IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2021-10-15

DGFT Committee Minutes

Document text

Government of India Ministry of Commerce and Industry Department of Commerce

DIRECTORATE GENERAL OF FOREIGN TRADE (DES - III SECTION)

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Oct/202122/9 DATED: 15/10/2021

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/202122/9 dated 15/10/2021 of Norms Committee - III for the year 2021-22 was actually held on 21.10.2021 and 29.10.2021 under the Chairmanship of Dr. Amiya Chandra,Additional DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

S.No.	Name and Designation of Representatives	Department
1	AJAY KUMAR,Deputy Director	Directorate General of Foreign Trade, Delhi
2	SHAISH KUMAR,Technical Authority	Technical Consultant,DGFT
3	DINESHNARAIN MATHUR,Technical Authority	Technical Consultant,DGFT

Signature Not Verified Signature Not Verified Digitally Signed. Digitally signe Name: Ajay Kumar( Deputy Director ) Name: Ajay Kumar( uty Director ) Date: 03-Nov-2021 12:58:18 Date: 03-Nov-2021 #2:58:18 Reason: AJAY.DHIMAN88@GOV.IN Reason: AJAY. IAN88@GOV.IN Location: DGFT(HQ) Location: DGFT)

This document has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 03-Nov-2021.

Case Details and Decision(s):

Case No. 1 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name BROOKS LABORATORIES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001339AM21 RA File Number 302404000010 AM21 Licence No and 3010105213/02/06/2020 Date

Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 23.10.2020. Reply still awaited from the firm.

Hence, the Committee decided to reject the case.

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

Case No. 2 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name CLEAN SCIENCE AND TECHNOLOGY LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

HQ File Number 018205001344AM21 RA File Number 318304000011 AM21

Licence No and 3110067749/03/06/2020 Date

Norms Committee Decision:

The Committee considered the case as per agenda and it was decided to call for following information from the firm:

i. Justification for low yield of 54.2% for Phosphorus Oxy Chloride and 56.2% for Ammonia.

Justification for use of Iodine as a Catalyst.

Case No. 3 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001355AM21

RA File Number 052404000082 AM21

Licence No and 0510414338/05/06/2020 Date

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.<br>Sl. No.	Import items	Qty.
1	Azelastine Hydrochloride Nasal Solution (Nasal Spray) 0.1% (137 mcg per	<br>1270000.000 Number 1	Azelastine Hydrochloride	35494.00 gram

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

spray) 30ML. (Each spray contains Azelastine Hydrochloride equivalent to<br>30 mg) (Equivalent to 38100.000 Gram of bulk drug)<br>2<br>Azelastine Hydrochloride Ophthalmic Solution 0.05% W/V 6ML.<br>(Each solution contains Azelastine Hydrochloride equivalent to 3 mg)<br>(Equivalent to 9600.000 Gram of bulk drug) (Total Net Contents<br>47700.000 Gram)<br>3200000.000 Number 1<br>Azelastine Hydrochloride<br>9792.00 gram<br>RA concerned may take further necessary action as per above decision of NC.		spray) 30ML. (Each spray contains Azelastine Hydrochloride equivalent to<br>30 mg) (Equivalent to 38100.000 Gram of bulk drug)
	2	Azelastine Hydrochloride Ophthalmic Solution 0.05% W/V 6ML.<br>(Each solution contains Azelastine Hydrochloride equivalent to 3 mg)<br>(Equivalent to 9600.000 Gram of bulk drug) (Total Net Contents<br>47700.000 Gram)	<br> <br>3200000.000 Number	1	Azelastine Hydrochloride	9792.00 gram

Case No. 4 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name KUSUMA PHARMA Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001360AM21 RA File Number 039404000115 AM21 Licence No and 0310836572/08/06/2020 Date

i. Complete technical details as per Annexure to Appendix 4E.

Justification for wastage claimed.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 5 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AMI ORGANICS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001362AM21 RA File Number 522404000013 AM21 Licence No and 5210043424/08/06/2020 Date

i. Justification for low yield of 70% in first stage.
ii. Quantity and value of By-Product Acetic Acid generated in production process.

Case No. 6 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name INDO AMINES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001366AM21 RA File Number 039404000141 AM21 Licence No and 0310836585/09/06/2020 Date

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

i. Justification for low yield of 40%.
ii. Authentic Literature to certify the low yield.
iii. Commercial Value of By-Product and their quantity. iv. Production / Consumption data for last two years duly certified by GST.

Case No. 7 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name MANGALAM INTERMEDIATES Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001372AM21 RA File Number 522104000033 AM21 Licence No and 5210043430/10/06/2020 Date

Norms Committee Decision:

Case No. 8 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001374AM21 RA File Number 052404000100 AM21 Licence No and 0510414377/11/06/2020 Date

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.
Ciprofloxacin and Dexamethasone Sterile Otic<br>Suspension 7.5ml (Each ml contains Ciprofloxacin<br>3mg. & Dexamethasone 1mg (Equivalent to<br>3375gm Ciprofloxacin and 1125gm Dexamethasone<br>Bulk Drug)	<br> <br> <br> <br>150000.000<br>Number	1	Ciprofloxacin HCL	3933.56 gram
		2	Dexamethasone USP ( Micronised )	1181.25 gram


Case No.	9 / NC/3/MEET/Oct/202122/9	Verified
Case Status	Case Approved
Party Name	TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021
HQ File Number	018205001375AM21
RA File Number	072404000067 AM21
Licence No and	0710116585/11/06/2020<br>
Signature Not
ment has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 03-Nov-2021.<br>Digitally Signed.<br>Name: Ajay Kumar( Dep<br>Date: 03-Nov-2021 12:58<br>Reason: AJAY.DHIMAN<br>Location: DGFT(HQ)

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Date

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 7/82-ALC4/2020 dated 04.12.2020 against advance authorization No. 0710112820 dated 13.02.2018 , 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:

Export product	Qty.	Sl. No.	Import items	Qty.
ISO NONYL ACETATE	1 kg	1	3,5,5,<br>TRIMETHYL<br>HEXANOL<br>(NONANOL)	<br>0.774 kg

Case No. 10 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name FRESENIUS KABI ONCOLOGY LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001847AM21 RA File Number 052304000050 AM21 Licence No and 0510414389/12/06/2020 Date Norms Committee Decision:

Deferred for comments of TE.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 11 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name VANDANA LIFE SCIENCES PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001378AM21 RA File Number 092404000127 AM21 Licence No and 0910068863/12/06/2020 Date

Case No.	Case No.	11 / NC/3/MEET/Oct/202122/9	11 / NC/3/MEET/Oct/202122/9	11 / NC/3/MEET/Oct/202122/9	11 / NC/3/MEET/Oct/202122/9	11 / NC/3/MEET/Oct/202122/9
Case Status		Case Approved
Party Name		VANDANA LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021
HQ File Number		018205001378AM21
RA File Number		092404000127 AM21
Licence No and<br>Date		0910068863/12/06/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided<br>whichever is less:<br>Export product<br>Qty.<br>CYCLOHEXYL ESTER (CEI)<br>1 kg				to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,
	Export product		Qty.	Sl. No.	Import items	Qty.
	CYCLOHEXYL ESTER (CEI)		1 kg	1	GLYOXYLIC ACID-50%	0.726 kg
				2	L(-) MENTHOL	0.663 kg
				3	2,5 DI HYDROXY 1,4 DITHIANE (DIOL)	0.312 kg
				4	CYTOSINE	0.395 kg
				5	HEXAMETHYL DISILAZANE (HMDS)	0.286 kg
				6	METHYLENE CHLORIDE STABILIZED WITH AMYLENE 50 PPM<br>(MDC)<br>~~Sit Nt Vifid~~	<br>2.63 kg

~~Signature Not Verified~~

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

0.400 kg

7 TRIPHOSGENE

Case No. 12 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name 3AK CHEMIE PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001380AM21 RA File Number 092404000129 AM21 Licence No and 0910068864/12/06/2020 Date

i. Exact chemical name of export product.

ii. If it is blended product, then furnish complete percentage composition of export with COA (Certificate of Analysis).
iii. Justification for wastage claimed, if any.

Case No. 13 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name RA CHEM PHARMA LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

and Date HQ File Number 018205001394AM21 RA File Number 092404000169 AM21 Licence No and 0910068886/18/06/2020 Date

Case No. 14 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name BENZO CHEM INDUSTRIES PVT LTD Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001397AM21 RA File Number 039404000169 AM21 Licence No and 0310836740/18/06/2020 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 3/82-ALC4/2020 dated 07.08.2020 against advance authorization No. 0310831519 dated 13.09.2019 , 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:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>4-HYDROXYBENZALDEHYDE OR<br>PARA HYDROXY BENZALDEHYDE<br>1.20 kg<br>4-HYDROXYBENZYL ALCOHOL<br>1 kg<br>2<br>SODIUM BOROHYDRIDE<br>0.23 kg<br> RA concerned may take further necessary action as per above decision of NC.	Export product	Qty.	Sl. No.	Import items	Qty.
	4-HYDROXYBENZYL ALCOHOL	1 kg	1	4-HYDROXYBENZALDEHYDE OR<br>PARA HYDROXY BENZALDEHYDE	1.20 kg
			2	SODIUM BOROHYDRIDE	0.23 kg

Case No. 15 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name HALDIA PETROCHEMICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001399AM21 RA File Number 022404000027 AM21 Licence No and 0210209928/18/06/2020 Date

Norms Committee Decision:

The Committee considered case as per agenda in the presence of the technical experts and it was decided to refer the case to Department of Chemical & Petrochemical (D/o C&PC) for obtaining its comments.

Case No. 16 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Party Name HALDIA PETROCHEMICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date

HQ File Number 018205001400AM21 RA File Number 022404000028 AM21 Licence No and 0210209929/18/06/2020 Date

Norms Committee Decision:

Case No. 17 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name BALAJI SPECIALITY CHEMICALS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date

HQ File Number 018205001406AM21 RA File Number 318304000021 AM21 Licence No and 3110067767/22/06/2020 Date

The Committee considered the case as per agenda and taking 96% yield, 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.
ETHYLENE DIAMINE	1 kg	1	MONOETHANOLAMINE	1.06 kg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

AMMONIA ANHYDROUS

0.294 kg

Case No. 18 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name HALDIA PETROCHEMICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001418AM21 RA File Number 022404000031 AM21 Licence No and 0210209935/23/06/2020 Date

Case No. 19 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name SONGWON SPECIALTY CHEMICALS - INDIA PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001415AM21 RA File Number 342404000060 AM21 Licence No and 3410046173/23/06/2020

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Date

i. Justification of import item No. 2 and 3 together.
ii. Percentage yield of each stage of reaction with stiochiometric balance on molar basis.
iii. Dimethylformamide and Ethylene Dichloride are used as a solvent and recovery of these solvent.

Production / Consumption data for last two years duly certified by GST.

Case No. 20 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name SONGWON SPECIALTY CHEMICALS - INDIA PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001416AM21 RA File Number 342404000064 AM21 Licence No and 3410046174/23/06/2020 Date

Norms Committee Decision:

Complete technical details as per Annexure to Appendix 4E.

Case No. 21 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred

Signature Not Verified

Digitally Signed.

Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Party Name HALDIA PETROCHEMICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date

HQ File Number 018205001417AM21 RA File Number 022404000030 AM21 Licence No and 0210209934/23/06/2020 Date

Norms Committee Decision:

Case No. 22 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name CLEAN SCIENCE AND TECHNOLOGY LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001421AM21 RA File Number 318304000022 AM21 Licence No and 3110067771/24/06/2020 Date

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 6/82-ALC4/2020 dated 13.11.2020 against advance authorization No. 3110067787 dated 07.07.2020 , 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.
Guaiacol	1 kg	1	Phenol	0.97 kg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

2<br>Methanol<br>0.38 kg<br>3<br>Hydrogen Peroxide PURITY 60%<br>0.687 kg<br>4<br>Acetone (Solvent)<br>0.1 kg<br> RA concerned may take further necessary action as per above decision of NC.			2	Methanol	0.38 kg
			3	Hydrogen Peroxide PURITY 60%	0.687 kg
			4	Acetone (Solvent)	0.1 kg

Case No. 23 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name RONAK CHEMICALS

Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001422AM21 RA File Number 342404000017 AM21 Licence No and 3410046180/24/06/2020 Date

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.
BARBITURIC ACID	1 kg	1	DI ETHYL MALONATE	1.38 kg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

0.467 kg

SODIUM METHOXIDE POWDER

Case No. 24 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name ZEISS PHARMACEUTICALS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001428AM21 RA File Number 302204000037 AM21 Licence No and 3010105262/25/06/2020 Date

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.
Drug Formulations Injections (vials 30 ML) -	<br>1 Vial	1	Relevant Bulk Drug - Cefpirome sulphate (sterile) (buffered with	<br>1.447 gram
CEFPIROME SULPHATE for Injection 1 G Each			sodium carbonate)
vial contain Cefpirome sulphate (sterile) (buffered
with sodium carbonate)-1.46 Grams equivalent to
CEFPIROME SULPHATE for Injection - 1 G)

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 25 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001431AM21 RA File Number 072404000092 AM21 Licence No and 0710116675/29/06/2020 Date

i. Justification for converting Granular Form to Powder Form.
ii. Mesh size of Export Product.

Production / Consumption data for last two years duly certified by GST.

Case No. 26 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name NAARI PHARMA PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001436AM21 RA File Number 052404000144 AM21

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Licence No and 0510414508/30/06/2020 Date

Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

Case No. 27 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001437AM21 RA File Number 039404000210 AM21 Licence No and 0310836960/30/06/2020 Date Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 28 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name MAHI DRUGS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001438AM21 RA File Number 262404000003 AM21 Licence No and 2610012912/30/06/2020 Date Norms Committee Decision: Deferred for comments of TE.

Case No. 29 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name SRINI PHARMACEUTICALS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001447AM21 RA File Number 092404000143 AM21 Licence No and 0910068917/30/06/2020 Date Norms Committee Decision:

Production / Consumption data duly certified by GST.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 30 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001440AM21 RA File Number 039404000201 AM21 Licence No and 0310836986/01/07/2020 Date Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

Case No. 31 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001441AM21 RA File Number 039404000202 AM21 Licence No and 0310836987/01/07/2020 Date Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

Case No. 32 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001442AM21 RA File Number 039404000200 AM21 Licence No and 0310836988/01/07/2020 Date

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

Case No. 33 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001443AM21 RA File Number 039404000979 AM20 Licence No and 0310836990/01/07/2020 Date

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

Case No. 34 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001444AM21 RA File Number 039404001071 AM20 Licence No and 0310836991/01/07/2020 Date

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 35 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name TOJO VIKAS INTERNATIONAL PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001445AM21 RA File Number 052404000149 AM21 Licence No and 0510414531/01/07/2020 Date 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.
Delta Decalactone Natural (Tetrahydro-6-	935.00 kg	1	Massoia C-10 Lactone Natural (6-Pentyl-5,6-dihydro-2H-pyran-2-One)	970.00 kg
pentyl-2H pyran-2-One)

Case No. 36 / NC/3/MEET/Oct/202122/9

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case Status Case Rejected Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001446AM21 RA File Number 039404000157 AM21 Licence No and 0310837001/01/07/2020 Date

Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

Case No. 37 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name ENCEE AROMATICS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001449AM21 RA File Number 322404000019 AM21 Licence No and 3210079591/02/07/2020 Date

i. Justification for having low yield percentage.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Production / Consumption data for last two years duly certified by GST.

