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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

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Jan/202324/20 DATED: 18/01/2024

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.

Meeting No. NC/3/MEET/Jan/202324/20 dated 18/01/2024 of Norms Committee - III for the year 2023-24 was held on 18/01/2024 under the Chairmanship of Rajiv Soni ,Joint DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

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

The following members were present in the meeting:-

S.No. Name and Designation of Representatives Department
1 UTTAM SARKAR,Assistant Section Officer 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

1 This document has been digitally signed by Raman Kumar, Deputy DGFT on 12-02-2024 12:35:23.

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Case Details and Decision(s):

Case No. Case No. 1 / NC/3/MEET/Jan/202324/20 1 / NC/3/MEET/Jan/202324/20 1 / NC/3/MEET/Jan/202324/20 1 / NC/3/MEET/Jan/202324/20 1 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name SMILAX LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00006097AM24
RA File Number NA
Licence No and<br>Date NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to 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>Dimethyl-3-Hydroxy Glutarate<br>1.106 kg.<br>2<br>Ditertbutyl Dicarbonate<br>1.564 kg.<br>3<br>Tertiary Butyl dimethyl Silyl Chloride<br>2.136 kg.<br>4<br>Imidazole<br>1.319 kg.<br>5<br>R-Phenylethyl amine<br>0.480 kg.<br>(R)-3- (Tert-butyl dimethyl<br>silyloxy)-pentane-dioic acid mono<br>tert-butyl ester (TB-17) (TERT-<br>BUTYL 3R-TERT-<br>BUTYL DIMETHYL SILYLOXY-<br>GLUTARATE)<br>1 kg.<br>6<br>Tertiary Butanol<br>1.310 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Export Product Qty. **Sl. No. ** Import Items **Qty.

r>1 kg.<br>6<br>Tertiary Butanol<br>1.310 kg.<br>RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||(R)-3- (Tert-butyl dimethyl<br>silyloxy)-pentane-dioic acid mono<br>tert-butyl ester (TB-17) (TERT-<br>BUTYL 3R-TERT-<br>BUTYL DIMETHYL SILYLOXY-<br>GLUTARATE)||1 kg.|1|Dimethyl-3-Hydroxy Glutarate|1.106 kg.| |||||2|Ditertbutyl Dicarbonate|1.564 kg.| |||||3|Tertiary Butyl dimethyl Silyl Chloride|2.136 kg.| |||||4|Imidazole|1.319 kg.| |||||5|R-Phenylethyl amine|0.480 kg.| |||||6|Tertiary Butanol|1.310 kg.| |||||s per above decision of NC.|||

Case No. 2 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name AQUILA ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM REVIW00005238AM24
RA File Number NA
Licence No and 0310830783/null

This document has been digitally signed by Raman Kumar, Deputy DGFT on 12-02-2024 12:35:23.

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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.
7-Acetyl-1,1,3,4,6-Hexamethyl 1,2,3,4-<br>Tetrahydro Napthalene (GANOLID) 1 kg. 1 2,3 Dimethyl 1 Butene 0.93 kg.
2 PARACYMENE 0.74 kg.

Import Items**|Qty. allowed.| |---|---|---|---|---| |7-Acetyl-1,1,3,4,6-Hexamethyl 1,2,3,4-<br>Tetrahydro Napthalene (GANOLID)|1 kg.|1|2,3 Dimethyl 1 Butene|0.93 kg.| |||2|PARACYMENE|0.74 kg.|

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

Case No. 3 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM REVIW00004138AM23
RA File Number 092404000365 AM21
Licence No and<br>Date 0910069368/22/10/2020
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 4 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name SWISS PARENTERALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM REVIW00003403AM23
RA File Number 08AA04007143 AM22
Licence No and<br>Date 0811001742/15/06/2021
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 authorization<br>No. 0511007079 dated 21/12/2021, 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:-

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7079** dated 21/12/2021, 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:-||

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Export Product Qty. **Sl. No. ** Import Items Qty.<br>allowed.
CEFEPIME FOR INJECTION 1GM<br>USP/BP/CEP/EP/ChP/IP 1 Number 1 CEFEPIME HCL + ARGENINE<br>STERILE 1.05 gm.
CEFEPIME FOR INJECTION 2GM<br>USP/BP/CEP/EP/ChP/IP 1 Number 2 CEFEPIME HCL + ARGENINE<br>STERILE 2.10 gm
Case No. 5 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name SYNOKEM PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00147457AM22
RA File Number 05AA04059070 AM22
Licence No and<br>Date 0511003826/26/07/2021
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Get the license amended with correct export product and import item.
Case No. 6 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name SUNDYOTA NUMANDIS PROBIOCEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM REVIW00004161AM24
RA File Number 08AA04021121 AM22
Licence No and<br>Date 0811002324/16/08/2021
Norms Committee Decision:

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20 and 18/01/2024| |HQ File Number|HQRNORM REVIW00004161AM24| |RA File Number|08AA04021121 AM22| |Licence No and<br>Date|0811002324/16/08/2021| |Norms Committee Decision:||

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

  1. NBA approval.

  2. Technical process flow diagram of manufacturing of Bifidobacterium longum w11 5 bn and Fructooligosacc haride 2.5. gm. Powder involving all the imported items and wastage involved at each steps.

Case No. 7 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name CUCKOS PHARMACEUTICAL PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00184568AM22
RA File Number 33AA04006480 AM22
Licence No and<br>Date 3311000430/15/09/2021
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>Liquid Amitraz DIP Concentrate 12.5<br>Percent<br>w/v(Liquid<br>Amitraz<br>DIP<br>Concentrate 12.5 Percent w/v)<br>3000 Liters<br>1<br>Amitraz<br>CAS NO.: 33089-61-1<br>382.5 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Amitraz<br>DIP<br>Concentrate 12.5 Percent w/v)<br>3000 Liters<br>1<br>Amitraz<br>CAS NO.: 33089-61-1<br>382.5 kg.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 8 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00212058AM22
RA File Number 03AA040109332 AM22
Licence No and<br>Date 0311007711/14/10/2021
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<br>product/import product in meetingNo. NC/3/MEET/Jul/202324/9 datedagainst advance authorizationNo.<br>**0310819230 dated 19/02/2018,**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.

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>Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical<br>ingredient(API) SANAL P<br>Net content in<br>export + 2%<br>wastage<br>2<br>UFR2 150/524 Plastic film non PVC for<br>Secondary packing<br>Net + 5% Wastage<br>3<br>Hot Stamping foil<br>Net + 1% Wastage<br>4<br>Ship Shape Corpus Infusion<br>Net + 1% Wastage<br>5<br>Ship Shape Corpus Injection with PP<br>membrane 0.8<br>Net + 1% Wastage<br>6<br>Ship Shape Break of Infusion blue<br>Net + 1% Wastage<br>7<br>Ship Shape Break of Injection<br>Net + 1% Wastage<br>8<br>SF9 195/95 Plastic film non PVC for<br>Primary packing<br>Net + 5% Wastage<br>9<br>OFR2 150/524 Plastic film non PVC for<br>Secondary packing<br>Net + 5% Wastage<br>10<br>Corrugated Boxes 385 x 285 x<br>220mm(FFX Karton) AUS<br>Net + 1% Wastage<br>11<br>Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net<br>12<br>Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net<br>Sodium Chloride NACL Pharmaceutical<br>Net content in<br>Sodium Chloride 9 % 100<br>ml<br>1 Number<br>13|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/Jul/202324/9 datedagainst advance authorizationNo.<br>**0310819230 dated 19/02/2018,**it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

import product in meetingNo. NC/3/MEET/Jul/202324/9 datedagainst advance authorizationNo.<br>**0310819230 dated 19/02/2018,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>Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical<br>ingredient(API) SANAL P<br>Net content in<br>export + 2%<br>wastage<br>2<br>UFR2 150/524 Plastic film non PVC for<br>Secondary packing<br>Net + 5% Wastage<br>3<br>Hot Stamping foil<br>Net + 1% Wastage<br>4<br>Ship Shape Corpus Infusion<br>Net + 1% Wastage<br>5<br>Ship Shape Corpus Injection with PP<br>membrane 0.8<br>Net + 1% Wastage<br>6<br>Ship Shape Break of Infusion blue<br>Net + 1% Wastage<br>7<br>Ship Shape Break of Injection<br>Net + 1% Wastage<br>8<br>SF9 195/95 Plastic film non PVC for<br>Primary packing<br>Net + 5% Wastage<br>9<br>OFR2 150/524 Plastic film non PVC for<br>Secondary packing<br>Net + 5% Wastage<br>10<br>Corrugated Boxes 385 x 285 x<br>220mm(FFX Karton) AUS<br>Net + 1% Wastage<br>11<br>Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net<br>12<br>Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net<br>Sodium Chloride NACL Pharmaceutical<br>Net content in<br>Sodium Chloride 9 % 100<br>ml<br>1 Number<br>13|The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import product in meetingNo.

n<br>Sodium Chloride 9 % 100<br>ml<br>1 Number<br>13|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/Jul/202324/9 datedagainst advance authorizationNo.<br>**0310819230 dated 19/02/2018,**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>Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical<br>ingredient(API) SANAL P<br>Net content in<br>export + 2%<br>wastage<br>2<br>UFR2 150/524 Plastic film non PVC for<br>Secondary packing<br>Net + 5% Wastage<br>3<br>Hot Stamping foil<br>Net + 1% Wastage<br>4<br>Ship Shape Corpus Infusion<br>Net + 1% Wastage<br>5<br>Ship Shape Corpus Injection with PP<br>membrane 0.8<br>Net + 1% Wastage<br>6<br>Ship Shape Break of Infusion blue<br>Net + 1% Wastage<br>7<br>Ship Shape Break of Injection<br>Net + 1% Wastage<br>8<br>SF9 195/95 Plastic film non PVC for<br>Primary packing<br>Net + 5% Wastage<br>9<br>OFR2 150/524 Plastic film non PVC for<br>Secondary packing<br>Net + 5% Wastage<br>10<br>Corrugated Boxes 385 x 285 x<br>220mm(FFX Karton) AUS<br>Net + 1% Wastage<br>11<br>Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net<br>12<br>Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net<br>Sodium Chloride NACL Pharmaceutical<br>Net content in<br>Sodium Chloride 9 % 100<br>ml<br>1 Number<br>13|The Committee considered the case as per agenda a

3 1140 x 870(Aus)(Heat Treated) Net to Net<br>Sodium Chloride NACL Pharmaceutical<br>Net content in<br>Sodium Chloride 9 % 100<br>ml<br>1 Number<br>13|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/Jul/202324/9 datedagainst advance authorizationNo.<br>**0310819230 dated 19/02/2018,**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>Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical<br>ingredient(API) SANAL P<br>Net content in<br>export + 2%<br>wastage<br>2<br>UFR2 150/524 Plastic film non PVC for<br>Secondary packing<br>Net + 5% Wastage<br>3<br>Hot Stamping foil<br>Net + 1% Wastage<br>4<br>Ship Shape Corpus Infusion<br>Net + 1% Wastage<br>5<br>Ship Shape Corpus Injection with PP<br>membrane 0.8<br>Net + 1% Wastage<br>6<br>Ship Shape Break of Infusion blue<br>Net + 1% Wastage<br>7<br>Ship Shape Break of Injection<br>Net + 1% Wastage<br>8<br>SF9 195/95 Plastic film non PVC for<br>Primary packing<br>Net + 5% Wastage<br>9<br>OFR2 150/524 Plastic film non PVC for<br>Secondary packing<br>Net + 5% Wastage<br>10<br>Corrugated Boxes 385 x 285 x<br>220mm(FFX Karton) AUS<br>Net + 1% Wastage<br>11<br>Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net<br>12<br>Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net<br>Sodium Chloride NACL Pharmaceutical<br>Net content in<br

