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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/Jul/202324/9 DATED: 28/07/2023

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/Jul/202324/9 dated 28/07/2023 of Norms Committee - III for the year 2023-24 was held on 28/07/2023 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 T SONGZALIAN,Deputy DGFT DGFT(HQ)
2 UTTAM SARKAR,Assistant Section Officer 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

This document has been digitally signed by T SONGZALIAN, Deputy DGFT on 25-08-2023 11:30:28.

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Case Details and Decision(s):

Case No. 1 / NC/3/MEET/Jul/202324/9 1 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name SUDEEP NUTRITION PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00004920AM23
RA File Number NA
Licence No and<br>Date NA
Norms Committee Decision:
The Committee considered the request of firm for fixation of ad-hoc norms to enable them to obtain Advance
Authorization from concerned RA and it was decided to ratify ad-hoc norms as per details given below or as applied
by the firm, whichever is less: -
Export Product Qty. Sl. No. Import Items Qty.
Vitamin AD3 Oily Premix 2500 kg. 1 Vitamin A Palmitate 1.7 MIU 1485.30 kg.
(Each gm export item contains 1.00
MIU of Vitamin A Palmitate)
RA concerned may take further necessary action as per above decision of NC.

almitate 1.7 MIU||1485.30 kg.|| |(Each gm export item contains 1.00|||||||| |MIU of Vitamin A Palmitate)|||||||| |RA concerned may take further necessary||action as per above decision of NC.||||||

Case No. 2 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name SUDEEP NUTRITION PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00004921AM23
RA File Number NA
Licence No and<br>Date NA
Norms Committee Decision:
The Committee considered the request of firm for fixation of ad-hoc norms to enable them to obtain Advance
Authorization from concerned RA and it was decided to ratify ad-hoc norms as per details given below or as applied
by the firm, whichever is less: -

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Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>A Palmitate 250 CWS<br>(Containing NLT 57% modified<br>starch)<br>8333.33 kg<br>1<br>Modified Starch<br>4823.50 kg.<br>RA concerned may take further necessary action as per above decision of NC. Export Product Qty. Sl. No. Import Items Qty.
A Palmitate 250 CWS<br>(Containing NLT 57% modified<br>starch) <br>8333.33 kg 1 Modified Starch 4823.50 kg.

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

--|---| ||A Palmitate 250 CWS<br>(Containing NLT 57% modified<br>starch)|<br>8333.33 kg|1|Modified Starch|4823.50 kg.|

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

Case No. 3 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name SRIAM LABS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00005208AM23
RA File Number NA
Licence No and<br>Date NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has not submitted the application<br>properly on DGFT back office portal. Hence, the Committee decided towithdrawnthe case.
Case No. Case No. 4 / NC/3/MEET/Jul/202324/9 4 / NC/3/MEET/Jul/202324/9 4 / NC/3/MEET/Jul/202324/9 4 / NC/3/MEET/Jul/202324/9 4 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name MANKIND PHARMA LIMITED
Meeting Number and<br>Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00005709AM23
RA File Number 052404000450 AM21
Licence No and Date 0511000017/null
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>SPIROKIND 25 (SPIRONOLACTONE<br>TABLETS. BP 25 MG)<br>1 Number<br>1<br>SPIRONOLACTONE PH.EUR.

applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>SPIROKIND 25 (SPIRONOLACTONE<br>TABLETS. BP 25 MG)<br>1 Number<br>1<br>SPIRONOLACTONE PH.EUR. 25.50 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||SPIROKIND 25 (SPIRONOLACTONE<br>TABLETS. BP 25 MG)||<br>1 Number|1|SPIRONOLACTONE PH.EUR.|25.50 mg|

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SPIROKIND 50 (SPIRONOLACTONE <br>1 Number 2 SPIRONOLACTONE PH.EUR. 51.00 mg
TABLETS. BP 50 MG)
Case No. 5 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name ROYAL PHARMA
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00000117AM24
RA File Number 039504000958 AM15
Licence No and<br>Date 0310793866/12/02/2015
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has not furnished valid justification<br>for enhancement. Hence, the Committee decided torejectthe case.

<br>The Committee considered the case as per agenda and it was observed that the firm has not furnished valid justification<br>for enhancement. Hence, the Committee decided torejectthe case.||

Case No. 6 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name SHREE GANESH REMEDIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00003812AM23
RA File Number 342404000295 AM15
Licence No and<br>Date 3410040965/16/02/2015
Norms Committee Decision:<br>Shri Chandu Kothia had attended the virtual meeting and explained firm’s case. The Committee heard the explanation<br>of Representatives of the firm and after deliberation, firm was requested to furnish the following<br>information/documents: -<br>1.Percentage yield on molar basis of three stage reaction as stated in personal hearing.<br>2. Sample of shipping bills and bill of entry of the export products and statement of export import of the<br>Authorization.
Case No. 7 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name SWATI MENTHOL AND ALLIED CHEMICALS LIMITED

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Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00006223AM23
RA File Number 292404000002 AM17
Licence No and<br>Date 2910025262/23/09/2016
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case

rms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case||

Case No. 8 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name PARAMOUNT AROMACHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00001869AM23
RA File Number 052404000399 AM17
Licence No and<br>Date 0510400599/02/12/2016
Norms Committee Decision:<br>The committee considered the request of the firm for review of ad-hoc norms and committee has observed that<br>information given by the firm in reply to DL is not clear. Therefore, Committee has decided to call forMetal Balance<br>Sheeton the basis of information given by the firm.
Case No. 9 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name SWATI MENTHOL AND ALLIED CHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00006224AM23
RA File Number 292404000009 AM17
Licence No and<br>Date 2910025281/23/02/2017
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.

Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.||

Case No. 10 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name NATURAL HERBS & FORMULATIONS
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00004230AM23

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RA File Number 612404000001 AM18
Licence No and<br>Date 6110001419/13/04/2017
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.
Case No. 11 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name PARAMOUNT AROMACHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00001867AM23
RA File Number 052404000008 AM18
Licence No and<br>Date 0510402246/18/04/2017
Norms Committee Decision:
The committee considered the request of the firm for review of ad-hoc norms and committee has observed that
information given by the firm in reply to DL is not clear. Therefore, Committee has decided to call forMetal Balance
Sheeton the basis of information given by the firm.

served that|| |information given by the firm in reply to DL is not clear. Therefore, Committee has decided to call forMetal Balance|| |Sheeton the basis of information given by the firm.||

Case No. 12 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name NATURAL HERBS & FORMULATIONS
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00004226AM23
RA File Number 612404000002 AM18
Licence No and<br>Date 6110001452/18/08/2017
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.
Case No. 13 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name ROYAL PHARMA
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00000123AM24
RA File Number 039504000424 AM18
Licence No and<br>Date 0310815337/23/08/2017

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Norms Committee Decision:

The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply. Hence, the Committee decided to reject the case.

Case No. 14 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name SWATI MENTHOL AND ALLIED CHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00006225AM23
RA File Number 292404000006 AM18
Licence No and<br>Date 2910025308/30/10/2017
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.
Case No. 15 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name PARAMOUNT AROMACHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00001870AM23
RA File Number 052404000297 AM18
Licence No and<br>Date 0510404439/31/10/2017
Norms Committee Decision:<br>The committee considered the request of the firm for review of ad-hoc norms and committee has observed that<br>information given by the firm in reply to DL is not clear. Therefore, Committee has decided to call forMetal Balance<br>Sheeton the basis of information given by the firm.

served that<br>information given by the firm in reply to DL is not clear. Therefore, Committee has decided to call forMetal Balance<br>Sheeton the basis of information given by the firm.||

Case No. 16 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name NATURAL HERBS & FORMULATIONS
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00004092AM23
RA File Number 612404000004 AM18
Licence No and<br>Date 6110001484/16/01/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not attended the personal

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UDIN00233900AM24

hearing even after repeated reminder. Hence, the Committee decided to reject the case.

Case No. Case No. Case No. 17 / NC/3/MEET/Jul/202324/9 17 / NC/3/MEET/Jul/202324/9 17 / NC/3/MEET/Jul/202324/9 17 / NC/3/MEET/Jul/202324/9 17 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00003343AM23
RA File Number 039404000911 AM18
Licence No and Date 0310819230/19/02/2018
Norms Committee Decision:<br>**Decision:**The Committee considered the case<br>of HBP Vol.