Case No. 38 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001453AM21 RA File Number 039404001083 AM20 Licence No and 0310837056/07/07/2020 Date

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

Case No. 39 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name SAVLA CHEMICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001455AM21 RA File Number 039504000192 AM21

==> picture [101 x 11] intentionally omitted <==

----- Start of picture text ----- Signature Not Verified ----- End of picture text -----

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Licence No and 0310837078/08/07/2020 Date

Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

Case No. 40 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name GLENMARK PHARMACEUTICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001456AM21 RA File Number 039404000227 AM21 Licence No and 0310837081/08/07/2020 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 6/82-ALC4/2020 dated 13.11.2020 against advance authorization No. 0310838803 dated 08.10.2020 , 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:

Sl. No.	Export Product	Qty.
1	Desonide Cream 0.05% 15gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.188 Kgs)	1 Number

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

2	2	Desonide Cream 0.05% 60gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.750 Kgs)	Desonide Cream 0.05% 60gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.750 Kgs)	Desonide Cream 0.05% 60gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.750 Kgs)	Desonide Cream 0.05% 60gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.750 Kgs)	Desonide Cream 0.05% 60gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.750 Kgs)	Desonide Cream 0.05% 60gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.750 Kgs)	Desonide Cream 0.05% 60gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.750 Kgs)	1 Number
3		Desonide Lotion 0.05% 59ml ( Net Wt. of Desonide USP Micronised (Sicor) is 0.738 Kgs)							1 Number
4		Desonide Lotion 0.05% 118ml ( Net Wt. of Desonide USP Micronised (Sicor) is 1.475 Kgs)							1 Number
5		Desonide Ointment 0.05% 15gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.188 Kgs)							1 Number
6		Desonide Ointment 0.05% 60gm ( Net Wt. of Desonide USP Micronised (Sicor) is 0.750 Kgs)							1 Number
			For the Export of 1 No. Pack<br>0.05%<br>15 gm pack<br>0.05%<br>60 gm pack<br>0.05%<br>59 ml pack<br>0.05%<br>118 ml pack<br>0.05%<br>15 gm pack<br>0.05%<br>60 gm pack<br> <br>0.00765 gm<br>0.0306 gm<br>0.301 gm<br>0.602 gm<br>0.00765 gm<br>0.0306 gm
SI.<br>No.	Import Items		For the Export of 1 No. Pack
			0.05%<br>15 gm pack	0.05%<br>60 gm pack	0.05%<br>59 ml pack	0.05%<br>118 ml pack	0.05%<br>15 gm pack	0.05%<br>60 gm pack
1	Desonide<br>USP<br>Micronised (Sicor)		<br>0.00765 gm	0.0306 gm	0.301 gm	0.602 gm	0.00765 gm	0.0306 gm

Case No. 41 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name CLEAN SCIENCE AND TECHNOLOGY LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001457AM21 RA File Number 318304000020 AM21 Licence No and 3110067788/08/07/2020 Date

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

Case No. 42 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name KEVA FRAGRANCES PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001458AM21 RA File Number 039404000218 AM21 Licence No and 0310837120/09/07/2020 Date Norms Committee Decision:

i. Exact chemical name of import and export item.
ii. COA and Catalogue of import item from foreign supplier.
iii. Composition of Export Product.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

iv. Complete manufacturing process.

Chemical reaction with molecular and structural formula.

Case No. 43 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name LINK PHARMACHEM LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001463AM21 RA File Number 342404000085 AM21 Licence No and 3410046202/10/07/2020 Date

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.
1,3 - DICHLORO ACETONE	1 kg	1	1-CHLORO-2,3-EXPOXYPROPANE (EPICHLOROHYDRIN)	0.94 kg
		2	SODIUM DICHLOROMATE	1.55 kg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 44 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001464AM21 RA File Number 072404000102 AM21 Licence No and 0710116730/10/07/2020 Date

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 2/82-ALC4/2018 dated 16.05.2018 against advance authorization No. 0710111644 dated 23.05.2017 , 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	CALCIUM<br>GLUCONATE<br>(EP<br>FOR<br>INJECTION/JP/USP/POWDER)	<br>1 kg	1	CALCIUM GLUCONATE	1.09 kg
2	CALCIUM BOROGLUCONATE	1 kg	1	CALCIUM GLUCONATE	0.913 kg
3	CALCIUM GLUBIONATE (FOR INJECTION) / CALCIUM<br>GLUBIONATE	1 kg	1	CALCIUM GLUCONATE	0.430 kg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 45 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name ALPHAMED FORMULATIONS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001471AM21 RA File Number 092404000159 AM21 Licence No and 0910068951/10/07/2020 Date

Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

Case No. 46 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name SHARON BIO-MEDICINE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001459AM21 RA File Number 039504000141 AM21 Licence No and 0310837129/10/07/2020 Date Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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.
LOPERAMIDE	2 MG	ORAL DISPERSIBLE TABLETS LOPERAMIDE 2 MG				<br>1 Number	1	PHARMABURST B1	184.00 mg
FAST<br>MELT	TAB	6S	<br>EACH<br>TABLETS	CONTAINS	LOPERAMIDE
HYDROCHLORIDE 2		MG	AND PHARMABRUST B1 184 KGS		FOR 1 BATCH	<br>Tablet
EQUAL TO 1000000		TABLETS 85645 PACKS		OF 36S EQUAL TO 3083220
TABLETS

Case No. 47 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name MANKIND PHARMA LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001461AM21 RA File Number 052404000168 AM21 Licence No and 0510414600/10/07/2020 Date Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Copy of DML showing Approved Composition of Export item.

Case No. 48 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001466AM21 RA File Number 072404000105 AM21 Licence No and 0710116735/13/07/2020 Date Norms Committee Decision:

i. Specification of Pharma Goods of Export as per Pharmacopia.

COA of Export and import item stating percentage purity and impurity profile

Case No. 49 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name ATUL LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001468AM21 RA File Number 082404000075 AM21 Licence No and 0810148122/14/07/2020

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Date

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.|
|---|---|---|---|---|
|Formulated Amine Curing Agent (containing 50% Diethyl|<br>80000.000 kg|1|Di Ethyl Toluene Diamine | Ethacure 100 | Lonzacure DETDA 80 ||<br>40400.000 kg|
|Toluene Diamine, 50% Isophorone Diamine)|||DETDA 80 | DETDA||
|||2|Iso Phoron Diamine | Vestamine IPD | Baxxodur EC 201 ||<br>40400.000 kg|
||||Wanamine IPDA||

Case No.	50 / NC/3/MEET/Oct/202122/9
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021
HQ File Number	018205001473AM21
RA File Number	039404000254 AM21
Licence No and<br>Date	0310837163/14/07/2020
Norms Committee	Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

i. Detailed manufacturing process.
ii. COA of import item from foreign supplier indicating percentage purity.

Manufacturing process of Export Item No. 2.

Case No. 51 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name GLENMARK PHARMACEUTICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001474AM21 RA File Number 039404000257 AM21 Licence No and 0310837175/14/07/2020 Date

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 2/82-ALC4/2020 dated 10.07.2020 against advance authorization No. 0310834476 dated 24.01.2020 , 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:

Sl.	Export Product	Qty.	Import items	Qty.
No.
1	Clobetasol Propionate Foam 0.05% 50gm	150000.000	CLOBETASOL PROPIONATE USP (MICRONIZED)	24.65 kg
	(Net. wt. of Net. wt. of Clobetasol Propionate USP (Micronized) is 3.750 Kgs.)	Packs
2	Clobetasol Propionate Foam 0.05% 100gm	150000.000
	(Net. wt. of Clobetasol Propionate USP (Micronized) is 7.500 Kgs.)	Packs

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

	3	Clobetasol Propionate Cream USP 0.05% (Pack Size 15gm) (Net Weight of Clobetasol<br>Propionate USP (Micronized) 0.750 Kgs)	<br>100000.000<br>Packs
	4	Clobetasol Propionate Cream USP 0.05% (Pack size 30gm) (Net Weight of Clobetasol<br>Propionate USP (Micronized) 0.300 Kgs)	<br>20000.000 Packs
	5	Clobetasol Propionate Cream USP 0.05% (Pack size 45 gm) (Net Weight of Clobetasol<br>Propionate USP (Micronized) 0.450 Kgs)	<br>20000.000 Packs
	6	Clobetasol Propionate Cream USP 0.05% (Pack size 60gm) (Net Weight of Clobetasol<br>Propionate USP (Micronized) 0.600 Kgs)	<br>20000.000 Packs
	7	Clobetasol Propionate Ointment USP 0.05% (Pack size 15gm) (Net Weight of Clobetasol<br>Propionate USP (Micronized) 0.150 Kgs)	<br>20000.000 Packs
	8	Clobetasol Propionate Ointment USP 0.05% (Pack size 30gm) (Net Weight of Clobetasol<br>Propionate USP (Micronized) 0.750 Kgs)	<br>50000.000 Packs
	9	Clobetasol Propionate Ointment USP 0.05% (Pack size 45gm) (Net Weight of Clobetasol<br>Propionate USP (Micronized) 0.900 Kgs)	<br>40000.000 Packs
	10	Clobetasol Propionate Ointment USP 0.05% (Pack size 60gm) (Net Weight of Clobetasol<br>Propionate USP (Micronized) 0.600 Kgs)	<br>20000.000 Packs
	11	Clobetasol Propionate Spray 0.05% (Pack size 59ml) (Net Weight of Clobetasol Propionate<br>USP (Micronized) 1.180 Kgs)	<br>40000.000 Packs
	12	Clobetasol Propionate Spray 0.05% (Pack size 125ml) (Net Weight of Clobetasol Propionate<br>USP (Micronized) 2.500 Kgs)	<br>40000.000 Packs
	13	Clobetasol Prop. Top Sol USP, 0.05% 25ml<br>(Net Weight of Clobetasol Propionate USP (Micronized) 0.625 Kgs)	50000.000 Packs
	14	Clobetasol Prop. Top Sol USP, 0.05% 50ml	40000.000 Packs<br>~~Sinatu~~
ment has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 03-Nov-2021.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 03-Nov-2021 12:58:18<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>g

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

	(Net Weight of Clobetasol Propionate USP (Micronized) 1.000 Kgs)
15	Clobetasol Pro Shampoo, 0.05 % 118ml<br>(Net Weight of Clobetasol Propionate USP (Micronized) 2.360 Kgs)	40000.000 Packs
16	Clobetasol Propionate Foam 0.05% 100gm<br>(Net. wt. of Clobetasol Propionate USP (Micronized) is 0.500 Kgs.)	10000.000 Packs
17	Clobetasol Propionate Foam 0.05% 50gm<br>(Net. wt. of Clobetasol Propionate USP (Micronized) is 0.250 Kgs.)	10000.000 Packs

Case No.	52 / NC/3/MEET/Oct/202122/9
Case Status	Case Rejected
Party Name	BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021
HQ File Number	018205001478AM21
RA File Number	039404000232 AM21
Licence No and<br>Date	0310837216/15/07/2020
Norms Committee	Decision:

The Committee considered the case as per agenda and it was observed that the description of Export Product does not match with the DML. Hence, it was decided to reject the case.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 53 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name J B CHEMICALS AND PHARMACEUTICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001479AM21 RA File Number 039404000260 AM21 Licence No and 0310837228/16/07/2020 Date

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	Benzocaine and Cetylpyridinium Chloride Anaesthetic Throat	<br>1 Number		1		Benzocaine	12.24 mg
	Lozenges.
	Flavours Black Current, Honey Lemon & Other Flavours. Each
	Lozenge Contains 12mg Benzocaine. Net content of Benzocaine -
	97.015 Kgs.
2	Benzocaine and Cetylpyridinium Chloride Anaesthetic Throat	<br>1 Number		2		Benzocaine	10.20 mg
	Lozenges.
	Flavours Black Current and Lime & Lemon and Other Flavours. Each
	Lozenge contains 10mg Benzocaine. Net content of Benzocaine -
	33.52 Kgs.
3	Benzocaine, Cetylpyridinium Chloride And Dextromethorphan	<br>1 Number		3		Benzocaine	1.275 mg
	Hydrobromide Anaesthetic Throat Lozenges.
	Each Lozenge Contains 1.25mg Benzocaine. Net content of
			~~Signature Not~~		~~Verified~~

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

4	Benzocaine - 4.695 Kgs.	1 Number	4	Benzocaine	15.30 mg
	Life Brand Sore Throat & Nasal Congestion Relief Extra Strength<br>(Flavours Cherry/Honey & Lemon/Other flavours) Sugar Free<br>Lozenges.Each Lozenge Contains Bezocaine 15 mg & Isomalt ST-M<br>2571 Mg. Net Content Benzocaine 13.333 Kgs and Isomalt ST-M -<br>2285.352 Kgs.	<br> <br>	5	Isomalt ST-M	2571.00 mg
5	Personnelle Oral Anesthetic Sore Throat Lozenges Extra Strenght<br>Sugar Free<br>(Flavours Cherry/Honey Lemon/Other flavours) Each Lozenge<br>Contains Bezocaine 15 mg & Isomalt ST-M 2571 Mg. Net Content<br>Benzocaine 13.333 Kgs and Isomalt ST-M - 2285.352 Kgs.	<br> <br> <br>1 Number	6	Benzocaine	15.30 mg
			7	Isomalt ST-M	2571.00 mg
6	Option+Oral Lozenges Sore Throat & Nasal Congestion Relief Extra<br>Strenght (Flavours Cherry/Honey Lemon /Other flavours). Each<br>Lozenge Contains Bezocaine 15 mg & Isomalt ST-M 2571 Mg. Net<br>Content Benzocaine 13.333 Kgs and Isomalt ST-M - 2285.352 Kgs.	<br> <br> <br>1 Number	8	Benzocaine	15.30 mg
			9	Isomalt ST-M	2571.00 mg
7	Biomedic Oral Anesthetic Lozenges Sore Throat & Nasal Congestion<br>Relief Extra Strength Cherry ST & NC RELEX Lozenges (Flavours<br>Cherry / Honey Lemon/ Other flavours) Each Lozenge Contains<br>Bezocaine 15 mg & Isomalt ST-M 2571 Mg. Net Content Benzocaine<br>13.333 Kgs and Isomalt ST-M - 2285.352 Kgs.	<br> <br> <br> <br>1 Number	10	Benzocaine	15.30 mg
			11	Isomalt ST-M	2571.00 mg
8	Atoma Sore Throat & Nasal Congestion Relief Extra Strength<br>Lozenges Cherry/Honey & Lemon Flavour. Each Lozenge Contains<br>Bezocaine 15 mg & Isomalt ST-M 2700 Mg. Net Content Benzocaine<br>13.333 Kgs and Isomalt ST-M - 2285.352 Kgs.	<br> <br> <br>1 Number	12	Benzocaine	15.30 mg
			13	Isomalt ST-M	2571.00 mg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 54 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name MEHTA API PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001480AM21 RA File Number 039504000231 AM21 Licence No and 0310837276/20/07/2020 Date

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

Case No. 55 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name ASTRAL STERITECH PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001481AM21 RA File Number 342404000096 AM21

==> picture [101 x 11] intentionally omitted <==

----- Start of picture text ----- Signature Not Verified ----- End of picture text -----

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Licence No and 3410046228/20/07/2020 Date

Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

Case No. 56 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name INNOVARE LABS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001483AM21 RA File Number 092404000174 AM21 Licence No and 0910068965/20/07/2020 Date Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 57 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name AUROBINDO PHARMA LTD Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001494AM21 RA File Number 092404000209 AM21 Licence No and 0910068983/21/07/2020 Date

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.
Sultamicillin	1 kg	1	6-Aminopenicillanic acid (6-APA)	0.60 kg
		2	Acetonitrile	1.24 kg
		3	Activated Carbon (Carbon Enoanticromos)	0.070 kg
		4	D(-) Alpha Phenyl Glycine Base (PG Base)	0.472 kg
		5	Dimethylformamide	1.00 kg
		6	Iodomethyl sulbactam	0.87 kg
		7	Isopropyl alcohol	2.85 kg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

	8	Methanol (Methyl Alcohol)	0.25 kg
	9	Penicillin G Amidase (Particle size 250 - 500 micron, Creamish to Brown regularly shaped beads)	<br>0.0014 kg
		or (Immobilized Acylase Enzyme) Xinase

Case No. 58 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001485AM21 RA File Number 052404000176 AM21 Licence No and 0510414657/21/07/2020 Date

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.
Moxifloxacin HCL and Dexamethasone Sodium	<br>26300.000	1	Moxifloxacin Hydrochloride	752.50 gram
Phosphate Eye Drops 0.5%w/v, 0.1% w/v, 5ml	<br>Number
(MILFLOX DM, MILFODOX, MIFLOCO DELTA)
(Each ml contain Moxifloxacin Base 5mg. equi. to		2	Dexamethasone Sodium Phosphate<br>	151.88 gram

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Moxifloxacin HCL 5.45mg. & Dexamethasone Phosphate 1mg equi. to Dexamethasone Sodium Phosphate 1.1mg (Equi.to 716.675gm Moxifloxacin HCL and 144.650gm Dexamethasone Sodium Phosphate Bulk Drug)

Case No. 59 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name ADVANCE PETROCHEMICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001486AM21 RA File Number 082404000095 AM21 Licence No and 0810148200/21/07/2020 Date Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 60 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name ALEOR DERMACEUTICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001492AM21 RA File Number 342404000098 AM21 Licence No and 3410046235/22/07/2020 Date

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.
Diclofenac Sodium Gel 3 % 100g Tube	20000.000	1	Diclofenac Sodium USP	61.2 kg
	Number
(Net Content of Active Ingredients = 60 kg)

Case No. 61 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name SYNTHO CHIRALS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001496AM21 RA File Number 092404000185 AM21

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Licence No and 0910068991/22/07/2020 Date

i. Catalogue of import item from foreign supplier indicating the use of item in this type of reaction.

Production / Consumption data for last two years duly certified by GST.

