IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2022-04-08

DGFT Committee Minutes

Document text

Government of India Ministry of Commerce and Industry Department of Commerce

DIRECTORATE GENERAL OF FOREIGN TRADE (DES - III SECTION)

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Mar/202122/16 DATED: 08/04/2022

Please Note

  • I. For information of exporters, Norms Committee - III handles all cases pertaining to fixation/ratification of norms for Export Products falling under ITC (HS) Chapter 29, 30 .Communications in respect of cases/pertaining to NC- III may be sent to email address: nc3.dgft@nic.in

  • II. The Norms Committee has taken decision only with respect to technical aspect/wastage norms. While redeeming the applications, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure including those in Policy Circulars issued from time to time or any other provisions under FTP/HBP for EODC.

  • III. Wherever the Committee has fixed Norms, the concerned RA may ensure that AA is issued on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less.

Meeting No. NC/3/MEET/Mar/202122/16 dated 08/04/2022 of Norms Committee - III for the year 2022-23 was held on 08/04/2022 under the Chairmanship of Amiya Chandra,Additional DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

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

Signature Not Verified Signature Not Verified Digitally Signed. Digitally signe Name: Ajay Kumar( Deputy Director ) Name: Ajay Kumar( uty Director ) Date: 26-Apr-2022 17:44:42 Date: 26-Apr-2022 f:44:42 Reason: AJAY.DHIMAN88@GOV.IN Reason: AJAY. IAN88@GOV.IN Location: DGFT(HQ) Location: DGFT)

This document has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.

1

Case Details and Decision(s):

Case No. 1 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name ASTRAL STERITECH PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00234779AM22
RA File Number 342404000230 AM21
Licence No and<br>Date 3411000016/null
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.4/82-ALC4/2018 dated 19.06.2018against advance<br>authorization No.3410043654 dt. 27.11.2017, 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:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>NAFCILLIN SODUIUM FOR INJECTION<br>(STERILE BULK)<br>1200.85 kg<br>Nafcillin For Injection USP 2 gm<br>(Each vial contains nafcillin Sodium<br>equivalent to 2 gm nafcillin)<br>511000 kg<br>2<br>"20MM INJECTION RUBBER STOPPER 110008242<br>Relevant as per packing<br>policy<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 2 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name COVALENT LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00234849AM22
RA File Number 092404000480 AM21<br>Signature Not Verified
2<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

Signature Not Verified

2

Licence No and 0911000006/null Date Norms Committee Decision: Deferred for comments of TE.

Case No. Case No. 3 / NC/3/MEET/Mar/202122/16 3 / NC/3/MEET/Mar/202122/16 3 / NC/3/MEET/Mar/202122/16 3 / NC/3/MEET/Mar/202122/16 3 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name MALWA OXYGEN & INDUSTRIAL GASES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00235075AM22
RA File Number 562404000034 AM21
Licence No and<br>Date 5611000134/null
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.5/82-ALC4/2020 dated 09.10.2020against advance<br>authorization No.5610005606dt.09.05.2019, 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:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>PARA CHLORO BENZOTRICHLORIDE<br>1.73 kg<br>2<br>PHENOL<br>0.71 kg<br>3<br>ALUMINIUM CHLORIDE<br>1.00 kg<br>4<br>SODIUM HYDROXIDE<br>0.23 kg<br>5<br>DICHLOROETHEN<br>2.50 kg<br>4,4-DIHYDROXY BENZOPHENONE 1 kg
Export product Qty. Sl. No. Import items Qty.
4,4-DIHYDROXY BENZOPHENONE 1 kg 1 PARA CHLORO BENZOTRICHLORIDE 1.73 kg
2 PHENOL 0.71 kg
3 ALUMINIUM CHLORIDE 1.00 kg
4 SODIUM HYDROXIDE 0.23 kg
5 DICHLOROETHEN 2.50 kg
Case No. Case No. 3 / NC/3/MEET/Mar/202122/16 3 / NC/3/MEET/Mar/202122/16 3 / NC/3/MEET/Mar/202122/16 3 / NC/3/MEET/Mar/202122/16 3 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name MALWA OXYGEN & INDUSTRIAL GASES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00235075AM22
RA File Number 562404000034 AM21
Licence No and<br>Date 5611000134/null
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.5/82-ALC4/2020 dated 09.10.2020against advance<br>authorization No.5610005606dt.09.05.2019, 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:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>PARA CHLORO BENZOTRICHLORIDE<br>1.73 kg<br>2<br>PHENOL<br>0.71 kg<br>3<br>ALUMINIUM CHLORIDE<br>1.00 kg<br>4<br>SODIUM HYDROXIDE<br>0.23 kg<br>5<br>DICHLOROETHEN<br>2.50 kg<br>4,4-DIHYDROXY BENZOPHENONE 1 kg
Export product Qty. Sl. No. Import items Qty.
4,4-DIHYDROXY BENZOPHENONE 1 kg 1 PARA CHLORO BENZOTRICHLORIDE 1.73 kg
2 PHENOL 0.71 kg
3 ALUMINIUM CHLORIDE 1.00 kg
4 SODIUM HYDROXIDE 0.23 kg
5 DICHLOROETHEN 2.50 kg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

3

6 CUPROUS CHLORIDE 0.10 kg
7 METHYLE ALCOHOL 2.50 kg

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

Case No. Case No. 4 / NC/3/MEET/Mar/202122/16 4 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name AUROBINDO PHARMA LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00235234AM22
RA File Number 092404000487 AM21
Licence No and<br>Date 0911000014/null
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify no<br>less:<br>Export product<br>Qty.<br>Clindamycin Palmitate Hydrochloride<br>1 kg<br>RA concerned may take further necessary action as per above decision of NC. rms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is
Export product Qty. Sl. No. Import items Qty.
Clindamycin Palmitate Hydrochloride 1 kg 1 Clindamycin Hydrochloride 1.06 kg
2 Methylene Chloride (MDC) 2.06 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

4

Case No. 5 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name ANUH PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00232514AM22
RA File Number 039404000663 AM21
Licence No and<br>Date 0311000563/null
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 per details given below or as applied by the firm, whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Betamethasone Sodium Phosphate<br>1 kg<br>1<br>Betamethasone IP/BP/EP/USP<br>0.78 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No.<br> 6 / NC/3/MEET/Mar/202122/16
Case Status<br> Case Deferred
Party Name<br> BHARAT SERUMS AND VACCINES LIMITED
Meeting Number<br>and Date<br> NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number<br> 018205000446AM20
RA File Number<br> 039404000313 AM20
Licence No and<br>Date<br> 0310830591/25/07/2019
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

5

The Committee considered the case as per agenda and it was decided to refer the case to Department of Biotechnology (DBT) for obtaining its comments.

Case No. Case No. 7 / NC/3/MEET/Mar/202122/16 7 / NC/3/MEET/Mar/202122/16 7 / NC/3/MEET/Mar/202122/16 7 / NC/3/MEET/Mar/202122/16 7 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name UPL LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number 018205000523AM20
RA File Number 039504001337 AM19
Licence No and<br>Date 0310830995/14/08/2019
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 per details given below or as applied by the firm, whichever is<br>less:<br>Export Product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Phenol<br>0.886 kg<br>2<br>Yellow Phosphorus<br>0.097 kg<br>3<br>Yellow Phosphorus<br>0.063 kg<br>Diphenyl Methyl Phosphonate (DPMP)<br>1 kg<br>4<br>Methanol<br>0.197 kg<br>RA concerned may take further necessary action as per above decision of NC.
Export Product Qty. Sl. No. Import items Qty.
Diphenyl Methyl Phosphonate (DPMP) 1 kg 1 Phenol 0.886 kg
2 Yellow Phosphorus 0.097 kg
3 Yellow Phosphorus 0.063 kg
4 Methanol 0.197 kg
Case No. 8 / NC/3/MEET/Mar/202122/16
Case Status Case Approved<br>Sinature Not Verified

Signature Not Verified Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

6

Party Name SOMU ORGANO CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00209972AM22
RA File Number 072404000296 AM20
Licence No and<br>Date 0710116207/05/03/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.5/82-ALC4/2019 dated 02.08.2019against advance<br>authorization No.0710114735 dt.01.04.2019, 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:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1,3-CYCLOHEXANEDIONE<br>1 kg<br>1<br>RESORCINOL<br>1.196 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 9 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name SOMU ORGANO CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00209971AM22
RA File Number 072404000113 AM21
Licence No and<br>Date 0710116779/22/07/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.5/82-ALC4/2019 dated 02.08.2019against advance<br>authorization No.0710114735 dt.01.04.2019, 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:<br>Sinature Not Verified
7<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>g

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

7

Export product Qty. Sl. No. Import items Qty.
1,3-CYCLOHEXANEDIONE 1 kg 1 RESORCINOL 1.196 kg
Case No. 10 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name BRAWN LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00203510AM22
RA File Number 05AA04088439 AM22
Licence No and<br>Date 0511005222/05/10/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Export Product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>LINCOMYCIN<br>INJECTION<br>USP<br>600MG/2ML<br>VIAL(CLEAR,<br>COLORLESSS<br>TO<br>SLIGHTLY<br>YELLOW SOLUTION, HAVING A SLIGHT ODOR)<br>1 Number Vial<br>1<br>LINCOMYCIN HYDROCHLORIDE USP<br>719.26 mg<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 11 / NC/3/MEET/Mar/202122/16

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

8

Case Status Case Approved Case Approved
Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00204293AM22
RA File Number 05AA04088821 AM22
Licence No and Date 0511005240/06/10/2021
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:
Export Product Qty. Sl. No. Import items Qty.
Moxifloxacin HCL and Dexamethasone 32000 Number 1 Moxifloxacin Hydrochloride 915.59 gram
Sodium Phosphate Eye Drops 0.5%w/v,
0.1%<br>w/v,<br>5ml <br>(MILFLOX
DM,MILFODOX,(MIFLOCO<br>DELTA) 2 Dexamethasone Sodium Phosphate 184.80 gram
(Each ml contain Moxifloxacin Base 5mg.
equi. to Moxifloxacin HCL 5.45mg. &
Dexamethasone Phosphate1mg equi. to
Dexamethasone Sodium Phosphate 1.1mg
(Equi.to 872.000gm Moxifloxacin HCL
and<br>176.000gm Dexamethasone
SodiumPhosphate ))
RA concerned may take further necessary action as per above decision of NC.
Case No. 12 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name SAVLA CHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00204398AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

9

RA File Number 03AA040107958 AM22
Licence No and<br>Date 0311007527/06/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.12/82-ALC4/2018 dated 12.12.2018against advance<br>authorization No.0310820207dt.02.04.2018, 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:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>HIGH PURITY METHYL TERTIARY BUTYL ETHER 99.8% 1 kg<br>1<br>METHYL TERTIARY BUTYL ETHER (MTBE)<br>1 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 13 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name AARTI DRUGS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00204926AM22
RA File Number 03AA040107079 AM22
Licence No and<br>Date 0311007539/06/10/2021
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 Authorities.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

10

Case No. 14 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name KALPSUTRA CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00205042AM22
RA File Number 03AA040108575 AM22
Licence No and<br>Date 0311007542/07/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 15 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00207439AM22
RA File Number 03AA040109530 AM22
Licence No and<br>Date 0311007595/08/10/2021
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>Description of all Excipients shown in items to be imported may be furnished as per their chemical name.<br>i.<br>Details of Packaging Material may be furnished.<br>ii.<br>Copy of Master Batch Formula for all export items indicating net content of inputs in each export.<br>iii.
Case No. 16 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name CHEMPLAST SANMAR LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

11

HQ File Number HQRNORM APPLY 00206478AM22
RA File Number 04AA04028427 AM22
Licence No and<br>Date 0411001606/08/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 17 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name GLAND PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00206565AM22
RA File Number 09AA04010507 AM22
Licence No and<br>Date 0911001380/08/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 18 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name AMANTA HEALTHCARE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00206644AM22
RA File Number 08AA04030760 AM22
Licence No and<br>Date 0811002839/08/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.13/82-ALC4/2019 dated<br>31.01.2020against advance authorization No.0810144674<br>dated 25.02.2019, 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:<br>Sinatre Not Verified
12<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>gu