0003343AM23||||| |RA File Number|||039404000911 AM18||||| |Licence No and Date|||0310819230/19/02/2018||||| |Norms Committee Decision:<br>**Decision:**The Committee considered the case<br>of HBP Vol. I as per details given below or as<br>S.<br>No.<br>Export Product<br>Qty.<br>1<br>Sodium Chloride 9%<br>50 ml<br>1 Number|||||as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>applied by the firm, whichever is less:-||| ||S.<br>No.|Export Product||Qty.|Sl.<br>No.|Import Items|Qty.| ||1|Sodium Chloride 9%<br>50 ml||<br>1 Number|1|Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical ingredient(API)<br>SANAL P|Net content in<br>export + 2%<br>wastage| ||||||2|UFR2 150/524 Plastic film non-PVC for<br>Secondary packing|Net + 1%<br>Wastage| ||||||3|Hot Stamping foil|Net + 1%<br>Wastage| ||||||4|Ship Shape Corpus Infusion|Net + 1%<br>Wastage| ||||||5|Ship Shape Corpus Injection with PP<br>membrane 0.8|Net + 1%<br>Wastage| ||||||6|Ship Shape Break of Infusion blue|Net + 1%<br>Wastage| ||||||7|Ship Shape Break of Injection|Net + 1%<br>Wastage| ||||||11|SF9 195/95 Plastic film non PVC for Primary|Net + 1%|

br>Wastage| ||||||6|Ship Shape Break of Infusion blue|Net + 1%<br>Wastage| ||||||7|Ship Shape Break of Injection|Net + 1%<br>Wastage| ||||||11|SF9 195/95 Plastic film non PVC for Primary|Net + 1%|

Case No. Case No. Case No. 17 / NC/3/MEET/Jul/202324/9 17 / NC/3/MEET/Jul/202324/9 17 / NC/3/MEET/Jul/202324/9 17 / NC/3/MEET/Jul/202324/9 17 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00003343AM23
RA File Number 039404000911 AM18
Licence No and Date 0310819230/19/02/2018
Norms Committee Decision:<br>**Decision:**The Committee considered the case<br>of HBP Vol. I as per details given below or as<br>S.<br>No.<br>Export Product<br>Qty.<br>1<br>Sodium Chloride 9%<br>50 ml<br>1 Number as per agenda and it was decided to fix ad-hoc norms under Para 4.07<br>applied by the firm, whichever is less:-
S.<br>No. Export Product Qty. Sl.<br>No. Import Items Qty.
1 Sodium Chloride 9%<br>50 ml <br>1 Number 1 Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical ingredient(API)<br>SANAL P Net content in<br>export + 2%<br>wastage
2 UFR2 150/524 Plastic film non-PVC for<br>Secondary packing Net + 1%<br>Wastage
3 Hot Stamping foil Net + 1%<br>Wastage
4 Ship Shape Corpus Infusion Net + 1%<br>Wastage
5 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1%<br>Wastage

1%<br>Wastage| ||||||3|Hot Stamping foil|Net + 1%<br>Wastage| ||||||4|Ship Shape Corpus Infusion|Net + 1%<br>Wastage| ||||||5|Ship Shape Corpus Injection with PP<br>membrane 0.8|Net + 1%<br>Wastage| ||||||6|Ship Shape Break of Infusion blue|Net + 1%<br>Wastage| ||||||7|Ship Shape Break of Injection|Net + 1%<br>Wastage| ||||||11|SF9 195/95 Plastic film non PVC for Primary|Net + 1%|

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

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king|Net + 1%<br>Wastage| |||||15|OFR2 150/524 Plastic film non PVC for<br>Secondary packing|Net + 1%<br>Wastage| |||||18|Corrugated Boxes 385 x 285 x 220mm(FFX|Net + 1%|

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Karton) AUS Wastage
19 Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net
20 Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net
3 Sodium Chloride 9%<br>250 ml <br>1 Number 1 Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical ingredient(API)<br>SANAL P Net content in<br>export + 2%<br>wastage
2 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
3 Hot Stamping foil Net + 1%<br>Wastage
4 Ship Shape Corpus Infusion Net + 1%<br>Wastage
5 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1%<br>Wastage
6 Ship Shape Break of Infusion blue Net + 1%<br>Wastage
7 Ship Shape Break of Injection Net + 1%<br>Wastage
12 SF9 195/100 Plastic film non-PVC for<br>Primary packing Net + 1%<br>Wastage
15 OFR2 150/524 Plastic film non-PVC for<br>Secondary packing Net + 1%<br>Wastage
18 Corrugated Boxes 385 x 285 x 220mm(FFX<br>Karton) AUS Net + 1%<br>Wastage
19 Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net
20 Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net

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220mm(FFX<br>Karton) AUS|Net + 1%<br>Wastage| |||||19|Pallets CP5 1140x1170(Aus)(Heat Treated)|Net to Net| |||||20|Pallets CP3 1140 x 870(Aus)(Heat Treated)|Net to Net|

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4 Sodium<br>Chloride<br>0.9% 500 ml <br>1 Number 1 Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical ingredient(API)<br>SANAL P Net content in<br>export + 2%<br>wastage
2 UFR2 150/524 Plastic film non- PVC for<br>Secondary packing Net + 1%<br>Wastage
3 Hot Stamping foil Net + 1%<br>Wastage
4 Ship Shape Corpus Infusion Net + 1%<br>Wastage
5 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1%<br>Wastage
6 Ship Shape Break of Infusion blue Net + 1%<br>Wastage
7 Ship Shape Break of Injection Net + 1%<br>Wastage
13 SF9 195/135 Plastic film non PVC for<br>Primary packing Net + 1%<br>Wastage
16 OFR2 120/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
18 Corrugated Boxes 385 x 285 x 220mm(FFX<br>Karton) AUS Net + 1%<br>Wastage
19 Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net
20 Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net
5 Sodium<br>Chloride<br>0.9% 1000 ml <br>1 Number 1 Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical ingredient(API)<br>SANAL P Net content in<br>export + 2%<br>wastage
2 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage

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harmaceutical ingredient(API)<br>SANAL P|Net content in<br>export + 2%<br>wastage| |||||2|UFR2 150/524 Plastic film non PVC for<br>Secondary packing|Net + 1%<br>Wastage|

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3 Hot Stamping foil Net + 1%<br>Wastage
4 Ship Shape Corpus Infusion Net + 1%<br>Wastage
5 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1%<br>Wastage
6 Ship Shape Break of Infusion blue Net + 1%<br>Wastage
7 Ship Shape Break of Injection Net + 1%<br>Wastage
14 SF9 195/140 Plastic film non PVC for<br>Primary packing Net + 1%<br>Wastage
16 OFR2 120/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
18 Corrugated Boxes 385 x 285 x 220mm(FFX<br>Karton) AUS Net + 1%<br>Wastage
19 Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net
20 Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net
6 Glucose 10% 500 ml 1 Number 2 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
3 Hot Stamping foil Net + 1%<br>Wastage
4 Ship Shape Corpus Infusion Net + 1%<br>Wastage
5 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1%<br>Wastage
6 Ship Shape Break of Infusion blue Net + 1%

12

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e Corpus Infusion|Net + 1%<br>Wastage| |||||5|Ship Shape Corpus Injection with PP<br>membrane 0.8|Net + 1%<br>Wastage| |||||6|Ship Shape Break of Infusion blue|Net + 1%|

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Wastage
7 Ship Shape Break of Injection Net + 1%<br>Wastage
13 SF9 195/135 Plastic film non PVC for<br>Primary packing Net + 1%<br>Wastage
16 OFR2 120/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
18 Corrugated Boxes 385 x 285 x 220mm(FFX<br>Karton) AUS Net + 1%<br>Wastage
19 Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net
20 Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net
7 Glucose 5%100 ml 1 Number 2 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
3 Hot Stamping foil Net + 1%<br>Wastage
4 Ship Shape Corpus Infusion Net + 1%<br>Wastage
5 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1%<br>Wastage
6 Ship Shape Break of Infusion blue Net + 1%<br>Wastage
7 Ship Shape Break of Injection Net + 1%<br>Wastage
11 SF9 195/95 Plastic film non PVC for Primary<br>packing Net + 1%<br>Wastage
15 OFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage

13

UDIN00233900AM24

|||11|SF9 195/95 Plastic film non PVC for Primary<br>packing|Net + 1%<br>Wastage| |||||15|OFR2 150/524 Plastic film non PVC for<br>Secondary packing|Net + 1%<br>Wastage|

13

UDIN00233900AM24

18 Corrugated Boxes 385 x 285 x 220mm(FFX<br>Karton) AUS Net + 1%<br>Wastage
19 Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net
20 Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net
8 Glucos 5% 250 ml 1 Number 2 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
3 Hot Stamping foil Net + 1%<br>Wastage
4 Ship Shape Corpus Infusion Net + 1%<br>Wastage
5 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1%<br>Wastage
6 Ship Shape Break of Infusion blue Net + 1%<br>Wastage
7 Ship Shape Break of Injection Net + 1%<br>Wastage
12 SF9 195/100 Plastic film non PVC for<br>Primary packing Net + 1%<br>Wastage
15 OFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
18 Corrugated Boxes 385 x 285 x 220mm(FFX<br>Karton) AUS Net + 1%<br>Wastage
19 Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net
20 Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net
9 Glucose 5% 500 ml 1 Number 2 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage

14

UDIN00233900AM24

20|Pallets CP3 1140 x 870(Aus)(Heat Treated)|Net to Net| ||9|Glucose 5% 500 ml|1 Number|2|UFR2 150/524 Plastic film non PVC for<br>Secondary packing|Net + 1%<br>Wastage|

14

UDIN00233900AM24

3 Hot Stamping foil Net + 1%<br>Wastage
4 Ship Shape Corpus Infusion Net + 1%<br>Wastage
5 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1%<br>Wastage
6 Ship Shape Break of Infusion blue Net + 1%<br>Wastage
7 Ship Shape Break of Injection Net + 1%<br>Wastage
13 SF9 195/135 Plastic film non PVC for<br>Primary packing Net + 1%<br>Wastage
16 OFR2 120/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
18 Corrugated Boxes 385 x 285 x 220mm(FFX<br>Karton) AUS Net + 1%<br>Wastage
19 Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net
20 Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net
10 Glucose 5% 1000 ml 1 Number 2 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
3 Hot Stamping foil Net + 1%<br>Wastage
4 Ship Shape Corpus Infusion Net + 1%<br>Wastage
5 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1%<br>Wastage
6 Ship Shape Break of Infusion blue Net + 1%

15

UDIN00233900AM24

e Corpus Infusion|Net + 1%<br>Wastage| |||||5|Ship Shape Corpus Injection with PP<br>membrane 0.8|Net + 1%<br>Wastage| |||||6|Ship Shape Break of Infusion blue|Net + 1%|

15

UDIN00233900AM24

Wastage
7 Ship Shape Break of Injection Net + 1%<br>Wastage
14 SF9 195/140 Plastic film non PVC for<br>Primary packing Net + 1%<br>Wastage
16 OFR2 120/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
18 Corrugated Boxes 385 x 285 x 220mm(FFX<br>Karton) AUS Net + 1%<br>Wastage
19 Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net
20 Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net
11 Water for injection<br>500ml <br>1 Number 2 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
3 Hot Stamping foil Net + 1%<br>Wastage
4 Ship Shape Corpus Infusion Net + 1%<br>Wastage
5 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1%<br>Wastage
6 Ship Shape Break of Infusion blue Net + 1%<br>Wastage
7 Ship Shape Break of Injection Net + 1%<br>Wastage
13 SF9 195/135 Plastic film non PVC for<br>Primary packing Net + 1%<br>Wastage
16 OFR2 120/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage

16

UDIN00233900AM24

||13|SF9 195/135 Plastic film non PVC for<br>Primary packing|Net + 1%<br>Wastage| |||||16|OFR2 120/524 Plastic film non PVC for<br>Secondary packing|Net + 1%<br>Wastage|

16

UDIN00233900AM24

18 Corrugated Boxes 385 x 285 x 220mm(FFX<br>Karton) AUS Net + 1%<br>Wastage
19 Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net
20 Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net
12 Water for injection<br>1000ml <br>1 Number 2 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
3 Hot Stamping foil Net + 1%<br>Wastage
4 Ship Shape Corpus Infusion Net + 1%<br>Wastage
5 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1%<br>Wastage
6 Ship Shape Break of Infusion blue Net + 1%<br>Wastage
7 Ship Shape Break of Injection Net + 1%<br>Wastage
14 SF9 195/140 Plastic film non PVC for<br>Primary packing Net + 1%<br>Wastage
16 OFR2 120/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
18 Corrugated Boxes 385 x 285 x 220mm(FFX<br>Karton) AUS Net + 1%<br>Wastage
19 Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net
20 Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net
13 Sodium<br>Lactate<br>/<br>(Hartmanns) 500 ml <br>1 Number 1 Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical ingredient(API)<br>SANAL P Net content in<br>export + 2%<br>wastage

17

UDIN00233900AM24

artmanns) 500 ml|<br>1 Number|1|Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical ingredient(API)<br>SANAL P|Net content in<br>export + 2%<br>wastage|

17

UDIN00233900AM24

2 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
3 Hot Stamping foil Net + 1%<br>Wastage
4 Ship Shape Corpus Infusion Net + 1%<br>Wastage
5 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1%<br>Wastage
6 Ship Shape Break of Infusion blue Net + 1%<br>Wastage
7 Ship Shape Break of Injection Net + 1%<br>Wastage
13 SF9 195/135 Plastic film non PVC for<br>Primary packing Net + 1%<br>Wastage
16 OFR2 120/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
17 SODIUM LACTATE ( PURASAL SP/F<br>60)(Pharma grade) Net content in<br>export + 2%<br>wastage
18 Corrugated Boxes 385 x 285 x 220mm(FFX<br>Karton) AUS Net + 1%<br>Wastage
19 Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net
20 Pallets CP3 1140 x 870(Aus)(Heat Treated) Net to Net
14 Sodium<br>Lactate<br>/<br>(Hartmanns) 1000 ml <br>1 Number 1 Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical ingredient(API)<br>SANAL P Net content in<br>export + 2%<br>wastage
2 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage

18

UDIN00233900AM24

harmaceutical ingredient(API)<br>SANAL P|Net content in<br>export + 2%<br>wastage| |||||2|UFR2 150/524 Plastic film non PVC for<br>Secondary packing|Net + 1%<br>Wastage|

18

UDIN00233900AM24

3 Hot Stamping foil Net + 1%<br>Wastage
4 Ship Shape Corpus Infusion Net + 1%<br>Wastage
5 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1%<br>Wastage
6 Ship Shape Break of Infusion blue Net + 1%<br>Wastage
7 Ship Shape Break of Injection Net + 1%<br>Wastage
14 SF9 195/140 Plastic film non PVC for<br>Primary packing Net + 1%<br>Wastage
16 OFR2 120/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
17 SODIUM LACTATE ( PURASAL SP/F<br>60)(Pharma grade) Net content in<br>export + 2%<br>wastage
18 Corrugated Boxes 385 x 285 x 220mm(FFX<br>Karton) AUS Net + 1%<br>Wastage
19 Pallets CP5 1140x1170(Aus)(Heat Treated) Net to Net
15 Sodium<br>Chloride<br>0.9% 50ml (DE) <br>1 Number 1 Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical ingredient(API)<br>SANAL P Net content in<br>export + 2%<br>wastage
2 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
3 Hot Stamping foil Net + 1%<br>Wastage
4 Ship Shape Corpus Infusion Net + 1%

19

UDIN00233900AM24

UFR2 150/524 Plastic film non PVC for<br>Secondary packing|Net + 1%<br>Wastage| |||||3|Hot Stamping foil|Net + 1%<br>Wastage| |||||4|Ship Shape Corpus Infusion|Net + 1%|