Case No. 62 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name USV PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001489AM21 RA File Number 039504000240 AM21 Licence No and 0310837311/22/07/2020 Date 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	Desipramine Hydrochloride Tablets, USP 25 MG 100 S (24,000 Bottles x 100 Per Bottles	<br>2400000.000 Tablets	1	Desipramine HCL	61.20 kg
	= 24,00,000 Tablets) ( Net Content Weight = 60.000 Kgs)

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Desipramine HCL

64.26 kg

2 Desipramine Hydrochloride Tablets, USP 50 MG 100 S (12,600 Bottles x 100 Per Bottles 1260000.000 Tablets 1 = 12,60,000 Tablets) ( Net Content Weight = 63.000 Kgs)

Case No. 63 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name SUPERMINT EXPORTS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001490AM21 RA File Number 052404000191 AM21 Licence No and 0510414685/22/07/2020 Date

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

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

Case No. 64 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name VENOR PHARMA LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001497AM21 RA File Number 052404000159 AM21 Licence No and 0510414709/24/07/2020 Date

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.<br>	Import items	Qty.
1	Inj. Fentanyl Citrate eqv. to Fentanyl 50mcg/ml, 2ml Ampoule	2290000.000<br>Number	1<br>	Fentanyl Citrate	395.72 gram
2	Inj. Fentanyl Citrate eqv. to Fentanyl 50mcg/ml, 10ml Ampoule	190000.000<br>Number	1<br>	Fentanyl Citrate	164.16 gram

Case No. 65 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name PHAROSE REMEDIES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001502AM21

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

RA File Number 182404000004 AM21 Licence No and 1810004355/24/07/2020 Date

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.
Alpha Ketoanalogue+ Essential Amino Acids Film-Coated Tablet - MEDICINE<br>(Each tablet contains L-Histidine 38.0 mg)	1 Number	1	L-HISTIDINE<br>BULK DRUG	38.76 mg

Case No. 66 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001501AM21 RA File Number 072404000118 AM21 Licence No and 0710116798/27/07/2020 Date

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

(i) Justification for converting Granular Form to Powder Form.

i. Mesh size of Export Product.

Production / Consumption data for last two years duly certified by GST.

Case No. 67 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name ALPHAMED FORMULATIONS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001508AM21 RA File Number 092404000160 AM21 Licence No and 0910068998/28/07/2020 Date Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, 7/82-ALC4/2020 dated 04.12.2020, followed by Reminder to firm on 16.10.2020. Reply still awaited from the firm.

Case No. 68 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name STYRAX LIFE SCIENCES PRIVATE LIMITED

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001509AM21 RA File Number 092404000167 AM21 Licence No and 0910069002/28/07/2020 Date

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:

Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021	NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021	NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021	NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021	NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021
HQ File Number		018205001509AM21
RA File Number		092404000167 AM21
Licence No and<br>Date		0910069002/28/07/2020
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 Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>GLYOXALIC ACID 50%<br>0.746 kg<br>2<br>2,5-DIHYDROXY-1,4-DIATHINE<br>0.327 kg<br>3<br>SODIUM BOROHYDRIDE<br>0.26 kg<br>4<br>DI METHYL FORMAMIDE (DMF)<br>0.26 kg<br>5<br>CYTOSINE<br>0.434 kg<br>6<br>HEXA METHYL DISILAZANE (HMDS)<br>0.69 kg<br>7<br>METHYLENE DI CHLORIDE (MDC)<br>2.63 kg<br>8<br>L-MENTHOL (FRESH / RECOVERY)<br>0.665 kg<br>9<br>TRI ETHYL AMINE (TEA)<br>0.233 kg<br>2(R)-(Hydroxy<br>Methyl)-5(S)<br>cytosine-1-YI-1,<br>3-<br>oxathiolane salicylic acid salt (Lamivudine Salicylate)<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	2(R)-(Hydroxy<br>Methyl)-5(S)<br>cytosine-1-YI-1,<br>3-<br>oxathiolane salicylic acid salt (Lamivudine Salicylate)		1 kg	1	GLYOXALIC ACID 50%	0.746 kg
				2	2,5-DIHYDROXY-1,4-DIATHINE	0.327 kg
				3	SODIUM BOROHYDRIDE	0.26 kg
				4	DI METHYL FORMAMIDE (DMF)	0.26 kg
				5	CYTOSINE	0.434 kg
				6	HEXA METHYL DISILAZANE (HMDS)	0.69 kg
				7	METHYLENE DI CHLORIDE (MDC)	2.63 kg
				8	L-MENTHOL (FRESH / RECOVERY)	0.665 kg
				9	TRI ETHYL AMINE (TEA)	0.233 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

	10	TRIPHOSGINE	0.40 kg
	11	SALICYLIC ACID	0.30 kg

Case No. 69 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name SAFECON LIFESCIENCES Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001504AM21 RA File Number 062404000092 AM20 Licence No and 0610039560/28/07/2020 Date

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, 7/82-ALC4/2020 dated 04.12.2020, followed by Reminder to firm on 16.10.2020. Reply still awaited from the firm.

Case No. 70 / NC/3/MEET/Oct/202122/9

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case Status Case Approved Party Name S.M. HERBALS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001506AM21 RA File Number 052404000146 AM21 Licence No and 0510414764/28/07/2020 Date

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.
10-DEACETYLE BACCATIN -III (OTHER VEGETABLE<br>ALKALOID) MADE OF TAXUS WALLICHIANA TWIG &<br>LEAF	<br> <br>1 kg	1	TAXUS WALLICHIANA TWIG & LEAF	244.68 kg

Case No. 71 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name TIDE INDUSTRIES Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001512AM21 RA File Number 342404000111 AM21 Licence No and 3410046259/29/07/2020

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Date

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Jan/202021/4 dated 12.02.2021 against advance authorization No. 3410045217 dated 18.06.2019 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export Product	Qty	Sl. No.	Import Items	Qty
Rose Oxide (Tetrahydro-4-Methyl -2-(2-Methyl Propenyl) 2 H Pyron	1 kg	1	Citral Synthetic	3.454 kg

Case No. 72 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name MATRIX LIFE SCIENCE PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001513AM21 RA File Number 039504000239 AM21 Licence No and 0310837496/30/07/2020 Date

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:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Sl. No.<br>Export product<br>Qty.<br>1<br>Phytosterol Natural Refined Phytosterol 95%<br>120000.000 kg<br>2<br>Natural Mixed Tocopherol 70%<br>55000.000 kg	Sl. No.<br>Export product<br>Qty.<br>1<br>Phytosterol Natural Refined Phytosterol 95%<br>120000.000 kg<br>2<br>Natural Mixed Tocopherol 70%<br>55000.000 kg	Sl. No.<br>Export product<br>Qty.<br>1<br>Phytosterol Natural Refined Phytosterol 95%<br>120000.000 kg<br>2<br>Natural Mixed Tocopherol 70%<br>55000.000 kg
Sl. No.<br>I	mport items	Qty.
1<br>	Fatty Acid Distillate / Deoderised Distillate	1842500 kg
2<br>	Acetone	88000 kg
3<br>	Heptane-S	188100 kg

Case No. 73 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name DR.REDDY'S LABORATORIES LTD Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

HQ File Number	018205001524AM21
RA File Number	092404000239 AM21
Licence No and<br>Date	0910069013/31/07/2020

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.
Ibuclin Cold & Flu Max powder for oral solution -	<br>9056250.000	1	Ascorbic Acid	554.240 kg
Lemon flavour (Each Sachet contains Paracetamol
750 mg, Phenylephrine Hydrochloride 10 mg and	<br>Number		THIS LICENCE IS ISSUED WITH PRIOR IMPORT CONDITON AND
Ascorbic acid 60 mg)			THE E.O. SHOULD BE COMPLETED WITHIN 12 MONTHS FROM
			THE DATE OF EACH IMPORT CONSIGNMENT AS PER APPX.4J OF
			FTP 2015-20, read with PN.No.62, dt.24.03.2017 read with PN.No.62,
			dt.24.03.2017

Case No.	74 / NC/3/MEET/Oct/202122/9
Case Status	Case Approved
Party Name	CADILA HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021
HQ File Number	018205001516AM21
RA File Number	082404000110 AM21
Licence No and	0810148274/04/08/2020

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Date

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Aug/202122/7 dated 13.08.2021 against advance authorization No. 0810143923 dated 20.11.2018 , 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:

Date	Date	Date
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Aug/202122/7 dated 13.08.2021against<br>advance authorization No.0810143923 dated 20.11.2018, 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,<br>whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>AZITHROMYCIN DIHYDRATE USP (This Licence is<br>issued with condition that import of any Drug against this<br>Licence will<br>be allowed through Registered Sources as per provision laid<br>down in Drug & Cosmetic Act. and as per Para 4.07 of HBP<br>2015-20 subject to fixation of norms by ALC, New Delhi)<br>330.12 mg<br>1<br>AZITHROMYCIN<br>ORAL<br>SUSPENSION<br>USP<br>100MG/5ML (300MG/15ML BOTTLE)<br>(ACTIVE<br>INGREDIENT:<br>AZITHROMYCIN<br>DIHYDRATE USP - NET WEIGHT 106.078 KGS.)<br>1 Number<br>2<br>SUCROSE NF FINE GRADE (COMPRESSUC PS)<br>11616.00 mg<br>1<br>AZITHROMYCIN DIHYDRATE USP (This Licence is<br>issued with condition that import of any Drug against this<br>Licence will<br>be allowed through Registered Sources as per provision laid<br>down in Drug & Cosmetic Act. and as per Para 4.07 of HBP<br>2015-20 subject to fixation of norms by ALC, New Delhi)<br>660.24 mg<br>2<br>AZITHROMYCIN<br>ORAL<br>SUSPENSION<br>USP<br>200MG/5ML (600MG/15ML BOTTLE)<br>(ACTIVE<br>INGREDIENT:<br>AZITHROMYCIN<br>DIHYDRATE USP - NET WEIGHT 424.315 KGS.)<br>1 Number<br>2<br>SUCROSE NF FINE GRADE (COMPRESSUC PS)<br>11616.00 mg<br>1<br>AZITHROMYCIN DIHYDRATE USP (This Licence is<br>issued with condition that import of any Drug against this<br>Licence will<br>be allowed through Registered Sources as per provision laid<br>down in Drug & Cosmetic Act. and as per Para 4.07 of HBP<br>2015-20 subject to fixation of norms by ALC, New Delhi)<br>990.36 mg<br>3<br>AZITHROMYCIN<br>ORAL<br>SUSPENSION<br>USP<br>200MG/5ML (900MG/22.5ML BOTTLE)<br>(ACTIVE<br>INGREDIENT:<br>AZITHROMYCIN<br>DIHYDRATE USP - NET WEIGHT 446.378 KGS.)<br>1 Number<br>2<br>SUCROSE NF FINE GRADE (COMPRESSUC PS)<br>17424.00 mg
	Sl. No.	Export product	Qty.	Sl. No.	Import items	Qty.
	1	AZITHROMYCIN<br>ORAL<br>SUSPENSION<br>USP<br>100MG/5ML (300MG/15ML BOTTLE)<br>(ACTIVE<br>INGREDIENT:<br>AZITHROMYCIN<br>DIHYDRATE USP - NET WEIGHT 106.078 KGS.)	<br> <br>1 Number	1	AZITHROMYCIN DIHYDRATE USP (This Licence is<br>issued with condition that import of any Drug against this<br>Licence will<br>be allowed through Registered Sources as per provision laid<br>down in Drug & Cosmetic Act. and as per Para 4.07 of HBP<br>2015-20 subject to fixation of norms by ALC, New Delhi)	<br> <br> <br> <br>330.12 mg
				2	SUCROSE NF FINE GRADE (COMPRESSUC PS)	11616.00 mg
	2	AZITHROMYCIN<br>ORAL<br>SUSPENSION<br>USP<br>200MG/5ML (600MG/15ML BOTTLE)<br>(ACTIVE<br>INGREDIENT:<br>AZITHROMYCIN<br>DIHYDRATE USP - NET WEIGHT 424.315 KGS.)	<br> <br>1 Number	1	AZITHROMYCIN DIHYDRATE USP (This Licence is<br>issued with condition that import of any Drug against this<br>Licence will<br>be allowed through Registered Sources as per provision laid<br>down in Drug & Cosmetic Act. and as per Para 4.07 of HBP<br>2015-20 subject to fixation of norms by ALC, New Delhi)	<br> <br> <br> <br>660.24 mg
				2	SUCROSE NF FINE GRADE (COMPRESSUC PS)	11616.00 mg
	3	AZITHROMYCIN<br>ORAL<br>SUSPENSION<br>USP<br>200MG/5ML (900MG/22.5ML BOTTLE)<br>(ACTIVE<br>INGREDIENT:<br>AZITHROMYCIN<br>DIHYDRATE USP - NET WEIGHT 446.378 KGS.)	<br> <br>1 Number	1	AZITHROMYCIN DIHYDRATE USP (This Licence is<br>issued with condition that import of any Drug against this<br>Licence will<br>be allowed through Registered Sources as per provision laid<br>down in Drug & Cosmetic Act. and as per Para 4.07 of HBP<br>2015-20 subject to fixation of norms by ALC, New Delhi)	<br> <br> <br> <br>990.36 mg
				2	SUCROSE NF FINE GRADE (COMPRESSUC PS)	17424.00 mg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

1<br>AZITHROMYCIN DIHYDRATE USP (This Licence is<br>issued with condition that import of any Drug against this<br>Licence will<br>be allowed through Registered Sources as per provision laid<br>down in Drug & Cosmetic Act. and as per Para 4.07 of HBP<br>2015-20 subject to fixation of norms by ALC, New Delhi)<br>1320.48 mg<br>4<br>AZITHROMYCIN<br>ORAL<br>SUSPENSION<br>USP<br>200MG/5ML (1200MG/30ML BOTTLE)<br>(ACTIVE<br>INGREDIENT:<br>AZITHROMYCIN<br>DIHYDRATE USP - NET WEIGHT 463.958 KGS.)<br>1 Number<br>2<br>SUCROSE NF FINE GRADE (COMPRESSUC PS)<br>23232.00 mg<br>RA concerned may take further necessary action as per above decision of NC.	4	AZITHROMYCIN<br>ORAL<br>SUSPENSION<br>USP<br>200MG/5ML (1200MG/30ML BOTTLE)<br>(ACTIVE<br>INGREDIENT:<br>AZITHROMYCIN<br>DIHYDRATE USP - NET WEIGHT 463.958 KGS.)	<br> <br>1 Number	1	AZITHROMYCIN DIHYDRATE USP (This Licence is<br>issued with condition that import of any Drug against this<br>Licence will<br>be allowed through Registered Sources as per provision laid<br>down in Drug & Cosmetic Act. and as per Para 4.07 of HBP<br>2015-20 subject to fixation of norms by ALC, New Delhi)	<br> <br> <br> <br>1320.48 mg
				2	SUCROSE NF FINE GRADE (COMPRESSUC PS)	23232.00 mg

Case No. 75 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name ORTIN LABORATORIES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001532AM21 RA File Number 092404000197 AM21 Licence No and 0910069018/05/08/2020 Date Norms Committee Decision: Deferred for comments of TE.

Case No. 76 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name SHARON BIO-MEDICINE LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001518AM21 RA File Number 039504000269 AM21 Licence No and 0310837562/07/08/2020 Date

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.
Diarrhoea Relief Instant 2 mg Orodispersible Tablets Loperamide 2	<br>1 Number Tablet	1	PHARMABURST B1	184.00 mg
mg Fast Melt Tablets each Tablet contains Pharmaburst 188.6 mg
108790 packs 36s equal to 3946152 Tablets

Case No. 77 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name AVIEUM LIFE SCIENCES PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001521AM21 RA File Number 318304000035 AM21 Licence No and 3110067807/07/08/2020 Date Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, 7/82-ALC4/2020 dated 04.12.2020, followed by Reminder to firm on 16.10.2020. Reply still awaited from the firm.

Case No. 78 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name SHIVA BIOCHEM INDUSTRIES Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001522AM21 RA File Number 502404000009 AM21 Licence No and 5010002703/07/08/2020 Date

i. COA of import item from foreign supplier indicating percentage moisture content.
ii. Complete specification of export item.

Process of manufacturing indicating wastage at each stage of manufacturing.

Case No. 79 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Party Name R.L.FINE CHEM PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001526AM21 RA File Number 072404000129 AM21 Licence No and 0710116853/10/08/2020 Date

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, 7/82-ALC4/2020 dated 04.12.2020, followed by Reminder to firm on 16.10.2020. Reply still awaited from the firm.

Case No. 80 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name KOSHA CHEMTECH PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001528AM21 RA File Number 039404000306 AM21 Licence No and 0310837580/10/08/2020 Date Norms Committee Decision:

i. Complete chemical reaction with molecular and structural formula and molecular weights alongwith stagewise percentage yield on molar basis.
ii. Stoichiometric balance details for the entire manufacturing process.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Production / Consumption data for last two years duly certified by Central Excise / GST.