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

12

Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>SODIUM HYALURONATE EYE DROPS 0.2 W/V (XAILIN HA /<br>XILIN<br>HA<br>/<br>AQAEYE<br>HA)((EACH<br>10ML<br>EYEDROPS<br>CONTAINING SODIUM HYALURONATE 20MG + WASTAGE<br>29.81 PERCENTAGE = 25.961 MG))<br>1 Number<br>1<br>SODIUM HYALURONATE<br>20 mg /<br>Vial<br>RA concerned may take further necessary action as per above decision of NC. Export product Qty. Sl.<br>No. Import items Qty.
SODIUM HYALURONATE EYE DROPS 0.2 W/V (XAILIN HA /<br>XILIN<br>HA<br>/<br>AQAEYE<br>HA)((EACH<br>10ML<br>EYEDROPS<br>CONTAINING SODIUM HYALURONATE 20MG + WASTAGE<br>29.81 PERCENTAGE = 25.961 MG)) <br> <br> <br>1 Number 1 SODIUM HYALURONATE 20 mg /<br>Vial
Case No. Case No. 19 / NC/3/MEET/Mar/202122/16 19 / NC/3/MEET/Mar/202122/16 19 / NC/3/MEET/Mar/202122/16 19 / NC/3/MEET/Mar/202122/16 19 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00207088AM22
RA File Number 09AA04016018 AM22
Licence No and<br>Date 0911001702/08/10/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>APREPITANT<br>1 kg<br>1<br>(2R)-4-Benzyl-2-[(1R) 1-[3,5-bis-(trifluoromethyl) Phenyl]-ehoxy] Morpholin-3-one<br>2.00 kg
Export product Qty. Sl.<br>No. Import items Qty.
APREPITANT 1 kg 1 (2R)-4-Benzyl-2-[(1R) 1-[3,5-bis-(trifluoromethyl) Phenyl]-ehoxy] Morpholin-3-one 2.00 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

13

Case No. 20 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00208598AM22
RA File Number 03AA040109754 AM22
Licence No and<br>Date 0311007605/10/10/2021
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>Description of all Excipients shown in items to be imported may be furnished as per their chemical name.<br>i.<br>Details of Packaging Material may be furnished.<br>ii.<br>Copy of Master Batch Formula for all export items indicating net content of inputs in each export.<br>iii.
Case No. 21 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00208798AM22
RA File Number 05AA04089568 AM22
Licence No and<br>Date 0511005321/11/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

14

Case No. 22 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name OPTRIX LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00208960AM22
RA File Number 09AA04016030 AM22
Licence No and<br>Date 0911001704/11/10/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>L-Proline<br>0.855 kg<br>2<br>1-Adamantanamine Hydrochloride<br>0.904 kg<br>3<br>DMF<br>0.50 kg<br>VILDAGLIPTIN<br>1 kg<br>4<br>Isopropyl alcohol<br>1.20 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No.<br> 23 / NC/3/MEET/Mar/202122/16
Case Status<br> Case Approved
Party Name<br> CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date<br> NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

15
The Committee co<br>advance authorizat<br> nsidered the case as per agenda and taking cue from earlier decision for same export product in Me<br>ion No.3111000353 dt.24.05.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as
less:<br>Export product<br>Qty.<br>Acetyl Anisole (4 Methoxy<br>Acetophenone)<br>1 kg
Export product Qty. Sl. No. Import items Qty.
Acetyl Anisole (4 Methoxy<br>Acetophenone) 1 kg 1 Phenol 0.72 kg
2 Methanol 0.276 kg
3 Acetic Anhydride PURITY 99 Percent age 0.755 kg
Case No. 24 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name KRITI NUTRIENTS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00210670AM22
RA File Number 56AA04005794 AM22
Licence No and<br>Date 5611000556/12/10/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

16

Deferred for comments of TE.

Case No. 25 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00210066AM22
RA File Number 34AA04008458 AM22
Licence No and<br>Date 3411001256/12/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 26 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name NEON LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00210390AM22
RA File Number 03AA040106734 AM22
Licence No and<br>Date 0311007655/12/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 27 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00211838AM22
RA File Number 05AA04081672 AM22<br>
17<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

17

Licence No and<br>Date 0511005408/13/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 28 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00211144AM22
RA File Number 03AA040110377 AM22
Licence No and<br>Date 0311007674/13/10/2021
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>Description of all Excipients shown in items to be imported may be furnished as per their chemical name.<br>i.<br>Details of Packaging Material may be furnished.<br>ii.<br>Copy of Master Batch Formula for all export items indicating net content of inputs in each export.<br>iii.
Case No. 29 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name AMARA LABS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00211472AM22
RA File Number 09AA04016055 AM22
Licence No and<br>Date 0911001711/13/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

18

Case No. 30 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00211526AM22
RA File Number 03AA040110500 AM22
Licence No and<br>Date 0311007683/13/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. Case No. 31 / NC/3/MEET/Mar/202122/16 31 / NC/3/MEET/Mar/202122/16 31 / NC/3/MEET/Mar/202122/16 31 / NC/3/MEET/Mar/202122/16 31 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name RUMIT LIFE CARE
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00211689AM22
RA File Number 03AA040109382 AM22
Licence No and<br>Date 0311007694/13/10/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Betamethasone Dipropionate IP/BP/EP/USP<br>1 kg<br>1<br>Betamethasone IP/BP/EP/USP<br>0.886 kg
Export product Qty. Sl. No. Import items Qty.
Betamethasone Dipropionate IP/BP/EP/USP 1 kg 1 Betamethasone IP/BP/EP/USP 0.886 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

19

Case No. 32 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00211729AM22
RA File Number 05AA04088434 AM22
Licence No and<br>Date 0511005403/13/10/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Export description is incomplete. Does not give proportion of two APIs. Please furnish justification for it and get the Advance Authorization amended from RA.
Case No. Case No. 33 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00211731AM22
RA File Number 05AA04090286 AM22
Licence No and<br>Date 0511005404/13/10/2021
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:
Export product Qty. Sl. No. Import items<br>Sinature Not Verified Qty.

Signature Not Verified Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

20

Brinzolamide Ophthalmic Suspension, 1% w/v 5ml ( Sterile Eye 24000 Numbers 1 Brinzolamide Micronized Sterile 1224 gram Drops) (BRINOLAR / BRAZTEC)((Each ml contains Brinzolamide equivalent to Brinzolamide Micronized Sterile 10 mg (Equivalent to 1200 Gm of Bulk Drug),)

Case No. 34 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00212058AM22
RA File Number 03AA040109332 AM22
Licence No and<br>Date 0311007711/14/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 35 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name RUMIT LIFE CARE
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00212190AM22
RA File Number 03AA040109327 AM22
Licence No and<br>Date 0311007716/14/10/2021
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 per details given below or as applied by the firm, whichever is<br>less:

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:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

21

Export product Qty. Sl. No. Import items Qty.
Betamethasone Dipropionate IP/BP/EP/USP 1 kg 1 Betamethasone IP/BP/EP/USP 0.886 kg
Case No. 36 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name RUMIT LIFE CARE
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00212191AM22
RA File Number 03AA040109313 AM22
Licence No and<br>Date 0311007717/14/10/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Clobetasol Propionate IP/BP/EP/USP<br>1 kg<br>1<br>Betamethasone IP/BP/EP/USP<br>1.00 kg<br>RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

22

Case No. 37 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00214698AM22
RA File Number 03AA040110385 AM22
Licence No and<br>Date 0311007732/17/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 38 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name MILAN LABORATORIES (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00215619AM22
RA File Number 03AA040110497 AM22
Licence No and<br>Date 0311007757/18/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 39 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name LUPIN LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00215795AM22
RA File Number 03AA040109357 AM22
Licence No and<br>Date 0311007760/18/10/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

23

Deferred for comments of TE.

Case No. 40 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00217903AM22
RA File Number 05AA04091965 AM22
Licence No and<br>Date 0511005458/20/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Dec/202122/12dated 17.12.2021against<br>advance authorization No.0511003791dt.23.07.2021, 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<br>less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Broxinac Eye Drops 0.09% 2.5 ml / Bromfenac Eye Drops<br>0.09% 2.5ml<br>1 Vial<br>1<br>BROMFENAC SODIUM HYDRATE<br>2.639 mg / vial<br>2<br>Broxinac Eye Drops 0.09% 1.7 ml / Bromfenac Eye Drops<br>0.09% 1.7ml<br>1 Vial<br>2<br>BROMFENAC SODIUM HYDRATE<br>1.235 mg / vial<br>RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

24

Case No. 41 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name BIODEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00218076AM22
RA File Number 05AA04090221 AM22
Licence No and<br>Date 0511005461/20/10/2021
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 DML with Approved Composition of the export product.
Case No. Case No. Case No. 42 / NC/3/MEET/Mar/202122/16 42 / NC/3/MEET/Mar/202122/16 42 / NC/3/MEET/Mar/202122/16 42 / NC/3/MEET/Mar/202122/16 42 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00218590AM22
RA File Number 08AA04033170 AM22
Licence No and Date 0811002920/20/10/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>(for 1 Number Vial)<br>METHOTREXATE<br>INJECTION<br>BP<br>25MG/ML<br>[2ML<br>METHOTREXATE EP / BP / IP /<br>1<br>1 Number<br>1<br>55.00 mg<br>
Sl. No. Export product Qty. Sl. No. Import items Qty.<br>(for 1 Number Vial)
1 METHOTREXATE<br>INJECTION<br>BP<br>25MG/ML<br>[2ML <br>1 Number<br> 1<br> METHOTREXATE EP / BP / IP /<br> <br>55.00 mg
25<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

25

VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR.<br>25MG) VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR.<br>25MG) VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR.<br>25MG) VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR.<br>25MG) VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR.<br>25MG) VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR.<br>25MG) USP / PH. EUR. USP / PH. EUR.
2 METHOTREXATE INJECTION BP 100MG/ML [5 ML<br>VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR. <br> <br>1 Number 2 METHOTREXATE EP / BP / IP /<br>USP / PH. EUR. <br>550.00 mg
100 MG)
3 METHOTREXATE INJECTION BP 100MG/ML [10ML<br>VIAL](EACH ML CONTAINS: METHOREXATE PH. EUR.<br>100MG) <br> <br>1 Number 3 ME<br>USP THOTREXATE EP / BP / IP /<br>/ PH. EUR. <br>1100.00 mg
4 METHOTREXATE INJECTION USP 25MG/ML [10ML<br>VIAL](EACH ML CONTAINS: METHOTREXATE USP <br>1 Number 4 ME<br>USP <br>275.00 mg
25M G)
THOTREXATE EP / BP / IP /<br>/ PH. EUR. <br>525.00 mg
5 ME THOTREXATE<br>INJECTION<br>BP<br>25MG/ML<br>[20ML <br>1 Number 5 ME
VIA<br>25M <br>L](EACH ML CONTAINS: METHOTREXATE PH. EUR.<br>G) <br> USP
THOTREXATE EP / BP / IP /<br>/ PH. EUR. <br>1050.00 mg
6 ME THOTREXATE<br>INJECTION<br>BP<br>25MG/ML<br>[40ML <br>1 Number 6 ME
<br>VIA<br>25M <br> <br> <br> <br> <br>L](EACH ML CONTAINS: METHOTREXATE PH. EUR.<br>G) <br> <br> <br>USP
R
7 METHOTREXATE INJECTION BP 100MG/ML [50ML<br>VIAL](EACH ML CONTAINS: METHOTREXATE PH. EUR.<br>100MG<br>[IN<br>WHICH<br>ACTIVE<br>INGREDIENT<br>METHOTREXATE USED IS 32.500 KGS.]) <br> <br> <br>1 Number 7 ME<br>USP THOTREXATE EP / BP / IP /<br>/ PH. EUR. <br>5250.00 mg
A concerned may take f urther nece ssary act ion as per above decision of NC.
C ase No. 43 /
NC/3/ EET/Mar/202122/16
C ase Status Cas e Appro ved Signature Not V erified
u ment has been digitally signe d by AJAY KUMAR, 26<br>Deputy Director,DGFT(HQ) on 26-Apr-2022. Digitally Signed.<br>Name: Ajay Kumar( Deput<br>Date: 26-Apr-2022 17:44:4<br>Reason: AJAY.DHIMAN88<br> <br> y Director )<br>2<br>@GOV.IN<br>
Location: DGFT (HQ )
Case No. 43 / NC/3/MEET/Mar/202122/16
Case Status Case Approved Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

26

Party Name MICRO LABS LIMITED
Meeting Number and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00218694AM22
RA File Number 04AA04006916 AM21
Licence No and Date 0711000597/20/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jul/202122/4dated 15.07.2021against<br>advance authorization No.0711000720 dt. 19.03.2021, 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<br>less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>CIPROFLOXACIN 250MG TABLETS (BP/EP/IP/USP<br>(2500000 Nos.))<br>2500000<br>Numbers<br>1<br>CIPROFLOXACIN HCL<br>693.75 kg<br>2<br>CIPROFLOXACIN 500MG TABLETS (BP/EP/IP/USP<br>(34800000 Nos.))<br>34800000<br>Numbers<br>2<br>CIPROFLOXACIN HCL<br>19314 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 44 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00218995AM22
RA File Number 08AA04033169 AM22
Licence No and Date 0811002929/20/10/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Signature Not Verified
27<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<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 per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

