IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2021-09-24

DGFT Committee Minutes

Document text

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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/Sep/202122/8 DATED: 24/09/2021

Please Note

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

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

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

Minutes of the Norms Committee – 3 Meeting No. NC/3/MEET/Sep/202122/8 dated 24.09.2021, actually held on 01.10.2021 under the Chairmanship of Dr. Amiya Chandra, Addl. DGFT for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30.

Following members were present in the Meeting:

S.No. Name and Designation of Representatives Name and Designation of Representatives Department
1 AJAY KUMAR,Deputy Director AJAY KUMAR,Deputy Director Directorate General of Foreign Trade, Delhi
2 SHAISH KUMAR,Technical Authority Technical Consultant,DGFT
3 DINESHNARAIN MATHUR,Technical<br>Authority Technical Consultant,DGFT
Case Details and Decision(s):
Case No. 1 / NC/3/MEET/Sep/202122/8

Case Details and Decision(s):

This document has been digitally signed by Amiya Chandra, Additional DGFT on 09-12-2021 10:30:08.

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Case Status<br>Case Approved
Party Name<br>ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number<br>018205000699AM13
RA File Number<br>082404000160 AM13
Licence No and<br>Date<br>0810114398/21/08/2012
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the norms for the subject Advance
Authorization have already been ratified by NC-3 in its Meeting No.2/82-ALC4/2013 dated 18.04.2013.
In view of above, the Committee decided towithdrawthe case.

The Committee considered the case as per agenda and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 2/82-ALC4/2013 dated 18.04.2013 .

Case No. 2 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000314AM16
RA File Number 072404000393 AM15
Licence No and<br>Date 0710108142/01/05/2015
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the norms for the subject Advance
Authorization have already been ratified by NC-3 in its Meeting No.15/82-ALC4/2016 dated 15.12.2016.
In view of above, the Committee decided towithdrawthe case.

The Committee considered the case as per agenda and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. 15/82-ALC4/2016 dated 15.12.2016 .

Case No. 3 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name CADILA HEALTHCARE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001471AM17
RA File Number 082404000452 AM17
Licence No and<br>Date 0810139654/06/02/2017

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Norms Committee Decision:

The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is less:

Sl. No. Export product Qty. Sl. No. Import items Qty.
1 BISOPROLOL<br>FUMARATE<br>AND<br>HYDROCHLOROTHIAZIDE TABLETS 2.5 MG/6.25<br>MG<br>(ACTIVE<br>INGREDIENT<br>:<br>BISOPROLOL<br>FUMARATE - NET WT. 2.87 KGS) <br> <br> <br>1 Number 1 BISOPROLOL<br>FUMARATE 2.55 mg /<br>2.5 mg Tablet
2 BISOPROLOL<br>FUMARATE<br>AND<br>HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG<br>(ACTIVE INGREDIENT : BISOPROLOL FUMARATE -<br>NET WT. 9.68 KGS) <br> <br> <br>1 Number 1 BISOPROLOL<br>FUMARATE 5.10 mg /<br>5 mg Tablet
3 BISOPROLOL<br>FUMARATE<br>AND<br>HYDROCHLOROTHIAZIDE TABLETS 10 MG/6.25 MG<br>(ACTIVE INGREDIENT : BISOPROLOL FUMARATE -<br>NET WT. 21.74 KGS) <br> <br> <br>1 Number 1 BISOPROLOL<br>FUMARATE 10.20 mg /<br>10 mg Tablet
4 BISOPROLOL TABLETS 1.25 MG (BISOPROLOL<br>ZYDUS 1.25 MG TABLETS) (ACTIVE INGREDIENT :<br>BISOPROLOL FUMARATE - NET WT. 1.70 KGS) <br> <br>1 Number 1 BISOPROLOL<br>FUMARATE 1.275 mg /<br>1.25 mg Tablet
5 BISOPROLOL TABLETS 2.5 MG (BISOPROLOL<br>ZYDUS 2.5 MG TABLETS) (ACTIVE INGREDIENT :<br>BISOPROLOL FUMARATE - NET WT. 4.18 KGS) <br> <br>1 Number 1 BISOPROLOL<br>FUMARATE 2.55 mg /<br>2.5 mg Tablet
6 BISOPROLOL TABLETS 5 MG (BISOPROLOL ZYDUS<br>5<br>MG<br>TABLETS)<br>(ACTIVE<br>INGREDIENT<br>:<br>BISOPROLOL FUMARATE - NET WT. 9.87 KGS) <br> <br>1 Number 1 BISOPROLOL<br>FUMARATE 5.1 0 mg /<br>5 mg Tablet

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

Case No. 4 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021

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HQ File Number 018205000452AM19
RA File Number 092404000438 AM18
Licence No and<br>Date 0910065915/20/01/2018
Norms Committee Decision:<br>The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the<br>ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>THIOPHENOL<br>1.00 kg<br>2<br>MORPHOLINE<br>0.70 kg<br>3<br>TERITARY BUTANOL<br>1.78 kg<br>4<br>METHYL ETHYL PYRIDINE<br>Not shown in the<br>process<br>5<br>TETRA HYDRO FURAN (THF)<br>1.78 kg<br>6<br>KTB (POTASSIUM TERT BUTOXIDE)<br>0.47 kg<br>7<br>METHANOL<br>4.22 kg<br>8<br>ISOPROPYL ALCOHOL (IPA)<br>1.10 kg<br>9<br>METHYLENE CHLORIDE (MDC)<br>2.84 kg<br>ETORICOXIB<br>1 kg<br>10<br>TOLUENE<br>2.10 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 5 / NC/3/MEET/Sep/202122/8

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Case Status<br>Case Approved
Party Name<br>CADILA HEALTHCARE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number<br>018205000960AM19
RA File Number<br>082404000326 AM18
Licence No and<br>Date<br>0810142004/14/02/2018
Norms Committee Decision:
The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the
ad-hoc input output norms as perSION A-3645.
RA concerned may take further necessary action as per above decision of NC.
Case No. 6 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000380AM19
RA File Number 039504001007 AM18
Licence No and<br>Date 0310819263/20/02/2018
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Molecular weight of Export Product.
Case No. 7 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name SONGWON SPECIALTY CHEMICALS - INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001164AM19
RA File Number 342404000341 AM18
Licence No and 3410043908/22/02/2018

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Date

Norms Committee Decision:

The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 4/82ALC4/2020 dated 18.09.2020, followed by Reminder on 16.10.2020:

  • i. % yield on molar basis at every stage.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No. 8 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name AKTINOS HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000888AM19
RA File Number 092404000668 AM18
Licence No and<br>Date 0910066131/11/04/2018
Norms Committee Decision:
The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the
firm still has not furnished the following information asked for by NC-3 in its Meeting No. 4/82-
ALC4/2020 dated 18.09.2020, followed by Reminder on 16.10.2020:
Whether export item is physical blending of two compounds as mentioned in export description. If no,<br>i.
please give the chemical name of the export item.
Molecular weight of export item and its chemical structure.<br>ii.
Use of D-(-) Threo compound in the final step.<br>iii.
In view of above, the Committee decided to issueFinal Reminder<br> to firm to furnish its reply, failing which the case
will be rejected.

The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 4/82ALC4/2020 dated 18.09.2020, followed by Reminder on 16.10.2020:

Case No. 9 / NC/3/MEET/Sep/202122/8

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Case Status Case Deferred
Party Name GLAND CHEMICALS PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001483AM19
RA File Number 092404000008 AM19
Licence No and<br>Date 0910066148/17/04/2018
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 chemical reaction, molecular weight and % yield on molar basis.<br>i.<br>Stage-wise material balance.
Case No. 10 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000537AM19
RA File Number 522404000016 AM19
Licence No and<br>Date 5210042638/10/05/2018
Norms Committee Decision:<br>The firm vide e-mail dated29.09.2021has furnished its reply. Deferred for comments of TE
Case No. 11 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name MANGALAM ORGANICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000795AM19
RA File Number 039504001140 AM18
Licence No and<br>Date 0310821107/21/05/2018
Norms Committee Decision:

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The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not proper. Hence, it was decided to again call for following information from the firm:

  • i. Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and % of yield at every stage.
Case No. 12 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name STERLING AUXILIARIES PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000723AM19
RA File Number 039504000332 AM19
Licence No and<br>Date 0310822247/11/07/2018
Norms Committee Decision:
The Committee considered the case as per and it was observed that for Export Product No. 1, it is stated that it is blend,
however in the manufacturing process provided , it is shown as water of reaction, which is not possible. If it is
chemical reaction, then the firm may provide Molecular weight of import and export.
Case No. 13 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name YASH RASAYAN & CHEMICALS
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001167AM19
RA File Number 342404000114 AM19
Licence No and<br>Date 3410044333/16/07/2018
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not
proper. Hence, it was decided to call for following information from the firm:
Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and % of yield at
every stage.

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Case No. 14 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name YASH RASAYAN & CHEMICALS
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001991AM19
RA File Number 342404000184 AM19
Licence No and<br>Date 3410044523/26/09/2018
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 Appendix 4E including complete chemistry, molecular weight, % yield,<br>Stoichiometric Balance, Structural formula
Case No. 15 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name YASH RASAYAN & CHEMICALS
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001993AM19
RA File Number 342404000185 AM19
Licence No and<br>Date 3410044524/26/09/2018
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>Molecular weight of import and export.<br>i.<br>% yield of reaction.<br>ii.<br>% recovery of Dimethyl Formamide (DMF) with justification of requirement.

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Case No. 16 / NC/3/MEET/Sep/202122/8 16 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name MANGALAM ORGANICS LIMITED
i b
Meetng Numer<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205002069AM19
RA File Number 039504000560 AM19
i d
Lcence No an<br>Date 0310824148/03/10/2018
Norms Committee Decision:
<br>The Committee co <br>nsidered the case as per agenda in the presence of technical experts and it was observed that the
reply furnished by the firm is not proper. Hence, it was decided to call for following information from the firm:<br>
Complete chemistry, molecular weight, yield of reaction, stoichiometric balance
17 / NC/3/MEET/Se/202122/8
Case No 17 / NC/3/MEET/Se/202122/8
. p
Case Status Case Aroved
pp
Party Name DEEPAK NITRITE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001402AM19
RA File Number 342404000144 AM19
Licence No and<br>Date 3410044635/25/10/2018
Norms Committee Decision:<br>
The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input<br>output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>BENZO TRIFLUORIDE<br>1.260 kg<br>2<br>SODIUM NITRITE<br>Not allowed as shown domestic<br>3<br>TOLUENE<br>0.150 kg<br>4<br>CAUSTIC SODA LYE<br>0.50 kg<br>TRIFLUOROMETHYL<br>ACETO PHENONE<br>1 kg
Export product Qty. Sl. No. Import items Qty.
TRIFLUOROMETHYL<br>ACETO PHENONE 1 kg 1 BENZO TRIFLUORIDE 1.260 kg
2 SODIUM NITRITE Not allowed as shown domestic
3 TOLUENE 0.150 kg
4 CAUSTIC SODA LYE 0.50 kg

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5<br>ACETALDOXIME<br>50%<br>MIN.<br>SOLUION IN WATER<br>0.951 kg<br>6<br>COPPER SULPHATE<br>Not allowed as not importable and<br>shown as indigenous<br>7<br>ACETIC ACID<br>Not allowed as not importable and<br>shown as indigenous<br>8<br>SULPHURIC ACID<br>Not allowed as not importable and<br>shown as indigenous<br>9<br>SODA ASH<br>Not allowed as not importable and<br>shown as indigenous<br>10<br>NITRIC ACID<br>Not allowed as not importable and<br>shown as indigenous<br>11<br>CATALYST<br>Not allowed as not importable and<br>shown as indigenous<br>12<br>HYDROGEN<br>Not allowed as not importable and<br>shown as indigenous<br>13<br>HYDROCHLORIC ACID<br>Not allowed as not importable and<br>shown as indigenous<br>RA concerned may take further necessary action as per above decision of NC. 5 ACETALDOXIME<br>50%<br>MIN.<br>SOLUION IN WATER <br>0.951 kg
6 COPPER SULPHATE Not allowed as not importable and<br>shown as indigenous
7 ACETIC ACID Not allowed as not importable and<br>shown as indigenous
8 SULPHURIC ACID Not allowed as not importable and<br>shown as indigenous
9 SODA ASH Not allowed as not importable and<br>shown as indigenous
10 NITRIC ACID Not allowed as not importable and<br>shown as indigenous
11 CATALYST Not allowed as not importable and<br>shown as indigenous
12 HYDROGEN Not allowed as not importable and<br>shown as indigenous
13 HYDROCHLORIC ACID Not allowed as not importable and<br>shown as indigenous
Case No. 18 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name DEEPAK NITRITE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001404AM19
RA File Number 342404000208 AM19
Licence No and<br>Date 3410044636/25/10/2018
Norms Committee Decision:

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The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is less:

Export product Qty. Sl. No. Import items Qty.
**3-**TRIFLUOROMETHYL<br>ACETO PHENONE 1 kg 1 BENZO TRIFLUORIDE 99.5% 1.260 kg
2 SODIUM NITRITE Not allowed as shown domestic
3 TOLUENE 0.150 kg
4 CAUSTIC SODA LYE 47% 0.50 kg
5 ACETALDOXIME<br>50%<br>MIN.<br>SOLUION IN WATER <br>0.951 kg
6 COPPER SULPHATE Not allowed as not importable and<br>shown as indigenous
7 ACETIC ACID Not allowed as not importable and<br>shown as indigenous
8 SULPHURIC ACID Not allowed as not importable and<br>shown as indigenous
9 SODA ASH Not allowed as not importable and<br>shown as indigenous
10 NITRIC ACID Not allowed as not importable and<br>shown as indigenous
11 CATALYST Not allowed as not importable and<br>shown as indigenous
12 HYDROGEN Not allowed as not importable and<br>shown as indigenous
13 HYDROCHLORIC ACID Not allowed as not importable and<br>shown as indigenous

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Case No. Case No. 19 / NC/3/MEET/Sep/202122/8 19 / NC/3/MEET/Sep/202122/8 19 / NC/3/MEET/Sep/202122/8 19 / NC/3/MEET/Sep/202122/8 19 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name DEEPAK NITRITE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001459AM19
RA File Number 342404000254 AM19
Licence No and<br>Date 3410044710/20/11/2018
Norms Committee Decision:<br>The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input<br>output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>BENZO TRIFLUORIDE<br>1.260 kg<br>2<br>SODIUM NITRITE<br>Not allowed as shown domestic<br>3<br>TOLUENE<br>0.150 kg<br>4<br>CAUSTIC SODA LYE 47%<br>0.50 kg<br>5<br>ACETALDOXIME<br>50%<br>MIN.<br>SOLUION IN WATER<br>0.951 kg<br>6<br>COPPER SULPHATE<br>Not allowed as not importable and<br>shown as indigenous<br>7<br>ACETIC ACID<br>Not allowed as not importable and<br>shown as indigenous<br>8<br>SULPHURIC ACID<br>Not allowed as not importable and<br>shown as indigenous<br>**3-**TRIFLUOROMETHYL<br>ACETO PHENONE<br>1 kg
Export product Qty. Sl. No. Import items Qty.
**3-**TRIFLUOROMETHYL<br>ACETO PHENONE 1 kg 1 BENZO TRIFLUORIDE 1.260 kg
2 SODIUM NITRITE Not allowed as shown domestic
3 TOLUENE 0.150 kg
4 CAUSTIC SODA LYE 47% 0.50 kg
5 ACETALDOXIME<br>50%<br>MIN.<br>SOLUION IN WATER <br>0.951 kg
6 COPPER SULPHATE Not allowed as not importable and<br>shown as indigenous
7 ACETIC ACID Not allowed as not importable and<br>shown as indigenous
8 SULPHURIC ACID Not allowed as not importable and<br>shown as indigenous