Net + 1% Wastage<br>11<br>Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net<br>12<br>Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net<br>Sodium Chloride NACL Pharmaceutical<br>Net content in<br>Sodium Chloride 9 % 100<br>ml<br>1 Number<br>13|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/Jul/202324/9 datedagainst advance authorizationNo.<br>**0310819230 dated 19/02/2018,**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>Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical<br>ingredient(API) SANAL P<br>Net content in<br>export + 2%<br>wastage<br>2<br>UFR2 150/524 Plastic film non PVC for<br>Secondary packing<br>Net + 5% Wastage<br>3<br>Hot Stamping foil<br>Net + 1% Wastage<br>4<br>Ship Shape Corpus Infusion<br>Net + 1% Wastage<br>5<br>Ship Shape Corpus Injection with PP<br>membrane 0.8<br>Net + 1% Wastage<br>6<br>Ship Shape Break of Infusion blue<br>Net + 1% Wastage<br>7<br>Ship Shape Break of Injection<br>Net + 1% Wastage<br>8<br>SF9 195/95 Plastic film non PVC for<br>Primary packing<br>Net + 5% Wastage<br>9<br>OFR2 150/524 Plastic film non PVC for<br>Secondary packing<br>Net + 5% Wastage<br>10<br>Corrugated Boxes 385 x 285 x<br>220mm(FFX Karton) AUS<br>Net + 1% Wastage<br>11<br>Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net<br>12<br>Pallets CP3 11

dary packing<br>Net + 5% Wastage<br>10<br>Corrugated Boxes 385 x 285 x<br>220mm(FFX Karton) AUS<br>Net + 1% Wastage<br>11<br>Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net<br>12<br>Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net<br>Sodium Chloride NACL Pharmaceutical<br>Net content in<br>Sodium Chloride 9 % 100<br>ml<br>1 Number<br>13|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/Jul/202324/9 datedagainst advance authorizationNo.<br>**0310819230 dated 19/02/2018,**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>Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical<br>ingredient(API) SANAL P<br>Net content in<br>export + 2%<br>wastage<br>2<br>UFR2 150/524 Plastic film non PVC for<br>Secondary packing<br>Net + 5% Wastage<br>3<br>Hot Stamping foil<br>Net + 1% Wastage<br>4<br>Ship Shape Corpus Infusion<br>Net + 1% Wastage<br>5<br>Ship Shape Corpus Injection with PP<br>membrane 0.8<br>Net + 1% Wastage<br>6<br>Ship Shape Break of Infusion blue<br>Net + 1% Wastage<br>7<br>Ship Shape Break of Injection<br>Net + 1% Wastage<br>8<br>SF9 195/95 Plastic film non PVC for<br>Primary packing<br>Net + 5% Wastage<br>9<br>OFR2 150/524 Plastic film non PVC for<br>Secondary packing<br>Net + 5% Wastage<br>10<br>Corrugated Boxes 385 x 285 x<br>220mm(FFX Karton) AUS<br>Net

for<br>Primary packing<br>Net + 5% Wastage<br>9<br>OFR2 150/524 Plastic film non PVC for<br>Secondary packing<br>Net + 5% Wastage<br>10<br>Corrugated Boxes 385 x 285 x<br>220mm(FFX Karton) AUS<br>Net + 1% Wastage<br>11<br>Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net<br>12<br>Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net<br>Sodium Chloride NACL Pharmaceutical<br>Net content in<br>Sodium Chloride 9 % 100<br>ml<br>1 Number<br>13| |---|---|---|---|---|---| ||Export Product|Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Sodium Chloride 9 % 100<br>ml|<br>1 Number|1|Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical<br>ingredient(API) SANAL P|Net content in<br>export + 2%<br>wastage| ||||2|UFR2 150/524 Plastic film non PVC for<br>Secondary packing|Net + 5% Wastage| ||||3|Hot Stamping foil|Net + 1% Wastage| ||||4|Ship Shape Corpus Infusion|Net + 1% Wastage| ||||5|Ship Shape Corpus Injection with PP<br>membrane 0.8|Net + 1% Wastage| ||||6|Ship Shape Break of Infusion blue|Net + 1% Wastage| ||||7|Ship Shape Break of Injection|Net + 1% Wastage| ||||8|SF9 195/95 Plastic film non PVC for<br>Primary packing|Net + 5% Wastage| ||||9|OFR2 150/524 Plastic film non PVC for<br>Secondary packing|Net + 5% Wastage| ||||10|Corrugated Boxes 385 x 285 x<br>220mm(FFX Karton) AUS|Net + 1% Wastage| ||||11|Pallets CP5 1140x1170(Aus)(Heat Treated)|Net to Net| ||||12|Pallets CP3 1140 x 870(Aus)(Heat Treated)|Net to Net| ||||13|Sodium Chloride NACL Pharmaceutical|Net content in|

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Pallets CP5 1140x1170(Aus)(Heat Treated)|Net to Net| ||||12|Pallets CP3 1140 x 870(Aus)(Heat Treated)|Net to Net| ||||13|Sodium Chloride NACL Pharmaceutical|Net content in|

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quality active pharmaceutical<br>ingredient(API) SANAL P export + 2%<br>wastage
14 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 5% Wastage
15 Hot Stamping foil Net + 1% Wastage
16 Ship Shape Corpus Infusion Net + 1% Wastage
17 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1% Wastage
18 Ship Shape Break of Infusion blue Net + 1% Wastage
19 Ship Shape Break of Injection Net + 1% Wastage
20 SF9 195/95 Plastic film non PVC for<br>Primary packing Net + 5% Wastage
Sodium Chloride 0.9 %<br>500ml <br>1 Number 1 Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical<br>ingredient(API) SANAL P Net content in<br>export + 2%<br>wastage
2 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 5% Wastage
3 Hot Stamping foil Net + 1% Wastage
4 Ship Shape Corpus Infusion Net + 1% Wastage
5 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1% Wastage
6 Ship Shape Break of Infusion blue Net + 1% Wastage
7 Ship Shape Break of Injection Net + 1% Wastage
8 SF9 195/135 Plastic film non PVC for<br>Primary packing Net + 5% Wastage

7

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eak of Infusion blue|Net + 1% Wastage| ||||7|Ship Shape Break of Injection|Net + 1% Wastage| ||||8|SF9 195/135 Plastic film non PVC for<br>Primary packing|Net + 5% Wastage|

7

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9 OFR2 120/524 Plastic film non PVC for<br>Secondary packing Net + 5% Wastage
10 Corrugated Boxes 385 x 285 x<br>220mm(FFX Karton) AUS Net + 1% Wastage
11 Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net
12 Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net
13 Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical<br>ingredient(API) SANAL P Net content in<br>export + 2%<br>wastage
14 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 5% Wastage
15 Hot Stamping foil Net + 1% Wastage
16 Ship Shape Corpus Infusion Net + 1% Wastage
17 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1% Wastage
18 Ship Shape Break of Infusion blue Net + 1% Wastage
19 Ship Shape Break of Injection Net + 1% Wastage
20 SF9 195/135 Plastic film non PVC for<br>Primary packing Net + 5% Wastage
Sodium<br>Chloride<br>0.9%<br>1000 ml <br>1 Number 1 Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical<br>ingredient(API) SANAL P Net content in<br>export + 2%<br>wastage
2 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 5% Wastage
3 Hot Stamping foil Net + 1% Wastage

8

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NAL P|Net content in<br>export + 2%<br>wastage| ||||2|UFR2 150/524 Plastic film non PVC for<br>Secondary packing|Net + 5% Wastage| ||||3|Hot Stamping foil|Net + 1% Wastage|

8

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4 Ship Shape Corpus Infusion Net + 1% Wastage
5 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1% Wastage
6 Ship Shape Break of Infusion blue Net + 1% Wastage
7 Ship Shape Break of Injection Net + 1% Wastage
8 SF9 195/140 Plastic film non PVC for<br>Primary packing Net + 5% Wastage
9 OFR2 120/524 Plastic film non PVC for<br>Secondary packing Net + 5% Wastage
10 Corrugated Boxes 385 x 285 x<br>220mm(FFX Karton) AUS Net + 1% Wastage
11 Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net
12 Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net
13 Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical<br>ingredient(API) SANAL P Net content in<br>export + 2%<br>wastage
14 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 5% Wastage
15 Hot Stamping foil Net + 1% Wastage
16 Ship Shape Corpus Infusion Net + 1% Wastage
17 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1% Wastage
18 Ship Shape Break of Infusion blue Net + 1% Wastage
19 Ship Shape Break of Injection Net + 1% Wastage

9

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20 SF9 195/140 Plastic film non PVC for Net + 5% Wastage
Primary packing
  • 1% Wastage| ||||19|Ship Shape Break of Injection|Net + 1% Wastage|

9

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20 SF9 195/140 Plastic film non PVC for Net + 5% Wastage
Primary packing
Case No.<br>9 / NC/3/MEET/Jan/202324/20
Case Status<br>Case Approved
Party Name<br>TOJO VIKAS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number<br>HQRNORM APPLY 00226905AM22
RA File Number<br>05AA04094141 AM22
Licence No and<br>Date<br>0511005704/26/10/2021
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/Oct/202122/9 dated 15/10/2021against advance
authorizationNo. 0510414531 dated 01/07/2020, 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.
Delta Decalactone (Natural)<br>935.00 kg.<br>1 Massoia C10 Lactone 970.00 kg.
RA concerned may take further necessary action as per above decision of NC.

Import Items*|Qty. allowed.|| |Delta Decalactone (Natural)<br>935.00 kg.<br>1|Massoia C10 Lactone|970.00 kg.|| |RA concerned may take further necessary action as per above decision|of NC.|||

Case No. 10 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name LAZERHEAD LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00266328AM22
RA File Number 09AA04012424 AM22
Licence No and<br>Date 0911001950/26/11/2021
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for

10

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following information/documents from the firm:-

  1. The documents provided by the firm are incomplete.

  2. Complete application with all relevant documents may be provided.

Case No. 11 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number and<br>Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000512AM23
RA File Number 08AX04000074 AM23
Licence No and Date 0811004832/29/04/2022
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.

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>PYRIDOSTIGMINE TABLETS 60<br>MG(EACH UNCOATED TABLET<br>CONTAINS: PYRIDOSTIGMINE<br>BROMIDE PH.EUR. 60 MG [IN<br>WHICH ACTIVE INGREDIENT<br>PYRIDOSTIGMINE BROMIDE<br>USED IS 332.400 KGS.])<br>1 Number<br>1<br>PYRIDOSTIGMINE BROMIDE<br>61.50 mg.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 12 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name VISION DRUGS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000893AM23
RA File Number 09AX04000124 AM23
Licence No and<br>Date 0911003032/20/05/2022
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/Nov/202324/16 dated 17/01/2023 against advance authorization No.0310836469 dated 01/06/2020 , 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.
Piroctone Olamine 1 kg. 1 3,3-dimethylacrylic acid 0.84 kg.
2 Isononanoyl Chloride 1.62 kg.
3 Hydroxylamine Hcl 1.04 kg.

No.**|Import Items|Qty. allowed.| |---|---|---|---|---| |Piroctone Olamine|1 kg.|1|3,3-dimethylacrylic acid|0.84 kg.| |||2|Isononanoyl Chloride|1.62 kg.| |||3|Hydroxylamine Hcl|1.04 kg.|

Case No. 13 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name METROPOLITAN EXIMCHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000920AM23
RA File Number 03AX04000550 AM23
Licence No and<br>Date 0311014915/22/05/2022
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and 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.
Sample of shipping bills and bill of entry of the export products along with statement of Input-output as<br>vi.
per export documents of the said authorization.
  • ii. Complete chemical reactions with molecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.
Case No. 14 / NC/3/MEET/Jan/202324/20
Case Status Case Rejected

12

lecular and structural formula and molecular weights along with stage wise percentage yields on molar basis.**

Case No. 14 / NC/3/MEET/Jan/202324/20
Case Status Case Rejected

12

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Party Name MAYA BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM REVIW00003358AM24
RA File Number 30AX04000065 AM23
Licence No and<br>Date 3011002150/23/05/2022
Norms Committee Decision:
The Committee considered the request of firm for review of ad-hoc norms andit was observed that the firm has not
provided any technical justification / information for enhancement. Hence, it was decided torejectthe case
maintaining thestatus quo.
Case No. 15 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name ALTA LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000980AM23
RA File Number 03AX04000822 AM23
Licence No and<br>Date 0311014992/25/05/2022
Norms Committee Decision:
The case is under consideration for want of comments of TE.

Y 00000980AM23| |RA File Number|03AX04000822 AM23| |Licence No and<br>Date|0311014992/25/05/2022| |Norms Committee Decision:|| |The case is under|consideration for want of comments of TE.|
Case No. 16 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name ZENFOLD SUSTAINABLE TECHNOLOGIES PRIVATELIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00001090AM23
RA File Number 09AX04000132 AM23
Licence No and<br>Date 0911003083/31/05/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-
Chemical Reaction on Molar Basis with percentage yield at every stage not given.
Case No. 17 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name GLENMARK LIFE SCIENCES LIMITED
Case No. 17 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name GLENMARK LIFE SCIENCES LIMITED

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--|---| |Case Status|Case Approved| |Party Name|GLENMARK LIFE SCIENCES LIMITED|

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Meeting Number<br>and Date Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024 NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024 NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024 NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024 NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00001358AM23
RA File Number 03AX04001122 AM23
Licence No and<br>Date 0311015470/13/06/2022
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>(3R,4R)-1-BENZYL-N,4-<br>DIMETHYLPIPERIDIN-3-AMINE<br>DIHYDROCHLORIDE<br>1.75 kg.<br>2<br>2,4-DICHLORO-7H-PYRROLO-[2,3-D]-<br>PYRIMIDINE<br>1.37 kg.<br>3<br>ACETONE<br>11.00 kg.<br>4<br>ACETONITRILE<br>4.64 kg.<br>5<br>DIMETHYL FORMAMIDE (DMF)<br>4.50 kg.<br>6<br>ETHYL ACETATE<br>5.00 kg.<br>7<br>INDUSTRIAL SOLVENT<br>2.24 kg.<br>8<br>METHANOL<br>6.84 kg.<br>9<br>METHYLENE CHLORIDE (MDC)<br>11.20 kg.<br>10<br>TETRA HYDRO FURAN (THF)<br>4.00 kg.<br>TOFACITINIB CITRATE<br>1 kg.<br>11<br>TRI ETHYL AMINE (TEA)<br>2.10 kg.
Export Product Qty. **Sl.

THYLENE CHLORIDE (MDC)<br>11.20 kg.<br>10<br>TETRA HYDRO FURAN (THF)<br>4.00 kg.<br>TOFACITINIB CITRATE<br>1 kg.<br>11<br>TRI ETHYL AMINE (TEA)<br>2.10 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.<br>allowed.| ||TOFACITINIB CITRATE||1 kg.|1|(3R,4R)-1-BENZYL-N,4-<br>DIMETHYLPIPERIDIN-3-AMINE<br>DIHYDROCHLORIDE|1.75 kg.| |||||2|2,4-DICHLORO-7H-PYRROLO-[2,3-D]-<br>PYRIMIDINE|1.37 kg.| |||||3|ACETONE|11.00 kg.| |||||4|ACETONITRILE|4.64 kg.| |||||5|DIMETHYL FORMAMIDE (DMF)|4.50 kg.| |||||6|ETHYL ACETATE|5.00 kg.| |||||7|INDUSTRIAL SOLVENT|2.24 kg.| |||||8|METHANOL|6.84 kg.| |||||9|METHYLENE CHLORIDE (MDC)|11.20 kg.| |||||10|TETRA HYDRO FURAN (THF)|4.00 kg.| |||||11|TRI ETHYL AMINE (TEA)|2.10 kg.| ||||||||

14

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Case No. 18 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00001399AM23
RA File Number 03AX04001167 AM23
Licence No and<br>Date 0311015523/15/06/2022
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.