27
Sl. No. Export product Qty. Sl. No.<br> Import items Qty.<br>(for 1 Number Vial)
1 MITOXA<br>INFUSIO NTRONE<br>2MG/M CONCE<br>L 5M NTRATE FOR SOLUTION FOR<br>VIALEACH ML CONTAINS <br> <br>1 Number 1<br> <br> MITOXANTRONE<br>HYDROCHLORIDE EP / BP /<br>IP / USP / PH. EUR. <br>12.233 mg
, ( :<br>MITOXANTRONE HYDROCHLORIDE PH. EUR. EQ. TO<br>MITOXANTRONE 2 MG) <br> <br>
MITOXANTRONE<br>HYDROCHLORIDE EP / BP /<br>IP / USP / PH. EUR. <br>24.465 mg
2 MITOXANTRONE CO NCENTRATE FOR SOLUTION FOR <br>1 Number 2
INF UISON 2MG/ML, 10 ML VIAL(EACH ML <br>
CO NTAINS: MITOXAN TRONE HYDROCHLORIDE PH. EUR.
EQ . TO MITOXANTRO NE 2 MG)
MITOXANTRONE<br>HYDROCHLORIDE EP / BP /<br>IP / USP / PH. EUR. <br>36.700 mg
<br>
3 MI<br>IN OXANTRONE CO<br>USION 2MG/ML NCENTRATE FOR SOLUTION FOR<br>5 ML VIAL(EACH ML CONTAINS: <br> <br>1 Number 3 <br>
<br>MI ,<br>TOXANTRONE HY <br>DROCHLORIDE PH. EUR. EQ. TO <br> <br>
<br>MI <br>TOXANTRONE 2 M <br>G [IN WHICH ACTIVE INGREDIENT
MITOXANTRONE HCL USED IS 134.000 GRAMS])<br>RA concerned may take further necessary action as per above decision of NC. MITOXANTRONE HCL USED IS 134.000 GRAMS])
C ase No. 45 / NC/3/MEET/Mar/202122/16
C ase Status Case Approved
P arty Name SENTISS PHARMA PRIV ATE LIMITE D
M eeting Number NC/ 3/ MEET/ M/ 2 0212 / 16 d 08/ 4/2022
a ar an
nd Date
H Q File Number HQRNORM APPLY 0021 7900AM22
A Fil Nb 05AA04092009 AM2 2
e umer
ifid
L icence No and 0511005457/20/10/20 21 Si
oc u <br>gnature ot ty Director )<br>42<br>8@GOV.IN<br>ere
ment has been digitally signed by AJAY KUM 28<br>AR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar(<br>Date: 26-Apr-2022<br>Reason: AJAY.DHI<br>Location: DGFT(HQ Depu<br>17:44:<br>MAN8<br>)
(HQ

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

28

Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Jun/202122/2dated 02.07.2021 against advance authorization No. 0511002496dt.08.05.2021 , 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.
Kombinil-DUO Eye/Ear Drops 5ml Vial(Kombinil-DUO<br>Eye/Ear Drops 5ml Vial) <br>1272727 Vials 1 Dexamethasone Micronised PH EUR USP JP 6.491 kg
Case No. 46 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00219582AM22
RA File Number 31AA04028567 AM22
Licence No and<br>Date 3111000633/21/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Mar/202122/15 dated17.03.2022against<br>advance authorization No.3111000177dt.11.03.2021, 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<br>less:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Mar/202122/15 dated17.03.2022 against advance authorization No. 3111000177dt.11.03.2021 , 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:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

29

Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Phenol<br>0.74 kg<br>2<br>Methanol<br>0.276 kg<br>Acetyl Anisole<br>(4 MethoxyAcetophenone)<br>1 kg<br>3<br>Acetic Anhydride PURITY 99%<br>0.755 kg<br>RA concerned may take further necessary action as per above decision of NC. Export product Qty. Sl. No. Import items Qty.
Acetyl Anisole<br>(4 MethoxyAcetophenone) 1 kg 1 Phenol 0.74 kg
2 Methanol 0.276 kg
3 Acetic Anhydride PURITY 99% 0.755 kg
Case No. Case No. 47 / NC/3/MEET/Mar/202122/16 47 / NC/3/MEET/Mar/202122/16 47 / NC/3/MEET/Mar/202122/16 47 / NC/3/MEET/Mar/202122/16 47 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name VETBIOCHEM INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00220047AM22
RA File Number 31AA04028555 AM22
Licence No and<br>Date 3111000636/21/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.7/82-ALC4/2020 dated<br>04.12.2020against advance authorization No.3110067816<br>dt. 11.08.2020, 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:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Florfenicol 20% w/v Oral Suspension<br>4000 Litres<br>1<br>Florfenicol API<br>800 kg
Export product Qty. Sl. No. Import items Qty.
Florfenicol 20% w/v Oral Suspension 4000 Litres 1 Florfenicol API 800 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

30

Case No. 48 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00220068AM22
RA File Number 31AA04027993 AM22
Licence No and<br>Date 3111000637/21/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 49 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name NAARI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00220580AM22
RA File Number 05AA04091063 AM22
Licence No and<br>Date 0511005553/21/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 50 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name NAARI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

31

HQ File Number HQRNORM APPLY 00220582AM22
RA File Number 05AA04091028 AM22
Licence No and<br>Date 0511005555/21/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 51 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name BHAGWATI INDUSTRIES
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00219420AM22
RA File Number 08AA04033013 AM22
Licence No and<br>Date 0811002934/21/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 52 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name NAARI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00220583AM22
RA File Number 05AA04091027 AM22
Licence No and<br>Date 0511005556/21/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 53 / NC/3/MEET/Mar/202122/16
Case Status Case Approved<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

32

Party Name DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00219562AM22
RA File Number 31AA04028367 AM22
Licence No and<br>Date 3111000631/21/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Mar/202122/15 dated 17.03.2022against<br>advance authorization No.3111000130 dt.03.02.2021, 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<br>less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>DNOVO BP838<br>1 kg<br>1<br>2,6 xylenol<br>0.954 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 54 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name NAARI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00220585AM22
RA File Number 05AA04090983 AM22
Licence No and<br>Date 0511005557/21/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

33

Case No. Case No. 55 / NC/3/MEET/Mar/202122/16 55 / NC/3/MEET/Mar/202122/16 55 / NC/3/MEET/Mar/202122/16 55 / NC/3/MEET/Mar/202122/16 55 / NC/3/MEET/Mar/202122/16 55 / NC/3/MEET/Mar/202122/16 55 / NC/3/MEET/Mar/202122/16 55 / NC/3/MEET/Mar/202122/16 55 / NC/3/MEET/Mar/202122/16 55 / NC/3/MEET/Mar/202122/16 55 / NC/3/MEET/Mar/202122/16 55 / NC/3/MEET/Mar/202122/16 55 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name DEEPAK NOVOCHEM TECHNOLOGIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00219566AM22
RA File Number 31AA04028264 AM22
Licence No and<br>Date 3111000632/21/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Mee<br>advance authorization No.3111000493 dt. 30.07.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>less:<br>Export Product<br>Qty.<br>Sl. No.<br>Im<br>1<br>2,6<br>DNOVO BP818 (Powder)<br>1 kg ting No.NC/3/MEET/Dec/202122/12 dated 17.12.2021against<br>per details given below or as applied by the firm, whichever is
he Committee considered the case as per agenda<br>vance authorization No.3111000493 dt. 30.07.2 and taking cue<br>021, it was dec from earl<br>ided to ra ier decision for same export<br>tify norms under Para 4.07 o product in Mee<br>f HBP Vol. I as
ss:
Export Product Qty. Sl. No. Im port items Qty.
DNOVO BP818 (Powder) 1 kg 1 2,6 1.06 kg
(Tetra Methyl B isphenol F) 2 P raformaldehyde 0.130 kg
a
ethanol 0.100 kg
3 M
RA concerned may take further necessary action as per above decision of NC.
Case No. 56 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
P arty Name TRANSPEK INDUSTRY LIMITED
M<br>an eeting Number<br>d Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
H
Q File Number HQRNORM APPLY 00 221193AM22
R A File Number 34AA04008496 AM22 Sig nature Not V erified
um y Director )<br>2<br>@GOV.IN<br>
ent has been digitally signed by AJAY KUMAR , Deputy Direc tor,DGFT 34<br>(HQ) on 26-Apr-2022.<br>Digital<br>Name<br>Date:<br>Reaso<br>Locati ly Signed.<br>: Ajay Kumar( Deput<br>26-Apr-2022 17:44:4<br>n: AJAY.DHIMAN88<br>on: DGFT(HQ)
Case No. 56 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name TRANSPEK INDUSTRY LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00221193AM22
RA File Number 34AA04008496 AM22 Signature Not Verified

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

34

Licence No and 3411001299/22/10/2021 Date

Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Oct/202122/9 dated15.10.2021 against advance authorization No. 3410046491dt.22.10.2020 , 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:

Export product Qty. Sl. No. Import items Qty.
N-OCTANOYL CHLORIDE 1 kg 1 CAPRYLIC ACID 0.904 kg
Case No. 57 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00221196AM22
RA File Number 07AA04035640 AM22
Licence No and<br>Date 0711002189/22/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 58 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

35

HQ File Number HQRNORM APPLY 00221594AM22
RA File Number 08AA04033661 AM22
Licence No and<br>Date 0811002958/22/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 59 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name THEMIS NUTRITIONALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00221695AM22
RA File Number 03AA040108212 AM22
Licence No and<br>Date 0311007847/22/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 60 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name SWATI MENTHOL AND ALLIED CHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00221840AM22
RA File Number 05AA04092995 AM22
Licence No and<br>Date 0511005572/22/10/2021
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>COA of import and export item with impurity profile.<br>i.<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

36

ii. Process of manufacturing.

iii. Justification for 2.5% wastage.

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

DML.

Case No. 61 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name GRANULES INDIA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00221872AM22
RA File Number 09AA04016492 AM22
Licence No and<br>Date 0911001748/22/10/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>R 9 2 Phosphonyl Methoxy Propyl Adenine<br>0.769 kg<br>Tenofovir Disoproxil Succinate<br>1 kg<br>2<br>Chloromethyl Isopropyl Carbonate<br>1.3527 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 62 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name VINEET LABORATORIES LIMITED<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

37

Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00221961AM22
RA File Number 09AA04016348 AM22
Licence No and<br>Date 0911001751/22/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 63 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00221158AM22
RA File Number 07AA04035636 AM22
Licence No and<br>Date 0711002187/22/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 64 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name OLON ACTIVE PHARMACEUTICAL INGREDIENTS INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00222021AM22
RA File Number 03AA040112432 AM22
Licence No and<br>Date 0311007856/22/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

38

Case No. 65 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00224720AM22
RA File Number 31AA04028703 AM22
Licence No and<br>Date 3111000643/25/10/2021
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>Justification for low yield of 50% in Phosphorus Oxy Chloride and 42.6% in Ammonia.
Case No.<br> Case No.<br> Case No.<br> 66 / NC/3/MEET/Mar/202122/16 66 / NC/3/MEET/Mar/202122/16 66 / NC/3/MEET/Mar/202122/16 66 / NC/3/MEET/Mar/202122/16 66 / NC/3/MEET/Mar/202122/16
Case Status<br> Case Approved
Party Name<br> CIPLA LIMITED
Meeting Number<br>and Date<br> NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number<br> HQRNORM APPLY 00224766AM22
RA File Number<br> 03AA040110548 AM22
Licence No and<br>Date<br> 0311007891/25/10/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Telmisartan and Amlodipine Tablets 40/10mg / Each uncoated tablets contains :(Telmisartan 40 mg<br>Telmisartan 40 mg equivalent to Telmisartan granules 67.36mg Amlodipine Besilate equivalent to<br>10.20 mg<br>1<br>1 Number<br>1<br>Amlodipine Besilate
Sl. No. Export product Qty. Sl. No. Import items Qty.
1 Telmisartan and Amlodipine Tablets 40/10mg / Each uncoated tablets contains :(Telmisartan 40 mg<br>Telmisartan 40 mg equivalent to Telmisartan granules 67.36mg Amlodipine Besilate equivalent to 1 Number 1 Amlodipine Besilate 10.20 mg

==> picture [738 x 304] intentionally omitted <==

----- Start of picture text -----<br> Case No. 66 / NC/3/MEET/Mar/202122/16<br>Case Status Case Approved<br>Party Name CIPLA LIMITED<br>Meeting Number<br>NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022<br>and Date<br>HQ File Number HQRNORM APPLY 00224766AM22<br>RA File Number 03AA040110548 AM22<br>Licence No and<br>0311007891/25/10/2021<br>Date<br>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 per details given below or as applied by the firm, whichever is<br>less:<br>Sl. No. Export product Qty. Sl. No. Import items Qty.<br>1 Telmisartan and Amlodipine Tablets 40/10mg / Each uncoated tablets contains :(Telmisartan 40 mg 1 Number 1 Amlodipine Besilate 10.20 mg<br>Telmisartan 40 mg equivalent to Telmisartan granules 67.36mg Amlodipine Besilate equivalent to<br>Signature Not Verified<br>----- End of picture text -----<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