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9<br>SODA ASH<br>Not allowed as not importable and<br>shown as indigenous<br>10<br>NITRIC ACID<br>Not allowed as not importable and<br>shown as indigenous<br>11<br>CATALYST<br>Not allowed as not importable and<br>shown as indigenous<br>12<br>HYDROGEN<br>Not allowed as not importable and<br>shown as indigenous<br>13<br>HYDROCHLORIC ACID<br>Not allowed as not importable and<br>shown as indigenous<br>RA concerned may take further necessary action as per above decision of NC. 9 SODA ASH Not allowed as not importable and<br>shown as indigenous
10 NITRIC ACID Not allowed as not importable and<br>shown as indigenous
11 CATALYST Not allowed as not importable and<br>shown as indigenous
12 HYDROGEN Not allowed as not importable and<br>shown as indigenous
13 HYDROCHLORIC ACID Not allowed as not importable and<br>shown as indigenous
Case No. Case No. 20 / NC/3/MEET/Sep/202122/8 20 / NC/3/MEET/Sep/202122/8 20 / NC/3/MEET/Sep/202122/8 20 / NC/3/MEET/Sep/202122/8 20 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name DEEPAK NITRITE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001542AM19
RA File Number 342404000255 AM19
Licence No and<br>Date 3410044711/20/11/2018
Norms Committee Decision:<br>The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input<br>output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>BENZO TRIFLUORIDE<br>1.260 kg<br>2<br>SODIUM NITRITE<br>Not allowed as shown domestic<br>**3-**TRIFLUOROMETHYL<br>ACETO PHENONE<br>1 kg
Export product Qty. Sl. No. Import items Qty.
**3-**TRIFLUOROMETHYL<br>ACETO PHENONE 1 kg 1 BENZO TRIFLUORIDE 1.260 kg
2 SODIUM NITRITE Not allowed as shown domestic

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3<br>TOLUENE<br>0.150 kg<br>4<br>CAUSTIC SODA LYE 47%<br>0.50 kg<br>5<br>ACETALDOXIME 50% MIN.<br>SOLUION IN WATER<br>0.951 kg<br>6<br>COPPER SULPHATE<br>Not allowed as not importable and<br>shown as indigenous<br>7<br>ACETIC ACID<br>Not allowed as not importable and<br>shown as indigenous<br>8<br>SULPHURIC ACID<br>Not allowed as not importable and<br>shown as indigenous<br>9<br>SODA ASH<br>Not allowed as not importable and<br>shown as indigenous<br>10<br>NITRIC ACID<br>Not allowed as not importable and<br>shown as indigenous<br>11<br>CATALYST<br>Not allowed as not importable and<br>shown as indigenous<br>12<br>HYDROGEN<br>Not allowed as not importable and<br>shown as indigenous<br>13<br>HYDROCHLORIC ACID<br>Not allowed as not importable and<br>shown as indigenous<br>RA concerned may take further necessary action as per above decision of NC. 3 TOLUENE 0.150 kg
4 CAUSTIC SODA LYE 47% 0.50 kg
5 ACETALDOXIME 50% MIN.<br>SOLUION IN WATER 0.951 kg
6 COPPER SULPHATE Not allowed as not importable and<br>shown as indigenous
7 ACETIC ACID Not allowed as not importable and<br>shown as indigenous
8 SULPHURIC ACID Not allowed as not importable and<br>shown as indigenous
9 SODA ASH Not allowed as not importable and<br>shown as indigenous
10 NITRIC ACID Not allowed as not importable and<br>shown as indigenous
11 CATALYST Not allowed as not importable and<br>shown as indigenous
12 HYDROGEN Not allowed as not importable and<br>shown as indigenous
13 HYDROCHLORIC ACID Not allowed as not importable and<br>shown as indigenous
Case No. 21 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name DEEPAK NITRITE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001543AM19

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RA File Number RA File Number 342404000256 AM19 342404000256 AM19 342404000256 AM19 342404000256 AM19 342404000256 AM19
Licence No and<br>Date 3410044712/20/11/2018
Norms Committee Decision:<br>The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input<br>output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>BENZO TRIFLUORIDE<br>1.260 kg<br>2<br>SODIUM NITRITE<br>Not allowed as shown domestic<br>3<br>TOLUENE<br>0.150 kg<br>4<br>CAUSTIC SODA LYE 47%<br>0.50 kg<br>5<br>ACETALDOXIME<br>50%<br>MIN.<br>SOLUION IN WATER<br>0.951 kg<br>6<br>COPPER SULPHATE<br>Not allowed as not importable and<br>shown as indigenous<br>7<br>ACETIC ACID<br>Not allowed as not importable and<br>shown as indigenous<br>8<br>SULPHURIC ACID<br>Not allowed as not importable and<br>shown as indigenous<br>9<br>SODA ASH<br>Not allowed as not importable and<br>shown as indigenous<br>10<br>NITRIC ACID<br>Not allowed as not importable and<br>shown as indigenous<br>11<br>CATALYST<br>Not allowed as not importable and<br>shown as indigenous<br>12<br>HYDROGEN<br>Not allowed as not importable and<br>shown as indigenous<br>**3-**TRIFLUOROMETHYL<br>ACETO PHENONE<br>1 kg
Export product Qty. Sl. No. Import items Qty.
**3-**TRIFLUOROMETHYL<br>ACETO PHENONE 1 kg 1 BENZO TRIFLUORIDE 1.260 kg
2 SODIUM NITRITE Not allowed as shown domestic
3 TOLUENE 0.150 kg
4 CAUSTIC SODA LYE 47% 0.50 kg
5 ACETALDOXIME<br>50%<br>MIN.<br>SOLUION IN WATER <br>0.951 kg
6 COPPER SULPHATE Not allowed as not importable and<br>shown as indigenous
7 ACETIC ACID Not allowed as not importable and<br>shown as indigenous
8 SULPHURIC ACID Not allowed as not importable and<br>shown as indigenous
9 SODA ASH Not allowed as not importable and<br>shown as indigenous
10 NITRIC ACID Not allowed as not importable and<br>shown as indigenous
11 CATALYST Not allowed as not importable and<br>shown as indigenous
12 HYDROGEN Not allowed as not importable and<br>shown as indigenous

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13 HYDROCHLORIC ACID Not allowed as not importable and shown as indigenous RA concerned may take further necessary action as per above decision of NC.

13 HYDROCHLORIC ACID HYDROCHLORIC ACID HYDROCHLORIC ACID Not allowed as not importable and<br>shown as indigenous Not allowed as not importable and<br>shown as indigenous
RA concerned may t ake further necessary action as per above decision of NC.
Case No. 22 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name GLAND PHARMA LIMITED
Meeting Number<br> NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
and Date
HQ File Number 018205002141AM19
RA File Number 092404000419 AM19
Licence No and<br>Dt 0910066930/03/12/2018
ae
Norms Committee Decision:
The Committee co nsidered the case as per agenda and taking cue from earlier decision for same export product in
<br>Meeting No.NC/ <br>3/MEET/Jan/202021/4 dated 12.02.2021against advance authorization No.0910067519 dated
14.05.2019, it was<br>the firm, whicheve decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>r is less:
Sl. No. Export Product Qty Sl. No. Import Items Qty
1 Enoxap arin<br>Sodium <br>1 Number 1 Heparin Sodium 39.733 mg
Injectio n<br>20mg<br>Pre-
filled S yringes 2 0.5 ml Barrel Syringes Net to Net
3 0.5 ml Needle Shield Net to Net
4 05 ml Plunger Stoppers Net to Net
.
5 0.5 ml Plunger Rods Net to Net
6 0.5 ml Preventis Needle Shielding <br>Net to Net
System

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2 Enoxaparin<br>Sodium<br>Injection<br>40mg<br>Pre-<br>filled Syringes <br>1 Number 1 Heparin Sodium 79.466 mg
2 0.5 ml Barrel Syringes Net to Net
3 0.5 ml Needle Shield Net to Net
4 0.5 ml Plunger Stoppers Net to Net
5 0.5 ml Plunger Rods Net to Net
6 0.5 ml Preventis Needle Shielding<br>System <br>Net to Net
3 Enoxaparin<br>Sodium<br>Injection<br>60mg<br>Pre-<br>filled Syringes <br>1 Number 1 Heparin Sodium 119.187 mg
2 0.5 ml Barrel Syringes Net to Net
3 0.5 ml Needle Shield Net to Net
4 0.5 ml Plunger Stoppers Net to Net
5 0.5 ml Plunger Rods Net to Net
6 0.5 ml Preventis Needle Shielding<br>System <br>Net to Net
4 Enoxaparin<br>Sodium<br>Injection<br>80mg<br>Pre-<br>filled Syringes <br>1 Number 1 Heparin Sodium 158.93 mg
2 0.5 ml Barrel Syringes Net to Net
3 0.5 ml Needle Shield Net to Net
4 0.5 ml Plunger Stoppers Net to Net
5 0.5 ml Plunger Rods Net to Net
6 0.5 ml Preventis Needle Shielding<br>System <br>Net to Net

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

Case No. 23 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name STERLING AUXILIARIES PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001560AM19
RA File Number 039504000851 AM19
Licence No and<br>Date 0310825462/05/12/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for<br>following information from the firm:<br>Justification for wastage more than 2% in Export products, where wastage is claimed more.

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

Case No. 24 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name SONGWON SPECIALTY CHEMICALS - INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001563AM19
RA File Number 342404000294 AM19
Licence No and<br>Date 3410044750/12/12/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for<br>following information from the firm:<br>% yield at every stage of reaction.<br>i.<br>Quantity of MIBK used (without recovery) in each stage of reaction.

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

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Case No. 25 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name SI GROUP - INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205002308AM19
RA File Number 039504001108 AM19
Licence No and<br>Date 0310826724/30/01/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was noted that the firm still has not furnished the following<br>information asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020, followed by Reminder to firm<br>on 20.03.2020 and Final Reminder on 23.10.2020:<br>(i)<br>Complete<br>chemical<br>reaction<br>from<br>raw<br>material<br>acetone<br>to<br>3,3,5TRIMETHYLCYCLOHEXANONE showing molecular weights of each component with<br>percentage yield on molar basis at each step of the reaction.<br>Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

(i) Complete chemical reaction from raw material acetone to 3,3,5TRIMETHYLCYCLOHEXANONE showing molecular weights of each component with percentage yield on molar basis at each step of the reaction.

Case No. 26 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name INDO AMINES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205002381AM19
RA File Number 039404000984 AM19
Licence No and<br>Date 0310827206/21/02/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was noted that the firm still has not furnished the following<br>information asked for by NC-3 in its Meeting No. 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm<br>on 10.12.2020:

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  • i. Exact chemical name of import and export.

  • ii. COA and purity of import item.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No. 27 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205002595AM19
RA File Number 522404000085 AM19
Licence No and<br>Date 5210043000/19/03/2019
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 (material balance details) to arrive at quantity of raw material asked on the basis<br>of yield (23%) claimed and justification thereof.<br>i.<br>Use of Tetrahydrofuran in one charge and recovery thereof.<br>ii.<br>Production / Consumption data for the year 2019-20 duly certified by GST.
Case No. 28 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000113AM20
RA File Number 092404000011 AM20
Licence No and<br>Date 0910067466/09/05/2019
Norms Committee Decision:

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Deferred for comments of TE.

Case No. 29 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name MALWA OXYGEN & INDUSTRIAL GASES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000140AM20
RA File Number 562404000035 AM19
Licence No and<br>Date 5610005605/09/05/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the information furnished by the firm is not<br>proper. Hence, it was decided to again call for following information from the firm:<br>Justification for low yield of 33%.<br>i.<br>Recovery of solvent i.e. MCB.<br>ii.<br>Production / Consumption data for last two years duly certified by GST.<br>iii.

The Committee considered the case as per agenda and it was observed that the information furnished by the firm is not proper. Hence, it was decided to again call for following information from the firm:

Case No. 30 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name RUMIT CHEMISYNTH PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000211AM20
RA File Number 039504000196 AM20
Licence No and<br>Date 0310829292/28/05/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was noted that the firm still has not furnished the following<br>information asked for by NC-3 in its Meeting No. 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm<br>on 21.12.2020:<br>Complete chemistry, molecular weight, % yield, material balance and stoichiometric balance.<br>i.

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In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No. 31 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name NOVEL NUTRIENTSS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000262AM20
RA File Number 072404000056 AM20
Licence No and<br>Date 0710115041/11/06/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was noted that the firm still has not furnished the following<br>information asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm<br>on 06.10.2020 and Final Reminder on 21.12.2020:<br>Copy of Approval from Food & Drugs Administration (FDA) for the export product.<br>i.<br>COA for import item from foreign supplier.<br>ii.<br>Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC
Case No. 32 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name DIPS BIOSCIENCE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000260AM20
RA File Number 039404000199 AM20
Licence No and<br>Date 0310829573/12/06/2019
Norms Committee Decision:

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The Committee considered the case as per agenda and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 3/82-ALC4/2020 dated 07.08.2020, followed by Reminder to firm on 06.10.2020 and Final Reminder on 21.12.2020:

i. Copy of DML for each export product item showing Approved composition

Hence, the Committee decided to reject the case.

Case No. 33 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name DHANUKA LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000275AM20
RA File Number 052304000104 AM20
Licence No and<br>Date 0510410949/14/06/2019
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 34 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name ASTRAL STERITECH PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000287AM20
RA File Number 342404000102 AM20
Licence No and<br>Date 3410045218/19/06/2019
Norms Committee Decision:<br>Deferred for comments of TE.

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Case No. 35 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name ASTRAL STERITECH PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000293AM20
RA File Number 342404000100 AM20
Licence No and<br>Date 3410045222/20/06/2019
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 36 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000508AM20
RA File Number 072404000095 AM20
Licence No and<br>Date 0710115189/19/07/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the norms for the subject Advance<br>Authorization have already been ratified by NC-3 in its Meeting No.NC/3/MEET/Jun/202122/2 dated 02.07.2021.<br>In view of above, the Committee decided towithdrawthe case.

The Committee considered the case as per agenda and it was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its Meeting No. NC/3/MEET/Jun/202122/2 dated 02.07.2021 .

Case No. 37 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000694AM20

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RA File Number 072404000141 AM20
Licence No and<br>Date 0710115523/03/10/2019
Norms Committee Decision:<br>The Committee considered case as per agenda in the presence of the technical experts and taking into consideration<br>95% yield, it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or<br>as applied by firm whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Phenoxy Ethyl Iso Butyrate<br>1 kg<br>1<br>PHENOXY ETHANOL<br>0.70 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 38 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name LINK PHARMACHEM LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000714AM20
RA File Number 342404000099 AM20
Licence No and<br>Date 3410045519/07/10/2019
Norms Committee Decision:<br>The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the<br>ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>5 CHLORO SALICYLIC ACID<br>1 kg<br>1<br>SALICYLIC ACID (TECHNICAL GRADE)<br>0.845 kg<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00181683AM22

Case No. 39 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000719AM20
RA File Number 052404000377 AM20
Licence No and<br>Date 0510412070/10/10/2019
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 40 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name MENTHA AND ALLIED PRODUCTS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000763AM20
RA File Number 052404000375 AM20
Licence No and<br>Date 0510412231/23/10/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:<br>Complete chemical name of export and import item.<br>i.<br>Catalogue of import item and COA from foreign supplier indicating percentage constituents of different<br>item in import.<br>ii.<br>Production / Consumption data for last two years duly certified by GST.
Case No. 41 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name SPC LIFE SCIENCES PRIVATE LIMITED

UDIN00181683AM22

Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000762AM20
RA File Number 342404000143 AM20
Licence No and<br>Date 3410045565/23/10/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019,<br>14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020,<br>followed by Reminder to firm on 14.08.2020 and 06.10.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019, 14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 14.08.2020 and 06.10.2020. Reply still awaited from the firm.