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>TETRAHYDROFURAN (PURITY 99%)<br>1 kg.<br>1<br>1,4 BUTANDIOL<br>(Purity Minimum 95% )<br>1.42 kg.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. Case No. 19 / NC/3/MEET/Jan/202324/20 19 / NC/3/MEET/Jan/202324/20 19 / NC/3/MEET/Jan/202324/20 19 / NC/3/MEET/Jan/202324/20 19 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00001605AM23
RA File Number 08AX04000497 AM23
Licence No and<br>Date 0811005314/23/06/2022
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.
Export Product Qty. **Sl. No. ** Import Items Qty. allowed.

firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.|

Case No. Case No. 19 / NC/3/MEET/Jan/202324/20 19 / NC/3/MEET/Jan/202324/20 19 / NC/3/MEET/Jan/202324/20 19 / NC/3/MEET/Jan/202324/20 19 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00001605AM23
RA File Number 08AX04000497 AM23
Licence No and<br>Date 0811005314/23/06/2022
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.
Export Product Qty. **Sl. No. ** Import Items Qty. allowed.

15

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1<br>TAXUS WALLICHIANA<br>(TWIG AND LEAF)<br>178.75 kg.<br>PACLITAXEL IP / PH. EUR<br>1 kg.<br>2<br>(3R,4S)-3-HYDROXY-4-PHENYL-2-<br>AZETIDINONE<br>1.20 kg.<br>RA concerned may take further necessary action as per above decision of NC. PACLITAXEL IP / PH. EUR 1 kg. 1 TAXUS WALLICHIANA<br>(TWIG AND LEAF) 178.75 kg.
2 (3R,4S)-3-HYDROXY-4-PHENYL-2-<br>AZETIDINONE 1.20 kg.
s per above decision of NC. PACLITAXEL IP / PH. EUR 1 kg. 1 TAXUS WALLICHIANA<br>(TWIG AND LEAF) 178.75 kg.
2 (3R,4S)-3-HYDROXY-4-PHENYL-2-<br>AZETIDINONE 1.20 kg.
Case No. 20 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00001959AM23
RA File Number 03AX04002151 AM23
Licence No and<br>Date 0311016241/11/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case alongwith relevant information / documents from the Personal Hearing<br>firm
Case No. 21 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00001963AM23
RA File Number 05AX04001045 AM23
Licence No and<br>Date 0511013693/11/07/2022
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Complete Chemistry, Molecular Weight and Percentage Yield on molar basis for each export products.<br>1.
Case No. 22 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name ALEMBIC PHARMACEUTICALS LIMITED

16

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lar basis for each export products.**<br>1.||

Case No. 22 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name ALEMBIC PHARMACEUTICALS LIMITED

16

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Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00001993AM23
RA File Number 34AX04000353 AM23
Licence No and<br>Date 3411002522/12/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 23 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name LECILITE INGREDIENTS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00001997AM23
RA File Number 50AX04000028 AM23
Licence No and<br>Date 5011000524/12/07/2022
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>Rapeseed Lecithin Powder/ Granules<br>1 MT.<br>1<br>Crude Rape seed Lecithin<br>1.40 MT.<br>Soya Lecithin Powder/ Granules<br>1 MT.<br>2<br>Crude Soya Lecithin<br>1.40 MT<br>Sunflower lecithin Powder/ Granules<br>1 MT.<br>3<br>Crude Sunflower Lecithin<br>1.40 MT.<br>RA concerned may take further necessary action as per above decision of NC.

a Lecithin<br>1.40 MT<br>Sunflower lecithin Powder/ Granules<br>1 MT.<br>3<br>Crude Sunflower Lecithin<br>1.40 MT.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 24 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00002017AM23
RA File Number 09AX04000301 AM23

17

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Licence No and 0911003338/13/07/2022 Date Norms Committee Decision: The case is under consideration for want of comments of TE.

Case No. 25 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00002018AM23
RA File Number 09AX04000333 AM23
Licence No and<br>Date 0911003339/13/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 26 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00002019AM23
RA File Number 09AX04000338 AM23
Licence No and<br>Date 0911003340/13/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00002019AM23| |RA File Number|09AX04000338 AM23| |Licence No and<br>Date|0911003340/13/07/2022| |Norms Committee Decision:<br>The case is under consideration for want of comments of TE.||

Case No. 27 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00002067AM23
RA File Number 34AX04000361 AM23
Licence No and<br>Date 3411002535/15/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

Case No. 28 / NC/3/MEET/Jan/202324/20

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Case Status Case Deferred
Party Name AUROBINDO PHARMA LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00002087AM23
RA File Number 09AX04000341 AM23
Licence No and<br>Date 0911003356/15/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00002087AM23| |RA File Number|09AX04000341 AM23| |Licence No and<br>Date|0911003356/15/07/2022| |Norms Committee Decision:<br>The case is under consideration for want of comments of TE.||

Case No. 29 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name SYMBIOTEC PHARMALAB PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00002133AM23
RA File Number 56AX04000094 AM23
Licence No and Date 5611001068/19/07/2022
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.9/82-ALC/2014 dated 20/10/2014against advance authorization<br>No.5610003035 dated 21/10/2013, 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.<br>allowed.<br>METHYLPREDNISOLONE HYDROGEN<br>SUCCINATE EP or<br>METHYLPREDNISOLONE<br>HEMISUCCINATE<br>USP(API BULK DRUG)<br>1 kg.<br>1<br>METHYLPREDNISOLONE EP<br>0.86 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 30 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name ADCOCK INGRAM LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024

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NC/3/MEET/Jan/202324/20| |---|---| |Case Status|Case Approved| |Party Name|ADCOCK INGRAM LIMITED| |Meeting Number<br>and Date|NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024|

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HQ File Number HQRNORM APPLY 00002158AM23
RA File Number 07AX04000582 AM23
Licence No and<br>Date 0711004714/20/07/2022
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 authorization<br>No. 0711005063 dated 19/08/2022, 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. Import Items<br>Qty. allowed.<br>1<br>ASCORBIC ACID DC 97<br>Percentage -SF. I.H<br>63.087 mg.<br>FERROUS<br>FORTE<br>TABLETS<br>(FERROUS FORTE TABLETS (Vitamin<br>C (as Ascorbic Acid) -71mg (177.500<br>KGS) +Iron<br>(From<br>Ferrous<br>BisglycinateChelate-<br>126mg<br>(315.00<br>KGS)<br>With<br>Other<br>Essential Vitamins & Minerals (No of<br>Tabs-2500000))<br>1 Number<br>2<br>IRON BISGLYCINATE<br>122.400 mg<br>RA concerned may take further necessary action as per above decision of NC.

Other<br>Essential Vitamins & Minerals (No of<br>Tabs-2500000))<br>1 Number<br>2<br>IRON BISGLYCINATE<br>122.400 mg<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. Case No. 31 / NC/3/MEET/Jan/202324/20 31 / NC/3/MEET/Jan/202324/20 31 / NC/3/MEET/Jan/202324/20 31 / NC/3/MEET/Jan/202324/20 31 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name ASTEC LIFESCIENCES LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00002174AM23
RA File Number 03AX04002330 AM23
Licence No and Date 0311016485/21/07/2022
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/2023214/17 dated 20/12/2023against advance<br>authorizationNo.0311018382 dated 06/10/2022, 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. Import Items<br>Qty. allowed.
Export Product Qty. **Sl. No. ** Import Items Qty. allowed.

20

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-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.|

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1<br>2 FLUORO ANILINE<br>0.66 kg.<br>2<br>ETHYL CHLOROFORMATE<br>0.55 kg.<br>3<br>DIMETHYL FORMAMIDE<br>Deleted (not given in<br>production /<br>consumption data &<br>also not a main reactant<br>4<br>ETHYL 3 AMINO 4 4 4<br>TRIFLUOROCROTONATE<br>0.66 kg.<br>PDSH(3-(4-CHLORO-2-<br>FLUORO-5-MERCAPTO-<br>PHENYL)-1-METHYL-6<br>TRIFLOUOROMETHYL-1H-<br>PYRIMIDINE-2,4-DIONE<br>TECHNICAL (PDSH))<br>1 kg.<br>5<br>POTASSIUM CARBONATE<br>0.31 kg.<br>RA concerned may take further necessary action as per above decision of NC. PDSH(3-(4-CHLORO-2-<br>FLUORO-5-MERCAPTO-<br>PHENYL)-1-METHYL-6<br>TRIFLOUOROMETHYL-1H-<br>PYRIMIDINE-2,4-DIONE<br>TECHNICAL (PDSH)) 1 kg. 1 2 FLUORO ANILINE 0.66 kg.
2 ETHYL CHLOROFORMATE 0.55 kg.
3 DIMETHYL FORMAMIDE Deleted (not given in<br>production /<br>consumption data &<br>also not a main reactant
4 ETHYL 3 AMINO 4 4 4<br>TRIFLUOROCROTONATE 0.66 kg.
5 POTASSIUM CARBONATE 0.31 kg.

YL FORMAMIDE|Deleted (not given in<br>production /<br>consumption data &<br>also not a main reactant| ||||4|ETHYL 3 AMINO 4 4 4<br>TRIFLUOROCROTONATE|0.66 kg.| ||||5|POTASSIUM CARBONATE|0.31 kg.|

Case No. Case No. 32 / NC/3/MEET/Jan/202324/20 32 / NC/3/MEET/Jan/202324/20 32 / NC/3/MEET/Jan/202324/20 32 / NC/3/MEET/Jan/202324/20 32 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number and<br>Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00002228AM23
RA File Number 03AX04002208 AM23
Licence No and Date 0311016558/25/07/2022
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/Oct/202324/15dated13/10/2023against advance authorization<br>No.0311004745 dated 19/06/2021, 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>MEROPENEM NON STERILE<br>MEROPENEM TRIHYDRATE<br>NON STERILE<br>0.8968 kg.<br>PACKING MATERIALS<br>:ALUMINIUM CANISTER(5KG)<br>Relevant, as<br>per Packing<br>MEROPENEM FOR INJECTION<br>(MEROPENEM BUFFERED STERILE)<br>(Containing NLT 84% Sterile Meropenem)<br>1 kg.<br>2
Export Product Qty. Sl. No. Import Items **Qty.

er Packing<br>MEROPENEM FOR INJECTION<br>(MEROPENEM BUFFERED STERILE)<br>(Containing NLT 84% Sterile Meropenem)<br>1 kg.<br>2||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||MEROPENEM FOR INJECTION<br>(MEROPENEM BUFFERED STERILE)<br>(Containing NLT 84% Sterile Meropenem)||1 kg.|1|MEROPENEM NON STERILE<br>MEROPENEM TRIHYDRATE<br>NON STERILE|0.8968 kg.| |||||2|PACKING MATERIALS<br>:ALUMINIUM CANISTER(5KG)|Relevant, as<br>per Packing|

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/ALUMINIUM BOTTLE Policy
ANODIZED
2M(20L000T.8020XY)(ONE SET
CONTAINS ONE CANISTER /
Case No. Case No. 33 / NC/3/MEET/Jan/202324/20 33 / NC/3/MEET/Jan/202324/20 33 / NC/3/MEET/Jan/202324/20 33 / NC/3/MEET/Jan/202324/20 33 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name AUROBINDO PHARMA LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00002294AM23
RA File Number 09AX04000377 AM23
Licence No and<br>Date 0911003411/27/07/2022
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/202223/22dated24/03/2023against advance<br>authorizationNo.0911003801 dated 14/10/2022, 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.

14/10/2022**, 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>1<br>6-Amino Penicillanic Acid (6-APA)<br>0.5139 kg.<br>2<br>Carbon Enoanticromos (Activated Carbon)<br>0.063 kg.<br>3<br>D(-) Alpha Phenyl Glycine Base (PG Base)<br>0.4015 kg.<br>4<br>lsopropyl Alcohol (IPA)<br>0.320 kg.<br>5<br>Methanol (Methyl Alcohol)<br>0.2778 kg.<br>6<br>Methylene Chloride<br>2.810 kg.<br>7<br>Pivaloyl Chloride<br>0.3058 kg.<br>Piperacillin Hydrate<br>1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Piperacillin Hydrate||1 kg.|1|6-Amino Penicillanic Acid (6-APA)|0.5139 kg.| |||||2|Carbon Enoanticromos (Activated Carbon)|0.063 kg.| |||||3|D(-) Alpha Phenyl Glycine Base (PG Base)|0.4015 kg.| |||||4|lsopropyl Alcohol (IPA)|0.320 kg.| |||||5|Methanol (Methyl Alcohol)|0.2778 kg.| |||||6|Methylene Chloride|2.810 kg.| |||||7|Pivaloyl Chloride|0.3058 kg.|

22

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8<br>Potassium Carbonate (Anhydrous)<br>0.1838 kg.<br>9<br>4-Ethyl-2, 3 Dioxo Piperazine (EDP)<br>0.4113 kg.<br>10<br>Trimethyl Chlorosilane<br>0.3778 kg.<br>11<br>Triphosgene<br>0.3778 kg<br>RA concerned may take further necessary action as per above decision of NC. 8 Potassium Carbonate (Anhydrous) 0.1838 kg.
9 4-Ethyl-2, 3 Dioxo Piperazine (EDP) 0.4113 kg.
10 Trimethyl Chlorosilane 0.3778 kg.
11 Triphosgene 0.3778 kg

Potassium Carbonate (Anhydrous)|0.1838 kg.| |---|---|---|---|---|---| ||||9|4-Ethyl-2, 3 Dioxo Piperazine (EDP)|0.4113 kg.| ||||10|Trimethyl Chlorosilane|0.3778 kg.| ||||11|Triphosgene|0.3778 kg|

Case No. 34 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00002358AM23
RA File Number 34AX04000398 AM23
Licence No and<br>Date 3411002586/29/07/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. Case No. 35 / NC/3/MEET/Jan/202324/20 35 / NC/3/MEET/Jan/202324/20 35 / NC/3/MEET/Jan/202324/20 35 / NC/3/MEET/Jan/202324/20 35 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name RA CHEM PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00002388AM23
RA File Number 09AX04000378 AM23
Licence No and<br>Date 0911003424/01/08/2022
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/202324/8 dated 30/06/2023against advance<br>authorizationNo.0911004848 dated 19/04/2023, 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.