Case No. 81 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name INDOCO REMEDIES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001529AM21 RA File Number 039404000310 AM21 Licence No and 0310837582/10/08/2020 Date

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.
Ciprofloxacin and Dexamethasone Otic Suspension USP ( 0.3% - 0.1% )	<br>12,00,000	1	Ciprofloxacin HCL	31.05 kg
7.5ml Bottle. (Each ml Contains: CIPROFLOXACIN HCL Equivalent to	<br>Number
CIPROFLOXACIN BASE 3mg & DEXAMETHASONE 1mg ) per<br>bottle of 7.5ml) (Each 7.5 ml Cont.: Ciprofloxacin 22.5mg &	<br>	2	Dexamethasone	9.45 kg
Dexamethasone 7.5 mg) Nt.wt Ciprofloxacin HCL 27 kgs &
Dexamethasone 9 kgs.		3	Ear Drop Bottle	Relevant as per packing policy
		4	Ear Drop Caps	Relevant as per packing policy
		5	Ear Drop Insert	Relevant as per packing policy

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 82 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name VENOR PHARMA LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001539AM21 RA File Number 052404000223 AM21 Licence No and 0510414876/11/08/2020 Date

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.
Inj. Norepinephrine Bitartrate 2mg eq. to Norepinephrine 1mg/ml, 4ml<br>Ampoule	<br>1 Number	1	Noradrenaline Bitartrate<br>(Norepinephrine Bitartrate)	8.80 mg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 83 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name OPTRIX LABORATORIES PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001568AM21 RA File Number 092404000262 AM21 Licence No and 0910069046/17/08/2020 Date

Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, 7/82-ALC4/2020 dated 04.12.2020, followed by Reminder to firm on 16.10.2020. Reply still awaited from the firm.

Case No. 84 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name INNOVARE LABS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001569AM21 RA File Number 092404000263 AM21 Licence No and 0910069049/18/08/2020 Date Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, 7/82-ALC4/2020 dated 04.12.2020, followed by Reminder to firm on 16.10.2020. Reply still awaited from the firm.

Case No. 85 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name NITIKA PHARMACEUTICAL SPECIALITIES PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001546AM21 RA File Number 502404000011 AM21 Licence No and 5010002710/18/08/2020 Date

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, 7/82-ALC4/2020 dated 04.12.2020, followed by Reminder to firm on 16.10.2020. Reply still awaited from the firm.

Case No. 86 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Party Name AURA LIFECARE PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001558AM21 RA File Number 342404000133 AM21 Licence No and 3410046298/18/08/2020 Date

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, 7/82-ALC4/2020 dated 04.12.2020, followed by Reminder to firm on 16.10.2020. Reply still awaited from the firm.

Case No. 87 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name SRF LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001563AM21 RA File Number 052404000225 AM21 Licence No and 0510414951/20/08/2020 Date

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, 7/82-ALC4/2020 dated 04.12.2020, followed by Reminder to firm on 16.10.2020. Reply still awaited from the firm.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 88 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name PIRAMAL ENTERPRISES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001565AM21 RA File Number 039504000288 AM21 Licence No and 0310837797/20/08/2020 Date Norms Committee Decision: The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Jan/202021/4 dated 12.02.2021 against advance authorization No. 0310835077 dated 26.02.2020 , 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:

Sl. No.	Export Product	Qty.
1	Atorvastatin Calcium Tablets USP 10mg (Pack Size 90 tabs) (Net wt. of Import Sr. No. 1	1 Number Tablet
	is 1454.336 kgs, Sr. No. 2 is 8054.601 kg, Sr. No. 3 is 2287.27 kg, Sr. No. 4 is 1466227 Nos., Sr. No. 8 is 1466227 Nos.)
2	Atorvastatin Calcium Tablets USP 10mg (Pack Size 1000 tabs) (Net wt. of Import Sr. No. 1	1 Number Tablet
	is 1869.856 kgs, Sr. No. 2 is 10355.890 kg, Sr. No. 3 is 2940.769 kg, Sr. No. 5 is 169663 Nos., Sr. No. 9 is 169663 Nos.)
3	Atorvastatin Calcium Tablets USP 20mg (Pack Size 90 tabs) (Net wt. of Import Sr. No. 1	1 Number Tablet
	is 301.168 kgs, Sr. No. 2 is 1673.870 kg, Sr. No. 3 is 475.075 kg, Sr. No. 4 is 151815 Nos., Sr. No. 8 is 151815 Nos.)

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

4	Atorvastatin Calcium Tablets USP 40mg (Pack Size 90 tabs) (Net wt. of Import Sr. No. 1	1 Number Tablet
	is 8102.726 kgs, Sr. No. 2 is 44878.925 kg, Sr. No. 3 is 12744.093 kg, Sr. No. 4 is 2042244 Nos., Sr. No. 8 is 2042244 Nos.)
5	Atorvastatin Calcium Tablets USP 80mg (Pack Size 90 tabs) (Net wt. of Import Sr. No. 1	1 Number Tablet
	is 3324.196 kgs, Sr. No. 2 is 18500.438 kg, Sr. No. 3 is 5249.650 kg, Sr. No. 6 is 418922 Nos., Sr. No. 8 is 418922 Nos.)
6	Atorvastatin Calcium Tablets USP 80mg (Pack Size 1000 tabs) (Net wt. of Import Sr. No. 1	1 Number Tablet
	is 3843.596 kgs, Sr. No. 2 is 21391.096 kg, Sr. No. 3 is 6069.90kg, Sr. No. 7 is 43594 Nos., Sr. No. 10 is 43594 Nos.)

Sl. No.	Import Item	For export of 1 Number Tablet<br>(All Qty. in mg)	For export of 1 Number Tablet<br>(All Qty. in mg)	For export of 1 Number Tablet<br>(All Qty. in mg)	For export of 1 Number Tablet<br>(All Qty. in mg)
		10 mg	20 mg	40 mg	80 mg
1	Atorvastatin Calcium Propylene Glycol Solvate USP	11.241	22.483	44.965	89.931
2	Microcrystalline Cellulose (MCC) NF (Avicel PH 102)	61.038	122.508	244.170	488.340
3	Calcium Acetate	17.333	34.770	69.336	138.672
4	Plastic Bottles 75CC white HDPE Round 38mm	<br>Relevant as per packing policy
5	250cc Rnd White 53/400 Hdpe Sclair 58a (Plastic Bottles<br>250CC white HDPE Round 38mm)
6	Plastic Bottles 120CC white HDPE Round 38mm

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

7	1500cc Round Extrusion 89/400 Neck White	(Plastic
	Bottles 1500CC white HDPE Round 38mm)
8	CR38400APJT865<br>BLUE<br>PP465<br>1400	(Plastics
	Caps/Closures PP 38MM-400 Blue CR)
9	Blue 53mm Pp Cap Lp-E & Triseal F217hy	(Plastics
	Caps/Closures PP 53MM-400 Blue PP)
10	CC8940AFS837 WHITE PP551 CT 89 400SP	(Plastics
	Caps/Closures PP 89MM-400 White Plain)

Case No. 89 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name FDC LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001567AM21 RA File Number 039404000362 AM21 Licence No and 0310837815/20/08/2020 Date

Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, 7/82-ALC4/2020 dated 04.12.2020, followed by Reminder to firm on 16.10.2020. Reply still awaited from the firm.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 90 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name AURORE LIFE SCIENCES PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001571AM21 RA File Number 092404000264 AM21 Licence No and 0910069070/20/08/2020 Date

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.
Valaciclovir Hydrochloride	1 kg	1	Acyclovir	0.758 kg
		2	N,N-Dicyclohexyal Carbodimide (DCC)	1.061 kg
		3	Dimethyl Formamide (DMF)	3.515 kg
		4	CBZ L-Valine	1.112 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 91 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name THERAPIVA PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001572AM21 RA File Number 092404000250 AM21 Licence No and 0910069090/24/08/2020 Date Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, 7/82-ALC4/2020 dated 04.12.2020, followed by Reminder to firm on 16.10.2020. Reply still awaited from the firm.

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

Case No. 92 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name HIKAL LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001573AM21

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

RA File Number 039404000344 AM21 Licence No and 0310837840/24/08/2020

Date

Norms Committee Decision:

Complete technical details as per Annexure to Appendix 4E.

Whether BPPA is indigenous or to be imported, as it is shown indigenous under Appendix 4E.

Case No. 93 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name BRAWN LABORATORIES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001574AM21 RA File Number 052304000115 AM21 Licence No and 0510414997/25/08/2020 Date

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.
SOMATOSTATIN FOR INJECTION 3MG VIAL (WHITE LYOPHILIZED	<br>1 Vial	1	SOMATOSTATIN BP				3.30 mg
POWDER/CAKE FILLED IN A CLEAR GLASS TUBULAR VIALS)
			(WHITE	OR	ALMOST	WHITE,

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

HYGROSCOPIC, AMORPHOUS POWDER)

Case No. 94 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name OPTRIX LABORATORIES PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001575AM21 RA File Number 092404000047 AM21 Licence No and 0910069097/25/08/2020 Date

Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, 7/82-ALC4/2020 dated 04.12.2020, followed by Reminder to firm on 16.10.2020. Reply still awaited from the firm.

Case No. 95 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name OPTRIX LABORATORIES PRIVATE LIMITED

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001576AM21 RA File Number 092404000042 AM21 Licence No and 0910069098/25/08/2020 Date

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, 7/82-ALC4/2020 dated 04.12.2020, followed by Reminder to firm on 16.10.2020. Reply still awaited from the firm.

Case No. 96 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name MEDREICH LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001578AM21 RA File Number 072404000144 AM21 Licence No and 0710116931/26/08/2020 Date 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.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

1<br>Ferrous Sulphate Pellets 18/25<br>324.00 mg<br>Sustained Release Capsules of Ferrous Sulphate with Folic<br>Acid [FEFOL 270mg/0.3mg] [11820000 NO] Each spansule<br>capsule contains Dried Ferrous Sulphate BP 270mg [in time<br>release form] Folic Acid 0.3mg] [Iron 270mg/Folic Acid<br>0.3mg Capsules]<br>1 Number<br>2<br>Folic Acid Pellets 18/25<br>90.00 mg<br>RA concerned may take further necessary action as per above decision of NC.	Sustained Release Capsules of Ferrous Sulphate with Folic<br>Acid [FEFOL 270mg/0.3mg] [11820000 NO] Each spansule<br>capsule contains Dried Ferrous Sulphate BP 270mg [in time<br>release form] Folic Acid 0.3mg] [Iron 270mg/Folic Acid<br>0.3mg Capsules]	<br> <br> <br> <br>1 Number	1	Ferrous Sulphate Pellets 18/25	324.00 mg
			2	Folic Acid Pellets 18/25	90.00 mg

Case No.	97 / NC/3/MEET/Oct/202122/9
Case Status	Case Rejected
Party Name	VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021
HQ File Number	018205001584AM21
RA File Number	318304000048 AM21
Licence No and<br>Date	3110067835/27/08/2020
Norms Committee	Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, 7/82-ALC4/2020 dated 04.12.2020, followed by Reminder to firm on 16.10.2020. Reply still awaited from the firm.

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

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 98 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name BIOLOGICAL E. LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001585AM21 RA File Number 092404000253 AM21 Licence No and 0910069107/27/08/2020 Date Norms Committee Decision:

Deferred for comments of Department of Biotechnology (DBT).

Case No. 99 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001589AM21 RA File Number 072404000145 AM21 Licence No and 0710116940/28/08/2020 Date

i. Mesh size of Export Product.

Production / Consumption data for last one year duly certified by GST.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 100 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name MANGALAM DRUGS AND ORGANICS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001586AM21 RA File Number 039504000299 AM21 Licence No and 0310837947/28/08/2020 Date Norms Committee Decision: Deferred for comments of TE.

Case No. 101 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name GLOBAL CALCIUM PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001588AM21 RA File Number 072404000146 AM21 Licence No and 0710116939/28/08/2020 Date Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm: Complete technical details as per Annexure to Appendix 4E.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 102 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name ASTEC LIFESCIENCES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001603AM21 RA File Number 039404000388 AM21 Licence No and 0310838005/31/08/2020 Date Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, 7/82-ALC4/2020 dated 04.12.2020, followed by Reminder to firm on 16.10.2020. Reply still awaited from the firm.

Case No. 103 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name DHANUKA LABORATORIES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001604AM21 RA File Number 052304000157 AM21 Licence No and 0510415066/31/08/2020 Date Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Deferred for comments of TE.

Case No. 104 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name CADILA HEALTHCARE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001605AM21 RA File Number 082404000157 AM21 Licence No and 0810148453/01/09/2020 Date

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	CLOBETASOL PROPIONATE OINTMENT USP 0.05%, 15 GM	<br>53330.000 Number	1	CLOBETASOL PROPIONATE USP (THIS	407.975 gram
	(EACH GRAM CONTAIN 0.5 MG OF CLOBETASOL			LICENCE IS ISSUED WITH CONDITION
	PROPIONATE USP) (ACTIVE INGREDIENT: CLOBETASOL			THAT IMPORT OF ANY DRUG AGAINST
	PROPIONATE USP - NET WT. 399.975 GMS. & RELEVENT			THIS<br>LICENSE<br>WILL<br>BE<br>ALLOWED
	PACKING MATERIAL IN FINISHED FORM - NET NOS.			THROUGH REGISTERED SOURCES AS PER
	53330)			PROVISION LAID DOWN IN DRUG &
				COSMETIC ACT AND AS PER PARA 4.07 OF
				HBP 2015-20 SUBJECT TO FIXATION OF
				NORMS BY ALC, NEW DELHI)
			3	AL TUBE FOR CLOBETASOL PROPIONATE	Relevant as per packing policy
				~~Signature Not Verified~~

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

							OINTMENT USP 0.05%, 15 GM<br>(AS PER GENERAL POLICY FOR PACKING<br>MATERIAL, WASTAGE ALLOWED @ 1%<br>ON NET QUANTITY)	OINTMENT USP 0.05%, 15 GM<br>(AS PER GENERAL POLICY FOR PACKING<br>MATERIAL, WASTAGE ALLOWED @ 1%<br>ON NET QUANTITY)
					<br>		CLOBETASOL PROPIONATE USP (THIS<br>LICENCE IS ISSUED WITH CONDITION<br>THAT IMPORT OF ANY DRUG AGAINST<br>THIS<br>LICENSE<br>WILL<br>BE<br>ALLOWED<br>THROUGH REGISTERED SOURCES AS PER<br>PROVISION LAID DOWN IN DRUG &<br>COSMETIC ACT AND AS PER PARA 4.07 OF<br>HBP 2015-20 SUBJECT TO FIXATION OF<br>NORMS BY ALC, NEW DELHI)		3059.510 gram
	2	CLOBETASOL PROPIONATE OINTMENT USP 0.05%, 30 GM<br>(EACH GRAM CONTAIN 0.5 MG OF CLOBETASOL<br>PROPIONATE USP) (ACTIVE INGREDIENT: CLOBETASOL<br>PROPIONATE USP - NET WT. 2999.520 GMS. & RELEVENT<br>PACKING MATERIAL IN FINISHED FORM - NET NOS.<br>199968)			<br> <br> <br> <br> <br>199968.000<br>Number	1	CLOBETAS<br>LICENCE I<br>THAT IMPO<br>THIS<br>LICE<br>THROUGH<br>PROVISION<br>COSMETIC<br>HBP 2015-2<br>NORMS BY
									Relevant as per packing policy
						4

	3	CLO	BETASOL PROPIONATE OINTMENT USP 005	% 45 GM	<br>35546000 Number	1	CLOBETAS	OL PROPIONATE USP (THIS<br>S ISSUED WITH CONDITION<br>RT OF ANY DRUG AGAINST<br>NSE<br>WILL<br>BE<br>ALLOWED<br>REGISTERED SOURCES AS PER<br>LAID DOWN IN DRUG &<br>ACT AND AS PER PARA 4.07 OF<br>0 SUBJECT TO FIXATION OF<br>ALC, NEW DELHI)	815.780 gram
		<br>(EA	.<br>CH GRAM CONTAIN 0.5 MG OF CLO	,<br>BETASOL	<br> <br>.		<br>LICENCE I
		PRO<br>PRO<br>	PIONATE USP) (ACTIVE INGREDIENT: CLO<br>PIONATE USP - NET WT. 799.785 GMS. & R<br>	BETASOL<br>ELEVENT<br>	<br> <br>		THAT IMPO<br>THIS<br>LICE<br>
		PAC<br>3554	KING MATERIAL IN FINISHED FORM -<br>6)	ET NOS.			THROUGH<br>PROVISION
							COSMETIC
							HBP 2015-2<br>NORMS BY

						5	AL TUBE F<br>OINTMENT<br>(AS PER GE<br>MATERIAL,<br>ON NET QU	OR CLOBETASOL PROPIONATE<br>USP 0.05%, 45 GM<br>NERAL POLICY FOR PACKING<br>WASTAGE ALLOWED @ 1%<br>ANTITY)	Relevant as per packing policy

