IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2021-12-17

DGFT Committee Minutes

Document text

Government of India Ministry of Commerce and Industry

DIRECTORATE GENERAL OF FOREIGN TRADE

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Dec/202122/12 DATED: 17/12/2021

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/Dec/202122/12 dated 17/12/2021 of Norms Committee - III for the year 2021-22 was actually held on 17/12/2021 and 07/01/2022 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:-

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

The following members were present in the meeting:-

	Name and Designation of Representatives	Department
1	AJAY KUMAR,Deputy Director	Directorate General of Foreign Trade, Delhi
2	SHAISH KUMAR,Technical Authority	Technical Consultant,DGFT
3	DINESHNARAIN MATHUR,Technical<br>Authority	Technical Consultant,DGFT

Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	LACTOSE (INDIA) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00000933AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:

Signature Not Verified Signature Not Verified Digitally Signed. Digitally signe Name: Ajay Kumar( Deputy Director ) Name: Ajay Kumar( uty Director ) Date: 21-Jan-2022 12:16:20 Date: 21-Jan-2022 2:16:20 Reason: AJAY.DHIMAN88@GOV.IN Reason: AJAY. IAN88@GOV.IN Location: DGFT(HQ) Location: DGFTIHG)

This document has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022.

The Committee considered the case as per agenda and it was observed that this case having Advance Authorization No. 0310834414 dated 23.01.2020 (Hqrs. F. No. 01/82/050/01043/AM20/DES-III) has already been considered by Norms Committee-3 in its Meeting No. NC/3/MEET/Jan/202021/4 dated 12.02.2021 and certain information have also been called for from the firm. Further, it was also observed that this case has come up in the DGFT Back Office Portal due to some technical error. UDIN00217773AM22

In view of above, the Committee decided to withdraw the case.

her, it was also observed that this case has come up in the DGFT Back Office Portal due to some technical error. UDIN00217773AM22

In view of above, the Committee decided to withdraw the case.

Case No.<br>2 / NC/3/MEET/Dec/202122/12
Case Status<br>Case Approved
Party Name<br>CONVERGENCE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number<br>HQRNORM APPLY 00007986AM22
RA File Number<br>NA
Licence No and<br>Date<br>NA
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that this case having Advance Authorization
No. 3410046157 dated 17.06.2020 (Hqrs. F. No. 01/82/050/01391/AM21/DES-III) has already been considered by
Norms Committee-3 in its Meeting No. NC/3/MEET/Jan/202021/4 dated 12.02.2021 and certain information have also
been called for from the firm. Further, it was also observed that this case has come up in the DGFT Back Office
Portal due to some technical error.
In view of above, the Committee decided towithdrawthe case.

The Committee considered the case as per agenda and it was observed that this case having Advance Authorization No. 3410046157 dated 17.06.2020 (Hqrs. F. No. 01/82/050/01391/AM21/DES-III) has already been considered by Norms Committee-3 in its Meeting No. NC/3/MEET/Jan/202021/4 dated 12.02.2021 and certain information have also been called for from the firm. Further, it was also observed that this case has come up in the DGFT Back Office Portal due to some technical error.

ed 12.02.2021 and certain information have also been called for from the firm. Further, it was also observed that this case has come up in the DGFT Back Office Portal due to some technical error.

Case No.	3 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00104235AM21
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Copy of 4.07 application having copy of Advance Authorization alongiwth complete technical details as<br>i.
per Annexure to Appendix 4E.

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

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

ure to Appendix 4E.**

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

	UDIN00217773AM2
Case No.	4 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00150599AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Copy of 4.07 application having copy of Advance Authorization alongiwth complete technical details as<br>i.
per Annexure to Appendix 4E.

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

Case No.	5 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	LACTOSE (INDIA) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00001987AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that in the DGFT Back Office Portal, the firm
has enclosed a copy of 4.07 application for fixation of adhoc norms against Advance Authorization No. 0310839161
dated 27.10.2020 (Hqrs. F. No.

ved that in the DGFT Back Office Portal, the firm|| |has enclosed a copy of 4.07 application for fixation of adhoc norms against Advance Authorization No. 0310839161|| |dated 27.10.2020 (Hqrs. F. No. 01/82/050/01785/AM21/DES-III), however Norms Committee-3 in its Meeting No.|| |NC/3/MEET/Oct/202122/10 dated 12.11.2021 has already fixed the adhoc norms against Advance Authorization No.|| |0310839161 dated|27.10.2020. Further it was also observed that this case has come up in the portal due to some| |technical error. Hence, the Committee decided towithdrawthe case.||

Case No.	6 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00020736AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

The Committee considered the case as per agenda and it was decided to call for following information from the firm: UDIN00217773AM22

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

r following information from the firm: UDIN00217773AM22

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

Case No.	7 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00108942AM21
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that in the DGFT Back Office Portal, the firm<br>has enclosed a copy of 4.07 application for fixation of adhoc norms against Advance Authorization No. 0310836784<br>dated 22.06.2020 (Hqrs. F. No. 01/82/050/01407/AM21/DES-III), however Norms Committee-3 in its Meeting No.<br>NC/3/MEET/Jan/202021/4 dated 12.02.2021 has already fixed the adhoc norms against Advance Authorization No.<br>0310839161 dated 27.10.2020. Further it was also observed that this case has come up in the portal due to some<br>technical error. Hence, the Committee decided towithdrawthe case.

n No. 0310839161 dated 27.10.2020. Further it was also observed that this case has come up in the portal due to some technical error. Hence, the Committee decided towithdrawthe case.||

Case No.	8 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	LACTOSE (INDIA) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00002034AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having copy of Advance Authorization alongiwth complete technical details as per<br>Annexure to Appendix 4E

Case No.	9 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	FERMENTA BIOTECH LIMITED	Signature Not V

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

me|FERMENTA BIOTECH LIMITED|Signature Not V|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021<br>UDIN00217773AM2
HQ File Number<br>HQRNORM APPLY 00027621AM22
RA File Number<br>NA
Licence No and<br>Date<br>NA
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that in the DGFT Back Office Portal, the firm
has enclosed a copy of 4.07 application for fixation of adhoc norms against Advance Authorization No. 0310832316
dated 18.10.2019 (Hqrs. F. No. 01/82/050/00746/AM20/DES-III), however Norms Committee-3 in its Meeting No.
10/82-ALC4/2019 dated 29.11.2019 has already rejected the request of firm for fixation of adhnoc norms against
Advance Authorization No. 0310832316 dated 18.10.2019. Further it was also observed that this case has come up in
the portal due to some technical error. Hence, the Committee decided towithdrawthe case.

zation No. 0310832316 dated 18.10.2019. Further it was also observed that this case has come up in| |the portal due to some technical error. Hence, the Committee decided towithdrawthe case.|

Case No.	10 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00138599AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that in the DGFT Back Office Portal, the firm
has enclosed a copy of 4.07 application for fixation of adhoc norms against Advance Authorization No. 0310837797
dated 20.08.2020 (Hqrs. F. No. 01/82/050/01565/AM21/DES-III), however Norms Committee-3 in its Meeting No.
NC/3/MEET/Oct/202122/9 dated 15.10.2021 has already fixed the adhoc norms against Advance Authorization No.
0310837797 dated	20.08.2020. Further it was also observed that this case has come up in the portal due to some
technical error. Hence, the Committee decided towithdrawthe case.

on No.|| |0310837797 dated|20.08.2020. Further it was also observed that this case has come up in the portal due to some| |technical error. Hence, the Committee decided towithdrawthe case.||


Case No.	11 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	SOMERSET THERAPEUTICS LIMITED
Meeting Number
<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00147209AM22
RA File Number	NA
Licence No and
Date	NA
Norms Committee Decision:<br>Th Citt idd th d d it didd t ll f flli ifti f th fi
e ommee consere e case as per agena an was ece o ca or oowng normaon rom e rm:

C f 4<br>i	7 liti hi f Ad Athiti lith lt thil dtil
opy o . appcaon avng copy o vance uorzaon aongw compee ecnca eas as<br>per Annexure to Appendix 4E.<br>.<br>Signature Not V
		ure Not
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022.<br>Digitally Sig<br>Name: Ajay<br>Date: 21-Ja<br>Reason: AJ<br>Location: D<br>		ned.<br>Kumar( Dep<br>n-2022 12:1<br>AY.DHIMAN<br>GFT(HQ)<br>	ut<br>6:2<br>88<br>

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Case No.	12 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	SONGWON SPECIALTY CHEMICALS - INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00002300AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that this case having Advance Authorization<br>No. 3410045298 dated 18.07.2019 has already been considered by Norms Committee-3 in its Meeting No.<br>NC/3/MEET/Jan/202021/4 dated 12.02.2021 and certain information have also been called for from the firm. Further,<br>it was also observed that this case has come up in the DGFT Back Office Portal due to some technical error.<br>In view of above, the Committee decided towithdrawthe case.

The Committee considered the case as per agenda and it was observed that this case having Advance Authorization No. 3410045298 dated 18.07.2019 has already been considered by Norms Committee-3 in its Meeting No. NC/3/MEET/Jan/202021/4 dated 12.02.2021 and certain information have also been called for from the firm. Further, it was also observed that this case has come up in the DGFT Back Office Portal due to some technical error.

ed 12.02.2021 and certain information have also been called for from the firm. Further, it was also observed that this case has come up in the DGFT Back Office Portal due to some technical error.

Case No.	13 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00037731AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that in the DGFT Back Office Portal, the firm<br>has enclosed a copy of 4.07 application for fixation of adhoc norms against Advance Authorization No. 0711000869<br>dated 09.04.2021 (Hqrs. F. No. HQNORMAPPLY00008718AM22/DES-III), however Norms Committee-3 in its<br>Meeting No. NC/3/MEET/Jun/202122/2 dated 02.07.2021 has already fixed the adhoc norms against Advance<br>Authorization No. 0711000869 dated 09.04.2021. Further it was also observed that this case has come up in the portal<br>due to some technical error. Hence, the Committee decided towithdrawthe case.

Case No.	14 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00122426AM22
RA File Number	NA

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Licence No and NA Date

UDIN00217773AM22

|RA File Number|NA|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Licence No and NA Date

UDIN00217773AM22

Norms Committee Decision:

The Committee considered the case as per agenda and it was observed that in the DGFT Back Office Portal, the firm has enclosed a copy of 4.07 application for fixation of adhoc norms against Advance Authorization No. 0711000657 dated 15.03.2021 (Hqrs. F. No. HQNORMAPPLY00009852AM21/DES-III), however Norms Committee-3 in its Meeting No. NC/3/MEET/Jul/202122/4 dated 15.07.2021 has already fixed the adhoc norms against Advance Authorization No. 0711000657 dated 15.03.2021. Further it was also observed that this case has come up in the portal due to some technical error. Hence, the Committee decided to withdraw the case.

Case No.	15 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	SONGWON SPECIALTY CHEMICALS - INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00002458AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that this case having Advance Authorization<br>No. 3410046173 dated 23.06.2020 (Hqrs. F. No. 01/82/050/01415/AM21/DES-III) has already been considered by<br>Norms Committee-3 in its Meeting No. NC/3/MEET/Oct/202122/9 dated 15.10.2021 and certain information have<br>also been called for from the firm.

01415/AM21/DES-III) has already been considered by Norms Committee-3 in its Meeting No. NC/3/MEET/Oct/202122/9 dated 15.10.2021 and certain information have also been called for from the firm. Further, it was also observed that this case has come up in the DGFT Back Office Portal due to some technical error. In view of above, the Committee decided towithdrawthe case.||

The Committee considered the case as per agenda and it was observed that this case having Advance Authorization No. 3410046173 dated 23.06.2020 (Hqrs. F. No. 01/82/050/01415/AM21/DES-III) has already been considered by Norms Committee-3 in its Meeting No. NC/3/MEET/Oct/202122/9 dated 15.10.2021 and certain information have also been called for from the firm. Further, it was also observed that this case has come up in the DGFT Back Office Portal due to some technical error.

Case No.	16 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00041071AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br> Production Consumption data duly certified by GST.<br>i.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

mption data duly certified by GST.** i.||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

	UDIN00217773AM2
Case No.	17 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	ZENITH DYEINTERMEDIATES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00132289AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that in the DGFT Back Office Portal, the firm<br>has enclosed a copy of 4.07 application for fixation of adhoc norms against Advance Authorization No. 0310838112<br>dated 07.09.2020 (Hqrs. F. No. 01/82/050/01685/AM21/DES-III), however Norms Committee-3 in its Meeting No.<br>NC/3/MEET/Oct/202122/9 dated 15.10.2021 has already fixed the adhoc norms against Advance Authorization No.<br>0310838112 dated 07.09.2020. Further it was also observed that this case has come up in the portal due to some<br>technical error. Hence, the Committee decided towithdrawthe case.

n No. 0310838112 dated 07.09.2020. Further it was also observed that this case has come up in the portal due to some technical error. Hence, the Committee decided towithdrawthe case.||

Case No.	18 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00259962AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Complete process of manufacturing, stoichiometric balance on molar basis and percentage yield.

Case No.	19 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	CLARIANT INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00000532AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

er|NA| |Licence No and Date|NA| |Norms Committee Decision:||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

The Committee considered the case as per agenda and it was observed that this case having Advance Authorization No. 0310836469 dated 01.06.2020 (Hqrs. F. No. 01/82/050/01343/AM21/DES-III) has already been considered by Norms Committee-3 in its Meeting No. NC/3/MEET/Jan/202021/4 dated 12.02.2021 and certain information have also been called for from the firm. Further, it was also observed that this case has come up in the DGFT Back Office Portal due to some technical error. UDIN00217773AM22

In view of above, the Committee decided to withdraw the case.

Case No.	20 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	SHARON BIO-MEDICINE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00003109AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that in the DGFT Back Office Portal, the firm
has enclosed a copy of 4.07 application for fixation of adhoc norms against Advance Authorization No. 0310837562
dated 07.08.2020 (Hqrs. F. No. 01/82/050/01518/AM21/DES-III), however Norms Committee-3 in its Meeting No.
NC/3/MEET/Oct/202122/9 dated 15.10.2021 has already fixed the adhoc norms against Advance Authorization No.
0310837562 dated	07.08.2020.

/DES-III), however Norms Committee-3 in its Meeting No.|| |NC/3/MEET/Oct/202122/9 dated 15.10.2021 has already fixed the adhoc norms against Advance Authorization No.|| |0310837562 dated|07.08.2020. Further it was also observed that this case has come up in the portal due to some| |technical error. Hence, the Committee decided towithdrawthe case.||

Case No.	21 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	ORGANICA AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00065792AM21
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Copy of 4.07 application having copy of Advance Authorization alongiwth complete technical details as<br>i.
per Annexure to Appendix 4E.

