IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2024-03-22

DGFT Committee Minutes

Document text

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Government of India / भारत सरकार

Ministry of Commerce and Industry / वािणज्य और उद्योग मंत्रालय Department of Commerce / वािणज्य िवभाग Directorate General of Foreign Trade, Delhi / िवदेश व्यापार महािनदेशालय, िदल्ली

VANIJYA BHAWAN, AKBAR ROAD, CENTRAL DELHI, DELHI, 110011 / वािणज्य भवन, अकबर रोड, नई िदल्ली Email Office : dgft@nic.in , Phone Office : 011-23062777

(DES - III SECTION)

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Mar/202324/26 DATED: 22/03/2024

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.

  • IV. RAs shall also ensure compliance of SION General Notes and Chapter Notes wherever applicable.

  • V. RAs shall ensure that authorization is issued or redeemed based on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less. In this regard full compliance of the provisions of Para 4.12 of FTP, Para 4.16; Para 4.21; and Para 4.51 of HBP shall be made.

Meeting No. NC/3/MEET/Mar/202324/26 dated 22/03/2024 of Norms Committee - III for the year 2023-24 was held on 22/03/2024 under the Chairmanship of Rakesh Kumar,Additional DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2023.

The following members were present in the meeting:-

S.No. Name and Designation of Representatives Department

1 This document has been digitally signed by Raman Kumar, Deputy DGFT on 25-04-2024 11:42:40.

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1 Rakesh Kumar, Addl. DGFT DGFT(HQ)
2 Raman Kumar,Deputy DGFT DGFT(HQ)
3 NAND Lal,Technical Consultant DPIIT
4 SHAISH KUMAR,Technical Consultant DGFT
5 DINESHNARAIN MATHUR,Technical<br>Consultant DGFT
6 Nand Lal,Technical Consultant DGFT
7 Uttam Dey Sarkar, ASO Directorate General of Foreign Trade, Delhi

2 This document has been digitally signed by Raman Kumar, Deputy DGFT on 25-04-2024 11:42:40.

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Case Details and Decision(s):

Case No. 1 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008231AM24
RA File Number NA
Licence No and<br>Date NA
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. Case No. 2 / NC/3/MEET/Mar/202324/26 2 / NC/3/MEET/Mar/202324/26 2 / NC/3/MEET/Mar/202324/26 2 / NC/3/MEET/Mar/202324/26 2 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name ZYDUS LIFESCIENCES LIMITED
Meeting Number and<br>Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008565AM24
RA File Number NA
Licence No and Date NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jan/202324/20 dated 18/01/2024against advance<br>authorizationNo.0811007464 dated 07/03/2023, it was decided to fix ad-hoc 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>Export Product<br>Qty.<br>Sl. No.Import Items<br>Qty. allowed.<br>1<br>MEMANTINE<br>HYDROCHLORIDE<br>USP<br>7.14 mg.<br>2<br>SUGAR SPHERES (NON-PAREIL)<br>NF<br>30.60 mg.<br>3<br>HYPROMELLOSE 5 CPS 2910 USP<br>3.824 mg.<br>4<br>HYPROMELLOSE 3 CPS 2910 USP<br>3.06 mg.<br>MEMANTINE<br>HYDROCHLORIDE EXTENDED<br>RELEASE CAPSULES 7 MG<br>((ACTIVE PHARMACEUTICAL<br>INGREDIENT: MEMANTINE<br>HYDROCHLORIDE USP))<br>1 Number
Export Product Qty. Sl. No. Import Items Qty. allowed.
MEMANTINE<br>HYDROCHLORIDE EXTENDED<br>RELEASE CAPSULES 7 MG<br>((ACTIVE PHARMACEUTICAL<br>INGREDIENT: MEMANTINE<br>HYDROCHLORIDE USP)) 1 Number 1<br> <br> MEMANTINE<br>HYDROCHLORIDE<br>USP <br>7.14 mg.
2<br> <br> SUGAR SPHERES (NON-PAREIL)<br>NF <br>30.60 mg.
3<br> HYPROMELLOSE 5 CPS 2910 USP 3.824 mg.
4<br> HYPROMELLOSE 3 CPS 2910 USP 3.06 mg.
Case No. Case No. 2 / NC/3/MEET/Mar/202324/26 2 / NC/3/MEET/Mar/202324/26 2 / NC/3/MEET/Mar/202324/26 2 / NC/3/MEET/Mar/202324/26 2 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name ZYDUS LIFESCIENCES LIMITED
Meeting Number and<br>Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008565AM24
RA File Number NA
Licence No and Date NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jan/202324/20 dated 18/01/2024against advance<br>authorizationNo.0811007464 dated 07/03/2023, it was decided to fix ad-hoc 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>Export Product<br>Qty.<br>Sl. No.Import Items<br>Qty. allowed.<br>1<br>MEMANTINE<br>HYDROCHLORIDE<br>USP<br>7.14 mg.<br>2<br>SUGAR SPHERES (NON-PAREIL)<br>NF<br>30.60 mg.<br>3<br>HYPROMELLOSE 5 CPS 2910 USP<br>3.824 mg.<br>4<br>HYPROMELLOSE 3 CPS 2910 USP<br>3.06 mg.<br>MEMANTINE<br>HYDROCHLORIDE EXTENDED<br>RELEASE CAPSULES 7 MG<br>((ACTIVE PHARMACEUTICAL<br>INGREDIENT: MEMANTINE<br>HYDROCHLORIDE USP))<br>1 Number
Export Product Qty. Sl. No. Import Items Qty. allowed.
MEMANTINE<br>HYDROCHLORIDE EXTENDED<br>RELEASE CAPSULES 7 MG<br>((ACTIVE PHARMACEUTICAL<br>INGREDIENT: MEMANTINE<br>HYDROCHLORIDE USP)) 1 Number 1<br> <br> MEMANTINE<br>HYDROCHLORIDE<br>USP <br>7.14 mg.
2<br> <br> SUGAR SPHERES (NON-PAREIL)<br>NF <br>30.60 mg.
3<br> HYPROMELLOSE 5 CPS 2910 USP 3.824 mg.
4<br> HYPROMELLOSE 3 CPS 2910 USP 3.06 mg.

This document has been digitally signed by Raman Kumar, Deputy DGFT on 25-04-2024 11:42:40.

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5<br> TRIETHYL CITRATE NF 0.829 mg.
6<br> TALC PH EUR/USP 1.594 mg.
MEMANTINE<br>HYDROCHLORIDE EXTENDED<br>RELEASE CAPSULES 14 MG<br>((ACTIVE PHARMACEUTICAL<br>INGREDIENT: MEMANTINE<br>HYDROCHLORIDE USP)) 1 Number 7<br> <br> MEMANTINE<br>HYDROCHLORIDE<br>USP <br>14.28 mg.
8<br> <br> SUGAR SPHERES (NON-PAREIL)<br>NF <br>61.20 mg.
9<br> HYPROMELLOSE 5 CPS 2910 USP 7.648 mg.
10<br> HYPROMELLOSE 3 CPS 2910 USP 6.12 mg.
11<br> TRIETHYL CITRATE NF 1.658 mg.
12<br> TALC PH EUR/USP 3.188 mg.
MEMANTINE<br>HYDROCHLORIDE EXTENDED<br>RELEASE CAPSULES 21 MG<br>((ACTIVE PHARMACEUTICAL<br>INGREDIENT: MEMANTINE<br>HYDROCHLORIDE USP)) 1 Number 13<br> <br> MEMANTINE<br>HYDROCHLORIDE<br>USP <br>21.42 mg.
14<br> <br> SUGAR SPHERES (NON-PAREIL)<br>NF <br>91.80 mg.
15<br> HYPROMELLOSE 5 CPS 2910 USP 11.472 mg.
16<br> HYPROMELLOSE 3 CPS 2910 USP 9.18 mg.
17<br> TRIETHYL CITRATE NF 2.487 mg.
18<br> TALC PH EUR/USP 4.782 mg.
MEMANTINE<br>HYDROCHLORIDE EXTENDED<br>RELEASE CAPSULES 28 MG<br>((ACTIVE PHARMACEUTICAL<br>INGREDIENT: MEMANTINE<br>HYDROCHLORIDE USP)) 1 Number 19<br> <br> MEMANTINE<br>HYDROCHLORIDE<br>USP <br>28.56 mg.
20<br> <br> SUGAR SPHERES (NON-PAREIL)<br>NF <br>122.40 mg.
21<br> HYPROMELLOSE 5 CPS 2910 USP 15.296 mg.

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22<br>HYPROMELLOSE 3 CPS 2910 USP<br>12.24 mg.<br>23<br>TRIETHYL CITRATE NF<br>3.316 mg.<br>24<br>TALC PH EUR/USP<br>6.376 mg.<br>25<br>MEMANTINE<br>HYDROCHLORIDE<br>USP<br>5.10 mg.<br>26<br>TALC PH EUR/USP<br>1.02 mg.<br>27<br>CROSCARMELLOSE SODIUM NF<br>5.61 mg.<br>28<br>DIBASIC CALCIUM PHOSPHATE<br>DIHYDRATE USP<br>73.95 mg.<br>MEMANTINE<br>HYDROCHLORIDE TABLETS 5<br>MG ((ACTIVE<br>PHARMACEUTICAL<br>INGREDIENT: MEMANTINE<br>HYDROCHLORIDE USP))<br>1 Number<br>29<br>MAGNESIUM<br>STEARATE<br>PH.E/NF/JP<br>1.02 mg.<br>30<br>MEMANTINE<br>HYDROCHLORIDE<br>USP<br>10.20 mg.<br>31<br>TALC PH EUR/USP<br>2.04 mg.<br>32<br>CROSCARMELLOSE SODIUM NF<br>11.22 mg.<br>33<br>DIBASIC CALCIUM PHOSPHATE<br>DIHYDRATE USP<br>147.90 mg.<br>MEMANTINE<br>HYDROCHLORIDE TABLETS 10<br>MG ((ACTIVE<br>PHARMACEUTICAL<br>INGREDIENT: MEMANTINE<br>HYDROCHLORIDE USP))<br>1 Number<br>34<br>MAGNESIUM<br>STEARATE<br>PH.E/NF/JP<br>2.04 mg.<br>RA concerned may take further necessary action as per above decision of NC. 22<br> HYPROMELLOSE 3 CPS 2910 USP 12.24 mg.
23<br> TRIETHYL CITRATE NF 3.316 mg.
24<br> TALC PH EUR/USP 6.376 mg.
MEMANTINE<br>HYDROCHLORIDE TABLETS 5<br>MG ((ACTIVE<br>PHARMACEUTICAL<br>INGREDIENT: MEMANTINE<br>HYDROCHLORIDE USP)) 1 Number 25<br> <br> MEMANTINE<br>HYDROCHLORIDE<br>USP <br>5.10 mg.
26<br> TALC PH EUR/USP 1.02 mg.
27<br> CROSCARMELLOSE SODIUM NF 5.61 mg.
28<br> <br> DIBASIC CALCIUM PHOSPHATE<br>DIHYDRATE USP <br>73.95 mg.
29<br> <br> MAGNESIUM<br>STEARATE<br>PH.E/NF/JP <br>1.02 mg.
MEMANTINE<br>HYDROCHLORIDE TABLETS 10<br>MG ((ACTIVE<br>PHARMACEUTICAL<br>INGREDIENT: MEMANTINE<br>HYDROCHLORIDE USP)) 1 Number 30<br> <br> MEMANTINE<br>HYDROCHLORIDE<br>USP <br>10.20 mg.
31<br> TALC PH EUR/USP 2.04 mg.
32<br> CROSCARMELLOSE SODIUM NF 11.22 mg.
33<br> <br> DIBASIC CALCIUM PHOSPHATE<br>DIHYDRATE USP <br>147.90 mg.
34<br> <br> MAGNESIUM<br>STEARATE<br>PH.E/NF/JP <br>2.04 mg.

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

Case No. 3 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred

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Party Name MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008586AM24
RA File Number NA
Licence No and<br>Date NA
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 4 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name GULSHAN POLYOLS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008806AM24
RA File Number NA
Licence No and<br>Date NA
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it<br>was decided to call for following information/documents from the firm:-<br>Complete calculation for the requirement of Export item from yellow maize.<br>1.<br>To fill Annexure to Appendix-4E for the both imported and indigenous items.<br>2.<br>The value of by-product obtained during the process with evidence.<br>3.<br>Certificate of Analysis (CoA) report of Yellow Maize indicating moisture content in it.<br>4.<br>Production/Consumption data enclosed with the application, indicates consumption of 1.4 MT/MT of<br>production of Sorbitol 70% whereas in application ratio has been indicated as 1.00 MT/MT.<br>5.<br>Norms fixed in the past, if any, by the Norms Committee.<br>6.
  1. Production/Consumption data enclosed with the application, indicates consumption of 1.4 MT/MT of production of Sorbitol 70% whereas in application ratio has been indicated as 1.00 MT/MT.
Case No. 5 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name AMI ORGANICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM REVIW00000095AM24
RA File Number 522404000013 AM21
Licence No and 5210043424/08/06/2020

6 This document has been digitally signed by Raman Kumar, Deputy DGFT on 25-04-2024 11:42:40.

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Date

Norms Committee Decision:

The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:-

  1. To give proper chemistry as per the inputs requested for.

  2. Complete justification for higher norms asked for, making the revised quantity.

  3. Stoichiometric Material balance on a molar basis.

  4. Production/Consumption date for the last three years durly certified by CA

  5. End use of export product.

Case No. 6 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name VINYL PRODUCTS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM REVIW00008920AM24
RA File Number 05AX04002728 AM23
Licence No and<br>Date 0511016407/15/12/2022
Norms Committee Decision:<br>Decision :The Committee considered the request of applicant for correction of export description and on the basis<br>of request, the Committee deliberately felt that there was a typographical error in the export description, therefore,<br>it was decided to correct the description of export product as per license:<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>PURE TERA PHTHALIC ACID<br>0.447 kg.<br>PHTHALATE (PVC)<br>PLASTICIZER(DOTP)<br>1 kg.<br>2<br>2 ETHYL HEXANOL<br>0.680 kg.<br>RA concerned may take further necessary action as per above decision of NC.