									2651.43 gram
	4	CLOBETASOL PROPIONATE OINTMENT USP 0.05%, 60 GM<br>(EACH GRAM CONTAIN 0.5 MG OF CLOBETASOL			<br> <br>86648.000 Number	1<br>
ment has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 03-Nov-2021.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 03-Nov-2021 12:58:18<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified
ment has been digital			y signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 03-Nov-2021.<br>Name: Ajay Kumar( Depu<br>Date: 03-Nov-2021 12:58:<br>Reason: AJAYDHIMAN8
				.<br>Location: DGFT(HQ)

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

		PROPIONATE USP) (ACTIVE INGREDIENT: CLOBETASOL<br>PROPIONATE USP - NET WT. 2599.440 GMS. & RELEVENT<br>PACKING MATERIAL IN FINISHED FORM - NET NOS.<br>86648)	<br> <br> <br>		THAT IMPORT OF ANY DRUG AGAINST<br>THIS<br>LICENSE<br>WILL<br>BE<br>ALLOWED<br>THROUGH REGISTERED SOURCES AS PER<br>PROVISION LAID DOWN IN DRUG &<br>COSMETIC ACT AND AS PER PARA 4.07 OF<br>HBP 2015-20 SUBJECT TO FIXATION OF<br>NORMS BY ALC, NEW DELHI)
				6	AL TUBE FOR CLOBETASOL PROPIONATE<br>OINTMENT USP 0.05%, 60 GM<br>(AS PER GENERAL POLICY FOR PACKING<br>MATERIAL, WASTAGE ALLOWED @ 1%<br>ON NET QUANTITY)	Relevant as per packing policy
	5	CLOBETASOL PROPIONATE CREAM USP 0.05%, 15 GM<br>(EACH GRAM CONTAIN 0.5 MG OF CLOBETASOL<br>PROPIONATE USP) (ACTIVE INGREDIENT: CLOBETASOL<br>PROPIONATE USP - NET WT. 1999.875 GMS. & RELEVENT<br>PACKING MATERIAL IN FINISHED FORM - NET NOS.<br>266650)	<br> <br> <br> <br> <br>266650.000<br>Number	1	CLOBETASOL PROPIONATE USP (THIS<br>LICENCE IS ISSUED WITH CONDITION<br>THAT IMPORT OF ANY DRUG AGAINST<br>THIS<br>LICENSE<br>WILL<br>BE<br>ALLOWED<br>THROUGH REGISTERED SOURCES AS PER<br>PROVISION LAID DOWN IN DRUG &<br>COSMETIC ACT AND AS PER PARA 4.07 OF<br>HBP 2015-20 SUBJECT TO FIXATION OF<br>NORMS BY ALC, NEW DELHI)	2040.00 gram
				7	AL TUBE FOR CLOBETASOL PROPIONATE<br>CREAM USP 0.05%, 15 GM<br>(AS PER GENERAL POLICY FOR PACKING<br>MATERIAL, WASTAGE ALLOWED @ 1%<br>ON NET QUANTITY)	Relevant as per packing policy
	6	CLOBETASOL PROPIONATE CREAM USP 0.05%, 30 GM<br>(EACH GRAM CONTAIN 0.5 MG OF CLOBETASOL<br>PROPIONATE USP) (ACTIVE INGREDIENT: CLOBETASOL<br>PROPIONATE USP - NET WT. 1199.760 GMS. & RELEVENT<br>PACKING MATERIAL IN FINISHED FORM - NET NOS.<br>79984)	<br> <br> <br> <br> <br>79984.000 Number	1<br>	CLOBETASOL PROPIONATE USP (THIS<br>LICENCE IS ISSUED WITH CONDITION<br>THAT IMPORT OF ANY DRUG AGAINST<br>THIS<br>LICENSE<br>WILL<br>BE<br>ALLOWED<br>THROUGH REGISTERED SOURCES AS PER<br>PROVISION LAID DOWN IN DRUG &<br>COSMETIC ACT AND AS PER PARA 4.07 OF<br>HBP 2015-20 SUBJECT TO FIXATION OF<br>	1223.76 gram
ment has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 03-Nov-2021.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 03-Nov-2021 12:58:18<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>~~Signature Not Verified~~

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

							NORMS BY ALC, NEW DELHI)	NORMS BY ALC, NEW DELHI)
						8	AL TUBE FOR CLOBETASOL PROPIONATE<br>CREAM USP 0.05%, 30 GM<br>(AS PER GENERAL POLICY FOR PACKING<br>MATERIAL, WASTAGE ALLOWED @ 1%<br>ON NET QUANTITY)		Relevant as per packing policy
							MATERIAL,<br>ON NET QU



	7	CLO	BETASOL PROPIONATE CREAM USP 0.05%, 45 GM		<br>26658.000 Number	1	CLOBETAS	OL PROPIONATE USP (THIS<br>S ISSUED WITH CONDITION<br>RT OF ANY DRUG AGAINST<br>NSE<br>WILL<br>BE<br>ALLOWED<br>REGISTERED SOURCES AS PER<br>LAID DOWN IN DRUG &<br>ACT AND AS PER PARA 4.07 OF<br>0 SUBJECT TO FIXATION OF<br>ALC, NEW DELHI)	611.80 gram
		(EAC<br>	H GRAM CONTAIN 0.5 MG OF CLOBETASOL<br>		<br>		LICENCE I<br>
		PRO<br>PRO	PIONATE USP) (ACTIVE INGREDIENT: CLOBETASOL<br>PIONATE USP - NET WT 599805 GMS & RELEVENT		<br>		THAT IMP<br>THIS<br>LIC
		<br>PAC<br>2665	. . .<br>KING MATERIAL IN FINISHED FORM - NET NOS.<br>8)		<br>		<br> <br>THROUGH<br>PROVISION
							COSMETIC<br>HBP 2015-2<br>NORMS BY
						9	AL TUBE F<br>CREAM USP<br>(AS PER GE<br>MATERIAL,<br>ON NET QU		Relevant as per packing policy

	8	CLOBETASOL PROPIONATE CREAM USP 0.05%, 60 GM<br>(EACH GRAM CONTAIN 0.5 MG OF CLOBETASOL<br>PROPIONATE USP) (ACTIVE INGREDIENT: CLOBETASOL<br>PROPIONATE USP - NET WT. 6198.840 GMS. & RELEVENT			<br> <br> <br> <br>206628.000<br>Number	1	CLOBETASOL PROPIONATE USP (THIS<br>LICENCE IS ISSUED WITH CONDITION<br>THAT IMPORT OF ANY DRUG AGAINST<br>THIS<br>LICENSE<br>WILL<br>BE<br>ALLOWED<br>THROUGH REGISTERED SOURCES AS PER<br>PROVISION LAID DOWN IN DRUG &<br>COSMETIC ACT AND AS PER PARA 4.07 OF<br>HBP 2015-20 SUBJECT TO FIXATION OF<br>NORMS BY ALC, NEW DELHI)		6322.82 gram
		PAC	KING MATERIAL IN FINISHED FORM - NET NOS.				THROUGH
		2066	28)				PROVISION<br>
							COSMETIC<br>HBP 2015-2
							NORMS BY
						10	AL TUBE F	OR CLOBETASOL PROPIONATE	Relevant as per packing policy

ment has been digitall			y signed by AJAY KUMAR Deputy DirectorDGFT(H	Q) on 03-Nov-2021.<br>Digitally Signed.<br>Nm: A Kmr D<br>Signature Not V				ty Director )<br>18<br>8@GOV.IN<br>erified
, ,

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

							CREAM USP 0.05%, 60 GM<br>(AS PER GENERAL POLICY FOR PACKING<br>MATERIAL, WASTAGE ALLOWED @ 1%<br>ON NET QUANTITY)	CREAM USP 0.05%, 60 GM<br>(AS PER GENERAL POLICY FOR PACKING<br>MATERIAL, WASTAGE ALLOWED @ 1%<br>ON NET QUANTITY)
					<br>		CLOBETASOL PROPIONATE USP (THIS<br>LICENCE IS ISSUED WITH CONDITION<br>THAT IMPORT OF ANY DRUG AGAINST<br>THIS<br>LICENSE<br>WILL<br>BE<br>ALLOWED<br>THROUGH REGISTERED SOURCES AS PER<br>PROVISION LAID DOWN IN DRUG &<br>COSMETIC ACT AND AS PER PARA 4.07 OF<br>HBP 2015-20 SUBJECT TO FIXATION OF<br>NORMS BY ALC, NEW DELHI)		930.907 gram
	9	CLO<br>ML	BETASOL PROPIONATE LOTION 0.05%, 59 M<br>CONTAIN 0415 MG OF CLOBETASOL PRO	L (EACH<br>PIONATE	<br> <br>37274.000 Number	1	CLOBETAS<br>LICENCE I
		<br>USP<br>USP	.<br>) (ACTIVE INGREDIENT: CLOBETASOL PRO<br>- NET WT. 912.654 GMS. & RELEVENT	<br>PIONATE<br>PACKING	<br> <br>		<br>THAT IMPO<br>THIS<br>LICE
		MA	TERIAL IN FINISHED FORM - NET NOS. 37274)				THROUGH<br>
							PROVISION<br>COSMETIC
							HBP 2015-2<br>NORMS BY


						11	BOTTLE 6<br>COLOR<br>(AS PER GE<br>MATERIAL,<br>ON NET QU	0ML HDPE FLAT & WHITE<br>NERAL POLICY FOR PACKING<br>WASTAGE ALLOWED @ 1%<br>ANTITY)	Relevant as per packing policy
						13	WHITE DI<br>INDLINER		Relevant as per packing policy

							CLOBETASOL PROPIONATE USP (THIS<br>LICENCE IS ISSUED WITH CONDITION<br>THAT IMPORT OF ANY DRUG AGAINST<br>THIS<br>LICENSE<br>WILL<br>BE<br>ALLOWED<br>THROUGH REGISTERED SOURCES AS PER<br>PROVISION LAID DOWN IN DRUG &<br>COSMETIC ACT AND AS PER PARA 4.07 OF<br>HBP 2015-20 SUBJECT TO FIXATION OF<br>NORMS BY ALC, NEW DELHI)		1353.03 gram
			BETASOL PROPIONATE LOTION 0.05%, 118 ML (EACH<br>		<br> <br>27088.000 Number	1	CLOBETAS<br>
	10	CL<br>	BETASOL PROPIONATE LOTION 0.05%, 118<br>
		ML<br>USP	CONTAIN 0.415 MG OF CLOBETASOL PRO<br>) (ACTIVE INGREDIENT: CLOBETASOL PRO	PIONATE<br>PIONATE	<br>		LICENCE I<br>THAT IMPO
		<br>USP	<br>- NET WT. 1326.499 GMS. & RELEVENT	<br>PACKING	<br>		THIS<br>LICE
		MA	TERIAL IN FINISHED FORM - NET NOS. 27088)				THROUGH<br>PROVISION<br>COSMETIC
							<br>HBP 2015-2
							NORMS BY

						12	BOTTLE 12	0ML HDPE FLAT & WHITE<br>	Relevant as per packing policy
							COLOR<br>

ment has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 03-Nov-2021.<br>Digitally Signed.<br>Name: Ajay Kumar( Depu<br>Date: 03-Nov-2021 12:58:<br>Reason: AJAY.DHIMAN8<br>Location: DGFT(HQ)<br>Signature Not V								ty Director )<br>18<br>8@GOV.IN<br>erified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

				(AS PER GENERAL POLICY FOR PACKING<br>MATERIAL, WASTAGE ALLOWED @ 1%<br>ON NET QUANTITY)
			13	WHITE DISCTOP CAP 20MM-410 WITH<br>INDLINER<br>(AS PER GENERAL POLICY FOR PACKING<br>MATERIAL, WASTAGE ALLOWED @ 1%<br>ON NET QUANTITY)	Relevant as per packing policy
11	CLOBETASOL PROPIONATE SPRAY 0.05%, 59 ML (EACH<br>ML CONTAIN 0.415 MG OF CLOBETASOL PROPIONATE<br>USP) (ACTIVE INGREDIENT: CLOBETASOL PROPIONATE<br>USP - NET WT. 801.835 GMS. & RELEVENT PACKING<br>MATERIAL IN FINISHED FORM - NET NOS. 32748)	<br> <br> <br> <br>32748.000 Number	1	CLOBETASOL PROPIONATE USP (THIS<br>LICENCE IS ISSUED WITH CONDITION<br>THAT IMPORT OF ANY DRUG AGAINST<br>THIS<br>LICENSE<br>WILL<br>BE<br>ALLOWED<br>THROUGH REGISTERED SOURCES AS PER<br>PROVISION LAID DOWN IN DRUG &<br>COSMETIC ACT AND AS PER PARA 4.07 OF<br>HBP 2015-20 SUBJECT TO FIXATION OF<br>NORMS BY ALC, NEW DELHI)	817.88 gram
			2	UNDECYLENIC ACID USP	4811.00 gram
			14	PUMP+ACTUATOR FOR 75ML BOTTLE (AS<br>PER GENERAL POLICY FOR PACKING<br>MATERIAL, WASTAGE ALLOWED @ 1%<br>ON NET QUANTITY)	Relevant as per packing policy
12	CLOBETASOL PROPIONATE SPRAY 0.05%, 125 ML (EACH<br>ML CONTAIN 0.415 MG OF CLOBETASOL PROPIONATE<br>USP) (ACTIVE INGREDIENT: CLOBETASOL PROPIONATE<br>USP - NET WT. 601.335 GMS. & RELEVENT PACKING<br>MATERIAL IN FINISHED FORM - NET NOS. 11592)	<br> <br> <br> <br>11592.000 Number	1	CLOBETASOL PROPIONATE USP (THIS<br>LICENCE IS ISSUED WITH CONDITION<br>THAT IMPORT OF ANY DRUG AGAINST<br>THIS<br>LICENSE<br>WILL<br>BE<br>ALLOWED<br>THROUGH REGISTERED SOURCES AS PER<br>PROVISION LAID DOWN IN DRUG &<br>COSMETIC ACT AND AS PER PARA 4.07 OF<br>HBP 2015-20 SUBJECT TO FIXATION OF<br>NORMS BY ALC, NEW DELHI)	613.36 gram

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

2<br>UNDECYLENIC ACID USP<br>3608.00 gram<br>15<br>PUMP+ACTUATOR FOR 125ML BOTTLE<br>(AS PER GENERAL POLICY FOR PACKING<br>MATERIAL, WASTAGE ALLOWED @ 1%<br>ON NET QUANTITY)<br>Relevant as per packing policy<br>RA concerned may take further necessary action as per above decision of NC.				2	UNDECYLENIC ACID USP	3608.00 gram
				15	PUMP+ACTUATOR FOR 125ML BOTTLE<br>(AS PER GENERAL POLICY FOR PACKING<br>MATERIAL, WASTAGE ALLOWED @ 1%<br>ON NET QUANTITY)	Relevant as per packing policy

Case No. 105 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name SRF LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001608AM21 RA File Number 052404000258 AM21 Licence No and 0510415088/02/09/2020 Date Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, 7/82-ALC4/2020 dated 04.12.2020, followed by Reminder to firm on 16.10.2020. Reply still awaited from the firm.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 106 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name SHARP MINT LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001609AM21 RA File Number 052404000265 AM21 Licence No and 0510415091/02/09/2020 Date

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 4/82-ALC4/2020 dated 18.09.2020, 7/82-ALC4/2020 dated 04.12.2020, followed by Reminder to firm on 16.10.2020. Reply still awaited from the firm.

Case No. 107 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name SHITAL CHEMICAL INDUSTRIES Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001610AM21 RA File Number 342404000140 AM21 Licence No and 3410046347/02/09/2020 Date Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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.
CHLORO ACETYL CHLORIDE	1 kg	1	MONOCHLORO ACETIC ACID	0.884 kg

Case No. 108 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name CONCORD BIOTECH LTD Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001614AM21 RA File Number 082404000395 AM20 Licence No and 0810148478/03/09/2020 Date Norms Committee Decision: Deferred for comments of TE.