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

cal details as per Annexure to Appendix 4E.**

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Case No.	22 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved<br>UDIN00217773AM2
Party Name	CLARIANT INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00000546AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that in the DGFT Back Office Portal, the firm<br>has enclosed a copy of 4.07 application for fixation of adhoc norms against Advance Authorization No. 0310832792<br>dated 14.11.2019 (Hqrs. F. No. 01/82/050/00826/AM20/DES-III), however Norms Committee-3 in its Meeting No.<br>NC/3/MEET/Sep/202122/8 dated 24.09.2021 has already fixed the adhoc norms against Advance Authorization No.<br>0310832792 dated 14.11.2019. Further it was also observed that this case has come up in the portal due to some<br>technical error. Hence, the Committee decided towithdrawthe case.

n No. 0310832792 dated 14.11.2019. Further it was also observed that this case has come up in the portal due to some technical error. Hence, the Committee decided towithdrawthe case.||

Case No.	23 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	SHARON BIO-MEDICINE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00003114AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that in the DGFT Back Office Portal, the firm<br>has enclosed a copy of 4.07 application for fixation of adhoc norms against Advance Authorization No. 0310837129<br>dated 10.07.2020 (Hqrs. F. No. 01/82/050/01459/AM21/DES-III), however Norms Committee-3 in its Meeting No.<br>NC/3/MEET/Sep/202122/8 dated 24.09.2021 has already fixed the adhoc norms against Advance Authorization No.<br>0310837129 dated 10.07.2020. Further it was also observed that this case has come up in the portal due to some<br>technical error. Hence, the Committee decided towithdrawthe case.

Case No.	24 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	ZIM LABORATORIES LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00082562AM21
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:

|RA File Number|NA| |Licence No and Date|NA| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

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

Case No.	25 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	LACTOSE (INDIA) LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00000924AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that in the DGFT Back Office Portal, the firm<br>has enclosed a copy of 4.07 application for fixation of adhoc norms against Advance Authorization No. 0310830184<br>dated 09.07.2019 (Hqrs. F. No. 01/82/050/00370/AM20/DES-III), however Norms Committee-3 in its Meeting No.<br>NC/3/MEET/Aug/202122/7 dated 13.08.2021 has already fixed the adhoc norms against Advance Authorization No.<br>0310830184 dated 09.07.2019. Further it was also observed that this case has come up in the portal due to some<br>technical error. Hence, the Committee decided towithdrawthe case.

n No. 0310830184 dated 09.07.2019. Further it was also observed that this case has come up in the portal due to some technical error. Hence, the Committee decided towithdrawthe case.||

Case No.	Case No.	26 / NC/3/MEET/Dec/202122/12	26 / NC/3/MEET/Dec/202122/12	26 / NC/3/MEET/Dec/202122/12
Case Status		Case Approved
Party Name		ZENTIVA PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number		HQRNORM APPLY 00007775AM22
RA File Number		NA
Licence No and<br>Date		NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>CLOPIDOGREL 75MG TABLETS<br>(Clopidogrel Zentiva / Clopidogrel<br>Almus / Trombex Each Tablet<br>contain 75mg of CLOPIDOGREL<br>BISULFATE FORM II Total Net<br>Weight<br>of<br>CLOPIDOGREL<br>BISULFATE FORM II 12590.05<br>1 Number<br>1<br>CLOPIDOGREL<br>BISULFATE FORM II<br>Net content in Export<br>Description + 2%<br>~~Signature Not V~~
	Export product		Qty.	Sl.

r>CLOPIDOGREL BISULFATE FORM II 12590.05 1 Number 1 CLOPIDOGREL BISULFATE FORM II Net content in Export Description + 2% ~~Signature Not V~~|||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.|| ||CLOPIDOGREL 75MG TABLETS (Clopidogrel Zentiva / Clopidogrel Almus / Trombex Each Tablet contain 75mg of CLOPIDOGREL BISULFATE FORM II Total Net Weight of CLOPIDOGREL BISULFATE FORM II 12590.05|| 1 Number|1|CLOPIDOGREL BISULFATE FORM II|Net content in Export Description + 2% ~~Signature Not V~~|| |ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022. Digitally Signed. Name: Ajay Kumar( Deput Date: 21-Jan-2022 12:16: Reason: AJAY.DHIMAN88 Location: DGFT(HQ) ||||||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

KGS)

UDIN00217773AM22

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

Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

KGS)

UDIN00217773AM22

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

Case No.	27 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	SHIVAM ADDITIVES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00102272AM22
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that in the DGFT Back Office Portal, the firm<br>has enclosed a copy of 4.07 application for fixation of adhoc norms against Advance Authorization No. 1311000341<br>dated 19.05.2021 (Hqrs. F. No. HQNORMAPPLY00046134AM22/DES-III), however Norms Committee-3 in its<br>Meeting No. NC/3/MEET/Jun/202122/2 dated 02.07.2021 has already fixed the adhoc norms against Advance<br>Authorization No. 1311000341 dated 19.05.2021. Further it was also observed that this case has come up in the portal<br>due to some technical error. Hence, the Committee decided towithdrawthe case.

tion No. 1311000341 dated 19.05.2021. Further it was also observed that this case has come up in the portal due to some technical error. Hence, the Committee decided towithdrawthe case.||

Case No.	28 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	VASISTA LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205000814AM13
RA File Number	092404000308 AM13
Licence No and<br>Date	0910053881/21/09/2012
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having copy of Advance Authorization alongiwth complete technical details as<br>per Annexure to Appendix 4E.<br>i.

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

Case No.	29 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
PartyName	CDYMAX (INDIA) PHARMA PRIVATE LIMITED	Signature Not V

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

DIA) PHARMA PRIVATE LIMITED|Signature Not V|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021<br>UDIN00217773AM2
HQ File Number	018205001377AM13
RA File Number	072404000317 AM13
Licence No and<br>Date	0710091789/06/11/2012
Norms Committee Decision:<br>RLA, Bangalore vide e-mail dated 04.01.2022 has informed that Norms Committee-3 in its Meeting No. 12/82-<br>ALC4/2015 dated 18.11.2015 has already fixed the adhoc norms against Advance Authorization No. 0710091789<br>dated 06.11.2012 and it has also been redeemed on 27.05.2019.<br>In view of above, the Committee decided towithdrawthe case.

Case No.	30 / NC/3/MEET/Dec/202122/12
Case Status	Case Rejected
Party Name	IND SWIFT LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205000966AM13
RA File Number	222404000051 AM13
Licence No and<br>Date	2210013450/17/12/2012
Norms Committee Decision:<br>The Committee consider the case and it was observed that Norms Committee-3 in its Meeting No. 22/82-ALC4/2013<br>dated 20.02.2014 has alreadyrejectedthe case.<br>In view of above the Committee decided towithdrawthe case.

The Committee consider the case and it was observed that Norms Committee-3 in its Meeting No. 22/82-ALC4/2013 dated 20.02.2014 has already rejected the case.

ecided towithdrawthe case.||

The Committee consider the case and it was observed that Norms Committee-3 in its Meeting No. 22/82-ALC4/2013 dated 20.02.2014 has already rejected the case.

Case No.	31 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	CHAMPIONX DAI-ICHI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001143AM13
RA File Number	039404000792 AM13
Licence No and<br>Date	0310717692/19/12/2012
Norms Committee Decision:<br>RLA, Mumbai vide e-mail dated 04.01.2022 has informed that the Advance Authorization No. 0310717692 dated<br>19.12.2012 has already been surrendered by the firm on 20.03.2015.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

In view of above, the Committee decided to withdraw the case.

UDIN00217773AM22

Case No.	32 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205000113AM14
RA File Number	072404000020 AM14
Licence No and<br>Date	0710095227/06/05/2013
Norms Committee Decision:
RLA, Bangalore vide e-mail dated 06.12.2021 has informed that the Advance Authorization No. 0710095227 dated
06.05.2013 was issued on Repeat Basis taking cue from decision of Norms Committee-3 Meeting No.

galore vide e-mail dated 06.12.2021 has informed that the Advance Authorization No. 0710095227 dated|| |06.05.2013 was issued on Repeat Basis taking cue from decision of Norms Committee-3 Meeting No. 21/82-|| |ALC4/2012 dated 04.10.2012 and EODC has also been issued on 30.12.2014.|| |In view of above, the Committee decided towithdrawthe case.||

RLA, Bangalore vide e-mail dated 06.12.2021 has informed that the Advance Authorization No. 0710095227 dated 06.05.2013 was issued on Repeat Basis taking cue from decision of Norms Committee-3 Meeting No. 21/82ALC4/2012 dated 04.10.2012 and EODC has also been issued on 30.12.2014.

Case No.	33 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	HESTER BIOSCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205000216AM14
RA File Number	082404000081 AM14
Licence No and<br>Date	0810121432/27/05/2013
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Copy of 4.07 application having copy of Advance Authorization alongiwth complete technical details as per
Annexure to Appendix 4E

Case No.	34 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	CALYX CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205000515AM14

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

RA File Number 039404000536 AM13 Licence No and 0310736143/30/05/2013 Date

UDIN00217773AM22

RLA, Mumbai vide e-mail dated 04.01.2022 has informed that the Advance Authorization No. 0310736143 dated 19.12.2012 has already been surrendered by the firm on 21.07.2015.

In view of above, the Committee decided to withdraw the case.

Case No.<br>35 / NC/3/MEET/Dec/202122/12
Case Status<br>Case Approved
Party Name<br>CALYX CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number<br>018205000714AM14
RA File Number<br>039404000199 AM14
Licence No and<br>Date<br>0310736614/04/06/2013
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in
Meeting No.18/82-ALC4/2013 dated 19.12.2013against advance authorization No.0310731505 dt.		16.04.2013, it
was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,
whichever is less:<br>
Export product<br>Qty.<br>Sl.

||16.04.2013, it|| |was decided to ratify 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.|| |Azithromycin Dihydrate 1 kg 1|Azithromycin Amine|1.007 kg|| |RA concerned may take further necessary action as per above decision of NC.||||

Case No.	36 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	THINQ PHARMA-CRO LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205000736AM14
RA File Number	039504000432 AM14
Licence No and<br>Date	0310749651/16/09/2013
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

RLA, Mumbai vide e-mail dated 04.01.2022 has informed that the Advance Authorization No. 0310749651 dated 01.11.2013 has already been redeemed on 24.10.2016. UDIN00217773AM22

In view of above, the Committee decided to withdraw the case.

informed that the Advance Authorization No. 0310749651 dated 01.11.2013 has already been redeemed on 24.10.2016. UDIN00217773AM22

In view of above, the Committee decided to withdraw the case.

Case No.		37 / NC/3/MEET/Dec/202122/12
Case Status		Case Approved
Party Name		SOMU SOLVENTS PVT. LTD
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number		018205000762AM14
RA File Number		072404000233 AM14
Licence No and<br>Date		0710099060/18/10/2013
Norms Committee Decision:
RLA, Bangalore	vide e-mail dated 04.01.2022 has informed that the Advance Authorization No. 0710099060 dated
18.10.2013 was	issued on Repeat Basis taking cue from decision of Norms Committee-3 Meeting No. 8/82-
ALC4/2012 dated 22.05.2012 and the licence has also been redeemed on 27.04.2015.
In view of above, the Committee decided towithdrawthe case.

RLA, Bangalore vide e-mail dated 04.01.2022 has informed that the Advance Authorization No. 0710099060 dated 18.10.2013 was issued on Repeat Basis taking cue from decision of Norms Committee-3 Meeting No. 8/82ALC4/2012 dated 22.05.2012 and the licence has also been redeemed on 27.04.2015.

0710099060 dated 18.10.2013 was issued on Repeat Basis taking cue from decision of Norms Committee-3 Meeting No. 8/82ALC4/2012 dated 22.05.2012 and the licence has also been redeemed on 27.04.2015.

Case No.	38 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	BLISS GVS PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205000959AM14
RA File Number	039404000687 AM14
Licence No and<br>Date	0310756546/01/11/2013
Norms Committee Decision:
RLA, Mumbai vide e-mail dated 04.01.2022 has informed that the Advance Authorization No. 0310756546 dated
01.11.2013 has already been redeemed on 29.10.2018.
In view of above, the Committee decided towithdrawthe case.

Case No.	39 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred

~~Signature Not V~~ erified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Party Name	ATGC BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021<br>UDIN00217773AM2
HQ File Number	018205001228AM14
RA File Number	092404000275 AM14
Licence No and<br>Date	0910058222/13/11/2013
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Copy of 4.07 application having copy of Advance Authorization alongiwth complete technical details as per
Annexure to Appendix 4E

d to call for following information from the firm:|| |Copy of 4.07 application having copy of Advance Authorization alongiwth complete technical details as per|| |Annexure to Appendix 4E||

Case No.	40 / NC/3/MEET/Dec/202122/12	40 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	AUCTUS PHARMA LIMITED
Meeting Number
<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205000937AM14
RA File Number	092404000436 AM14
Licence No and
Date	0910058486/06/12/2013
Norms Committee<br>	Decision:<br>
The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having copy of Advance Authorization alongiwth complete technical details as<br>per Annexure to Appendix 4E.<br>i.

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

Case No.	41 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	NECTAR LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205000137AM15
RA File Number	222404000096 AM14
Licence No and<br>Date	2210014646/28/02/2014
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having copy of Advance Authorization alongiwth complete technical details as<br>i.

per agenda and it was decided to call for following information from the firm: Copy of 4.07 application having copy of Advance Authorization alongiwth complete technical details as i.||

i. Copy of 4.07 application having copy of Advance Authorization alongiwth complete technical details as

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

per Annexure to Appendix 4E.

UDIN00217773AM22

Case No.	42 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	VIVIMED LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205000965AM15
RA File Number	092404000039 AM15
Licence No and<br>Date	0910059887/28/04/2014
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Copy of 4.07 application having copy of Advance Authorization alongiwth complete technical details as<br>i.
per Annexure to Appendix 4E.

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

tails as** i.|| |per Annexure to Appendix 4E.||

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

Case No.	43 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	WANBURY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205000547AM16
RA File Number	039504000934 AM15
Licence No and<br>Date	0310794735/20/03/2015
Norms Committee Decision:
RLA, Mumbai vide e-mail dated 04.01.2022 has informed that the Advance Authorization No. 0310794735 dated
20.03.2015 has already been surrendered by the firm on 21.02.2018.
In view of above, the Committee decided towithdrawthe case.