04/2023**, 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.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

Case No. Case No. 35 / NC/3/MEET/Jan/202324/20 35 / NC/3/MEET/Jan/202324/20 35 / NC/3/MEET/Jan/202324/20 35 / NC/3/MEET/Jan/202324/20 35 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name RA CHEM PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00002388AM23
RA File Number 09AX04000378 AM23
Licence No and<br>Date 0911003424/01/08/2022
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/202324/8 dated 30/06/2023against advance<br>authorizationNo.0911004848 dated 19/04/2023, 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.
Export Product Qty. Sl. No. Import Items Qty. allowed.

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:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

23

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|Isosorbide Mononitrate Extended-<br>Relesed Tablets USP 30-<br>MG(Isosorbide Mononitrate<br>Extended-Relesed Tablets USP 30-<br>MG Each Extended-Released<br>Tablets Contains : Diluted ISMN<br>(40% Diluted With Lactose<br>Monohydate ) USP Equivelent to<br>ISMN 30Mg Colour : Titanium<br>Dioxide Excipient q.s. Net Conte)<br>1 Number<br>1<br>IS5MN 60% LACTOSE 200 G 40 %<br>(Isosorbide Mononitrate 60% and<br>Lactose 40%)<br>50.90 mg.<br>Isosorbide Mononitrate Extended-<br>Relesed Tablets USP 60-<br>MG(Isosorbide Mononitrate<br>Extended-Relesed Tablets USP 60-<br>MG Each Extended-Released<br>Tablets Contains : Diluted ISMN<br>(40% Diluted With Lactose<br>Monohydate ) USP Equivelent to<br>ISMN 60Mg Colour : Titanium<br>Dioxide Excipient q.s. Net Cont)<br>1 Number<br>2<br>IS5MN 60% LACTOSE 200 G 40 %<br>(Isosorbide Mononitrate 60% and<br>Lactose 40%)<br>101.80 mg.<br>Isosorbide Mononitrate Extended-<br>Relesed Tablets USP 120-<br>MG(Isosorbide Mononitrate<br>Extended-Relesed Tablets USP<br>120-MG Each Extended Released<br>Tablets Contains : Diluted ISMN<br>(40% Diluted With Lactose<br>Monohydate ) USP Equivelent to<br>ISMN 120Mg Colour : Titanium<br>Dioxide Excipient q.s.

ablets USP<br>120-MG Each Extended Released<br>Tablets Contains : Diluted ISMN<br>(40% Diluted With Lactose<br>Monohydate ) USP Equivelent to<br>ISMN 120Mg Colour : Titanium<br>Dioxide Excipient q.s. Net Conte)<br>1 Number<br>3<br>IS5MN 60% LACTOSE 200 G 40 %<br>(Isosorbide Mononitrate 60% and<br>Lactose 40%)<br>203.60 mg.<br>RA concerned may take further necessary action as per above decision of NC. Isosorbide Mononitrate Extended-<br>Relesed Tablets USP 30-<br>MG(Isosorbide Mononitrate<br>Extended-Relesed Tablets USP 30-<br>MG Each Extended-Released<br>Tablets Contains : Diluted ISMN<br>(40% Diluted With Lactose<br>Monohydate ) USP Equivelent to<br>ISMN 30Mg Colour : Titanium<br>Dioxide Excipient q.s. Net Conte) <br>1 Number 1 IS5MN 60% LACTOSE 200 G 40 %<br>(Isosorbide Mononitrate 60% and<br>Lactose 40%) 50.90 mg.
Isosorbide Mononitrate Extended-<br>Relesed Tablets USP 60-<br>MG(Isosorbide Mononitrate<br>Extended-Relesed Tablets USP 60-<br>MG Each Extended-Released<br>Tablets Contains : Diluted ISMN<br>(40% Diluted With Lactose<br>Monohydate ) USP Equivelent to<br>ISMN 60Mg Colour : Titanium<br>Dioxide Excipient q.s. Net Cont) <br>1 Number 2 IS5MN 60% LACTOSE 200 G 40 %<br>(Isosorbide Mononitrate 60% and<br>Lactose 40%) 101.80 mg.
Isosorbide Mononitrate Extended-<br>Relesed Tablets USP 120-<br>MG(Isosorbide Mononitrate<br>Extended-Relesed Tablets USP<br>120-MG Each Extended Released<br>Tablets Contains : Diluted ISMN<br>(40% Diluted With Lactose<br>Monohydate ) USP Equivelent to<br>ISMN 120Mg Colour : Titanium<br>Dioxide Excipient q.s.

ablets USP<br>120-MG Each Extended Released<br>Tablets Contains : Diluted ISMN<br>(40% Diluted With Lactose<br>Monohydate ) USP Equivelent to<br>ISMN 120Mg Colour : Titanium<br>Dioxide Excipient q.s. Net Conte)|1 Number|3|IS5MN 60% LACTOSE 200 G 40 %<br>(Isosorbide Mononitrate 60% and<br>Lactose 40%)|203.60 mg.|

Case No. 36 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name NIFTY LABS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00002449AM23
RA File Number 09AX04000391 AM23
Licence No and<br>Date 0911003436/03/08/2022
Norms Committee Decision:

24

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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/Jan/202021/4 dated 12/02/2021 against advance authorization No.0910068761 dated 18/05/2020 , 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.
N-[dibenzo [b,f] [1,4] thiazepin -11-YL]<br>piperazine Hydrochloride(API) <br>1 kg. 1 Thiophenol 0.59 kg.
2 Hydrazien Hydrate 64% 0.688 kg.
3 Poly Phosphoric Acid 117% 4.03 kg.

---|---| |N-[dibenzo [b,f] [1,4] thiazepin -11-YL]<br>piperazine Hydrochloride(API)|<br>1 kg.|1|Thiophenol|0.59 kg.| |||2|Hydrazien Hydrate 64%|0.688 kg.| |||3|Poly Phosphoric Acid 117%|4.03 kg.|

Case No. 37 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00002474AM23
RA File Number 34AX04000434 AM23
Licence No and<br>Date 3411002610/04/08/2022
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 38 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name BLUE JET HEALTHCARE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00003358AM23
RA File Number 03AX04002988 AM23
Licence No and<br>Date 0311018145/25/09/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing

25

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before Norms Committee to explain its case alongwith relevant documents.

the case as per agenda and it was decided to call the firm for attending||Personal Hearing|

25

UDIN00478312AM24

before Norms Committee to explain its case alongwith relevant documents.

Case No. 39 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name BLUE JET HEALTHCARE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00006770AM23
RA File Number 03AX04005861 AM23
Licence No and<br>Date 0311021934/06/03/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case alongwith relevant documents. Personal Hearing
Case No. Case No. Case No. 40 / NC/3/MEET/Jan/202324/20 40 / NC/3/MEET/Jan/202324/20 40 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00006779AM23
RA File Number 03AX04005915 AM23
Licence No and<br>Date 0311021940/07/03/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>**Sl.

considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>Sl. No<br>Export Product<br>Quantity<br>1<br>Medicals Creams & Ointments(Ciclopirox 1% Shampoo 120 ml Total Wt:6225.00<br>Kgs(Net Con:Sodium Laur Sulphate 2010.158Kgs, Disodium Laur Sulfosuccinate<br>933.75 Kgs,Jeecol LA-2(Laureth-2)124.50 Kgs, Ciclopirox 62.25Kgs, Bottle 50000 Nos,<br>Top cap 50000 Nos))<br>1 Number<br>S. No<br>Import Product<br>Quantity allowed.<br>1<br>Relevant Bulk Drugs<br>Net content in the export product plus 3% wastage.|||||| ||Sl. No|Export Product<br>|||Quantity| ||1|Medicals Creams & Ointments(Ciclopirox 1% Shampoo 120 ml Total Wt:6225.00<br>Kgs(Net Con:Sodium Laur Sulphate 2010.158Kgs, Disodium Laur Sulfosuccinate<br>933.75 Kgs,Jeecol LA-2(Laureth-2)124.50 Kgs, Ciclopirox 62.25Kgs, Bottle 50000 Nos,<br>Top cap 50000 Nos))<br>|||1 Number| ||||||| ||S. No|Import Product||Quantity allowed.|| ||1|Relevant Bulk Drugs||Net content in the export product plus 3% wastage.||

26 This document has been digitally signed by Raman Kumar, Deputy DGFT on 12-02-2024 12:35:23.

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2 Relevant Excipients Net content in the export product plus 3% wastage.
3 Relevant Packaging Material Relevant as per Packing Policy

Note:

  • i. 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments solely for export to US.

  • ii. 1.02 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments for the export to other than US.

  • iii. The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

Case No. Case No. 41 / NC/3/MEET/Jan/202324/20 41 / NC/3/MEET/Jan/202324/20 41 / NC/3/MEET/Jan/202324/20 41 / NC/3/MEET/Jan/202324/20 41 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name ZYDUS LIFESCIENCES LIMITED
Meeting Number and<br>Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00006783AM23
RA File Number 08AX04001767 AM23
Licence No and Date 0811007464/07/03/2023
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 authorization<br>No. 0811003776 dated 13/01/2022, 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. Import Items<br>**Qty.

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>MEMANTINE<br>HYDROCHLORIDE USP<br>7.14 mg.<br>MEMANTINE HYDROCHLORIDE<br>EXTENDED RELEASE CAPSULES 7<br>1 Number||||||| ||Export Product||Qty.<br>|**Sl. No. **|Import Items|Qty. allowed.| ||MEMANTINE HYDROCHLORIDE<br>EXTENDED RELEASE CAPSULES 7||<br>1 Number|1|MEMANTINE<br>HYDROCHLORIDE USP|7.14 mg.|

27

UDIN00478312AM24

MG((ACTIVE INGREDIENT:<br>MEMANTINE HYDROCHLORIDE<br>USP - NET WT. 11.199 KGS)) 2 SUGAR SPHERES (NON-<br>PAREIL) NF 30.60 mg.
3 HYPROMELLOSE 5 CPS 2910<br>USP 3.824 mg.
4 HYPROMELLOSE 3 CPS 2910<br>USP 3.06 mg.
5 TRIETHYL CITRATE NF 0.829 mg.
6 TALC PH EUR/USP 1.594 mg.
MEMANTINE HYDROCHLORIDE<br>EXTENDED RELEASE CAPSULES<br>14 MG((ACTIVE INGREDIENT:<br>MEMANTINE HYDROCHLORIDE<br>USP - NET WT. 36.389 KGS)) 1 Number 7 MEMANTINE<br>HYDROCHLORIDE USP 14.28 mg.
8 SUGAR SPHERES (NON-<br>PAREIL) NF 61.20 mg.
9 HYPROMELLOSE 5 CPS 2910<br>USP 7.648 mg.
10 HYPROMELLOSE 3 CPS 2910<br>USP 6.12 mg.
11 TRIETHYL CITRATE NF 1.658 mg.
12 TALC PH EUR/USP 3.188 mg.
MEMANTINE HYDROCHLORIDE<br>EXTENDED RELEASE CAPSULES<br>21 MG((ACTIVE INGREDIENT:<br>MEMANTINE HYDROCHLORIDE<br>USP - NET WT.

||||11|TRIETHYL CITRATE NF|1.658 mg.| ||||12|TALC PH EUR/USP|3.188 mg.| ||MEMANTINE HYDROCHLORIDE<br>EXTENDED RELEASE CAPSULES<br>21 MG((ACTIVE INGREDIENT:<br>MEMANTINE HYDROCHLORIDE<br>USP - NET WT. 16.796 KGS))|1 Number|13|MEMANTINE<br>HYDROCHLORIDE USP|21.42 mg.| ||||14|SUGAR SPHERES (NON-<br>PAREIL) NF|91.80 mg.| ||||15|HYPROMELLOSE 5 CPS 2910<br>USP|11.472 mg.| ||||16|HYPROMELLOSE 3 CPS 2910<br>USP|9.18 mg.|

28

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17 TRIETHYL CITRATE NF 2.487 mg.
18 TALC PH EUR/USP 4.782 mg.
MEMANTINE HYDROCHLORIDE<br>EXTENDED RELEASE CAPSULES<br>28 MG((ACTIVE INGREDIENT:<br>MEMANTINE HYDROCHLORIDE<br>USP - NET WT. 284.169 KGS)) 1 Number 19 MEMANTINE<br>HYDROCHLORIDE USP 28.56 mg.
20 SUGAR SPHERES (NON-<br>PAREIL) NF 122.40 mg.
21 HYPROMELLOSE 5 CPS 2910<br>USP 15.296 mg.
22 HYPROMELLOSE 3 CPS 2910<br>USP 12.24 mg.
23 TRIETHYL CITRATE NF 3.316 mg.
24 TALC PH EUR/USP 6.376 mg.
MEMANTINE HYDROCHLORIDE<br>TABLETS 5 MG((ACTIVE<br>INGREDIENT: MEMANTINE<br>HYDROCHLORIDE<br>USP - NET WT. 379.460 KGS)) 1 Number 25 MEMANTINE<br>HYDROCHLORIDE USP 5.10 mg.
26 TALC PH EUR/USP 1.02 mg.
27 CROSCARMELLOSE SODIUM<br>NF 5.61 mg.
28 DIBASIC CALCIUM<br>PHOSPHATE DIHYDRATE USP 73.95 mg.
29 MAGNESIUM STEARATE<br>PH.E/NF/JP 1.02 mg.
MEMANTINE HYDROCHLORIDE<br>TABLETS 10 MG((ACTIVE<br>INGREDIENT: MEMANTINE<br>HYDROCHLORIDE<br>USP - NET WT. 183.964 KGS)) 1 Number 30 MEMANTINE<br>HYDROCHLORIDE USP 10.20 mg.
31 TALC PH EUR/USP 2.04 mg.
32 CROSCARMELLOSE SODIUM 11.22 mg.