19

UDIN00233900AM24

Wastage Wastage
5 Ship Shape Corpus Injection with PP<br>membrane 08 Net + 1%<br>Wastage
.
6 Ship Shape Break of Infusion blue Net + 1%<br>
Wastage
7 Ship Shape Break of Injection Net + 1%
Wastage
8 Corrugated Boxes 385 x 285 x 220mm(FFX<br>Karton) Net + 1%<br>Wastage
9 Direction Sheet(insert)for NS 50,100,250, 500<br>&1000ml Net + 1%<br>Wastage
10 EURO PALLETHEAT TREATED1200 N N
<br>800 ( ) x et t et
11 SF9 1<br>packin 95/95 P<br>g lastic film non PVC for Primary Net +<br>Wast 1%<br>age
15 OFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
21 Shipper Label Net + 1%
Wastage
16 Sodiu <br>Chloride <br>1 Number 1 Sodium Chloride NACL Pharmaceutical Net content in
<br>0.9% 1 <br> <br>00ml (DE) <br> <br>quality active pharmaceutical ingredient(API)<br>SANAL P <br>export + 2%<br>wastage
2 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
3 Hot Stamping foil Net + 1%<br>Wastage

%<br>wastage|| ||||||||||||| ||||||||||||| ||||||2||UFR2 150/524 Plastic film non PVC for<br>Secondary packing|||Net + 1%<br>Wastage|| ||||||||||||| ||||||3||Hot Stamping foil|||Net + 1%<br>Wastage|| ||||||4||Ship Shape Corpus Infusion|||Net + 1%<br>Wastage||

20

UDIN00233900AM24

5 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1%<br>Wastage
6 Ship Shape Break of Infusion blue Net + 1%<br>Wastage
7 Ship Shape Break of Injection Net + 1%<br>Wastage
8 Corrugated Boxes 385 x 285 x 220mm(FFX<br>Karton) Net + 1%<br>Wastage
9 Direction Sheet(insert)for NS 50,100,250, 500<br>&1000ml Net + 1%<br>Wastage
10 EURO PALLET(HEAT TREATED)1200 x<br>800 Net to Net
11 SF9 195/95 Plastic film non PVC for Primary<br>packing Net + 1%<br>Wastage
15 OFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
21 Shipper Label Net + 1%<br>Wastage
17 Sodium<br>Chloride<br>0.9% 250ml (DE) <br>1 Number 1 Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical ingredient(API)<br>SANAL P Net content in<br>export + 2%<br>wastage
2 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
3 Hot Stamping foil Net + 1%<br>Wastage
4 Ship Shape Corpus Infusion Net + 1%<br>Wastage
5 Ship Shape Corpus Injection with PP Net + 1%

21

UDIN00233900AM24

1%<br>Wastage| |||||3|Hot Stamping foil|Net + 1%<br>Wastage| |||||4|Ship Shape Corpus Infusion|Net + 1%<br>Wastage| |||||5|Ship Shape Corpus Injection with PP|Net + 1%|

21

UDIN00233900AM24

membrane 0.8 Wastage
6 Ship Shape Break of Infusion blue Net + 1%<br>Wastage
7 Ship Shape Break of Injection Net + 1%<br>Wastage
8 Corrugated Boxes 385 x 285 x 220mm(FFX<br>Karton) Net + 1%<br>Wastage
9 Direction Sheet(insert)for NS 50,100,250, 500<br>&1000ml Net + 1%<br>Wastage
10 EURO PALLET(HEAT TREATED)1200 x<br>800 Net to Net
12 SF9 195/100 Plastic film non PVC for<br>Primary packing Net + 1%<br>Wastage
15 OFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
21 Shipper Label Net + 1%<br>Wastage
18 Sodium<br>Chloride<br>0.9% 500ml (DE) <br>1 Number 1 Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical ingredient(API)<br>SANAL P Net content in<br>export + 2%<br>wastage
2 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
3 Hot Stamping foil Net + 1%<br>Wastage
4 Ship Shape Corpus Infusion Net + 1%<br>Wastage
5 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1%<br>Wastage

22

UDIN00233900AM24

Stamping foil|Net + 1%<br>Wastage| |||||4|Ship Shape Corpus Infusion|Net + 1%<br>Wastage| |||||5|Ship Shape Corpus Injection with PP<br>membrane 0.8|Net + 1%<br>Wastage|

22

UDIN00233900AM24

6 Ship Shape Break of Infusion blue Net + 1%<br>Wastage
7 Ship Shape Break of Injection Net + 1%<br>Wastage
8 Corrugated Boxes 385 x 285 x 220mm(FFX<br>Karton) Net + 1%<br>Wastage
9 Direction Sheet(insert)for NS 50,100,250, 500<br>&1000ml Net + 1%<br>Wastage
10 EURO PALLET(HEAT TREATED)1200 x<br>800 Net to Net
13 SF9 195/135 Plastic film non PVC for<br>Primary packing Net + 1%<br>Wastage
16 OFR2 120/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
21 Shipper Label Net + 1%<br>Wastage
19 Sodium<br>Chloride<br>0.9% 1000ml (DE) <br>1 Number 1 Sodium Chloride NACL Pharmaceutical<br>quality active pharmaceutical ingredient(API)<br>SANAL P Net content in<br>export + 2%<br>wastage
2 UFR2 150/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
3 Hot Stamping foil Net + 1%<br>Wastage
4 Ship Shape Corpus Infusion Net + 1%<br>Wastage
5 Ship Shape Corpus Injection with PP<br>membrane 0.8 Net + 1%<br>Wastage
6 Ship Shape Break of Infusion blue Net + 1%

23

UDIN00233900AM24

e Corpus Infusion|Net + 1%<br>Wastage| |||||5|Ship Shape Corpus Injection with PP<br>membrane 0.8|Net + 1%<br>Wastage| |||||6|Ship Shape Break of Infusion blue|Net + 1%|

23

UDIN00233900AM24

Wastage<br>7<br>Ship Shape Break of Injection<br>Net + 1%<br>Wastage<br>8<br>Corrugated Boxes 385 x 285 x 220mm(FFX<br>Karton)<br>Net + 1%<br>Wastage<br>9<br>Direction Sheet(insert)for NS 50,100,250, 500<br>&1000ml<br>Net + 1%<br>Wastage<br>10<br>EURO PALLET(HEAT TREATED)1200 x<br>800<br>Net to Net<br>14<br>SF9 195/140 Plastic film non PVC for<br>Primary packing<br>Net + 1%<br>Wastage<br>16<br>OFR2 120/524 Plastic film non PVC for<br>Secondary packing<br>Net + 1%<br>Wastage<br>21<br>Shipper Label<br>Net + 1%<br>Wastage<br>RA concerned may take further necessary action as per above decision of NC Wastage
7 Ship Shape Break of Injection Net + 1%<br>Wastage
8 Corrugated Boxes 385 x 285 x 220mm(FFX<br>Karton) Net + 1%<br>Wastage
9 Direction Sheet(insert)for NS 50,100,250, 500<br>&1000ml Net + 1%<br>Wastage
10 EURO PALLET(HEAT TREATED)1200 x<br>800 Net to Net
14 SF9 195/140 Plastic film non PVC for<br>Primary packing Net + 1%<br>Wastage
16 OFR2 120/524 Plastic film non PVC for<br>Secondary packing Net + 1%<br>Wastage
21 Shipper Label Net + 1%<br>Wastage

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

2 120/524 Plastic film non PVC for<br>Secondary packing|Net + 1%<br>Wastage| |||||21|Shipper Label|Net + 1%<br>Wastage|

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

Case No. 18 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name CROPNOSYS (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00005535AM23
RA File Number 039404000527 AM19
Licence No and<br>Date 0310823957/24/09/2018
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing<br>before Norms Committee to explain why the firm has shown the export product as (FI) and what is the meaning of (FI)<br>in export description given in their application.