39

Amlodipine USP 10mg Net wt of Telmisartan Granules is 2020.800 Kgs. Net wt of Amlodipine<br>Besilate is 300.000 Kgs.)<br> <br>2<br>Telmisartan and Amlodipine Tablets 80/10mg / Each uncoated tablets contains : Telmisartan 80<br>mg(Telmisartan 80 mg equivalent to Telmisartan granules 134.72mg Amlodipine Besilate equivalent to<br>Amlodipine USP 10mg Net wt of Telmisartan Granules is 10777.600 Kgs. Net wt of Amlodipine<br>Besilate is 800.000 Kgs.)<br>1 Number<br>2<br>Amlodipine Besilate<br>10.20 mg<br>3<br>Telmisartan and Amlodipine Tablets 40/5mg / Each uncoated tablets contains : Telmisartan 40<br>mg(Telmisartan 40 mg equivalent to Telmisartan granules 67.36mg Amlodipine Besilate equivalent to<br>Amlodipine USP 5mg Net wt of Telmisartan Granules is 6286.933 Kgs. Net wt of Amlodipine Besilate<br>is 466.667 Kgs.)<br>1 Number<br>3<br>Amlodipine Besilate<br>5.10 mg<br>4<br>Telmisartan and Amlodipine Tablets 80/5mg / Each uncoated tablets contains : Telmisartan 80<br>mg(Telmisartan 80 mg equivalent to Telmisartan granules 134.72mg Amlodipine Besilate equivalent to<br>Amlodipine USP 5mg Net wt of Telmisartan Granules is 10777.600 Kgs. Net wt of Amlodipine<br>Besilate is 400.000 Kgs.)<br>1 Number<br>4<br>Amlodipine Besilate<br>5.10 mg<br>RA concerned may take further necessary action as per above decision of NC. Amlodipine USP 10mg Net wt of Telmisartan Granules is 2020.800 Kgs. Net wt of Amlodipine<br>Besilate is 300.000 Kgs.)
2 Telmisartan and Amlodipine Tablets 80/10mg / Each uncoated tablets contains : Telmisartan 80<br>mg(Telmisartan 80 mg equivalent to Telmisartan granules 134.72mg Amlodipine Besilate equivalent to<br>Amlodipine USP 10mg Net wt of Telmisartan Granules is 10777.600 Kgs. Net wt of Amlodipine<br>Besilate is 800.000 Kgs.) 1 Number 2 Amlodipine Besilate 10.20 mg
3 Telmisartan and Amlodipine Tablets 40/5mg / Each uncoated tablets contains : Telmisartan 40<br>mg(Telmisartan 40 mg equivalent to Telmisartan granules 67.36mg Amlodipine Besilate equivalent to<br>Amlodipine USP 5mg Net wt of Telmisartan Granules is 6286.933 Kgs. Net wt of Amlodipine Besilate<br>is 466.667 Kgs.) 1 Number 3 Amlodipine Besilate 5.10 mg
4 Telmisartan and Amlodipine Tablets 80/5mg / Each uncoated tablets contains : Telmisartan 80<br>mg(Telmisartan 80 mg equivalent to Telmisartan granules 134.72mg Amlodipine Besilate equivalent to<br>Amlodipine USP 5mg Net wt of Telmisartan Granules is 10777.600 Kgs. Net wt of Amlodipine<br>Besilate is 400.000 Kgs.) 1 Number 4 Amlodipine Besilate 5.10 mg
Case No. 67 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name HONOUR LAB LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00224852AM22
RA File Number 09AA04016256 AM22
Licence No and<br>Date 0911001764/25/10/2021
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 Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Signature Not Verified
40<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

40

Export product Qty. Sl. No. Import items Qty.
LINAGLIPTIN 1 kg 1 8-Bromo-7-(but-2-ynyl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-1H-purine- 1.10 kg
2,6(3H,7H)-dione
Case No. 68 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name METROPOLITAN EXIMCHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00225235AM22
RA File Number 03AA040108347 AM22
Licence No and<br>Date 0311007901/25/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 69 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00225362AM22
RA File Number 05AA04093389 AM22
Licence No and<br>Date 0511005627/25/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

41

Case No. 70 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00226883AM22
RA File Number 08AA04033768 AM22
Licence No and Date 0811002982/26/10/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Feb/202122/14dated 21.02.2022against
advance authorization No.0811002770dt.04.10.2021, 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.
NALTREXONE<br>HYDROCHLORIDE<br>1 Number 1 NALTREXONE HYDROCHLORIDE EP / BP / IP / USP / 51.00 mg
TABLETS<br>50<br>MG(EACH<br>FILM PH. EUR
COATED<br>TABLET CONTAINS:
NALTREXONEHYDROCHLORIDE PH.
EUR. 50 MG [IN WHICH ACTIVE
INGREDIENT NALTREXONE
HYDROCHLORIDE USED IS 513.540
KGS.])
RA concerned may take further necessary action as per above decision of NC.
Case No. 71 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00226895AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

42

RA File Number 02AA04031501 AM22
Licence No and<br>Date 0211001401/26/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case to Department of Chemical & Petrochemicals (D/o C&PC) for obtaining its comments.
Case No. 72 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name TOJO VIKAS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00226905AM22
RA File Number 05AA04094141 AM22
Licence No and<br>Date 0511005704/26/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 73 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00227461AM22
RA File Number 03AA04097792 AM22
Licence No and<br>Date 0311007966/27/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 74 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name HALDIA PETROCHEMICALS LIMITED<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

43

Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00227901AM22
RA File Number 02AA04030895 AM22
Licence No and<br>Date 0211001406/27/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case to Department of Chemical & Petrochemicals (D/o C&PC) for obtaining its comments.
Case No. 75 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name SHREE JAYA LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00229681AM22
RA File Number 09AA04016739 AM22
Licence No and<br>Date 0911001789/28/10/2021
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>Complete technical details as per Annexure to Appendix 4E.<br>i.<br>NOC from MOEF for the import and use of Freon Gas.
Case No. 76 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name KREATIVE ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00229743AM22
RA File Number 09AA04016534 AM22
Licence No and<br>Date 0911001791/28/10/2021<br>Sinature Not Verified

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

44

Norms Committee Decision: Deferred for comments of TE.

Case No. 77 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00229799AM22
RA File Number 05AA04094507 AM22
Licence No and<br>Date 0511005751/28/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 78 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00235646AM22
RA File Number 03AA040116357 AM22
Licence No and<br>Date 0311008044/29/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 79 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name AUROBINDO PHARMA LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00230750AM22<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

45

RA File Number 09AA04016788 AM22
Licence No and<br>Date 0911001796/29/10/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 80 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name ENALTEC LABS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00235674AM22
RA File Number 03AA040115872 AM22
Licence No and<br>Date 0311008046/29/10/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Trospium Chloride USP<br>1 kg<br>1<br>Nortropine<br>0.55 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 81 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name AARTI DRUGS LIMITED
MeetingNumber NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022 Signature Not Verified

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

46

and Date
HQ File Number HQRNORM APPLY 00231062AM22
RA File Number 03AA040112473 AM22
Licence No and<br>Date 0311008038/29/10/2021
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 Authorities.
Case No. 82 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name BAZAYAN ENTERPRISES LLP
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00235681AM22
RA File Number 03AA04078009 AM22
Licence No and<br>Date 0311008047/29/10/2021
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>Drug Manufacturing Licence of Export Product.
Case No. 83 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name INDOCO REMEDIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00237170AM22
RA File Number 03AA040116473 AM22
Licence No and 0311008055/31/10/2021<br>
47<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

47

Date

Norms Committee Decision:

Deferred for comments of TE.

Case No. 84 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name RUMIT LIFE CARE
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00238234AM22
RA File Number 03AA040116165 AM22
Licence No and<br>Date 0311008108/01/11/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Betamethasone Dipropionate IP/BP/EP/USP<br>1 kg<br>1<br>Betamethasone IP/BP/EP/USP<br>0.886 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 85 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name RUMIT LIFE CARE
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00238265AM22<br>Signature Not Verified

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

48

RA File Number 03AA040116164 AM22
Licence No and<br>Date 0311008110/01/11/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Clobetasol Propionate IP/BP/EP/USP<br>1 kg<br>1<br>Betamethasone IP/BP/EP/USP<br>1.00 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. Case No. 86 / NC/3/MEET/Mar/202122/16 86 / NC/3/MEET/Mar/202122/16 86 / NC/3/MEET/Mar/202122/16 86 / NC/3/MEET/Mar/202122/16 86 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00238470AM22
RA File Number 05AA04094508 AM22
Licence No and<br>Date 0511005871/01/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>advance authorization No.0510414007dt.16.04.2020, 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<br>less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.
Export product Qty. Sl. No. Import items Qty.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

49

VANCOMYCIN HYDROCHLORIDE( STERILE) 1 kg 1 Vancomycin HCL (Non Sterile)

1.01 kg

Case No. Case No. 87 / NC/3/MEET/Mar/202122/16 87 / NC/3/MEET/Mar/202122/16 87 / NC/3/MEET/Mar/202122/16 87 / NC/3/MEET/Mar/202122/16 87 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00238502AM22
RA File Number 05AA04094832 AM22
Licence No and<br>Date 0511005876/01/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.7/82-ALC4/2020 dated<br>04.12.2020against advance authorization No.0510415816 dt.<br>10.11.2020, 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:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty. per 5 ml vial<br>1<br>Dorzolamide Hydrochloride<br>117.095 mg<br>Dorzolamide and Timolol Ophthalmic Solution, 2.0%w/v +<br>0.5%w/v, 5ml (TIMODOL Sterile Eye Drops) (LOFTEMIDE)<br>((Each ml contains Dorzolamide Hydrochloride equivalent to<br>Dorzolamide 20 mg (Equivalent to 2.200 Kg of<br>Bulk Drug),and Timolol Maleate equivalent to Timolol 5.0 mg<br>(Equivalent to 0.550 Kg. of Bulk Drug))<br>1 Number<br>2<br>Timolol Maleate<br>35.70 mg
Export product Qty. Sl. No. Import items Qty. per 5 ml vial
Dorzolamide and Timolol Ophthalmic Solution, 2.0%w/v +<br>0.5%w/v, 5ml (TIMODOL Sterile Eye Drops) (LOFTEMIDE)<br>((Each ml contains Dorzolamide Hydrochloride equivalent to<br>Dorzolamide 20 mg (Equivalent to 2.200 Kg of<br>Bulk Drug),and Timolol Maleate equivalent to Timolol 5.0 mg<br>(Equivalent to 0.550 Kg. of Bulk Drug)) 1 Number 1 Dorzolamide Hydrochloride 117.095 mg
2 Timolol Maleate 35.70 mg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

50

Case No. 88 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name AMI LIFESCIENCES PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00238511AM22
RA File Number 34AA04009023 AM22
Licence No and<br>Date 3411001360/01/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Dec/202122/12dated<br>17.12.2021against advance authorization No.3411000856dt.<br>16.07.2021, 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:<br>Export product<br>Qty.<br>Sl. No.<br>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. 89 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00238516AM22
RA File Number 03AA040109085 AM22

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

51

Licence No and Date 0311008136/01/11/2021 Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Dec/202122/12dated 17.12.2021 against advance authorization No. 0311005189dt.

07.07.2021 , 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.
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
6 METHYLENE DICHLORIDE (MDC) 1.83 kg
Case No. 90 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name BHARAT PARENTERALS LIMITED
Meeting Number NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

52

and Date
HQ File Number HQRNORM APPLY 00239596AM22
RA File Number 34AA04008748 AM22
Licence No and<br>Date 3411001363/02/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 91 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00239687AM22
RA File Number 03AA040115878 AM22
Licence No and<br>Date 0311008179/02/11/2021
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>Description of all Excipients shown in items to be imported may be furnished as per their chemical name.<br>i.<br>Details of Packaging Material may be furnished.<br>ii.<br>Copy of Master Batch Formula for all export items indicating net content of inputs in each export.<br>iii.
Case No. 92 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00239722AM22
RA File Number 07AA04038456 AM22
Licence No and<br>Date 0711002275/02/11/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

53

Norms Committee Decision: Deferred for comments of TE.

Case No. 93 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00239729AM22
RA File Number 07AA04038459 AM22
Licence No and Date 0711002276/02/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jun/202122/2 dated 02.07.2021against<br>advance authorization No.0710115189dt.19.07.2019, 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<br>less:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>CALCIUM GLUCONATE (EP FOR INJECTION/JP/USP/POWDER)<br>1 kg<br>1<br>CALCIUM GLUCONATE<br>1.09 kg<br>2<br>CALCIUM BOROGLUCONATE<br>1 kg<br>1<br>CALCIUM GLUCONATE<br>0.946 kg<br>3<br>CALCIUM GLUBIONATE(FOR INJECTION) / CALCIUM GLUBIONATE<br>1 kg<br>1<br>CALCIUM GLUCONATE<br>0.430 kg<br>RA concerned may take further necessary action as per above decision of NC.