Case No.	44 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	U SQUARE LIFESCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001592AM16
RA File Number	082404000237 AM16<br>
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deput<br>Date: 21-Jan-2022 12:16:2<br>Reason: AJAY.DHIMAN88<br>Location: DGFT(HQ)<br>~~Signature Not~~

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Licence No and 0810136380/28/10/2015 Date Norms Committee Decision:

UDIN00217773AM22

: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Licence No and 0810136380/28/10/2015 Date Norms Committee Decision:

UDIN00217773AM22

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

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

Case No.	45 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	INDO AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001545AM16
RA File Number	039404000240 AM16
Licence No and<br>Date	0310799907/30/10/2015
Norms Committee Decision:<br>RLA, Mumbai vide e-mail dated 04.01.2022 has informed that the Advance Authorization No. 0310799907 dated<br>30.10.2015 has already been surrendered by the firm on 27.12.2016.<br>In view of above, the Committee decided towithdrawthe case.

ormed that the Advance Authorization No. 0310799907 dated 30.10.2015 has already been surrendered by the firm on 27.12.2016. In view of above, the Committee decided towithdrawthe case.||

Case No.	46 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	U SQUARE LIFESCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205000190AM17
RA File Number	082404000453 AM16
Licence No and<br>Date	0810137554/30/03/2016
Norms Committee Decision:<br>The Committee considered the case as per Agenda and it was observed that Norms Committee-3 in its Meeting No.<br>7/82-ALC4/2016 dated 07.07.2016has already ratified the adhoc noms against Advance Authorization No.<br>0810137554 dated 30.03.2016.<br>In view of above, the Committee decided towithdrawthe case.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Committee decided towithdrawthe case.||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

	UDIN00217773AM2
Case No.	47 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	AVA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205000864AM18
RA File Number	039404000467 AM18
Licence No and<br>Date	0310815663/11/09/2017
Norms Committee Decision:<br>The Committee considered the case as per Agenda and it was observed that Norms Committee-3 in its Meeting No.<br>8/82-ALC4/2016 dated 31.08.2018has already ratified the adhoc noms against Advance Authorization No.<br>0310815663 dated 11.09.2017.<br>In view of above, the Committee decided towithdrawthe case.

Case No.	48 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205000782AM19
RA File Number	039404001053 AM18
Licence No and<br>Date	0310819947/20/03/2018
Norms Committee Decision:<br>The Committee considered the case as per Agenda and it was observed that Norms Committee-3 in its Meeting No.<br>12/82-ALC4/2018 dated 20.03.2018has already ratified the adhoc noms against Advance Authorization No.<br>0310819947 dated 20.03.2018.<br>In view of above, the Committee decided towithdrawthe case.

dated 20.03.2018has already ratified the adhoc noms against Advance Authorization No. 0310819947 dated 20.03.2018. In view of above, the Committee decided towithdraw**the case.||

The Committee considered the case as per Agenda and it was observed that Norms Committee-3 in its Meeting No. 12/82-ALC4/2018 dated 20.03.2018 has already ratified the adhoc noms against Advance Authorization No. 0310819947 dated 20.03.2018.

Case No.	49 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001836AM19
RA File Number	052304000070 AM19
Licence No and<br>Date	0510406734/05/06/2018

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Deferred for comments of TE.

Case No.	50 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001842AM19
RA File Number	052304000501 AM18
Licence No and<br>Date	0510406802/08/06/2018
Norms Committee Decision:<br>Deferred for comments of TE.

12 and 17/12/2021| |HQ File Number|018205001842AM19| |RA File Number|052304000501 AM18| |Licence No and Date|0510406802/08/06/2018| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	51 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001840AM19
RA File Number	052304000121 AM19
Licence No and<br>Date	0510406800/08/06/2018
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	52 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001874AM19
RA File Number	052304000167 AM19
Licence No and<br>Date	0510407069/04/07/2018
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

	UDIN00217773AM2
Case No.	53 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001875AM19
RA File Number	052304000163 AM19
Licence No and<br>Date	0510407077/04/07/2018
Norms Committee Decision:<br>Deferred for comments of TE.

12 and 17/12/2021| |HQ File Number|018205001875AM19| |RA File Number|052304000163 AM19| |Licence No and Date|0510407077/04/07/2018| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	54 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205002074AM19
RA File Number	052304000166 AM19
Licence No and<br>Date	0510407070/04/07/2018
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	55 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001876AM19
RA File Number	052304000164 AM19
Licence No and<br>Date	0510407078/04/07/2018
Norms Committee Decision:<br>Deferred for comments of TE

Case No.	56 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD	~~Sit Nt~~

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

|Party Name|AUROBINDO PHARMA LTD|~~Sit Nt~~|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021<br>UDIN00217773AM2
HQ File Number	018205001503AM19
RA File Number	092404000181 AM19
Licence No and<br>Date	0910066442/11/07/2018
Norms Committee Decision:<br>The Committee considered the reply received from the firm and it was observed that the firm now intends to change<br>the description of the export product (nine export products) which will directly change the import entitlement without<br>getting the licence amended. Further, the UOM of Import Item No. 2 – Clavulanate Potassium + Syolid is in KG<br>Activity, which has no relevance with the quantity applied.<br>In view of above discrepancies, the Committee has decided to grant Personal Hearing to firm to<br>explain their case.

The Committee considered the reply received from the firm and it was observed that the firm now intends to change the description of the export product (nine export products) which will directly change the import entitlement without getting the licence amended. Further, the UOM of Import Item No. 2 – Clavulanate Potassium + Syolid is in KG Activity, which has no relevance with the quantity applied.

import entitlement without getting the licence amended. Further, the UOM of Import Item No. 2 – Clavulanate Potassium + Syolid is in KG Activity, which has no relevance with the quantity applied.

Case No.	57 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001889AM19
RA File Number	052304000183 AM19
Licence No and<br>Date	0510407217/17/07/2018
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	Case No.	58 / NC/3/MEET/Dec/202122/12	58 / NC/3/MEET/Dec/202122/12	58 / NC/3/MEET/Dec/202122/12	58 / NC/3/MEET/Dec/202122/12	58 / NC/3/MEET/Dec/202122/12
Case Status		Case Approved
Party Name		YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number		018205001112AM19
RA File Number		039504000445 AM19
Licence No and<br>Date		0310822942/09/08/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.
	Export product		Qty.	Sl. No.	Import items	Qty.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

r>Qty.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

R	MOLYBDENUM<br>DI<br>(2-<br>ETHYLHEXYL) PHOSPHORO<br>DITHIOATE(YALUB LA)	10000 kg	1	MOLYBDENUM TRIOXIDE<br>UD	2100 kg<br>IN00217773AM2
			2	2-ETHYL HEXANOL	5600 kg
	A concerned may take further necessary action as per above decision of NC.

Case No.	59 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001927AM19
RA File Number	052304000232 AM19
Licence No and<br>Date	0510407550/20/08/2018
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	60 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001928AM19
RA File Number	052304000231 AM19
Licence No and<br>Date	0510407551/20/08/2018
Norms Committee Decision:<br>Deferred for comments of TE.

12 and 17/12/2021| |HQ File Number|018205001928AM19| |RA File Number|052304000231 AM19| |Licence No and Date|0510407551/20/08/2018| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	61 / NC/3/MEET/Dec/202122/12
Case Status	Case Rejected
Party Name	DCM SHRIRAM INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001413AM19
RA File Number	052304000242 AM19
Licence No and<br>Date	0510407689/05/09/2018<br>~~Signature Not V~~
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deput<br>Date: 21-Jan-2022 12:16:2<br>Reason: AJAY.DHIMAN88<br>Location: DGFT(HQ)<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

The Committee considered the reply received from the firm and it was observed that the reply furnished by the firm was not proper.

Hence, the Committee decided to reject the case.

Case No.	62 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205002026AM19
RA File Number	052304000297 AM19
Licence No and<br>Date	0510408024/08/10/2018
Norms Committee Decision:<br>Deferred for comments of TE.

12 and 17/12/2021| |HQ File Number|018205002026AM19| |RA File Number|052304000297 AM19| |Licence No and Date|0510408024/08/10/2018| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	63 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205002027AM19
RA File Number	052304000295 AM19
Licence No and<br>Date	0510408025/08/10/2018
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	64 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	SONGWON SPECIALTY CHEMICALS - INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001146AM19
RA File Number	342404000232 AM19
Licence No and<br>Date	3410044578/11/10/2018
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

The Committee consider the case and it was observed that Norms Committee-3 in its Meeting No. 22/82-ALC4/2013 dated 20.02.2014 has already fixed the adhoc norms against Advance Authorization No. 3410044578 dated 11.10.2018 . UDIN00217773AM22

In view of above the Committee decided to withdraw the case.

0.02.2014** has already fixed the adhoc norms against Advance Authorization No. 3410044578 dated 11.10.2018 . UDIN00217773AM22

In view of above the Committee decided to withdraw the case.

Case No.	65 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205002054AM19
RA File Number	092404000345 AM19
Licence No and<br>Date	0910066762/25/10/2018
Norms Committee Decision:<br>The Committee considered the reply received from the firm and it was observed that the reply furnished by the firm<br>was not proper.<br> The Committee after deliberation has decided to grant Personal Hearing to firm to explain their<br>case.

The Committee considered the reply received from the firm and it was observed that the reply furnished by the firm was not proper.

Case No.	66 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205002095AM19
RA File Number	092404000386 AM19
Licence No and<br>Date	0910066874/20/11/2018
Norms Committee Decision:<br>The Committee considered the reply received from the firm and it was observed that the reply furnished by the firm<br>was not proper.<br> The Committee after deliberation has decided to grant Personal Hearing to firm to explain their<br>case.

m and it was observed that the reply furnished by the firm was not proper. The Committee after deliberation has decided to grant Personal Hearing to firm to explain their case.||

The Committee considered the reply received from the firm and it was observed that the reply furnished by the firm was not proper.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Case No.	67 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved<br>UDIN00217773AM2
Party Name	VENOR PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205002132AM19
RA File Number	612404000016 AM19
Licence No and<br>Date	6110001566/28/11/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Tab. Morphine Sulphate 10 mg<br>1 Number<br>1<br>Morphine Sulphate EP/BP<br>10.2 mg<br>2<br>Tab. Morphine Sulphate 10 mg<br>ER/PR/CR/SR<br>1 Number<br>1<br>Morphine Sulphate EP/BP<br>10.2 mg<br>3<br>Tab. Morphine Sulphate 20 mg<br>1 Number<br>1<br>Morphine Sulphate EP/BP<br>20.4 mg<br>4<br>Tab. Morphine Sulphate 20 mg<br>PR/ER/CR/SR<br>1 Number<br>1<br>Morphine Sulphate EP/BP<br>20.4 mg<br>5<br>Tab.

Morphine Sulphate 20 mg 1 Number 1 Morphine Sulphate EP/BP 20.4 mg 4 Tab. Morphine Sulphate 20 mg PR/ER/CR/SR 1 Number 1 Morphine Sulphate EP/BP 20.4 mg 5 Tab. Morphine Sulphate 30 mg 1 Number 1 Morphine Sulphate EP/BP 30.6 mg 6 Tab. Morphine Sulphate 30 mg PR/ER/CR/SR 1 Number 1 Morphine Sulphate EP/BP 30.6 mg 7 Tab. Morphine Sulphate 15 mg 1 Number 1 Morphine Sulphate EP/BP 15.3 mg 8 Inj. Morphine Sulphate 10 mg 1 Number 1 Morphine Sulphate EP/BP 11.00 mg 9 Inj. Morphine Sulphate 15 mg 1 Number 1 Morphine Sulphate EP/BP 16.5 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	68 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	VENOR PHARMA LIMITED	~~Sinature Not V~~

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Approved|| |Party Name|VENOR PHARMA LIMITED|~~Sinature Not V~~|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021<br>UDIN00217773AM2
HQ File Number	018205002127AM19
RA File Number	612404000013 AM19
Licence No and<br>Date	6110001561/28/11/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Inj. Fentanyl Citrate 50 mcg/ml,<br>2ml Ampoule<br>2316150.0<br>Number<br>1<br>Fentanyl Citrate USP/EP<br>400 gram<br>2<br>Inj. Fentanyl Citrate 50 mcg/ml,<br>10ml Ampoule<br>231600.0<br>Number<br>1<br>Fentanyl Citrate USP/EP<br>200 gram<br>RA concerned may take further necessary action as per above decision of NC.

Inj. Fentanyl Citrate 50 mcg/ml, 10ml Ampoule 231600.0 Number 1 Fentanyl Citrate USP/EP 200 gram RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	Case No.	69 / NC/3/MEET/Dec/202122/12	69 / NC/3/MEET/Dec/202122/12	69 / NC/3/MEET/Dec/202122/12	69 / NC/3/MEET/Dec/202122/12	69 / NC/3/MEET/Dec/202122/12
Case Status			Case Approved
Party Name			VENOR PHARMA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number			018205002129AM19
RA File Number			612404000015 AM19
Licence No and<br>Date			6110001563/28/11/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Tab. Hydromorphone HCl 2mg<br>1 Number<br>1<br>Hydromorphone HCL<br>2.04 mg /<br>2 mg Tablet<br>2<br>Tab. Hydromorphone HCl 4mg<br>1 Number<br>1<br>Hydromorphone HCL<br>4.08 mg /<br>4 mg Tablet
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.
	1	Tab. Hydromorphone HCl 2mg		1 Number	1	Hydromorphone HCL	2.04 mg /<br>2 mg Tablet
	2	Tab. Hydromorphone HCl 4mg		1 Number	1	Hydromorphone HCL	4.08 mg /<br>4 mg Tablet

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

R	3	Inj. Hydromorphone HCl 10mg	1 Number	1	Hydromorphone HCL	11.00 mg /<br>10 mg Injection<br>UDIN00217773AM2
	4	Inj. Hydromorphone HCL 2mg	1 Number	1	Hydromorphone HCL	2.20 mg /<br>2 mg Injection
	A concerned may take further necessary action as per above decision of NC.

Case No.	70 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	VENOR PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205002130AM19
RA File Number	612404000018 AM19
Licence No and<br>Date	6110001564/28/11/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Inj. Adrenaline BP (Epinephrine) 1mg/ml<br>,<br>1<br>ml<br>Ampoule<br>Inj.<br>Adrenaline<br>(Epinephrine)<br>1mg/ml<br>,<br>1<br>ml<br>Ampoule(content 1.2082kgs. of imported<br>item).<br>1 Number<br>1<br>Adrenaline Bitartrate BP<br>1.10 mg<br>RA concerned may take further necessary action as per above decision of NC.

1 ml Ampoule(content 1.2082kgs. of imported item). 1 Number 1 Adrenaline Bitartrate BP 1.10 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	71 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205002145AM19
RA File Number	052304000385 AM19<br>
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deput<br>Date: 21-Jan-2022 12:16:<br>Reason: AJAY.DHIMAN88<br>Location: DGFT(HQ)<br>~~Signature Not V~~

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Licence No and 0510408748/04/12/2018 Date

UDIN00217773AM22

Deferred for comments of TE.