Case No. 19 / NC/3/MEET/Jul/202324/9

24

UDIN00233900AM24

Case Status Case Rejected
Party Name ROYAL PHARMA
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00000091AM24
RA File Number 039504000720 AM19
Licence No and<br>Date 0310824487/17/10/2018
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has not furnished valid justification
for enhancement. Hence, the Committee decided torejectthe case.

|| |The Committee considered the case as per agenda and it was observed that the firm has not furnished valid justification|| |for enhancement. Hence, the Committee decided torejectthe case.||

Case Status Case Status Case Rejected Case Rejected Case Rejected Case Rejected Case Rejected Case Rejected Case Rejected
Party Name ROYAL PHARMA
Meeting Number<br> NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
and Date
HQ File Number HQRNORM REVIW00000091AM24
RA File Number 039504000720 AM19
Licence No and<br>Date 0310824487/17/10/2018
Norms Committee ecision:
The Committee co nsidered the case as per agenda and it was observed that the firm has not furnished valid justification
for enhancement. H ence, the Committee decided torejectthe case.
Case No. 20 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Par ty Name MALLADI DRUGS AND PHARMACEUTICALS LIMITED
Me<br>and eting Number<br>Date NC/ 3/ MEET/ Jul/ 202324/ 9 an d 28/07/2023
HQ File Number HQRNORM REVIW0 0002622A M23
RA File Number 042404000143 AM19
Lic<br>Dat
ence No and<br>e 0410164962/10/12/20 18
Nor<br>Th<br>Vo ms Committee Decision:<br>e Committee considered the case as<br>l.

3|||| |RA|File Number|042404000143 AM19||||||| |Lic<br>Dat||||||||| ||ence No and<br>e|0410164962/10/12/20||18||||| |Nor<br>Th<br>Vo|ms Committee Decision:<br>e Committee considered the case as<br>l. I as per details given below or as ap|||per agenda<br>plied by th||||| ||||||and it was<br>e firm, whi|decided to fix ad-hoc norms under Para<br>chever is less: -||4.07 of HBP| |||||||||| ||Export Product|||Qty.||||| ||||||Sl. No.|Import Items|Qty.|| ||Trioxabicyclooctane|||1 kg.||||| ||||||1|cis-2-Butane-1.4-diol|1.29 kg.|| |||||||||| ||||||2|Methanol|Not showin|g in GST.| |||||||||| ||||||3|2,2-Dimethoxy Propane|2.59 kg.|| |||||||||| ||||||4|Acetonitrile|1.80 kg.|| ||||||5|Methylene Di chloride|2.20 kg.|| |||||||||| |||||||||| |RA concerned ma||y take further necessary action as|||per above decision of NC.|||| ||||||||||

25

UDIN00233900AM24

Case No. Case No. 21 / NC/3/MEET/Jul/202324/9 21 / NC/3/MEET/Jul/202324/9 21 / NC/3/MEET/Jul/202324/9 21 / NC/3/MEET/Jul/202324/9 21 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name MALLADI DRUGS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00001752AM23
RA File Number 042404000218 AM19
Licence No and<br>Date 0410165065/04/01/2019
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||0410165065/04/01/2019||||| |Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>cis-2-Butane-1.4-diol<br>1.29 kg.<br>2<br>Methanol<br>Not showing in GST.<br>3<br>2,2-Dimethoxy Propane<br>2.59 kg.<br>4<br>Acetonitrile<br>1.80 kg.<br>Trioxabicyclooctane<br>1 kg.<br>5<br>Methylene Di chloride<br>2.20 kg.<br>RA concerned may take further necessary action as per above decision of NC.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||Trioxabicyclooctane||1 kg.|1|cis-2-Butane-1.4-diol|1.29 kg.| |||||2|Methanol|Not showing in GST.| |||||3|2,2-Dimethoxy Propane|2.59 kg.| |||||4|Acetonitrile|1.80 kg.| |||||5|Methylene Di chloride|2.20 kg.| |||||per above decision of NC.|||

Case No.<br> 22 / NC/3/MEET/Jul/202324/9
Case Status<br> Case Rejected
Party Name<br> SYMBIOSIS PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date<br> NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number<br> HQRNORM REVIW00000804AM23
RA File Number<br> 332404000002 AM20
Licence No and<br>Date<br> 3310030527/16/04/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.

26

UDIN00233900AM24

Hence, the Committee decided to reject the case.

Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.||

26

UDIN00233900AM24

Hence, the Committee decided to reject the case.

Case No. Case No. 23 / NC/3/MEET/Jul/202324/9 23 / NC/3/MEET/Jul/202324/9 23 / NC/3/MEET/Jul/202324/9 23 / NC/3/MEET/Jul/202324/9 23 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name MALLADI DRUGS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00001751AM23
RA File Number 042404000089 AM20
Licence No and<br>Date 0410166026/29/08/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>cis-2-Butane-1.4-diol<br>1.29 kg.<br>2<br>Methanol<br>Not showing in GST.<br>3<br>2,2-Dimethoxy Propane<br>2.59 kg.<br>4<br>Acetonitrile<br>1.80 kg.<br>Trioxabicyclooctane<br>1 kg.<br>5<br>Methylene Di chloride<br>2.20 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Export Product Qty. Sl. No. Import Items Qty.
Trioxabicyclooctane 1 kg. 1 cis-2-Butane-1.4-diol 1.29 kg.
2 Methanol Not showing in GST.
3 2,2-Dimethoxy Propane 2.59 kg.
4 Acetonitrile 1.80 kg.
5 Methylene Di chloride 2.20 kg.
per above decision of NC.

.4-diol|1.29 kg.| |||||2|Methanol|Not showing in GST.| |||||3|2,2-Dimethoxy Propane|2.59 kg.| |||||4|Acetonitrile|1.80 kg.| |||||5|Methylene Di chloride|2.20 kg.| |||||per above decision of NC.|||

Case No. 24 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00004154AM23
RA File Number 039404000526 AM20
Licence No and<br>Date 0310832396/23/10/2019

27

UDIN00233900AM24

Norms Committee Decision:

The Committee considered the case as per agenda and the Committee has observed that information/documents furnished by the firm is mismatch, therefore, the Committee has decided to call the firm for attending Personal Hearing before Norms Committee to explain its case alongwith all relevant documents

Norms Committee Norms Committee Norms Committee Norms Committee Decision: Decision: Decision: Decision: Decision: Decision:
The Committee co<br>fihd b h fi nsidered the case as per agenda and the Committee has observed that information/documents<br>i ih hf h i h didd ll h fi f diPl
urnse y te r<br>Hearing<br>before No m s msmatc, tereore, te Commttee as ece to ca te rm or attenngersona<br>rms Committee to explain its case alongwith all relevant documents
<br>
Case No. 25 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name MENTHA AND ALLIED PRODUCTS PRIVATE LIMITED
Me<br>and eting Number<br>Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number 018205000947AM20
RA Fil Nb 052404000601 AM20
e umer
Lic<br>Dat ence No and<br>e 0510413159/01/01/2020

3/ MEET/ Jul/ 202324/ 9 and 28/07/2023|||||| |HQ|File Number|||018205000947AM20|||||| |RA|Fil Nb|||052404000601 AM20|||||| ||e umer||||||||| |Lic<br>Dat|ence No and<br>e|||0510413159/01/01/2020|||||| |Norms Committee Decision:<br>Shri Harshvardhan Nanda, Director, Shri Suresh Ch<br>attended the Personal Hearing and explained firm’s ca<br>the firm and after deliberation it has been decided to fi<br>S.<br>No.<br>Item Of Export<br>1<br>ORANGE ALDEHYDE<br>2<br>D LIMONENE<br>3<br>ORANGE OIL 10X<br>S.<br>Item Of Import|ms Committee Decision:<br>ri Harshvardhan Nanda, Director, Shri<br>ended the Personal Hearing and explaine<br>firm and after deliberation it has been d<br>S.<br>No.<br>Item Of Export<br>1<br>ORANGE ALDEHYDE<br>2<br>D LIMONENE<br>3<br>ORANGE OIL 10X||||Suresh Ch<br>d firm’s ca<br>ecided to fi|andra D<br>se. The C|hyani, General Manager and Shri Aru<br>ommittee heard the explanation of Rep||n Khetan had<br>resentatives of| |||||||<br>x the ad-|<br>hoc norms as under: -||| ||||||||||| |||S.<br>No.|Item Of Export|||||Quantity|| ||||||||||| |||1|ORANGE ALDEHYDE|||||645.89 kg|| |||2|D LIMONENE|||||82348 kg|| |||3|ORANGE OIL 10X|||||9042.11 kg|| ||||||||||| |||S.|Item Of Import|||||Quantity Allowed|| ||||||||||| |||No.|||||||| ||||||||||| ||||||||||| |||1|O|RANGE OIL (Aldehyde content 0.8 percent to 1.6||||96,576 kg|| ||||pe|rcent)|||||| ||||||||||| ||||||||||| ||||||||||| |RA concerned may||||take further necessary action as per above decision of NC.|||||| |||||||||||