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Case No. 7 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name LACTOSE (INDIA) LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM REVIW00008977AM24
RA File Number 03AX04005338 AM23
Licence No and<br>Date 0311021031/30/01/2023
Norms Committee Decision:<br>**Decision :**The Committee considered the request of firm for review of ad-hoc norms and on the basis of information<br>provided by the firm, it was decided to revise ad-hoc norms as under:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>LACTULOSE<br>CONCENTRATE<br>USP/EP/LACTULOSE<br>SOLUTION<br>USP/EP/LACTULOSE FOOD GRADE<br>(Assy not less than 95%)<br>1 kg.<br>1<br>Food Grade Lactose/ Edible<br>Grade Lactose/ Refined Edible<br>Grade Lactose / Lactose<br>Monohydrate BP/EP/USP-NF /<br>Lactose 100 Mesh<br>1.00 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No.<br> 8 / NC/3/MEET/Mar/202324/26
Case Status<br> Case Deferred
Party Name<br> USV PRIVATE LIMITED
Meeting Number<br>and Date<br> NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number<br> HQRNORM REVIW00008930AM24
RA File Number<br> 03AX04003005 AM24
Licence No and<br>Date<br> 0311027533/03/10/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

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Case No. 9 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name UNIMAX LABORATORIES
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007665AM24
RA File Number 05AX04002801 AM24
Licence No and<br>Date 0511022533/01/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Amoxicillin Capsules BP, 500<br>mg(Each Capsules contains<br>Amoxicillin BP (As Trihydrate))<br>1 Number<br>1<br>Amoxicillin Trihydrate BP<br>585.28 mg/Capsule<br>Amoxicillin Tablets USP, 1000<br>mg(Each Tablet contains<br>Amoxicillin USP (As Trihydrate))<br>1 Number<br>2<br>Amoxicillin Trihydrate USP<br>1170.55 mg/Tablet<br>Note: The RA to examiene xport item description in Shipping Bill whether the term “ Trihydrate” appears or<br>not. The above wastage shall be allowed with the condition that “Trihydrate) is mentioned in Export Product.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 10 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name ZEOLITES AND ALLIED PRODUCTS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007666AM24
RA File Number 03AX04004399 AM24
Licence No and<br>Date 0311029806/01/01/2024
Norms Committee Decision:

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The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Feb/202324/23 dated 19/02/2024 against advance authorization No.0311028138 dated 25/10/2023 , it was decided to fix ad-hoc 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. allowed.
Cyclopentanone(CAS No. 120- 92-3) 1 kg. 1 Adipic Acid 1.93 kg.
Case No. 11 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name USV PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007667AM24
RA File Number 03AX04004448 AM24
Licence No and<br>Date 0311029807/01/01/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 12 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name NAPROD LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007671AM24
RA File Number 03AX04004482 AM24
Licence No and<br>Date 0311029813/01/01/2024
Norms Committee Decision:

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The Committee considered the case as per agenda and it was decided to fix ad-hoc 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. allowed.
Fluorouracil INJ BP 1000 MG/20 ML 1 Vial 1 Fluorouracil IP/BP 1050 mg/Vial
Case No. 13 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name TRANSPEK INDUSTRY LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007693AM24
RA File Number 34AX04000716 AM24
Licence No and<br>Date 3411004490/02/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>ISONONANOYL CHLORIDE<br>1 kg.<br>1<br>ISONONANOIC ACID<br>0.942 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 14 / NC/3/MEET/Mar/202324/26

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Case Status Case Approved
Party Name HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007697AM24
RA File Number 03AX04004502 AM24
Licence No and<br>Date 0311029840/03/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Feb/202324/24 dated 05/03/2024against advance<br>authorizationNo.0311014263 dated 29/04/2022, it was decided to fix ad-hoc 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>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Sacubitril+Calcium<br>(Sacubitril Calcium)<br>1 kg.<br>1<br>2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-<br>butoxycarbonyl)amino)-2-methylpentanoic acid<br>(BMPA)<br>1.237 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 15 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007698AM24
RA File Number 03AX04004501 AM24
Licence No and<br>Date 0311029842/03/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Feb/202324/24 dated 05/03/2024against advance<br>authorizationNo.0311014263 dated 29/04/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>as per details given below or as applied by the firm, whichever is less:-

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Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Sacubitril+Calcium<br>(Sacubitril Calcium)<br>1 kg.<br>1<br>2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-<br>butoxycarbonyl)amino)-2-methylpentanoic acid<br>(BMPA)<br>1.237 kg.<br>RA concerned may take further necessary action as per above decision of NC. Export Product Qty. Sl. No. Import Items Qty. allowed.
Sacubitril+Calcium<br>(Sacubitril Calcium) 1 kg. 1 2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-<br>butoxycarbonyl)amino)-2-methylpentanoic acid<br>(BMPA) 1.237 kg.
Case No. 16 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name AARTI INDUSTRIES LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007699AM24
RA File Number 03AX04004508 AM24
Licence No and<br>Date 0311029843/03/01/2024
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it<br>was decided to call for following information/documents from the firm:-<br>Stoichiometic material balance on a molar basis.<br>1.<br>Calculation for the requirement of input chemicals indicating justification of wastage.<br>2.<br>End use of export item.<br>3.
Case No. 17 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007702AM24
RA File Number 03AX04003989 AM24
Licence No and<br>Date 0311029847/03/01/2024
Norms Committee Decision:

13

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The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:-

  • i. End use of the export product.

  • ii. Step wise manufacturing process.

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

  • iv. Complete technical details as per Annexure to Appendix 4E for chemical products.

  • v. Stoichiometric balance between import and export on molar basis.

  • vi. Details of indigenous input with quantity.

Case No. 18 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name BILCARE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007714AM24
RA File Number 31AX04000266 AM24
Licence No and<br>Date 3111002947/03/01/2024
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it<br>was decided to call for following information/documents from the firm:-<br>Annexure to Appendix-4E with chemical reaction and flow chart.
Case No. 19 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name CIPLA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007715AM24
RA File Number 03AX04004142 AM24
Licence No and<br>Date 0311029863/03/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jun/202324/6 dated 14/06/2023against advance authorization

14 This document has been digitally signed by Raman Kumar, Deputy DGFT on 25-04-2024 11:42:40.

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No.0311021534 dated 17/02/2023 , it was decided to fix ad-hoc 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. allowed.
Testosterone Topical Solution 30mg /<br>1.5 ml Pack Size 110ml (Each<br>Actuation delivers : Testosterone USP<br>30mg Also contains Alcohol USP<br>Approx. 49.55% w/v (QS to 100%<br>w/v)) 59000<br>Numbers 1 Testosterone USP 112.1 kg.
2 Alcohol (Ethanol 95% v/v) 3215.5 kg.
Case No. Case No. 20 / NC/3/MEET/Mar/202324/26 20 / NC/3/MEET/Mar/202324/26 20 / NC/3/MEET/Mar/202324/26 20 / NC/3/MEET/Mar/202324/26 20 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007722AM24
RA File Number 05AX04003154 AM24
Licence No and<br>Date 0511023042/03/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Dec/202223/15 dated 29/12/2022against advance authorization<br>No.0511014015 dated 28/07/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Cyclomed Eye Drops 1% 5ml<br>(Each ml contains 10 mg of Cyclopentolate<br>Hydochloride)<br>1 Pack<br>1<br>Cyclopentolate HCL<br>51.00 mg.
Export Product Qty. Sl. No. Import Items Qty. allowed.
Cyclomed Eye Drops 1% 5ml<br>(Each ml contains 10 mg of Cyclopentolate<br>Hydochloride) 1 Pack 1 Cyclopentolate HCL 51.00 mg.

15

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Case No. 21 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007728AM24
RA File Number 09AX04000875 AM24
Licence No and<br>Date 0911006481/03/01/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 22 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name ALPHAMED FORMULATIONS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007770AM24
RA File Number 09AX04000867 AM24
Licence No and<br>Date 0911006493/05/01/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 23 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007772AM24

16 This document has been digitally signed by Raman Kumar, Deputy DGFT on 25-04-2024 11:42:40.

UDIN00057719AM25

RA File Number 09AX04000883 AM24
Licence No and<br>Date 0911006495/05/01/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. Case No. 24 / NC/3/MEET/Mar/202324/26 24 / NC/3/MEET/Mar/202324/26 24 / NC/3/MEET/Mar/202324/26 24 / NC/3/MEET/Mar/202324/26 24 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name ALCHEMIE FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007782AM24
RA File Number 03AX04004420 AM24
Licence No and<br>Date 0311029946/06/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/May/202324/4 dated 26/05/2023against advance authorization<br>No.0311020895 dated 23/01/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>ORTHOTOLUIDINE<br>0.834 kg.<br>N,ETHYL ORTHOTOLUIDINE<br>1kg.<br>2<br>DENATURED ETHYL<br>ALCOHOL<br>0.358 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Export Product Qty. Sl. No. Import Items Qty. allowed.
N,ETHYL ORTHOTOLUIDINE 1kg. 1 ORTHOTOLUIDINE 0.834 kg.
2 DENATURED ETHYL<br>ALCOHOL 0.358 kg.
decision of NC.
Case No. 25 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name TORRENT PHARMACEUTICALS LTD
MeetingNumber NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024

17

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and Date
HQ File Number HQRNORM APPLY 00007828AM24
RA File Number 08AX04001867 AM24
Licence No and<br>Date 0811010468/09/01/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. Case No. 26 / NC/3/MEET/Mar/202324/26 26 / NC/3/MEET/Mar/202324/26 26 / NC/3/MEET/Mar/202324/26 26 / NC/3/MEET/Mar/202324/26 26 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007829AM24
RA File Number 08AX04001863 AM24
Licence No and<br>Date 0811010469/09/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Opipramol Dihydrochloride<br>Tablets 50 MG (OPIPRAMOL<br>HEUMANN 50 MG) Each film<br>coated tablet contains: Opipramol<br>Dihydrochloride 50 mg<br>Excipients....q.s. Net content of<br>active ingredient Opipramol<br>Dihydrochloride should not be<br>less than 80.00 kgs in export<br>product.<br>1 Number<br>1<br>Opipramol Dihydrochloride<br>51 mg/Tablet<br>Opipramol Dihydrochloride<br>Tablets 100 MG (OPIPRAMOL<br>HEUMANN 100 MG) Each film<br>coated tablet contains: Opipramol<br>Dihydrochloride 100 mg<br>Excipients....q.s. Net content of<br>1 Number<br>2<br>Opipramol Dihydrochloride<br>102 mg/Tablet
Export Product Qty. Sl. No. Import Items Qty. allowed.
Opipramol Dihydrochloride<br>Tablets 50 MG (OPIPRAMOL<br>HEUMANN 50 MG) Each film<br>coated tablet contains: Opipramol<br>Dihydrochloride 50 mg<br>Excipients....q.s. Net content of<br>active ingredient Opipramol<br>Dihydrochloride should not be<br>less than 80.00 kgs in export<br>product. 1 Number 1 Opipramol Dihydrochloride 51 mg/Tablet
Opipramol Dihydrochloride<br>Tablets 100 MG (OPIPRAMOL<br>HEUMANN 100 MG) Each film<br>coated tablet contains: Opipramol<br>Dihydrochloride 100 mg<br>Excipients....q.s. Net content of 1 Number 2 Opipramol Dihydrochloride 102 mg/Tablet
Case No. Case No. 26 / NC/3/MEET/Mar/202324/26 26 / NC/3/MEET/Mar/202324/26 26 / NC/3/MEET/Mar/202324/26 26 / NC/3/MEET/Mar/202324/26 26 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007829AM24
RA File Number 08AX04001863 AM24
Licence No and<br>Date 0811010469/09/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Opipramol Dihydrochloride<br>Tablets 50 MG (OPIPRAMOL<br>HEUMANN 50 MG) Each film<br>coated tablet contains: Opipramol<br>Dihydrochloride 50 mg<br>Excipients....q.s. Net content of<br>active ingredient Opipramol<br>Dihydrochloride should not be<br>less than 80.00 kgs in export<br>product.<br>1 Number<br>1<br>Opipramol Dihydrochloride<br>51 mg/Tablet<br>Opipramol Dihydrochloride<br>Tablets 100 MG (OPIPRAMOL<br>HEUMANN 100 MG) Each film<br>coated tablet contains: Opipramol<br>Dihydrochloride 100 mg<br>Excipients....q.s. Net content of<br>1 Number<br>2<br>Opipramol Dihydrochloride<br>102 mg/Tablet
Export Product Qty. Sl. No. Import Items Qty. allowed.
Opipramol Dihydrochloride<br>Tablets 50 MG (OPIPRAMOL<br>HEUMANN 50 MG) Each film<br>coated tablet contains: Opipramol<br>Dihydrochloride 50 mg<br>Excipients....q.s. Net content of<br>active ingredient Opipramol<br>Dihydrochloride should not be<br>less than 80.00 kgs in export<br>product. 1 Number 1 Opipramol Dihydrochloride 51 mg/Tablet
Opipramol Dihydrochloride<br>Tablets 100 MG (OPIPRAMOL<br>HEUMANN 100 MG) Each film<br>coated tablet contains: Opipramol<br>Dihydrochloride 100 mg<br>Excipients....q.s. Net content of 1 Number 2 Opipramol Dihydrochloride 102 mg/Tablet

18

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active ingredient Opipramol Dihydrochloride should not be less than 109.000 kgs in export product.

Case No.<br>Case Status<br>Party Name<br>Meeting Number and Date 27 / NC/3/MEET/Mar/202324/26<br>Case Approved<br>TORRENT PHARMACEUTICALS LTD<br> NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007830AM24
RA File Number 08AX04001864 AM24
Licence No and Date 0811010470/09/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>CINNARIZINE AND<br>DIMENHYDRINATE<br>20MG+40MGTABLETS<br>(CINZATOR) (EACH<br>UNCOATED TABLETS<br>CONTAINS: CINNARIZINE PH.<br>EUR. 20 MG &<br>DIMENHYDRINATE PH. EUR.<br>40 MG NET CONTENT OF<br>DIMENHYDRINATE<br>SHOULD NOT BE LESS THAN<br>88.840 KGS IN EXPORT<br>PRODUCT)<br>1 Number<br>1<br>DIMENHYDRINATE<br>MICRONIZED PH.EUR<br>40.80 mg/Tablet<br>RA concerned may take further necessary action as per above decision of NC.