==> picture [738 x 48] intentionally omitted <==

----- Start of picture text -----<br> Case No. 94 / NC/3/MEET/Mar/202122/16<br>Case Status Case Deferred<br>Party Name JODAS EXPOIM PRIVATE LIMITED Signature Not Verified<br>----- End of picture text -----<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

54

Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00239769AM22
RA File Number 09AA04001389 AM22
Licence No and<br>Date 0911001808/02/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case to Department of Biotechnology (DBT) for obtaining its comments.
Case No. 95 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name KUSUMA PHARMA
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00239788AM22
RA File Number 03AA040117605 AM22
Licence No and<br>Date 0311008185/02/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Mar/202122/15 dated 17.03.2022<br>against advance authorization No.0311002428dt.11.03.2021, 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,<br>whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>ZINC CITRATE TRIHYDRATE (PURE)<br>50000 kg<br>1<br>CITRIC ACID MONOHYDRATE<br>34109.5 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 96 / NC/3/MEET/Mar/202122/16

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

55

Case Status Case Status Case Deferred Case Deferred Case Deferred Case Deferred Case Deferred Case Deferred Case Deferred Case Deferred Case Deferred Case Deferred
Party Name BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00239319AM22
RA File Number 03AA040117252 AM22
Li<br>D cence No and<br>ate 0311008158/02/11/2021
N<br>D
orms Committee Decision:<br>eferred for comments of TE.
C ase No. 97 / NC/3/MEET/ Mar/202122/16
C ase Status Case Deferred
Pa rty Name BELCHEM INDU STRIES (INDI A) PVT LTD
M<br>an eeting Number<br>d Date NC/ 3/ MEET/ Ma r/ 202122/ 16 a nd 08/0 4/2022
H Q File Number HQRNORM APP LY 00239808A M22
R A File Number 03AA040117646 AM22
Li<br>D cence No and<br>ate 0311008190/02/11/2021
N<br>D orms Committee Decision:<br>ferred for comments of TE
.
C ase No. 98 / NC/3/MEET/Mar/202122/16
C ase Status Case Deferred
Pa rty Name YASHO INDUSTRIES LIMITED
M eeting Number
<br>an <br>d Date NC/ 3/ MEET/ Mar/ 20 122/ 16 and 0 /04/2022
H Q File Number HQRNORM APPLY 0 239466AM22
R A File Number 03AA040116810 AM22
Li cence No and
D ate 0311008170/02/11/202
N orms Committee Decision:
Signature Not V
um ent has been diita l sined b AJAY KUMA Deut Direct
rDGFT(H Q) on 26-Ar-2022<br> <br> igitally Signed.<br>
g y g y , py , 56<br>p.<br> <br>D<br>R ame: Ajay Kumar( Deput<br>ate: 26-Apr-2022 17:44:4<br>eason: AJAYDHIMAN88
<br>L .<br>ocation: DGFT(HQ)

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

56

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

  • i. Stoichiometric balance on molar basis to arrive at the quantity of raw material asked for.

Clarification regarding yield shown as 121% in step No. 2, since yield can not be more than 100%.

Case No. 99 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name KHILARI LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00240478AM22
RA File Number 03AA040117695 AM22
Licence No and<br>Date 0311008211/03/11/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>ARTEMETHER<br>1 kg<br>1<br>ARTEMISININ<br>1.04 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 100 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

57

and Date
HQ File Number HQRNORM APPLY 00240653AM22
RA File Number 09AA04017004 AM22
Licence No and<br>Date 0911001811/03/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 101 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00240922AM22
RA File Number 03AA040114188 AM22
Licence No and<br>Date 0311008242/03/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 102 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00240924AM22
RA File Number 03AA040114092 AM22
Licence No and<br>Date 0311008243/03/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Mar/202122/15 dated 17.03.2022<br>against advance authorization No.0311000630dt.04.01.2021, 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,<br>whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

58

Export product Qty. Sl. No. Import items Qty.
DIPHENYL ISODECYL<br>PHOSPHITE((DPDP)) 1 kg 1 PHENOL 0.557 kg
2 ISODECYL ALCOHOL OR 2 PROPYL HEPTANOL 0.419 kg
3 YELLOW PHOSPHORUS 0.087 kg
Case No. Case No. 103 / NC/3/MEET/Mar/202122/16 103 / NC/3/MEET/Mar/202122/16 103 / NC/3/MEET/Mar/202122/16 103 / NC/3/MEET/Mar/202122/16 103 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name HETERO LABS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00240943AM22
RA File Number 09AA04016704 AM22
Licence No and<br>Date 0911001814/03/11/2021
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 Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>(2S,3S,5S)-2-amino-3-hydroxy-5-tert<br>butyl<br>carbonyl<br>amino-1,6-<br>(S,E)-5-AMINO-2-(DIBENZYLAMINO)-1,6-<br>1 kg<br>1<br>1.77 kg
Export product Qty. Sl. No. Import items Qty.
(2S,3S,5S)-2-amino-3-hydroxy-5-tert<br>butyl<br>carbonyl<br>amino-1,6- 1 kg 1 (S,E)-5-AMINO-2-(DIBENZYLAMINO)-1,6- 1.77 kg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

59

DIPHENYLHEX-4-EN-3-ONE<br>2<br>SODIUM BORO HYDRIDE<br>0.45 kg<br>3<br>TETRA HYDRO FURAN<br>0.48 kg<br>4<br>2,2,2 TRI FLUORO ACETIC ACID<br>2.16 kg<br>diphenyl-hexane<br>5<br>DI TERT.BUTYL DI CARBONATE<br>0.92 kg<br>RA concerned may take further necessary action as per above decision of NC. diphenyl-hexane DIPHENYLHEX-4-EN-3-ONE
2 SODIUM BORO HYDRIDE 0.45 kg
3 TETRA HYDRO FURAN 0.48 kg
4 2,2,2 TRI FLUORO ACETIC ACID 2.16 kg
5 DI TERT.BUTYL DI CARBONATE 0.92 kg
Case No. Case No. 104 / NC/3/MEET/Mar/202122/16 104 / NC/3/MEET/Mar/202122/16 104 / NC/3/MEET/Mar/202122/16 104 / NC/3/MEET/Mar/202122/16 104 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name PORUS LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00241165AM22
RA File Number 09AA04016450 AM22
Licence No and<br>Date 0911001817/03/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.5/82-ALC4/2020 dated<br>09.10.2020against advance authorization No.0910068738 dt.<br>11.05.2020, 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:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.
Export product Qty. Sl. No. Import items Qty.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

60

2-Phenyl-3,3-bis(4-hydroxy phenyl)phthalimide (PPP-BP)<br>1 kg<br>RA concerned may take further necessary action as per above decision of NC. 2-Phenyl-3,3-bis(4-hydroxy phenyl)phthalimide (PPP-BP) 2-Phenyl-3,3-bis(4-hydroxy phenyl)phthalimide (PPP-BP) 1 kg 1 PHTHALIC ANHYDRIDE 0.927 kg
2 PHENOL 1.145 kg
3 ZINC CHLORIDE 0.104 kg
4 ANILINE 0.596 kg
5 METHANOL 0.715 kg
6 ACTIVATED CARBON 0.100 kg
Case No. 105 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00240477AM22
RA File Number 03AA040115048 AM22
Licence No and<br>Date 0311008210/03/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.5/82-ALC4/2020 dated<br>09.10.2020against advance authorization No.0910068738 dt.<br>11.05.2020, 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:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

61

Export product Export product Qty. Sl. No. Import items Import items Qty.
CEFEPIME FOR INJECTION 1 kg 1 CEFEPIME HCL NON STERILE 0.655 kg
L ARGININE 0.370 kg
2 L ARGININE
LUMINIUM CANISTER 10KG Relevant as per packing<br>policy
3 PACKING MATERIAL A
RA concerned may take further necessary action as per above decision of NC.
Case No 106 / NC/3/MEET/Mar/202122/16
.
Case Status Case Deferred
Part Name INDIA GLYCOLS LIMITED
y
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00244346AM22
RA File Number 05AA04093440 AM22
Licence No and<br>Date 0511005996/08/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Case No. 107 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name HETERO DRUGS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
Sit Nt Vifid

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

62

HQ File Number HQRNORM APPLY 00244472AM22
RA File Number 09AA04016986 AM22
Licence No and<br>Date 0911001820/08/11/2021
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 Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Imeglimin HCl<br>1 kg<br>1<br>L (+) TARTARIC ACID<br>2.40 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 108 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00245478AM22
RA File Number 03AA040118307 AM22
Licence No and<br>Date 0311008357/09/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 109 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name NITIKA PHARMACEUTICAL SPECIALITIES PRIVATE LIMITED
Meeting Number NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

63

and Date
HQ File Number HQRNORM APPLY 00245623AM22
RA File Number 50AA04003867 AM22
Licence No and<br>Date 5011000294/09/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 110 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name AARTI INDUSTRIES LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00246187AM22
RA File Number 03AA04078980 AM22
Licence No and<br>Date 0311008372/09/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 111 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name LUPIN LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00246327AM22
RA File Number 03AA040117674 AM22
Licence No and<br>Date 0311008377/09/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No. 112 / NC/3/MEET/Mar/202122/16

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

64

Case Status Case Deferred
Party Name LUPIN LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00246330AM22
RA File Number 03AA040117679 AM22
Licence No and<br>Date 0311008378/09/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 113 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name UNITED MUD-CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00246334AM22
RA File Number 03AA040116697 AM22
Licence No and<br>Date 0311008379/09/11/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>RHEOLOGY MODIFIER (containing 95% Dimer Acid)<br>1 kg<br>1<br>Dimer Acid<br>0.969 kg<br>RA concerned may take further necessary action as per above decision of NC.<br>Signature Not Verified
65<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

65

Case No. 114 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name REYAANSH HEALTHCARE
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00246356AM22
RA File Number 03AA040110381 AM22
Licence No and<br>Date 0311008381/09/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. Case No. Case No. 115 / NC/3/MEET/Mar/202122/16 115 / NC/3/MEET/Mar/202122/16 115 / NC/3/MEET/Mar/202122/16 115 / NC/3/MEET/Mar/202122/16 115 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00247246AM22
RA File Number 05AA04097736 AM22
Licence No and<br>Date 0511006029/10/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against<br>advance authorization No.0510413849dt.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<br>less:<br>Sl. No.<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Broxinac Eye Drops 0.09% 2.5 ml / Bromfenac Eye Drops 0.09%<br>2.5ml<br>1 Vial<br>1<br>Bromfenac Sodium Hydrate<br>1.235 mg<br>Sinature Not Verified
Sl. No. Export Product Qty. Sl. No. Import Items Qty.
1 Broxinac Eye Drops 0.09% 2.5 ml / Bromfenac Eye Drops 0.09%<br>2.5ml 1 Vial 1<br>Sinatu Bromfenac Sodium Hydrate<br>re Not Verified 1.235 mg
66<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>g

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

66

2<br>Broxinac Eye Drops 0.09% 1.7 ml / Bromfenac Eye Drops 0.09%<br>1.7ml<br>1 Vial<br>2<br>Bromfenac Sodium Hydrate<br>2.639 mg<br>RA concerned may take further necessary action as per above decision of NC. 2 Broxinac Eye Drops 0.09% 1.7 ml / Bromfenac Eye Drops 0.09%<br>1.7ml Broxinac Eye Drops 0.09% 1.7 ml / Bromfenac Eye Drops 0.09%<br>1.7ml 1 Vial 2 Bromfenac Sodium Hydrate 2.639 mg
Case No. 116 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name FDC LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00246932AM22
RA File Number 03AA040119771 AM22
Licence No and<br>Date 0311008387/10/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 117 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00248392AM22
RA File Number 03AA040117919 AM22
Licence No and<br>Date 0311008437/11/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 118 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred<br>
67<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