Case No. 42 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name PORUS LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000786AM20
RA File Number 092404000394 AM20
Licence No and<br>Date 0910068157/04/11/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019,<br>14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020,<br>followed by Reminder to firm on 14.08.2020 and 06.10.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019, 14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 14.08.2020 and 06.10.2020. Reply still awaited from the firm.

Case No. 43 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected

UDIN00181683AM22

UDIN00181683AM2 UDIN00181683AM2
Part Name PORUS LABORATORIES PRIVATE LIMITED
y
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000787AM20
RA File Number 092404000393 AM20
Licence No and
<br>Date 0910068158/04/11/2019
Norms Committee Decision:
The Committee co<br> nsidered the case as per online agenda in the presence of technical experts and it was noted that the<br>
firm still has not f<br> urnished the following information asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated<br>
29.11.2019, follow ed by Reminder to firm on 20.01.2020 and Final Reminder on 06.10.2020.
<br>
Complete chemical name of the export item.<br>i.<br>Complete 4E with all technical details i.e chemistry, molecular weight, stoichiometric reaction and % of<br>yield on molar basis at every stage<br>ii.<br>A copy of 4.07 application of subject advance authorization.<br>iii.<br>Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019, followed by Reminder to firm on 20.01.2020 and Final Reminder on 06.10.2020.

Case No. 44 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name GRANDEUR PHARMA PRIVATE LIMITED
Meeting Number NC/ 3/ MEET/ S/ 202122/ 8 d 24/09/2021
and Date ep an
HQ File Number 018205000788AM20
RA File Number 052304000251 AM20
Licence No and 0510412350/05/11/2019
Date
Norms Committee Decision:
The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019,<br>14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020,<br>followed by Reminder to firm on 14.08.2020 and 06.10.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019, 14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 14.08.2020 and 06.10.2020. Reply still awaited from the firm.

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Case No. 45 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name MAPAEX CONSUMER HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000797AM20
RA File Number 562404000018 AM20
Licence No and<br>Date 5610005722/07/11/2019
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 for each export item showing approved composition.<br>i.<br>Copy of Mater Batch Formula showing net content of all ingredient and wastage claimed for each export<br>item.<br>ii.<br>Net weight of one Lozenges and net weight of Isomalt containing in it.<br>iii.
Case No. 46 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name ATUL LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000812AM20
RA File Number 082404000258 AM20
Licence No and<br>Date 0810146544/13/11/2019
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, molecular weight of chemical reaction involved.<br>i.<br>Percentage yield of reaction.<br>ii.<br>Percentage composition of export product.<br>iii.<br>Recovery of Methanol.<br>iv.<br>Production / Consumption data for last two years duly certified by GST.

UDIN00181683AM22

Case No. Case No. Case No. 47 / NC/3/MEET/Sep/202122/8 47 / NC/3/MEET/Sep/202122/8 47 / NC/3/MEET/Sep/202122/8 47 / NC/3/MEET/Sep/202122/8 47 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000818AM20
RA File Number 039404000636 AM20
Licence No and<br>Date 0310832767/14/11/2019
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<br>as per details given below or as applied by the firm, whichever is less:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>FLUOCINOLONE<br>ACE<br>EAR<br>DROPS<br>0.01%<br>20ML<br>(Fluocinolone Acetonide 0.01%)<br>(Net Wt. of FLUOCINOLONE<br>ACETONIDE BP in 110 Gms.)<br>50000<br>Number<br>1<br>FLUOCINOLONE ACETONIDE BP<br>102.00<br>grams<br>2<br>FLUOCINOLONE ACE SCALP<br>OIL 0.01% 118ML (Fluocinolone<br>Acetonide 0.01% Topical Oil) (Net<br>Wt.<br>of<br>FLUOCINOLONE<br>ACETONIDE BP in 649 Gms.)<br>50000<br>Number<br>1<br>FLUOCINOLONE ACETONIDE BP<br>607.80<br>grams<br>3<br>FLUOCINOLONE ACE BODY<br>OIL 0.01% 118ML (Fluocinolone<br>Acetonide 0.01% Topical Oil)<br>( Net Wt. of FLUOCINOLONE<br>ACETONIDE BP in 129.80 Gms.)<br>10000<br>Number<br>1<br>FLUOCINOLONE ACETONIDE BP<br>120.36<br>grams<br>RA may take appropriate action as per the decision of Norms Committee.
Sl.<br>No. Export product Qty. Sl. No. Import items Qty.
1 FLUOCINOLONE<br>ACE<br>EAR<br>DROPS<br>0.01%<br>20ML<br>(Fluocinolone Acetonide 0.01%)<br>(Net Wt. of FLUOCINOLONE<br>ACETONIDE BP in 110 Gms.) <br> <br> <br> <br>50000<br>Number 1 FLUOCINOLONE ACETONIDE BP 102.00<br>grams
2 FLUOCINOLONE ACE SCALP<br>OIL 0.01% 118ML (Fluocinolone<br>Acetonide 0.01% Topical Oil) (Net<br>Wt.<br>of<br>FLUOCINOLONE<br>ACETONIDE BP in 649 Gms.) <br> <br> <br> <br>50000<br>Number 1 FLUOCINOLONE ACETONIDE BP 607.80<br>grams
3 FLUOCINOLONE ACE BODY<br>OIL 0.01% 118ML (Fluocinolone<br>Acetonide 0.01% Topical Oil)<br>( Net Wt. of FLUOCINOLONE<br>ACETONIDE BP in 129.80 Gms.) <br> <br> <br>10000<br>Number 1 FLUOCINOLONE ACETONIDE BP 120.36<br>grams
RA may take appropriate action as per the decision of Norms Committee.

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Case No. 48 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name SUVEN LIFE SCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000819AM20
RA File Number 092404000414 AM20
Licence No and<br>Date 0910068184/14/11/2019
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 49 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name NISARG BIOSCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000820AM20
RA File Number 092404000403 AM20
Licence No and<br>Date 0910068187/14/11/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019,<br>14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020,<br>followed by Reminder to firm on 14.08.2020 and 06.10.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019, 14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 14.08.2020 and 06.10.2020. Reply still awaited from the firm.

Case No. 50 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name YASHO INDUSTRIES LIMITED
Meeting Number NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021

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and Date
HQ File Number 018205000823AM20
RA File Number 039504000791 AM20
Licence No and<br>Date 0310832783/14/11/2019
Norms Committee Decision:<br>The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the<br>ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is<br>less:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>2,6-DI-TERTIARY-BUTYL<br>PHENOL<br>0.825 kg<br>2<br>METHYL ACRYLATE<br>0.349 kg<br>YALUB PA 135(3,5-DI-TERTIARY-BUTYL-<br>4-HYDROXYHYDROCINNAMIC ACID)<br>1 kg<br>3<br>EXXAL 8(ISO OCTANOL)<br>0.366 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 51 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name MANGALAM ORGANICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000824AM20
RA File Number 039504000702 AM20
Licence No and<br>Date 0310832785/14/11/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not<br>proper. Hence, it was decided to again call for following information from the firm:<br>Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and % of<br>i.

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yield at every stage.

Case No. 52 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name CLARIANT INDIA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000826AM20
RA File Number 039404000639 AM20
Licence No and<br>Date 0310832792/14/11/2019
Norms Committee Decision:<br>The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the<br>ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>ECLIPSOGEN<br>SORB<br>M<br>(containing 50% Sorbm-3 (2,2-<br>Methylenebis[6-(benzotriazol-2-<br>yl)-4-tert-octylphenol] )<br>1 kg<br>1<br>Sorbm-3 (2,2-Methylenebis[6-(benzotriazol-2-yl)-4-<br>tert-octylphenol] )<br>1.00 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 53 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name SMILAX LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000815AM20
RA File Number 092404000411 AM20
Licence No and<br>Date 0910068182/14/11/2019

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Norms Committee Decision:

Deferred for comments of TE.

Case No. 54 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name PORUS LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000829AM20
RA File Number 092404000421 AM20
Licence No and<br>Date 0910068191/15/11/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019,<br>14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020,<br>followed by Reminder to firm on 14.08.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019, 14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 14.08.2020. Reply still awaited from the firm.

Case No. 55 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000821AM20
RA File Number 318304000104 AM20
Licence No and<br>Date 3110067591/15/11/2019
Norms Committee Decision:<br>Deferred for comments of TE.

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Case No. 56 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000828AM20
RA File Number 039404000628 AM20
Licence No and<br>Date 0310832799/15/11/2019
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.
Case No. 57 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name WEXFORD LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000832AM20
RA File Number 072404000178 AM20
Licence No and<br>Date 0710115700/18/11/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019,<br>14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020,<br>followed by Reminder to firm on 14.08.2020 and 06.10.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019, 14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 14.08.2020 and 06.10.2020. Reply still awaited from the firm.

Case No. 58 / NC/3/MEET/Sep/202122/8

UDIN00181683AM22

Case Status Case Rejected
Party Name NISARG BIOSCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000833AM20
RA File Number 092404000424 AM20
Licence No and<br>Date 0910068197/18/11/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019,<br>14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020,<br>followed by Reminder to firm on 14.08.2020 and 06.10.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019, 14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 14.08.2020 and 06.10.2020. Reply still awaited from the firm.

Case No. 59 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name AVIEUM LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000835AM20
RA File Number 318304000101 AM20
Licence No and<br>Date 3110067594/18/11/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019,<br>14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020,<br>followed by Reminder to firm on 14.08.2020 and 06.10.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019, 14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 14.08.2020 and 06.10.2020. Reply still awaited from the firm.

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Case No.<br>60 / NC/3/MEET/Sep/202122/8
Case Status<br>Case Rejected
Party Name<br>REYAANSH HEALTHCARE
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number<br>018205000836AM20
RA File Number<br>039504000757 AM20
Licence No and<br>Date<br>0310832850/18/11/2019
Norms Committee Decision:
The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm
still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019,
14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020,
followed by Reminder to firm on 10.09.2020. Reply still awaited from the firm.
Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019, 14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 10.09.2020. Reply still awaited from the firm.

Case No. 61 / NC/3/MEET/Sep/202122/8 61 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000840AM20
RA File Number 092404000412 AM20
Licence No and<br>Date 0910068203/19/11/2019
Norms Committee Decision:
Deferred for comments of TE.
Case No. 62 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name AVIEUM LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000841AM20

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RA File Number<br>318304000108 AM20
Licence No and<br>Date<br>3110067598/19/11/2019
Norms Committee Decision:
The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm
still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019,
14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020,
followed by Reminder to firm on 14.08.2020. Reply still awaited from the firm.
Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019, 14/82-ALC4/2019 dated 06.03.2020, 3/82-ALC4/2020 dated 07.08.2020, 6/82-ALC4/2020 dated 13.11.2020, followed by Reminder to firm on 14.08.2020. Reply still awaited from the firm.

Case No. 63 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name LINK PHARMACHEM LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000844AM20
RA File Number 342404000248 AM20
Licence No and<br>Date 3410045631/20/11/2019
Norms Committee Decision:
The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm
still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020,
2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 07.08.2020
and 19.11.2020. Reply still awaited from the firm.
Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020, 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 07.08.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 64 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021

UDIN00181683AM22

HQ File Number<br>018205000842AM20
RA File Number<br>092404000365 AM20
Licence No and<br>Date<br>0910068207/20/11/2019
Norms Committee Decision:
The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the
ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is
less:
Export product<br>Qty. Sl. No. Import items Qty.
Ertapenem for Injection 1 gram/<br>1 Number 1 ERTAPENEM SODIUM (Imports <br>and 1.10
vial (Net content of the import exports are governed by PC 9 dated gram
item is 66.666 Kgs ) 30.06.2003 as amended)
RA concerned may take further necessary action as per above decision of NC.
Case No. 65 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name LINK PHARMACHEM LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000855AM20
RA File Number 342404000256 AM20
Licence No and<br>Date 3410045634/21/11/2019
Norms Committee Decision:
Deferred for comments of TE.
Case No. 66 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name GOVIND LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021

UDIN00181683AM22

HQ File Number 018205000860AM20 018205000860AM20 018205000860AM20
RA File Number 082404000272 AM20
i d
Lcence No an<br>Date 0810146634/22/11/2019
Norms Committee Decision:
<br>The Committee co <br>nsidered the case as per online agenda in the presence of technical experts and it was noted that the
firm still has not furnished the following information asked for by NC-3 in its Meeting No. 5/82-
ALC4/2020 dated 09.10.2020, followed by Reminder on 11.12.2020:
Complete and balanced chemical reactions, molecular weight and % yield on molar basis.<br>i.<br>% recovery of solvents at each step.<br>ii.
In view of above, the Committee decided to issue<br>will be rejected. Final Reminder<br> to firm to furnish its reply, failing which the case

The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 5/82ALC4/2020 dated 09.10.2020, followed by Reminder on 11.12.2020:

Case No.<br>67 / NC/3/MEET/Sep/202122/8
Case Status<br>Case Rejected
Party Name<br>SRF LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number<br>018205000866AM20
RA File Number<br>052404000501 AM20
Licence No and<br>Date<br>0510412619/25/11/2019
Norms Committee Decision:
The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm
still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020,
2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on
23.10.2020. Reply still awaited from the firm.
Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020, 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 23.10.2020. Reply still awaited from the firm.

Case No. 68 / NC/3/MEET/Sep/202122/8
Case Status Case Approved

UDIN00181683AM22

Party Name<br>DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number<br>018205000874AM20
RA File Number<br>342404000223 AM20
Licence No and<br>Date<br>3410045650/27/11/2019
Norms Committee Decision:
The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the
ad-hoc input output norms as perSION A-3678.
RA concerned may take further necessary action as per above decision of NC.
Case No.<br>69 / NC/3/MEET/Sep/202122/8
Case Status<br>Case Rejected
Party Name<br>VIVIMED LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number<br>018205000885AM20
RA File Number<br>092404000374 AM20
Licence No and<br>Date<br>0910068241/02/12/2019
Norms Committee Decision:
The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm
still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020,
2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on
23.10.2020. Reply still awaited from the firm.
Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020, 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 23.10.2020. Reply still awaited from the firm.

Case No. 70 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name VN CREATIVE CHEMICALS PRIVATE LIMITED
Meeting Number NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021

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and Date
HQ File Number 018205000892AM20
RA File Number 039504000849 AM20
Licence No and<br>Date 0310833213/04/12/2019
Norms Committee Decision:
The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm
still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020,
2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 07.08.2020
and 19.11.2020. Reply still awaited from the firm.
Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020, 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 07.08.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 71 / NC/3/MEET/Sep/202122/8 71 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name RUBICON RESEARCH PRIVATE LIMITED
Meeting Number NC/ 3/ MEET/ S/ 202122/ 8 d 24/09/2021
and Date ep an
HQ File Number 018205000889AM20
RA File Number 039504000793 AM20
Licence No and 0310833193/04/12/2019
Date
Norms Committee Decision:
The Committee c nsidered the case as er aenda in the resence of technical exerts and it was noted that the firm
p g p p<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020,<br>2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020<br>and 19.11.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020, 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 72 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name ORTIN LABORATORIES LIMITED

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Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001593AM21
RA File Number 092404000449 AM20
Licence No and<br>Date 0910068271/10/12/2019
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 73 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name HIMALAYAN PRODUCTS AND INDUSTRIES CORPN PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000902AM20
RA File Number 052404000483 AM20
Licence No and<br>Date 0510412862/12/12/2019
Norms Committee Decision:<br>The firm has furnished its reply on DGFT Back Office Portal. Deferred for comments of TE
Case No. 74 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name ANTHEA AROMATICS PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000907AM20
RA File Number 039404000576 AM20
Licence No and<br>Date 0310833390/13/12/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020,<br>2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 07.08.2020<br>and 19.11.2020. Reply still awaited from the firm.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020, 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 07.08.2020 and 19.11.2020. Reply still awaited from the firm.