Case No.	72 / NC/3/MEET/Dec/202122/12
Case Status	Case Rejected
Party Name	VENOR PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205002178AM19
RA File Number	612404000020 AM19
Licence No and<br>Date	6110001570/13/12/2018
Norms Committee Decision:<br>The Committee considered the reply received from the firm and it was observed that the firm does not hold valid DML<br>for 10 ml injection.<br> Hence, the Committee decided torejectthe case.

The Committee considered the reply received from the firm and it was observed that the firm does not hold valid DML for 10 ml injection. Hence, the Committee decided torejectthe case.||

Case No.	Case No.	73 / NC/3/MEET/Dec/202122/12	73 / NC/3/MEET/Dec/202122/12	73 / NC/3/MEET/Dec/202122/12	73 / NC/3/MEET/Dec/202122/12	73 / NC/3/MEET/Dec/202122/12
Case Status		Case Approved
Party Name		ATUL LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number		018205002209AM19
RA File Number		082404000303 AM19
Licence No and<br>Date		0810144142/21/12/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Methanol<br>168000 kg<br>Aromatic Amines<br>700000 kg<br>2<br>Aniline<br>700000 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Aromatic Amines		700000 kg	1	Methanol	168000 kg
				2	Aniline	700000 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

8000 kg| |||||2|Aniline|700000 kg| ||||||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Case No.	74 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205002275AM19
RA File Number	318304000136 AM19
Licence No and<br>Date	3110067283/15/01/2019
Norms Committee Decision:<br>The Committee consider the case and it was observed that Norms Committee-3 in its Meeting No.15/82-ALC4/2018<br>dated 22.03.2019has already fixed the adhoc norms against Advance Authorization No.3110067283 dated<br>15.01.2019.<br>In view of above the Committee decided towithdrawthe case.

Case No.	75 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	TITAN LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205000340AM20
RA File Number	039504000318 AM20
Licence No and<br>Date	0310830043/03/07/2019
Norms Committee Decision:<br>The Committee considered the reply received from the firm and it was observed that the reply furnished by the firm<br>was not proper.

and Date|0310830043/03/07/2019| |Norms Committee Decision: The Committee considered the reply received from the firm and it was observed that the reply furnished by the firm was not proper. Hence, it was decided to again call for following information from the firm: Copy of Master Batch Formula showing net content in export product. i. Percentage overages applied in each import. ii. Copy of COA of Eudragit L 30 D55.||

Case No.	76 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	THINQ PHARMA-CRO LIMITED
Meeting Number	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021	~~Signature Not V~~erified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

and Date	and Date
HQ File Number		018205000374AM20<br>UDIN00217773AM2
RA File Number		039504000338 AM20
Licence No and		0310830207/10/07/2019
Date
Norms Committee		Decision:
The Committee co		nsidered the case as er aenda and it was decided to ratif adhoc norms under Para 407 of HBP
<br>Vol. I as per detail		p g y .<br>s given below or as applied by the firm, whichever is less:



	Export product		Qty.	Sl. No.	Import items	Qty.
	2-Phenoxypropionyl Chloride		1 kg	1	Methyl 2-Chloropropionate	1.66 kg

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

Sl. No.|Import items|Qty.|| ||2-Phenoxypropionyl Chloride||1 kg|1|Methyl 2-Chloropropionate|1.66 kg|| ||||||||| |RA concerned may take further necessary action as per above decision of NC.||||||||

Case No.<br>77 / NC/3/MEET/Dec/202122/12
Case Status<br>Case Approved
Party Name<br>ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number<br>018205000381AM20
RA File Number<br>039504000335 AM20
Licence No and<br>Date<br>0310830246/12/07/2019
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm even after reminder has stated that
yield is 1.45% which is vague. Hence, taking 90% yield, the Committee 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:<br>
Export product<br>Qty.	Sl. No.	Import items	Qty.
Rose Nitrile AB15143 (Benzeneα<br>1 kg	1	Benzyl Cyanide	0.66 kg
Acetonitrile Cyclohexylidene)
	2	Cyclo hexanone	0.5527 kg
RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Case No.	78 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved<br>UDIN00217773AM2
Party Name	ACME GENERICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205000462AM20
RA File Number	222404000031 AM20
Licence No and<br>Date	2210016214/26/07/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Acetylsalicylic Asid (ASA) Enteric<br>coated<br>tablet<br>80mg((Each<br>Tablet<br>contain ASPIRIN DC90 20-100M -<br>90.40 mg))<br>1,44,00,000<br>Numbers<br>1<br>ASPIRIN DC90 20- 100M<br>1300 kg<br>RA concerned may take further necessary action as per above decision of NC

t contain ASPIRIN DC90 20-100M - 90.40 mg)) 1,44,00,000 Numbers 1 ASPIRIN DC90 20- 100M 1300 kg RA concerned may take further necessary action as per above decision of NC||

Case No.<br>	Case No.<br>	79 / NC/3/MEET/Dec/202122/12	79 / NC/3/MEET/Dec/202122/12	79 / NC/3/MEET/Dec/202122/12	79 / NC/3/MEET/Dec/202122/12	79 / NC/3/MEET/Dec/202122/12
Case Status<br>		Case Approved
Party Name<br>		PANACEA BIOTEC LIMITED
Meeting Number<br>and Date<br>		NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number<br>		018205001041AM20
RA File Number<br>		052404000683 AM20
Licence No and<br>Date<br>		0510413419/22/01/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Purified Diptheria Toxoid<br>Concentrate Antigen Bulk<br>@2050 Lf/ml<br>13.64 Litre<br>Purified Tetanus Toxoid<br>Easy Five TT Vaccine DTwP-Hep B-<br>Hib-Pentavalent Vaccine (Each vial of<br>0.5 ml contains 1 dose)<br>1<br>Million<br>Vials<br>2<br>5.23 Litre
	Export product		Qty.	Sl. No.	Import items	Qty.
	Easy Five TT Vaccine DTwP-Hep B-<br>Hib-Pentavalent Vaccine (Each vial of<br>0.5 ml contains 1 dose)		<br>1<br>Million<br>Vials	1<br>	Purified Diptheria Toxoid<br>Concentrate Antigen Bulk<br>@2050 Lf/ml	13.64 Litre
				2	Purified Tetanus Toxoid	5.23 Litre

ch vial of 0.5 ml contains 1 dose)|| 1 Million Vials|1 |Purified Diptheria Toxoid Concentrate Antigen Bulk @2050 Lf/ml|13.64 Litre| |||||2|Purified Tetanus Toxoid|5.23 Litre|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)


		Concentrate Antigen @1900	UDIN00217773AM22
		Lf/ml
	3	Inactivated Whole Cell Pertussis		86.46 ml
		Bulk @192 OU/ml
	4	Rubber Stopper		1010000
				Numbers
	5	AGS HB Purification MABS		5.4 Litre
		Column
A concerned may take further necessary action as per above decision of NC.

Case No.	80 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001169AM20
RA File Number	039504001164 AM20
Licence No and<br>Date	0310835580/20/03/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that Norms Committee-3 in its Meeting No.
NC/3/MEET/Jan/202021/4 dated 12.02.2021 has already fixed the adhoc norms against Advance Authorization No.
0310835580 dated	20.03.2020. Further it was also observed that this case has come up in the portal due to some
technical error. Hence, the Committee decided towithdrawthe case.

on No.|| |0310835580 dated|20.03.2020. Further it was also observed that this case has come up in the portal due to some| |technical error. Hence, the Committee decided towithdrawthe case.||

Case No.	81 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	PIRAMAL ENTERPRISES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001175AM21
RA File Number	039504001215 AM20
Licence No and<br>Date	0310835591/11/04/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that Norms Committee-3 in its Meeting No.<br>NC/3/MEET/Jan/202021/4 dated 12.02.2021 has already fixed the adhoc norms against Advance Authorization No.<br>0310835591 dated 11.04.2020. Further it was also observed that this case has come up in the portal due to some<br>
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deput<br>Date: 21-Jan-2022 12:16:2<br>Reason: AJAY.DHIMAN88<br>Location: DGFT(HQ)<br>~~Signature Not V~~

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

technical error. Hence, the Committee decided to withdraw the case.

UDIN00217773AM22

ay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

technical error. Hence, the Committee decided to withdraw the case.

UDIN00217773AM22

Case No.	82 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001847AM21
RA File Number	052304000050 AM21
Licence No and<br>Date	0510414389/12/06/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm vide its letter dated 08.01.2021<br>has stated that they have filed this application under Para 4.12 of HBP Vol. I instead of Para 4.07 HBP Vol. I.<br>Accordingly, the Committee decided to advise the firmto first get the licence amended from CLA, New Delhi<br>and then they should apply for fixation of adhoc norms.

Case No.	83 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001399AM21
RA File Number	022404000027 AM21
Licence No and<br>Date	0210209928/18/06/2020
Norms Committee Decision:<br>Deferred for comments of D/o C&PC.

d 17/12/2021| |HQ File Number|018205001399AM21| |RA File Number|022404000027 AM21| |Licence No and Date|0210209928/18/06/2020| |Norms Committee Decision: Deferred for comments of D/o C&PC.||

Case No.	84 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001400AM21
RA File Number	022404000028 AM21
Licence No and<br>Date	0210209929/18/06/2020
Norms Committee Decision:<br>Deferred for comments of D/o C&PC

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Case No.	85 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001417AM21
RA File Number	022404000030 AM21
Licence No and<br>Date	0210209934/23/06/2020
Norms Committee Decision:
Deferred for comments of D/o C&PC.

Case No.	86 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001418AM21
RA File Number	022404000031 AM21
Licence No and<br>Date	0210209935/23/06/2020
Norms Committee Decision:
Deferred for comments of D/o C&PC.

d 17/12/2021| |HQ File Number|018205001418AM21| |RA File Number|022404000031 AM21| |Licence No and Date|0210209935/23/06/2020| |Norms Committee Decision:|| |Deferred for comments of D/o C&PC.||

Case No.<br>87 / NC/3/MEET/Dec/202122/12	Case No.<br>87 / NC/3/MEET/Dec/202122/12	Case No.<br>87 / NC/3/MEET/Dec/202122/12
Case Status<br>Case Approved
Party Name<br>MAHI DRUGS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number<br>018205001438AM21
RA File Number<br>262404000003 AM21
Licence No and<br>Date<br>2610012912/30/06/2020
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<br>				is less:
	Export product	Qty.	Sl. No.	Import items	Qty.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

||is less:||| ||Export product|Qty.|Sl. No.|Import items|Qty.||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)


N-(2-AMINO-4,	6-DICHLORO-5-		1 kg	1	GUANIDINE NITRATE	1.32 kg<br>UDIN00217773AM22
PYRIMIDINYL)-FORMAMIDE		(OR)
FADCP (OR) ABV3 INTERMEDIATE OF
ABACAVIR				2	DIETHYL MALONATE		1.73 kg
				3	PROPIONIC ACID		0.88<br>kg
				4	POTASSIUM CARBONATE		1.88 kg
				5	HYDRAZINE HYDRATE		0.78 kg
				6	TOLUENE		0.80 kg
				7	METHANOL		0.85 kg
A concerned may take further necessary		action as per above decision of NC.

Case No.<br>88 / NC/3/MEET/Dec/202122/12
Case Status<br>Case Approved
Party Name<br>ENCEE AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number<br>018205001449AM21
RA File Number<br>322404000019 AM21
Licence No and<br>Date<br>3210079591/02/07/2020
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:<br>
Export product<br>Qty.	Sl. No.	Import items	Qty.
Secondary Butyl Quinoline<br>1 kg	1	Glycerine	2.748 kg
RA concerned may take further necessary action as per above decision of NC.

Case No. 89 / NC/3/MEET/Dec/202122/12

rt items|Qty.|| |Secondary Butyl Quinoline 1 kg|1|Glycerine|2.748 kg|| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No. 89 / NC/3/MEET/Dec/202122/12

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Case Status	Case Approved
Party Name	ORTIN LABORATORIES LIMITED<br>UDIN00217773AM2
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001532AM21
RA File Number	092404000197 AM21
Licence No and<br>Date	0910069018/05/08/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Imidazole Ester<br>0.42 kg<br>OLMESARTAN (OTL) III<br>1 kg<br>2<br>4-Chloromethyl-5-Methyl-1,3- Dioxalene SH 0.375 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	90 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	BIOLOGICAL E. LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001585AM21
RA File Number	092404000253 AM21
Licence No and<br>Date	0910069107/27/08/2020
Norms Committee Decision:<br>Deferred for comments of D/o Bio Technology

021| |HQ File Number|018205001585AM21| |RA File Number|092404000253 AM21| |Licence No and Date|0910069107/27/08/2020| |Norms Committee Decision: Deferred for comments of D/o Bio Technology||

Case No.	91 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001586AM21
RA File Number	039504000299 AM21
Licence No and Date	0310837947/28/08/2020
Norms Committee Decision:<br>
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deput<br>Date: 21-Jan-2022 12:16:2<br>Reason: AJAY.DHIMAN88<br>Location: DGFT(HQ)<br>~~Signature Not~~

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 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: UDIN00217773AM22

Export product	Qty.	Sl. No.	Import items	Qty.
LUMEFANTRINE	1 kg	1	FLUORINE	0.900 kg
		2	DIMETHYL FORMAMIDE (DMF)	0.555 kg
		3	SODIUM BOROHYDRIDE	0.060 kg
		4	N,N-DIBUTYL AMINE (N- DBA)	0.500 kg
		5	4- CHLOROBENZALDEHYDE	0.3476 kg

| |LUMEFANTRINE|1 kg|1|FLUORINE|0.900 kg| |||2|DIMETHYL FORMAMIDE (DMF)|0.555 kg| |||3|SODIUM BOROHYDRIDE|0.060 kg| |||4|N,N-DIBUTYL AMINE (N- DBA)|0.500 kg| |||5|4- CHLOROBENZALDEHYDE|0.3476 kg|

Case No.	92 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001604AM21
RA File Number	052304000157 AM21
Licence No and<br>Date	0510415066/31/08/2020
Norms Committee Decision:<br>The Committee considered the reply received from the firm and it was observed that the reply furnished by the firm<br>was not proper. Hence, it was decided to again call for following information from the firm:<br>The firm has shown molar yield of 100%, 84% and 90% in three steps reactions under Appendix 4E. However,<br>norms applied for import item No. 1 (MNT –V) does not match with the given yields. Technical justification<br>with correct c.c. may be furnished with calculation.