67

Party Name AMINES AND PLASTICIZERS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00248395AM22
RA File Number 03AA040113998 AM22
Licence No and<br>Date 0311008443/11/11/2021
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>Stoichiometric balance on molar basis to arrive at the quantity of raw material asked for.
Case No. Case No. Case No. 119 / NC/3/MEET/Mar/202122/16 119 / NC/3/MEET/Mar/202122/16 119 / NC/3/MEET/Mar/202122/16 119 / NC/3/MEET/Mar/202122/16 119 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name ZENTIVA PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00248989AM22
RA File Number 03AA040119863 AM22
Licence No and Date 0311008474/11/11/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Sl. No.<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>Hydrochlorothiazide<br>12.75 mg<br>1<br>Ramilich / Ramilich Comp / Ramipril HCT ZT/ZTV 5-12.5mg((Net<br>Wt. Hydrochlorothiazide 125.00 KGS) (Net Wt.Ramipril 50.00 KGS))<br>1 Number<br>2<br>Ramipril<br>5.10 mg<br>3<br>Hydrochlorothiazide<br>12.75 mg<br>Ramilich / Ramilich Comp / Ramipril HCT ZT/ZTV 2.5-12.5mg((Net<br>2<br>1 Number<br>
Sl. No. Export Product Qty. Sl. No. Import Items Qty.
1 Ramilich / Ramilich Comp / Ramipril HCT ZT/ZTV 5-12.5mg((Net<br>Wt. Hydrochlorothiazide 125.00 KGS) (Net Wt.Ramipril 50.00 KGS)) <br>1 Number 1 Hydrochlorothiazide 12.75 mg
2 Ramipril 5.10 mg
2 Ramilich / Ramilich Comp / Ramipril HCT ZT/ZTV 2.5-12.5mg((Net <br>1 Number<br> 3<br> Hydrochlorothiazide<br> 12.75 mg
um 68<br>ent has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified
Wt. Hydrochlorothiazide 125.00 KGS) (Net Wt.Ramipril 25.00 KGS))<br>4<br>Ramipril<br>2.55 mg<br>5<br>Hydrochlorothiazide<br>25.50 mg<br>3<br>Ramilich / Ramilich Comp / Ramipril HCT ZT/ZTV 5-25mg((Net Wt.<br>Hydrochlorothiazide 750.00 KGS) (Net Wt.Ramipril 150.00 KGS))<br>1 Number<br>6<br>Ramipril<br>5.10 mg<br>RA concerned may take further necessary action as per above decision of NC. 3 Wt. Hydrochlorothiazide 125.00 KGS) (Net Wt.Ramipril 25.00 KGS)) 4 Ramipril 2.55 mg
Ramilich / Ramilich Comp / Ramipril HCT ZT/ZTV 5-25mg((Net Wt.<br>Hydrochlorothiazide 750.00 KGS) (Net Wt.Ramipril 150.00 KGS)) <br>1 Number 5 Hydrochlorothiazide 25.50 mg
6 Ramipril 5.10 mg
Case No. Case No. Case No. 120 / NC/3/MEET/Mar/202122/16 120 / NC/3/MEET/Mar/202122/16 120 / NC/3/MEET/Mar/202122/16 120 / NC/3/MEET/Mar/202122/16 120 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name RECKITT BENCKISER HEALTHCARE INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00249183AM22
RA File Number 05AA04098079 AM22
Licence No and<br>Date 0511006070/11/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202122/13 dated 21.01.2022against<br>advance authorization No.0510413971dt.13.04.2020, 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<br>less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>(for 1 Number,<br>100 ml Bottle)<br>1<br>Ibuprofen<br>2.10 gram<br>Nurofen For Children Orange ((Total qty<br>1<br>1 Number
Sl. No. Export product Qty. Sl. No. Import Items Qty.<br>(for 1 Number,<br>100 ml Bottle)
1 Nurofen For Children Orange ((Total qty <br>1 Number 1 Ibuprofen 2.10 gram

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

69

in ML = 23,40,00,000 ML)) 2 Tween 80 (Polysorbate 80) 0.01 gram
3 Glycerine 12.616 gram
4 Lycasin 80/55 (Maltotol) 46.30 gram
5 Sodium Saccharin 40/80 0.20 gram
6 Citric Acid Monohydrate 0.40 gram
7 Tri Sodium Citrate Dihydrate 0.509 gram
8 Xanthan Gum 0.75 gram
9 Sodium Chloride 0.11 gram
10 Orange flavour 0.25 gram
11 Domiphen Bromide (BP) 0.01 gram
12 987 PP28mm M-LOC H&A White T/E Relevant as per packing<br>policy
13 A001 5ML Syrnge
14 0195 NRFN SYRNG PLG
15 Pet Bottle<br>Si N Vifid
70<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>gnature ot ere

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

70
2 Nurofen For Children Strawberry ((Total<br>qty in ML = 3,60,00,000 ML)) <br>1 Number 16 Ibuprofen 2.10 gram
17 Tween 80 (Polysorbate 80) 0.01 gram
18 Glycerine 12.616 gram
19 Lycasin 80/55 (Maltotol) 46.30 gram
20 Sodium Saccharin 40/80 0.20 gram
21 Citric Acid Monohydrate 0.40 gram
22 Tri Sodium Citrate Dihydrate 0.509 gram
23 Xanthan Gum 0.75 gram
24 Sodium Chloride 0.11 gram
25 Domiphen Bromide (BP) 0.01 gram
26 Straw flav KOSHER PHL-142134 0.25 gram
27 987 PP28mm M-LOC H&A White T/E Relevant as per packing<br>policy
28 A001 5ML Syrnge

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

71

29 0195 NRFN SYRNG PLG
30 Pet Bottle
Case No. 121 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name NEXUS PHARMA CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00249362AM22
RA File Number 08AA04034685 AM22
Licence No and<br>Date 0811003119/11/11/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Dexamethasone Sodium Phosphate USP<br>1 kg<br>1<br>Dexamethasone base<br>0.78 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 122 / NC/3/MEET/Mar/202122/16
Case Status Case Approved

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

72

Party Name SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00250405AM22
RA File Number 05AA04097584 AM22
Licence No and<br>Date 0511006110/12/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202122/13 dated 21.01.2022against<br>advance authorization No.0511003964dt.02.08.2021, 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<br>less:<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Brinex / Brinex-M / Brinarga / Brinera (BrinzolamideOpthalmic Suspension 1%)-<br>5ml<br>1 Vial<br>1<br>Brinzolamide<br>51.00 mg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 123 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00250407AM22
RA File Number 05AA04096391 AM22
Licence No and<br>Date 0511006111/12/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202122/13 dated 21.01.2022against<br>advance authorization No.0510414035dt.20.04.2020, 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<br>Signature Not Verified
73<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<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/Jan/202122/13 dated 21.01.2022 against advance authorization No. 0510414035dt.20.04.2020 , 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 Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

73

less:

Export Product Qty. Sl. No. Import Items Qty.
Meropenem Buffered (Meropenem Sod Carbonate Blend)(Bulk <br>1 kg 1 (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3- 0.8278 kg
Drug / Pharmacopeal Grade) pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4methyl-7-oxo-1-
azabicyclo
Case No. 124 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name FREESIA CHEMICALS
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00249915AM22
RA File Number 03AA040117893 AM22
Licence No and<br>Date 0311008508/12/11/2021
Norms Committee Decision:
Deferred for comments of TE.
Case No. 125 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name ENCEE AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00250347AM22
RA File Number 32AA04026501 AM22
Licence No and 3211001926/12/11/2021<br>
74<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

74

Date

Norms Committee Decision:

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

i. Justification of low yield of 37%.

Production / Consumption data duly certified by GST.

Case No. 126 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name KUSUMA PHARMA
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00250919AM22
RA File Number 03AA040116489 AM22
Licence No and<br>Date 0311008529/13/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 127 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00253270AM22
RA File Number 05AA04099135 AM22
Licence No and<br>Date 0511006147/15/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

75

Case No. Case No. 128 / NC/3/MEET/Mar/202122/16 128 / NC/3/MEET/Mar/202122/16 128 / NC/3/MEET/Mar/202122/16 128 / NC/3/MEET/Mar/202122/16 128 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00253463AM22
RA File Number 08AA04034748 AM22
Licence No and<br>Date 0811003137/15/11/2021
Norms Committee Decision:
The Committee co nsidered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Feb/202122/14dated 21.02.2022against
<br>advance authorizat <br>ion No.0811002770dt. 04.10.2021, 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 Produc t Qty Sl No Import Items Qty
. . . .
NALTREXON<br> E HYDROCHLORIDE TABLETS 50 MG(EACH FILM<br> 1 Number 1 NALTREXONE 51.00 mg / Tablet
COATED TABLET CONTAINS: NALTREXONE HYDROCHLORIDE<br>PH.EUR.50MG [IN WHICH ACTIVE INGREDIENT NALTREXONE<br>HYDROCHLORIDE USED IS 76.500 KGS.]) HYDROCHLORIDE<br>EP / BP / IP / USP / PH. EUR
RA concerned may take further necessary action as per above decision of NC.
Case No. 129 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number<br> NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
and Date
HQ File Number HQRNORM APPLY 00253467AM22
RA File Number 08AA04034735 AM22
Licence No and<br> 0811003139/15/11/2021
Date
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

76

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Jan/202122/13dated 21.01.2022 against advance authorization No. 0811002234dt.04.08.2021 , 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.
BIVALIRUDIN FOR INJECTION 250 MG/VIAL (5ML VIAL)(EACH VIAL <br>1 Number 1 BIVALIRUDIN 275 mg / Vial
CONTAINS: BIVALIRUDIN 250 MG[IN WHICH ACTIVE INGREDIENT
BIVALIRUDIN USED IS 1075.000 GRAMS])
Case No. 130 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name AARTI DRUGS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00252656AM22
RA File Number 03AA040113394 AM22
Licence No and<br>Date 0311008534/15/11/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Production / Consumption data duly certified by GST Authorities.
Case No. 131 / NC/3/MEET/Mar/202122/16
Case Status Case Approved Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

77

Party Name Party Name AMINES AND PLASTICIZERS LIMITED AMINES AND PLASTICIZERS LIMITED AMINES AND PLASTICIZERS LIMITED AMINES AND PLASTICIZERS LIMITED AMINES AND PLASTICIZERS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00252657AM22
RA File Number 03AA040113271 AM22
Licence No and 0311008536/15/11/2021
Date
Norms Committee<br>The Committee co Decision:<br>nsidered the case as er aenda and takin cue from earlier decision for same exort roduct in Meetin No4/82-ALC4/2018 dated 19062018aainst advance
<br>authorization No.0 p g g p p g .**..**g<br>310818924dt.06.02.2018, 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:
Export product Qty. Sl. No. Import items Qty.
N-METHYL MORPHOLINE OXIDE - 50% 1 kg 1 MORPHOLINE 0412 kg
.
2 HYDROGEN PEROXIDE 50% 0.322 kg
3 FORMIC ACID 0.218 kg
RA concerned may take further necessary action as per above decision of NC.
Case No. 132 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name AMINES AND PLASTICIZERS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00252833AM22
RA File Number 03AA040113273 AM22
Licence No and<br>Date 0311008552/15/11/2021
Norms Committee Decision:<br>Signature Not Verified
78<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>
Case No. 132 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name AMINES AND PLASTICIZERS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00252833AM22
RA File Number 03AA040113273 AM22
Licence No and<br>Date 0311008552/15/11/2021
Norms Committee Decision: Signature Not Verified

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

78

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. 0310818924dt.06.02.2018 , 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:

Export product Qty. Sl. No. Import items Qty.
N-METHYL MORPHOLINE OXIDE - 50% 1 kg 1 MORPHOLINE 0.412 kg
2 HYDROGEN PEROXIDE 50% 0.322 kg
3 FORMIC ACID 0.218 kg
RA concerned may take further necessary action as per above decision of NC.
Case No. 133 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name ALTA LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00253168AM22
RA File Number 03AA040121121 AM22
Licence No and<br>Date 0311008559/15/11/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.3/82-ALC4/2018 dated 05.06.2018against advance
authorization No.**0310803707dt.01.04.2016,**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: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

79

Export product Qty. Sl. No. Import items Qty.
METHYL PARABEN 1 kg 1 Para Hydroxy Benzoic Acid 0.97 kg
2 Methanol 0.50 kg
Export product Export product Qty. Sl. No. Import items Qty.
METHYL PAR ABEN 1 kg 1 Para Hydroxy Benzoic Acid 0.97 kg
2 Methanol 0.50 kg
RA concerned may take further necessary action as per above decision of NC.
Case No. 134 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00253243AM22
RA File Number 34AA04009242 AM22
Licence No and<br>Date 3411001396/15/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 135 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00255075AM22
RA File Number 03AA040109434 AM22
Licence No and<br>Date 0311008612/16/11/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

80

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Feb/202122/14 dated 21.02.2022 against advance authorization No. 0310831861dt.27.09.2019 , 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:

Export product Qty. Sl. No. Import items Qty.
ACETONITRILE 350 MT 1 ACETONITRILE – LOW PURITY (Purity 416.51 MT
98%)
(Purity Min. 99.9%, Moisture less than 500 PPM)
Case No. Case No. 136 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00255076AM22
RA File Number 03AA040118606 AM22
Licence No and<br>Date 0311008613/16/11/2021
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:
Export product Qty. Sl. No. Import items Qty.
MEROPENEM FOR INJECTION (MEROPENEM BUFFERED <br>1 kg 1 MEROPENEM<br> NON<br> <br>STERILE<br> <br>MEROPENEM <br>0.655 kg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

81

STERILE) TRIHYDRATE NON STERILE
2 PACKING MATERIAL Relevant as per packing
policy
Case No. 137 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00255256AM22
RA File Number 03AA040120589 AM22
Licence No and<br>Date 0311008617/17/11/2021
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>Description of all Excipients shown in items to be imported may be furnished as per their chemical name.<br>i.<br>Details of Packaging Material may be furnished.<br>ii.<br>Copy of Master Batch Formula for all export items indicating net content of inputs in each export.<br>iii.
Case No. 138 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name ALTA LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00255269AM22
RA File Number 03AA040121144 AM22
Licence No and 0311008618/17/11/2021<br>Sinature Not Verified
82<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>g

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

82

Date Norms Committee Decision:

The Committee considered the case as per agenda and it was decided to allow adhoc norms as per SION A-3680.