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||||96,576 kg|| ||||pe|rcent)|||||| ||||||||||| ||||||||||| ||||||||||| |RA concerned may||||take further necessary action as per above decision of NC.|||||| |||||||||||

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Case No. 26 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name ARENE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00004461AM23
RA File Number 092404000024 AM21
Licence No and<br>Date 0910068681/28/04/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.
Case No. 27 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number 018205001399AM21
RA File Number 022404000027 AM21
Licence No and<br>Date 0210209928/18/06/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Benzene (from olefinic complex)<br>1 MT<br>1<br>Light Naphtha<br>1.194 MT<br>RA concerned may take further necessary action as per above decision of NC.

ty.<br>Sl. No.<br>Import Items<br>Qty.<br>Benzene (from olefinic complex)<br>1 MT<br>1<br>Light Naphtha<br>1.194 MT<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 28 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number 018205001400AM21
RA File Number 022404000028 AM21

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UDIN00233900AM24

Licence No and<br>Date 0210209929/18/06/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Benzene (from olefinic complex)<br>1 MT<br>1<br>Light Naphtha<br>1.194 MT<br>RA concerned may take further necessary action as per above decision of NC.

ty.<br>Sl. No.<br>Import Items<br>Qty.<br>Benzene (from olefinic complex)<br>1 MT<br>1<br>Light Naphtha<br>1.194 MT<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 29 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number 018205001417AM21
RA File Number 022404000030 AM21
Licence No and<br>Date 0210209934/23/06/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Benzene (from olefinic complex)<br>1 MT<br>1<br>Light Naphtha<br>1.194 MT<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 30 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name HALDIA PETROCHEMICALS LIMITED

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UDIN00233900AM24

ecessary action as per above decision of NC.||

Case No. 30 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name HALDIA PETROCHEMICALS LIMITED

30

UDIN00233900AM24

Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number 018205001418AM21
RA File Number 022404000031 AM21
Licence No and<br>Date 0210209935/23/06/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Benzene (from olefinic complex)<br>1 MT<br>1<br>Light Naphtha<br>1.194 MT<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 31 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name SRF LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00007266AM23
RA File Number 052404000225 AM21
Licence No and<br>Date 0510414951/20/08/2020

D| |Meeting Number<br>and Date|NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023| |HQ File Number|HQRNORM REVIW00007266AM23| |RA File Number|052404000225 AM21| |Licence No and<br>Date|0510414951/20/08/2020| |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>Technical Literature in support of yield at step –I and III.<br>i.<br>Details of byproducts, their quantity and documented sale value.<br>ii.<br>Requirement and recovery of solvents at each step.<br>iii.<br>Past production/consumption data for 2020-21, 2021-22 and 2022-23 duly certified by Central taxes and<br>GST Authorities.<br>iv.<br>Sample of shipping bills and bill of entry of the export products along with statement of Input-output as<br>per export documents of the said authorization.<br>v.||

  • iv. Past production/consumption data for 2020-21, 2021-22 and 2022-23 duly certified by Central taxes and GST Authorities.
Case No. 32 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name SHARP MINT LIMITED

31

UDIN00233900AM24

-23 duly certified by Central taxes and GST Authorities.**

Case No. 32 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name SHARP MINT LIMITED

31

UDIN00233900AM24

Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00004537AM23
RA File Number 052404000265 AM21
Licence No and<br>Date 0510415091/02/09/2020
Norms Committee Decision:<br>The committee considered the request of firm for review of ad-hoc norms and it was decided to call for following<br>information/documents from the firm:-<br>Commercial value of Terpenes and High Boiler obtained. With documentary evidence.<br>1.<br>Recovery of Iso Propyl Alcohol (IPA) in manufactured process.<br>2.<br>We may call sample shipping bills from the firm and call the comments of TE.<br>3.
Case No. 33 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name MANKIND PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00005708AM23
RA File Number 052404000277 AM21
Licence No and<br>Date 0510415162/09/09/2020
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.

case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>REHEPTIN TABLETS ((EACH FILM COATED<br>TABLET CONTAINS: METADOXINE,<br>SILYMARIN, L- ORNITHINE L-ASPARTATE,<br>PYRIDOXINE HYDROCHLORIDE & FOLIC<br>ACID)) (Each Tablet contains L-Aspartate 150<br>mg.)<br>1 Number<br>1<br>L-ORNITHINE<br>L-ASPARTATE<br>153.00 mg.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 34 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred

32

UDIN00233900AM24

Party Name STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00000568AM23
RA File Number 052404000295 AM21
Licence No and<br>Date 0510415273/21/09/2020
Norms Committee Decision:
We may call sample shipping bills from the firm and call the comments of TE.

| |RA File Number|052404000295 AM21| |Licence No and<br>Date|0510415273/21/09/2020| |Norms Committee Decision:|| |We may call sample shipping bills from the firm and call the comments of TE.||

Case No. 35 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00004138AM23
RA File Number 092404000365 AM21
Licence No and<br>Date 0910069368/22/10/2020
Norms Committee Decision:
The Committee considered the case as per agenda and following have been observed by the committee: -
Firm has now changed the starting stage and the entire chemistry and the yields.<br>i.
No technical justification for above change or enhancement.<br>ii.
No technical literature in support of molar requirement of import item No.1.<br>iii.
We may call sample shipping bills from the firm and call the comments of TE.<br>iv.
In view of the above, the Committee decided to call the firm for attendingPersonal Hearing <br>before Norms Committee
to explain the above points.

d call the comments of TE.<br>iv.||| |In view of the above, the Committee decided to call the firm for attendingPersonal Hearing**||<br>before Norms Committee| |to explain the above points.|||

Case No. 36 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name SRF LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00007267AM23
RA File Number 052404000395 AM21
Licence No and<br>Date 0510415782/09/11/2020
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for

33

UDIN00233900AM24

following information/documents from the firm: -

  1. Justification of low yield of 76%.

  2. We may call sample shipping bills from the firm and call the comments of TE

Case No. 37 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name SRF LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number 018205001869AM21
RA File Number 052404000441 AM21
Licence No and<br>Date 0510415972/24/11/2020
Norms Committee Decision:<br>We may call sample shipping bills from the firm and call the comments of TE.

| |RA File Number|052404000441 AM21| |Licence No and<br>Date|0510415972/24/11/2020| |Norms Committee Decision:<br>We may call sample shipping bills from the firm and call the comments of TE.||

Case No. 38 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00056201AM21
RA File Number 02AA04007088 AM21
Licence No and<br>Date 0211000149/06/01/2021
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.<br>Import Items<br>Qty.<br>Benzene (from olefinic complex)<br>1 MT<br>1<br>Light Naphtha<br>1.194 MT<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 39 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name HALDIA PETROCHEMICALS LIMITED

34

UDIN00233900AM24

ecessary action as per above decision of NC.||

Case No. 39 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name HALDIA PETROCHEMICALS LIMITED

34

UDIN00233900AM24

Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number<br>HQRNORM APPLY 00073161AM21
RA File Number<br>02AA04008233 AM21
Licence No and<br>Date<br>0211000237/29/01/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty. Sl. No. Import Items Qty.
Benzene (from olefinic complex)<br>1 MT 1 Light Naphtha 1.194 MT
RA concerned may take further necessary action as per above decision of NC.
Case No. 40 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00092003AM21
RA File Number 038504000144 AM21
Licence No and<br>Date 0311000450/25/02/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.