19

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Case No. 28 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name MICRO LABS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007856AM24
RA File Number 07AX04001598 AM24
Licence No and<br>Date 0711010168/10/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Feb/202324/23 dated 19/02/2024against advance authorization<br>No.0711009545 dated 26/10/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>PREMIX OF NIFUROXAZIDE<br>(PREMIX OF NIFUROXAZIDE<br>(1 GM OF PREMIX CONTAINS 0.552<br>GMS OF NIFUROXAZIDE)<br>Net content 3974.40 KG))<br>7200 kg.<br>1<br>NIFUROXAZIDE BP/EP<br>4014.146 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 29 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name USV PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007861AM24
RA File Number 03AX04004600 AM24
Licence No and 0311030078/10/01/2024

20

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Date

Norms Committee Decision:

The Committee considered the case as per agenda and it was decided to fix ad-hoc 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. allowed.
Delofine XL 10 mg Prolonged Release<br>Tablets 28 s (Felodipine 10 mg<br>Prolonged Release Tablets 28 s) ((<br>1,07,140 Packs X 28 Tablets per Packs =<br>29,99,920 Tablets) (Total Weight of<br>Export Product = 30.00 Kgs) (Net<br>Content weight of Import Product =<br>31.85 kgs)) <br>1 Tablet 1 Felodipine Ph. Eur. 10.2 mg/Tablet
Case No. Case No. 30 / NC/3/MEET/Mar/202324/26 30 / NC/3/MEET/Mar/202324/26 30 / NC/3/MEET/Mar/202324/26 30 / NC/3/MEET/Mar/202324/26 30 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007863AM24
RA File Number 07AX04001615 AM24
Licence No and<br>Date 0711010174/10/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Mar/202324/25 dated 11/03/2024against advance<br>authorizationNo. **0711009827 dated 01/12/2023,**it was decided to fix ad-hoc 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>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
Export Product Qty. Sl. No. Import Items Qty. allowed.

21

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1<br>1 BROMO 3 CHLORO PROPANE<br>0.96 kg.<br>2<br>TETRA HYDRO FURAN<br>0.71 kg.<br>3<br>ACETONE<br>1.00 kg.<br>NORTRIPTYLINE HCL(IP/BP/USP)<br>1 kg.<br>4<br>TOLUENE<br>1.00 kg.<br>RA concerned may take further necessary action as per above decision of NC. NORTRIPTYLINE HCL(IP/BP/USP) 1 kg. 1 1 BROMO 3 CHLORO PROPANE 0.96 kg.
2 TETRA HYDRO FURAN 0.71 kg.
3 ACETONE 1.00 kg.
4 TOLUENE 1.00 kg.
Case No. 31 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007864AM24
RA File Number 07AX04001614 AM24
Licence No and<br>Date 0711010175/10/01/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 32 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007865AM24
RA File Number 07AX04001617 AM24
Licence No and<br>Date 0711010176/10/01/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

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Case No. 33 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name MICRO LABS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007866AM24
RA File Number 07AX04001599 AM24
Licence No and<br>Date 0711010178/10/01/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. Case No. 34 / NC/3/MEET/Mar/202324/26 34 / NC/3/MEET/Mar/202324/26 34 / NC/3/MEET/Mar/202324/26 34 / NC/3/MEET/Mar/202324/26 34 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007874AM24
RA File Number 07AX04001631 AM24
Licence No and<br>Date 0711010184/10/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.10/82-ALC4/2018 dated 16/10/2018against advance authorization<br>No.0710112769 dated 02/02/2018, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>2 CHLORO PHENOTHIAZINE<br>0.90 kg.<br>2<br>1 BROMO 3 CHLORO PROPANE<br>0.95 kg.<br>3<br>TOLUENE<br>Not allowed<br>CHLORPROMAZINE<br>HYDROCHLORIDE<br>(BP/EP/USP/IP)<br>1 Kg.
Export Product Qty. **Sl. No. ** Import Items Qty. allowed.
CHLORPROMAZINE<br>HYDROCHLORIDE<br>(BP/EP/USP/IP) 1 Kg. 1 2 CHLORO PHENOTHIAZINE 0.90 kg.
2 1 BROMO 3 CHLORO PROPANE 0.95 kg.
3 TOLUENE Not allowed

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4 ACETONE 3.30 kg.

Case No. 35 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name FDC LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007890AM24
RA File Number 03AX04004630 AM24
Licence No and<br>Date 0311030104/11/01/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 36 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name UNIMAX LABORATORIES
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007901AM24
RA File Number 05AX04003229 AM24
Licence No and<br>Date 0511023203/11/01/2024
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it<br>was decided to call for following information/documents from the firm:-<br>Certificate of Analysis (CoA) of import item from foreign supplier showing the actual potency.

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Case No. 37 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007911AM24
RA File Number 05AX04003160 AM24
Licence No and<br>Date 0511023216/11/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance authorization<br>No.0511020040 dated 25/07/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>INOKAIN EYE DROPS 0.4 PERCENT 5 ML<br>(Each ml contains 4mg of Benoxinate<br>Hydrochloride)(INOKAIN EYE DROPS 0.4<br>PERCENT 5 ML (Each ml contains 4mg of<br>Benoxinate Hydrochloride))<br>1 Vial<br>1<br>Benoxinate HCL<br>20.4 mg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 38 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name ABHILASH LIFE SCIENCES LLP
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007918AM24
RA File Number 32AX04000594 AM24
Licence No and<br>Date 3211006159/11/01/2024
Norms Committee Decision:

25

UDIN00057719AM25

The Committee considered the case as per agenda and it was decided to fix ad-hoc 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. allowed.
PARACETAMOL DIRECTLY COMPRESSIBLE<br>GRANULES 90% W/W<br>(ACTIVE PHARMA INGREDIENT) <br>1 kg. 1 PARACETAMOL 0.909 kg.
Case No. 39 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name AVIK PHARMACEUTICAL LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007926AM24
RA File Number 52AX04000307 AM24
Licence No and<br>Date 5211007035/12/01/2024
Norms Committee Decision:<br>Decision: The case is under consideration for want of comments of TE.
Case No. 40 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name CREDO LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007939AM24
RA File Number 09AX04000902 AM24
Licence No and<br>Date 0911006573/12/01/2024
Norms Committee Decision:

26

UDIN00057719AM25

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Sep/202324/14 dated 27/09/2023 against advance authorization No.0911005430 dated 18/07/2023 , it was decided to fix ad-hoc 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. allowed.
Azithromycin Taste Mask Pellets 7.5%<br>(Each 1 Gram Taste Mask Pellets contains<br>Azithromycin as Azithromycin Dihydrate<br>- 75 mg) <br>21500 kg. 1 Azithromycin Dihydrate 1628.615 kg.
Case No. Case No. 41 / NC/3/MEET/Mar/202324/26 41 / NC/3/MEET/Mar/202324/26 41 / NC/3/MEET/Mar/202324/26 41 / NC/3/MEET/Mar/202324/26 41 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007961AM24
RA File Number 03AX04004656 AM24
Licence No and<br>Date 0311030162/15/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Feb/202324/24 dated 05/03/2024against advance authorization<br>No.0311014263 dated 29/04/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Sacubitril+Calcium<br>(Sacubitril Calcium)<br>1 kg.<br>1<br>2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-<br>butoxycarbonyl)amino)-2-methylpentanoic acid<br>(BMPA)<br>1.237 kg.
Export Product Qty. Sl. No. Import Items Qty. allowed.
Sacubitril+Calcium<br>(Sacubitril Calcium) 1 kg. 1 2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-<br>butoxycarbonyl)amino)-2-methylpentanoic acid<br>(BMPA) 1.237 kg.

27

UDIN00057719AM25

Case No. 42 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007962AM24
RA File Number 03AX04004657 AM24
Licence No and<br>Date 0311030163/15/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Feb/202324/24 dated 05/03/2024against advance authorization<br>No.0311014263 dated 29/04/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Sacubitril+Calcium<br>(Sacubitril Calcium)<br>1 kg.<br>1<br>2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-<br>butoxycarbonyl)amino)-2-methylpentanoic acid<br>(BMPA)<br>1.237 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 43 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007963AM24
RA File Number 03AX04004676 AM24

28

UDIN00057719AM25

Licence No and<br>Date<br>0311030164/15/01/2024 Licence No and<br>Date<br>0311030164/15/01/2024 Licence No and<br>Date<br>0311030164/15/01/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Feb/202324/24 dated 05/03/2024against advance authorization
No.0311014263 dated 29/04/2022, it was decided to fix ad-hoc 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.<br>Sl. No.<br>Import Items Qty. allowed.
Sacubitril+Calcium 1 kg. 1<br>2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert- 1.237 kg.
butoxycarbonyl)amino)-2-methylpentanoic acid
(Sacubitril Calcium) (BMPA)
RA concerned may take further necessary action as per above decision of NC.
Case No.<br>44 / NC/3/MEET/Mar/202324/26
Case Status<br>Case Approved
Party Name<br>HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number<br>HQRNORM APPLY 00007964AM24
RA File Number<br>03AX04004677 AM24
Licence No and<br>Date<br>0311030165/15/01/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Feb/202324/24 dated 05/03/2024against advance authorization
No.0311014263 dated 29/04/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details
given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No.<br>Import Items Qty. allowed.
2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-<br>Sacubitril+Calcium<br>1 kg.<br>1 1.237 kg.
butoxycarbonyl)amino)-2-methylpentanoic acid<br>(Sacubitril Calcium)

29

UDIN00057719AM25

(BMPA)

Case No. 45 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name MANKIND PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007970AM24
RA File Number 05AX04003290 AM24
Licence No and<br>Date 0511023265/15/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jan/202324/21 dated 24/01/2024against advance authorization<br>No.0511018851 dated 17/05/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Tobramycin Inhalation Solution, 300mg/<br>4ml (Having net content of 106.031 kg of<br>Bulk drug (filling volume 4.35ml in each<br>number))<br>1 Number<br>1<br>TOBRAMYCIN USP<br>306 mg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 46 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name HARMAN FINOCHEM LIMITED
Meeting Number NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024

30

UDIN00057719AM25

and Date
HQ File Number HQRNORM APPLY 00007979AM24
RA File Number 03AX04004700 AM24
Licence No and<br>Date 0311030205/16/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Feb/202324/24 dated 05/03/2024against advance authorization<br>No.0311014263 dated 29/04/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Sacubitril+Calcium<br>(Sacubitril Calcium)<br>1 kg.<br>1<br>2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert-<br>butoxycarbonyl)amino)-2-methylpentanoic acid<br>(BMPA)<br>1.237 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. Case No. 47 / NC/3/MEET/Mar/202324/26 47 / NC/3/MEET/Mar/202324/26 47 / NC/3/MEET/Mar/202324/26 47 / NC/3/MEET/Mar/202324/26 47 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007980AM24
RA File Number 03AX04004696 AM24
Licence No and<br>Date 0311030206/16/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Feb/202324/24 dated 05/03/2024against advance authorization<br>No.0311014263 dated 29/04/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
Export Product Qty. Sl. No. Import Items Qty. allowed.

31

UDIN00057719AM25

Sacubitril+Calcium 1 kg. 1 2R,4S)-5-([1,1 -biphenyl]-4-yl)-4-(tert- 1.237 kg.
butoxycarbonyl)amino)-2-methylpentanoic acid
(Sacubitril Calcium) (BMPA)
Case No. Case No. 48 / NC/3/MEET/Mar/202324/26 48 / NC/3/MEET/Mar/202324/26 48 / NC/3/MEET/Mar/202324/26 48 / NC/3/MEET/Mar/202324/26 48 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name REYAANSH HEALTHCARE
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00007997AM24
RA File Number 03AX04004636 AM24
Licence No and<br>Date 0311030230/16/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>IMPACT SOLUTION FOR CATS 0.40 ML.(Each ml contains<br>Imidacloprid 100 mg + Moxidectin 10 mg. Moxidectin<br>consumed including wastages & overages :- 0.400 Kg. ( Net<br>content of Moxidectin is 0.3636 KGS))<br>90912<br>Numbers<br>1<br>Moxidectin<br>370.92 gm.<br>IMPACT SOLUTION FOR CATS 0.80 ML(Each ml contains<br>Imidacloprid 100 mg + Moxidectin 10 mg. Moxidectin<br>consumed including wastages & overages :- 1.400 Kg. ( Net<br>content of Moxidectin is 1.2727 KGS))<br>159093<br>Numbers<br>2<br>Moxidectin<br>1298.20 gm<br>IMPACT SOLUTION FOR DOGS 0.40 ML(Each ml contains<br>Imidacloprid 100 mg + Moxidectin 25 mg. Moxidectin<br>consumed including wastages & overages :- 1 Kg. ( Net<br>content of Moxidectin is 0.9091KGS))<br>90912<br>Numbers<br>3<br>Moxidectin<br>927.30 gm<br>IMPACT SOLUTION FOR DOGS 1 ML.(Each ml contains<br>Imidacloprid 100 mg + Moxidectin 25 mg. Moxidectin<br>134550<br>Moxidectin<br>4<br>3431.025 gm.
Export Product Qty. Sl. No. Import Items Qty. allowed.
IMPACT SOLUTION FOR CATS 0.40 ML.(Each ml contains<br>Imidacloprid 100 mg + Moxidectin 10 mg. Moxidectin<br>consumed including wastages & overages :- 0.400 Kg. ( Net<br>content of Moxidectin is 0.3636 KGS)) 90912<br>Numbers 1 Moxidectin 370.92 gm.
IMPACT SOLUTION FOR CATS 0.80 ML(Each ml contains<br>Imidacloprid 100 mg + Moxidectin 10 mg. Moxidectin<br>consumed including wastages & overages :- 1.400 Kg. ( Net<br>content of Moxidectin is 1.2727 KGS)) 159093<br>Numbers 2 Moxidectin 1298.20 gm
IMPACT SOLUTION FOR DOGS 0.40 ML(Each ml contains<br>Imidacloprid 100 mg + Moxidectin 25 mg. Moxidectin<br>consumed including wastages & overages :- 1 Kg. ( Net<br>content of Moxidectin is 0.9091KGS)) 90912<br>Numbers 3 Moxidectin 927.30 gm
IMPACT SOLUTION FOR DOGS 1 ML.(Each ml contains<br>Imidacloprid 100 mg + Moxidectin 25 mg. Moxidectin 134550 4 Moxidectin 3431.025 gm.