29

IENT: MEMANTINE<br>HYDROCHLORIDE<br>USP - NET WT. 183.964 KGS))|1 Number|30|MEMANTINE<br>HYDROCHLORIDE USP|10.20 mg.| ||||31|TALC PH EUR/USP|2.04 mg.| ||||32|CROSCARMELLOSE SODIUM|11.22 mg.|

29

UDIN00478312AM24

NF<br>33<br>DIBASIC CALCIUM<br>PHOSPHATE DIHYDRATE USP<br>147.90 mg.<br>34<br>MAGNESIUM STEARATE<br>PH.E/NF/JP<br>2.04 mg.<br>RA concerned may take further necessary action as per above decision of NC. NF
33 DIBASIC CALCIUM<br>PHOSPHATE DIHYDRATE USP 147.90 mg.
34 MAGNESIUM STEARATE<br>PH.E/NF/JP 2.04 mg.
Case No. 42 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00006807AM23
RA File Number 09AX04001097 AM23
Licence No and<br>Date 0911004646/08/03/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 43 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00006898AM23
RA File Number 08AX04002105 AM23
Licence No and<br>Date 0811007519/10/03/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00006898AM23| |RA File Number|08AX04002105 AM23| |Licence No and<br>Date|0811007519/10/03/2023| |Norms Committee Decision:<br>The case is under consideration for want of comments of TE.||

Case No. 44 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name MAHIMA LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00006908AM23

30

UDIN00478312AM24

RA File Number 05AX04003427 AM23
Licence No and<br>Date 0511017696/10/03/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 45 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name CANPEX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00006911AM23
RA File Number 31AX04000365 AM23
Licence No and<br>Date 3111002080/10/03/2023
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>CYANAMIDE 50% SOLUTION<br>1 kg.<br>1<br>CALCIUM CYANAMIDE<br>(Purity 63% as per CoA)<br>1.913 kg.<br>RA concerned may take further necessary action as per above decision of NC.

ty. allowed.**<br>CYANAMIDE 50% SOLUTION<br>1 kg.<br>1<br>CALCIUM CYANAMIDE<br>(Purity 63% as per CoA)<br>1.913 kg.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 46 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name BELCHEM INDUSTRIES (INDIA) PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00006926AM23
RA File Number 03AX04005865 AM23
Licence No and<br>Date 0311022096/13/03/2023
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/Jul/202324/9 dated 28/07/2023against advance authorization

31

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No. 0311016511 dated 22/07/2022, 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.
BELGUARD PBSA<br>(Phenylbenzimidazole Sulfonic Acid) 1 kg. 1 Ortho Phenylene Diamine 0.4925 kg.
Export Product* Qty. **Sl. No. ** Import Items Qty. allowed.
BELGUARD PBSA<br>(Phenylbenzimidazole Sulfonic Acid) 1 kg. 1 Ortho Phenylene Diamine 0.4925 kg.
Case No. 47 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name BELCHEM INDUSTRIES (INDIA) PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00006927AM23
RA File Number 03AX04005864 AM23
Licence No and<br>Date 0311022097/13/03/2023
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/Jul/202324/9 dated 28/07/2023against advance authorization<br>No. **0311016511 dated 22/07/2022,**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. Import Items<br>Qty. allowed.<br>BELGUARD PBSA<br>(Phenylbenzimidazole Sulfonic Acid)<br>1 kg.<br>1<br>Ortho Phenylene Diamine<br>0.4925 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 48 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name JUBILANT INGREVIA LIMITED

32

UDIN00478312AM24

her necessary action as per above decision of NC.||

Case No. 48 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name JUBILANT INGREVIA LIMITED

32

UDIN00478312AM24

Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00006963AM23
RA File Number 05AX04003473 AM23
Licence No and<br>Date 0511017740/14/03/2023
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/202324/16 dated 17/11/2023against advance<br>authorizationNo. **0511013888 dated 21/07/2022,**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. Import Items<br>Qty. allowed.<br>1<br>Propionic Acid<br>1.41 kg.<br>Propionic Anhydride<br>1 kg.<br>2<br>Acetic Acid Glacial<br>0.50 kg.<br>RA concerned may take further necessary action as per above decision of NC.

lowed.**<br>1<br>Propionic Acid<br>1.41 kg.<br>Propionic Anhydride<br>1 kg.<br>2<br>Acetic Acid Glacial<br>0.50 kg.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 49 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00007011AM23
RA File Number 07AX04001891 AM23
Licence No and<br>Date 0711006773/16/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>1. Complete chemical reaction with molecular and structural formula and molecular weights along with stage<br>wise percentage yield on molar basis.
Case No. 50 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name SENTISS PHARMA PRIVATE LIMITED

33

UDIN00478312AM24

br>wise percentage yield on molar basis.||

Case No. 50 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name SENTISS PHARMA PRIVATE LIMITED

33

UDIN00478312AM24

Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00007016AM23
RA File Number 05AX04003495 AM23
Licence No and<br>Date 0511017773/16/03/2023
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/202324/13 dated 14/09/2023against advance authorization<br>No. 05110197 dated 18/07/2023, 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>Mydrimax Eye Drops 5 ml Vials<br>(Tropicamide 0.8%)<br>1 Number<br>1<br>Tropicamide<br>40.8 mg / 5 ml Vial<br>RA concerned may take further necessary action as per above decision of NC.

ed.**<br>Mydrimax Eye Drops 5 ml Vials<br>(Tropicamide 0.8%)<br>1 Number<br>1<br>Tropicamide<br>40.8 mg / 5 ml Vial<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. Case No. 51 / NC/3/MEET/Jan/202324/20 51 / NC/3/MEET/Jan/202324/20 51 / NC/3/MEET/Jan/202324/20 51 / NC/3/MEET/Jan/202324/20 51 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name HAFFKINE BIO PHARMACEUTICAL CORPORATION LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00007033AM23
RA File Number 03AX04006031 AM23
Licence No and<br>Date 0311022201/16/03/2023
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. 0311018754 dated 20/10/2022, 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. Import Items<br>Qty. allowed.<br>1<br>Monovalent Bulk for Poliomyelitis<br>Type I<br>665.5 Liters<br>Oral Polio Vaccine (OPV) with VVM<br>5000000<br>Numbers
Export Product Qty. **Sl. No. ** Import Items Qty. allowed.
Oral Polio Vaccine (OPV) with VVM 5000000<br>Numbers 1 Monovalent Bulk for Poliomyelitis<br>Type I 665.5 Liters

||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Oral Polio Vaccine (OPV) with VVM||5000000<br>Numbers|1|Monovalent Bulk for Poliomyelitis<br>Type I|665.5 Liters|

Case No. Case No. 51 / NC/3/MEET/Jan/202324/20 51 / NC/3/MEET/Jan/202324/20 51 / NC/3/MEET/Jan/202324/20 51 / NC/3/MEET/Jan/202324/20 51 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name HAFFKINE BIO PHARMACEUTICAL CORPORATION LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00007033AM23
RA File Number 03AX04006031 AM23
Licence No and<br>Date 0311022201/16/03/2023
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. 0311018754 dated 20/10/2022, 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. Import Items<br>Qty. allowed.<br>1<br>Monovalent Bulk for Poliomyelitis<br>Type I<br>665.5 Liters<br>Oral Polio Vaccine (OPV) with VVM<br>5000000<br>Numbers
Export Product Qty. **Sl. No. ** Import Items Qty. allowed.
Oral Polio Vaccine (OPV) with VVM 5000000<br>Numbers 1 Monovalent Bulk for Poliomyelitis<br>Type I 665.5 Liters

34

UDIN00478312AM24

Qty.**|**Sl. No. **|Import Items|Qty. allowed.| ||Oral Polio Vaccine (OPV) with VVM||5000000<br>Numbers|1|Monovalent Bulk for Poliomyelitis<br>Type I|665.5 Liters|

34

UDIN00478312AM24

2<br>Monovalent Bulk for Poliomyelitis<br>Type III<br>423.5 Liters<br>3<br>Vaccine Vial (VVM)<br>5120000<br>Numbers<br>RA concerned may take further necessary action as per above decision of NC. 2 Monovalent Bulk for Poliomyelitis<br>Type III 423.5 Liters
3 Vaccine Vial (VVM) 5120000<br>Numbers
Case No. 52 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name KOPRAN LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00007070AM23
RA File Number 03AX04005973 AM23
Licence No and<br>Date 0311022272/20/03/2023
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/Oct/202324/15 dated 13/10/2023against advance<br>authorizationNo.0311004745 dated 19/06/2021, 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.

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>MEROPENEM NON-STERILE<br>(MEROPENEM TRIHYDRATE<br>NON-STERILE)<br>0.8968 kg.<br>MEROPENEM FOR INJECTION<br>(MEROPENEM BUFFERED STERILE)<br>[Containing NLT 84% Sterile Meropenem]<br>1 kg.<br>2<br>PACKING MATERIAL<br>Relevant, as<br>per Packing<br>Policy<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 53 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name KOPRAN LIMITED

35

UDIN00478312AM24

Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00007071AM23
RA File Number 03AX04005971 AM23
Licence No and<br>Date 0311022273/20/03/2023
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/Oct/202324/15 dated 13/10/2023against advance authorization<br>No.0311004745 dated 19/06/2021, 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.

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>MEROPENEM NON-STERILE<br>(MEROPENEM TRIHYDRATE<br>NON-STERILE)<br>0.8968 kg.<br>MEROPENEM FOR INJECTION<br>(MEROPENEM BUFFERED STERILE)<br>[Containing NLT 84% Sterile Meropenem]<br>1 kg.<br>2<br>PACKING MATERIAL<br>Relevant, as<br>per Packing<br>Policy<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. Case No. 54 / NC/3/MEET/Jan/202324/20 54 / NC/3/MEET/Jan/202324/20 54 / NC/3/MEET/Jan/202324/20 54 / NC/3/MEET/Jan/202324/20 54 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name CHEMIPRIME IMPEX PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00007144AM23
RA File Number 03AX04006176 AM23
Licence No and<br>Date 0311022361/23/03/2023
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.
Export Product Qty. **Sl. No. ** Import Items Qty. allowed.

firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.|

Case No. Case No. 54 / NC/3/MEET/Jan/202324/20 54 / NC/3/MEET/Jan/202324/20 54 / NC/3/MEET/Jan/202324/20 54 / NC/3/MEET/Jan/202324/20 54 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name CHEMIPRIME IMPEX PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00007144AM23
RA File Number 03AX04006176 AM23
Licence No and<br>Date 0311022361/23/03/2023
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.
Export Product Qty. **Sl. No. ** Import Items Qty. allowed.

36

UDIN00478312AM24

-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.|

36

UDIN00478312AM24

1<br>Epoxy Hardener (IPDA Epocure HD 42)<br>0.5025 kg.<br>2<br>Benzyl Alcohol<br>0.3015 kg.<br>Cycloaliphatic amine<br>((Epocure HD 1618))<br>1 Kg.<br>3<br>Liquid Epoxy Resin (Epocure LQ 6010)<br>0.201 kg.<br>RA concerned may take further necessary action as per above decision of NC. Cycloaliphatic amine<br>((Epocure HD 1618)) 1 Kg. 1 Epoxy Hardener (IPDA Epocure HD 42) 0.5025 kg.
2 Benzyl Alcohol 0.3015 kg.
3 Liquid Epoxy Resin (Epocure LQ 6010) 0.201 kg.
Case No. 55 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name AMINES AND PLASTICIZERS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00007212AM23
RA File Number 03AX04006163 AM23
Licence No and<br>Date 0311022443/25/03/2023
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>Tertiary Butyl Amine<br>0.487 kg.<br>Tertiary Butyl Diethanolamine<br>1 Kg.<br>2<br>Ethylene Oxide<br>0.588 kg.<br>RA concerned may take further necessary action as per above decision of NC.