Case No.	93 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	CONCORD BIOTECH LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
		~~Sit Nt~~

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

/ 202122/ 12 and 17/12/2021|| |||~~Sit Nt~~|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

HQ File Number	018205001614AM21
RA File Number	082404000395 AM20	UDIN00217773AM2
Licence No and<br>Date	0810148478/03/09/2020
Norms Committee Decision:
The Committee considered the reply received from the firm and it was observed that the reply furnished by the firm
was not proper. Hence, it was decided to call the firm for Personal		Hearing before Norms Committee alongwith
following documents / information:
Production / Consumption data duly certified by Central<br>i.		Taxes & GST Authorities for the specific
Export Quantities as approved by FDA, Gujarat.

The Committee considered the reply received from the firm and it was observed that the reply furnished by the firm was not proper. Hence, it was decided to call the firm for Personal Hearing before Norms Committee alongwith following documents / information:

i. Production / Consumption data duly certified by Central Taxes & GST Authorities for the specific Export Quantities as approved by FDA, Gujarat.

ngwith following documents / information:

i. Production / Consumption data duly certified by Central Taxes & GST Authorities for the specific Export Quantities as approved by FDA, Gujarat.

Case No.	Case No.	94 / NC/3/MEET/Dec/202122/12
Case Status		Case Approved
Party Name		VENKATA NARAYANA ACTIVE INGREDIENTS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number		018205001669AM21
RA File Number		042404000098 AM21
Licence No and<br>Date		0410167074/18/09/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:<br>
	Export product	Qty.<br>Sl. No. Import items	Qty.
	1<br>Methylene Chloride { CAS NO. 75-09-2 }<br>Lacosamide (APIs<br>1 kg		9.58 kg
	/ Bulk Drugs)
		2<br>D-SERINE	0.71 kg
		3<br>DI TERTBUTYL DICARBONATE	1.60 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	95 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	ETERNIS FINE CHEMICALS LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

us|Case Approved|| |Party Name|ETERNIS FINE CHEMICALS LIMITED||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021<br>UDIN00217773AM2
HQ File Number	018205001693AM21
RA File Number	039404000283 AM21
Licence No and<br>Date	0310838453/24/09/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>PHENOL<br>1.15 kg<br>2<br>XYLENE<br>0.50 kg<br>3<br>MAGNESIUM TURNINGS<br>0.148 kg<br>4<br>PARAFORMALDEHYDE<br>0.9177 kg<br>COUMARIN<br>1 kg<br>5<br>ACETIC ANHYDRIDE<br>0.210 kg<br>RA concerned may take further necessary action as per above decision of NC.

TURNINGS 0.148 kg 4 PARAFORMALDEHYDE 0.9177 kg COUMARIN 1 kg 5 ACETIC ANHYDRIDE 0.210 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	96 / NC/3/MEET/Dec/202122/12	96 / NC/3/MEET/Dec/202122/12	96 / NC/3/MEET/Dec/202122/12	96 / NC/3/MEET/Dec/202122/12	96 / NC/3/MEET/Dec/202122/12
Case Status		Case Approved
Party Name		DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number		018205001703AM21
RA File Number		052304000197 AM21
Licence No and<br>Date		0510415370/30/09/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>L-2Aminobutyric Acid /<br>Levetiracetam USP/BP/EP/IP(Powder)<br>1 kg<br>1<br>0.95 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Levetiracetam USP/BP/EP/IP(Powder)		1 kg	1	L-2Aminobutyric Acid /	0.95 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

am USP/BP/EP/IP(Powder)||1 kg|1|L-2Aminobutyric Acid /|0.95 kg|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

			(L-2 Aminobutanoic Acid)<br>U	DIN00217773AM2
		2	Thionyl Chloride	1.20 kg

		3	4 -Chloro Butric Acid	1.02 kg
		4	Methylene Chloride<br>(Dichloromethane)	1.44 kg
		5	Ethyl Acetate	0.40 kg
		6	Methanol	0.78 kg

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

Case No.	97 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001710AM21
RA File Number	092404000362 AM21
Licence No and<br>Date	0910069287/30/09/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that overall yield claimed by the firm is very
low, that is in the range of 7% to 8%. Hence, it was decided to call for following information from the firm:
Technical Literature in support of the low yields claimed by the firm.<br>i.
Production / Consumption data duly certified by Central Taxes & GST Authorities.<br>ii.

from the firm:|| |Technical Literature in support of the low yields claimed by the firm. i.|| |Production / Consumption data duly certified by Central Taxes & GST Authorities. ii.||

Case No.	98 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001713AM21
RA File Number	039404000468 AM21
Licence No and<br>Date	0310838628/01/10/2020

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 9/82-ALC4/2019 dated 18.10.2019 against advance authorization No. 0310825931 dt. 26.12.2018 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: UDIN00217773AM22

Export product	Qty.	Sl. No.	Import items	Qty.
2,4-DICHLORO PHENYL<br>ACETYL CHLORIDE	1 kg	1	2,4- DICHLORO BENZYL CHLORIDE	1.27 kg
		2	SODIUM CYANIDE	0.3184 kg

Case No.	99 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	018205001724AM21
RA File Number	022404000087 AM21
Licence No and<br>Date	0210210144/06/10/2020
Norms Committee Decision:<br>Deferred for comments of D/o C&PC.

Case No.	100 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00117698AM21
RA File Number	03AA04033579 AM21
Licence No and<br>Date	0311002962/31/03/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Decision: Deferred for comments of TE.||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

	UDIN00217773AM2
Case No.	101 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00131100AM22
RA File Number	03AA04042288 AM22
Licence No and<br>Date	0311005109/05/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Sl. No. Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Ciclopirox Gel 0.77percent ( Pack 30<br>Gms) (Net wt. of Ciclopirox USP is<br>20.790 Kgs.)<br>1 Number<br>1<br>Ciclopirox USP<br>235.62 mg<br>2<br>Ciclopirox Gel 0.77percent ( Pack 45<br>Gms) (Net wt. of Ciclopirox USP is<br>17.325 Kgs.)<br>1 Number<br>1<br>Ciclopirox USP<br>352.967 mg<br>3<br>Ciclopirox Gel 0.77percent ( Pack 100<br>Gms) (Net wt. of Ciclopirox USP is<br>61.600 Kgs.)<br>1 Number<br>1<br>Ciclopirox USP<br>785.00 mg<br>RA concerned may take further necessary action as per above decision of NC.

nt ( Pack 100 Gms) (Net wt. of Ciclopirox USP is 61.600 Kgs.) 1 Number 1 Ciclopirox USP 785.00 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	102 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00131294AM22
RA File Number	03AA04000438 AM22
Licence No and<br>Date	0311005125/05/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:

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: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Export product	Qty.	Sl. No.	Import items	Qty.
2,5-DIMETHYL PHENYL	1 kg	1	PARA XYLENE	1.485 kg
ACETYL CHLORIDE
		2	PARAFORMALDEHYDE	1.032 kg
		3	SODIUM CYANIDE	0.570 kg
		4	CAUSTIC SODA FLAKES	Being	shown
				indigenous,	hence not
				allowed
		5	THIONYL CHLORIDE	Being	shown
				indigenous,	hence not
				allowed
		6	HYDROCHLORIC ACID 30 PERCENT	Being	shown
				indigenous,	hence not
				allowed
		7	ZINC CHLORIDE	Being	shown
				indigenous,	hence not
				allowed


Case No		103 / NC/3/MEET/Dec/202122/12
.
Case Status		Case Approved

Party Name		ALKALOIDS CORPORATION

Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021

HQ File Number		HQRNORM APPLY 00131333AM22

RA File Number		02AA04012158 AM22

Licence No and<br>Date		0211000889/05/07/2021

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

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

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.|||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Digoxin 1 kg 1 Digitalis Lanata Leaves Dried UDIN00217773AM22 266.24 kg

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

Case No.	104 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	CUTCH OIL AND ALLIED INDUSTRIES 1949 PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00131418AM22
RA File Number	02AA04007136 AM22
Licence No and<br>Date	0211000893/05/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>End use of Export Product.<br>i.<br>Chemical process involved for Activation of Clay.<br>ii.<br>Justification for the quantity of import asked for.<br>iii.<br>Production / Consumption data for last two years duly certified by GST

process involved for Activation of Clay.** ii. Justification for the quantity of import asked for. iii. Production / Consumption data for last two years duly certified by GST||

Case No.	105 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00131665AM22
RA File Number	07AA04010170 AM22
Licence No and<br>Date	0711001416/06/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Whether the export product is Pitofenone Base or Pitofenone HCL.<br>i.<br>Molecular formula and molecular weight of Step III item appears to be incorrect.<br>ii.<br>Complete and balanced chemical reactions, molecular weight etc. for all the steps

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

molecular weight etc. for all the steps**||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

	UDIN00217773AM2
Case No.	106 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	LYRUS LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00131666AM22
RA File Number	07AA04005177 AM22
Licence No and<br>Date	0711001417/06/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the quantity of import appears to be<br>incorrect. Hence, it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i.<br>DML

Case No.	107 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00131778AM22
RA File Number	34AA04004352 AM22
Licence No and<br>Date	3411000801/06/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Commercial value of Residue and Low & High Boiler.<br>i.<br>Production / Consumption Data for last one year duly certified by GST.<br>ii.

call for following information from the firm: Commercial value of Residue and Low & High Boiler. i. Production / Consumption Data for last one year duly certified by GST. ii.||

Case No.	108 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	TATVA CHINTAN PHARMA CHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00131841AM22
RA File Number	34AA04004832 AM22
Licence No and<br>Date	3411000805/06/07/2021
Norms Committee Decision:<br>~~Signature Not V~~
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deput<br>Date: 21-Jan-2022 12:16:2<br>Reason: AJAY.DHIMAN88<br>Location: DGFT(HQ)<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 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. 3/82-ALC4/2019 dated 05.07.2019 against advance authorization No. 3410044856 dt. 31.01.2019 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: UDIN00217773AM22

Export product	Qty.	Sl. No.	Import items	Qty.
ETHYL TRIPHENYL PHOSPHONIUM<br>BROMIDE (CAS NO. 1530-32-1 ASSAY<br>NLT 99 PERCENT)	1 kg	1	TRIPHENYL PHOSPHINE	0.78 kg

M22

Export product	Qty.	Sl. No.	Import items	Qty.
ETHYL TRIPHENYL PHOSPHONIUM<br>BROMIDE (CAS NO. 1530-32-1 ASSAY<br>NLT 99 PERCENT)	1 kg	1	TRIPHENYL PHOSPHINE	0.78 kg

Case No.	Case No.	Case No.	109 / NC/3/MEET/Dec/202122/12	109 / NC/3/MEET/Dec/202122/12	109 / NC/3/MEET/Dec/202122/12	109 / NC/3/MEET/Dec/202122/12	109 / NC/3/MEET/Dec/202122/12
Case Status			Case Approved
Party Name			SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number			HQRNORM APPLY 00132390AM22
RA File Number			05AA04029795 AM22
Licence No and<br>Date			0511003464/06/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Sl. No. Export product<br>Qty.<br>Sl. No.

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 Azelastine Hydrochloride Nasal Solution (Nasal Spray) 0.1Percent W/V 30ML.((Each spray contains Azelastine Hydrochloride equivalent to 30 mg) (Equivalent to 18810.000 Gram of bulk drug)) 627000 Number 1 Azelastine Hydrochloride 17523.40 grams 2 Azelastine Hydrochloride Ophthalmic Solution 0.05 Percent W/V 6ML((Each solution contains Azelastine Hydrochloride equivalent to 3 mg) (Equivalent to 600.000 Gram of bulk drug) (Total Net Contents 19410 Gram)) 200000 Number 1 Azelastine Hydrochloride 612.00 grams ~~Sinature Not~~|||||||| ||Sl. No.|Export product||Qty.|Sl. No.|Import items|Qty.| ||1|Azelastine Hydrochloride Nasal Solution (Nasal Spray) 0.1Percent W/V 30ML.((Each spray contains Azelastine Hydrochloride equivalent to 30 mg) (Equivalent to 18810.000 Gram of bulk drug))|| 627000 Number|1|Azelastine Hydrochloride|17523.40 grams| ||2|Azelastine Hydrochloride Ophthalmic Solution 0.05 Percent W/V 6ML((Each solution contains Azelastine Hydrochloride equivalent to 3 mg) (Equivalent to 600.000 Gram of bulk drug) (Total Net Contents 19410 Gram))|| 200000 Number|1|Azelastine Hydrochloride|612.00 grams ~~Sinature Not~~|

to 3 mg) (Equivalent to 600.000 Gram of bulk drug) (Total Net Contents 19410 Gram))|| 200000 Number|1|Azelastine Hydrochloride|612.00 grams ~~Sinature Not~~| |ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022. Digitally Signed. Name: Ajay Kumar( Deput Date: 21-Jan-2022 12:16: Reason: AJAY.DHIMAN88 Location: DGFT(HQ) g||||||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Case No.<br>110 / NC/3/MEET/Dec/202122/12
Case Status<br>Case Deferred
Party Name<br>CIPLA LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number<br>HQRNORM APPLY 00132405AM22
RA File Number<br>03AA04031879 AM22
Licence No and<br>Date<br>0311005159/06/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Copy of DML with Approved Composition.<br>i.
C.C. for 1 kg Remesivir a.i. achieved.<br>ii.
Quantity of Remdesivir required for 1 Number vial.<br>iii.
Percentage wastage applied from Remdesivir a.i. stage.

position.** i.| |C.C. for 1 kg Remesivir a.i. achieved. ii.| |Quantity of Remdesivir required for 1 Number vial. iii.| |Percentage wastage applied from Remdesivir a.i. stage.|

Case No.<br>111 / NC/3/MEET/Dec/202122/12	Case No.<br>111 / NC/3/MEET/Dec/202122/12
Case Status<br>Case Approved
Party Name<br>RINI LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202122/ 12 and		17/12/2021
HQ File Number<br>HQRNORM APPLY 00132483AM22
RA File Number<br>56AA04002017 AM22
Licence No and<br>Date<br>5611000361/06/07/2021
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-ALC4/2019 dated 21.06.2019against advance authorization No.0910062959 dt.					10.12.2015, it
was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,
whichever is less:
Export product<br>Qty.	Sl. No.	Import items			Qty.
Moxifloxacin Hydrochloride<br>1 kg	1	1-CYCLOPROPYL-6,7-		DIFLUORO-1,4-	0.9765 kg
		DIHYDRO-8-	METHOXY-4-OXO-3-
BP / USP / IP / BP-EP / EP		QUINOLINE CARBOXYLIC ACID

rt items|||Qty.|| |Moxifloxacin Hydrochloride 1 kg|1|1-CYCLOPROPYL-6,7-||DIFLUORO-1,4-|0.9765 kg|| |||DIHYDRO-8-|METHOXY-4-OXO-3-|||| |BP / USP / IP / BP-EP / EP||QUINOLINE CARBOXYLIC ACID|||||

Case No.<br>111 / NC/3/MEET/Dec/202122/12	Case No.<br>111 / NC/3/MEET/Dec/202122/12
Case Status<br>Case Approved
Party Name<br>RINI LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202122/ 12 and		17/12/2021
HQ File Number<br>HQRNORM APPLY 00132483AM22
RA File Number<br>56AA04002017 AM22
Licence No and<br>Date<br>5611000361/06/07/2021
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-ALC4/2019 dated 21.06.2019against advance authorization No.0910062959 dt.					10.12.2015, it
was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,
whichever is less:
Export product<br>Qty.	Sl. No.	Import items			Qty.
Moxifloxacin Hydrochloride<br>1 kg	1	1-CYCLOPROPYL-6,7-		DIFLUORO-1,4-	0.9765 kg
		DIHYDRO-8-	METHOXY-4-OXO-3-
BP / USP / IP / BP-EP / EP		QUINOLINE CARBOXYLIC ACID

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

||| |BP / USP / IP / BP-EP / EP||QUINOLINE CARBOXYLIC ACID|||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)


		ETHYL ESTER	UDIN00217773AM22
	2	(S,S)-2,8- DIAZABICYCLO NONANE		0.37 kg
A concerned may take further necessary action as per		above decision of NC.

