking the yield as<br>78% (as per application), also 70% recovery of solvent mixture and the price offsetting it with THF, it was decided<br>to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever<br>is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>4-Hydroxyacetophenone<br>0.79 kg<br>2<br>Tetrahydrofuran<br>2.30 kg<br>3<br>Ethyl Valerate<br>0.75 kg<br>4<br>Sodium Tertiary Butoxide<br>1.65 kg<br>1-(4-Hydroxyphenyl)-heptane-1,3-dione<br>1 kg<br>5<br>Acetic Acid<br>Not allowed, as<br>it is shown<br>indigenous<br>RA concerned may take further necessary action as per above decision of NC.

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