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

Case No. 75 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name STYRAX PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000939AM20
RA File Number 262404000014 AM20
Licence No and<br>Date 2610012889/27/12/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020,<br>2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on<br>23.10.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020, 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 23.10.2020. Reply still awaited from the firm.

Case No. 76 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name DIPS BIOSCIENCE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000942AM20
RA File Number 039404000788 AM20
Licence No and<br>Date 0310833754/27/12/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020,<br>2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 07.08.2020<br>and 19.11.2020 . Reply still awaited from the firm.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020, 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 07.08.2020 and 19.11.2020 . Reply still awaited from the firm.

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Case No. 77 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name REFLUX PHARMACEUTICALS
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000948AM20
RA File Number 039504000931 AM20
Licence No and<br>Date 0310833815/01/01/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020,<br>2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on<br>23.10.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020, 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 23.10.2020. Reply still awaited from the firm.

Case No. 78 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name REYAANSH HEALTHCARE
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205000964AM20
RA File Number 039504000826 AM20
Licence No and<br>Date 0310833938/06/01/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020,

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020,

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2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 23.10.2020. Reply still awaited from the firm.

Case No. 79 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name SREEPATHI PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001594AM21
RA File Number 092404000502 AM20
Licence No and<br>Date 0910068349/09/01/2020
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 80 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001020AM20
RA File Number 052404000670 AM20
Licence No and<br>Date 0510413367/17/01/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020,<br>2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 07.08.2020<br>and 19.11.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 13/82-ALC4/2019 dated 31.01.2020, 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 07.08.2020 and 19.11.2020. Reply still awaited from the firm.

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Case No. 81 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name VETBIOCHEM INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001040AM20
RA File Number 318304000138 AM20
Licence No and<br>Date 3110067663/21/01/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 23.10.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

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

Case No. 82 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name AQUILA ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001042AM20
RA File Number 039404000879 AM20
Licence No and<br>Date 0310834406/22/01/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 23.10.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.

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

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Case No. Case No. Case No. 83 / NC/3/MEET/Sep/202122/8 83 / NC/3/MEET/Sep/202122/8 83 / NC/3/MEET/Sep/202122/8 83 / NC/3/MEET/Sep/202122/8 83 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001046AM20
RA File Number 039404000906 AM20
Licence No and<br>Date 0310834474/24/01/2020
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<br>as per details given below or as applied by the firm, whichever is less:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>FLUOCINOLONE<br>ACE<br>EAR<br>DROPS<br>0.01%<br>20ML<br>(Fluocinolone Acetonide 0.01%)<br>(Net Wt. of FLUOCINOLONE<br>ACETONIDE BP in 110 Gms.)<br>50000<br>Number<br>1<br>FLUOCINOLONE ACETONIDE BP<br>102.00<br>grams<br>2<br>FLUOCINOLONE ACE SCALP<br>OIL 0.01% 118ML (Fluocinolone<br>Acetonide 0.01% Topical Oil) (Net<br>Wt.<br>of<br>FLUOCINOLONE<br>ACETONIDE BP in 649 Gms.)<br>50000<br>Number<br>1<br>FLUOCINOLONE ACETONIDE BP<br>607.80<br>grams<br>3<br>FLUOCINOLONE ACE BODY<br>OIL 0.01% 118ML (Fluocinolone<br>Acetonide 0.01% Topical Oil)<br>( Net Wt. of FLUOCINOLONE<br>ACETONIDE BP in 129.80 Gms.)<br>10000<br>Number<br>1<br>FLUOCINOLONE ACETONIDE BP<br>120.36<br>grams<br>RA may take appropriate action as per the decision of Norms Committee.
Sl.<br>No. Export product Qty. Sl. No. Import items Qty.
1 FLUOCINOLONE<br>ACE<br>EAR<br>DROPS<br>0.01%<br>20ML<br>(Fluocinolone Acetonide 0.01%)<br>(Net Wt. of FLUOCINOLONE<br>ACETONIDE BP in 110 Gms.) <br> <br> <br> <br>50000<br>Number 1 FLUOCINOLONE ACETONIDE BP 102.00<br>grams
2 FLUOCINOLONE ACE SCALP<br>OIL 0.01% 118ML (Fluocinolone<br>Acetonide 0.01% Topical Oil) (Net<br>Wt.<br>of<br>FLUOCINOLONE<br>ACETONIDE BP in 649 Gms.) <br> <br> <br> <br>50000<br>Number 1 FLUOCINOLONE ACETONIDE BP 607.80<br>grams
3 FLUOCINOLONE ACE BODY<br>OIL 0.01% 118ML (Fluocinolone<br>Acetonide 0.01% Topical Oil)<br>( Net Wt. of FLUOCINOLONE<br>ACETONIDE BP in 129.80 Gms.) <br> <br> <br>10000<br>Number 1 FLUOCINOLONE ACETONIDE BP 120.36<br>grams
RA may take appropriate action as per the decision of Norms Committee.

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Case No. 84 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name SYNTHO CHIRALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001055AM20
RA File Number 092404000540 AM20
Licence No and<br>Date 0910068421/28/01/2020
Norms Committee Decision:<br>Deferred for comments of TE
Case No. 85 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name GENERIC HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001058AM20
RA File Number 318304000135 AM20
Licence No and<br>Date 3110067669/29/01/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 23.10.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

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

Case No. 86 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name JODAS EXPOIM PRIVATE LIMITED

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Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001064AM20
RA File Number 092404000531 AM20
Licence No and<br>Date 0910068454/05/02/2020
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 for the export item.<br>i.<br>Technical literature in support of low yield from P 1 to API stage.
Case No. 87 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001066AM20
RA File Number 318304000140 AM20
Licence No and<br>Date 3110067673/06/02/2020
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>Quantity and commercial value of By product obtained that is (1) Mixed Mono Cresol and (2) Acetic Acid.
Case No. 88 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001069AM20
RA File Number 318304000142 AM20
Licence No and<br>Date 3110067677/06/02/2020

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Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 4/82-ALC4/2020 dated 18.09.2020 against advance authorization No. 3110067825 dated 14.08.2020 , 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:

Export product Qty. Sl. No. Import items Qty.
Mono<br>Methyl<br>Ether<br>of<br>Hydroquinone - MEHQ <br>1 kg 1 Phenol 1.012 kg
2 Methanol 0.396 kg
3 Hydrogen Peroxide PURITY 60% 0.8 kg
4 Acetone (Solvent) 0.14 kg
Case No. 89 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001065AM20
RA File Number 039504000985 AM20
Licence No and<br>Date 0310834682/06/02/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 10.08.2020 and 23.11.2020. Reply still<br>awaited from the firm.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 10.08.2020 and 23.11.2020. Reply still awaited from the firm.

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Case No. 90 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name MAGNOLIA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001551AM21
RA File Number 039504001071 AM20
Licence No and<br>Date 0310834718/07/02/2020
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. Case No. 91 / NC/3/MEET/Sep/202122/8 91 / NC/3/MEET/Sep/202122/8 91 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001077AM20
RA File Number 039504001070 AM20
Licence No and<br>Date 0310834755/11/02/2020
Norms Committee Decision:<br>The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the<br>ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is<br>less:<br>Sl. No.<br>Export product<br>Qty.<br>1<br>Phytosterol Natural Refined Phytosterol 95%<br>60000 kg
Sl. No. Export product Qty.
1 Phytosterol Natural Refined Phytosterol 95% 60000 kg

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2<br>Natural Mixed Tocopherol 70%<br>27500 kg<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Fatty Acid Distillate / Deoderised Distillate<br>921250 kg<br>2<br>Acetone<br>44000 kg<br>3<br>Heptane-S<br>94050 kg<br>RA concerned may take further necessary action as per above decision of NC. 2 Natural Mixed Tocopherol 70% 27500 kg
Sl. No. Import items Qty.
1 Fatty Acid Distillate / Deoderised Distillate 921250 kg
2 Acetone 44000 kg
3 Heptane-S 94050 kg
Case No. Case No. 92 / NC/3/MEET/Sep/202122/8 92 / NC/3/MEET/Sep/202122/8 92 / NC/3/MEET/Sep/202122/8 92 / NC/3/MEET/Sep/202122/8 92 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name BALAJI AMINES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001079AM20
RA File Number 318304000144 AM20
Licence No and<br>Date 3110067681/11/02/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.7/82-ALC4/2020 dated 04.12.2020against advance authorization No.3110067809 dated 11.08.2020, it<br>was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>1,4 BUTANEDIOL<br>1.16 kg<br>GAMMA BUTYROLACTONE<br>1 kg
Export Product Qty. Sl. No. Import items Qty.
GAMMA BUTYROLACTONE 1 kg 1 1,4 BUTANEDIOL 1.16 kg

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2 GBL CATAYLYST 0.001 kg

Case No. Case No. 93 / NC/3/MEET/Sep/202122/8 93 / NC/3/MEET/Sep/202122/8 93 / NC/3/MEET/Sep/202122/8 93 / NC/3/MEET/Sep/202122/8 93 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001090AM20
RA File Number 039404000962 AM20
Licence No and<br>Date 0310834862/13/02/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.10/82-ALC4/2019 dated 29.11.2019against advance authorization No.0310829436 dated 06.06.2019, it<br>was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>PROPIOPHENONE<br>1.408 kg<br>2<br>SODIUM CYANIDE<br>0.599 kg<br>3<br>PARA FORMALDEHYDE<br>0.528 kg<br>4<br>SODIUM BOROHYDRIDE<br>0.528 kg<br>2-DIMETHYLAMINO-2-<br>PHENYLBUTAN-1-OL (DAFOL)<br>1 kg<br>5<br>TETRA HYDRO FURAN (THF)<br>1.00 kg
Export Product Qty. Sl. No. Import items Qty.
2-DIMETHYLAMINO-2-<br>PHENYLBUTAN-1-OL (DAFOL) 1 kg 1 PROPIOPHENONE 1.408 kg
2 SODIUM CYANIDE 0.599 kg
3 PARA FORMALDEHYDE 0.528 kg
4 SODIUM BOROHYDRIDE 0.528 kg
5 TETRA HYDRO FURAN (THF) 1.00 kg

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Case No. 94 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name SHREE GANESH REMEDIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001082AM20
RA File Number 342404000333 AM20
Licence No and<br>Date 3410045871/13/02/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 23.10.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

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

Case No. Case No. Case No. 95 / NC/3/MEET/Sep/202122/8 95 / NC/3/MEET/Sep/202122/8 95 / NC/3/MEET/Sep/202122/8 95 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001083AM20
RA File Number 039404000948 AM20
Licence No and Date 0310834835/13/02/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against advance authorization No.0310838273 dated<br>15.09.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br>Sl.<br>Export Product<br>Qty<br>Import Items<br>Qty
Export Product Qty Sl. Import Items Qty
Case No. Case No. Case No. 95 / NC/3/MEET/Sep/202122/8 95 / NC/3/MEET/Sep/202122/8 95 / NC/3/MEET/Sep/202122/8 95 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001083AM20
RA File Number 039404000948 AM20
Licence No and Date 0310834835/13/02/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against advance authorization No.0310838273 dated<br>15.09.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br>Sl.<br>Export Product<br>Qty<br>Import Items<br>Qty
Export Product Qty Sl. Import Items Qty

UDIN00181683AM22

No.<br>1<br>MAP(METHYL VINYL PHOSPHATE:CAS NO.189177-38-<br>3)(4R-5S-6S-3-DIPHENYLOXY-6-1R-HYDROXYETHYL-4-<br>METHYL-7-OXO-1<br>2.50 kg<br>DORIPENEM<br>STERILE<br>1 kg<br>2<br>DORIPENEM<br>SIDE<br>CHAIN(4-NITROBENZYL(2S-4S)-4-<br>ACETYLTHIO-2-(N-SULFAMOYL-N-(TERT-<br>BUTOXYCARBONOYL)AMINO)PYRRROLIDINE-1)<br>2.463 kg<br> RA may take appropriate action as per the decision of Norms Committee. No.
DORIPENEM<br>STERILE 1 kg 1 MAP(METHYL VINYL PHOSPHATE:CAS NO.189177-38-<br>3)(4R-5S-6S-3-DIPHENYLOXY-6-1R-HYDROXYETHYL-4-<br>METHYL-7-OXO-1 2.50 kg
2 DORIPENEM<br>SIDE<br>CHAIN(4-NITROBENZYL(2S-4S)-4-<br>ACETYLTHIO-2-(N-SULFAMOYL-N-(TERT-<br>BUTOXYCARBONOYL)AMINO)PYRRROLIDINE-1) 2.463 kg
Case No. 96 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001084AM20
RA File Number 039404000961 AM20
Licence No and<br>Date 0310834847/13/02/2020
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 item indicating percentage purity from foreign supplier for entire quantity of import.<br>i.<br>Percentage purity of export item.
Case No. 97 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001085AM20

UDIN00181683AM22

RA File Number 039404000960 AM20
Licence No and<br>Date 0310834848/13/02/2020
Norms Committee Decision:
Th Ci idd h d d i didd ll f flli ifi f h fi
e ommttee co nsere te case as per agena an t was ece to ca or oowng normaton rom te rm:
COA of import item indicating percentage purity from foreign supplier for entire quantity of import.<br>i.<br>Percentage purity of export item
Case No. 98 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name YASHO INDUSTRIES LIMITED
Meeting Number NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
and Date
HQ File Number 018205001091AM20
RA File Number 039504001083 AM20
Licence No and 0310834867/14/02/2020
Date
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in
Meeting No.10/82-ALC4/2019 dated 29.11.2019against advance authorization No.0310832689 dated 11.11.2019, it<br>was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:
Export produ ct Qty. Sl. No. Import items Qty.
"
YAPOX CL 3<br>BIS" 2 HYD /10 HYDROQUINONE<br>OXY ETHYL ETHER 1 kg 1 HYDROQUINONE 0.579 kg
( )
2 ETHYLENE CARBONATE 0.934 kg
RA may take appropriate action as per the decision of Norms Committee.

UDIN00181683AM22

Case No. 99 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001095AM20
RA File Number 072404000276 AM20
Licence No and<br>Date 0710116142/18/02/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Complete chemistry, molecular weight, percentage yield , stoichiometric balance of chemical reaction.<br>i.
Case No. 100 / NC/3/MEET/Sep/202122/8 100 / NC/3/MEET/Sep/202122/8 100 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name BALAJI AMINES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001096AM20
RA File Number 318304000151 AM20
Licence No and<br>Date 3110067689/19/02/2020
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in
Meeting No.1/82-ALC4/2019 dated 03.06.2019against advance authorization No.3110067348 dated 11.03.2019, 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<br>Qty. Sl. No. Import items Qty.
N-ETHYL-2-PYRROLIDONE<br>1 kg 1 GAMMA BUTYROLACTONE 0.72 kg
2 MONOETHYLAMINE 70% SOLUTION 0.533 kg

UDIN00181683AM22

Case No. 101 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001097AM20
RA File Number 052404000729 AM20
Licence No and<br>Date 0510413656/19/02/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still<br>awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 102 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001107AM20
RA File Number 342404000272 AM20
Licence No and<br>Date 3410045894/21/02/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 10.08.2020 and 19.11.2020. Reply still<br>awaited from the firm.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 10.08.2020 and 19.11.2020. Reply still awaited from the firm.