Case No. 109 / NC/3/MEET/Oct/202122/9 Case Status Case Approved

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Party Name VENOR PHARMA LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001613AM21 RA File Number 052404000255 AM21 Licence No and 0510415104/03/09/2020 Date

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	Inj. Labetalol HCL 5mg/ml, 20 ml Ampoule	1 Number	2	Labetalol HCL<br>(For Inj. Use)	105 mg /<br>Ampoule
2	Tab. Labetalol HCL 100 mg	1 Number	1	Labetalol HCL	102 mg / Tablet

Case No. 110 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name VENOR PHARMA LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001617AM21

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

RA File Number 052404000248 AM21 Licence No and 0510415116/04/09/2020 Date

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:

whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>1<br>Inj. Hydromorphone HCL2mg/ml, 1 ml Ampoule<br>500000.000<br>Number<br>1<br>2<br>Inj. Hydromorphone HCL1mg/ml, 1 ml Ampoule<br>100000.000<br>Number<br>1<br>3<br>Inj. Hydromorphone HCL4mg/ml, 1 ml Ampoule<br>10000.000 Number 1<br>4<br>Tab. Hydromorphone HCL2mg<br>500000.000<br>Number<br>1<br>5<br>Tab. Hydromorphone HCL4mg<br>500000.000<br>1	whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>1<br>Inj. Hydromorphone HCL2mg/ml, 1 ml Ampoule<br>500000.000<br>Number<br>1<br>2<br>Inj. Hydromorphone HCL1mg/ml, 1 ml Ampoule<br>100000.000<br>Number<br>1<br>3<br>Inj. Hydromorphone HCL4mg/ml, 1 ml Ampoule<br>10000.000 Number 1<br>4<br>Tab. Hydromorphone HCL2mg<br>500000.000<br>Number<br>1<br>5<br>Tab. Hydromorphone HCL4mg<br>500000.000<br>1	whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>1<br>Inj. Hydromorphone HCL2mg/ml, 1 ml Ampoule<br>500000.000<br>Number<br>1<br>2<br>Inj. Hydromorphone HCL1mg/ml, 1 ml Ampoule<br>100000.000<br>Number<br>1<br>3<br>Inj. Hydromorphone HCL4mg/ml, 1 ml Ampoule<br>10000.000 Number 1<br>4<br>Tab. Hydromorphone HCL2mg<br>500000.000<br>Number<br>1<br>5<br>Tab. Hydromorphone HCL4mg<br>500000.000<br>1	whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>1<br>Inj. Hydromorphone HCL2mg/ml, 1 ml Ampoule<br>500000.000<br>Number<br>1<br>2<br>Inj. Hydromorphone HCL1mg/ml, 1 ml Ampoule<br>100000.000<br>Number<br>1<br>3<br>Inj. Hydromorphone HCL4mg/ml, 1 ml Ampoule<br>10000.000 Number 1<br>4<br>Tab. Hydromorphone HCL2mg<br>500000.000<br>Number<br>1<br>5<br>Tab. Hydromorphone HCL4mg<br>500000.000<br>1	whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>1<br>Inj. Hydromorphone HCL2mg/ml, 1 ml Ampoule<br>500000.000<br>Number<br>1<br>2<br>Inj. Hydromorphone HCL1mg/ml, 1 ml Ampoule<br>100000.000<br>Number<br>1<br>3<br>Inj. Hydromorphone HCL4mg/ml, 1 ml Ampoule<br>10000.000 Number 1<br>4<br>Tab. Hydromorphone HCL2mg<br>500000.000<br>Number<br>1<br>5<br>Tab. Hydromorphone HCL4mg<br>500000.000<br>1	whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>1<br>Inj. Hydromorphone HCL2mg/ml, 1 ml Ampoule<br>500000.000<br>Number<br>1<br>2<br>Inj. Hydromorphone HCL1mg/ml, 1 ml Ampoule<br>100000.000<br>Number<br>1<br>3<br>Inj. Hydromorphone HCL4mg/ml, 1 ml Ampoule<br>10000.000 Number 1<br>4<br>Tab. Hydromorphone HCL2mg<br>500000.000<br>Number<br>1<br>5<br>Tab. Hydromorphone HCL4mg<br>500000.000<br>1	whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>1<br>Inj. Hydromorphone HCL2mg/ml, 1 ml Ampoule<br>500000.000<br>Number<br>1<br>2<br>Inj. Hydromorphone HCL1mg/ml, 1 ml Ampoule<br>100000.000<br>Number<br>1<br>3<br>Inj. Hydromorphone HCL4mg/ml, 1 ml Ampoule<br>10000.000 Number 1<br>4<br>Tab. Hydromorphone HCL2mg<br>500000.000<br>Number<br>1<br>5<br>Tab. Hydromorphone HCL4mg<br>500000.000<br>1	whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>1<br>Inj. Hydromorphone HCL2mg/ml, 1 ml Ampoule<br>500000.000<br>Number<br>1<br>2<br>Inj. Hydromorphone HCL1mg/ml, 1 ml Ampoule<br>100000.000<br>Number<br>1<br>3<br>Inj. Hydromorphone HCL4mg/ml, 1 ml Ampoule<br>10000.000 Number 1<br>4<br>Tab. Hydromorphone HCL2mg<br>500000.000<br>Number<br>1<br>5<br>Tab. Hydromorphone HCL4mg<br>500000.000<br>1	whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>1<br>Inj. Hydromorphone HCL2mg/ml, 1 ml Ampoule<br>500000.000<br>Number<br>1<br>2<br>Inj. Hydromorphone HCL1mg/ml, 1 ml Ampoule<br>100000.000<br>Number<br>1<br>3<br>Inj. Hydromorphone HCL4mg/ml, 1 ml Ampoule<br>10000.000 Number 1<br>4<br>Tab. Hydromorphone HCL2mg<br>500000.000<br>Number<br>1<br>5<br>Tab. Hydromorphone HCL4mg<br>500000.000<br>1

Sl.	No.	Export product		Qty.		Sl. No.	Import items	Qty.
1							Hydromorphone HCL	1.10 kg
		Inj.	Hydromorphone HCL2mg/ml, 1 ml Ampoule	5<br>N	00000.000<br>umber	1
2		Inj.	Hydromorphone HCL1mg/ml, 1 ml Ampoule	1<br>N	00000.000<br>umber	1	Hydromorphone HCL	0.11 kg

3		Inj.	Hydromorphone HCL4mg/ml, 1 ml Ampoule	1	0000.000 Number	1	Hydromorphone HCL	0.044 kg

4							Hydromorphone HCL	1.02 kg
		Tab. Hydromorphone HCL2mg		500000.000<br>Number		1
5		Tab. Hydromorphone HCL4mg		500000.000		1	Hydromorphone HCL	2.04 kg
				<br>Number

Case No. 111 / NC/3/MEET/Oct/202122/9

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case Status Case Approved Party Name YASHO INDUSTRIES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001618AM21 RA File Number 039504000350 AM21 Licence No and 0310838091/04/09/2020 Date

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.
YALUB PA 135(3,5-DI-TERTIARY-BUTYL-	<br>1 kg	1	2,6-DI-TERTIARY-BUTYL PHENOL	0.825 kg
4-HYDROXYHYDROCINNAMIC ACID)
		2	METHYL ACRYLATE	0.349 kg
		3	EXXAL 8(ISO OCTANOL)	0.366 kg

Case No. 112 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name ZENITH DYEINTERMEDIATES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

HQ File Number	018205001685AM21
RA File Number	039504000328 AM21
Licence No and<br>Date	0310838112/07/09/2020

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 7/82-ALC4/2020 dated 04.12.2020 against advance authorization No. 0310835403 dated 16.03.2020 , 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.<br>No.	Import items	Qty.
NAS-5 (2-DIAZO-1-NAPTHOL-5-SULFONIC ACID, SODIUM SALT)	1 kg	1	TOBIAS ACID<br>(PURITY MIN. 97%)	1.618 kg

Case No.	113 / NC/3/MEET/Oct/202122/9
Case Status	Case Approved
Party Name	ZIM LABORATORIES LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021
HQ File Number	018205001619AM21
RA File Number	039504000310 AM21
Licence No and<br>Date	0310838114/07/09/2020
Norms Committee	Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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.
Prolonged-release Indapamide Granules 0.77% for Direct Compression	2000.000 kg	1	Indapamide EP	15.538 kg

Case No. 114 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name TADIMETY AROMATICS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001620AM21 RA File Number 072404000154 AM21 Licence No and 0710116964/07/09/2020 Date Norms Committee Decision:

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.
ii. Stoichiometric balance, molecular weight, percentage yield at every stage of reaction.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 115 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name CHIRAG ENTERPRISE Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001621AM21 RA File Number 242404000040 AM21 Licence No and 2410043228/07/09/2020 Date

Norms Committee Decision:

i. Percentage wastage at each stage of manufacturing.

Production / Consumption data for last two years duly certified by Central Excise / GST.

Case No. 116 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name BALAJI AMINES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date

HQ File Number 018205001624AM21 RA File Number 318304000060 AM21 Licence No and 3110067848/08/09/2020 Date

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Sep/202122/8 dated 24.09.2021 against

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

advance authorization No. 3110067681 dated 11.02.2020 , 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.
GAMMA BUTYROLACTONE	1 kg	1	1,4 BUTANEDIOL	1.16 kg
		2	GBL CATAYLYST	0.001 kg

Case No. 117 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AMINES AND PLASTICIZERS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001625AM21 RA File Number 039404000370 AM21 Licence No and 0310838163/08/09/2020 Date Norms Committee Decision:

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E. ii. Stoichiometric balance, molecular weight, percentage yield at every stage of reaction.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 118 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name TADIMETY AROMATICS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001622AM21 RA File Number 072404000153 AM21

Licence No and 0710116971/08/09/2020 Date

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.
ii. Stoichiometric balance, molecular weight, percentage yield at every stage of reaction.

Case No. 119 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name BALAJI AMINES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001623AM21 RA File Number 318304000061 AM21 Licence No and 3110067847/08/09/2020 Date Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Jan/202021/4 dated 12.02.2021 against advance authorization No. 3110067616 dated 02.12.2019 , it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
N-METHYL-2-PYRROLIDONE	1 kg	1	METHANOL	0.370 kg
		2	AMMONIA ANHYDROUS	0.160 kg
		3	GAMMA BUTYROLACTONE	0.885 kg

Case No. 120 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name MANKIND PHARMA LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001626AM21 RA File Number 052404000277 AM21 Licence No and 0510415162/09/09/2020 Date Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 121 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name VISWAAT CHEMICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001627AM21 RA File Number 039504000327 AM21 Licence No and 0310838181/09/09/2020 Date Norms Committee Decision:

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.
ii. Stoichiometric balance, molecular weight, percentage yield at every stage of reaction.

Case No. 122 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name ALTA LABORATORIES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001636AM21 RA File Number 039404000422 AM21

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Licence No and 0310838206/10/09/2020 Date

Norms Committee Decision:

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 123 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name GLENMARK PHARMACEUTICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001628AM21 RA File Number 039404000341 AM21 Licence No and 0310838186/10/09/2020 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 2/82-ALC4/2020 dated 10.07.2020 against advance authorization No. 0310834275 dated 17.01.2020 , 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:

Sl.	Export Product	Qty.	Import items	Qty.
No.
1	Alclometasone Dipropionate USP Cream 0.05% 15gm (Pack Size 15gm) (Net Wt. of Alclometasone	<br>90000.000 Packs	Alclometasone	5.036 kg
	Dipropionate USP is 0.675 Kgs.)		Dipropionate USP

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

2	Alclometasone Dipropionate USP Cream 0.05% 45gm (Pack Size 45gm) (Net Wt. of Alclometasone<br>Dipropionate USP is 1.058 Kgs.)	<br>47000.000 Packs
3	Alclometasone Dipropionate USP Cream 0.05% 60gm (Pack Size 60gm) (Net Wt. of Alclometasone<br>Dipropionate USP is 1.440 Kgs.)	<br>48000.000 Packs
4	Alclometasone Dipropionate Ointment 0.05% 15gm (Pack Size 15gm) (Net Wt. of Alclometasone<br>Dipropionate USP is 0.360 Kgs.)	<br>48000.000 Packs
5	Alclometasone Dipropionate Ointment 0.05% 45gm (Pack Size 45gm) (Net Wt. of Alclometasone<br>Dipropionate USP is 0.799 Kgs.)	<br>35500.000 Packs
6	Alclometasone Dipropionate Ointment 0.05% 60gm (Pack Size 60gm) (Net Wt. of Alclometasone<br>Dipropionate USP is 0.600 Kgs.)	<br>20000.000 Packs

Case No. 124 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name SRIAM LABS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001651AM21 RA File Number 097104000084 AM21 Licence No and 0910069160/10/09/2020 Date Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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.
(R)-2-(Diphenylmethyl) pyrrolidine hydrochloride (RDPH-II)	1 kg	1	D-Proline/R-Proline	1.167 kg

Case No. 125 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name ANUPAM RASAYAN INDIA LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001629AM21 RA File Number 522404000043 AM21 Licence No and 5210043532/10/09/2020 Date

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.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

1<br>2,6-Dichlorobenzonitrile<br>140000.000 kg<br>2<br>Potassium Fluoride<br>105000.000 kg<br>2,6-DIFLUOROBENZAMIDE<br>100000.000 kg<br>3<br>Sulfolane (Anhydrous)<br>90000.000 kg<br>RA concerned may take further necessary action as per above decision of NC.	2,6-DIFLUOROBENZAMIDE	100000.000 kg	1	2,6-Dichlorobenzonitrile	140000.000 kg
			2	Potassium Fluoride	105000.000 kg
			3	Sulfolane (Anhydrous)	90000.000 kg

Case No. 126 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name J B CHEMICALS AND PHARMACEUTICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001630AM21 RA File Number 039404000407 AM21 Licence No and 0310838188/10/09/2020 Date

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Aug/202122/7 dated 13.08.2021 against advance authorization No. 0310832013 dated 04.10.2019 , 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:

Sl. No.	Export product	Qty.	Sl. No.	Import items	Qty.
1	Nifedipine Extended-Release Tablets 30mg.(Each tablet	<br>1 Number	1	Sentry Polyox WSR Coagulant NF	56.8 mg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

	contains (i) Sentry Polyox WSR Coagulant NF - 56.80 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398- 10NF/EP)-<br>33.12 mg (iii) SENTRY POLYOX WSR N80 FP NF -<br>118.40 mg. Net content (i) 432 Kgs (ii) 251.90 Kgs (iii)<br>900.51 Kgs)	<br> <br> <br>	2	EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)	33.12 mg
			3	SENTRY POLYOX WSR N80 FP NF	118.40 mg
2	Nifedipine Extended-Release Tablets 60mg.(Each tablet<br>contains (i) Sentry Polyox WSR Coagulant NF - 113.60 mg<br>(ii) Eastman (TM Cellulose Acetate (CA 398- 10NF/EP)-<br>42.32 mg (iii) SENTRY POLYOX WSR N80 FP NF -<br>236.80 mg. Net content (i) 203 Kgs (ii) 75.62 Kgs (iii)<br>423.16 Kg)	<br> <br> <br> <br> <br>1 Number	4	Sentry Polyox WSR Coagulant NF	113.60 mg
			5	EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)	42.32 mg
			6	SENTRY POLYOX WSR N80 FP NF	236.80 mg

Case No. 127 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name STRATECHEM (INDIA) PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001631AM21 RA File Number 039504000359 AM21 Licence No and 0310838204/10/09/2020 Date

Norms Committee Decision:

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Digitally Signed.

Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

ii. Stoichiometric balance, molecular weight, percentage yield at every stage of reaction.