Date
Norms Committee Decision:
The Committee co nsidered the case as per agenda and it was decided to allow adhoc norms as perSION A-3680.
RA concerned may take further necessary action as per above decision of NC.
Case No. 139 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00255297AM22
RA File Number 34AA04009240 AM22
Licence No and<br>Date 3411001409/17/11/2021
Norms Committee Decision:
Deferred for comme nts of TE.
Case No. 140 / NC/3/MEET/Mar/202122/16
C S C Dfd
ase tatus ase eerre
P N AURORE LIFE SCIENCES PRIVATE LIMITED
arty ame
Mi Nb
eetng umer<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
H Fil Nb HRNORM APPLY 00255683AM22
Q e umer Q
RA File Number 09AA04016606 AM22
Licence No and<br>Date 0911001869/17/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 141 / NC/3/MEET/Mar/202122/16
Case Status Case Approved Sit Nt Vifid

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

83

Party Name NEULAND LABORATORIES LTD.
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00255721AM22
RA File Number 09AA04017059 AM22
Licence No and<br>Date 0911001871/17/11/2021
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 Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>IBREXAFUNGERP CITRATE<br>1 kg<br>1<br>ENFUMAFUNGIN<br>4.55 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 142 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name ENALTEC LABS PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00255251AM22
RA File Number 03AA040120798 AM22
Licence No and Date 0311008614/17/11/2021
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 per details given below or as applied by the firm, whichever is<br>less:

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:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

84

Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>ROSUVASTATIN CALCIUM (R-10 ROUTE)<br>1 kg<br>1<br>6-[(1E)-2-[4-(4-FLUOROPHENYL)-6-(1METHYLETHYL)-2-<br>[METHYL (METHYLSULFONYL)AMINO] -5-<br>PYRIMIDINYL]<br>ETHENYL]-2,2DIMETHYL-1,3-DIOXANE-4-<br>ACETIC ACID 1,1- DIMETHYLETHYL ESTER<br>1.30 kg<br>RA concerned may take further necessary action as per above decision of NC. Export product Export product Qty. Sl. No. Import items Qty.
ROSUVASTATIN CALCIUM (R-10 ROUTE) 1 kg 1 6-[(1E)-2-[4-(4-FLUOROPHENYL)-6-(1METHYLETHYL)-2-<br>[METHYL (METHYLSULFONYL)AMINO] -5-<br>PYRIMIDINYL]<br>ETHENYL]-2,2DIMETHYL-1,3-DIOXANE-4-<br>ACETIC ACID 1,1- DIMETHYLETHYL ESTER 1.30 kg
Case No. 143 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00255868AM22
RA File Number 03AA040112749 AM22
Licence No and<br>Date 0311008637/17/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 144 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name HELLA INFRA MARKET PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00255252AM22
RA File Number 03AA040117899 AM22
Licence No and<br>Date 0311008615/17/11/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

85

Deferred for comments of TE.

Case No. 145 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name HELLA INFRA MARKET PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00255254AM22
RA File Number 03AA040120188 AM22
Licence No and<br>Date 0311008616/17/11/2021
Norms Committee Decision:
Deferred for comments of TE.
Case No. 146 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name MAIVA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00256672AM22
RA File Number 07AA04039164 AM22
Licence No and<br>Date 0711002363/18/11/2021
Norms Committee Decision:
Deferred for comments of TE.
Case No. 147 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name SARACA LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00256800AM22
RA File Number 09AA04017459 AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

86

Licence No and<br>Date 0911001876/18/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 148 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00257369AM22
RA File Number 09AA04017800 AM22
Licence No and<br>Date 0911001879/18/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 149 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name ARKRAY HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00257390AM22
RA File Number 52AA04018127 AM22
Licence No and<br>Date 5211001587/18/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case to Department of Biotechnology (DBT) for obtaining its comments.
Case No. 150 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name NEXUS PHARMA CHEM PRIVATE LIMITED
Meeting Number NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

87

and Date
HQ File Number HQRNORM APPLY 00257413AM22
RA File Number 08AA04035268 AM22
Licence No and<br>Date 0811003180/18/11/2021
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 Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>Clobetasol Propionate USP<br>1 kg<br>1<br>Betamethasone base<br>1.00 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 151 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name AMINES AND PLASTICIZERS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00256513AM22
RA File Number 03AA040113620 AM22
Licence No and<br>Date 0311008653/18/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.4/82-ALC4/2018 dated 19.06.2018against advance<br>authorization No.0310818924dt.06.02.2018, 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:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

88

Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>MORPHOLINE<br>0.412 kg<br>2<br>HYDROGEN PEROXIDE 50%<br>0.322 kg<br>N-METHYL MORPHOLINE OXIDE - 50%<br>1 kg<br>3<br>FORMIC ACID<br>0.218 kg<br>RA concerned may take further necessary action as per above decision of NC. Export product Qty. Sl. No. Import items Qty.
N-METHYL MORPHOLINE OXIDE - 50% 1 kg 1 MORPHOLINE 0.412 kg
2 HYDROGEN PEROXIDE 50% 0.322 kg
3 FORMIC ACID 0.218 kg
Case No. Case No. 152 / NC/3/MEET/Mar/202122/16 152 / NC/3/MEET/Mar/202122/16 152 / NC/3/MEET/Mar/202122/16 152 / NC/3/MEET/Mar/202122/16 152 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name AMINES AND PLASTICIZERS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00256515AM22
RA File Number 03AA040113630 AM22
Licence No and<br>Date 0311008655/18/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.4/82-ALC4/2018 dated 19.06.2018against advance<br>authorization No.0310818924dt.06.02.2018, 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:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>MORPHOLINE<br>0.412 kg<br>2<br>HYDROGEN PEROXIDE 50%<br>0.322 kg<br>N-METHYL MORPHOLINE OXIDE - 50%<br>1 kg
Export product Qty. Sl. No. Import items Qty.
N-METHYL MORPHOLINE OXIDE - 50% 1 kg 1<br>2 MORPHOLINE 0.412 kg
HYDROGEN PEROXIDE 50% 0.322 kg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

89

3 FORMIC ACID 0.218 kg

3<br>FORMIC ACID<br>0.218 kg<br>RA concerned may take further necessary action as per above decision of NC.
3 FORMIC ACID 0.218 kg
Case No. 153 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name ALTA LABORATORIES LIMITED
Meeting Number
and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00258363AM22
RA File Number 03AA040121922 AM22
Licence No and<br>Date 0311008684/19/11/2021
Norms Committee Decision:
Dfd f t f TE
eerre or comm ns o .
Case No. 154 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name AUROBINDO PHARMA LTD
M<br>a eeting Number<br>nd Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
H Q Fil Nb HQRNORM APPLY 00261599AM22
e umer
R A File Number 09AA04017900 AM22
L<br>D icence No and
ate 0911001908/22/11/2021
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 Vol. I as per details given below or as applied by the firm,<br>whichever is less: orms Committee Decision:<br>

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

90

Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>MeropenemTrihydrate (Non-Sterile)<br>0.923 kg<br>2<br>Acetone<br>2.64 kg<br>3<br>Methanol (Methyl Alcohol)<br>0.0958 kg<br>Meropenem for Injection<br>(Sterile Bulk)<br>1 kg<br>4<br>Aluminium Canister 20 Ltrs (5Kg Capacity)<br>Relevant as per packing policy<br>RA concerned may take further necessary action as per above decision of NC. Export product Qty. Sl. No. Import items Qty.
Meropenem for Injection<br>(Sterile Bulk) 1 kg 1 MeropenemTrihydrate (Non-Sterile) 0.923 kg
2 Acetone 2.64 kg
3 Methanol (Methyl Alcohol) 0.0958 kg
4 Aluminium Canister 20 Ltrs (5Kg Capacity) Relevant as per packing policy
Case No. 155 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00261092AM22
RA File Number 09AA04016734 AM22
Licence No and<br>Date 0911001888/22/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 156 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00261552AM22

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

91

RA File Number 09AA04017897 AM22
Licence No and<br>Date 0911001904/22/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 157 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name AMI LIFESCIENCES PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00262704AM22
RA File Number 34AA04009517 AM22
Licence No and<br>Date 3411001447/23/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Dec/202122/12dated<br>17.12.2021against advance authorization No.3411000856dt.<br>16.07.2021, 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:<br>Export product<br>Qty.<br>Sl. No.<br>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. 158 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name SANDHYA ORGANIC CHEMICALS PVT LTD Signature Not Verified

Signature Not Verified Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

92

Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00262146AM22
RA File Number 03AA040119401 AM22
Licence No and<br>Date 0311008754/23/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 159 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name ELIXIR PHARMA
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00262257AM22
RA File Number 08AA04034885 AM22
Licence No and<br>Date 0811003200/23/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 160 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name DEEPAK NITRITE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00262416AM22
RA File Number 34AA04008408 AM22
Licence No and<br>Date 3411001440/23/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

93

C ase No. 161 / NC/3/MEET/Mar/202122/16
C ase Status Case Deferred
Party Name
FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00262423AM22
RA File Number 05AA04098088 AM22
Licence No and<br>Date 0511006367/23/11/2021
Norms Committee Decision:
Deferred for comm nts of TE
.
Case No. 162 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00262432AM22
RA File Number 05AA04098038 AM22
Licence No and<br>Date 0511006369/23/11/2021
Norms Committee Decision:
Deferred for comments of TE.
Case No. 163 / NC/3/MEET/Mar/202122/16
C S C Dfd
ase tatus ase eerre
Pt N LAXMI ORGANIC INDUSTRIES LIMITED
ary ame
Mti Nb
eeng umer<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00262564AM22
RA Fil Nb 03AA04013560 AM22
e umer
Li N d
cence o an<br>Date 0311008775/23/11/2021
Norms Committee Decision:
Si N Vifi
94<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>gnature ot ered

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

94

Deferred for comments of TE.

Case No. 164 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name SYMED LABS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00262695AM22
RA File Number 09AA04017472 AM22
Licence No and<br>Date 0911001919/23/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. Case No. 165 / NC/3/MEET/Mar/202122/16 165 / NC/3/MEET/Mar/202122/16 165 / NC/3/MEET/Mar/202122/16 165 / NC/3/MEET/Mar/202122/16 165 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name BIOXERA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00263422AM22
RA File Number 03AA040117391 AM22
Licence No and<br>Date 0311008809/24/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Dec/202122/12dated<br>17.12.2021against advance authorization No.3411000856dt.<br>16.07.2021, 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:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.
Export product Qty. Sl. No. Import items Qty.

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

----- Start of picture text -----<br> Signature Not Verified<br>----- End of picture text -----<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

95

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. Benfotiamine Benfotiamine 1 kg 1 Thiamine Mononitrate 0.922 kg
Case No. 166 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name AARTI DRUGS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00263425AM22
RA File Number 03AA040109731 AM22
Licence No and<br>Date 0311008810/24/11/2021
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 Authorities.
Case No. 167 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00263483AM22
RA File Number 03AA04003343 AM22
Licence No and<br>Date 0311008815/24/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

96

Case No. 168 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00263486AM22
RA File Number 03AA04009051 AM22
Licence No and<br>Date 0311008816/24/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 169 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00263488AM22
RA File Number 03AA04014060 AM22
Licence No and<br>Date 0311008817/24/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 170 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00263594AM22
RA File Number 31AA04029810 AM22
Licence No and<br>Date 3111000716/24/11/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

97

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Feb/202122/14 dated 21.02.2022 against advance authorization No. 3111000269 dt. 31.03.2021 , 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.
Guaiacol 1 kg 1 Phenol 0.93 kg
2 Methanol 0.36 kg
3 Hydrogen Peroxide (60%) 0.687 kg
4 Acetone(Solvent) 0.09 kg
Case No. 171 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00264927AM22
RA File Number 31AA04030073 AM22
Licence No and<br>Date 3111000727/25/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Feb/202122/14 dated 21.02.2022against<br>advance authorization No.3111000353 dt.24.05.2021, 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<br>less:<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

98

Export product Qty. Sl. No. Import items Qty.
Acetyl Anisole (4 Methoxy<br>Acetophenone) 1 kg 1 Phenol 0.72 kg
2 Methanol 0.276 kg
3 Acetic Anhydride PURITY 99% 0.755 kg
Case No. 172 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00265144AM22
RA File Number 09AA04017903 AM22
Licence No and<br>Date 0911001933/25/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 173 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00265259AM22
RA File Number 05AA040104139 AM22<br>Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

99

Licence No and 0511006448/25/11/2021 Date Norms Committee Decision: Deferred for comments of TE.