UDIN00181683AM22

Case No. Case No. 103 / NC/3/MEET/Sep/202122/8 103 / NC/3/MEET/Sep/202122/8 103 / NC/3/MEET/Sep/202122/8 103 / NC/3/MEET/Sep/202122/8 103 / NC/3/MEET/Sep/202122/8 103 / NC/3/MEET/Sep/202122/8 103 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name GITANJALI CHEMICALS PVT LTD
Meeting Number
and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001101AM20
RA File Number 039404000928 AM20
Licence No and
Date 0310834973/21/02/2020
Norms Committee Decision:
The Committee co<br>dh i nsidered case as per agenda in the presence of the technical experts and it was decided to ratify the<br>d 407 f HBP VlI dil bl lid b fi hih i
a-oc nput output norms uner para . o o. as per etas eow or as appe y rm wcever s<br>less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>4-BROMO ANISOLE<br>1 kg<br>1<br>PHENOL<br>0.728 kg<br>RA concerned may take further necessary action as per above decision of NC.
Export product Qty. Sl. No. Import items Qty.
4-BROMO ANISOLE 1 kg 1 PHENOL 0.728 kg
A concerned may take further necess ary action a s per abov e decision of NC.
C ase No. 104 / NC/3/MEET/Sep/202122/ 8
C ase Status Case Deferred
Party Name ORIENTAL AROMATICS LIMITED
Mti Nb
eeng umer<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001103AM20
RA File Number 039504001082 AM20
Licence No and
<br>Date 0310834955/21/02/2020
Case No. 104 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001103AM20
RA File Number 039504001082 AM20
Licence No and 0310834955/21/02/2020
Date

UDIN00181683AM22

Norms Committee Decision:

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

  • i. Complete chemical reaction with molecular and structural formula and molecular weight and yield.

  • ii. Specific chemical name of the Export Product with molecular weight.

Percentage non volatile material in export product.

Case No. 105 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name AARTI DRUGS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001105AM20
RA File Number 039404000969 AM20
Licence No and<br>Date 0310835028/24/02/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 23.10.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

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

Case No. 106 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name AARTI DRUGS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001106AM20
RA File Number 039404000980 AM20
Licence No and<br>Date 0310835029/24/02/2020
Norms Committee Decision:

UDIN00181683AM22

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

Case No. 107 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name J N P PRODUCTS
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001112AM20
RA File Number 342404000370 AM20
Licence No and<br>Date 3410045901/24/02/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 10.08.2020 and 19.11.2020. Reply still<br>awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 10.08.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 108 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name AARTI DRUGS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001104AM20
RA File Number 039404000970 AM20
Licence No and<br>Date 0310835027/24/02/2020
Norms Committee Decision:

UDIN00181683AM22

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 19.08.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. Case No. Case No. 109 / NC/3/MEET/Sep/202122/8 109 / NC/3/MEET/Sep/202122/8 109 / NC/3/MEET/Sep/202122/8 109 / NC/3/MEET/Sep/202122/8 109 / NC/3/MEET/Sep/202122/8 109 / NC/3/MEET/Sep/202122/8 109 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name BALAJI AMINES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001114AM20
RA File Number 318304000150 AM20
Licence No and<br>Date 3110067697/25/02/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.10/82-ALC4/2018 dated 16.10.2018against advance authorization No.3110067058 dated 21.05.2018, it<br>was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.
<br>whichever is <br>less:
Export product Qty. Sl. No. Import items Qty.
N-METH L-2-PYRROLIDONE 1 kg 1 METHANOL 0370 kg
2 AMMONIA ANHYDROUS 0.160 kg
3 GAMMA BUTYROLACTONE 0.00075 kg
RA may take appropriate action as per the decision of Norms Committee.

UDIN00181683AM22

Case No. 110 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001599AM21
RA File Number 052404000742 AM20
Licence No and<br>Date 0510413763/02/03/2020
Norms Committee Decision:
Deferred for comments of TE.
Case No.<br>111 / NC/3/MEET/Sep/202122/8
Case Status<br>Case Rejected
Party Name<br>VIVIMED LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number<br>018205001122AM20
RA File Number<br>092404000576 AM20
Licence No and<br>Date<br>0910068533/02/03/2020
Norms Committee Decision:
The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm
still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,
5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 23.10.2020. Reply still awaited from the firm.
Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

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

Case No. 112 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name THINQ PHARMA-CRO LIMITED

UDIN00181683AM22

Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001128AM20
RA File Number 039504001105 AM20
Licence No and<br>Date 0310835265/06/03/2020
Norms Committee Decision:
The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm
still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,
5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 07.08.2020 and 19.11.2020. Reply still
awaited from the firm.
Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 07.08.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 113 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001134AM20
RA File Number 039504001128 AM20
Licence No and<br>Date 0310835301/09/03/2020
Norms Committee Decision:
The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm
still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,
5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 10.08.2020 and 23.11.2020. Reply still
awaited from the firm.
Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 10.08.2020 and 23.11.2020. Reply still awaited from the firm.

Case No. 114 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected

UDIN00181683AM22

Party Name ASTEC LIFESCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001138AM20
RA File Number 039404001030 AM20
Licence No and<br>Date 0310835376/12/03/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 10.08.2020 and 19.11.2020. Reply still<br>awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 10.08.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 115 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name YASH RASAYAN & CHEMICALS
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001142AM20
RA File Number 342404000343 AM20
Licence No and<br>Date 3410045953/12/03/2020
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>Complete chemistry, material balance, stoichiometric balance, molecular weight and percentage yield.
Case No. 116 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name SALICYLATES & CHEMICALS PRIVATE LIMITED
Meeting Number NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021

UDIN00181683AM22

and Date
HQ File Number 018205001139AM20
RA File Number 092404000612 AM20
Licence No and<br>Date 0910068573/13/03/2020
Norms Committee Decision:<br>The firm vide e-mail dated 24.11.2020 has informed that they have not utilized the subject Advance Authorization and<br>hence they have surrendered it.<br>In view of above e-mail of firm, the Committee decided towithdrawthe case.
Case No. 117 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name YASH RASAYAN & CHEMICALS
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001143AM20
RA File Number 342404000389 AM20
Licence No and<br>Date 3410045957/13/03/2020
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>Complete chemistry, stoichiometric balance, molecular weight and percentage yield.
Case No. 118 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001154AM20
RA File Number 318304000161 AM20
Licence No and<br>Date 3110067716/17/03/2020

UDIN00181683AM22

Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 10.08.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. Case No. 119 / NC/3/MEET/Sep/202122/8 119 / NC/3/MEET/Sep/202122/8 119 / NC/3/MEET/Sep/202122/8 119 / NC/3/MEET/Sep/202122/8 119 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001146AM20
RA File Number 039404000907 AM20
Licence No and<br>Date 0310835431/17/03/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.4/82-ALC4/2020 dated 18.09.2020against advance authorization No.0310820647 dated 25.04.2018, it<br>was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>METHYL ETHYL KETONE (MEK)<br>0.4732 kg<br>1-[1,6-dimethyl-4-(4-methylpent-3-<br>enyl)-3-cyclohexen-1-yl]ethan-1-one<br>1 kg<br>2<br>MYRCENE<br>0.7265 kg<br>RA may take appropriate action as per the decision of Norms Committee.
Export product Qty. Sl. No. Import items Qty.
1-[1,6-dimethyl-4-(4-methylpent-3-<br>enyl)-3-cyclohexen-1-yl]ethan-1-one 1 kg 1 METHYL ETHYL KETONE (MEK) 0.4732 kg
2 MYRCENE 0.7265 kg
RA may take appropriate action as per the decision of Norms Committee.

UDIN00181683AM22

Case No. 120 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001148AM20
RA File Number 039404001032 AM20
Licence No and<br>Date 0310835439/17/03/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 10.08.2020 and 19.11.2020. Reply still<br>awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 10.08.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 121 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001149AM20
RA File Number 039404001033 AM20
Licence No and<br>Date 0310835441/17/03/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 10.08.2020 and 19.11.2020. Reply still<br>awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 10.08.2020 and 19.11.2020. Reply still awaited from the firm.

UDIN00181683AM22

Case No. Case No. Case No. 122 / NC/3/MEET/Sep/202122/8 122 / NC/3/MEET/Sep/202122/8 122 / NC/3/MEET/Sep/202122/8 122 / NC/3/MEET/Sep/202122/8 122 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001150AM20
RA File Number 039404001050 AM20
Licence No and<br>Date 0310835445/17/03/2020
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<br>as per details given below or as applied by the firm, whichever is less:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Benzocaine and Cetylpyridinium Chloride<br>Anaesthetic Throat Lozenges.<br>Flavours Black Current, Honey Lemon &<br>Other Flavours. Each Lozenge Contains 12mg<br>Benzocaine. Net content of Benzocaine - 61.94<br>Kgs.<br>5161680.000<br>Numbers<br>1<br>Benzocaine<br>63.18 kg<br>2<br>Benzocaine and Cetylpyridinium Chloride<br>Anaesthetic Throat Lozenges.<br>Flavours Black Current and Lime & Lemon<br>and Other Flavours. Each Lozenge contains 10<br>mg Benzocaine. Net content of Benzocaine -<br>40.782 Kgs.<br>4078208.000<br>Numbers<br>2<br>Benzocaine<br>41.60 kg<br>3<br>Benzocaine, Cetylpyridinium Chloride And<br>Dextromethorphan Hydrobromide Anaesthetic<br>Throat Lozenges.<br>Each Lozenge Contains 1.25mg Benzocaine.<br>Net content of Benzocaine - 2.347 Kgs.<br>1877936.000<br>Numbers<br>3<br>Benzocaine<br>2.394 kg<br>4<br>Benzocaine<br>7.48 kg<br>Life Brand Sore Throat & Nasal Congestion<br>Relief Extra Strength<br>(Flavours<br>Cherry/Honey<br>&<br>Lemon/Other<br>4<br>488896.000<br>Numbers<br>5<br>Isomalt ST-M<br>1256.952 kg
Sl.<br>No. Export product Qty. Sl. No. Import items Qty.
1 Benzocaine and Cetylpyridinium Chloride<br>Anaesthetic Throat Lozenges.<br>Flavours Black Current, Honey Lemon &<br>Other Flavours. Each Lozenge Contains 12mg<br>Benzocaine. Net content of Benzocaine - 61.94<br>Kgs. <br> <br> <br> <br>5161680.000<br>Numbers 1 Benzocaine 63.18 kg
2 Benzocaine and Cetylpyridinium Chloride<br>Anaesthetic Throat Lozenges.<br>Flavours Black Current and Lime & Lemon<br>and Other Flavours. Each Lozenge contains 10<br>mg Benzocaine. Net content of Benzocaine -<br>40.782 Kgs. <br> <br> <br> <br>4078208.000<br>Numbers 2 Benzocaine 41.60 kg
3 Benzocaine, Cetylpyridinium Chloride And<br>Dextromethorphan Hydrobromide Anaesthetic<br>Throat Lozenges.<br>Each Lozenge Contains 1.25mg Benzocaine.<br>Net content of Benzocaine - 2.347 Kgs. <br> <br> <br>1877936.000<br>Numbers 3 Benzocaine 2.394 kg
4 Life Brand Sore Throat & Nasal Congestion<br>Relief Extra Strength<br>(Flavours<br>Cherry/Honey<br>&<br>Lemon/Other <br> <br>488896.000<br>Numbers 4 Benzocaine 7.48 kg
5 Isomalt ST-M 1256.952 kg

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flavours) Sugar Free Lozenges. Each Lozenge<br>Contains Bezocaine 15 mg & Isomalt ST-M<br>2571 Mg. Net Content Benzocaine 7.333 Kgs.<br>And Isomalt ST-M - 1256.952 Kgs.<br>6<br>Benzocaine<br>4.76 kg<br>5<br>Personnelle Oral Anesthetic Sore Throat<br>Lozenges Extra Strenght Sugar Free<br>(Flavours<br>Cherry/Honey<br>Lemon/Other<br>flavours) Each Lozenge Contains Bezocaine 15<br>mg & Isomalt ST-M 2571 Mg. Net Content<br>Benzocaine 4.667 Kgs. and Isomalt ST-M -<br>799.89 Kgs.<br>311120.000<br>Numbers<br>7<br>Isomalt ST-M<br>799.89 kg<br>8<br>Benzocaine<br>4.76 kg<br>6<br>Option+Oral Lozenges Sore Throat & Nasal<br>Congestion Relief Extra Strenght (Flavours<br>Cherry/Honey Lemon /Other flavours).<br>Each Lozenge Contains Bezocaine 15 mg &<br>Isomalt<br>ST-M<br>2571<br>Mg.<br>Net<br>Content<br>Benzocaine 4.667 Kgs. And Isomalt ST-M -<br>799.89 Kgs.<br>311120.000<br>Numbers<br>9<br>Isomalt ST-M<br>799.89 kg<br>10<br>Benzocaine<br>4.76 kg<br>7<br>BIOMEDIC ST & NC RELEX Lozenges<br>(Flavours Cherry / Honey Lemon/ Other<br>flavours)<br>Each Lozenge Contains Bezocaine 15 mg &<br>Isomalt<br>ST-M<br>2571<br>Mg.<br>Net<br>Content<br>Benzocaine 4.667 Kgs. and Isomalt ST-M -<br>799.89 Kgs.<br>311120.000<br>Numbers<br>11<br>Isomalt ST-M<br>799.89 kg<br>12<br>Benzocaine<br>4.76 kg<br>8<br>Atoma Sore Throat & Nasal Congestion Relief<br>Extra Strength Lozenges Cherry/Honey &<br>Lemon Flavour.<br>Each Lozenge Contains Bezocaine 15 mg &<br>Isomalt<br>ST-M<br>2571<br>mg.<br>Net<br>Content<br>Benzocaine 4.667 Kgs. and Isomalt ST-M -<br>799.89 Kgs.<br>311120.000<br>Numbers<br>13<br>Isomalt ST-M<br>799.89 kg<br>RA may take appropriate action as per the decision of Norms Committee. flavours) Sugar Free Lozenges. Each Lozenge<br>Contains Bezocaine 15 mg & Isomalt ST-M<br>2571 Mg. Net Content Benzocaine 7.333 Kgs.<br>And Isomalt ST-M - 1256.952 Kgs. <br> <br>
5 Personnelle Oral Anesthetic Sore Throat<br>Lozenges Extra Strenght Sugar Free<br>(Flavours<br>Cherry/Honey<br>Lemon/Other<br>flavours) Each Lozenge Contains Bezocaine 15<br>mg & Isomalt ST-M 2571 Mg. Net Content<br>Benzocaine 4.667 Kgs. and Isomalt ST-M -<br>799.89 Kgs. <br> <br> <br> <br> <br>311120.000<br>Numbers 6 Benzocaine 4.76 kg
7 Isomalt ST-M 799.89 kg
6 Option+Oral Lozenges Sore Throat & Nasal<br>Congestion Relief Extra Strenght (Flavours<br>Cherry/Honey Lemon /Other flavours).<br>Each Lozenge Contains Bezocaine 15 mg &<br>Isomalt<br>ST-M<br>2571<br>Mg.<br>Net<br>Content<br>Benzocaine 4.667 Kgs. And Isomalt ST-M -<br>799.89 Kgs. <br> <br> <br> <br> <br>311120.000<br>Numbers 8 Benzocaine 4.76 kg
9 Isomalt ST-M 799.89 kg
7 BIOMEDIC ST & NC RELEX Lozenges<br>(Flavours Cherry / Honey Lemon/ Other<br>flavours)<br>Each Lozenge Contains Bezocaine 15 mg &<br>Isomalt<br>ST-M<br>2571<br>Mg.<br>Net<br>Content<br>Benzocaine 4.667 Kgs. and Isomalt ST-M -<br>799.89 Kgs. <br> <br> <br> <br> <br>311120.000<br>Numbers 10 Benzocaine 4.76 kg
11 Isomalt ST-M 799.89 kg
8 Atoma Sore Throat & Nasal Congestion Relief<br>Extra Strength Lozenges Cherry/Honey &<br>Lemon Flavour.<br>Each Lozenge Contains Bezocaine 15 mg &<br>Isomalt<br>ST-M<br>2571<br>mg.<br>Net<br>Content<br>Benzocaine 4.667 Kgs. and Isomalt ST-M -<br>799.89 Kgs. <br> <br> <br> <br> <br>311120.000<br>Numbers 12 Benzocaine 4.76 kg
13 Isomalt ST-M 799.89 kg
Case No. 123 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred

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Party Name SRIAM LABS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001155AM20
RA File Number 092404000631 AM20
Licence No and<br>Date 0910068585/18/03/2020
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 124 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name SRIAM LABS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001846AM21
RA File Number 092404000633 AM20
Licence No and<br>Date 0910068584/18/03/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.7/AM21 dated 24.12.2020against advance authorization No.0910050555 dated 30.12.2011, it was<br>decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever<br>is less:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>3, 5-Dihydroxy benzoic acid<br>0.99 kg<br>2<br>Sodium borohydride<br>0.628 kg<br>1,3-Dimethoxy-5-[(E)-2-(4-methoxy phenyl)-<br>1-ethenyl] benzene (BRVT-I)<br>1 kg<br>3<br>Triethylphosphite<br>1.384 kg<br>RA may take appropriate action as per the decision of Norms Committee.