<br>Tertiary Butyl Amine<br>0.487 kg.<br>Tertiary Butyl Diethanolamine<br>1 Kg.<br>2<br>Ethylene Oxide<br>0.588 kg.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 56 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00007275AM23
RA File Number 03AX04006282 AM23

37

UDIN00478312AM24

Licence No and<br>Date 0311022550/29/03/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>Sl. No<br>Export Product<br>Quantity<br>1<br>Medical Creams & Ointments(HYDROCORTISONE VALERATE CREAM 0.2% 15GM (TOT<br>WT:450.00KG NET CON HYDRO -0.90KG, CARBO -2.25KG, DIBASIC -0.27KG, METHYL<br>-0.90 KG, SODIUM -0.54KG, POLY -2 -18.00KG, STE 100 -1.44KG, STEARYL -13.50 KG,<br>SUPER -103.50KG, PROPYL -72KG, TUBES -30000Nos))<br>1 Number<br>2<br>Medical Creams & Ointments(HYDROCORTISONE VALERATE CREAM 0.2% 45GM (TOT<br>WT: 225.00KG NET CON HYDRO -0.45KG, CARBO -1.13KG, DIBASIC -0.14KG, METHYL -<br>0.45 KG, SODIUM -0.27KG, POLY -9.00KG, STE -0.72KG, STEARYL -6.75KG, SUPER-<br>51.75KG,PRO -36.00KG,TUBES -5000.00 Nos))<br>1 Number<br>3<br>Medical Creams & Ointments(HYDROCORTISONE VALERATE CREAM 0.2% 60GM (TOT<br>WT: 300.00KG NET CON HYDRO -0.60KG, CARBO -1.50KG, DIBASIC -0.18KG, MET

PRO -36.00KG,TUBES -5000.00 Nos))<br>1 Number<br>3<br>Medical Creams & Ointments(HYDROCORTISONE VALERATE CREAM 0.2% 60GM (TOT<br>WT: 300.00KG NET CON HYDRO -0.60KG, CARBO -1.50KG, DIBASIC -0.18KG, METHYL -<br>0.60 KG, SODIUM -0.36KG, POLY -12.00 KG, STE-0.96KG, STEARYL - 9.00 KG, SUPER-<br>69.00KG, PROPYLENE -48.00KG, TUBES -5000.00Nos))<br>1 Number<br>S. No<br>Import Product<br>Quantity allowed.<br>1<br>Relevant Bulk Drugs<br>Net content in the export product plus 3% wastage.<br>2<br>Relevant Excipients<br>Net content in the export product plus 3% wastage.<br>3<br>Relevant Packaging Material<br>Relevant as per Packing Policy<br>Note:<br>1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal<br>Cream/Ointmentssolely for export to US.<br>i.<br>1.02 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal<br>Cream/Ointments for the export toother than US.<br>ii.||

38 This document has been digitally signed by Raman Kumar, Deputy DGFT on 12-02-2024 12:35:23.

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iii. The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

r, Deputy DGFT on 12-02-2024 12:35:23.

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iii. The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

Case No. 57 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name SANDHYA ORGANIC CHEMICALS PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00007310AM23
RA File Number 03AX04006257 AM23
Licence No and<br>Date 0311022584/30/03/2023
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>NONYL PHENOL<br>1.066 kg.<br>TRIS<br>NONYL PHENYL<br>PHOSPHITE ((TNPP))<br>1 kg.<br>2<br>YELLOW<br>PHOSPHORUS<br>0.0506 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 58 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00007313AM23
RA File Number 07AX04002003 AM23
Licence No and<br>Date 0711007245/30/03/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export

39

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and<br>Date|0711007245/30/03/2023| |Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from the earlier decision for same export||

39

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product/import product in meeting No.NC/3/MEET/Nov/202324 dated 17/11/2023 against advance authorization No.0711004347 dated 17/06/2022 , 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.
MAGNESIUM ASPARTATE (BP /DIHYDRATE<br>Eur.Ph) / MAGNESIUM L- ASPARTATE<br>HYDROCHLORIDE TRIHYDRATE <br> <br>1 kg. 1 L-ASPARTIC ACID 1.05 kg.
Case No. 59 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name TOJO VIKAS INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00007338AM23
RA File Number 05AX04003614 AM23
Licence No and<br>Date 0511018112/31/03/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Production / Consumption data certified by GST.

d the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Production / Consumption data certified by GST.||

Case No. 60 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name MICRO LABS LIMITED
Meeting Number and<br>Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000035AM24
RA File Number 07AX04000011 AM24
Licence No and Date 0711007283/06/04/2023
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 authorization

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No.0711005338 dated 27/09/2022 , 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.
DIRECT COMPRESSION GRANULES OF<br>PHLOROGLUCINOL (DIRECT<br>COMPRESSION GRANULES OF<br>PHLOROGLUCINOL 160MG ODT PREMIX<br>(EACH 450MG PREMIX CONTAINS 160MG<br>PHLOROGLUCINOL) CONTENTS<br>160.00KG) 1 kg. 1 PHLOROGLUCINOL<br>DIHYDRATE BP/EP/IP/USP 0.359 kg.

OMPRESSION GRANULES OF<br>PHLOROGLUCINOL 160MG ODT PREMIX<br>(EACH 450MG PREMIX CONTAINS 160MG<br>PHLOROGLUCINOL) CONTENTS<br>160.00KG)|1 kg.|1|PHLOROGLUCINOL<br>DIHYDRATE BP/EP/IP/USP|0.359 kg.|

Case No. 61 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000059AM24
RA File Number 03AX04006327 AM23
Licence No and<br>Date 0311022677/10/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 62 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name VINS BIOPRODUCTS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000068AM24
RA File Number 09AX04001155 AM23
Licence No and<br>Date 0911004801/10/04/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-

41

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Batch Manufacturing record and material reconciliation sheet duly signed by dealing executive/manager from the applicant.

ing information/documents from the firm:-||

41

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Batch Manufacturing record and material reconciliation sheet duly signed by dealing executive/manager from the applicant.

Case No. 63 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name GENERIC HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000102AM24
RA File Number 31AX04000374 AM23
Licence No and<br>Date 3111002194/11/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 64 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000136AM24
RA File Number 03AX04006098 AM23
Licence No and<br>Date 0311022771/12/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 65 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name SHIVA BIO CHEM INDUSTRIES
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000148AM24
RA File Number 50AX04000001 AM24
Licence No and<br>Date 5011000862/12/04/2023
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:-

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:-||

42 This document has been digitally signed by Raman Kumar, Deputy DGFT on 12-02-2024 12:35:23.

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Export Product Qty. Sl. No. Import Items Qty. allowed.
Sunflower Lecithin (Liquid) 1 MT 1 Crude Sunflower Lecithin 1.01 MT
Case No. 66 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name TORRENT PHARMACEUTICALS LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000156AM24
RA File Number 08AX04000016 AM24
Licence No and<br>Date 0811007856/12/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 67 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000159AM24
RA File Number 03AX04000117 AM24
Licence No and<br>Date 0311022786/13/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00000159AM24| |RA File Number|03AX04000117 AM24| |Licence No and<br>Date|0311022786/13/04/2023| |Norms Committee Decision:<br>The case is under consideration for want of comments of TE.||

Case No. 68 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name AMINES AND PLASTICIZERS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000207AM24
RA File Number 03AX04006365 AM23
Licence No and<br>Date 0311022817/17/04/2023
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/Mar/202122/15 dated 17/03/2022 against advance authorization No. 0311004672 dated 17/06/2021 , 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.
BUTYL<br>MONO<br>ETHANOLAMINE (BMEA) <br>1 kg. 1 Mono N Butyl Amine 0.560 kg.
Case No. 69 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name S KANT CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000218AM24
RA File Number 03AX04000033 AM24
Licence No and<br>Date 0311022832/17/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00000218AM24| |RA File Number|03AX04000033 AM24| |Licence No and<br>Date|0311022832/17/04/2023| |Norms Committee Decision:<br>The case is under consideration for want of comments of TE.||

Case No. 70 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name MOREPEN LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000238AM24
RA File Number 05AX04000110 AM24
Licence No and<br>Date 0511018340/17/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 71 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name ZYDUS LIFESCIENCES LIMITED

44

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Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000266AM24
RA File Number 08AX04002260 AM23
Licence No and<br>Date 0811007905/18/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00000266AM24| |RA File Number|08AX04002260 AM23| |Licence No and<br>Date|0811007905/18/04/2023| |Norms Committee Decision:<br>The case is under consideration for want of comments of TE.||

Case No. 72 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000292AM24
RA File Number 03AX04000045 AM24
Licence No and<br>Date 0311022935/19/04/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>DML required for each export product.
Case No. Case No. Case No. 73 / NC/3/MEET/Jan/202324/20 73 / NC/3/MEET/Jan/202324/20 73 / NC/3/MEET/Jan/202324/20 73 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name SIDDHARTH CARBOCHEM PRODUCTS LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000322AM24
RA File Number 03AX04000098 AM24
Licence No and Date 0311022987/20/04/2023
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.

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>SALICYLIC ACID<br>0.7603 kg.<br>HOMOSALATE<br>1 kg.||||||| ||Export Product|Qty.||Sl. No.|Import Items|Qty. allowed.| ||HOMOSALATE|1 kg.||1|SALICYLIC ACID|0.7603 kg.|

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2 3,3,5-TRIMETHYLCYCLOHEXANOL 0.602 kg.
3 DI BUTYL TIN DIACETATE (DBTA) 0.010 kg.
Case No. 74 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000325AM24
RA File Number 03AX04000169 AM24
Licence No and<br>Date 0311022998/21/04/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>DML required for each export product.
Case No. 75 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000357AM24
RA File Number 03AX04000234 AM24
Licence No and<br>Date 0311023026/24/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

PPLY 00000357AM24| |RA File Number|03AX04000234 AM24| |Licence No and<br>Date|0311023026/24/04/2023| |Norms Committee Decision:<br>The case is under consideration for want of comments of TE.||

Case No. 76 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name IND SWIFT LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000384AM24

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RA File Number 30AX04000022 AM24
Licence No and<br>Date 3011003465/25/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. Case No. 77 / NC/3/MEET/Jan/202324/20 77 / NC/3/MEET/Jan/202324/20 77 / NC/3/MEET/Jan/202324/20 77 / NC/3/MEET/Jan/202324/20 77 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name MANKIND PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000387AM24
RA File Number 05AX04000213 AM24
Licence No and<br>Date 0511018490/25/04/2023
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<br>No.0511017272 dated 09/02/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

uct in meetingNo.NC/3/MEET/Jun/202324/6 dated 14/06/2023against advance authorization<br>No.0511017272 dated 09/02/2023, 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>DOXEPIN HYDROCHLORIDE CAPSULES USP 10 MG<br>5200000<br>Numbers<br>1<br>DOXEPIN HCL<br>59.036 kg.<br>DOXEPIN HYDROCHLORIDE CAPSULES USP 25 MG<br>2600000<br>Numbers<br>2<br>DOXEPIN HCL<br>73.799 kg.<br>DOXEPIN HYDROCHLORIDE CAPSULES USP 50 MG<br>1260000<br>Numbers<br>3<br>DOXEPIN HCL<br>71.525 kg.<br>DOXEPIN HYDROCHLORIDE CAPSULES USP 75 MG<br>1050000<br>Numbers<br>4<br>DOXEPIN HCL<br>89.41 kg.<br>DOXEPIN HYDROCHLORIDE CAPSULES USP 100 MG<br>980000<br>Numbers<br>5<br>DOXEPIN HCL<br>111.267 kg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||DOXEPIN HYDROCHLORIDE CAPSULES USP 10 MG||5200000<br>Numbers|1|DOXEPIN HCL|59.036 kg.| ||DOXEPIN HYDROCHLORIDE CAPSULES USP 25 MG||2600000<br>Numbers|2|DOXEPIN HCL|73.799 kg.| ||DOXEPIN HYDROCHLORIDE CAPSULES USP 50 MG||1260000<br>Numbers|3|DOXEPIN HCL|71.525 kg.| ||DOXEPIN HYDROCHLORIDE CAPSULES USP 75 MG||1050000<br>Numbers|4|DOXEPIN HCL|89.41 kg.| ||DOXEPIN HYDROCHLORIDE CAPSULES USP 100 MG||980000<br>Numbers|5|DOXEPIN HCL|111.267 kg.|

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IN HYDROCHLORIDE CAPSULES USP 75 MG||1050000<br>Numbers|4|DOXEPIN HCL|89.41 kg.| ||DOXEPIN HYDROCHLORIDE CAPSULES USP 100 MG||980000<br>Numbers|5|DOXEPIN HCL|111.267 kg.|

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Case No. 78 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name MANKIND PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000388AM24
RA File Number 05AX04000214 AM24
Licence No and<br>Date 0511018497/25/04/2023
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/202324/16 dated 17/11/2023against advance<br>authorizationNo.0511013170 dated 13/06/2022, 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. Import Items<br>Qty. allowed.<br>Ofloxacin Otic Solution, 5ml<br>(Having net content of 17.91 kg of Bulk Drug)<br>1 Number<br>1<br>OFLOXACIN USP<br>15.30 mg.<br>Ofloxacin Otic Solution, 10ml<br>(Having net content of 16.19 kg of Bulk Drug)<br>1 Number<br>2<br>OFLOXACIN USP<br>30.60 mg.<br>Ofloxacin Ophthalmic Solution, USP, 5ml<br>(Having net content of 16.03 kg of Bulk Drug)<br>1 Number<br>3<br>OFLOXACIN USP<br>15.30 mg.<br>RA concerned may take further necessary action as per above decision of NC.