32

UDIN00057719AM25

consumed including wastages & overages :- 3.700 Kg. ( Net<br>content of Moxidectin is 3.3637 KGS))<br>Numbers<br>IMPACT SOLUTION FOR DOGS 2.50 ML.(Each ml contains<br>Imidacloprid 100 mg + Moxidectin 25 mg. Moxidectin<br>consumed including wastages & overages :- 2.500 Kg. ( Net<br>content of Moxidectin is 2.2729 KGS))<br>36366<br>Numbers<br>5<br>Moxidectin<br>2318.33 gm.<br>IMPACT SOLUTION FOR DOGS 4 ML.(Each ml contains<br>Imidacloprid 100 mg + Moxidectin 25 mg. Moxidectin<br>consumed including wastages & overages :- 2 Kg. ( Net<br>content of Moxidectin is 1.8186 KGS))<br>18186<br>Numbers<br>6<br>Moxidectin<br>1854.972 gm.<br>RA concerned may take further necessary action as per above decision of NC. consumed including wastages & overages :- 3.700 Kg. ( Net<br>content of Moxidectin is 3.3637 KGS)) Numbers
IMPACT SOLUTION FOR DOGS 2.50 ML.(Each ml contains<br>Imidacloprid 100 mg + Moxidectin 25 mg. Moxidectin<br>consumed including wastages & overages :- 2.500 Kg. ( Net<br>content of Moxidectin is 2.2729 KGS)) <br>36366<br>Numbers 5 Moxidectin 2318.33 gm.
IMPACT SOLUTION FOR DOGS 4 ML.(Each ml contains<br>Imidacloprid 100 mg + Moxidectin 25 mg. Moxidectin<br>consumed including wastages & overages :- 2 Kg. ( Net<br>content of Moxidectin is 1.8186 KGS)) 18186<br>Numbers 6 Moxidectin 1854.972 gm.
Case No. 49 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name SAGA LIFESCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008014AM24
RA File Number 08AX04001772 AM24
Licence No and<br>Date 0811010513/17/01/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 50 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name SANPRAS HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008015AM24
RA File Number 31AX04000283 AM24
Licence No and<br>Date 3111003005/17/01/2024

33

UDIN00057719AM25

Norms Committee Decision:

The case is under consideration for want of comments of TE.

Case No. 51 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008036AM24
RA File Number 05AX04003341 AM24
Licence No and<br>Date 0511023326/17/01/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance authorization<br>No.0511019931 dated 19/07/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Moxifloxacin Hydrochloride<br>1547.09 gram<br>Moxifloxacin<br>HCL<br>and<br>Dexamethasone<br>Sodium<br>Phosphate<br>Eye Drops 0.5%w/v, 0.1% w/v,<br>5ml((Each ml contain Moxifloxacin<br>Base 5mg. equi. To Moxifloxacin HCL<br>5.45mg.<br>&<br>Dexamethasone<br>Phosphate1mg<br>equi.<br>To<br>Dexamethasone<br>Sodium<br>Phosphate<br>1.1mg<br>(Equi.to<br>1473.435gm<br>Moxifloxacin HCL and 297.391gm<br>Dexamethasone<br>Sodium<br>Phosphate<br>Bulk Drug))<br>54071<br>Numbers<br>2<br>Dexamethasone Sodium<br>Phosphate<br>312.26 gram<br>RA concerned may take further necessary action as per above decision of NC.

34

UDIN00057719AM25

Case No. 52 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name ABBOTT HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008039AM24
RA File Number 03AX04004687 AM24
Licence No and<br>Date 0311030266/18/01/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. Case No. 53 / NC/3/MEET/Mar/202324/26 53 / NC/3/MEET/Mar/202324/26 53 / NC/3/MEET/Mar/202324/26 53 / NC/3/MEET/Mar/202324/26 53 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name GLENFIN CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008040AM24
RA File Number 03AX04004722 AM24
Licence No and<br>Date 0311030267/18/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>1<br>1-(4-hydroxyphenyl) heptane-1,3 dione<br>0.94 kg.<br>2-Butyl-3-(4-hydroxybenzoyl)-5-<br>nitrobenzofuran<br>1 kg.<br>2<br>O-(4-nitrophenyl)hydroxylamine<br>0.66 kg.
Export Product Qty. Sl. No. Import Items Qty.<br>allowed.
2-Butyl-3-(4-hydroxybenzoyl)-5-<br>nitrobenzofuran 1 kg. 1 1-(4-hydroxyphenyl) heptane-1,3 dione 0.94 kg.
2 O-(4-nitrophenyl)hydroxylamine 0.66 kg.

35

UDIN00057719AM25

Note: Yield of the reaction is less at initial stage, therefore, recommended on one time basis.

Case No. 54 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name BLUE JET HEALTHCARE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008057AM24
RA File Number 03AX04004728 AM24
Licence No and<br>Date 0311030291/19/01/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 55 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name ANNORA PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008068AM24
RA File Number 09AX04000846 AM24
Licence No and<br>Date 0911006469/19/01/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 56 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name CHEMIPRIME IMPEX PRIVATE LIMITED
Meeting Number NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024

36

UDIN00057719AM25

and Date
HQ File Number HQRNORM APPLY 00008089AM24
RA File Number 03AX04004810 AM24
Licence No and<br>Date 0311030338/22/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jan/202324/20 dated 18/01/2024against advance authorization<br>No.0311022361 dated 23/03/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Epoxy Hardener<br>0.5025 kg.<br>2<br>Benzyl Alcohol<br>0.3015 kg.<br>Epocure HD 1618<br>(Cycloaliphatic amine)<br>1 kg.<br>3<br>Liquid Epoxy Resin<br>0.201 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 57 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008094AM24
RA File Number 08AX04001922 AM24
Licence No and<br>Date 0811010550/22/01/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

37

UDIN00057719AM25

Case No. Case No. 58 / NC/3/MEET/Mar/202324/26 58 / NC/3/MEET/Mar/202324/26 58 / NC/3/MEET/Mar/202324/26 58 / NC/3/MEET/Mar/202324/26 58 / NC/3/MEET/Mar/202324/26 58 / NC/3/MEET/Mar/202324/26 58 / NC/3/MEET/Mar/202324/26 58 / NC/3/MEET/Mar/202324/26 58 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name YASHO INDUSTRIES LIMITED
Meeting Number
and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008099AM24
RA File Number 03AX04004838 AM24
Licence No and 0311030345/22/01/2024
Date
Norms Committee Decision:
The Committee c<br>roduct/imort onsidered the case as per agenda and taking cue from the earlier decision for same export<br>roduct in meetinNoNC/3/MEET/Feb/202324/23dated 19/02/2024aainst advance
pp<br>authorizationNo.0<br>as per details give g**.** g<br>311028216 dated 26/10/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I<br>n below or as applied by the firm whichever is less:-
,<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>HYDRAZINE HYDRATE 80% (H.H)<br>0.134 kg.<br>2<br>CARBON DISULPHIDE<br>0.3502 kg.<br>2,5-bis-( Tert-Nonyldithio)-1,3,4,-<br>thiadizole ( YALUB DM -113)<br>1 kg.<br>3<br>TERT -NONYL MERCAPTAN (S-<br>MERCAPTAN)<br>0.700 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Export Product Qty. Sl. No. Import Items Qty. allowed.
2,5-bis-( Tert-Nonyldithio)-1,3,4,-<br>thiadizole ( YALUB DM -113) 1 k g. 1 HYDR AZINE H YDRATE 80% (H.H ) 0.134 kg.
2 CARBON DISULPHIDE 0.3502 kg.
3 TER T -NONYL<br>MER MERCAPTAN (S-<br>CAPTAN) 0.700 kg.
Case No. 59 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name MICRO LABS LIMITED
Meeting Number
<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008112AM24
RA File Number 07AX04001679 AM24
Licence No and<br>Date 0711010304/23/01/2024
Norms Committee Decision:

38

UDIN00057719AM25

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Dec/202324/17 dated 20/12/2023 against advance authorization No.0711005589 dated 21/10/2022 , it was decided to fix ad-hoc 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. allowed.
LISINOPRIL 2.50 MG 1 Number 1 LISINOPRIL DIHYDRATE 2.55 mg/Tablet
TABLETS(LISINOPRIL 2.5mg BP/EP/IP/USP
TABLETS (7.50KGS))
LISINOPRIL 5.0 MG 1 Number 2 LISINOPRIL DIHYDRATE 5.10 mg/Tablet
TABLETS(LISINOPRIL 5mg BP/EP/IP/USP
TABLETS (28.70 KGS))
LISINOPRIL 10 MG 1 Number 3 LISINOPRIL DIHYDRATE 10.2 mg/Tablet
TABLETS(LISINOPRIL 10 MG BP/EP/IP/USP
TABLETS (57.40 KGS))
LISINOPRIL 20 MG 1 Number 4 LISINOPRIL DIHYDRATE 20.4 mg/Tablet
TABLETS(LISINOPRIL 20 MG BP/EP/IP/USP
TABLETS (180.00 KGS))
Case No. 60 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008141AM24
RA File Number 09AX04000959 AM24
Licence No and<br>Date 0911006629/24/01/2024
Norms Committee Decision:
The case is under consideration for want of comments of TE.

39

UDIN00057719AM25

Case No. 61 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008150AM24
RA File Number 03AX04004874 AM24
Licence No and<br>Date 0311030426/24/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>DIPHENYLAMINE<br>0.405 kg.<br>2<br>DI ISOBUTYLENE<br>0.622 kg.<br>OCTYLATED DIPHENYLAMINE<br>(OCD FLAKES/POWDER)<br>1 kg.<br>3<br>ACTIVATED CLAY<br>0.100 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 62 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name SRI KRISHNA PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008152AM24
RA File Number 09AX04000948 AM24
Licence No and<br>Date 0911006637/24/01/2024
Norms Committee Decision:

40

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The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Feb/202324/23 dated 19/02/2024 against advance authorization No.0911005810 dated 20/09/2023 , it was decided to fix ad-hoc 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. allowed.
CARBIDOPA 12.5 MG LEVODOPA 50MG<br>TABLETS 1 Number 1 CARBIDOPA 12.75 mg.
2 LEVODOPA 51.00 mg
Case No. 63 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008154AM24
RA File Number 03AX04004736 AM24
Licence No and<br>Date 0311030436/25/01/2024
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.<br>Details of indigenous input with quantity.<br>v.
  • ii. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.

41

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Case No. 64 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008188AM24
RA File Number 34AX04000814 AM24
Licence No and<br>Date 3411004545/29/01/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 65 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name AMNEAL INJECTABLES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008190AM24
RA File Number 08AX04001949 AM24
Licence No and<br>Date 0811010589/29/01/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 66 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name AROCHEMA INGREDIENTS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008195AM24
RA File Number 26AX04000076 AM24
Licence No and<br>Date 2611001303/29/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo. NC/3/MEET/Jan/202324/21 dated 24/01/2024against advance<br>authorizationNo.2611001171 dated 13/10/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I

42 This document has been digitally signed by Raman Kumar, Deputy DGFT on 25-04-2024 11:42:40.

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as per details given below or as applied by the firm, whichever is less:-

Export Product Qty. Sl. No. Import Items Qty. allowed.
AMBRETTOLIDE VEG 1 kg. 1 7-OCTENOL 1.999 kg.
2 INHERENT UC 12 ME 2.69 kg.
3 ULTRACAT 0.000089 kg.
4 SNATCHCAT 0.000104 kg.
5 GREEN CAT Not imported.
Case No. 67 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name SAURAV CHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008198AM24
RA File Number 30AX04000481 AM24
Licence No and<br>Date 3011004726/29/01/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 68 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name JUBILANT INGREVIA LIMITED
Meeting Number NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024

43

UDIN00057719AM25

and Date
HQ File Number HQRNORM APPLY 00008210AM24
RA File Number 05AX04003445 AM24
Licence No and<br>Date 0511023507/30/01/2024
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Chemical reaction of the process indicating Structural formula of reactants and products and molecular<br>weight (without using abbreviation of chemicals name).<br>i.<br>Stage wise and also overall yield of the reactgio and Stoichiometric balance between import and export<br>items on molar basis.<br>ii.<br>Application/function of each chemical in the process with justification.<br>iii.<br>Indigenous items to use in the process and accordingly to fill Annexure to Appendix-4E.<br>iv.<br>Commercial value of the by-poroduct, if any.<br>v.

The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:-

Case No. 69 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008214AM24
RA File Number 34AX04000788 AM24
Licence No and<br>Date 3411004560/30/01/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 70 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008215AM24
RA File Number 34AX04000793 AM24
Licence No and<br>Date 3411004561/30/01/2024
Norms Committee Decision:

44 This document has been digitally signed by Raman Kumar, Deputy DGFT on 25-04-2024 11:42:40.

UDIN00057719AM25

The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:-

Certificate of Analysis (CoA) of import item from Foreign Supplier.