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Case No. 125 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name AARTI DRUGS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001156AM20
RA File Number 039404001042 AM20
Licence No and<br>Date 0310835503/19/03/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 23.10.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC

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

Case No. Case No. 126 / NC/3/MEET/Sep/202122/8 126 / NC/3/MEET/Sep/202122/8 126 / NC/3/MEET/Sep/202122/8 126 / NC/3/MEET/Sep/202122/8 126 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001157AM20
RA File Number 039504001108 AM20
Licence No and<br>Date 0310835505/19/03/2020
Norms Committee Decision:<br>The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the<br>ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Heptanoic Acid<br>0.800 kg<br>Allyl Heptoate AB15013<br>1 kg
Export product Qty. Sl. No. Import items Qty.
Allyl Heptoate AB15013 1 kg 1 Heptanoic Acid 0.800 kg

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2 Allyl Alcohol 0.380 kg

Case No. 127 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name ALTA LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001160AM20
RA File Number 039404001060 AM20
Licence No and<br>Date 0310835521/19/03/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 23.10.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC

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

Case No. 128 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name HIMALAYAN PRODUCTS AND INDUSTRIES CORPN PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001161AM20
RA File Number 052404000774 AM20
Licence No and<br>Date 0510413924/19/03/2020
Norms Committee Decision:<br>The firm has furnished its reply on DGFT Back Office Portal. Deferred for comments of TE

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Case No. 129 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name SWATI MENTHOL AND ALLIED CHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001162AM20
RA File Number 052404000781 AM20
Licence No and<br>Date 0510413938/20/03/2020
Norms Committee Decision:<br>The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the<br>ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Trans<br>Anethole<br>Double<br>Distilled<br>99.6% - 99.8%<br>155200 kg<br>1<br>Anethole<br>(Containing<br>Trans<br>Anethole 99%)<br>156752 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 130 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name ASTRAL STERITECH PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001164AM20
RA File Number 342404000406 AM20
Licence No and<br>Date 3410045972/24/03/2020
Norms Committee Decision:<br>Deferred for comments of TE.

UDIN00181683AM22

Case No. 131 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name ASTRAL STERITECH PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001165AM20
RA File Number 342404000407 AM20
Licence No and<br>Date 3410045973/24/03/2020
Norms Committee Decision:
Deferred for comments of TE.
Case No. 132 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name BHAGWATI INDUSTRIES
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001172AM21
RA File Number 082404000417 AM20
Licence No and<br>Date 0810147573/03/04/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Complete chemistry, molecular weight, percentage yield, stoichiometric balance of chemical reaction.
Case No. 133 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name ATUL LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001174AM21
RA File Number 082404000002 AM21

UDIN00181683AM22

Licence No and 0810147590/09/04/2020 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 7/82-ALC4/2020 dated 04.12.2020 against advance authorization No. 0810144290 dated 10.01.2019 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

|Export Product|Qty.|Sl. No.|Import items|Qty.|
|---|---|---|---|---|
|Amino Methyl Alcohol**(Formulated,**<br>**containing min. 94.7% 2 Amino-2**<br>**Methyl-1 Propanol)**|<br> <br>500000.000 kg|1|2-amino-2-methyl - 1-<br>propanol | AMP-95|473500.000 kg|
Case No. 134 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name ASTRAL STERITECH PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001180AM21
RA File Number 342404000003 AM21
Licence No and<br>Date 3410045982/15/04/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still<br>awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

UDIN00181683AM22

Case No. 135 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name VIVIN DRUGS & PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001183AM21
RA File Number 092404000618 AM20
Licence No and<br>Date 0910068613/16/04/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still<br>awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 136 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name VIVIN DRUGS & PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001181AM21
RA File Number 092404000616 AM20
Licence No and<br>Date 0910068611/16/04/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still<br>awaited from the firm.<br> Hence, the Committee decided torejectthe case.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

UDIN00181683AM22

Case No. 137 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name VIVIN DRUGS & PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001182AM21
RA File Number 092404000617 AM20
Licence No and<br>Date 0910068612/16/04/2020
Norms Committee Decision:
The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm
still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,
5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still
awaited from the firm.
Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 138 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001189AM21
RA File Number 072404000008 AM21
Licence No and<br>Date 0710116344/17/04/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Complete and balanced chemical reactions, molecular weight and percentage yield on molar basis.<br>i.
Justification for lower yield.<br>ii.

UDIN00181683AM22

Production / Consumption data duly certified by Central Excise and GST Authoritities.

Case No. 139 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name MEHTA API PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001191AM21
RA File Number 039504001244 AM20
Licence No and Date 0310835667/18/04/2020
Norms Committee Decision:<br>The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the<br>ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>AZITHROMYCIN/AZITHROMYCIN<br>DIHYDRATE BP/EP/USP<br>1 kg<br>1<br>AZITHROMYCIN<br>AMINE<br>HAVING<br>PURITY NMT 94%<br>1.00 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 140 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name SHREE BANKEY BEHARI LAL FLAVORS
Meeting Number and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001194AM21
RA File Number 052404000005 AM21
Licence No and Date 0510414033/20/04/2020
Norms Committee Decision:<br>The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the<br>ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is<br>less:

The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is less:

UDIN00181683AM22

Export product Qty. Sl. No. Import items Qty.
L-MENTHOL/ ENTHOL 1 k 1 META - CRESOL ABOVE 985% PURE 120 k
<br>(LAVEO)/MEN<br>MENTHOL <br>THOL(L)/LIQUID g . . g
2<br>ISO PROPYL ALCOHOL<br>0.089 kg<br><br>3<br>ARROWZYME/LIPASE AMANO IME<br>0.010 kg 2 ISO PROPYL ALCOHOL 0.089 kg
3 ARROWZYME/LIPASE AMANO IME 0.010 kg
RA concerned may take further necessary action as per above decision of NC.
C N 141 / NC/3/MEET/S/202122/8
ase o. ep
C Stt C Rtd
ase aus ase ejece
Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>d Dt NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
an ae
H Fil Nb 018205001195AM21
Q e umer
RA File Number 052404000010 AM21
Licence No and<br>Date 0510414034/20/04/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 23.10.2020. Reply still awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.
Hence, the Committee decide<br>A concerned may take furthe d torejec<br>r necessa tthe cas<br>ry action e.<br>as per above decision of NC.
C ase No. 142 / NC/3/MEET/Se p/202122/8
Case Status Case Rejected
Party Name VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
MeetingNumber NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021

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

Case No. 142 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
MeetingNumber NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021

UDIN00181683AM22

and Date
HQ File Number 018205001203AM21
RA File Number 039504000017 AM21
Licence No and<br>Date 0310835789/21/04/2020
Norms Committee Decision:
The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm
still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,
5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still
awaited from the firm.
Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

Case No.<br>143 / NC/3/MEET/Sep/202122/8
Case Status<br>Case Approved
Party Name<br>YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number<br>018205001198AM21
RA File Number<br>039504001234 AM20
Licence No and<br>Date<br>0310835751/21/04/2020
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in
Meeting No.3/82-ALC4/2020 dated 07.08.2020against advance authorization No.0310832030 dated 04.10.2019, 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.
ZINC<br>DIBUTYL<br>DITHIOCARBAMATE <br>1 kg 1 ZINC OXIDE 0.180 kg
(ZDBC)
2 DI-BUTYLAMINE 0.576 kg

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3 CARBON DISULPHIDE 0.343 kg

Case No. 144 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001199AM21
RA File Number 039504001231 AM20
Licence No and<br>Date 0310835753/21/04/2020
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 item from foreign supplier indicating Eugenol content.<br>i.<br>Production / Consumption data for last two years duly certified by GST.<br>ii.<br>Catalogue of import item No. 2.
Case No. 145 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001202AM21
RA File Number 092404000027 AM21
Licence No and<br>Date 0910068657/21/04/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information from the firm:

UDIN00181683AM22

Copy of DML for both the Export Items

Case No. 146 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001207AM21
RA File Number 039504001166 AM20
Licence No and<br>Date 0310835813/24/04/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still<br>awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 147 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name ALPHAMED FORMULATIONS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001210AM21
RA File Number 092404000036 AM21
Licence No and<br>Date 0910068668/24/04/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still<br>awaited from the firm.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

UDIN00181683AM22

Case No. 148 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001208AM21
RA File Number 039504000025 AM21
Licence No and<br>Date 0310835832/25/04/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still<br>awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 149 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001213AM21
RA File Number 039404000022 AM21
Licence No and<br>Date 0310835878/25/04/2020
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<br>as per details given below or as applied by the firm, whichever is less:

UDIN00181683AM22

Sl. Export product Qty. Sl. No. Import items Qty.
No.
1 FLUOCINOLONE ACE EAR DROPS <br>50000 1 FLUOCINOLONE 102.00 grams
0.01% 20ML (Fluocinolone Acetonide <br>Number ACETONIDE BP
0.01%) (Net Wt. of FLUOCINOLONE
ACETONIDE BP in 110 Gms.)
2 FLUOCINOLONE ACE SCALP OIL <br>50000 1 FLUOCINOLONE 607.80 grams
0.01% 118ML (Fluocinolone Acetonide <br>Number ACETONIDE BP
0.01%<br>Topical<br>Oil)<br>(Net<br>Wt.<br>of
FLUOCINOLONE ACETONIDE BP in
649 Gms.)
3 FLUOCINOLONE ACE<br>BODY<br>OIL <br>10000 1 FLUOCINOLONE 120.36 grams
0.01% 118ML (Fluocinolone Acetonide <br>Number ACETONIDE BP
0.01% Topical Oil)
(<br>Net<br>Wt.<br>of <br>FLUOCINOLONE
ACETONIDE BP in 129.80 Gms.)
Case No. 150 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name JINDAL DRUGS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001214AM21
RA File Number 039404000003 AM21
Licence No and<br>Date 0310835903/25/04/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Catalogue of import item<br>i.
COA of import item from foreign supplier indicating percentage composition of different fraction.<br>ii.
Quantity and value of other fractions obtained during Fractional Distillation.<br>iii.

UDIN00181683AM22

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

Case No. 151 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name JINDAL DRUGS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001216AM21
RA File Number 039404000005 AM21
Licence No and<br>Date 0310835906/25/04/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Catalogue of import item<br>i.
COA of import item from foreign supplier indicating percentage composition of different fraction.<br>ii.
Quantity and value of other fractions obtained during Fractional Distillation.<br>iii.
Production / Consumption data for last two years duly certified by GST.
Case No.<br>152 / NC/3/MEET/Sep/202122/8 Case No.<br>152 / NC/3/MEET/Sep/202122/8 Case No.<br>152 / NC/3/MEET/Sep/202122/8 Case No.<br>152 / NC/3/MEET/Sep/202122/8
Case Status<br>Case Approved
Party Name<br>J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number<br>018205001224AM21
RA File Number<br>039404000024 AM21
Licence<br>Date No and<br>0310836017/27/04/2020
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:
Sl. Export product Qty. Sl. No. Import items Qty.
Case No.<br>152 / NC/3/MEET/Sep/202122/8 Case No.<br>152 / NC/3/MEET/Sep/202122/8 Case No.<br>152 / NC/3/MEET/Sep/202122/8 Case No.<br>152 / NC/3/MEET/Sep/202122/8
Case Status<br>Case Approved
Party Name<br>J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number<br>018205001224AM21
RA File Number<br>039404000024 AM21
Licence<br>Date No and<br>0310836017/27/04/2020
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:
Sl. Export product Qty. Sl. No. Import items Qty.

UDIN00181683AM22

No.
1 Benzydamine<br>Hydrochloride<br>And<br>Cetylpyridinium<br>Chloride<br>Anti-<br>Inflammatory<br>And<br>Antiseptic<br>Lozenges Sugar Free and all<br>other flavours. Each lozenge contains<br>(i) Benzydamine Hydrochloride-3mg<br>(ii) Cetylpyridinium Chloride- 1.33mg<br>(iii) Isomalt ST-M - 2586mg. Net<br>content (i) 66.67 Kgs (ii) 29.56 Kgs<br>(iii) 57466.67 Kgs 1 Number 1 Benzydamine Hydrochloride 3.06 mg
2 Cetylpyridinium Chloride 1.33 mg
3 Isomalt ST-M 2586.00 mg
2 Benzydamine<br>Hydrochloride,<br>2,4-<br>Dichlorobenzyl<br>Alcohol<br>And<br>Lidocaine Hydrochloride Anaesthetic,<br>Anti-Inflammatory,<br>Anti-Bacterial Lozenges Sugar Free.<br>Each<br>lozenge<br>contains<br>(i)<br>Benzydamine Hydrochloride - 3mg<br>(ii) Isomalt ST-M- 2586mg. Net<br>content (i) 42.67 Kgs. (ii) 36778.67<br>Kg 1 Number 4 Benzydamine Hydrochloride 3.06 mg
5 Isomalt ST-M 2586.00 mg
3 Benzydamine<br>Hydrochloride<br>Anti-<br>Inflammatory Lozenges Sugar Free.<br>Each<br>lozenge<br>contains<br>(i)<br>Benzydamine Hydrochloride- 3mg (ii)<br>Isomalt ST-M - 2586mg. Net content<br>(i) 24 Kgs. (ii) 20688 Kgs. 1 Number 6 Benzydamine Hydrochloride 3.06 mg
7 Isomalt ST-M 2586.00 mg
4 Cetylpyridinium<br>Chloride<br>And<br>Bromhexine Hydrochloride Antiseptic<br>Lozenges Sugar Free and all other<br>flavours.<br>Each<br>lozenge<br>contains<br>(i)<br>Cetylpyridinium Chloride - 1.33mg<br>(ii) Isomalt ST-M - 2586 mg. Net<br>content (i) 5.38 Kg (ii) 10460.14 Kg 1 Number 8 Cetylpyridinium Chloride 1.33 mg
9 Isomalt ST-M 2586.00 mg
5 Cetylpyridinium<br>Chloride<br>And<br>Benzydamine<br>Hydrochloride<br>Antiseptic Lozenges Suger Free.<br>Each<br>lozenge<br>contains<br>(i)<br>Cetylpyridinium Chloride - 1.33mg<br>(ii) Isomalt ST-M - 2586 mg. Net<br>content (i) 5.38 Kg (ii) 10460.14 Kg 1 Number 10 Cetylpyridinium Chloride 1.33 mg
11 Isomalt ST-M 2586.00 mg