Solution, USP, 5ml<br>(Having net content of 16.03 kg of Bulk Drug)<br>1 Number<br>3<br>OFLOXACIN USP<br>15.30 mg.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 79 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000392AM24

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RA File Number 03AX04000300 AM24
Licence No and<br>Date 0311023089/25/04/2023
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/202223/20 dated 24/02/2023against advance<br>authorizationNo.0311016713 dated 29/07/2022, 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. Import Items<br>Qty. allowed.<br>ISOBORNEOL POWDER (AB08011)<br>1 kg.<br>1<br>GUM TURPENTINE OIL<br>0.9529 kg.<br>RA concerned may take further necessary action as per above decision of NC.

mport Items**<br>Qty. allowed.<br>ISOBORNEOL POWDER (AB08011)<br>1 kg.<br>1<br>GUM TURPENTINE OIL<br>0.9529 kg.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 80 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name ALKALOIDS PVT LTD.
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000398AM24
RA File Number 02AX04000047 AM24
Licence No and<br>Date 0211004284/25/04/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 81 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000404AM24
RA File Number 05AX04000234 AM24
Licence No and<br>Date 0511018526/25/04/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-

49

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  1. Get the amended Advance Authorisation with complete export description.

norms and it was decided to call for<br>following information/documents from the firm:-||

49

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  1. Get the amended Advance Authorisation with complete export description.
Case No. 82 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000446AM24
RA File Number 07AX04000091 AM24
Licence No and<br>Date 0711007425/27/04/2023
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>1. Complete chemical reaction with molecular and structural formula and molecular weights along with<br>stage wise percentage yield on molar basis.<br>1.
Case No. Case No. 83 / NC/3/MEET/Jan/202324/20 83 / NC/3/MEET/Jan/202324/20 83 / NC/3/MEET/Jan/202324/20 83 / NC/3/MEET/Jan/202324/20 83 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000461AM24
RA File Number 03AX04000246 AM24
Licence No and<br>Date 0311023171/28/04/2023
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.

|Licence No and<br>Date||0311023171/28/04/2023||||| |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>ISOPRENOL<br>0.604 kg.<br>PHENYL HEXANOL<br>1 kg.<br>2<br>N-HEPTANE<br>1.100 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||PHENYL HEXANOL||1 kg.|1|ISOPRENOL|0.604 kg.| |||||2|N-HEPTANE|1.100 kg.| ||||||||

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Case No. 84 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name AMI LIFESCIENCES PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000473AM24
RA File Number 34AX04000066 AM24
Licence No and<br>Date 3411003631/28/04/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Reason for asking high quantity of Pyridine 2-Ethanol and to give Stoichiometric balance on molar basis.<br>1.<br>Stepwise yield of reaction, indicating overall yield.<br>2.<br>End use of the product.<br>3.

quantity of Pyridine 2-Ethanol and to give Stoichiometric balance on molar basis.**<br>1.<br>Stepwise yield of reaction, indicating overall yield.<br>2.<br>End use of the product.<br>3.||

Case No. 85 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name AMI LIFESCIENCES PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000479AM24
RA File Number 34AX04000065 AM24
Licence No and<br>Date 3411003636/28/04/2023
Norms Committee Decision:<br>The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for<br>following information/documents from the firm:-<br>Reason for asking high quantity of Para Toluic Acid and to give Stoichiometric balance on molar basis.<br>1.<br>Stepwise yield of reaction, indicating overall yield.<br>2.<br>End use of the product.<br>3.
Case No. 86 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM REVIW00004946AM24
RA File Number 03AX04000416 AM24

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Licence No and 0311023239/01/05/2023 Date Norms Committee Decision: The case is under consideration for want of comments of TE.

Kumar, Deputy DGFT on 12-02-2024 12:35:23.

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Licence No and 0311023239/01/05/2023 Date Norms Committee Decision: The case is under consideration for want of comments of TE.

Case No. Case No. Case No. 87 / NC/3/MEET/Jan/202324/20 87 / NC/3/MEET/Jan/202324/20 87 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000539AM24
RA File Number 03AX04000343 AM24
Licence No and<br>Date 0311023300/03/05/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>Sl. No<br>Export Product<br>Quantity<br>1<br>Medical Ointment cream Gel(Clotrimazole and Betamethasone Dipropionate Cream USP<br>1% 0.05% 15 Gm (Tot wt 2941.16 Kgs Poly 66.18 Kgs, white petro 441.17 Kgs, Min oil<br>176.47, cetyl 148.23, Cetos 63.48Kgs, beta1.88 Kgs, Clotri 29.41 Kgs, Benzyl 29.41Kgs,<br>Tube 196077 Nos) )<br>1 Number<br>2<br>Medical ointment cream, Gel(Clotrimazole and Betamethasone Dipropionate Cream USP<br>1% 0.05% 45 Gm (Tot wt 2941.11 Kgs Poly 66.17 Kgs, white petro 441.17 Kgs, Min<br>oil176.47, cetyl 148.23, Cetos 63.48Kgs, beta 1.88 Kgs, Clotri 29.41 Kgs, Benzyl 29.41<br>Kgs, Tube 65358 Nos) )<br>1 Number<br>**S.

(Tot wt 2941.11 Kgs Poly 66.17 Kgs, white petro 441.17 Kgs, Min<br>oil176.47, cetyl 148.23, Cetos 63.48Kgs, beta 1.88 Kgs, Clotri 29.41 Kgs, Benzyl 29.41<br>Kgs, Tube 65358 Nos) )<br>1 Number<br>S. No<br>Import Product<br>Quantity allowed.<br>1<br>Relevant Bulk Drugs<br>Net content in the export product plus 3% wastage.<br>2<br>Relevant Excipients<br>Net content in the export product plus 3% wastage.<br>3<br>Relevant Packaging Material<br>Relevant as per Packing Policy|||||| ||Sl. No|Export Product<br>|||Quantity| ||1|Medical Ointment cream Gel(Clotrimazole and Betamethasone Dipropionate Cream USP<br>1% 0.05% 15 Gm (Tot wt 2941.16 Kgs Poly 66.18 Kgs, white petro 441.17 Kgs, Min oil<br>176.47, cetyl 148.23, Cetos 63.48Kgs, beta1.88 Kgs, Clotri 29.41 Kgs, Benzyl 29.41Kgs,<br>Tube 196077 Nos) )<br>|||<br>1 Number| ||2|Medical ointment cream, Gel(Clotrimazole and Betamethasone Dipropionate Cream USP<br>1% 0.05% 45 Gm (Tot wt 2941.11 Kgs Poly 66.17 Kgs, white petro 441.17 Kgs, Min<br>oil176.47, cetyl 148.23, Cetos 63.48Kgs, beta 1.88 Kgs, Clotri 29.41 Kgs, Benzyl 29.41<br>Kgs, Tube 65358 Nos) )<br>|||<br>1 Number| ||||||| ||S. No|Import Product||Quantity allowed.|| ||1|Relevant Bulk Drugs||Net content in the export product plus 3% wastage.|| ||2|Relevant Excipients||Net content in the export product plus 3% wastage.|| ||3|Relevant Packaging Material||Relevant as per Packing Policy||

Net content in the export product plus 3% wastage.|| ||2|Relevant Excipients||Net content in the export product plus 3% wastage.|| ||3|Relevant Packaging Material||Relevant as per Packing Policy||

Case No. Case No. Case No. 87 / NC/3/MEET/Jan/202324/20 87 / NC/3/MEET/Jan/202324/20 87 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000539AM24
RA File Number 03AX04000343 AM24
Licence No and<br>Date 0311023300/03/05/2023
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and on the basis of information provided<br>by the firm, it was decided to revise ad-hoc norms for export to US only are as under:-<br>Sl. No<br>Export Product<br>Quantity<br>1<br>Medical Ointment cream Gel(Clotrimazole and Betamethasone Dipropionate Cream USP<br>1% 0.05% 15 Gm (Tot wt 2941.16 Kgs Poly 66.18 Kgs, white petro 441.17 Kgs, Min oil<br>176.47, cetyl 148.23, Cetos 63.48Kgs, beta1.88 Kgs, Clotri 29.41 Kgs, Benzyl 29.41Kgs,<br>Tube 196077 Nos) )<br>1 Number<br>2<br>Medical ointment cream, Gel(Clotrimazole and Betamethasone Dipropionate Cream USP<br>1% 0.05% 45 Gm (Tot wt 2941.11 Kgs Poly 66.17 Kgs, white petro 441.17 Kgs, Min<br>oil176.47, cetyl 148.23, Cetos 63.48Kgs, beta 1.88 Kgs, Clotri 29.41 Kgs, Benzyl 29.41<br>Kgs, Tube 65358 Nos) )<br>1 Number<br>**S.

(Tot wt 2941.11 Kgs Poly 66.17 Kgs, white petro 441.17 Kgs, Min<br>oil176.47, cetyl 148.23, Cetos 63.48Kgs, beta 1.88 Kgs, Clotri 29.41 Kgs, Benzyl 29.41<br>Kgs, Tube 65358 Nos) )<br>1 Number<br>S. No<br>Import Product<br>Quantity allowed.<br>1<br>Relevant Bulk Drugs<br>Net content in the export product plus 3% wastage.<br>2<br>Relevant Excipients<br>Net content in the export product plus 3% wastage.<br>3<br>Relevant Packaging Material<br>Relevant as per Packing Policy|||||| ||Sl. No|Export Product<br>|||Quantity| ||1|Medical Ointment cream Gel(Clotrimazole and Betamethasone Dipropionate Cream USP<br>1% 0.05% 15 Gm (Tot wt 2941.16 Kgs Poly 66.18 Kgs, white petro 441.17 Kgs, Min oil<br>176.47, cetyl 148.23, Cetos 63.48Kgs, beta1.88 Kgs, Clotri 29.41 Kgs, Benzyl 29.41Kgs,<br>Tube 196077 Nos) )<br>|||<br>1 Number| ||2|Medical ointment cream, Gel(Clotrimazole and Betamethasone Dipropionate Cream USP<br>1% 0.05% 45 Gm (Tot wt 2941.11 Kgs Poly 66.17 Kgs, white petro 441.17 Kgs, Min<br>oil176.47, cetyl 148.23, Cetos 63.48Kgs, beta 1.88 Kgs, Clotri 29.41 Kgs, Benzyl 29.41<br>Kgs, Tube 65358 Nos) )<br>|||<br>1 Number| ||||||| ||S. No|Import Product||Quantity allowed.|| ||1|Relevant Bulk Drugs||Net content in the export product plus 3% wastage.|| ||2|Relevant Excipients||Net content in the export product plus 3% wastage.|| ||3|Relevant Packaging Material||Relevant as per Packing Policy||

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Note:

  • i. 1.03 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments solely for export to US.

  • ii. 1.02 kg. of bulk drug and excipients may be allowed per kg. content of bulk drug and excipients in the export of Medicinal Cream/Ointments for the export to other than US.

  • iii. The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption.

Case No. 88 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name AVIK PHARMACEUTICAL LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000541AM24
RA File Number 52AX04000022 AM24
Licence No and<br>Date 5211004680/03/05/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 89 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000547AM24
RA File Number 08AX04000159 AM24
Licence No and<br>Date 0811008069/03/05/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.
Case No. 90 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name MANGALAM DRUGS AND ORGANICS LIMITED

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-| |Case Status|Case Approved| |Party Name|MANGALAM DRUGS AND ORGANICS LIMITED|

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Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000648AM24
RA File Number 03AX04000385 AM24
Licence No and<br>Date 0311023414/08/05/2023
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 22/08/2023againstHQ. File No.<br>**HQRNORMAPPLY00000449AM24,**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. allowed.<br>1<br>4,6 Dichloro 5-Methoxy Pyrimidine (DCMP)<br>0.78 kg.<br>SULFADOXINE<br>1 kg.<br>2<br>SULFANILAMIDE<br>0.90 kg.<br>RA concerned may take further necessary action as per above decision of NC.

1<br>4,6 Dichloro 5-Methoxy Pyrimidine (DCMP)<br>0.78 kg.<br>SULFADOXINE<br>1 kg.<br>2<br>SULFANILAMIDE<br>0.90 kg.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. Case No. 91 / NC/3/MEET/Jan/202324/20 91 / NC/3/MEET/Jan/202324/20 91 / NC/3/MEET/Jan/202324/20 91 / NC/3/MEET/Jan/202324/20 91 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name SRIAM LABS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000668AM24
RA File Number 09AX04000119 AM24
Licence No and<br>Date 0911004980/08/05/2023
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/202324/13 dated 14/09/2023against advance<br>authorizationNo.0911005263 dated 26/06/2023, 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.<br>allowed.
Export Product Qty. **Sl. No. ** Import Items Qty.<br>allowed.