Case No.<br>112 / NC/3/MEET/Dec/202122/12
Case Status<br>Case Approved
Party Name<br>AUROBINDO PHARMA LTD
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number<br>HQRNORM APPLY 00132878AM22
RA File Number<br>09AA04007032 AM22
Licence No and<br>Date<br>0911001154/07/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it	was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:<br>
Export product<br>Qty.<br>Sl. No.	Import items	Qty.
FONDAPARINUX SODIUM<br>1 kg<br>1	N-3 intermediate of Fondaparinux	1.923 kg
RA concerned may take further necessary action as per above decision of NC.

. Sl. No.|Import items|Qty.|| |FONDAPARINUX SODIUM 1 kg 1|N-3 intermediate of Fondaparinux|1.923 kg|| |RA concerned may take further necessary action as per above decision of NC.||||

Case No.	113 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	WANKSONS CHEMICALS INDUSTRIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00133254AM22
RA File Number	03AA04041899 AM22
Licence No and<br>Date	0311005179/07/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:

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: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Export product	Qty.	Sl. No.	Import items	Qty.
CHLORAL	1 kg	1	ETHYL ALCOHOL	0.878 kg

n-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Export product	Qty.	Sl. No.	Import items	Qty.
CHLORAL	1 kg	1	ETHYL ALCOHOL	0.878 kg

Case No.	114 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	SUVEN PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00133260AM22
RA File Number	09AA04007209 AM22
Licence No and<br>Date	0911001161/07/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	115 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	SUVEN PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00133263AM22
RA File Number	09AA04003483 AM22
Licence No and<br>Date	0911001162/07/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	116 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00133324AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

RA File Number 34AA04004084 AM22 Licence No and 3411000813/07/07/2021 Date

Deferred for comments of TE.

21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

RA File Number 34AA04004084 AM22 Licence No and 3411000813/07/07/2021 Date

Deferred for comments of TE.

Case No.	Case No.	117 / NC/3/MEET/Dec/202122/12	117 / NC/3/MEET/Dec/202122/12	117 / NC/3/MEET/Dec/202122/12	117 / NC/3/MEET/Dec/202122/12	117 / NC/3/MEET/Dec/202122/12
Case Status		Case Approved
Party Name		MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number		HQRNORM APPLY 00133502AM22
RA File Number		03AA04042979 AM22
Licence No and Date		0311005189/07/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>FLUORENE<br>0.90 kg<br>2<br>DIMETHYL FORMAMIDE (DMF)<br>0.555 kg<br>3<br>DI N BUTYLAMINE (N- DBA)<br>0.50 kg<br>4<br>4- CHLOROBENZALDEHYDE<br>0.3476 kg<br>LUMEFANTRINE<br>1 kg<br>5<br>SODIUM BOROHYDRIDE<br>0.060 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl. No.	Import items	Qty.
	LUMEFANTRINE		1 kg	1	FLUORENE	0.90 kg
				2	DIMETHYL FORMAMIDE (DMF)	0.555 kg
				3	DI N BUTYLAMINE (N- DBA)	0.50 kg
				4	4- CHLOROBENZALDEHYDE	0.3476 kg
				5	SODIUM BOROHYDRIDE	0.060 kg
				as per above decision of NC.

|||||2|DIMETHYL FORMAMIDE (DMF)|0.555 kg| |||||3|DI N BUTYLAMINE (N- DBA)|0.50 kg| |||||4|4- CHLOROBENZALDEHYDE|0.3476 kg| |||||5|SODIUM BOROHYDRIDE|0.060 kg| |||||as per above decision of NC.|||

Case No.	118 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00134197AM22
RA File Number	03AA04035672 AM22
Licence No and	0311005214/08/07/2021<br>~~Signature Not V~~
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deput<br>Date: 21-Jan-2022 12:16:2<br>Reason: AJAY.DHIMAN88<br>Location: DGFT(HQ)<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Date

UDIN00217773AM22

Deferred for comments of TE.

Case No.	119 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	FINE ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00134580AM22
RA File Number	03AA04040353 AM22
Licence No and<br>Date	0311005221/08/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl.

s per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 Glycerine 0.193 kg Glycerol Tricaprate/Caprylate 1 kg 2 Capric Caprylic Acid 0.973 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	120 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00134043AM22
RA File Number	31AA04019783 AM22
Licence No and<br>Date	3111000444/08/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Export product	Qty.	Sl. No.	Import items<br>U	Qty.<br>DIN00217773AM2
Acetyl Anisole (4 Methoxy<br>Acetophenone)(-)	1 kg	1	Phenol	0.72 kg
		2	Methanol	0.276 kg
		3	Acetic Anhydride PURITY 99 Percentage	0.755 kg
A concerned may take further necessary action as per above decision of NC.

enone)(-)|1 kg|1|Phenol|0.72 kg| ||||2|Methanol|0.276 kg| ||||3|Acetic Anhydride PURITY 99 Percentage|0.755 kg| ||A concerned may take further necessary action as per above decision of NC.|||||

Case No.	121 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	BALAJI AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00134044AM22
RA File Number	31AA04019601 AM22
Licence No and<br>Date	3111000445/08/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	122 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	SAURAV CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00135125AM22
RA File Number	30AA04009718 AM22
Licence No and<br>Date	3011000867/09/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	123 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021	~~Sinature Not V~~

~~Signature Not V~~ erified Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

/12/2021| |HQ File Number|HQRNORM APPLY 00136846AM22| |RA File Number|34AA04005040 AM22| |Licence No and Date|3411000829/12/07/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	Case No.	139 / NC/3/MEET/Dec/202122/12	139 / NC/3/MEET/Dec/202122/12	139 / NC/3/MEET/Dec/202122/12	139 / NC/3/MEET/Dec/202122/12	139 / NC/3/MEET/Dec/202122/12
Case Status		Case Approved
Party Name		SHARON BIO-MEDICINE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number		HQRNORM APPLY 00136865AM22
RA File Number		03AA04046705 AM22
Licence No and<br>Date		0311005315/12/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>DIARRHOEA RELIEF INSTANT 2MG<br>ORODISPERSIBLE<br>TABLETS<br>/<br>LOPERAMIDE<br>2MG<br>FAST<br>MELT<br>TABLETS<br>6's((Each<br>Tablet<br>contains<br>1 Number<br>1<br>PHARMABURST B1<br>184.00 mg
	Export product		Qty.	Sl. No.	Import items	Qty.
	DIARRHOEA RELIEF INSTANT 2MG<br>ORODISPERSIBLE<br>TABLETS<br>/<br>LOPERAMIDE<br>2MG<br>FAST<br>MELT<br>TABLETS<br>6's((Each<br>Tablet<br>contains		1 Number	1	PHARMABURST B1	184.00 mg

ems|Qty.| ||DIARRHOEA RELIEF INSTANT 2MG ORODISPERSIBLE TABLETS / LOPERAMIDE 2MG FAST MELT TABLETS 6's((Each Tablet contains||1 Number|1|PHARMABURST B1|184.00 mg|

Case No.	Case No.	139 / NC/3/MEET/Dec/202122/12	139 / NC/3/MEET/Dec/202122/12	139 / NC/3/MEET/Dec/202122/12	139 / NC/3/MEET/Dec/202122/12	139 / NC/3/MEET/Dec/202122/12
Case Status		Case Approved
Party Name		SHARON BIO-MEDICINE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number		HQRNORM APPLY 00136865AM22
RA File Number		03AA04046705 AM22
Licence No and<br>Date		0311005315/12/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>DIARRHOEA RELIEF INSTANT 2MG<br>ORODISPERSIBLE<br>TABLETS<br>/<br>LOPERAMIDE<br>2MG<br>FAST<br>MELT<br>TABLETS<br>6's((Each<br>Tablet<br>contains<br>1 Number<br>1<br>PHARMABURST B1<br>184.00 mg
	Export product		Qty.	Sl. No.	Import items	Qty.
	DIARRHOEA RELIEF INSTANT 2MG<br>ORODISPERSIBLE<br>TABLETS<br>/<br>LOPERAMIDE<br>2MG<br>FAST<br>MELT<br>TABLETS<br>6's((Each<br>Tablet<br>contains		1 Number	1	PHARMABURST B1	184.00 mg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Loperamide Hydrochloride 2mg & PHARMABURST B1 184 Kgs for One Batch equal to 10,00,000 Tablets) (PHARMABURST B1 551.97 Kgs equal to 29,99,856 Tablets))

Case No.	140 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00137046AM22
RA File Number	03AA04044353 AM22
Licence No and<br>Date	0311005322/12/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>MEBEVERINE HYDROCHLORIDE<br>135MG FILM COATED TABLETS<br>1 Number<br>1<br>MEBEVERINE<br>HYDROCHLORIDE<br>137.70 mg<br>RA concerned may take further necessary action as per above decision of NC.

MEBEVERINE HYDROCHLORIDE 135MG FILM COATED TABLETS 1 Number 1 MEBEVERINE HYDROCHLORIDE 137.70 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.	141 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00138116AM22
RA File Number	26AA04002063 AM22
Licence No and<br>Date	2611000198/13/07/2021
Norms Committee Decision:<br>Signature Not V
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deput<br>Date: 21-Jan-2022 12:16:<br>Reason: AJAY.DHIMAN88<br>Location: DGFT(HQ)<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Deferred for comments of TE.

UDIN00217773AM22

GFT(HQ) ||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Deferred for comments of TE.

UDIN00217773AM22

Case No.	142 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00138226AM22
RA File Number	07AA04014195 AM22
Licence No and<br>Date	0711001479/13/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Sl. No. Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Sodium<br>Bicarbonate<br>Injection<br>84mg/mL -50mL Vial(50mL Vial -<br>filled with 4200mg of Sodium<br>Bicarbonate as bulk drug filled in<br>50mL Vial and capped with 20mm<br>Grey Chlorobutyl Rubber<br>Stopper-RFS)<br>1 Number<br>1<br>20mm Grey Chlorobutyl<br>Rubber Stopper-<br>RFS<br>Net + 1%<br>2<br>Furosemide Injection 10mg/mL -<br>4mL Vial(4mL Vial - filled with<br>40mg of Furosemide as bulk drug<br>filled in 4mL Vial and capped with<br>20mm Grey<br>Chlorobutyl Rubber Stopper-RFS)<br>1 Number<br>1<br>20mm Grey Chlorobutyl<br>Rubber Stopper-<br>RFS<br>Net + 1%<br>RA concerned may take further necessary action as per above decision of NC.

Chlorobutyl Rubber Stopper-RFS) 1 Number 1 20mm Grey Chlorobutyl Rubber Stopper- RFS Net + 1% RA concerned may take further necessary action as per above decision of NC.||

Case No.	143 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00137496AM22
RA File Number	02AA04013191 AM22<br>~~Signature Not V~~
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deput<br>Date: 21-Jan-2022 12:16:2<br>Reason: AJAY.DHIMAN88<br>Location: DGFT(HQ)<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Licence No and 0211000929/13/07/2021 Date

UDIN00217773AM22

Deferred for comments of D/o C&PC

Case No.	Case No.	144 / NC/3/MEET/Dec/202122/12	144 / NC/3/MEET/Dec/202122/12	144 / NC/3/MEET/Dec/202122/12	144 / NC/3/MEET/Dec/202122/12	144 / NC/3/MEET/Dec/202122/12
Case Status		Case Approved
Party Name		SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number		HQRNORM APPLY 00137504AM22
RA File Number		09AA04007266 AM22
Licence No and<br>Date		0911001202/13/07/2021

and Date||NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021||||| |HQ File Number||HQRNORM APPLY 00137504AM22||||| |RA File Number||09AA04007266 AM22||||| |Licence No and Date||0911001202/13/07/2021||||| |Norms Committee Decision: The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: Export product Qty. Sl. No. Import items Qty. 1 L Pyroglutamic acid 2.688 kg Sodium(S)-4-oxo-4,6,7,8-tetrahydropyrrolo [1,2- a] pyrimidine-6-carboxylate(Sodium(S)-4-oxo- 4,6,7,8-tetrahydropyrrolo[1,2-a]pyrimidine-6- carboxylate) 1 kg 2 Chlorosulfonyl Isocyanate 2.778 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||Sodium(S)-4-oxo-4,6,7,8-tetrahydropyrrolo [1,2- a] pyrimidine-6-carboxylate(Sodium(S)-4-oxo- 4,6,7,8-tetrahydropyrrolo[1,2-a]pyrimidine-6- carboxylate)||1 kg|1|L Pyroglutamic acid|2.688 kg| |||||2|Chlorosulfonyl Isocyanate|2.778 kg| |||||decision of NC.|||

rboxylate(Sodium(S)-4-oxo- 4,6,7,8-tetrahydropyrrolo[1,2-a]pyrimidine-6- carboxylate)||1 kg|1|L Pyroglutamic acid|2.688 kg| |||||2|Chlorosulfonyl Isocyanate|2.778 kg| |||||decision of NC.|||

Case No.	145 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	HETERO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00137643AM22
RA File Number	09AA04005351 AM22
Licence No and<br>Date	0911001117/13/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deput<br>Date: 21-Jan-2022 12:16:2<br>Reason: AJAY.DHIMAN88<br>Location: DGFT(HQ)<br>~~Signature Not V~~

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: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

etails given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Export product	Qty.	Sl. No.	Import items<br>U	Qty.<br>DIN00217773AM2
(2R-cis)-5-(4-amino-1,2-dihydro-2-<br>oxo-1-<br>pyrimidinyl)-1,3-<br>oxathiolane-2-carboxylic<br>acid<br>(2S,5R)-methyl ester.((2R-cis)-5-(4-<br>amino-<br>1,2-dihydro-2-oxo-1-<br>pyrimidinyl)-1,3-<br>oxathiolane-2-<br>carboxylic acid (2S,5R) –methyl<br>ester. )	1 kg	1	Glyoxylic Acid 50%	0.743 kg
		2	Sodium bisulphite	0.60 kg
		3	2,5-dihydroxy- 1,4-dithiane	0.325 kg
		4	Triethyl amine	0.034 kg
		5	Dimethyl formamide	0.26 kg
		6	Hexamethyl disilazane	0.509 kg
		7	Methane sulponic acid	0.010 kg
		8	Cytosine	0.428 kg
		9	N-Hexane	1.74 kg
		10	Toluene	2.60 kg
		11	Methylene chloride	2.18 kg
		12	L-Menthol	0.736 kg
A concerned may take further necessary action		as per above decision of NC.