UDIN00181683AM22

Case No. Case No. Case No. 153 / NC/3/MEET/Sep/202122/8 153 / NC/3/MEET/Sep/202122/8 153 / NC/3/MEET/Sep/202122/8 153 / NC/3/MEET/Sep/202122/8 153 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001225AM21
RA File Number 039404000023 AM21
Licence No and<br>Date 0310836018/27/04/2020
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<br>as per details given below or as applied by the firm, whichever is less:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Benzydamine Hydrochloride<br>3.06 mg<br>2<br>Cetylpyridinium Chloride<br>1.33 mg<br>1<br>Benzydamine<br>Hydrochloride<br>And Cetylpyridinium Chloride<br>Anti-Inflammatory<br>And<br>Antiseptic Lozenges Sugar Free<br>and all<br>other flavours. Each lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride-3mg<br>(ii)<br>Cetylpyridinium<br>Chloride-<br>1.33mg (iii) Isomalt ST-M -<br>2586mg. Net content (i) 66.67<br>Kgs<br>(ii)<br>29.56<br>Kgs<br>(iii)<br>57466.67 Kgs<br>1 Number<br>3<br>Isomalt ST-M<br>2586.00 mg<br>4<br>Benzydamine Hydrochloride<br>3.06 mg<br>Benzydamine<br>Hydrochloride,<br>2,4-Dichlorobenzyl<br>Alcohol<br>And Lidocaine Hydrochloride<br>Anaesthetic,<br>Anti-<br>2<br>1 Number<br>5<br>Isomalt ST-M<br>2586.00 mg
Sl.<br>No. Export product Qty. Sl. No. Import items Qty.
1 Benzydamine<br>Hydrochloride<br>And Cetylpyridinium Chloride<br>Anti-Inflammatory<br>And<br>Antiseptic Lozenges Sugar Free<br>and all<br>other flavours. Each lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride-3mg<br>(ii)<br>Cetylpyridinium<br>Chloride-<br>1.33mg (iii) Isomalt ST-M -<br>2586mg. Net content (i) 66.67<br>Kgs<br>(ii)<br>29.56<br>Kgs<br>(iii)<br>57466.67 Kgs 1 Number 1 Benzydamine Hydrochloride 3.06 mg
2 Cetylpyridinium Chloride 1.33 mg
3 Isomalt ST-M 2586.00 mg
2 Benzydamine<br>Hydrochloride,<br>2,4-Dichlorobenzyl<br>Alcohol<br>And Lidocaine Hydrochloride<br>Anaesthetic,<br>Anti- 1 Number 4 Benzydamine Hydrochloride 3.06 mg
5 Isomalt ST-M 2586.00 mg

UDIN00181683AM22

Inflammatory,<br>Anti-Bacterial Lozenges Sugar<br>Free. Each lozenge contains (i)<br>Benzydamine Hydrochloride -<br>3mg<br>(ii)<br>Isomalt<br>ST-M-<br>2586mg. Net content (i) 42.67<br>Kgs. (ii) 36778.67 Kg<br>6<br>Benzydamine Hydrochloride<br>3.06 mg<br>3<br>Benzydamine<br>Hydrochloride<br>Anti-Inflammatory<br>Lozenges<br>Sugar Free.<br>Each<br>lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride-<br>3mg<br>(ii)<br>Isomalt<br>ST-M<br>-<br>2586mg. Net content (i) 24 Kgs.<br>(ii) 20688 Kgs.<br>1 Number<br>7<br>Isomalt ST-M<br>2586.00 mg<br>8<br>Cetylpyridinium Chloride<br>1.33 mg<br>4<br>Cetylpyridinium Chloride And<br>Bromhexine<br>Hydrochloride<br>Antiseptic Lozenges Sugar Free<br>and all other flavours.<br>Each<br>lozenge<br>contains<br>(i)<br>Cetylpyridinium<br>Chloride<br>-<br>1.33mg (ii) Isomalt ST-M -<br>2586 mg. Net content (i) 5.38<br>Kg (ii) 10460.14 Kg<br>1 Number<br>9<br>Isomalt ST-M<br>2586.00 mg<br>10<br>Cetylpyridinium Chloride<br>1.33 mg<br>5<br>Cetylpyridinium Chloride And<br>Benzydamine<br>Hydrochloride<br>Antiseptic<br>Lozenges<br>Suger<br>Free.<br>Each<br>lozenge<br>contains<br>(i)<br>Cetylpyridinium<br>Chloride<br>-<br>1.33mg (ii) Isomalt ST-M -<br>2586 mg. Net content (i) 5.38<br>Kg (ii) 10460.14 Kg<br>1 Number<br>11<br>Isomalt ST-M<br>2586.00 mg<br>RA may take appropriate action as per the decision of Norms Committee. Inflammatory,<br>Anti-Bacterial Lozenges Sugar<br>Free. Each lozenge contains (i)<br>Benzydamine Hydrochloride -<br>3mg<br>(ii)<br>Isomalt<br>ST-M-<br>2586mg. Net content (i) 42.67<br>Kgs. (ii) 36778.67 Kg
3 Benzydamine<br>Hydrochloride<br>Anti-Inflammatory<br>Lozenges<br>Sugar Free.<br>Each<br>lozenge<br>contains<br>(i)<br>Benzydamine<br>Hydrochloride-<br>3mg<br>(ii)<br>Isomalt<br>ST-M<br>-<br>2586mg. Net content (i) 24 Kgs.<br>(ii) 20688 Kgs. 1 Number 6 Benzydamine Hydrochloride 3.06 mg
7 Isomalt ST-M 2586.00 mg
4 Cetylpyridinium Chloride And<br>Bromhexine<br>Hydrochloride<br>Antiseptic Lozenges Sugar Free<br>and all other flavours.<br>Each<br>lozenge<br>contains<br>(i)<br>Cetylpyridinium<br>Chloride<br>-<br>1.33mg (ii) Isomalt ST-M -<br>2586 mg. Net content (i) 5.38<br>Kg (ii) 10460.14 Kg 1 Number 8 Cetylpyridinium Chloride 1.33 mg
9 Isomalt ST-M 2586.00 mg
5 Cetylpyridinium Chloride And<br>Benzydamine<br>Hydrochloride<br>Antiseptic<br>Lozenges<br>Suger<br>Free.<br>Each<br>lozenge<br>contains<br>(i)<br>Cetylpyridinium<br>Chloride<br>-<br>1.33mg (ii) Isomalt ST-M -<br>2586 mg. Net content (i) 5.38<br>Kg (ii) 10460.14 Kg 1 Number 10 Cetylpyridinium Chloride 1.33 mg
11 Isomalt ST-M 2586.00 mg
Case No. 154 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name AURORE LIFE SCIENCES PRIVATE LIMITED

UDIN00181683AM22

Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001229AM21
RA File Number 092404000039 AM21
Licence No and<br>Date 0910068685/28/04/2020
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 155 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name ORTIN LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001223AM21
RA File Number 092404000584 AM20
Licence No and<br>Date 0910068680/28/04/2020
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 156 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name AMI ORGANICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001234AM21
RA File Number 522404000005 AM21
Licence No and<br>Date 5210043384/29/04/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.10/82-ALC4/2019 dated 29.11.2019against advance authorization No.5210043197 dated 09.10.2019, it<br>was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. 10/82-ALC4/2019 dated 29.11.2019 against advance authorization No. 5210043197 dated 09.10.2019 , 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:

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Export Product Qty. Sl. No. Import items Qty.
TERT- BUTYL 1-PIPERAZINE <br>1 kg 1 DI -TERT BUTYL DICARBONATE 1.94 kg
CARBOXYLATE (1-BOC PIPERAZINE)
2 PIPERAZINE ANHYDROUS 0.722 kg
Export Product Qty. Sl. No. Import items Qty.
TERT-<br>BUTYL<br>1-PIPERAZINE<br>CARBOXYLATE (1-BOC PIPERAZINE) <br>1 kg 1<br>2 DI -TERT BUTYL DICARBONATE 1.94 kg
PIPERAZINE ANHYDROUS 0.722 kg
RA may take appropriate action as per the decision of Norms Committee.
Case No. 157 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001240AM21
RA File Number 072404000026 AM21
Licence No and<br>Date 0710116403/30/04/2020
Norms Committee Decision:<br>
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against advance authorization No.0710116038 dated<br>17.01.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:
Sl. Export pro duct Qty. Sl. No. Import items Qty.
No.
1 CALCIUM LACTATE GLUCONATE 1 kg 1 LACTIC ACID - ANY GRADE 0.560 kg
2 CALCIUM GLUCONATE 0.686 kg
3 CALCIUM CARBONATE 0.310 kg
Export Product Qty. Sl. No. Import items Qty.
TERT-<br>BUTYL<br>1-PIPERAZINE<br>CARBOXYLATE (1-BOC PIPERAZINE) <br>1 kg 1<br>2 DI -TERT BUTYL DICARBONATE 1.94 kg
PIPERAZINE ANHYDROUS 0.722 kg
RA may take appropriate action as per the decision of Norms Committee.
Case No. 157 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001240AM21
RA File Number 072404000026 AM21
Licence No and<br>Date 0710116403/30/04/2020
Norms Committee Decision:<br>
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021against advance authorization No.0710116038 dated<br>17.01.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:
Sl. Export pro duct Qty. Sl. No. Import items Qty.
No.
1 CALCIUM LACTATE GLUCONATE 1 kg 1 LACTIC ACID - ANY GRADE 0.560 kg
2 CALCIUM GLUCONATE 0.686 kg
3 CALCIUM CARBONATE 0.310 kg

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2<br>FERROUS LACTATE<br>1 kg<br>1<br>LACTIC ACID - ANY GRADE<br>1.028 kg<br>3<br>MAGNESIUM LACTATE<br>1 kg<br>1<br>LACTIC ACID - ANY GRADE<br>1.19 kg<br>4<br>ZINC LACTATE<br>1 kg<br>1<br>LACTIC ACID - ANY GRADE<br>0.990 kg<br>1<br>LACTIC ACID - ANY GRADE<br>0.390 kg<br>5<br>MAGNESIUM LACTATE<br>GLUCONATE<br>1 kg<br>4<br>GLUCONO DELTA LACTONE<br>0.617 kg<br>1<br>LACTIC ACID – ANY GRADE<br>0.922 kg<br>6<br>CALCIUM LACTATE<br>1 kg<br>3<br>CALCIUM CARBONATE<br>0.50 kg<br>RA may take appropriate action as per the decision of Norms Committee. 2 FERROUS LACTATE 1 kg 1 LACTIC ACID - ANY GRADE 1.028 kg
3 MAGNESIUM LACTATE 1 kg 1 LACTIC ACID - ANY GRADE 1.19 kg
4 ZINC LACTATE 1 kg 1 LACTIC ACID - ANY GRADE 0.990 kg
5 MAGNESIUM LACTATE<br>GLUCONATE 1 kg 1 LACTIC ACID - ANY GRADE 0.390 kg
4 GLUCONO DELTA LACTONE 0.617 kg
6 CALCIUM LACTATE 1 kg 1 LACTIC ACID – ANY GRADE 0.922 kg
3 CALCIUM CARBONATE 0.50 kg
Case No. 158 / NC/3/MEET/Sep/202122/8 158 / NC/3/MEET/Sep/202122/8 158 / NC/3/MEET/Sep/202122/8 158 / NC/3/MEET/Sep/202122/8 158 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001241AM21
RA File Number 072404000024 AM21
Licence No and<br>Date 0710116404/30/04/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.7/AM21 dated 24.12.2020against advance authorization No.0710114983 dated 29.05.2019, it was<br>decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever<br>is less:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>CALCIUM<br>GLUCONATE<br>(EP<br>FOR<br>CALCIUM GLUCONATE –<br>1 kg<br>1<br>1.09 kg
Qty. Sl. No. Import items Qty.
<br>1 kg 1 CALCIUM GLUCONATE – 1.09 kg

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INJECTION/JP/ USP) ORAL GRADE
CALCIUM BO ROGLUCONATE 1 kg 1 CALCIUM GLUCONATE –<br>ORAL GRADE 0.946 kg
CALCIUM GLUBIONATE (FOR INJECTION) /<br>CALCIUM GLUBIONATE<br>1 kg<br>1<br>CALCIUM GLUCONATE –<br>ORAL GRADE<br>0.430 kg CALCIUM GLUBIONATE (FOR INJECTION) /<br>CALCIUM GLUBIONATE
<br>1 kg 1 CALCIUM GLUCONATE –<br>ORAL GRADE 0.430 kg
RA may take appropriate action as per the decision of Norms Committee.
Case No. 159 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number an<br> d NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
Date
HQ File Number 018205001242AM21
RA File Number 072404000025 AM21
Licence No and Date 0710116405/30/04/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.7/AM21 dated 24.12.2020against advance authorization No.0710110528 dated 19.10.2016, it was<br>decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever<br>is less:
Sl. No. EXPORT PRODUCT QTY. Sl. No. IMPORT ITEMS QTY.
1. CALCIUM LACTOBIONATE 1 kg 1. CALCIUM CARBONATE 0.172 kg
2. LACTOSE 1.16 kg
2. CALCIU<br>BROMO M<br>LACTOBIONATE 1 kg 1. CALCIUM CARBONATE 0.360 kg
2. LACTOSE 1.021 kg

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3.<br>HYDROBROMIC ACID<br>0.510 kg<br>1.<br>CALCIUM CARBONATE<br>0.140 kg<br>2.<br>LACTOSE<br>0.829 kg<br>3.<br>CALCIUM GLUBIONATE<br>1 kg<br>3.<br>CALCIUM GLUCONATE – ORAL<br>GRADE<br>0.42 kg<br>1.<br>CALCIUM CARBONATE<br>0.234 kg<br>4.<br>LACTOBIONIC ACID<br>1 kg<br>2.<br>LACTOSE<br>1.58 kg<br>RA may take appropriate action as per the decision of Norms Committee. 3. HYDROBROMIC ACID 0.510 kg
3. CALCIUM GLUBIONATE 1 kg 1. CALCIUM CARBONATE 0.140 kg
2. LACTOSE 0.829 kg
3. CALCIUM GLUCONATE – ORAL<br>GRADE <br>0.42 kg
4. LACTOBIONIC ACID 1 kg 1. CALCIUM CARBONATE 0.234 kg
2. LACTOSE 1.58 kg
Case No. Case No. 160 / NC/3/MEET/Sep/202122/8 160 / NC/3/MEET/Sep/202122/8 160 / NC/3/MEET/Sep/202122/8 160 / NC/3/MEET/Sep/202122/8 160 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001245AM21
RA File Number 092404000658 AM20
Licence No and<br>Date 0910068709/01/05/2020
Norms Committee Decision:<br>The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the<br>ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Ertapenem for Injection 1 gram/<br>vial (Net content of the import<br>item is 66.666 Kgs )<br>1 Number<br>1<br>ERTAPENEM<br>SODIUM<br>(Imports<br>and<br>exports are governed by PC 9 dated<br>30.06.2003 as amended)<br>1.10<br>gram
Export product Qty. Sl. No. Import items Qty.
Ertapenem for Injection 1 gram/<br>vial (Net content of the import<br>item is 66.666 Kgs ) <br> <br>1 Number 1 ERTAPENEM<br>SODIUM<br>(Imports<br>and<br>exports are governed by PC 9 dated<br>30.06.2003 as amended) 1.10<br>gram

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Case No. 161 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name OPTRIX LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001249AM21
RA File Number 092404000059 AM21
Licence No and<br>Date 0910068716/01/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still<br>awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 162 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name KUMAR ORGANIC PRODUCTS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001251AM21
RA File Number 072404000030 AM21
Licence No and<br>Date 0710116410/01/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 23.10.2020. Reply still<br>awaited from the firm.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 23.10.2020. Reply still awaited from the firm.