Case No. 128 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name GLENMARK PHARMACEUTICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001632AM21 RA File Number 039404000340 AM21 Licence No and 0310838214/11/09/2020 Date

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Jan/202021/4 dated 12.02.2021 against advance authorization No. 0310835905 dated 25.04.2020 , 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:

Sl. No.	Export product	Qty.	Sl. No.	Import items	Qty.
1	Clindamycin & Benzoyl Peroxide Gel 1%/5% ( Pack Size	<br>1 Number Pack	1	Clindamycin Phosphate USP	262.50 mg / pack
	25gm)((Net Wt. of Import Item Sr. No. 1 is 82.50 Kgs. & Sr. No. 2 is
	412.50 Kgs.))
			2	HYDROUS BENZOYL PEROXIDE USP	1312.50 mg / pack
2	Clindamycin & Benzoyl Peroxide Gel 1%/5% ( Pack Size	<br>1 Number Pack	1	Clindamycin Phosphate USP	367.50 mg / pack
	35gm)((Net Wt. of Import Item Sr. No. 1 is 115.50 Kgs. & Sr. No. 2
	is 577.50 Kgs.))
			2	HYDROUS BENZOYL PEROXIDE USP	1837.50 mg / pack
3	Clindamycin & Benzoyl Peroxide Gel 1%/5% ( Pack Size	1 Number Pack	1	Clindamycin Phosphate USP<br>	525.00 mg / pack

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

4<br>50gm)((Net Wt. of Import Item Sr. No. 1 is 150.00 Kgs. & Sr. No. 2<br>is 750.00 Kgs.))<br> <br>2<br>HYDROUS BENZOYL PEROXIDE USP<br>2625.00 mg / pack<br>Adapalene & Benzoyl Peroxide Gel 0.1%/2.5% (Pack Size<br>45gm)((Net Wt. of Import Item Sr. No. 2 is 45.00<br>Kgs.))<br>1 Number Pack<br>2<br>HYDROUS BENZOYL PEROXIDE USP<br>1181.25 mg / pack<br>RA concerned may take further necessary action as per above decision of NC.	4	50gm)((Net Wt. of Import Item Sr. No. 1 is 150.00 Kgs. & Sr. No. 2<br>is 750.00 Kgs.))	<br>	2	HYDROUS BENZOYL PEROXIDE USP	2625.00 mg / pack
		Adapalene & Benzoyl Peroxide Gel 0.1%/2.5% (Pack Size<br>45gm)((Net Wt. of Import Item Sr. No. 2 is 45.00<br>Kgs.))	<br>1 Number Pack	2	HYDROUS BENZOYL PEROXIDE USP	1181.25 mg / pack

Case No. 129 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name ASTEC LIFESCIENCES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001634AM21 RA File Number 039404000406 AM21 Licence No and 0310838227/11/09/2020 Date Norms Committee Decision:

i. Complete name of Export Product.

ii. Complete and Balanced chemical reactions showing molecular weight and percentage yield on molar basis.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 130 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name J B CHEMICALS AND PHARMACEUTICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001635AM21 RA File Number 039404000408 AM21 Licence No and 0310838219/11/09/2020 Date

Case No.	Case No.	Case No.	130 / NC/3/MEET/Oct/202122/9	130 / NC/3/MEET/Oct/202122/9	130 / NC/3/MEET/Oct/202122/9	130 / NC/3/MEET/Oct/202122/9	130 / NC/3/MEET/Oct/202122/9
Case Status			Case Approved
Party Name			J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021
HQ File Number			018205001635AM21
RA File Number			039404000408 AM21
Licence No and<br>Date			0310838219/11/09/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of<br>whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>1<br>Benzocaine and Cetylpyridinium Chloride Anaesthetic Throat Lozenges.<br>Flavours Black Current, Honey Lemon & Other Flavours. Each Lozenge<br>Contains 12mg Benzocaine. Net content of Benzocaine - 97.015 Kgs.<br>1 Number<br>Lozenges<br>2<br>Benzocaine and Cetylpyridinium Chloride Anaesthetic Throat Lozenges.<br>Flavours Black Current and Lime & Lemon and Other Flavours. Each Lozenge<br>contains 10mg Benzocaine. Net content of Benzocaine - 33.52 Kgs.<br>1 Number<br>Lozenges<br>Benzocaine, Cetylpyridinium Chloride And Dextromethorphan Hydrobromide<br>Anaesthetic Throat Lozenges.<br>Each Lozenge Contains 1.25mg Benzocaine. Net content of Benzocaine -<br>4.695 Kgs.<br>1 Number<br>Lozenges<br>3<br>~~Signature N~~					HBP Vol. I as per details given below or as applied by the firm,
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.<br>(for 1 Number Lozenges)
	1	Benzocaine and Cetylpyridinium Chloride Anaesthetic Throat Lozenges.<br>Flavours Black Current, Honey Lemon & Other Flavours. Each Lozenge<br>Contains 12mg Benzocaine. Net content of Benzocaine - 97.015 Kgs.		<br>1 Number<br>Lozenges	1	Benzocaine	12.24 mg
	2	Benzocaine and Cetylpyridinium Chloride Anaesthetic Throat Lozenges.<br>Flavours Black Current and Lime & Lemon and Other Flavours. Each Lozenge<br>contains 10mg Benzocaine. Net content of Benzocaine - 33.52 Kgs.		<br>1 Number<br>Lozenges	2	Benzocaine	10.20 mg
	3	Benzocaine, Cetylpyridinium Chloride And Dextromethorphan Hydrobromide<br>Anaesthetic Throat Lozenges.<br>Each Lozenge Contains 1.25mg Benzocaine. Net content of Benzocaine -<br>4.695 Kgs.		<br> <br>1 Number<br>Lozenges<br>~~Signature N~~	3	Benzocaine	1.275 mg
					4<br>~~ot Verified~~	Benzocaine	15.30 mg
ment has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 03-Nov-2021.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 03-Nov-2021 12:58:18<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)


	4	Life Brand Sore Throat & Nasal Congestion Relief Extra Strength<br>(Flavours Cherry/Honey & Lemon/Other flavours) Sugar Free Lozenges.Each<br>Lozenge Contains Bezocaine 15 mg & Isomalt ST-M 2571 Mg. Net Content<br>Benzocaine 13.333 Kgs and Isomalt ST-M - 2285.352 Kgs.	<br> <br>1 Number<br>Lozenges	5	Isomalt ST-M	2571.00 mg
	5	Personnelle Oral Anesthetic Sore Throat Lozenges Extra Strenght Sugar Free<br>(Flavours Cherry/Honey Lemon/Other flavours) Each Lozenge Contains<br>Bezocaine 15 mg & Isomalt ST-M 2571 Mg. Net Content Benzocaine 13.333<br>Kgs and Isomalt ST-M - 2285.352 Kgs.	<br> <br>1 Number<br>Lozenges	6	Benzocaine	15.30 mg
				7	Isomalt ST-M	2571.00 mg
	6	Option+Oral Lozenges Sore Throat & Nasal Congestion Relief Extra Strenght<br>(Flavours Cherry/Honey Lemon /Other flavours). Each Lozenge Contains<br>Bezocaine 15 mg & Isomalt ST-M 2571 Mg. Net Content Benzocaine 13.333<br>Kgs and Isomalt ST-M - 2285.352 Kgs.	<br> <br> <br>1 Number<br>Lozenges	8	Benzocaine	15.30 mg
				9	Isomalt ST-M	2571.00 mg
	7	Biomedic Oral Anesthetic Lozenges Sore Throat & Nasal Congestion Relief<br>Extra Strength Cherry ST & NC RELEX Lozenges (Flavours Cherry / Honey<br>Lemon/ Other flavours) Each Lozenge Contains Bezocaine 15 mg & Isomalt<br>ST-M 2571 Mg. Net Content Benzocaine 13.333 Kgs and Isomalt ST-M -<br>2285.352 Kgs.	<br> <br> <br> <br>1 Number<br>Lozenges	10	Benzocaine	15.30 mg
				11	Isomalt ST-M	2571.00 mg
	8	Atoma Sore Throat & Nasal Congestion Relief Extra Strength Lozenges<br>Cherry/Honey & Lemon Flavour. Each Lozenge Contains Bezocaine 15 mg &<br>Isomalt ST-M 2700 Mg. Net Content Benzocaine 13.333 Kgs and Isomalt ST-<br>M - 2285.352 Kgs.	<br> <br>1 Number<br>Lozenges<br>	12	Benzocaine	15.30 mg
				13<br>	Isomalt ST-M	2571.00 mg
ment has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 03-Nov-2021.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 03-Nov-2021 12:58:18<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>~~Signature Not Verified~~

~~Signature Not Verified~~

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 131 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name ALPA LABORATORIES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001661AM21 RA File Number 562404000020 AM21 Licence No and 5610005946/11/09/2020 Date

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.
Ciprofloxacin Hydrochloride Tablets BP 500 mg. (EACH<br>FILM COATED TABLET ONTAINS:CIPROFLOXACIN<br>HYDROCHLORIDE BP EQ. TO CIPROFLOXACIN 500<br>MG.)	<br> <br> <br>1 Number	1	CIPROFLOXACIN HYDROCHLORIDE IP/BP/USP	555.00 mg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 132 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name AUROBINDO PHARMA LTD Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001656AM21 RA File Number 092404000317 AM21 Licence No and 0910069173/14/09/2020 Date

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.
CARVEDILOL	1 kg	1	4-Hydroxy-9H-Carbazole	1.06 kg
		2	Activated Carbon (Carbon Enoanticromos)	0.100 kg
		3	Epichlorohydrin	0.95 kg
		4	Methanol (Methyl Alcohol)	1.00 kg
		5	Isopropyl Alcohol	1.00 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 133 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name KRITI NUTRIENTS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001662AM21 RA File Number 562404000021 AM21 Licence No and 5610005948/14/09/2020 Date

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.
Non GMO Soya Lecithin Liquid Food Grade (Acid<br>value upto 25)	<br>148 MT	1	Soya Lecithin Liquid (Acid value more than 25)	149.18 MT

Case No. 134 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name VIBRANT PHARMACHEM PRIVATE LIMITED

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date

HQ File Number 018205001663AM21 RA File Number 072404000163 AM21 Licence No and 0710117014/15/09/2020 Date

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 135 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name SUVEN PHARMACEUTICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001664AM21 RA File Number 092404000274 AM21 Licence No and 0910069187/15/09/2020 Date Norms Committee Decision:

Copy of DML.

==> picture [101 x 11] intentionally omitted <==

----- Start of picture text ----- Signature Not Verified ----- End of picture text -----

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 136 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name KEVA FRAGRANCES PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001666AM21 RA File Number 039404000395 AM21 Licence No and 0310838311/16/09/2020 Date

Stoichiometric balance, molecular weight, percentage yield at every stage of reaction.

Case No. 137 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name VPL CHEMICALS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001667AM21 RA File Number 072404000158 AM21 Licence No and 0710117023/17/09/2020 Date

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

i. Complete and balanced chemical reactions with molecular weight.

ii. Percentage yield on molar basis.

Whether the export item is Minoxidil or Monidil Sulphate.

Case No. 138 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name HIMALAYAN PRODUCTS AND INDUSTRIES CORPN PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001668AM21 RA File Number 052404000283 AM21 Licence No and 0510415240/17/09/2020 Date

Case No. 139 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AMI LIFESCIENCES PVT LTD Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001675AM21 RA File Number 342404000171 AM21

Digitally Signed.

Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Licence No and 3410046407/18/09/2020 Date

i. Technical literature in support of low yield at step II and III alongwith By-Product recovery and use.
ii. Production / Consumption data duly certified by GST.

Case No. 140 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name VENKATA NARAYANA ACTIVE INGREDIENTS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001669AM21 RA File Number 042404000098 AM21 Licence No and 0410167074/18/09/2020 Date Norms Committee Decision: Deferred for comments of TE.

Case No. 141 / NC/3/MEET/Oct/202122/9 Case Status Case Rejected Party Name GLENMARK LIFE SCIENCES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001673AM21

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

RA File Number 039404000430 AM21 Licence No and 0310838379/21/09/2020 Date

Norms Committee Decision:

The Committee considered the case as per agenda and it was observed that the firm has applied both raw materials and the intermediates made out of it. Hence, it was decided to reject the case.

Case No. 142 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name STERILE INDIA PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001674AM21 RA File Number 052404000295 AM21 Licence No and 0510415273/21/09/2020 Date

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 143 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name NASENSE LABS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

HQ File Number 018205001676AM21 RA File Number 092404000306 AM21 Licence No and 0910069226/21/09/2020 Date

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 144 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name FDC LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001671AM21 RA File Number 039404000421 AM21

Licence No and 0310838377/21/09/2020 Date

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 145 / NC/3/MEET/Oct/202122/9 Case Status Case Approved

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Party Name GLENMARK LIFE SCIENCES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date

HQ File Number 018205001672AM21 RA File Number 039404000431 AM21 Licence No and 0310838378/21/09/2020 Date

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.
GLIMEPIRIDE	1 kg	1	4-[2-(3-ETHYL-4-METHYL-2-OXO-3-PYRROLINE-1-CARBOXAMIDO)-ETHYL]BENZENE<br>SULFONAMIDE	0.80 kg
		2	TRANS-4-METHYL CYCLOHEXYL ISOCYANATE	0.39 kg
		3	METHANOL	4.56 kg
		4	TOLUENE	1.24 kg

Case No. 146 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name SIDMAK LABORATORIES (INDIA) PRIVATE LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date

HQ File Number 018205001682AM21 RA File Number 522404000047 AM21 Licence No and 5210043542/22/09/2020 Date Norms Committee Decision:

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 147 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name JODAS EXPOIM PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001683AM21 RA File Number 092404000282 AM21 Licence No and 0910069242/22/09/2020 Date Norms Committee Decision:

i. Copy of DML for each export item.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 148 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name CLEAN SCIENCE AND TECHNOLOGY LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001677AM21 RA File Number 318304000058 AM21 Licence No and 3110067866/22/09/2020 Date

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.
Acetyl Anisole<br>(4 Methoxy Acetophenone)	1 kg	1	Phenol	0.74 kg
		2	Methanol	0.276 kg
		3	Acetic Anhydride PURITY 99%	0.755 kg

Case No. 149 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name YASHO INDUSTRIES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

and Date HQ File Number 018205001678AM21 RA File Number 039504000378 AM21 Licence No and 0310838408/22/09/2020 Date

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.
ZINC DIMETHACRYLATE(ZDMA)	1 kg	1	METHACRYLIC ACID	0.769 kg
		2	ZINC OXIDE	0.364 kg

Case No. 150 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name JODAS EXPOIM PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001695AM21 RA File Number 092404000305 AM21 Licence No and 0910069254/23/09/2020 Date Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

i. Copy of DML for the export item.
ii. COA of import item from foreign supplier.

Case No. 151 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name NAARI PHARMA PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001686AM21 RA File Number 052404000299 AM21 Licence No and 0510415286/23/09/2020 Date

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 152 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name NAARI PHARMA PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001687AM21

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

RA File Number 052404000300 AM21

Licence No and 0510415287/23/09/2020 Date

Norms Committee Decision:

Case No. 153 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name SRIAM LABS PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001848AM21 RA File Number 092404000346 AM21

Licence No and 0910069251/23/09/2020 Date

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.
1,3-Dimethoxy-5-[(E)-2-(4-methoxy	phenyl)-1-ethenyl]	benzene	<br>1 kg	1	3,5- Dihydroxy benzoic acid	0.99 kg
(BRVT-1)
				2	Sodium Boro Hydride	0.628 kg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Triethylphosphite

1.384 kg

Case No. 154 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name MANKIND PHARMA LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001688AM21 RA File Number 052404000308 AM21 Licence No and 0510415295/23/09/2020 Date Norms Committee Decision:

Copy of DML showing Approved Composition of Export item.

Case No. 155 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name MAHARSHI PHARMA CHEM PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001680AM21

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

RA File Number 082404000186 AM21 Licence No and 0810148644/23/09/2020 Date

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.
TRIAMCINOLONE ACETONIDE	1 kg	1	(3TR)<br>1,4,9(11),<br>16-PREGNATETRAEN-21-OL-3,20-DIONE-21-<br>ACETATE	<br>1.00 kg

Case No. 156 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name AUROBINDO PHARMA LTD Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001689AM21 RA File Number 092404000344 AM21 Licence No and 0910069243/23/09/2020 Date 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:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Export product	Qty.	Sl. No.	Import items	Qty.
CINACALCET HYDROCHLORIDE	1 kg	1	3-(Trifluoromethyl)Cinnamic Acid	1.16 kg
		2	Triethylamine	0.57 kg
		3	Ethyl Chloroformate	0.70 kg
		4	Sodium Borohydride	0.19 kg
		5	2,3-Dichloro-5,6-Dicyano-1,4-Benzoquinone (DDQ)	1.29 kg
		6	Tetrahydrofuran	4.70 kg
		7	R-(+)-1-(1-Naphthyl)Ethylamine	0.65 kg
		8	Activated Carbon (Carbon Enoanticromos)	0.100 kg

Case No.	157 / NC/3/MEET/Oct/202122/9
Case Status	Case Approved
Party Name	MAHARSHI PHARMA CHEM PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

and Date HQ File Number 018205001681AM21 RA File Number 082404000187 AM21 Licence No and 0810148645/23/09/2020 Date

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.
BETAMETHASONE DIPROPIONATE BP93/USP 23	1 kg	1	17ALPHA<br>21-DIHYDROXY-16-BETA<br>METHYL-9-BETA-11-<br>BETA-EPOXY PREGNA-1, 4-DIENE-3, 20-DIONE (DB-XI)	1.10 kg

Case No. 158 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name ETERNIS FINE CHEMICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001693AM21 RA File Number 039404000283 AM21 Licence No and 0310838453/24/09/2020 Date Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Deferred for comments of TE.

Case No. 159 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name GLAND PHARMA LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001696AM21 RA File Number 092404000318 AM21 Licence No and 0910069256/24/09/2020 Date

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.
Rocuronium Bromide	1 kg	1	Rocuronium Bromide Diol<br>Condition Pre import condition is imposed in case this is unregistered and export obligation<br>should be completed within 12 months from the date of import of each consignment as per<br>Appendix 4J of FTP 2015 20	<br> <br>1.05 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 160 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name VENOR PHARMA LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001692AM21 RA File Number 052404000274 AM21 Licence No and 0510415306/24/09/2020 Date

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	Tab. Morphine Sulphate ( NR/PR) 10mg content per tablet	3800000.000	1	Morphine Sulphate	38.76 kg
		Number
2	Tab. Morphine Sulphate 30 mg (NR/PR)	700000.000	1	Morphine Sulphate	21.42 kg
		Number
3	Tab. Morphine Sulphate 60 mg ( NR/PR)	50000.000	1	Morphine Sulphate	3.06 kg
		Number
4	Inj. Morphine Sulphate 10 mg	1000000.000	1	Morphine Sulphate	11.00 kg
		Number
5	Inj. Morphine Sulphate 15 mg	880000.000	1	Morphine Sulphate	14.52 kg
		Number

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 161 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name ZENITH DYEINTERMEDIATES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001735AM21 RA File Number 039504000361 AM21 Licence No and 0310838514/28/09/2020 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 7/82-ALC4/2020 dated 04.12.2020 against advance authorization No. 0310835403 dated 16.03.2020 , 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.	Import items	Qty.
			No.
NAS-5	(2-DIAZO-1-NAPTHOL-5-SULFONIC ACID, SODIUM SALT)	1 kg	1	TOBIAS ACID	1.618 kg
				(PURITY MIN. 97%)

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 162 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name SUVEN PHARMACEUTICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001701AM21 RA File Number 092404000275 AM21 Licence No and 0910069265/28/09/2020 Date

i. End-use of the export item (Name the API).
ii. Technical justification with catalogue for the requirement of import item No. 4, 5 and 6.