Case No. 71 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008239AM24
RA File Number 08AX04001964 AM24
Licence No and<br>Date 0811010619/31/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>AMIKACIN SULFATE 500mg/2ml<br>1 Number<br>1<br>AMIKACIN SULFATE<br>715.81 mg.<br>AMIKACIN SULFATE 100mg/2ml<br>1 Number<br>2<br>AMIKACIN SULFATE<br>143.16 mg.<br>Note: RA may be clarified when the export item has already had a SION A-3646, which is published on<br>17.03.2016 vide Public Notice No. 64/2015-20 dated 17.03.2016, why the Advance Authorisation issued to<br>the firm under para 4.07 of HBP Vol.1<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 72 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024

45

UDIN00057719AM25

and Date and Date
HQ File Number HQRNORM APPLY 00008241AM24
RA File Number 05AX04003464 AM24
Licence No and
Date 0511023530/31/01/2024
Norms Committee Decision:
The Committee<br>di considered the case as per agenda and taking cue from the earlier decision for same export<br>d i iC/3/MEET/A/202223/6 09/09/2022i d hii
prouct/mport prouct n meetngNo. Nug datedaganst avance autorzaton<br>No.0511008191 dated 21/01/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Budesonide Suspension For Inhalation , 0.125 mg /<br>ml (2 ml Ampoule)(Budesonide Suspension For<br>Inhalation , 0.125 mg /ml ( 2 ml Ampoule ) (Each<br>ml contains Budesonide 0.125 mg (Equivalent to<br>2.100 Kg of Bulk Drug))<br>8400000<br>Numbers<br>1<br>Budesonide<br>2.205 kg.<br>Budesonide Suspension For Inhalation , 0.25 mg /<br>ml (2 ml Ampoule)(Budesonide Suspension For<br>Inhalation , 0.25 mg / ml (2 ml Ampoule) (Each ml<br>contains Budesonide 0.250 mg (Equivalent to 4.950<br>Kg. of Bulk Drug))<br>9900000<br>Numbers<br>2<br>Budesonide<br>5.198 kg.
Export Product Qty. Sl. No. Import Items Qty. allowed.
Budesonide Suspension For Inhalation , 0.125 m<br>ml (2 ml Ampoule)(Budesonide Suspension For<br>Inhalation , 0.125 mg /ml ( 2 ml Ampoule ) (Eac<br>ml contains Budesonide 0.125 mg (Equivalent to<br>2.100 Kg of Bulk Drug)) g /<br> <br>h<br> 8<br>N 00000<br>umbers 1 Budesonide 2.205 kg.
Budesonide Suspension For Inhalation , 0.25 mg<br>ml (2 ml Ampoule)(Budesonide Suspension For /<br> 99<br>N 00000<br>umbers 2 Budesonide 5.198 kg.
<br>Inhalation , 0.25 mg / ml (2 ml Ampoule) (Each ml<br>contains Budesonide 0.250 mg (Equivalent to 4.950<br>Kg. of Bulk Drug))
Budesonide Susension For Inhalation 05 m / ml 2400000 3 Budesonide 252 k
<br>(2 ml Ampoule p , . g<br>)(Budesonide Suspension For <br>Numbers . g.
<br>Inhalation , 0.5 <br>mg / ml (2 ml Ampoule) (Each ml
<br>contains Budes <br>onide 0.5 mg (Equivalent to 2.400
Kg. of Bulk Dr ug) Total Bulk Drug Qty. 9.450Kg.))
RA concerned may take further necessary action as per above decision of NC.
Case No. 73 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name METROCHEM API PRIVATE LIMITED
Meetin Number
g<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008252AM24
Case No. 73 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name METROCHEM API PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008252AM24

46

UDIN00057719AM25

RA File Number 09AX04000962 AM24
Licence No and<br>Date 0911006666/31/01/2024
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Complete and Balanced chemical reactions, molar weight and percentage yield on molar basis, for each<br>step.<br>i.<br>Production/Consumption data for last three years duly certified by GST Authorities.<br>ii.
Case No. 74 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name LASENOR INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008258AM24
RA File Number 50AX04000096 AM24
Licence No and<br>Date 5011001267/31/01/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jan/202324/20 dated 18/01/2024against advance<br>authorizationNo.5011000524 dated 12/07/2022, it was decided to fix ad-hoc 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>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Sunflower Lecithin Powder<br>1 MT.<br>1<br>Crude Sunflower Lecithin (Liquid form)<br>1.40 MT<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 75 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
PartyName RUBICON RESEARCH PRIVATE LIMITED

47

UDIN00057719AM25

Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008260AM24
RA File Number 03AX04004795 AM24
Licence No and<br>Date 0311030581/31/01/2024
Norms Committee Decision:
The case is under consideration for want of comments of TE.
Meeting Number<br>and Date Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number
File Number HQRNORM APPLY 00008 60AM24
RA File Number 03AX04004795 AM24
Lic<br>Dat ence No and
e 0311030581/31/01/2024
No<br>Th rms Committee Decision:<br>e case is under consideration for want of c omments of
TE.
Cas e No. 76 / NC/3/MEET/Mar/20232 4/26
Case Status Case Approved
Party Name VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008268AM24
RA File Number 03AX04004982 AM24
Licence No and 0311030597/01/02/2024
Date
Norms Committee<br>h i Decision:<br>idd h d d ki f h li dii f
e ommttee<br>roduct/imort r onsere te case as per agena an tang cue rom te earer ecson or same export<br>duct in meetinNoNC/3/MEET/Feb/202324/23 dated 19/02/2024aainst advance authorization
pp p<br>No.3111002689 g**.**g<br>dated 05/10/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details
given below or as <br>applied by the firm, whichever is less:-
Export Product Qty. Sl. No. Import Items<br> Qty. allowed.
TYLODOX GOLD WSP (Pack size 1 Kgs<br> 1 Number 1 Tylosin Tartrate BP/USP /EP 0.101 kg.
Jar)(Each gram contains:<br>(Vet) 100 mg, Doxycyclin ylosin Tartra<br>e Hyclate BP te BP<br>200 mg)
3 Doxycycline Hyclate BP/EP/ USP 0.202 kg.
TYLODOX GOLD WSP<br>sachet)(Each gram contain<br>BP (Vet) 100 mg, Doxycy<br>mg) (Pack size 10<br>s: Tylosin Ta<br>cline Hyclate 0 Gms<br>rtrate<br>BP 200 1 Number 2 Tylosin Tartrate BP/USP /EP 10.1 gm.
4 Doxycycline Hyclate BP/EP/ USP 20.2 gm.
GENTADOX GOLD 100 / 200 ( pack Size 1<br>Kgs Jar) (Each gram powder contains:<br>Doxycycline Hyclate BP 200mg, 1 Number 5 Doxycycline Hyclate BP/EP/USP 0.202 kg.
<br>
Gentamycin Sul phate USP 100mg)
Meeting Number<br>and Date Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024 NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number
File Number HQRNORM APPLY 00008 60AM24
RA File Number 03AX04004795 AM24
Lic<br>Dat ence No and
e 0311030581/31/01/2024
No<br>Th rms Committee Decision:<br>e case is under consideration for want of c omments of
TE.
Cas e No. 76 / NC/3/MEET/Mar/20232 4/26
Case Status Case Approved
Party Name VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008268AM24
RA File Number 03AX04004982 AM24
Licence No and 0311030597/01/02/2024
Date
Norms Committee<br>h i Decision:<br>idd h d d ki f h li dii f
e ommttee<br>roduct/imort r onsere te case as per agena an tang cue rom te earer ecson or same export<br>duct in meetinNoNC/3/MEET/Feb/202324/23 dated 19/02/2024aainst advance authorization
pp p<br>No.3111002689 g**.**g<br>dated 05/10/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details
given below or as <br>applied by the firm, whichever is less:-
Export Product Qty. Sl. No. Import Items<br> Qty. allowed.
TYLODOX GOLD WSP (Pack size 1 Kgs<br> 1 Number 1 Tylosin Tartrate BP/USP /EP 0.101 kg.
Jar)(Each gram contains:<br>(Vet) 100 mg, Doxycyclin ylosin Tartra<br>e Hyclate BP te BP<br>200 mg)
3 Doxycycline Hyclate BP/EP/ USP 0.202 kg.
TYLODOX GOLD WSP<br>sachet)(Each gram contain<br>BP (Vet) 100 mg, Doxycy<br>mg) (Pack size 10<br>s: Tylosin Ta<br>cline Hyclate 0 Gms<br>rtrate<br>BP 200 1 Number 2 Tylosin Tartrate BP/USP /EP 10.1 gm.
4 Doxycycline Hyclate BP/EP/ USP 20.2 gm.
GENTADOX GOLD 100 / 200 ( pack Size 1<br>Kgs Jar) (Each gram powder contains:<br>Doxycycline Hyclate BP 200mg, 1 Number 5 Doxycycline Hyclate BP/EP/USP 0.202 kg.
<br>
Gentamycin Sul phate USP 100mg)

48

UDIN00057719AM25

GENTADOX GOLD 100 /200 ( pack Size 100 1 Number 6 Doxycycline Hyclate BP/EP/USP 20.2 gm.
Gms Sachet) (Each gram powder contains:
Doxycycline Hyclate BP 200mg, Gentamycin
Sulphate USP 100mg)
NEODOX GOLD WSP (pack Size 1 Kgs 1 Number 7 Doxycycline Hyclate BP/EP/USP 0.101 kg.
Jar)(Each gram contains: Doxycycline Hyclate
BP 100 mg Neomycin Sulfate BP 100 mg)
NEODOX -GOLD WSP (pack Size 100 Gms 1 Number 8 Doxycycline Hyclate BP/EP/USP 10.1 gm.
Sachet) (Each gram contains: Doxycycline
Hyclate BP 100 mg Neomycin Sulfate BP 100
mg)
Case No. Case No. 77 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008271AM24
RA File Number 08AX04001973 AM24
Licence No and<br>Date 0811010634/01/02/2024
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc 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. allowed.
Tranexamic Acid in 0.7% Sodium<br>1 Number 1 Tranexamic acid 1.05 gm/100 ml
Chloride Injection 1,000 mg per 100 mL (Injectable grade, US FDA <br>Vial
(10 mg/mL) approved)
RA concerned may take further necessary action as per above decision of NC.

49

UDIN00057719AM25

Case No. 78 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name TOJO VIKAS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008274AM24
RA File Number 05AX04003478 AM24
Licence No and<br>Date 0511023580/01/02/2024
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.<br>Details of indigenous input with quantity.<br>v.
  • ii. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.
Case No. Case No. 79 / NC/3/MEET/Mar/202324/26 79 / NC/3/MEET/Mar/202324/26 79 / NC/3/MEET/Mar/202324/26 79 / NC/3/MEET/Mar/202324/26 79 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name NAPROD LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008275AM24
RA File Number 03AX04004861 AM24
Licence No and<br>Date 0311030600/01/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Fluorouracil INJ BP 1000 MG/20 ML<br>1 Vial<br>1<br>Fluorouracil IP/BP<br>1050 mg/Vial
Export Product Qty. Sl. No. Import Items Qty. allowed.
Fluorouracil INJ BP 1000 MG/20 ML 1 Vial 1 Fluorouracil IP/BP 1050 mg/Vial

50

UDIN00057719AM25

Case No. 80 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008278AM24
RA File Number 08AX04001950 AM24
Licence No and<br>Date 0811010645/01/02/2024
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the
TE, it was decided to call for following information/documents from the firm:-
Certificate of Analysis (CoA) of import item from Foreign Supplier.
Case No. 81 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name PRASOL CHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008287AM24
RA File Number 03AX04004987 AM24
Licence No and<br>Date 0311030614/01/02/2024
Norms Committee Decision:
TThe committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of
the TE, it was decided to call for following information/documents from the firm:-
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.
Stoichiometric balance between import and export on molar basis.<br>iv.
Details of indigenous input with quantity.<br>v.
  • ii. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.

51 This document has been digitally signed by Raman Kumar, Deputy DGFT on 25-04-2024 11:42:40.

UDIN00057719AM25

Case No. 82 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name SRI KRISHNA PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008307AM24
RA File Number 09AX04000889 AM24
Licence No and<br>Date 0911006687/02/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 83 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name SYSTOCHEM LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008313AM24
RA File Number 05AX04003564 AM24
Licence No and<br>Date 0511023623/02/02/2024
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Vial size of export product in line to DML.
Case No. 84 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008315AM24
RA File Number 05AX04003539 AM24

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Licence No and 0511023621/02/02/2024 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No. NC/3/MEET/Jan/202324/21 dated 24/01/2024 against advance authorization No.0511018894 dated18/05/2023 , it was decided to fix ad-hoc 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. allowed.
Brinex / Brinex-M / Brinarga / Brinera<br>(Brinzolamide Opthalmic Suspension<br>1%)- 5ml<br> 1 Vial 1 Brinzolamide Micronized Sterile 51.00 mg/Vial
Case No. Case No. 85 / NC/3/MEET/Mar/202324/26 85 / NC/3/MEET/Mar/202324/26 85 / NC/3/MEET/Mar/202324/26 85 / NC/3/MEET/Mar/202324/26 85 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008334AM24
RA File Number 03AX04005004 AM24
Licence No and<br>Date 0311030668/05/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>ALVERINE CITRATE 120 MG CAPSULES<br>1 Number<br>1<br>Alverine Citrate<br>122.4 mg./Capsule
Export Product Qty. **Sl. No. ** Import Items Qty. allowed.
ALVERINE CITRATE 120 MG CAPSULES 1 Number 1 Alverine Citrate 122.4 mg./Capsule

53

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ALVERINE CITRATE 60 MG CAPSULES 1 Number 2 Alverine Citrate 61.2 mg./Capsule

RA ALVERINE CITRATE 60 MG CAPSULES ALVERINE CITRATE 60 MG CAPSULES ALVERINE CITRATE 60 MG CAPSULES 1 Number 1 Number 1 Number 2 Alverine Citrate 61.2 mg./Capsule 61.2 mg./Capsule
concerned may take further neces sary action as per abov e decision of NC.
Cas e No. 86 / NC/3/MEET/ Mar/202324/2 6
Cas e Status Case Approved
Par ty Name TORRENT PHAR MACEUTICA LS LTD
Me<br>and eting Number<br>Date NC/ 3/ MEET/ Ma r/ 202324/ 26 and 22/03 /2024
HQ File Number HQRNORM APP LY 00008337A M24
RA File Number 08AX04001983 A M24
Lic<br>Dat ence No and<br>e 0811010681/05/02 /2024
Nor<br>T<br>pr<br>a<br>as<br>RA ms Committee Decision:<br>he Committee considered the ca<br>oduct/import product in meet<br>uthorizationNo.0811008938 date<br>per details given below or as app se as per ag<br>ingNo.NC/<br>d 30/07/2023,<br>lied by the fir enda and<br>3/MEET/ taking cue from the earlier decis<br>Sep/202324/14 dated 27/09/202 ion for same export<br>3against advance
<br>it was de<br>m, which <br>cided to fix ad-hoc norms under Par<br>ever is less:- <br>a 4.07 of HBP Vol. I
Export Product
Qty. Sl. No. Import Items Qty. allowed.
CLOZAPINE TABLETS 100<br>UNCOATED<br>TABLET<br> <br>CLOZAPINE B.P 100 MG NET<br>OF CLOZAPINE BP SHOUL<br>LESS THAN 39.000 KGS. I<br>ITEM) MG (EACH<br>CONTAINS:<br>CONTENT<br>D NOT BE<br>N EXPORT 1 Numb er 1 CLOZAPINE BP 102.00 mg/tablet
concerned may take further neces sary action as per abov e decision of NC.
Cas e No. 87 / NC/3/MEET/ Mar/202324/2 6
Cas e Status Case Deferred
Case No. 87 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred

54

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Party Name LOZEN PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008339AM24
RA File Number 03AX04004941 AM24
Licence No and<br>Date 0311030679/05/02/2024
Norms Committee Decision:
The case is under consideration for want of comments of TE.
Case No. 88 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name SPC LIFE SCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008350AM24
RA File Number 34AX04000824 AM24
Licence No and<br>Date 3411004576/05/02/2024
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the
TE, it was decided to call for following information/documents from the firm:-
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights along with<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.
Stoichiometric balance between import and export on molar basis.<br>iv.
Details of indigenous input with quantity.<br>v.
  • ii. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.
Case No. 89 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name AMI ORGANICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008367AM24
RA File Number 52AX04000336 AM24
Licence No and<br>Date 5211007280/06/02/2024

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UDIN00057719AM25

Norms Committee Decision:

The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:-

  1. Complete Chemical reaction starting from raw materials, stage wise yield and overall yield.

  2. Indigenous items to use in thr process and accordingly to file Annexure to Appendix-4E.

  3. Stoichiometic material balance on a molar basis, indicating requiremtn of raw materials. 4. End use of export product

Case No. 90 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008368AM24
RA File Number 09AX04000955 AM24
Licence No and<br>Date 0911006697/06/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Dec/202324/17 dated 20/12/2023against advance<br>authorizationNo.0911001093 dated 23/06/2021, it was decided to fix ad-hoc 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>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Tobramycin for Inhalation solution 60 mg /<br>ml (300 mg / 5 ml)<br>1 Number<br>1<br>Tobramycin Sulfate<br>466.49 mg./Vial<br>Tobramycin for Inhalation solution 75 mg /<br>ml (300 mg / 4 ml)<br>1 Number<br>2<br>Tobramycin Sulfate<br>466.49 mg./Vial<br>RA concerned may take further necessary action as per above decision of NC.

56

UDIN00057719AM25

Case No. Case No. 91 / NC/3/MEET/Mar/202324/26 91 / NC/3/MEET/Mar/202324/26 91 / NC/3/MEET/Mar/202324/26 91 / NC/3/MEET/Mar/202324/26 91 / NC/3/MEET/Mar/202324/26 91 / NC/3/MEET/Mar/202324/26 91 / NC/3/MEET/Mar/202324/26 91 / NC/3/MEET/Mar/202324/26 91 / NC/3/MEET/Mar/202324/26 91 / NC/3/MEET/Mar/202324/26 91 / NC/3/MEET/Mar/202324/26 91 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name FDC LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008379AM24
RA File Number 03AX04004853 AM24
Lic<br>Dat N d
ence o an<br>e 0311030 712/06/0 2/2024
No<br>T<br>V rms Committee Decision:
he Committee considere<br>ol. I as per details given d the case<br>below or as per age<br>as applied nda and it was decided to fix ad-hoc norms under P<br>by the firm, whichever is less:- ara 4.07 of HBP
Export Product Qty. Sl. No. Import Items Qty. allowed.
Sodium Cromoglicate (Allercrom , Allerfix,<br> 1 Vial 1 SODIUM<br> 0.204 gm./
Murine Hayfev<br>ML((EACH 10 er) Eye Drops 2% w/v 10<br>ML VIAL CONTAINS CROMOGLICATE 10 ml. vial
<br>SODIUM CRO <br>MOGLICATE 0.2 GM NET
WT OF BULK 28.830 KGS))
Cromolyn Sod<br>All E um Eye Drops 5 ML<br>DEACH 5 ML VIAL 1 Vial 2 SODIUM<br>CROMOGLICATE 0.102 gm./
(ercrom y<br>CONTAINS S rops)((<br>ODIUM CROMOGLICATE 5 ml. vial
<br>0.1 GM NET <br>WT OF BULK 10.175 KGS))
RA concerned may take further necessary action as per above decision of NC.
Cas e No. 92 / NC/3/MEET/Mar/202 324/26
Cas e Status Case Deferred
Par ty Name UNI MEDICOLABS
Me<br>and eting Number
Date NC/ 3/ MEET/ Mar/ 20232 4/ 26 and 22/0 /2024
HQ File Number HQRNORM APPLY 0000 8382AM24
RA File Number 05AX04003540 AM24
Lic<br>Dat ence No and<br>e 0511023728/06/02/2024
No rms Committee Decision:
Case No. 92 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name UNI MEDICOLABS
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008382AM24
RA File Number 05AX04003540 AM24
Licence No and<br>Date 0511023728/06/02/2024
Norms Committee Decision:

57

UDIN00057719AM25

The case is under consideration for want of comments of TE.

Case No. 93 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008383AM24
RA File Number 07AX04001749 AM24
Licence No and<br>Date 0711010420/06/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. Case No. 94 / NC/3/MEET/Mar/202324/26 94 / NC/3/MEET/Mar/202324/26 94 / NC/3/MEET/Mar/202324/26 94 / NC/3/MEET/Mar/202324/26 94 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name ENCEE AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008402AM24
RA File Number 32AX04000657 AM24
Licence No and<br>Date 3211006285/07/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Sep/202223/8 dated 23/09/2022against advance<br>authorizationNo.3211001926 dated 12/11/2021, it was decided to fix ad-hoc 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>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Triethyl Orthoformate<br>2.400 kg.<br>Enamber / Kephalis / Tetrambrone<br>1 kg.<br>2<br>Mesityl Oxide<br>2.700 kg.
Export Product Qty. Sl. No. Import Items Qty. allowed.
Enamber / Kephalis / Tetrambrone 1 kg. 1 Triethyl Orthoformate 2.400 kg.
2 Mesityl Oxide 2.700 kg.
Case No. Case No. 94 / NC/3/MEET/Mar/202324/26 94 / NC/3/MEET/Mar/202324/26 94 / NC/3/MEET/Mar/202324/26 94 / NC/3/MEET/Mar/202324/26 94 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name ENCEE AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008402AM24
RA File Number 32AX04000657 AM24
Licence No and<br>Date 3211006285/07/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Sep/202223/8 dated 23/09/2022against advance<br>authorizationNo.3211001926 dated 12/11/2021, it was decided to fix ad-hoc 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>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Triethyl Orthoformate<br>2.400 kg.<br>Enamber / Kephalis / Tetrambrone<br>1 kg.<br>2<br>Mesityl Oxide<br>2.700 kg.
Export Product Qty. Sl. No. Import Items Qty. allowed.
Enamber / Kephalis / Tetrambrone 1 kg. 1 Triethyl Orthoformate 2.400 kg.
2 Mesityl Oxide 2.700 kg.

58

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Case No. 95 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name ARIHANTANAM LIFECARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008403AM24
RA File Number 52AX04000332 AM24
Licence No and<br>Date 5211007299/07/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>LUMEFANTRINE<br>5754 kg.<br>1<br>(DIBUTYLAMINE METHYL)-2,7-<br>DICHLORO-4-FLUOREN<br>METHANOL (DBA)<br>5000 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 96 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008405AM24
RA File Number 03AX04004186 AM24
Licence No and<br>Date 0311030768/07/02/2024

59

UDIN00057719AM25

Norms Committee Decision:

The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:-

  • i. End use of the export product.

  • ii. Step wise manufacturing process.

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

  • iv. Complete technical details as per Annexure to Appendix 4E for chemical products.

  • v. Stoichiometric balance between import and export on molar basis.

  • vi. Details of indigenous input with quantity.

Case No. 97 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008409AM24
RA File Number 03AX04004239 AM24
Licence No and<br>Date 0311030769/07/02/2024
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>End use of the export product.<br>i.<br>Step wise manufacturing process.<br>ii.<br>Complete chemical reactions with molecular and structural formula and molecular weights along with<br>stage wise percentage yields on molar basis.<br>iii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iv.<br>Stoichiometric balance between import and export on molar basis.<br>v.<br>Details of indigenous input with quantity.<br>vi.
  • iii. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.
Case No. 98 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name ADCOCK INGRAM LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008420AM24
RA File Number 07AX04001738 AM24

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UDIN00057719AM25

Licence No and 0711010455/08/02/2024 Date Norms Committee Decision:

The case is under consideration for want of comments of TE.

Case No. 99 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008429AM24
RA File Number 05AX04003525 AM24
Licence No and<br>Date 0511023848/08/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jan/202324/21 dated 24/01/2024against advance<br>authorizationNo.0511021195 dated 27/09/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.<br>I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>CITRIC ACID<br>0.726 kg.<br>2<br>DENATURED ETHYL ALCOHOL<br>0.526 kg.<br>TRI ETHYL CITRATE (TEC)<br>(TRI ETHYL CITRATE (TEC)<br>(PACKED IN 800 NOS. OF<br>HM-HDPE DRUMS MADE<br>OF HDPE GRANULES<br>(6,800.000 KGS.WITHOUT<br>WASTAGE)) (EACH DRUM<br>SHALLWEIGHT 8.5KG AND<br>STORAGE CAPACITY<br>250.000 KGS.)<br>1 kg.<br>3<br>HDPE GRANULES<br>(TOTAL WEIGHT = 7,140.000 KGS.)<br>Relevant, as per<br>packing policy<br>and General<br>Notes.<br>RA concerned may take further necessary action as per above decision of NC.

61

UDIN00057719AM25

Case No. 100 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name AMI ORGANICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008436AM24
RA File Number 52AX04000323 AM24
Licence No and<br>Date 5211007312/08/02/2024
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the<br>TE, it was decided to call for following information/documents from the firm:-<br>Complete Chemical reaction starting from raw materials, stage wise yield and overall yield.<br>1.<br>Indigenous items to use in the process and accordingly to fill Annexure to Appendix-4E.<br>2.<br>Stoichiometic material balance on a molar basis, indicating requirement of raw material.<br>3.<br>End use of export product<br>4.
Case No. 101 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008450AM24
RA File Number 03AX04005000 AM24
Licence No and<br>Date 0311030997/09/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 102 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008464AM24
RA File Number 05AX04003559 AM24
Licence No and<br>Date 0511023876/09/02/2024

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UDIN00057719AM25

Norms Committee Decision:

The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:-

  1. Chemical reaction of the process indicating Structural formula of reactants and products and molecular weight (without using abbreviation of chemicals name).

  2. Stage wise and also overall yield of the reactgio and Stoichiometric balance between import and export items on molar basis.

  3. Application/function of each chemical in the process with justification.

  4. Indigenous items to use in the process and accordingly to fill Annexure to Appendix-4E.

  5. Commercial value of the by-poroduct, if any.

Case No. Case No. 103 / NC/3/MEET/Mar/202324/26 103 / NC/3/MEET/Mar/202324/26 103 / NC/3/MEET/Mar/202324/26 103 / NC/3/MEET/Mar/202324/26 103 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name MANKIND PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008469AM24
RA File Number 05AX04003618 AM24
Licence No and<br>Date 0511023881/09/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Jan/202324/21 dated 24/01/2024against advance<br>authorizationNo.0511021940 dated 07/11/2023, it was decided to fix ad-hoc 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>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Atropine Sulfate Ophthalmic Solution USP, 1%<br>2 ml(Having net content of 2.40 kg of Bulk drug<br>(filling volume 2.32 ml in each number))<br>1 Number<br>1<br>ATROPINE SULPHATE<br>20.40 mg.<br>Atropine Sulfate Ophthalmic Solution USP, 1%<br>5 ml(Having net content of 4.80 kg of Bulk drug<br>(filling volume 5.61 ml in each number))<br>1 Number<br>2<br>ATROPINE SULPHATE<br>51.00 mg.<br>Atropine Sulfate Ophthalmic Solution USP, 1%<br>15 ml(Having net content of 3.60 kg of Bulk<br>drug (filling volume 15.91 ml in each number))<br>1 Number<br>3<br>ATROPINE SULPHATE<br>153.0 mg
Export Product Qty. Sl. No. Import Items Qty. allowed.
Atropine Sulfate Ophthalmic Solution USP, 1%<br>2 ml(Having net content of 2.40 kg of Bulk drug<br>(filling volume 2.32 ml in each number)) <br>1 Number 1 ATROPINE SULPHATE 20.40 mg.
Atropine Sulfate Ophthalmic Solution USP, 1%<br>5 ml(Having net content of 4.80 kg of Bulk drug<br>(filling volume 5.61 ml in each number)) <br>1 Number 2 ATROPINE SULPHATE 51.00 mg.
Atropine Sulfate Ophthalmic Solution USP, 1%<br>15 ml(Having net content of 3.60 kg of Bulk<br>drug (filling volume 15.91 ml in each number)) 1 Number 3 ATROPINE SULPHATE 153.0 mg

63

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Case No. 104 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name ELPPE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008471AM24
RA File Number 03AX04004959 AM24
Licence No and<br>Date 0311031032/09/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. Case No. 105 / NC/3/MEET/Mar/202324/26 105 / NC/3/MEET/Mar/202324/26 105 / NC/3/MEET/Mar/202324/26 105 / NC/3/MEET/Mar/202324/26 105 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008498AM24
RA File Number 03AX04005150 AM24
Licence No and<br>Date 0311031086/12/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance<br>authorizationNo.0311026365 dated 16/08/2023, it was decided to fix ad-hoc 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>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Atorvastatin Calcium Propylene<br>Glycol Solvate USP<br>11.4415 mg<br>Atorvastatin Calcium Tablets USP 10mg ((Net<br>Content of Import Sr. No. 1 is 5.137 kgs, Sr.<br>1 Number<br>Tablet
Export Product Qty. Sl. No. Import Items Qty. allowed.
Atorvastatin Calcium Tablets USP 10mg ((Net<br>Content of Import Sr. No. 1 is 5.137 kgs, Sr. <br>1 Number<br>Tablet 1 Atorvastatin Calcium Propylene<br>Glycol Solvate USP 11.4415 mg