UDIN00181683AM22

Case No. 163 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name REACH GLOBAL INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001244AM21
RA File Number 318304000002 AM21
Licence No and<br>Date 3110067728/01/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 23.10.2020. Reply still<br>awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 23.10.2020. Reply still awaited from the firm.

Case No. 164 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name THINQ PHARMA-CRO LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001255AM21
RA File Number 039504000035 AM21
Licence No and<br>Date 0310836083/04/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,

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

UDIN00181683AM22

5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

Case No. Case No. Case No. 165 / NC/3/MEET/Sep/202122/8 165 / NC/3/MEET/Sep/202122/8 165 / NC/3/MEET/Sep/202122/8 165 / NC/3/MEET/Sep/202122/8 165 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001259AM21
RA File Number 092404000061 AM21
Licence No and<br>Date 0910068725/04/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.15/82/ALC4/2018 dated 22.03.2019against advance authorization No.0510405355 dated 15.01.2018, it<br>was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,<br>whichever is less:<br>Sl. No. Export Product<br>Qty<br>Sl. No. Import Items<br>Qty<br>1<br>Ceftazidime for Injection<br>USP 1 Gram<br>(Net quantity of exproduct<br>312.500 Kgs)<br>1 Number<br>1<br>Ceftazidime for Injection (Bulk Sterile)<br>1.281 gram<br>2<br>Ceftazidime for Injection<br>USP 2 Gram<br>(Net<br>quantity<br>of<br>export<br>product 78.126 Kgs)<br>1 Number<br>1<br>Ceftazidime for Injection (Bulk Sterile)<br>2.562 gram<br>RA may take appropriate action as per the decision of Norms Committee.
Sl. No. Export Product Qty Sl. No. Import Items Qty
1 Ceftazidime for Injection<br>USP 1 Gram<br>(Net quantity of exproduct<br>312.500 Kgs) <br> <br>1 Number 1 Ceftazidime for Injection (Bulk Sterile) 1.281 gram
2 Ceftazidime for Injection<br>USP 2 Gram<br>(Net<br>quantity<br>of<br>export<br>product 78.126 Kgs) <br> <br>1 Number 1 Ceftazidime for Injection (Bulk Sterile) 2.562 gram
RA may take appropriate action as per the decision of Norms Committee.

UDIN00181683AM22

Case No. 166 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name ENCEE AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001260AM21
RA File Number 322404000002 AM21
Licence No and<br>Date 3210079501/05/05/2020
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>Exact chemical name with structural and molecular formula.<br>i.<br>Chemical reaction involved with stoichiometric balance.
Case No. 167 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name AARTI INDUSTRIES LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001268AM21
RA File Number 039404000039 AM21
Licence No and<br>Date 0310836098/05/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 10.08.2020 and 19.11.2020. Reply still<br>awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 10.08.2020 and 19.11.2020. Reply still awaited from the firm.

UDIN00181683AM22

Case No. 168 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001271AM21
RA File Number 072404000032 AM21
Licence No and<br>Date 0710116423/06/05/2020
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 indicating percentage purity of import item from foreign supplier.<br>i.<br>Percentage purity of Export Item.
Case No. Case No. 169 / NC/3/MEET/Sep/202122/8 169 / NC/3/MEET/Sep/202122/8 169 / NC/3/MEET/Sep/202122/8 169 / NC/3/MEET/Sep/202122/8 169 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name SHREE BANKEY BEHARI LAL FLAVORS
Meeting Number and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001283AM21
RA File Number 052404000039 AM21
Licence No and Date 0510414144/11/05/2020
Norms Committee Decision:<br>The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the<br>ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is<br>less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>META - CRESOL ABOVE 98.5% PURE<br>1.20 kg<br>2<br>ISO PROPYL ALCOHOL<br>0.089 kg<br>L-MENTHOL/MENTHOL<br>(LAVEO)/MENTHOL(L)/LIQUID<br>MENTHOL<br>1 kg<br>3<br>ARROWZYME/LIPASE AMANO IME<br>0.010 kg
Export product Qty. Sl. No. Import items Qty.
L-MENTHOL/MENTHOL<br>(LAVEO)/MENTHOL(L)/LIQUID<br>MENTHOL 1 kg 1 META - CRESOL ABOVE 98.5% PURE 1.20 kg
2 ISO PROPYL ALCOHOL 0.089 kg
3 ARROWZYME/LIPASE AMANO IME 0.010 kg

UDIN00181683AM22

Case No. 170 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name OPTRIX LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001285AM21
RA File Number 092404000064 AM21
Licence No and<br>Date 0910068743/12/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still<br>awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 171 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001286AM21
RA File Number 092404000077 AM21
Licence No and<br>Date 0910068744/12/05/2020
Norms Committee Decision:<br>The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the<br>ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is<br>less:

The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is less:

UDIN00181683AM22

Sl. No. Export product Qty. Sl. No. Import items Qty.
1 Aztreonam for Injection USP <br>1 Number 1 Aztreonam and Arginine ( A <br>0.55 gram / vial
500 mg Blend of Sterile Aztreonam
(Contains blend of Sterile 56% and Arginine 44%)
Aztreonam 56% and Arginine Imports and exports governed
44%) (Net quantity of export under PC 9 dated 30.06.2003
product 16.667 Kgs)
2 Aztreonam for Injection USP <br>1 Number 1 Aztreonam and Arginine ( A <br>1.10 gram / vial
1 Gram Blend of Sterile Aztreonam
(Contains blend of Sterile 56% and Arginine 44%)
Aztreonam 56% and Arginine Imports and exports governed
44%) (Net quantity of export under PC 9 dated 30.06.2003
product 66.667 Kgs)
Case No.<br>172 / NC/3/MEET/Sep/202122/8 Case No.<br>172 / NC/3/MEET/Sep/202122/8 Case No.<br>172 / NC/3/MEET/Sep/202122/8
Case Status<br>Case Approved
Party Name<br>BALAJI AMINES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number<br>018205001287AM21
RA File Number<br>318304000004 AM21
Licence No and<br>Date<br>3110067731/12/05/2020
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in
Meeting No.7/82-ALC4/2020 dated 04.12.2020against advance authorization No.3110067809 dated 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:
Export Product Qty. Sl. No. Import items Qty.

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GAMMA BUTYROLACTONE 1 kg 1 1,4 BUTANEDIOL 1.16 kg
2 GBL CATAYLYST 0.001 kg
Case No. 173 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001291AM21
RA File Number 039504000062 AM21
Licence No and<br>Date 0310836183/13/05/2020
Norms Committee Decision:
The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm
still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,
5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still
awaited from the firm.
Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 174 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name MATRIX LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001292AM21
RA File Number 039504000056 AM21
Licence No and<br>Date 0310836184/13/05/2020
Norms Committee Decision:

UDIN00181683AM22

The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is less:

Sl. No. Export Product Qty.
1 Phytosterol Natural Refined Phytosterol 95% 60000 kg
2 Natural Mixed Tocopherol 70% 27500 kg
Sl. No. Import items Qty.
1 Fatty Acid Distillate / Deoderised Distillate 921250 kg
2 Acetone 44000 kg
3 Heptane-S 94050 kg
Case No. 175 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name OLIVE HEALTH CARE
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001295AM21
RA File Number 039504000069 AM21
Licence No and<br>Date 0310836213/15/05/2020
Norms Committee Decision:

UDIN00181683AM22

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 176 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001301AM21
RA File Number 318304000006 AM21
Licence No and<br>Date 3110067737/18/05/2020
Norms Committee Decision:
The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm
still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,
5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still
awaited from the firm.
Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 177 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name INNOVARE LABS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001300AM21
RA File Number 092404000072 AM21
Licence No and<br>Date 0910068763/18/05/2020

UDIN00181683AM22

Norms Committee Decision:

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

Hence, the Committee decided to reject the case.

Case No. 178 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001310AM21
RA File Number 318304000008 AM21
Licence No and<br>Date 3110067739/19/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still<br>awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 179 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name BALAJI AMINES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001311AM21
RA File Number 318304000007 AM21
Licence No and 3110067740/19/05/2020

UDIN00181683AM22

Date

Norms Committee Decision:

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

Quantity of commercial value of Co-products, that is, DMA & TMA.

Case No. 180 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001305AM21
RA File Number 052404000056 AM21
Licence No and<br>Date 0510414210/20/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still<br>awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 181 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name DORF-KETAL CHEMICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001329AM21
RA File Number 039404000085 AM21
Licence No and<br>Date 0310836308/21/05/2020
Norms Committee Decision:

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The firm vide e-mail dated 22.04.2021 has informed that they have redeemed the subject Advance Authorization. Hence, the Committee decided to withdraw the case.

Case No. 182 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001314AM21
RA File Number 318304000009 AM21
Licence No and<br>Date 3110067742/21/05/2020
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 183 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001316AM21
RA File Number 072404000046 AM21
Licence No and<br>Date 0710116483/22/05/2020
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>Percentage purity of import item Magnesium Oxide with its COA.<br>i.<br>As per manufacturing details, there is blending as such the details (such as name and quantity) of items<br>which are blended.<br>ii.<br>Production / Consumption data for last one year duly certified by GST
  • ii. As per manufacturing details, there is blending as such the details (such as name and quantity) of items which are blended.

UDIN00181683AM22

Case No.<br>184 / NC/3/MEET/Sep/202122/8
Case Status<br>Case Rejected
Party Name<br>AMI ORGANICS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number<br>018205001320AM21
RA File Number<br>522404000007 AM21
Licence No and<br>Date<br>5210043401/22/05/2020
Norms Committee Decision:
The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm
still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,
5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.
Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

Case No. 185 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name ALPHAMED FORMULATIONS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001322AM21
RA File Number 092404000632 AM20
Licence No and<br>Date 0910068801/26/05/2020
Norms Committee Decision:
The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm
still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,
5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020 . Reply still
awaited from the firm.
Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020 . Reply still awaited from the firm.

UDIN00181683AM22

Case No. 186 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name BALAJI SPECIALITY CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001321AM21
RA File Number 318304000001 AM21
Licence No and<br>Date 3110067744/26/05/2020
Norms Committee Decision:<br>The Committee considered case as per agenda in the presence of the technical experts and taking into consideration<br>96% yield, it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or<br>as applied by firm whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>MONOETHANOLAMINE<br>1.06 kg<br>ETHYLENE DIAMINE<br>1 kg<br>2<br>AMMONIA ANHYDROUS<br>0.294 kg<br>RA concerned may take further necessary action as per above decision of NC.
Case No.<br> 187 / NC/3/MEET/Sep/202122/8
Case Status<br> Case Rejected
Party Name<br> ALPHAMED FORMULATIONS PRIVATE LIMITED
Meeting Number<br>and Date<br> NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number<br> 018205001330AM21
RA File Number<br> 092404000605 AM20
Licence No and<br>Date<br> 0910068804/27/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020. Reply still awaited from the firm.

UDIN00181683AM22

Case No. 188 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001335AM21
RA File Number 072404000053 AM21
Licence No and<br>Date 0710116510/27/05/2020
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>Percentage purity of import item Magnesium Oxide with its COA.<br>i.<br>As per manufacturing details, there is blending as such the details (such as name and quantity) of items<br>which are blended.<br>ii.<br>Production / Consumption data for last one year duly certified by GST.
  • ii. As per manufacturing details, there is blending as such the details (such as name and quantity) of items which are blended.
Case No. 189 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name DELTA FINOCHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001334AM21
RA File Number 039404000112 AM21
Licence No and<br>Date 0310836419/29/05/2020
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>Molecular weight of each import item and export item.<br>i.

UDIN00181683AM22

ii. Whether IPA is being used as a reactant or solvent, if it is being used as a solvent, than please provide recovery of solvent.

iii. Justification of yield of 75%.

Production / Consumption data duly certified by GST.

Case No. 190 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name SUPERMINT EXPORTS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001336AM21
RA File Number 052404000071 AM21
Licence No and<br>Date 0510414288/29/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still<br>awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 191 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001338AM21
RA File Number 072404000054 AM21
Licence No and<br>Date 0710116526/29/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,

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

UDIN00181683AM22

5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 192 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name AARTI DRUGS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001376AM21
RA File Number 039404001084 AM20
Licence No and<br>Date 0310836635/11/06/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm<br>still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,<br>5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 19.08.2020 and 19.11.2020. Reply still<br>awaited from the firm.<br> Hence, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 19.08.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 193 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name AARTI INDUSTRIES LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001377AM21
RA File Number 039404000119 AM21
Licence No and<br>Date 0310836651/12/06/2020
Norms Committee Decision:

UDIN00181683AM22

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 10.08.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 194 / NC/3/MEET/Sep/202122/8
Case Status Case Rejected
Party Name VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001398AM21
RA File Number 039504000137 AM21
Licence No and<br>Date 0310836741/18/06/2020
Norms Committee Decision:
The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm
still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020,
5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still
awaited from the firm.
Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 2/82-ALC4/2020 dated 10.07.2020, 5/82-ALC4/2020 dated 09.10.2020, followed by Reminder to firm on 18.09.2020 and 19.11.2020. Reply still awaited from the firm.

Case No. 195 / NC/3/MEET/Sep/202122/8 195 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name YASHO INDUSTRIES LIMITED
Meeting Number<br> NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
and Date
HQ File Number 018205001408AM21
RA File Number 039504000168 AM21
Licence No and<br> 0310836789/22/06/2020
Date

UDIN00181683AM22

Norms Committee Decision:

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

Complete COA of import item No. 1 from foreign supplier for entire import indicating percentage content of Eugonol in it.

Case No. 196 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001426AM21
RA File Number 039504000182 AM21
Licence No and<br>Date 0310836907/26/06/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information from the firm:
Complete chemistry with structural formula.<br>i.
Stoichiometric balance on molar basis with percentage yield.<br>ii.
Complete composition of export product.<br>iii.
Production / Consumption data for last two years duly certified by GST.
Case No. 197 / NC/3/MEET/Sep/202122/8
Case Status Case Approved
Party Name YASHO INDUSTRIES LIMITED
Meeting Number and<br>Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001427AM21
RA File Number 039504000178 AM21
Licence No and Date 0310836909/26/06/2020
Norms Committee Decision:
The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the
ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is

The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is

UDIN00181683AM22

less:

Export product Qty. Sl. No. Import items Qty.
ZINC DIMETHACRYLATE(ZDMA) 1 kg 1 METHACRYLIC ACID 0.770 kg
2 ZINC OXIDE 0.364 kg
Case No. 198 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001432AM21
RA File Number 039504000198 AM21
Licence No and<br>Date 0310836938/29/06/2020
Norms Committee Decision:<br>Deferred for comments of TE.
Case No. 199 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name SHIRDI CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001433AM21
RA File Number 039504000196 AM21
Licence No and<br>Date 0310836944/30/06/2020
Norms Committee Decision:

UDIN00181683AM22

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

i. Complete technical details as per Annexure to Appendix 4E. ii. Molecular weight, yield, Stoichiometric balance.

Case No. 200 / NC/3/MEET/Sep/202122/8
Case Status Case Deferred
Party Name INNOVARE LABS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Sep/ 202122/ 8 and 24/09/2021
HQ File Number 018205001770AM21
RA File Number 262404000018 AM21
Licence No and<br>Date 2610012921/20/10/2020
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.

Meeting ended with thanks to Chair and participants


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