Committee Decision:|| |The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.|| |Hence, the Committee decided torejectthe case.||

Case No. 41 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00099106AM21
RA File Number 02AA04010200 AM21
Licence No and<br>Date 0211000381/08/03/2021
Norms Committee Decision:

35

UDIN00233900AM24

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.
Benzene (from olefinic complex) 1 MT 1 Light Naphtha 1.194 MT
Case No. 42 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00000419AM23
RA File Number 05AA04037727 AM21
Licence No and<br>Date 0511001580/08/03/2021
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.

case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Azithromycin (Lyophilized Bulk Sterile)<br>[Axithromycin Dihydrate Sodium Sterile,<br>Assay NLT 49.8%]<br>1 kg.<br>1<br>Azithromycin Dihydrate<br>0.508 kg.<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 43 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name LUPIN LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023

36

UDIN00233900AM24

HQ File Number HQRNORM APPLY 00103407AM21
RA File Number 03AA04019762 AM21
Licence No and<br>Date 0311002479/15/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm applied under para 4.18 of HBP
Vol.2 (Non-Infringing Process) applicable for pharmaceutical product manufacture which does not require for fixation
of ad-hoc norms. Hence, the Committee decided toWithdrawnthe case.

| |Vol.2 (Non-Infringing Process) applicable for pharmaceutical product manufacture which does not require for fixation||| |of ad-hoc norms.|Hence, the Committee decided toWithdrawnthe case.||

HQ File Number HQ File Number HQRNORM APPLY 00103407AM21 HQRNORM APPLY 00103407AM21 HQRNORM APPLY 00103407AM21 HQRNORM APPLY 00103407AM21 HQRNORM APPLY 00103407AM21 HQRNORM APPLY 00103407AM21 HQRNORM APPLY 00103407AM21 HQRNORM APPLY 00103407AM21 HQRNORM APPLY 00103407AM21
RA File Number 03AA04019762 AM21
Licence No and 0311002479/15/03/2021
Date
Norms Committee<br> Decision:<br>
The Committee co<br>Vl2 (NIfi nsidered the case as per agenda and it was observed that the firm applied under para 4.18 of HBP<br>i P) libl f htil dt ft hih d t i f fiti
o. on-nrng<br>of ad-hoc norms ng rocess appcae or parmaceuca prouc manuacure wc oes no requre or xaon<br>Hence the Committee decided toWithdrawnthe case
. ,.
Case No. 44 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name REYAANSH HEALTHCARE
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 001 07278AM21
RA File Number 03AA04022151 AM21
Lic<br>Dat ence No and<br>e 0311002655/ 19/03/2021
Nor<br>Th<br>Vo
ms Committee Decision:<br>e Committee considered the<br>l.

||||||| |RA|File Number|03AA04022151 AM21||||||||| |Lic<br>Dat|ence No and<br>e|0311002655/|19/03/2021|||||||| |Nor<br>Th<br>Vo||||||||||| ||ms Committee Decision:<br>e Committee considered the<br>l. I as per details given below||case as per<br>or as appli|agenda an||d it was decided to fix ad-hoc norms under P||||ara 4.07 of HBP| |||||ed by the fi||rm, whichever is less: -||||| |||||||||||| ||Export Product|||||Qty.|Sl. No.|Import Items||Qty.| |||||||||||| ||IMPACT SOLUTION FOR CA<br>ML(EACH ML CONTAINS I<br>100 MG +MOXIDECTIN<br>10 MG)||TS 0.40<br>MIDACLOPR||1|Number|1|MOXIDECTIN||122.40 gms| |||||ID||||||| |||||||||||| |||||||||||| ||IMPACT SOLUTION FOR CATS 0.80<br>ML(EACH ML CONTAINS IMIDACLOPR<br>100 MG +MOXIDECTIN<br>10 MG)|||ID|1 Number||2|MOXIDECTIN|244.80 gms|| |||||||||||| ||IMPACT SOLU|TION FOR DOGS 040|||1 Number||3|MOXIDECTIN|30600 gms|| ||<br>ML(EACH ML|.<br>CONTAINS IMIDACLOPRID|||||||.|| ||100 MG +MOX|IDECTIN||||||||| ||25 MG)|||||||||| |||||||||||| ||IMPACT SOLU<br>|TION FOR DOGS 1 ML(EACH<br>|||1 Number||4|MOXIDECTIN|765.00 gms|| ||ML CONTAIN|IMIDACLOPRID 100 MG||||||||| ||||||||||||

37

UDIN00233900AM24

|25 MG)|||||||||| |||||||||||| ||IMPACT SOLU<br>|TION FOR DOGS 1 ML(EACH<br>|||1 Number||4|MOXIDECTIN|765.00 gms|| ||ML CONTAIN|IMIDACLOPRID 100 MG||||||||| ||||||||||||

37

UDIN00233900AM24

+MOXIDECTIN 25<br>MG)<br>IMPACT SOLUTION FOR DOGS 2.50<br>ML(EACH ML CONTAINS IMIDACLOPRID<br>100 MG +MOXIDECTIN<br>25 MG)<br>1 Number<br>5<br>MOXIDECTIN<br>765.00 gms<br>IMPACT SOLUTION FOR DOGS 4 ML(EACH<br>ML CONTAINS IMIDACLOPRID 100 MG<br>+MOXIDECTIN 25<br>MG)<br>1 Number<br>6<br>MOXIDECTIN<br>1530.00 gms<br>RA concerned may take further necessary action as per above decision of NC. +MOXIDECTIN 25<br>MG)
IMPACT SOLUTION FOR DOGS 2.50<br>ML(EACH ML CONTAINS IMIDACLOPRID<br>100 MG +MOXIDECTIN<br>25 MG) 1 Number 5 MOXIDECTIN 765.00 gms
IMPACT SOLUTION FOR DOGS 4 ML(EACH<br>ML CONTAINS IMIDACLOPRID 100 MG<br>+MOXIDECTIN 25<br>MG) 1 Number 6 MOXIDECTIN 1530.00 gms
Case No. 45 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00004030AM23
RA File Number 03AA04033623 AM21
Licence No and<br>Date 0311003093/08/04/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was decided to call for following<br>information / documents from the firm:<br>**Yield is just about 50%.

e Decision:<br>The Committee considered the request of firm for review of ad-hoc norms and it was decided to call for following<br>information / documents from the firm:<br>Yield is just about 50%. Please submit any Publish Literature for low yield.<br>i.<br>Production / Consumption data for last two years duly certified by GST.<br>ii.<br>Any earlier decision of Norms Committee for same export product.<br>iii.<br>We may call sample shipping bills from the firm and call the comments of TE.<br>iv.||

Case No. 46 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00008340AM22
RA File Number 02AA04000735 AM22

38

UDIN00233900AM24

Licence No and<br>Date<br>0211000529/09/04/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less: -
Export Product<br>Qty. Sl. No. Import Items Qty.
Benzene (from olefinic complex)<br>1 MT 1 Light Naphtha 1.194 MT
RA concerned may take further necessary action as per above decision of NC

ort Product<br>Qty.|Sl. No.|Import Items|Qty.|| |Benzene (from olefinic complex)<br>1 MT|1|Light Naphtha|1.194 MT|| |RA concerned may take further necessary action as per above decision of NC|||||

Lic<br>Dat ence No and<br>e 0211000529/09/04/2021
No<br>Th<br>V<br>R rms Committee Decision:<br>e Committee considered the case as per ag<br>ol. I as per details given below or as applied enda and<br>by the fir
it was<br>m whi decided to fix ad-hoc norms under Para<br>hever is less: - 4.07 of HBP
,
Export Product<br>Benzene (from olefinic complex) Q ty. Sl. No. Import Items Q ty.
1 MT 1 Light Naphtha 1 .194 MT
A concerned may take further necessary acti on as per
above d ecision of NC
Case No. 47 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>d Dt NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
an ae
HQ File Number HQRNORM APPLY 00020260AM22
RA File Number 34AA04000021 AM22
Licence No and
<br>Date 3411000455/16/04/2021
Norms Committee Decision:
The Committee c onsidered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP
Vol.

|||||||||||| |Norms Committee||Decision:|||||||||||| ||||||||||||||| |The Committee c||onsidered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP|||||||||||| |Vol. I as per detai||ls given below or as applied by the firm, whichever is less:-|||||||||||| ||||||||||||||| ||Export Product|||||Qty.|||Sl. No.||Import Items<br>||Qty.| ||SORBIC ACID 50 (ENCAPSULATED SORBIC A<br>50 WITH VEGETABLE FAT)|||CID||<br>100 MT|||1||SORBIC ACID<br>||50.0 MT| ||<br>*Net content of SORBIC ACID 50% sho<br>export product.||uld be i|n the|||||||||| ||||||||||||||| ||SORBIC ACID 66(ENCAPSULATED S<br>66 WITH VEGETABLE FAT)<br>*Net content of SORBIC ACID 66% sho<br>export product.||ORBIC A<br>uld be i|CID||<br>|00 MT||2||SORBIC ACID<br>||60 MT| |||||<br>||<br> <br>|||||<br>||.| |||||n the||||||||||