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No. 2 is 29.060 kg, Sr. No. 3 is 8.122 kg, Sr.<br>No. 4 is 5050 Nos.)) 2 Microcrystalline Cellulose (MCC)<br>NF (Avicel PH 102) 64.578 mg.
3 Calcium Acetate 18.049 mg.
4 Silica Gel Dessicants - Packaged<br>Activated Carbon (Strippax Sorbent) Relevant, as per<br>packing policy<br>and General<br>Notes.
Atorvastatin Calcium Tablets USP 20 mg<br>((Net Content of Import Sr. No. 1 is 102.735<br>kgs, Sr. No. 2 is 582.422 kg, Sr. No. 3 is<br>162.405 kg, Sr. No. 4 is 50500 Nos.)) 1 Number<br>Tablet 5 Atorvastatin Calcium Propylene<br>Glycol Solvate USP 22.830 mg.
6 Microcrystalline Cellulose (MCC)<br>NF (Avicel PH 102) 129.427 mg.
7 Calcium Acetate 36.090 mg.
8 Silica Gel Dessicants - Packaged<br>Activated Carbon (Strippax Sorbent) Relevant, as per<br>packing policy<br>and General<br>Notes.
Atorvastatin Calcium Tablets USP 40mg ((Net<br>Content of Import Sr. No. 1 is 1436.243 kgs,<br>Sr. No. 2 is 8129.520 kg, Sr. No. 3 is 2266.835<br>kg, Sr. No. 4 is 353500 Nos.)) <br> <br>1 Number<br>Tablet 9 Atorvastatin Calcium Propylene<br>Glycol Solvate USP 45.595 mg.
10 Microcrystalline Cellulose (MCC)<br>NF (Avicel PH 102) 258.08 mg.
11 Calcium Acetate 71.963 mg.
12 Silica Gel Dessicants - Packaged<br>Activated Carbon (Strippax Sorbent) Relevant, as per<br>packing policy<br>and General<br>Notes.
Atorvastatin Calcium Tablets USP 80mg ((Net<br>Content of Import Sr. No. 1 is 4104.000 kgs,<br>Sr. No. 2 is 23319.720 kg, Sr. No. 3 is<br>6521.805 kg, Sr. No. 4 is 505000 Nos.)) <br>1 Number<br>Tablet 13 Atorvastatin Calcium Propylene<br>Glycol Solvate USP 91.20 mg.
14 Microcrystalline Cellulose (MCC)<br>NF (Avicel PH 102) 518.206 mg.
15 Calcium Acetate 144.929 mg.

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16 Silica Gel Dessicants - Packaged Relevant, as per
Activated Carbon (Strippax Sorbent) packing policy
and General
Notes.

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

  1. Export Product being Patented Medicine, be filed with USFDA filing ANDA (A New Drug Application ) of Apotex Corp, US. Agent for Apotex Inc., Canada.

  2. Export to USA only.

  3. Firm holding Certificate of Manufacturing Exclusivity.

Case No. Case No. 106 / NC/3/MEET/Mar/202324/26 106 / NC/3/MEET/Mar/202324/26 106 / NC/3/MEET/Mar/202324/26 106 / NC/3/MEET/Mar/202324/26 106 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name SMS PHARMACEUTICALS LIMITED
Meeting Number and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008513AM24
RA File Number 09AX04000992 AM24
Licence No and Date 0911006731/12/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance<br>authorizationNo.0911005461 dated 21/07/2023, it was decided to fix ad-hoc 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>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>1<br>2,4,5 TRIFLUOROPHENYLACETIC<br>ACID<br>1.146 kg.<br>2<br>MELDRUM ACID<br>0.88 kg.<br>SITAGLIPTIN HYDROCHLORIDE<br>1 kg.
Export Product Qty. Sl. No. Import Items Qty.<br>allowed.
SITAGLIPTIN HYDROCHLORIDE 1 kg. 1 2,4,5 TRIFLUOROPHENYLACETIC<br>ACID 1.146 kg.
2 MELDRUM ACID 0.88 kg.

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3<br>3-(TERIFLUOROMETHYL)-5,6,7,8-<br>TETRAHYDRI-[1,2,4] TRIAZOLO[4,3-<br>a] PYRAZINE HYDROCHLORIDE<br>0.75 kg.<br>4<br>DI-TERTIARY BUTYL<br>DICARBONATE (DIBOC)<br>1.50 kg.<br>5<br>TETRAHYDROFURAN<br>2.56 kg.<br>6<br>ISO PROPYL ALCOHOL<br>3.75 kg.<br>7<br>METHANOL<br>7.77 kg.<br>8<br>N-HEPTANE<br>1.80 kg.<br>9<br>TERTIARY BUTANOL (T-<br>BUTANOL)<br>2.17 kg.<br>10<br>R-(+)-Alpha-Phenylethylamine<br>1.00 kg.<br>11<br>SODIUM BOROHYDRIDE<br>0.30 kg.<br>12<br>ACETONITRILE<br>1.14 kg.<br>RA concerned may take further necessary action as per above decision of NC. 3 3-(TERIFLUOROMETHYL)-5,6,7,8-<br>TETRAHYDRI-[1,2,4] TRIAZOLO[4,3-<br>a] PYRAZINE HYDROCHLORIDE 0.75 kg.
4 DI-TERTIARY BUTYL<br>DICARBONATE (DIBOC) 1.50 kg.
5 TETRAHYDROFURAN 2.56 kg.
6 ISO PROPYL ALCOHOL 3.75 kg.
7 METHANOL 7.77 kg.
8 N-HEPTANE 1.80 kg.
9 TERTIARY BUTANOL (T-<br>BUTANOL) 2.17 kg.
10 R-(+)-Alpha-Phenylethylamine 1.00 kg.
11 SODIUM BOROHYDRIDE 0.30 kg.
12 ACETONITRILE 1.14 kg.
Case No. 107 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name SMILAX LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008518AM24
RA File Number 09AX04000984 AM24
Licence No and<br>Date 0911006732/12/02/2024
Norms Committee Decision:

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The case is under consideration for want of comments of TE.

Case No. 108 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name CATION PHARMA
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008519AM24
RA File Number 52AX04000341 AM24
Licence No and<br>Date 5211007357/12/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. Case No. 109 / NC/3/MEET/Mar/202324/26 109 / NC/3/MEET/Mar/202324/26 109 / NC/3/MEET/Mar/202324/26 109 / NC/3/MEET/Mar/202324/26 109 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008530AM24
RA File Number 05AX04003214 AM24
Licence No and<br>Date 0511023924/13/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Aug/202324/11 dated 22/08/2023against advance<br>authorizationNo.0510414006 dated 16/04/2020, it was decided to fix ad-hoc 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>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>CEFEPIME FOR INJECTION<br>1 kg.<br>1<br>CEFEPIME HCL (NON STERILE)<br>0.655 kg.
Export Product Qty. Sl. No. Import Items Qty. allowed.
CEFEPIME FOR INJECTION 1 kg. 1 CEFEPIME HCL (NON STERILE) 0.655 kg.

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Case No. 110 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name ATUL LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008531AM24
RA File Number 08AX04002041 AM24
Licence No and<br>Date 0811010749/13/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 111 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name MANKIND PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008554AM24
RA File Number 05AX04003657 AM24
Licence No and<br>Date 0511023947/13/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 112 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008559AM24
RA File Number 03AX04004580 AM24

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Licence No and 0311031163/14/02/2024 Date Norms Committee Decision:

The committee considered the request of firm for review/fixation of ad-hoc norms and as per the advise of the TE, it was decided to call for following information/documents from the firm:-

  • i. End use of the export product.

  • Step wise manufacturing process.

  • ii.

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

  • iv. Complete technical details as per Annexure to Appendix 4E for chemical products.

  • v. Stoichiometric balance between import and export on molar basis.

  • vi. Details of indigenous input with quantity.

Case No. 113 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name FDC LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008564AM24
RA File Number 03AX04005181 AM24
Licence No and<br>Date 0311031166/14/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 114 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name MANKIND PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008566AM24
RA File Number 05AX04003666 AM24
Licence No and<br>Date 0511023953/14/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

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Case No. 115 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name BASIL DRUGS AND PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008570AM24
RA File Number 03AX04005041 AM24
Licence No and<br>Date 0311031186/14/02/2024
Norms Committee Decision:
The case is under consideration for want of comments of TE.
Case No. 116 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008572AM24
RA File Number 09AX04000977 AM24
Licence No and Date 0911006753/14/02/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance
authorizationNo.0911005617 dated 10/08/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I
as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No. Import Items Qty.
allowed.
1<br>GCLE(7- PHENYLACETAMIDEO- 3-<br>1 kg. PENICILLIN G POTASSIUM FIRST 1.375 kg.
CHLOROMETHYLCEPHALOSPORANIC CRYSTAL
ACID PARA METHOXY BENZYL
ESTER)
2 ACETONE 1.971 kg.
(WHITE CRYSTALLINE POWDER)
3 METHYLENE CHLORIDE MDC 3.29 kg.
Case No. 116 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name VIRCHOW PETROCHEMICAL PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008572AM24
RA File Number 09AX04000977 AM24
Licence No and Date 0911006753/14/02/2024
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from the earlier decision for same export
product/import product in meetingNo.NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance
authorizationNo.0911005617 dated 10/08/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I
as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl. No. Import Items Qty.
allowed.
1<br>GCLE(7- PHENYLACETAMIDEO- 3-<br>1 kg. PENICILLIN G POTASSIUM FIRST 1.375 kg.
CHLOROMETHYLCEPHALOSPORANIC CRYSTAL
ACID PARA METHOXY BENZYL
ESTER)
2 ACETONE 1.971 kg.
(WHITE CRYSTALLINE POWDER)
3 METHYLENE CHLORIDE MDC 3.29 kg.

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4 2 MERCAPTO BENZO THIAZLOLE 0.511 kg.
MBT
5 METHANOL 1.971 kg.
Case No. 117 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008576AM24
RA File Number 03AX04005212 AM24
Licence No and<br>Date 0311031193/14/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>PHENOL<br>0.06 kg.<br>2<br>ISODECYL ALCOHOL OR 2<br>PROPYL HEPTANOL<br>0.98 kg.<br>Triisodecyl Phosphite((TDP))<br>1 kg.<br>3<br>YELLOW PHOSPHORUS<br>0.06 kg.<br>RA concerned may take further necessary action as per above decision of NC.

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Case No. 118 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name SUPRIYA LIFESCIENCE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008592AM24
RA File Number 03AX04005187 AM24
Licence No and<br>Date 0311031241/15/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Dec/202324/17 dated 20/12/2023against advance<br>authorizationNo.0311028054 dated 19/10/2023, it was decided to fix ad-hoc 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>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>VITAMIN B2 OR RIBOFLAVIN<br>1.10 kg.<br>2<br>PYRIDINE<br>2.00 kg.<br>3<br>ACETONITRILE<br>1.73 kg.<br>RIBOFLAVIN SODIUM PHOSPHATE<br>HYDRATE EP 11.2<br>1 kg.<br>4<br>PHOSPHORUS OXYCHLORIDE<br>2.00 kg.<br>Note: Above norms are for EP 11.2 grade only. No interchangeable of grade is permitted.<br>RA concerned may take further necessary action as per above decision of NC.
Case No.<br> 119 / NC/3/MEET/Mar/202324/26
Case Status<br> Case Approved
Party Name<br> STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date<br> NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number<br> HQRNORM APPLY 00008594AM24
RA File Number<br> 05AX04003543 AM24

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Licence No and 0511023989/15/02/2024 Date Norms Committee Decision:

The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import product in meeting No.NC/3/MEET/Nov/202324/12 dated 18/11/2022 against advance authorization No.0511010960 dated 11/03/2022 , it was decided to fix ad-hoc 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. allowed.
Ceftriaxone Sodium Sterile 1 kg. 1 Ceftriaxone Sodium Non Sterile 1.04 kg.
Case No. Case No. 120 / NC/3/MEET/Mar/202324/26 120 / NC/3/MEET/Mar/202324/26 120 / NC/3/MEET/Mar/202324/26 120 / NC/3/MEET/Mar/202324/26 120 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name AMI ORGANICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008597AM24
RA File Number 52AX04000349 AM24
Licence No and<br>Date 5211007412/15/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.4/82-ALC4/2018 dated 19/06/2018against advance authorization<br>No.5210042461 dated 22/12/2017, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>1<br>SEMICARBAZIDE HCL - 99% MIN<br>2.422 kg.<br>2<br>2-CHLORO PYRIDINE<br>1.14 kg.<br>1,2,4 - TRIAZOLO (4,3-a) PYRIDIN -3<br>(2H) - ONE - 98% MIN.<br>1 kg.
Export Product Qty. Sl. No. Import Items Qty.<br>allowed.
1,2,4 - TRIAZOLO (4,3-a) PYRIDIN -3<br>(2H) - ONE - 98% MIN. 1 kg. 1 SEMICARBAZIDE HCL - 99% MIN 2.422 kg.
2 2-CHLORO PYRIDINE 1.14 kg.