Production / Consumption data duly certified by GST Authorities.

Case No. 163 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name DHANUKA LABORATORIES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001703AM21 RA File Number 052304000197 AM21 Licence No and 0510415370/30/09/2020 Date Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Deferred for comments of TE.

Case No. 164 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name KAIRAV CHEMOFARBE INDUSTRIES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001704AM21 RA File Number 039404000467 AM21 Licence No and 0310838594/30/09/2020 Date Norms Committee Decision:

i. COA of import item indicating percentage purity from foreign supplier for entire quantity of import.

Percentage purity of export item.

Case No. 165 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AURORE LIFE SCIENCES PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001710AM21 RA File Number 092404000362 AM21 Licence No and 0910069287/30/09/2020

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Date

Norms Committee Decision: Deferred for comments of TE.

Case No. 166 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name BENZO CHEM INDUSTRIES PVT LTD Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001713AM21 RA File Number 039404000468 AM21 Licence No and 0310838628/01/10/2020 Date Norms Committee Decision: Deferred for comments of TE.

Case No. 167 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name HALDIA PETROCHEMICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001724AM21 RA File Number 022404000087 AM21 Licence No and 0210210144/06/10/2020 Date Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 168 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name GLENMARK PHARMACEUTICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001736AM21 RA File Number 039404000490 AM21 Licence No and 0310838813/09/10/2020 Date 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.
1	Clobetasol Propionate Foam 0.05% 50gm ( Net. wt. of Net. wt. of Clobetasol Propionate USP (Micronized) is 5.00 Kgs.)	200000.000<br>Number
2	Clobetasol Propionate Foam 0.05% 100gm (Net. wt. of Clobetasol Propionate USP (Micronized) is 10.00 Kgs.)	200000.000<br>Number
3	Clobetasol Propionate Cream USP 0.05% (Pack Size 15gm) (Net Weight of Clobetasol Propionate USP (Micronized) 0.15 Kgs)	20000.000<br>Number

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

	4	Clobetasol Propionate Cream USP 0.05% (Pack size 30gm) (Net Weight of Clobetasol Propionate USP (Micronized) 0.300 Kgs)	20000.000<br>Number
	5	Clobetasol Propionate Cream USP 0.05% (Pack size 45 gm) (Net Weight of Clobetasol Propionate USP (Micronized) 1.125 Kgs)	50000.000<br>Number
	6	Clobetasol Propionate Cream USP 0.05% (Pack size 60gm) (Net Weight of Clobetasol Propionate USP (Micronized) 1.500 Kgs)	50000.000<br>Number
	7	Clobetasol Propionate Ointment USP 0.05% (Pack size 15gm) (Net Weight of Clobetasol Propionate USP (Micronized) 0.375 Kgs)	50000.000<br>Number
	8	Clobetasol Propionate Ointment USP 0.05% (Pack size 30gm) (Net Weight of Clobetasol Propionate USP (Micronized) 0.750 Kgs)	50000.000<br>Number
	9	Clobetasol Propionate Ointment USP 0.05% (Pack size 45gm) (Net Weight of Clobetasol Propionate USP (Micronized) 0.900 Kgs)	40000.000<br>Number
	10	Clobetasol Propionate Ointment USP 0.05% (Pack size 60gm) (Net Weight of Clobetasol Propionate USP (Micronized) 0.600 Kgs)	20000.000<br>Number
	11	Clobetasol Propionate Spray 0.05% (Pack size 59ml) (Net Weight of Clobetasol Propionate USP (Micronized) 1.180 Kgs)	40000.000<br>Number
	12	Clobetasol Propionate Spray 0.05% (Pack size 125ml) (Net Weight of Clobetasol Propionate USP (Micronized) 2.500 Kgs)	40000.000<br>Number
	13	Clobetasol Prop. Top Sol USP, 0.05% 25ml (Net Weight of Clobetasol Propionate USP (Micronized) 0.625 Kgs)	50000.000<br>Number
	14	Clobetasol Prop. Top Sol USP, 0.05% 50ml (Net Weight of Clobetasol Propionate USP (Micronized) 1.000 Kgs)	40000.000<br>Number
ment has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 03-Nov-2021.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 03-Nov-2021 12:58:18<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

15	15	15	Clobetasol Pro Shampoo, 0.05 % 118ml (Net Weight of Clobetasol Propionate USP (Micronized) 2.360 Kgs)	Clobetasol Pro Shampoo, 0.05 % 118ml (Net Weight of Clobetasol Propionate USP (Micronized) 2.360 Kgs)	40000.000<br>Number
16			Clobetasol Propionate Foam 0.05% 100gm ( Net. wt. of Clobetasol Propionate USP (Micronized) is 0.500 Kgs.)		10000.000<br>Number
17			Clobetasol Propionate Foam 0.05% 50gm ( Net. wt. of Clobetasol Propionate USP (Micronized) is 0.250 Kgs.)		10000.000<br>Number
	Sl.<br>No.<br>Import Item<br>Qty.<br>1<br>CLOBETASOL PROPIONATE USP (MICRONIZED)<br>29.70 kg
	Sl.<br>No.	Import Item		Qty.
	1	CLOBETASOL PROPIONATE USP (MICRONIZED)		29.70 kg

Case No.	169 / NC/3/MEET/Oct/202122/9
Case Status	Case Deferred
Party Name	BELCHEM INDUSTRIES (INDIA) PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021
HQ File Number	018205001738AM21
RA File Number	039404000504 AM21
Licence No and<br>Date	0310838842/13/10/2020

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Norms Committee Decision:

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.
ii. Stoichiometric balance, molecular weight, percentage yield at every stage of reaction.

Case No. 170 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name ALTA LABORATORIES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001741AM21 RA File Number 039404000536 AM21 Licence No and 0310838904/15/10/2020 Date

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 171 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date

Signature Not Verified

Digitally Signed.

Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

HQ File Number 018205001749AM21 RA File Number 039404001019 AM20 Licence No and 0310838949/16/10/2020 Date

Norms Committee Decision:

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 172 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001750AM21 RA File Number 039404000978 AM20

Licence No and 0310838950/16/10/2020 Date

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 173 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date

HQ File Number 018205001751AM21 RA File Number 039404000297 AM21 Licence No and 0310838951/16/10/2020 Date

Case No. 174 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name BENZO CHEM INDUSTRIES PVT LTD Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001752AM21 RA File Number 039404000523 AM21 Licence No and 0310838952/16/10/2020 Date

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 6/82-ALC4/2020 dated 13.11.2020 against advance authorization No. 0310832317 dated 18.10.2019 , 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 Qty. Sl. No. Import items Qty.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

1<br>4-HYDROXYBENZALDEHYDE<br>OR<br>PARA HYDROXY BENZALDEHYDE<br>1.20 kg<br>4-HYDROXYBENZYL ALCOHOL<br>1 kg<br>2<br>SODIUM BOROHYDRIDE<br>0.23 kg<br> RA concerned may take further necessary action as per above decision of NC.	4-HYDROXYBENZYL ALCOHOL	1 kg	1	4-HYDROXYBENZALDEHYDE<br>OR<br>PARA HYDROXY BENZALDEHYDE	1.20 kg
			2	SODIUM BOROHYDRIDE	0.23 kg

Case No. 175 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001753AM21 RA File Number 039404000524 AM21 Licence No and 0310838953/16/10/2020 Date Norms Committee Decision:

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 176 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001745AM21 RA File Number 039404000392 AM21 Licence No and 0310838931/16/10/2020 Date

Norms Committee Decision:

Case No. 177 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name AVIK PHARMACEUTICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001754AM21 RA File Number 039404000531 AM21 Licence No and 0310838954/16/10/2020 Date

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:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Export product	Qty.	Sl. No.	Import items	Qty.
BUDESONIDE MICRONIZED IP / EP / BP /USP	1 kg	1	16 ALPHA-HYDROXYPREDNISOLONE ( 16-HPN)	0.972 kg

Case No. 178 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001746AM21 RA File Number 039404000516 AM21 Licence No and 0310838932/16/10/2020 Date

Norms Committee Decision:

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 179 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AARTI DRUGS LIMITED

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date

HQ File Number 018205001755AM21 RA File Number 039404000184 AM21 Licence No and 0310838958/16/10/2020 Date

Norms Committee Decision:

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 180 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name BENZO CHEM INDUSTRIES PVT LTD Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001748AM21 RA File Number 039404000514 AM21 Licence No and 0310838947/16/10/2020 Date

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Sep/202122/8 dated 24.09.2021 against advance authorization No. 0310834862 dated 13.02.2020 , 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.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

1	PROPIOPHENONE	1.408 kg
2	SODIUM CYANIDE	0.599 kg
3	PARA FORMALDEHYDE	0.528 kg
4	SODIUM BOROHYDRIDE	0.528 kg
5	TETRA HYDRO FURAN (THF)	1.00 kg

Case No. 181 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001756AM21 RA File Number 039404000825 AM20 Licence No and 0310838959/16/10/2020 Date

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 182 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name NEON LABORATORIES LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001757AM21 RA File Number 039504000409 AM21 Licence No and 0310838968/19/10/2020 Date

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 183 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001758AM21 RA File Number 039404000525 AM21 Licence No and 0310838974/19/10/2020 Date

Digitally Signed.

Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 184 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001759AM21 RA File Number 039404000528 AM21 Licence No and 0310838975/19/10/2020 Date Norms Committee Decision:

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 185 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name SYNNAT PHARMA PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001771AM21 RA File Number 022404000094 AM21 Licence No and 0210210167/20/10/2020

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Date

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 186 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name ANUH PHARMA LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001764AM21 RA File Number 039404000414 AM21 Licence No and 0310838998/20/10/2020 Date

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.
Erythromycin Phosphate BP/EP/USP/IP	1 kg	1	Erythromycin Thiocyanate	0.779 kg<br>Activity

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 187 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name ANUH PHARMA LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001765AM21 RA File Number 039404000415 AM21 Licence No and 0310838999/20/10/2020 Date

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.
Erythromycin Propionate BP/EP/USP/IP	1 kg	1	Erythromycin Thiocyanate	0.90 kg
				Activity

Case No. 188 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AARTI DRUGS LIMITED

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date

HQ File Number 018205001766AM21 RA File Number 039404000548 AM21 Licence No and 0310839000/20/10/2020 Date

Norms Committee Decision:

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 189 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name GLENMARK PHARMACEUTICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001850AM21 RA File Number 039404000550 AM21 Licence No and 0310839024/20/10/2020 Date

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.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

1	Drospirenone and Ethinyl Estradiol Tablets (YASMIN) 3 mg / 0.03 mg (Pack 3 x 28s)	490000.000
	(Net wt of Drospirenone USP (Micronized) is 92.610 Kgs)	Number
2	Drospirenone and Ethinyl Estradiol Tablets (YAZ) 3 mg / 0.02 mg (Pack 3 x 28s)	480000.000
	(Net wt of Drospirenone USP (Micronized) is 103.68 Kgs)	Number

Sl.<br>No.	Import Item	Qty.
1	Drospirenone USP (Micronized)	200.22 kg

Case No. 190 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001767AM21 RA File Number 039404000526 AM21 Licence No and 0310839001/20/10/2020 Date

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 191 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001769AM21 RA File Number 039404000527 AM21 Licence No and 0310839017/20/10/2020 Date Norms Committee Decision:

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 192 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name TRANSPEK INDUSTRY LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001776AM21 RA File Number 342404000196 AM21 Licence No and 3410046491/22/10/2020

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Date

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 3/82-ALC4/2020 dated 07.08.2020 and 7/AM21 dated 24.12.2020 against advance authorization No. 3410045473 dated 20.09.2019, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
N-OCTANOYL CHLORIDE	1 kg	1	CAPRYLIC ACID	0.904 kg

Case No. 193 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name TRANSPEK INDUSTRY LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001777AM21 RA File Number 342404000197 AM21 Licence No and 3410046492/22/10/2020 Date

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:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Export product	Qty.	Sl. No.	Import items	Qty.
N-VALERYL CHLORIDE	1 kg	1	PENTANOIC ACID	0.894 kg

Case No. 194 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001778AM21 RA File Number 039404000412 AM21 Licence No and 0310839084/23/10/2020 Date

Norms Committee Decision:

Case No. 195 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AARTI DRUGS LIMITED

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date

HQ File Number 018205001779AM21 RA File Number 039404000411 AM21 Licence No and 0310839085/23/10/2020 Date

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 196 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name ASHISH LIFE SCIENCE PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001783AM21 RA File Number 039404000571 AM21 Licence No and 0310839148/27/10/2020 Date

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

==> picture [101 x 11] intentionally omitted <==

----- Start of picture text ----- Signature Not Verified ----- End of picture text -----

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No. 197 / NC/3/MEET/Oct/202122/9 Case Status Case Approved Party Name J B CHEMICALS AND PHARMACEUTICALS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001790AM21 RA File Number 039404000569 AM21 Licence No and 0310839187/28/10/2020 Date

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Jan/202021/4 dated 12.02.2021 against advance authorization No. 0310836099 dated 05.05.2020 , 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:

Sl. No.	Sl. No.	Export Product	Qty.
1		GLIPIZIDE EXTENDED RELEASE TABLETS 10 MG. Each tablet contains	1 Number
		(i) Glipizide USP- 10 mg (ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 29.70 mg (iii) Sentry Polyox WSR N80 FP NF- 178.10 mg (iv) Sentry Polyox WSR
		303 NF- 100 mg. Net content (i) 150.44 Kgs (ii) 446.81 Kgs (iii) 2679.37 Kgs (iv) 1504.42 Kgs.
2		GLIPIZIDE EXTENDED RELEASE TABLETS 5 MG. Each tablet contains	1 Number
		(i) Glipizide USP- 5 mg (ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii) Sentry Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR
		303 NF- 50 mg. Net content (i) 58.70 Kgs (ii) 239.48 Kgs (iii) 1045.37 Kgs (iv) 586.96 Kgs.
3		GLIPIZIDE EXTENDED RELEASE TABLETS 2.5 MG. Each tablet contains	1 Number
		(i) Glipizide USP- 2.5 mg (ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii) Sentry Polyox WSR N80 FP NF- 89.05 mg (iv) Sentry Polyox WSR
		303 NF- 50 mg. Net content (i) 11.06 Kgs (ii) 90.27 Kgs (iii) 394.03 Kgs (iv) 221.24 Kgs.

	Sl. No.	For export of 1 Number of Tablet<br> Import Items

==> picture [101 x 11] intentionally omitted <==

----- Start of picture text ----- Signature Not Verified ----- End of picture text -----

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

		2.5 mg	5.0 mg	10.0 mg
1	GLIPIZIDE USP	2.55 mg	5.10 mg	10.20 mg
2	EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)	20.40 mg	20.40 mg	29.70 mg
3	SENTRY POLYOX WSR N80 FP NF	89.05 mg	89.05 mg	178.10 mg
4	SENTRY POLYOX WSR 303 NF	50.00 mg	50.00 mg	100.00 mg

Case No. 198 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name MAHIMA LIFESCIENCES PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001793AM21 RA File Number 052404000372 AM21 Licence No and 0510415667/28/10/2020 Date

Norms Committee Decision:

The Committee considered the case as per agenda and it was observed that both the import and export are the same API and the firm has not differentiated the Particle size of import and export. Hence, it was decided to call for following information from the firm:

i. COA of import item from foreign supplier showing particle size .

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

COA of Export item showing particle size .

Case No. 199 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001788AM21 RA File Number 039404000410 AM21 Licence No and 0310839173/28/10/2020 Date Norms Committee Decision:

Case No. 200 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name AARTI DRUGS LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001789AM21 RA File Number 039404000346 AM21 Licence No and 0310839184/28/10/2020 Date Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Case No. 201 / NC/3/MEET/Oct/202122/9 Case Status Case Deferred Party Name VEKO CARE PRIVATE LIMITED Meeting Number NC/ 3/ MEET/ Oct/ 202122/ 9 and 15/10/2021 and Date HQ File Number 018205001806AM21 RA File Number 318304000085 AM21 Licence No and 3110067911/29/10/2020 Date Norms Committee Decision:

i. Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 03-Nov-2021 12:58:18 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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