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Product**<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty.<br>allowed.|

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1<br>2-Azabicylo [2.2.1] hept-5-en-3-one<br>(Vince lactam)<br>1.337 kg.<br>2<br>Sodium borohydride<br>0.214 kg.<br>3<br>L(+) Tartaric acid<br>0.900 kg.<br>(1S, 4R)-Cis-4-Amino-2-cyclopentene-1-<br>methanol tartrate (CAP-II)<br>1 kg.<br>4<br>D (-) tartaric acid<br>0.742 kg.<br>RA concerned may take further necessary action as per above decision of NC. (1S, 4R)-Cis-4-Amino-2-cyclopentene-1-<br>methanol tartrate (CAP-II) 1 kg. 1 2-Azabicylo [2.2.1] hept-5-en-3-one<br>(Vince lactam) 1.337 kg.
2 Sodium borohydride 0.214 kg.
3 L(+) Tartaric acid 0.900 kg.
4 D (-) tartaric acid 0.742 kg.
Case No. Case No. 92 / NC/3/MEET/Jan/202324/20 92 / NC/3/MEET/Jan/202324/20 92 / NC/3/MEET/Jan/202324/20 92 / NC/3/MEET/Jan/202324/20 92 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000671AM24
RA File Number 04AX04000090 AM24
Licence No and<br>Date 0411005354/08/05/2023

and Date||NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024||||| |HQ File Number||HQRNORM APPLY 00000671AM24||||| |RA File Number||04AX04000090 AM24||||| |Licence No and<br>Date||0411005354/08/05/2023||||| |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.0411004084 dated 11/10/2022, 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>1<br>ISOBUTYL ACETOPHENONE<br>1.110 kg.<br>2<br>SODIUM METAL<br>0.235 kg.<br>3<br>MONOCHLORO ACETIC ACID<br>0.919 kg.<br>4<br>ISO PROPYL ALCOHOL<br>0.500 kg.<br>IBUPROFEN<br>1 kg.<br>5<br>SODIUM DICHROMATE<br>0.630 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||IBUPROFEN||1 kg.|1|ISOBUTYL ACETOPHENONE|1.110 kg.| |||||2|SODIUM METAL|0.235 kg.| |||||3|MONOCHLORO ACETIC ACID|0.919 kg.| |||||4|ISO PROPYL ALCOHOL|0.500 kg.| |||||5|SODIUM DICHROMATE|0.630 kg.|

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L ACETOPHENONE|1.110 kg.| |||||2|SODIUM METAL|0.235 kg.| |||||3|MONOCHLORO ACETIC ACID|0.919 kg.| |||||4|ISO PROPYL ALCOHOL|0.500 kg.| |||||5|SODIUM DICHROMATE|0.630 kg.|

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Case No. 93 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name SOLARA ACTIVE PHARMA SCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000672AM24
RA File Number 04AX04000094 AM24
Licence No and<br>Date 0411005356/08/05/2023
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.0411004084 dated 11/10/2022, 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>1<br>ISOBUTYL ACETOPHENONE<br>1.110 kg.<br>2<br>SODIUM METAL<br>0.235 kg.<br>3<br>MONOCHLORO ACETIC ACID<br>0.919 kg.<br>4<br>ISO PROPYL ALCOHOL<br>0.500 kg.<br>IBUPROFEN<br>1 kg.<br>5<br>SODIUM DICHROMATE<br>0.630 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 94 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name ALKEM LABORATORIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000683AM24

|---|---| |Case Status|Case Deferred| |Party Name|ALKEM LABORATORIES LIMITED| |Meeting Number<br>and Date|NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024| |HQ File Number|HQRNORM APPLY 00000683AM24|

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RA File Number 03AX04000499 AM24 Licence No and 0311023438/09/05/2023 Date Norms Committee Decision:

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

Case No. 95 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000696AM24
RA File Number 09AX04000101 AM24
Licence No and<br>Date 0911004999/09/05/2023
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.0911005580 dated 04/08/2023, 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. Import Items<br>Qty. allowed.<br>VALGANCICLOVIR HYDROCHLORIDE<br>1 kg.<br>1<br>GANCICLOVIR<br>1.75 kg.<br>RA concerned may take further necessary action as per above decision of NC.

l. No. Import Items**<br>Qty. allowed.<br>VALGANCICLOVIR HYDROCHLORIDE<br>1 kg.<br>1<br>GANCICLOVIR<br>1.75 kg.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 96 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name ADCOCK INGRAM LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000699AM24
RA File Number 07AX04000168 AM24
Licence No and Date 0711007506/09/05/2023
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/202324/8 dated 30/06/2023against advance authorization<br>No.0711007204 dated 27/03/2023, 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:-

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Export Product Qty. **Sl. No. ** Import Items Qty. allowed.
NORFLEX 100mg<br>TABLETS(Orphenadrine Citrate 100mg +<br>Lactose Monohydrate 167mg Tablets<br>(NORFLEX 100mg TABLETS)<br>(Orphenadrine-1400.000+ Lactose-<br>2338.000 KGS = Total KGS-3738.000<br>(No: Tablets: 14000000)<br>BP/EP/USP/PH.EUR/NF/USNF) 1 Tablet 1 ORPHENADRINE<br>CITRATE<br>BP/EP/USP/PH.EUR 102.00 mg per<br>tablet
2 PHARMATOSE R 130M<br>MILLED LACTOSE<br>MONOHYDRATE USP-<br>NF/ PH.EUR/JP 167.00 mg per<br>tablet

R/NF/USNF)|1 Tablet|1|ORPHENADRINE<br>CITRATE<br>BP/EP/USP/PH.EUR|102.00 mg per<br>tablet| |||2|PHARMATOSE R 130M<br>MILLED LACTOSE<br>MONOHYDRATE USP-<br>NF/ PH.EUR/JP|167.00 mg per<br>tablet|

Case No. 97 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name HINDYS LAB PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000706AM24
RA File Number 09AX04001065 AM23
Licence No and Date 0911005002/09/05/2023
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/202324/8 dated 30/06/2023against advance authorization<br>No.0911004974 dated 08/05/2023, 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. Import Items<br>Qty.<br>allowed.<br>GUANINE(Heterocycliccompoundswithnitrogen<br>Hetero-atom(s) Only - Compounds Containing An<br>Unfused Pyrazole Ring (whether Or Not<br>Hydrogenated) In The Structure-others)<br>1 kg.<br>1<br>2,4,5-Triamino-6-<br>hydroxypyrimidine sulphate<br>1.95 kg.<br>RA concerned may take further necessary action as per above decision of NC.

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cture-others)<br>1 kg.<br>1<br>2,4,5-Triamino-6-<br>hydroxypyrimidine sulphate<br>1.95 kg.<br>RA concerned may take further necessary action as per above decision of NC.||

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Case No. 98 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name RUMIT LIFE CARE
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000710AM24
RA File Number 03AX04000424 AM24
Licence No and<br>Date 0311023459/09/05/2023
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/202223/6 dated 09/09/2022against advance authorization<br>No. 0311010407 dated 12/01/2022, 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. Import Items<br>Qty. allowed.<br>Betamethasone Dipropionate IP/BP/EP/USP<br>115 kg.<br>1<br>Betamethasone IP/BP/EP/USP<br>99.82 kg.<br>RA concerned may take further necessary action as per above decision of NC.

y. allowed.**<br>Betamethasone Dipropionate IP/BP/EP/USP<br>115 kg.<br>1<br>Betamethasone IP/BP/EP/USP<br>99.82 kg.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No.<br> Case No.<br> 99 / NC/3/MEET/Jan/202324/20 99 / NC/3/MEET/Jan/202324/20 99 / NC/3/MEET/Jan/202324/20 99 / NC/3/MEET/Jan/202324/20 99 / NC/3/MEET/Jan/202324/20
Case Status<br> Case Approved
Party Name<br> HONOUR LAB LIMITED
Meeting Number<br>and Date<br> NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number<br> HQRNORM APPLY 00000723AM24
RA File Number<br> 09AX04001135 AM23
Licence No and<br>Date<br> 0911005005/10/05/2023
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/202324/8 dated 30/06/2023against advance authorization<br>No.0911004803 dated 10/04/2023, 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.<br>allowed.
Export Product Qty. Sl. No. Import Items Qty.<br>allowed.

er is less:-_<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.<br>allowed.|

Case No.<br> Case No.<br> 99 / NC/3/MEET/Jan/202324/20 99 / NC/3/MEET/Jan/202324/20 99 / NC/3/MEET/Jan/202324/20 99 / NC/3/MEET/Jan/202324/20 99 / NC/3/MEET/Jan/202324/20
Case Status<br> Case Approved
Party Name<br> HONOUR LAB LIMITED
Meeting Number<br>and Date<br> NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number<br> HQRNORM APPLY 00000723AM24
RA File Number<br> 09AX04001135 AM23
Licence No and<br>Date<br> 0911005005/10/05/2023
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/202324/8 dated 30/06/2023against advance authorization<br>No.0911004803 dated 10/04/2023, 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.<br>allowed.
Export Product Qty. Sl. No. Import Items Qty.<br>allowed.

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UDIN00478312AM24

Product**<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.<br>allowed.|

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1<br>N-((1R,2S,5S)-2-Amino-5-<br>(Dimethyllamino) carbonyl)<br>cyclohexyl) carbamic acid,<br>1,1-dimethyl ester,<br>Ethanedioate<br>1.17 kg.<br>2<br>2-[(5-Chloro-2-Pyridinyl)-2-<br>oxoacetate acid, Ethyl Ester<br>hydrochloride<br>0.80 kg.<br>3<br>4,5,6,7-tetrahydro-5-<br>methlthiazolo[5,4-c] pyride-<br>2-carboxylic acid<br>Hydrochloride<br>0.50 kg.<br>4<br>Tetra Hydro Furan<br>2.85 kg.<br>5<br>1-(3-Dimethylaminopyl)-3-<br>Ethylcarbodiimide<br>Hydrochloride<br>0.90 kg.<br>6<br>Dimethyl formamide<br>2.50 kg.<br>Ethanediamide, N1-(5-chloro-2-pyridinyl)-N2-<br>[(1S,2R,4S)-4-[(dimethylamino) carbonyl]-2-<br>[[(4,5,6,7-tetrahydro-5- Methylthi (Diloxanide<br>furoate, Cimetidine, Oxyclozanide, Famotidine:<br>Other)<br>1 kg.<br>7<br>N,N-Di Isopropyl ethyl<br>amine<br>0.72 kg.<br>RA concerned may take further necessary action as per above decision of NC. Ethanediamide, N1-(5-chloro-2-pyridinyl)-N2-<br>[(1S,2R,4S)-4-[(dimethylamino) carbonyl]-2-<br>[[(4,5,6,7-tetrahydro-5- Methylthi (Diloxanide<br>furoate, Cimetidine, Oxyclozanide, Famotidine:<br>Other) 1 kg. 1 N-((1R,2S,5S)-2-Amino-5-<br>(Dimethyllamino) carbonyl)<br>cyclohexyl) carbamic acid,<br>1,1-dimethyl ester,<br>Ethanedioate 1.17 kg.
2 2-[(5-Chloro-2-Pyridinyl)-2-<br>oxoacetate acid, Ethyl Ester<br>hydrochloride 0.80 kg.

<br>cyclohexyl) carbamic acid,<br>1,1-dimethyl ester,<br>Ethanedioate|1.17 kg.| |---|---|---|---|---|---| ||||2|2-[(5-Chloro-2-Pyridinyl)-2-<br>oxoacetate acid, Ethyl Ester<br>hydrochloride|0.80 kg.| ||||3|4,5,6,7-tetrahydro-5-<br>methlthiazolo[5,4-c] pyride-<br>2-carboxylic acid<br>Hydrochloride|0.50 kg.| ||||4|Tetra Hydro Furan|2.85 kg.| ||||5|1-(3-Dimethylaminopyl)-3-<br>Ethylcarbodiimide<br>Hydrochloride|0.90 kg.| ||||6|Dimethyl formamide|2.50 kg.| ||||7|N,N-Di Isopropyl ethyl<br>amine|0.72 kg.|

Case No. 100 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name HONOUR LAB LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000728AM24
RA File Number 09AX04001162 AM23
Licence No and<br>Date 0911005006/10/05/2023
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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UDIN00478312AM24

Export Product Qty. Sl. No. Import Items Qty. allowed.
S-(+)-2-2-AMINOBUTANAMIDE<br>HYDROCHLORIDE / BUTYRAMIDE / S-(+)-2-<br>AMINO BUTYRAMIDE HYDROCHLORIDE<br>(CARBOXYAMIDE-FUNCTION COMPOUNDS;<br>AMIDE-FUNCTION COMPOUNDS OF<br>CARBONIC ACID - ACYCLIC AMIDES<br>(INCLUDING ACYCLIC CARBAMATES) AND<br>THEIR DERIVATIVES; SALTS THEREOF :<br>OTHER.) 1 kg. 1 Propionaldehyde 1.65 kg.
2 Sodium cyanide 1.176 kg.
3 L-Tartaric acid 0.875 kg.

CLIC AMIDES<br>(INCLUDING ACYCLIC CARBAMATES) AND<br>THEIR DERIVATIVES; SALTS THEREOF :<br>OTHER.)|1 kg.|1|Propionaldehyde|1.65 kg.| |||2|Sodium cyanide|1.176 kg.| |||3|L-Tartaric acid|0.875 kg.|

Case No. 101 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name BLUE JET HEALTHCARE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000740AM24
RA File Number 03AX04000488 AM24
Licence No and<br>Date 0311023468/10/05/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending<br>before Norms Committee to explain its case alongwith relevant documents from the firm. Personal Hearing
Case No. 102 / NC/3/MEET/Jan/202324/20
Case Status Case Deferred
Party Name INNOVARE LABS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00000950AM24
RA File Number 09AX04000137 AM24
Licence No and<br>Date 0911005059/18/05/2023
Norms Committee Decision:<br>The case is under consideration for want of comments of TE.

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le Number|09AX04000137 AM24| |Licence No and<br>Date|0911005059/18/05/2023| |Norms Committee Decision:<br>The case is under consideration for want of comments of TE.||

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Case No. 103 / NC/3/MEET/Jan/202324/20
Case Status Case Approved
Party Name INDOCO REMEDIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jan/ 202324/ 20 and 18/01/2024
HQ File Number HQRNORM APPLY 00001114AM24
RA File Number 03AX04000805 AM24
Licence No and<br>Date 0311023932/25/05/2023
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/202324/8 dated 30/06/2023against advance authorization<br>No.0311023356 dated 04/05/2023, 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. Import Items<br>Qty. allowed.<br>1<br>Ketotifen Fumarate<br>1.785 mg.<br>2<br>Bottle<br>Relevant, as per<br>Packing Policy<br>3<br>Cap<br>Relevant, as per<br>Packing Policy<br>Ketotifen Fumarate ophthalmic solution<br>0.035% ( 5ml Bottle )(Each ml.

umarate<br>1.785 mg.<br>2<br>Bottle<br>Relevant, as per<br>Packing Policy<br>3<br>Cap<br>Relevant, as per<br>Packing Policy<br>Ketotifen Fumarate ophthalmic solution<br>0.035% ( 5ml Bottle )(Each ml. Contains:<br>Ketotifen(0.025%) Antihistamine<br>(Equivalent to Ketotifen Fumarate 0.035% )<br>=<br>1.750<br>mg<br>per<br>bottle<br>of<br>5ml.)<br>(i.e.1.75mg./5ml) Net Weight in Export<br>Products is : 2030 GRAMS)<br>1 Number<br>4<br>Dropper<br>Relevant, as per<br>Packing Policy<br>RA concerned may take further necessary action as per above decision of NC.||

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