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3 ETHYLENE GLYCOL MONOETHYL 1.20 kg. ETHER/2-ETHOXY ETHANOL

Case No. 121 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name TIDE INDUSTRIES
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008605AM24
RA File Number 34AX04000854 AM24
Licence No and<br>Date 3411004626/16/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.15/82-ALC4/2018 dated 22/03/2019against advance authorization<br>No.3410044015 dated 04/04/2018, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Aldehyde C10(Capric Aldehyde)<br>1 kg.<br>1<br>Fatty Alcohol C10<br>1.40 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 122 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name YELLOWSTONE FINE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008613AM24

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RA File Number 03AX04005249 AM24
Licence No and<br>Date 0311031269/16/02/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it<br>was decided to call for following information/documents from the firm:-<br>Molecular weight of export product.<br>i.<br>Stoichiometric Balance with percentage of yield on molar basis to arrive at the quantity of raw material<br>asked.<br>ii.
Case No. 123 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008616AM24
RA File Number 03AX04005267 AM24
Licence No and<br>Date 0311031276/16/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 124 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number and<br>Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008617AM24
RA File Number 03AX04005241 AM24
Licence No and Date 0311031277/16/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>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. allowed.
INDAPAMIDE 2.5MG TABLETS 1 Number 1 Indapamide 2.55 mg./Tablet
Case No. 125 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name UMEDICA LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008618AM24
RA File Number 03AX04005219 AM24
Licence No and<br>Date 0311031282/16/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Rosuvastatin<br>Calcium<br>USP/BP/EP/IH<br>1 kg<br>1<br> Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-fluorophenyl)-6-<br>isopropyl-2-(N-methylmethylsulfonamido) pyrimidin-<br>5-yl)vinyl)-2,2-dimethyl-1,3-dioxan-4-yl) acetate<br>1.30 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 126 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name CDYMAX (INDIA) PHARMA PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024

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HQ File Number HQRNORM APPLY 00008638AM24
RA File Number 07AX04001746 AM24
Licence No and Date 0711010558/19/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>TENOFOVIR<br>DISOPROXIL<br>FUMARATE (TDF) ((TDF))<br>1 kg.<br>1<br>(R) 9-(2 PHOSPHONOMETHOXYPROPYL)<br>ADENINE (PMPA)<br>0.689 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 127 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name SRF LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008643AM24
RA File Number 05AX04003613 AM24
Licence No and<br>Date 0511024042/19/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 128 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name PRASHI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008647AM24
RA File Number 03AX04005005 AM24

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Licence No and 0311031320/19/02/2024 Date Norms Committee Decision:

The case is under consideration for want of comments of TE.

Case No. 129 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name FDC LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008651AM24
RA File Number 03AX04005314 AM24
Licence No and<br>Date 0311031329/20/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>GENTAMICIN EYE/EAR DROPS 10<br>ML ((EACH VIAL CONTAINS<br>GENTAMICIN SULPHATE 0.030GM<br>NET WT OF BULK DRUG IS 4.140<br>KGS))<br>138000 Vials<br>1<br>GENTAMICIN SULPHATE<br>5.072 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 130 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024

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HQ File Number HQRNORM APPLY 00008671AM24
RA File Number 07AX04001818 AM24
Licence No and<br>Date 0711010595/21/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 131 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008672AM24
RA File Number 07AX04001823 AM24
Licence No and<br>Date 0711010596/21/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.NC/3/MEET/Nov/202223/12 dated 18/11/2022against advance<br>authorizationNo.0711003904 dated 04/05/2022, it was decided to fix ad-hoc 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>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>MAGNESIUM PIDOLATE (Eur.Ph)<br>1 MT<br>1<br>L-PYROGLUTAMIC ACID<br>0.90 MT<br>CALCIUM PIDOLATE<br>1 MT<br>2<br>L-PYROGLUTAMIC ACID<br>0.82 MT<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 132 / NC/3/MEET/Mar/202324/26

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Case Status Case Deferred
Party Name AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008680AM24
RA File Number 08AX04002108 AM24
Licence No and<br>Date 0811010830/21/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 133 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008681AM24
RA File Number 08AX04002104 AM24
Licence No and<br>Date 0811010831/21/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Tranexamic Acid in 0.7% Sodium<br>Chloride Injection 1,000 mg per 100<br>mL (10 mg/mL)<br>1 Number<br>1<br>Tranexamic acid<br>(Injectable grade, US FDA<br>approved)<br>1.05 gm/100 ml Vial<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 134 / NC/3/MEET/Mar/202324/26

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Case Status Case Deferred
Party Name SPAR PHARMA LLP
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008685AM24
RA File Number 09AX04000988 AM24
Licence No and<br>Date 0911006814/21/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. Case No. 135 / NC/3/MEET/Mar/202324/26 135 / NC/3/MEET/Mar/202324/26 135 / NC/3/MEET/Mar/202324/26 135 / NC/3/MEET/Mar/202324/26 135 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008687AM24
RA File Number 03AX04005332 AM24
Licence No and<br>Date 0311031376/21/02/2024
Norms Committee Decision:<br>The Committee considered the case<br>Vol. I as per details given below or a<br>Export Product<br>Qty.<br>CYCLAMEN<br>ALDEHYDE -Pure<br>1 kg. as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>s applied by the firm, whichever is less:-
Export Product Qty. **Sl. No. ** Import Items Qty. allowed.
CYCLAMEN<br>ALDEHYDE -Pure 1 kg. 1<br> CUMINIQUE ALDEHYDE 0.928 kg.
2<br> PROPIONALDEHYDE OR PROPANAL 0.393 kg.
3<br> 1% PALLADIUM ON CARBON CATALYST 0.00086 kg.
4<br> ACETIC ACID 0.064 kg.
5<br> METHANOL 0.131 kg.

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Case No. 136 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008696AM24
RA File Number 03AX04005309 AM24
Licence No and<br>Date 0311031390/22/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 137 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name HIND PHARMA
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008700AM24
RA File Number 56AX04000681 AM24
Licence No and<br>Date 5611002746/22/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 138 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008716AM24
RA File Number 05AX04003777 AM24

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Licence No and 0511024122/23/02/2024 Date Norms Committee Decision:

The committee considered the case as per agenda and it was decided to fix ad-hoc norms as per SION A-412.

Case No. 139 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008718AM24
RA File Number 03AX04005330 AM24
Licence No and<br>Date 0311031439/23/02/2024
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and as per the advise of the TE, it<br>was decided to call for following information/documents from the firm:-<br>Chemical name of**SYNPERONIC T/1301-LQ-(CQ) and:****Primol 352 and its function in the reaction and**<br>to enclosed the catalogue/literature.<br>1.<br>Calculation to arrive the quantity of inputs, giving stage wise and overall yield of the reaction.<br>2.<br>To fill Annexure to Appendix-4E giving indigenous items also to use.<br>3.
Case No. 140 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name SWISS PARENTERALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008744AM24
RA File Number 08AX04002112 AM24
Licence No and<br>Date 0811010864/26/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-

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Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>MEROPENEM FOR INJECTION<br>500MG (Meropenem 500mg Powder<br>for Solution for Injection or Infusion.<br>Eachvialcontains Active<br>Pharmaceutical Ingredients<br>Meropenem Trihydrate Eqv. to<br>Meropenem Anhydrous 500mg<br>Excipients: Anhydrous Sodium<br>Carbonate 104mg, Equivalent to<br>45.1mg of Sodium)<br>1 Number<br>1<br>STERILE MIXTURE OF<br>MEROPENEM<br>AND<br>SODIUM CARBONATE<br>0.645 gm/500 mg<br>Injection<br>MEROPENEM FOR INJECTION<br>1gm (Meropenem 1.0 GM Powder for<br>Solution for Injection or Infusion.<br>Each vialcontains Active<br>Pharmaceutical Ingredients<br>MeropenemTrihydrate Eqv. To<br>Meropenem Anhydrous 1000mg<br>Excipients: AnhydrousSodium<br>Carbonate 208mg, Equivalent to<br>90.2mg of Sodium)<br>1 Number<br>2<br>STERILE MIXTURE OF<br>MEROPENEM<br>AND<br>SODIUM CARBONATE<br>1.29 gm /1gm<br>Injection<br>RA concerned may take further necessary action as per above decision of NC. Export Product Qty. **Sl. No. ** Import Items Qty. allowed.
MEROPENEM FOR INJECTION<br>500MG (Meropenem 500mg Powder<br>for Solution for Injection or Infusion.<br>Eachvialcontains Active<br>Pharmaceutical Ingredients<br>Meropenem Trihydrate Eqv. to<br>Meropenem Anhydrous 500mg<br>Excipients: Anhydrous Sodium<br>Carbonate 104mg, Equivalent to<br>45.1mg of Sodium) 1 Number 1<br> <br> <br> STERILE MIXTURE OF<br>MEROPENEM<br>AND<br>SODIUM CARBONATE <br> <br>0.645 gm/500 mg<br>Injection
MEROPENEM FOR INJECTION<br>1gm (Meropenem 1.0 GM Powder for<br>Solution for Injection or Infusion.<br>Each vialcontains Active<br>Pharmaceutical Ingredients<br>MeropenemTrihydrate Eqv. To<br>Meropenem Anhydrous 1000mg<br>Excipients: AnhydrousSodium<br>Carbonate 208mg, Equivalent to<br>90.2mg of Sodium) 1 Number 2<br> <br> <br> STERILE MIXTURE OF<br>MEROPENEM<br>AND<br>SODIUM CARBONATE <br> <br>1.29 gm /1gm<br>Injection
Case No. 141 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name SRI KRISHNA PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008748AM24
RA File Number 09AX04001052 AM24
Licence No and<br>Date 0911006828/26/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-

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Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>CARBIDOPA<br>12.75 mg/Tablet<br>CARBIDOPA 12.5 MG LEVODOPA<br>50MG TABLETS<br>1 Number<br>2<br>LEVODOPA<br>51.00 mg/Tablet<br>RA concerned may take further necessary action as per above decision of NC. Export Product Qty. **Sl. No. ** Import Items Qty. allowed.
CARBIDOPA 12.5 MG LEVODOPA<br>50MG TABLETS <br>1 Number 1<br> CARBIDOPA 12.75 mg/Tablet
2<br> LEVODOPA 51.00 mg/Tablet
Case No. 142 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name MEDICLONE HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008751AM24
RA File Number 04AX04001035 AM24
Licence No and<br>Date 0411006998/26/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 143 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008754AM24
RA File Number 05AX04003662 AM24
Licence No and<br>Date 0511024074/26/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-

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Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>CEFIPRIN 200 TABLET(CEFIXIME 200 MG<br>TABLET (PACK SIZE - 1 X 10'S))<br>1 Number<br>1<br>CEFIXIME<br>204.00 mg / Tablet<br>CEFIPRIN 400 TABLET(CEFIXIME 400 MG<br>TABLET (PACK SIZE - 1 X 10'S))<br>1 Number<br>2<br>CEFIXIME<br>408 mg / Tablet<br>VIREXIM 400 CAPSULE(CEFIXIME 400 MG<br>CAPSULE (PACK SIZE - 10 X 10'S))<br>1 Number<br>3<br>CEFIXIME<br>408 mg / Capsule<br>RA concerned may take further necessary action as per above decision of NC. Export Product Qty. **Sl. No. ** Import Items Qty. allowed.
CEFIPRIN 200 TABLET(CEFIXIME 200 MG<br>TABLET (PACK SIZE - 1 X 10'S)) 1 Number 1<br> CEFIXIME 204.00 mg / Tablet
CEFIPRIN 400 TABLET(CEFIXIME 400 MG<br>TABLET (PACK SIZE - 1 X 10'S))<br> 1 Number 2<br> CEFIXIME 408 mg / Tablet
VIREXIM 400 CAPSULE(CEFIXIME 400 MG<br>CAPSULE (PACK SIZE - 10 X 10'S))<br> 1 Number 3<br> CEFIXIME 408 mg / Capsule
Case No. 144 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008755AM24
RA File Number 05AX04003663 AM24
Licence No and<br>Date 0511023926/26/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 145 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008761AM24
RA File Number 03AX04005401 AM24
Licence No and<br>Date 0311031503/27/02/2024
Norms Committee Decision:

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UDIN00057719AM25

The case is under consideration for want of comments of TE.

Case No. 146 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name S KANT CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008762AM24
RA File Number 03AX04005393 AM24
Licence No and<br>Date 0311031505/27/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 147 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name PRIVI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008765AM24
RA File Number 03AX04005326 AM24
Licence No and<br>Date 0311031507/27/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 148 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name UMEDICA LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008771AM24
RA File Number 03AX04005218 AM24

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Licence No and<br>Date 0311031522/27/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>(4R-CIS)-1, 1- Dimethylethyl-6-<br>Cyanomethyl-2, 2-Dimethyl-1-3-<br>Dioxane-4-Acetate<br>0.6259 kg<br>Atorvastatin Calcium Trihydrate<br>USP/BP/EP/IH<br>1 kg.<br>2<br>Iso Propyl Alcohol<br>2.56 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 149 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name SWISS PARENTERALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008773AM24
RA File Number 08AX04002087 AM24
Licence No and<br>Date 0811010888/27/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 150 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name PIRAMAL PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008780AM24

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RA File Number 03AX04005442 AM24
Licence No and<br>Date 0311031542/27/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 151 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008783AM24
RA File Number 03AX04005399 AM24
Licence No and<br>Date 0311031475/28/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 152 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008792AM24
RA File Number 08AX04002148 AM24
Licence No and<br>Date 0811010899/28/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 153 / NC/3/MEET/Mar/202324/26
Case Status Case Approved
Party Name UMEDICA LABORATORIES PRIVATE LIMITED

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Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008795AM24
RA File Number 03AX04005051 AM24
Licence No and<br>Date 0311031566/28/02/2024
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNoNC/3/MEET/Apr/202324/1 dated 28/04/2023against advance authorization<br>No.0311019954 dated 13/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Oxcarbazepine USP/BP/EP/IH<br>1 kg.<br>1<br>10-Methoxy Iminostilbene<br>1.10 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 154 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008801AM24
RA File Number 03AX04005270 AM24
Licence No and<br>Date 0311031579/28/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 155 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name MAXMED LIFE SCIENCES PRIVATE LIMITED
Meeting Number NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024

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UDIN00057719AM25

and Date
HQ File Number HQRNORM APPLY 00008802AM24
RA File Number 05AX04003602 AM24
Licence No and<br>Date 0511024076/28/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 156 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008814AM24
RA File Number 05AX04003827 AM24
Licence No and<br>Date 0511024211/29/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 157 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008824AM24
RA File Number 34AX04000861 AM24
Licence No and<br>Date 3411004655/29/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No. 158 / NC/3/MEET/Mar/202324/26

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Case Status Case Deferred
Party Name RUBICON RESEARCH PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008826AM24
RA File Number 03AX04005194 AM24
Licence No and<br>Date 0311031599/29/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 159 / NC/3/MEET/Mar/202324/26
Case Status Case Deferred
Party Name TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Mar/ 202324/ 26 and 22/03/2024
HQ File Number HQRNORM APPLY 00008831AM24
RA File Number 08AX04002140 AM24
Licence No and<br>Date 0811010931/29/02/2024
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

93 This document has been digitally signed by Raman Kumar, Deputy DGFT on 25-04-2024 11:42:40.

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