Case No. Case No. 174 / NC/3/MEET/Mar/202122/16 174 / NC/3/MEET/Mar/202122/16 174 / NC/3/MEET/Mar/202122/16 174 / NC/3/MEET/Mar/202122/16 174 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name SUPARNA CHEMICALS LIMITED
Meeting Number and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00265266AM22
RA File Number 03AA040124215 AM22
Licence No and Date 0311008850/25/11/2021
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 Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>POTASSIUM METAL<br>0.0733 kg<br>2<br>TERTIARY BUTANOL<br>0.139 kg<br>POTASSIUM TERTIARY BUTOXIDE IN TETRAHYDROFURAN 20%<br>1 kg<br>3<br>TETRAHYDROFURAN<br>0.84 kg<br>RA concerned may take further necessary action as per above decision of NC.
Export product Qty. Sl. No. Import items Qty.
POTASSIUM TERTIARY BUTOXIDE IN TETRAHYDROFURAN 20% 1 kg 1 POTASSIUM METAL 0.0733 kg
2 TERTIARY BUTANOL 0.139 kg
3 TETRAHYDROFURAN 0.84 kg

==> picture [738 x 56] intentionally omitted <==

----- Start of picture text -----<br> Case No. 175 / NC/3/MEET/Mar/202122/16<br>Case Status Case Approved<br>Party Name DEEPAK NOVOCHEM TECHNOLOGIES LIMITED<br>Signature Not Verified<br>----- End of picture text -----<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

100

Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00265267AM22
RA File Number 31AA04017311 AM22
Licence No and<br>Date 3111000729/25/11/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>ORTHO CRESOL<br>1 kg<br>1<br>OCP 50 (containing 58% O-Cresol & 38% Phenol)<br>0.809 kg<br>RA concerned may take further necessary action as per above decision of NC.
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00265267AM22
RA File Number 31AA04017311 AM22
Licence No and<br>Date 3111000729/25/11/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>ORTHO CRESOL<br>1 kg<br>1<br>OCP 50 (containing 58% O-Cresol & 38% Phenol)<br>0.809 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 176 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name BIODEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00265372AM22
RA File Number 05AA040103458 AM22
Licence No and<br>Date 0511006452/25/11/2021
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 DML with Approved Composition of the export product.<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

101

Case No. 177 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00264884AM22
RA File Number 03AA040120003 AM22
Licence No and<br>Date 0311008832/25/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. Case No. 178 / NC/3/MEET/Mar/202122/16 178 / NC/3/MEET/Mar/202122/16 178 / NC/3/MEET/Mar/202122/16 178 / NC/3/MEET/Mar/202122/16 178 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name HONOUR LAB LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00266451AM22
RA File Number 09AA04017934 AM22
Licence No and<br>Date 0911001952/26/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202122/13dated 21.01.2022against<br>advance authorization No.0911001405dt.24.08.2021, 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<br>less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Ethyl 4-(2-Hydroxypropan-2-yl)-2-Propyl-1H-Imidazole-5-Carboxylate<br>0.70 kg<br>OlmesartanMedoximil<br>1 kg<br>2<br>1-(triphenylmethyl)-5-[4-(bromomethylbiphenyl)-2-yl] tetrazole<br>1.35 kg<br>Sinature Not Verified
Export product Qty. Sl. No. Import items Qty.
OlmesartanMedoximil 1 kg 1 Ethyl 4-(2-Hydroxypropan-2-yl)-2-Propyl-1H-Imidazole-5-Carboxylate 0.70 kg
2 1-(triphenylmethyl)-5-[4-(bromomethylbiphenyl)-2-yl] tetrazole<br>Sinature Not Verified 1.35 kg
102<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>g

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

102

Case No. 179 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name HONOUR LAB LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00266455AM22
RA File Number 09AA04017936 AM22
Licence No and<br>Date 0911001953/26/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Jan/202122/13dated 21.01.2022against<br>advance authorization No.0911001389dt.23.08.2021, 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<br>less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>2,7-DIHYDROXY FLUOREN-9-ONE<br>0.686 kg<br>2<br>2-DIETHYLE AMINO ETHYL CHLORIDE HCL<br>1.430 kg<br>3<br>TETRA BUTYL AMMONIUM BROMIDE<br>0.686 kg<br>TILORONE<br>DIHYDROCHLORIDE<br>1 kg<br>4<br>METHONOL<br>2.36 kg<br>RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

103

Case No. 180 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00266181AM22
RA File Number 08AA04035102 AM22
Licence No and<br>Date 0811003242/26/11/2021
Norms Committee Decision:
Deferred for comments of TE
Case No. 181 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name LAZERHEAD LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00266328AM22
RA File Number 09AA04012424 AM22
Licence No and<br>Date 0911001950/26/11/2021
Norms Committee Decision:
Deferred for comments of TE.
Case No. 182 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name AUROBINDO PHARMA LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00268778AM22
RA File Number 09AA04017927 AM22
Licence No and<br>Date 0911001956/29/11/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

104

Norms Committee Decision: Deferred for comments of TE.

Case No. 183 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name USV PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00268952AM22
RA File Number 03AA040120475 AM22
Licence No and<br>Date 0311009010/29/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. Case No. 184 / NC/3/MEET/Mar/202122/16 184 / NC/3/MEET/Mar/202122/16 184 / NC/3/MEET/Mar/202122/16 184 / NC/3/MEET/Mar/202122/16 184 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name WANKSONS CHEMICALS INDUSTRIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00269239AM22
RA File Number 03AA040125522 AM22
Licence No and<br>Date 0311009018/29/11/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.NC/3/MEET/Dec/202122/12 dated 17.12.2021against<br>advance authorization No.0311005179dt.07.07.2021, 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<br>less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.
Export product Qty. Sl. No. Import items Qty.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

105

CHLORAL

1

DENATURED ETHYLALCOHOL

1 kg

0.878 kg

Case No. 185 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00270155AM22
RA File Number 342404000285 AM20
Licence No and<br>Date 3411001477/30/11/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 186 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name UPL LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00271160AM22
RA File Number 03AA040125862 AM22
Licence No and<br>Date 0311009068/01/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 187 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name NEXUS PHARMA CHEM PRIVATE LIMITED<br>Si N Vifid

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

106

Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00271316AM22
RA File Number 08AA04035774 AM22
Licence No and<br>Date 0811003272/01/12/2021
Norms Committee Decision:
Deferred for comments of TE.
Meeting Number<br>and Date Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022 NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022 NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022 NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022 NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
H Fil Nb HRNORM APPLY 00271316AM22
Q e umer Q
RA File Number 08AA04035774 AM22
Licence No and<br>Date 0811003272/01/12/2021
Norms Committee Decision:
Deferred for comme nts of TE.
Case No. 188 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00271464AM22
RA File Number 09AA04018101 AM22
Licence No and<br>Date 0911001974/01/12/2021
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 per details given below or as applied by the firm, whichever is<br>less:
Et dt t Sl N It it t
xpor prouc Qy. . o. mpor ems Qy.
FAVIPIRAVIR 1 kg 1 6-bromo-3-hydroxypyrazine-2-carboxamide 2.32 kg
2 Triethylamine 2.15 kg
3 NN Dimethylformamide 5.00 kg
4 Tri-n-butylamine<br> 3.40 kg
107<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

107

2.59 kg

Dimethyl Sulfoxide

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

Case No. 189 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00271471AM22
RA File Number 342404000079 AM21
Licence No and<br>Date 3411001482/01/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 190 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00271583AM22
RA File Number 342404000002 AM21
Licence No and<br>Date 3411001484/01/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 191 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name SUDEEP PHARMA PRIVATE LIMITED<br>Si N Vifid
108<br>ument has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 26-Apr-2022.<br>Digitally Signed.<br>Name: Ajay Kumar( Deputy Director )<br>Date: 26-Apr-2022 17:44:42<br>Reason: AJAY.DHIMAN88@GOV.IN<br>Location: DGFT(HQ)<br>gnature ot ere

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

108

Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00271633AM22
RA File Number 342404000080 AM21
Licence No and<br>Date 3411001485/01/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. Case No. Case No. 192 / NC/3/MEET/Mar/202122/16 192 / NC/3/MEET/Mar/202122/16 192 / NC/3/MEET/Mar/202122/16 192 / NC/3/MEET/Mar/202122/16 192 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name ANANTA MEDICARE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00271002AM22
RA File Number 05AA040106538 AM22
Licence No and Date 0511006538/01/12/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>CEFTAZIDIME POWDER FOR SOLUTION<br>FOR<br>INJECTION,<br>WEIGHT<br>1<br>GMS/VIAL(CEFTAZIDIME WITH<br>SODIUM<br>CARBONATE<br>USP<br>FOR<br>INJECTION) (Each vial contains Sterile<br>mixture of sterile ceftazidime USP and<br>Sodium Carbonate equivalent to Anhydrous<br>ceftazidime 1 gm)<br>380000 vials<br>1<br>CEFTAZIDIME WITH SODIUM CARBONATE USP<br>400 kg
Sl. No. Export product Qty. Sl. No. Import items Qty.
1 CEFTAZIDIME POWDER FOR SOLUTION<br>FOR<br>INJECTION,<br>WEIGHT<br>1<br>GMS/VIAL(CEFTAZIDIME WITH<br>SODIUM<br>CARBONATE<br>USP<br>FOR<br>INJECTION) (Each vial contains Sterile<br>mixture of sterile ceftazidime USP and<br>Sodium Carbonate equivalent to Anhydrous<br>ceftazidime 1 gm) <br> <br> <br> <br> <br> <br>380000 vials 1 CEFTAZIDIME WITH SODIUM CARBONATE USP 400 kg
Case No. Case No. Case No. 192 / NC/3/MEET/Mar/202122/16 192 / NC/3/MEET/Mar/202122/16 192 / NC/3/MEET/Mar/202122/16 192 / NC/3/MEET/Mar/202122/16 192 / NC/3/MEET/Mar/202122/16
Case Status Case Approved
Party Name ANANTA MEDICARE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00271002AM22
RA File Number 05AA040106538 AM22
Licence No and Date 0511006538/01/12/2021
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 per details given below or as applied by the firm, whichever is<br>less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>CEFTAZIDIME POWDER FOR SOLUTION<br>FOR<br>INJECTION,<br>WEIGHT<br>1<br>GMS/VIAL(CEFTAZIDIME WITH<br>SODIUM<br>CARBONATE<br>USP<br>FOR<br>INJECTION) (Each vial contains Sterile<br>mixture of sterile ceftazidime USP and<br>Sodium Carbonate equivalent to Anhydrous<br>ceftazidime 1 gm)<br>380000 vials<br>1<br>CEFTAZIDIME WITH SODIUM CARBONATE USP<br>400 kg
Sl. No. Export product Qty. Sl. No. Import items Qty.
1 CEFTAZIDIME POWDER FOR SOLUTION<br>FOR<br>INJECTION,<br>WEIGHT<br>1<br>GMS/VIAL(CEFTAZIDIME WITH<br>SODIUM<br>CARBONATE<br>USP<br>FOR<br>INJECTION) (Each vial contains Sterile<br>mixture of sterile ceftazidime USP and<br>Sodium Carbonate equivalent to Anhydrous<br>ceftazidime 1 gm) <br> <br> <br> <br> <br> <br>380000 vials 1 CEFTAZIDIME WITH SODIUM CARBONATE USP 400 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

109

2<br>CEFTAZIDIME POWDER FOR SOLUTION<br>FOR<br>INJECTION,<br>WEIGHT<br>2<br>GMS/VIAL(CEFTAZIDIME WITH<br>SODIUM<br>CARBONATE<br>USP<br>FOR<br>INJECTION) (Each vial contains Sterile<br>mixture of sterile ceftazidime USP and<br>Sodium Carbonate equivalent to Anhydrous<br>ceftazidime2 gm)<br>95000 vials<br> <br>CEFTAZIDIME WITH SODIUM CARBONATE USP<br>200 kg<br>RA concerned may take further necessary action as per above decision of NC. 2 CEFTAZIDIME POWDER FOR SOLUTION<br>FOR<br>INJECTION,<br>WEIGHT<br>2<br>GMS/VIAL(CEFTAZIDIME WITH<br>SODIUM<br>CARBONATE<br>USP<br>FOR<br>INJECTION) (Each vial contains Sterile<br>mixture of sterile ceftazidime USP and<br>Sodium Carbonate equivalent to Anhydrous<br>ceftazidime2 gm) <br> <br> <br> <br> <br> <br>95000 vials CEFTAZIDIME WITH SODIUM CARBONATE USP 200 kg
Case No. 193 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00271106AM22
RA File Number 03AA040124209 AM22
Licence No and<br>Date 0311009064/01/12/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Description of all Excipients shown in items to be imported may be furnished as per their chemical name.<br>i.<br>Details of Packaging Material may be furnished.<br>ii.<br>Copy of Master Batch Formula for all export items indicating net content of inputs in each export.<br>iii.
Case No. 194 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

110

and Date
HQ File Number HQRNORM APPLY 00272089AM22
RA File Number 07AA04039105 AM22
Licence No and<br>Date 0711002509/02/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 195 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00272093AM22
RA File Number 07AA04040783 AM22
Licence No and<br>Date 0711002512/02/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 196 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00272095AM22
RA File Number 07AA04040782 AM22
Licence No and<br>Date 0711002513/02/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 197 / NC/3/MEET/Mar/202122/16<br>

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

111

Case Status Case Deferred
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00272097AM22
RA File Number 07AA04040799 AM22
Licence No and<br>Date 0711002516/02/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 198 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00272098AM22
RA File Number 07AA04040797 AM22
Licence No and<br>Date 0711002517/02/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 199 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00272084AM22
RA File Number 07AA04039101 AM22
Licence No and<br>Date 0711002507/02/12/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

112

Deferred for comments of TE.

Case No. 200 / NC/3/MEET/Mar/202122/16
Case Status Case Deferred
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202122/ 16 and 08/04/2022
HQ File Number HQRNORM APPLY 00272085AM22
RA File Number 07AA04039096 AM22
Licence No and<br>Date 0711002508/02/12/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 26-Apr-2022 17:44:42 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

113

Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.

Analysis

No analysis has been generated for this document yet.

Citation copied