Case No.	146 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	HETERO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00138623AM22
RA File Number	09AA04006890 AM22
Licence No and<br>Date	0911001210/14/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>

mmittee 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: ||

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: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Export product	Qty.	Sl. No.	Import items<br><br>UD	Qty.<br>IN00217773AM2
2, 6-Difluoro Benzyl Bromide	1 kg	1	2, 6-Diflurobenzoic Acid	1.114 kg
		2	TETRA HYDRO FURAN	3.50 kg
		3	SODIUM BORO HYDRIDE	0.40 kg
A concerned may take further necessary action		as per above decision of NC.

Case No.	147 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	INDOCO REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00138657AM22
RA File Number	03AA04047965 AM22
Licence No and<br>Date	0311005362/14/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/12/2021| |HQ File Number|HQRNORM APPLY 00138657AM22| |RA File Number|03AA04047965 AM22| |Licence No and Date|0311005362/14/07/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	Case No.	148 / NC/3/MEET/Dec/202122/12	148 / NC/3/MEET/Dec/202122/12	148 / NC/3/MEET/Dec/202122/12	148 / NC/3/MEET/Dec/202122/12	148 / NC/3/MEET/Dec/202122/12
Case Status		Case Approved
Party Name		FDC LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number		HQRNORM APPLY 00139225AM22
RA File Number		03AA04048444 AM22
Licence No and<br>Date		0311005383/14/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against advance authorization No.0310836666 dt.<br>15.06.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less: <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.
	Export product		Qty.	Sl. No.	Import items	Qty.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Chloramphenicol Micronized UDIN00217773AM22 51.00 mg

CHLORAMPHENICOL EYE DROPS 1 Number 0.5% w/v of 10 ML (Chlorafast Eye Drops 10 ML & Clorogen Eye Drops 10 ML)

Case No.	149 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00139649AM22
RA File Number	02AA04013519 AM22
Licence No and<br>Date	0211000948/15/07/2021
Norms Committee Decision:
Deferred for comments of D/o C&PC.

	150 / NC/3/MEET/Dec/202122/12	150 / NC/3/MEET/Dec/202122/12
Case No	150 / NC/3/MEET/Dec/202122/12
.
Case Status	Case Deferred

Party Name	ENCUBE ETHICALS PRIVATE LIMITED

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021

HQ File Number	HQRNORM APPLY 00139912AM22

RA File Number	03AA04027532 AM22

Licence No and
<br>Date	0311005407/15/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	151 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	AMI LIFESCIENCES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00140697AM22
RA File Number	34AA04005460 AM22
Licence No and<br>Date	3411000856/16/07/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 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. 5/82-ALC4/2020 dated 09.10.2020 against advance authorization No. 3410045821 dt. 28.01.2020 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: UDIN00217773AM22

Export product	Qty.	Sl. No.	Import items	Qty.
Benfotiamine	1 kg	1	Thiamine Mononitrate	0.922 kg

Case No.	152 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	RUMIT LIFE CARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00141494AM22
RA File Number	03AA04048428 AM22
Licence No and<br>Date	0311005437/17/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.

r 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 ( Net Content Betamethasone 17 Propionate BP/EP/USP = 100 kgs) 1 kg 1 Betamethasone 17 Propionate 0.94 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	153 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	ELIXIR PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021<br>Signature Not V
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deput<br>Date: 21-Jan-2022 12:16:<br>Reason: AJAY.DHIMAN88<br>Location: DGFT(HQ)<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

HQ File Number	HQRNORM APPLY 00141649AM22
RA File Number	08AA04016381 AM22<br>UDIN00217773AM2
Licence No and<br>Date	0811002031/19/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

NORM APPLY 00141649AM22| |---|---| |RA File Number|08AA04016381 AM22 UDIN00217773AM2| |Licence No and Date|0811002031/19/07/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	154 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	AMI LIFESCIENCES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00142414AM22
RA File Number	34AA04005585 AM22
Licence No and<br>Date	3411000875/19/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.5/82-ALC4/2020 dated 09.10.2020against advance authorization No.3410045821 dt. 28.01.2020, it<br>was decided to ratify 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. Import items<br>Qty.<br>Benfotiamine<br>1 kg<br>1<br>Thiamine Mononitrate<br>0.922 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	155 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00143025AM22
RA File Number	07AA04016475 AM22
Licence No and<br>Date	0711001517/20/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

12/2021| |HQ File Number|HQRNORM APPLY 00143025AM22| |RA File Number|07AA04016475 AM22| |Licence No and Date|0711001517/20/07/2021| |Norms Committee Decision: Deferred for comments of TE.||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Case No.	156 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00143189AM22
RA File Number	52AA04009806 AM22
Licence No and<br>Date	5211001019/20/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	157 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00143924AM22
RA File Number	07AA04016516 AM22
Licence No and<br>Date	0711001521/21/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	158 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00144695AM22
RA File Number	07AA04016662 AM22
Licence No and<br>Date	0711001530/22/07/2021
Norms Committee Decision:<br>Deferred for comments of TE

Case No. 159 / NC/3/MEET/Dec/202122/12

0144695AM22| |RA File Number|07AA04016662 AM22| |Licence No and Date|0711001530/22/07/2021| |Norms Committee Decision: Deferred for comments of TE||

Case No. 159 / NC/3/MEET/Dec/202122/12

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Case Status	Case Approved
Party Name	LYRUS LIFE SCIENCES PRIVATE LIMITED<br>UDIN00217773AM2
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00144723AM22
RA File Number	07AA04016287 AM22
Licence No and<br>Date	0711001531/22/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Sep/202122/8 dated 24.09.2021against advance authorization No.0810139654 dt.<br>06.02.2017, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less: <br>Sl. No. Export product<br>Qty.<br>Sl. No.

06.02.2017, it was decided to ratify 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 Bisoprolol Fumarate TABLETS 2.5 MG ( No of Tablets-4400000)(Bisoprolol Fumarate TABLETS 2.5 MG ( No of Tablets-4400000)) 1 Number 1 Bisoprolol Fumarate Micronized EP 2.55 mg / 2.5 mg Tablet 2 Bisoprolol Fumarate TABLETS 5 MG ( No of Tablets-5600000)(Bisoprolol Fumarate TABLETS 5 MG ( No of Tablets-5600000)) 1 Number 1 Bisoprolol Fumarate Micronized EP 5.10 mg / 5 mg Tablet 3 Bisoprolol Fumarate TABLETS 10 MG ( No of Tablets-2100000)(Bisoprolol Fumarate TABLETS 10 MG ( No of Tablets-2100000)) 1 Number 1 Bisoprolol Fumarate Micronized EP 10.20 mg / 10 mg Tablet RA concerned may take further necessary action as per above decision of NC.||

Case No.	160 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	NAARI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00145072AM22
RA File Number	05AA04057335 AM22
Licence No and<br>Date	0511003777/22/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Decision: Deferred for comments of TE.||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Case No.	161 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	DIAMINES AND CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00145203AM22
RA File Number	34AA04005573 AM22
Licence No and<br>Date	3411000885/22/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	162 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00145220AM22
RA File Number	34AA04004907 AM22
Licence No and<br>Date	3411000793/22/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/12/2021| |HQ File Number|HQRNORM APPLY 00145220AM22| |RA File Number|34AA04004907 AM22| |Licence No and Date|3411000793/22/07/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	Case No.	163 / NC/3/MEET/Dec/202122/12	163 / NC/3/MEET/Dec/202122/12	163 / NC/3/MEET/Dec/202122/12	163 / NC/3/MEET/Dec/202122/12	163 / NC/3/MEET/Dec/202122/12
Case Status		Case Approved
Party Name		FINE ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number		HQRNORM APPLY 00145329AM22
RA File Number		03AA04042839 AM22
Licence No and<br>Date		0311005545/22/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Jul/202122/4 dated 15.07.2021, it was decided to ratify norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>~~Signature Not V~~
	Export Product		Qty.	Sl. No.	Import items<br>S	Qty.<br>~~ignature Not V~~
um	ent has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deput<br>Date: 21-Jan-2022 12:16:2<br>Reason: AJAY.DHIMAN88<br>Location: DGFT(HQ)<br>

ned by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022. Digitally Signed. Name: Ajay Kumar( Deput Date: 21-Jan-2022 12:16:2 Reason: AJAY.DHIMAN88 Location: DGFT(HQ) |||||||

R	MONOGLYCERIDE FATTY ACID	1 kg	1	GLYCERINE<br>U	0.252 kg<br>DIN00217773AM2
			2	STEARIC ACID	0.667 kg
	A may take appropriate action as per the decision of Norms Committee.

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

Case No.	164 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00144650AM22
RA File Number	07AA04016659 AM22
Licence No and<br>Date	0711001528/22/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	165 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	MERIDIAN ENTERPRISES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00145626AM22
RA File Number	03AA04051822 AM22
Licence No and<br>Date	0311005561/23/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

/12/2021| |HQ File Number|HQRNORM APPLY 00145626AM22| |RA File Number|03AA04051822 AM22| |Licence No and Date|0311005561/23/07/2021| |Norms Committee Decision: Deferred for comments of TE.||

Case No.	166 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00145761AM22
RA File Number	05AA04052523 AM22
Licence No and<br>Date	0511003790/23/07/2021<br>~~Sinature Not V~~
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deput<br>Date: 21-Jan-2022 12:16:2<br>Reason: AJAY.DHIMAN88<br>Location: DGFT(HQ)<br>g

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 4/82-ALC4/2018 dated 19.06.2018 against advance authorization No. 0510405633 dt. 13.02.2018 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less: UDIN00217773AM22

Export product	Qty.	Sl. No.	Import items	Qty.
Ceftriaxone Sodium (Sterile)	1 kg	1	Ceftriaxone Sodium (Non Sterile)	1.04 kg

Case No.	167 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00145763AM22
RA File Number	05AA04056378 AM22
Licence No and<br>Date	0511003791/23/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against advance authorization No.0510413849 dt.<br>12.03.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br>Sl. No. Export Product<br>Qty<br>Sl. No.

12.03.2020, it was decided to ratify 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 Broxinac Eye Drops 0.09 Percent 1.7 ml / Bromfenac Eye Drops 0.09 Percent 1.7ml 1 Vial 1 Bromfenac Sodium Hydrate 1.235 mg 2 Broxinac Eye Drops 0.09 Percent 2.5 ml / Bromfenac Eye Drops 0.09 Percent 2.5ml 1 Vial 1 Bromfenac Sodium Hydrate 2.639 mg RA concerned may take further necessary action as per above decision of NC.||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Case No.	168 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved<br>UDIN00217773AM2
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00145764AM22
RA File Number	05AA04056330 AM22
Licence No and<br>Date	0511003792/23/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against advance authorization No.0510414133 dt.<br>08.05.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br>Sl. No. Export Product<br>Qty<br>Sl. No.

r>08.05.2020, it was decided to ratify 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 Visallergol Eye Drops 0.2 Percent 2.5ml 1 Number Vial 1 Olopatadine HCL 5.61 mg 2 Oftahist (Olopatadine Eye Solution 0.1 Percent in 5ml Vial) 1 Number Vial 1 Olopatadine HCL 5.61 mg RA concerned may take further necessary action as per above decision of NC.||

Case No.<br>	Case No.<br>	169 / NC/3/MEET/Dec/202122/12	169 / NC/3/MEET/Dec/202122/12	169 / NC/3/MEET/Dec/202122/12
Case Status<br>		Case Approved
Party Name<br>		PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date<br>		NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number<br>		HQRNORM APPLY 00145843AM22
RA File Number<br>		03AA04048122 AM22
Licence No and<br>Date<br>		0311005566/23/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less: <br>Export Product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Bempedoic Acid<br>189.90 mg<br>Bempedoic Acid and Ezetimibe Fixed Dose<br>Combination Tablets(Net content of Bempedoic<br>1 Number
	Export Product		Qty.	Sl.

o. Import items Qty. 1 Bempedoic Acid 189.90 mg Bempedoic Acid and Ezetimibe Fixed Dose Combination Tablets(Net content of Bempedoic 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import items|Qty.| ||Bempedoic Acid and Ezetimibe Fixed Dose Combination Tablets(Net content of Bempedoic||1 Number|1|Bempedoic Acid|189.90 mg| ||||||||

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: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Acid 1039.500 kgs(and Ezetimibe 57.750 Kgs in 2 Ezetimibe 10.55 mg Total Export Qty) (AA for Free of cost material as per Para 4.11 of HBP & Para 4.19 of FTP & RBI Master Circular C-26 - Disallowing remittances for material being supplied free of cost)) UDIN00217773AM22

Note: The above norms are valid only for subject to fulfillment of following conditions:

Export Product being Patented Medicine, be filed with USFDA as an NDA (New Drug Application.
Export to USA and Europe only.
Firm holding Certificate of Manufacturing Exclusivity.

port Product being Patented Medicine, be filed with USFDA as an NDA (New Drug Application.**

Export to USA and Europe only.
Firm holding Certificate of Manufacturing Exclusivity.

Case No.	170 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	ALTA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00146194AM22
RA File Number	03AA04051472 AM22
Licence No and<br>Date	0311005584/23/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	171 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00145549AM22
RA File Number	09AA04008489 AM22
Licence No and<br>Date	0911001257/23/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Decision:|| |Deferred for comments of TE.||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Case No.	Case No.	172 / NC/3/MEET/Dec/202122/12	172 / NC/3/MEET/Dec/202122/12	172 / NC/3/MEET/Dec/202122/12
Case Status		Case Approved
Party Name		EMMENNAR PHARMA PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number		HQRNORM APPLY 00145561AM22
RA File Number		09AA04004956 AM22
Licence No and Date		0911001258/23/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>PROPIONALDEHYDE<br>1.66 kg<br>2<br>SODIUM CYANIDE<br>1.40 kg<br>3<br>L(+) TARTARIC ACID<br>1.45 kg<br>4<br>METHYLENE DICHLORIDE<br>1.12 kg<br>5<br>ACETONE<br>1.795 kg<br>S(+)-2-AMINOBUTYRAMIDE<br>HYDROCHLORIDE<br>1 kg<br>6<br>METHANOL<br>1.39 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl.

.795 kg S(+)-2-AMINOBUTYRAMIDE HYDROCHLORIDE 1 kg 6 METHANOL 1.39 kg RA concerned may take further necessary action as per above decision of NC.||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||S(+)-2-AMINOBUTYRAMIDE HYDROCHLORIDE||1 kg|1|PROPIONALDEHYDE|1.66 kg| |||||2|SODIUM CYANIDE|1.40 kg| |||||3|L(+) TARTARIC ACID|1.45 kg| |||||4|METHYLENE DICHLORIDE|1.12 kg| |||||5|ACETONE|1.795 kg| |||||6|METHANOL|1.39 kg| |||||above decision of NC.|||

Case No.	173 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00146728AM22
RA File Number	03AA04046766 AM22
Licence No and<br>Date	0311005598/24/07/2021
Norms Committee Decision:

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

The Committee considered the case as per agenda and it was decided to call for following information from the firm: UDIN00217773AM22

i. Whether the export item contains import item No. 1 and 2 as claimed in the Export description.

If so, please give COA of export item in support of above.

Otherwise get the description of export item amended in the licence.

Case No.	174 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00146729AM22
RA File Number	03AA04029068 AM22
Licence No and<br>Date	0311005599/24/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	175 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00146743AM22
RA File Number	03AA04045550 AM22
Licence No and<br>Date	0311005604/25/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Quantity of Nonene used as a solvent and its recovery.<br>i.
Quantity of Activity Clay used in the process and its recovery

Case No.	176 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	AARTI INDUSTRIES LTD
Meeting Number	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

C/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

and Date
HQ File Number	HQRNORM APPLY 00146811AM22<br>UDIN00217773AM2
RA File Number	03AA04052117 AM22
Licence No and<br>Date	0311005613/26/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>ADIPIC ACID<br>0.415 kg<br>DI-OCTYL ADIPATE (DOA)<br>1 kg<br>2<br>2 ETHYL HEXANOL<br>0.720 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	177 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	ZENTIVA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00147236AM22
RA File Number	34AA04005732 AM22
Licence No and<br>Date	3411000898/26/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E.<br>i.<br>DML.<br>ii.

nda and it was decided to call for following information from the firm: Copy of 4.07 application having complete technical details as per Annexure to Appendix 4E. i. DML. ii.||

Case No.	178 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	CONNEX PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00147368AM22
RA File Number	26AA04002378 AM22
Licence No and	2611000203/26/07/2021<br>
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deput<br>Date: 21-Jan-2022 12:16:2<br>Reason: AJAY.DHIMAN88<br>Location: DGFT(HQ)<br>~~Signature Not~~

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Date

UDIN00217773AM22

Deferred for comments of TE.

Case No.	179 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	SYNOKEM PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00147457AM22
RA File Number	05AA04059070 AM22
Licence No and<br>Date	0511003826/26/07/2021
Norms Committee Decision:
Deferred for comments of TE.

/12/2021| |HQ File Number|HQRNORM APPLY 00147457AM22| |RA File Number|05AA04059070 AM22| |Licence No and Date|0511003826/26/07/2021| |Norms Committee Decision:|| |Deferred for comments of TE.||

Case No.	180 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00147545AM22
RA File Number	52AA04008175 AM22
Licence No and<br>Date	5211001047/26/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Complete chemistry, molecular weight and percentage yield.<br>i.
Stoichiometric balance on molar basis to arrive at the quantity of raw material asked for.<br>ii.
Recovery of By-Product and its commercial value, if any

Case No.	181 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	FDC LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00147719AM22
RA File Number	03AA04052143 AM22
Licence No and	0311005641/26/07/2021	~~Signature Not V~~

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Date

UDIN00217773AM22

5641/26/07/2021|~~Signature Not V~~|

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Date

UDIN00217773AM22

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Jul/202122/4 dated 15.07.2021 against advance authorization No. 0311004667 dt. 16.06.2021 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export Product	Qty	Sl. No.	Import Items	Qty
BRIMONIDINE EYE DROPS 5ML (EYE	<br>25000 vials	1	BRIMONIDINE L	255 gms
DROPS)
			TARTRATE

Case No.	182 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00147767AM22
RA File Number	03AA04052613 AM22
Licence No and<br>Date	0311005647/27/07/2021
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 13.11.2020against advance authorization No.0310838803 dt. 08.10.2020, it
was decided to ratify 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.<br>Export Product		Qty.
1<br>Desonide Cream 0.05 Percent 15gm (Net Wt.

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 Percent 15gm (Net Wt. of Desonide USP is 0.375 Kgs)||1 Number|| |2 Desonide Cream 0.05 Percent 60gm (Net Wt. of Desonide USP is 1.500 Kgs)||1 Number|| |3 Desonide Lotion 0.05 Percent 59ml (Net Wt. of Desonide USP is 1.475 Kgs)||1 Number|| |4 Desonide Lotion 0.05 Percent 118ml (Net Wt. of Desonide USP is 2.950 Kgs)||1 Number|| |5 Desonide Ointment 0.05 Percent 15gm (Net Wt. of Desonide USP is 0.375 Kgs) ||1 Number ||

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 dt. 08.10.2020 , it was decided to ratify 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: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Desonide Ointment 0.05 Percent 60gm (Net Wt. of Desonide USP is 1.050 Kgs)

UDIN00217773AM22 1 Number

y Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Desonide Ointment 0.05 Percent 60gm (Net Wt. of Desonide USP is 1.050 Kgs)

UDIN00217773AM22 1 Number

				For the Export of 1 No. Pack	For the Export of 1 No. Pack	For the Export of 1 No. Pack
	Import Items
SI.		0.05%
No.		15gm pack	0.05%<br>60gm pack	0.05%<br>59ml pack	0.05%<br>118ml pack	0.05% 15gm<br>pack	0.05%<br>60gm pack
1	Desonide USP<br>Micronised (Sicor)	0.00765 gm	0.0306 gm	0.301 gm	0.602 gm	0.00765 gm	0.0306 gm

Case No.<br>183 / NC/3/MEET/Dec/202122/12
Case Status<br>Case Approved
Party Name<br>CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number<br>HQRNORM APPLY 00147932AM22
RA File Number<br>31AA04021398 AM22
Licence No and<br>Date<br>3111000475/27/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of	HBP Vol. I as
per details given below or as applied by the firm, whichever is less:<br>
Export product<br>Qty.<br>Sl. No. Import items	Qty.
1<br>Phenol<br>Acetyl Anisole (4 Methoxy<br>1 kg	0.72 kg
Acetophenone)(-)
2<br>Methanol	0.276 kg
3<br>Acetic Anhydride PURITY 99 Percentage	0.755 kg
RA concerned may take further necessary action as per above decision of NC.

kg|0.72 kg|| |Acetophenone)(-)||| |2 Methanol|0.276 kg|| |3 Acetic Anhydride PURITY 99 Percentage|0.755 kg|| |RA concerned may take further necessary action as per above decision of NC.|||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Case No.	184 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00148387AM22
RA File Number	52AA04010429 AM22
Licence No and<br>Date	5211001058/27/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	185 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00148419AM22
RA File Number	31AA04021097 AM22
Licence No and<br>Date	3111000476/27/07/2021
Norms Committee Decision:<br>Deferred for comments of TE

7/12/2021| |HQ File Number|HQRNORM APPLY 00148419AM22| |RA File Number|31AA04021097 AM22| |Licence No and Date|3111000476/27/07/2021| |Norms Committee Decision: Deferred for comments of TE||

Case No.	186 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00148425AM22
RA File Number	31AA04021827 AM22
Licence No and<br>Date	3111000477/27/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Oct/202122/9 dated 15.10.2021against advance authorization No.3110067771 dt.<br>24.069.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br>

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Oct/202122/9 dated 15.10.2021 against advance authorization No. 3110067771 dt. 24.069.2020 , it was decided to ratify 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: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

etails given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Export product	Qty.	Sl. No.	Import items<br>U	Qty.<br>DIN00217773AM2
Guaiacol	1 kg	1	Phenol	0.93 kg
		2	Methanol	0.36 kg
		3	Hydrogen Peroxide PURITY 60 Percentage	0.687 kg
		4	Acetone (Solvent)	0.09 kg
A concerned may take further necessary action as per above decision of NC.

Case No.	187 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	AARTI DRUGS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00148514AM22
RA File Number	03AA04052584 AM22
Licence No and<br>Date	0311005674/27/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Production Consumption data duly certified by GST.<br>i.

Case No.	188 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00148633AM22
RA File Number	07AA04017970 AM22
Licence No and<br>Date	0711001564/27/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Decision: Deferred for comments of TE.||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

	UDIN00217773AM2
Case No.	189 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00148635AM22
RA File Number	07AA04017973 AM22
Licence No and<br>Date	0711001565/27/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	190 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	FERMENTA BIOTECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00148770AM22
RA File Number	03AA04052563 AM22
Licence No and<br>Date	0311005682/28/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Ergocalciferol Oral Solution USP (Vitamin D2<br>1.0<br>to<br>4.0<br>MIU<br>in<br>Edible<br>Oil-<br>Soyabean/Corn/Arachis/MCT Oil)<br>1 kg<br>1<br>Ergocalciferol (Vitamin D2)<br>0.0255 kg<br>RA concerned may take further necessary action as per above decision of NC.

in Edible Oil- Soyabean/Corn/Arachis/MCT Oil) 1 kg 1 Ergocalciferol (Vitamin D2) 0.0255 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	191 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	ZEE LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00149067AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

RA File Number 05AA04057371 AM22 Licence No and 0511003868/28/07/2021 Date Norms Committee Decision:

Deferred for comments of TE.

Case No.	192 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	BALAJI SPECIALITY CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00149127AM22
RA File Number	31AA04000987 AM22
Licence No and<br>Date	3111000484/28/07/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Percentage yield of chemical reaction.<br>i.
Stoichiometric balance on molar basis to arrive at the quantity of raw material asked for.<br>ii.

following information from the firm:|| |Percentage yield of chemical reaction. i.|| |Stoichiometric balance on molar basis to arrive at the quantity of raw material asked for. ii.||

Case No.	193 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00149310AM22
RA File Number	05AA04061858 AM22
Licence No and<br>Date	0511003876/28/07/2021
Norms Committee Decision:
Deferred for comments of TE.




Case No.	194 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	CUTCH OIL AND ALLIED INDUSTRIES 1949 PRIVATE LIMITED
Meeting Number
and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00149372AM22
RA File Number	02AA04015335 AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Licence No and 0211001003/28/07/2021 Date Norms Committee Decision:

UDIN00217773AM22

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

i. End use of Export Product.
ii. Chemical process involved for Activation of Clay.
iii. Justification for the quantity of import asked for.

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

Case No.	195 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	FINE ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00149586AM22
RA File Number	03AA04055266 AM22
Licence No and<br>Date	0311005705/28/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Glycerine<br>0.1928 kg<br>Glycerol Tricaprate/Caprylate<br>1 kg<br>2<br>Capric Caprylic Acid<br>0.9528 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	196 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	THINQ PHARMA-CRO LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00150092AM22
RA File Number	03AA04053651 AM22
Licence No and<br>Date	0311005719/29/07/2021<br>~~Signature Not V~~
ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deput<br>Date: 21-Jan-2022 12:16:2<br>Reason: AJAY.DHIMAN88<br>Location: DGFT(HQ)<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

2 12:16:2 Reason: AJAY.DHIMAN88 Location: DGFT(HQ) ||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Export product	Qty.	Sl. No. Import items	Qty.
Dimethyl Isosorbide	1 kg	1<br>Isosorbide	0.93 kg

Case No.	197 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00150128AM22
RA File Number	03AA04054005 AM22
Licence No and<br>Date	0311005722/29/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	198 / NC/3/MEET/Dec/202122/12
Case Status	Case Deferred
Party Name	RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00150875AM22
RA File Number	05AA04055660 AM22
Licence No and<br>Date	0511003910/30/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	199 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

roved|| |Party Name|CLEAN SCIENCE AND TECHNOLOGY LIMITED|| ||||

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00217773AM22

Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021<br>UDIN00217773AM2
HQ File Number	HQRNORM APPLY 00151173AM22
RA File Number	31AA04022273 AM22
Licence No and<br>Date	3111000489/30/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Oct/202122/9 dated 15.10.2021against advance authorization No.3110067866 dt.<br>22.09.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Phenol<br>0.93 kg<br>2<br>Methanol<br>0.36 kg<br>3<br>Hydrogen Peroxide PURITY 60 Percentage<br>0.687 kg<br>Guaiacol<br>1 kg<br>4<br>Acetone (Solvent)<br>0.09 kg<br>RA concerned may take further necessary action as per above decision of NC.

br>3 Hydrogen Peroxide PURITY 60 Percentage 0.687 kg Guaiacol 1 kg 4 Acetone (Solvent) 0.09 kg RA concerned may take further necessary action as per above decision of NC.||

Case No.	200 / NC/3/MEET/Dec/202122/12	200 / NC/3/MEET/Dec/202122/12	200 / NC/3/MEET/Dec/202122/12
Case Status	Case Approved
Party Name	DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Dec/ 202122/ 12 and 17/12/2021
HQ File Number	HQRNORM APPLY 00151177AM22
RA File Number	31AA04021121 AM22
Licence No and<br>Date	3111000493/30/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Jun/202122/2 dated 02.07.2021against advance authorization No.3111000246 dt.<br>15.04.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2,6 xylenol<br>1.06 kg<br>~~Signature Not V~~
		Qty.	Sl.

tails given below or as applied by the firm, whichever is less: Export Product Qty. Sl. No. Import items Qty. 1 2,6 xylenol 1.06 kg ~~Signature Not V~~|||||||| ||||Qty.|Sl. No.|Import items|Qty.|| |||||1|2,6 xylenol Si|1.06 kg ~~gnature Not V~~|| |um|ent has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 21-Jan-2022. Digitally Signed. Name: Ajay Kumar( Deput Date: 21-Jan-2022 12:16: Reason: AJAY.DHIMAN88 Location: DGFT(HQ) |||||||

R	DNOVO BP818 (Tetra Methyl Bisphenol F)	1 kg	2	Paraformaldehyde<br>U	0.130 kg<br>DIN00217773AM2
			3	Methanol	0.100 kg
	A may take appropriate action as per the decision of Norms Committee.

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

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 21-Jan-2022 12:16:20 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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