Lic<br>Dat ence No and<br>e 0211000529/09/04/2021
No<br>Th<br>V<br>R rms Committee Decision:<br>e Committee considered the case as per ag<br>ol. I as per details given below or as applied enda and<br>by the fir
it was<br>m whi decided to fix ad-hoc norms under Para<br>hever is less: - 4.07 of HBP
,
Export Product<br>Benzene (from olefinic complex) Q ty. Sl.

|||||it was<br>m whi|||decided to fix ad-hoc norms under Para<br>hever is less: -||||||4.07 of HBP| |||||,|||||||||| ||||||||||||||| ||Export Product<br>Benzene (from olefinic complex)||||Q||ty.|Sl. No.||Import Items||Q|ty.| ||||||||||||||| ||||||1||MT|1||Light Naphtha||1|.194 MT| ||||||||||||||| ||A concerned may take further necessary acti||on as per||||||||||| |||||above d|||ecision of NC||||||| ||||||||||||||| |Case No.||47 / NC/3/MEET/Jul/202324/9|||||||||||| |Case Status||Case Approved|||||||||||| |Party Name||SUDEEP PHARMA PRIVATE LIMITED|||||||||||| ||||||||||||||| |Meeting Number<br>d Dt||NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023|||||||||||| |an ae|||||||||||||| |HQ File Number||HQRNORM APPLY 00020260AM22|||||||||||| ||||||||||||||| |RA File Number||34AA04000021 AM22|||||||||||| ||||||||||||||| |Licence No and|||||||||||||| |<br>Date||3411000455/16/04/2021|||||||||||| |Norms Committee||Decision:|||||||||||| ||||||||||||||| |The Committee c||onsidered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP|||||||||||| |Vol. I as per detai||ls given below or as applied by the firm, whichever is less:-|||||||||||| ||||||||||||||| ||Export Product|||||Qty.|||Sl.

to fix ad-hoc norms under Para 4.07 of HBP|||||||||||| |Vol. I as per detai||ls given below or as applied by the firm, whichever is less:-|||||||||||| ||||||||||||||| ||Export Product|||||Qty.|||Sl. No.||Import Items<br>||Qty.| ||SORBIC ACID 50 (ENCAPSULATED SORBIC A<br>50 WITH VEGETABLE FAT)|||CID||<br>100 MT|||1||SORBIC ACID<br>||50.0 MT| ||<br>*Net content of SORBIC ACID 50% sho<br>export product.||uld be i|n the|||||||||| ||||||||||||||| ||SORBIC ACID 66(ENCAPSULATED S<br>66 WITH VEGETABLE FAT)<br>*Net content of SORBIC ACID 66% sho<br>export product.||ORBIC A<br>uld be i|CID||<br>|00 MT||2||SORBIC ACID<br>||60 MT| |||||<br>||<br> <br>|||||<br>||.| |||||n the||||||||||

39

UDIN00233900AM24

SORBIC ACID 70(ENCAPSULATED SORBIC ACID <br>100 MT 3 SORBIC ACID 70.0 MT
70 WITH VEGETABLE FAT)
*Net content of SORBIC ACID 70% should be in the
export product.
SORBIC ACID 85(ENCAPSULATED SORBIC ACID <br>100 MT 4 SORBIC ACID 85.0 MT
85 WITH VEGETABLE FAT)
*Net content of SORBIC ACID 85% should be in the
export product.

*||||| |SORBIC ACID 85(ENCAPSULATED SORBIC ACID|<br>100 MT|4|SORBIC ACID|85.0 MT| |85 WITH VEGETABLE FAT)||||| |*Net content of SORBIC ACID 85% should be in the||||| |export product.|||||

Case No. 48 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00023689AM22
RA File Number 07AA04002023 AM22
Licence No and<br>Date 0711000922/21/04/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.
Case No. 49 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00027802AM22
RA File Number 07AA04002553 AM22
Licence No and<br>Date 0711000992/27/04/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.
Case No. 50 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected

40

UDIN00233900AM24

as still not furnished its reply.|| |Hence, the Committee decided torejectthe case.||

Case No. 50 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected

40

UDIN00233900AM24

Party Name R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00027804AM22
RA File Number 07AA04002549 AM22
Licence No and<br>Date 0711000993/27/04/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.
Case No.<br>51 / NC/3/MEET/Jul/202324/9
Case Status<br>Case Approved
Party Name<br>HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number<br>HQRNORM APPLY 00035006AM22
RA File Number<br>02AA04003459 AM22
Licence No and<br>Date<br>0211000648/07/05/2021
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.
Benzene (from olefinic complex) 1 MT 1 Light Naphtha 1.194 MT
RA concerned may take further necessary action as per above decision of NC

|Export Product|Qty.|Sl. No.|Import Items|Qty.|| |Benzene (from olefinic complex)|1 MT|1|Light Naphtha|1.194 MT|| |RA concerned may take further necessary action as per above decision of NC||||||

Case No. 52 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name ASTEC LIFESCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00036355AM22
RA File Number 03AA04007493 AM22
Licence No and<br>Date 0311003675/09/05/2021
Norms Committee Decision:

41

UDIN00233900AM24

The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply. Hence, the Committee decided to reject the case.

Case No.<br>53 / NC/3/MEET/Jul/202324/9
Case Status<br>Case Approved
Party Name<br>STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number<br>HQRNORM APPLY 00108212AM22
RA File Number<br>05AA04019922 AM22
Licence No and<br>Date<br>0511002989/05/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty. Sl. No. Import Items Qty.
CEFEPIME FOR INJECTION<br>1 kg. 1 CEFEPIME HCL 0.655 kg.
RA concerned may take further necessary action as per above decision of NC.

|Export Product<br>Qty.||Sl. No.|Import Items|Qty.|| |CEFEPIME FOR INJECTION<br>1 kg.||1|CEFEPIME HCL|0.655 kg.|| |RA concerned may take further necessary action as per above decision of NC.||||||

Case No. 54 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00116038AM22
RA File Number 09AA04003251 AM22
Licence No and<br>Date 0911001059/16/06/2021
Norms Committee Decision:
T
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:-

42

UDIN00233900AM24

Export Product Qty. Sl. No. Import Items Qty.
Ertapenem for Injection 1 Gram / Vial((Each vial <br>1 Number 1 Ertapenem 1.151 gm.
contains Ertapenem Sodium equivalent to Ertapenem Sodium
1 Gram))

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

h vial|<br>1 Number|1|Ertapenem|1.151 gm.| |contains Ertapenem Sodium equivalent to Ertapenem|||Sodium|| |1 Gram))|||||

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

Export Product Export Product Export Product Qty. Qty. Qty. Sl. No. Sl. No. Import Items Qty.
Ertapenem fo r Injection 1 Gram / Vial((Each vial <br>1 Number 1 Ertapenem 1.151 gm.
contains Ertap<br> enem Sodium equivalent to Ertapenem Sodium
1 Gram))
RA concerned ma y take further necessary action as per above decision of NC
Case No 55 / NC/3/MEET/Jul/202324/9
.
Case Status Case Approved
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number
<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00122392AM22
RA File Number 09AA04004589 AM22
Licence No and
Date 0911001093/23/06/2021
Norms Committee Decision:
The Committee<br>product/import pr considered the case as per agenda and taking cue from the earlier decision for same export<br>oduct in meetingNo.NC/3/MEET/Apr/202324/1dated28/04/2023against advance authorization
<br>No. 0911004131dated08/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

eetingNo.NC/3/MEET/Apr/202324/1dated28/04/2023against advance authorization||||||||| |<br>No. 0911004131dated08/12/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Tobramycin for Inhalation solution 60 mg / ml<br>(300 mg / 5 ml)<br>1 Number<br>1<br>Tobramycin Sulfate<br>370.20 mg<br>Tobramycin for Inhalation solution 75 mg / ml<br> <br>1 Number<br>2<br>Tobramycin Sulfate<br>370.20 mg||||||||||| ||Export Product||Qty.||Sl. No.|||Import Items||Qty.| ||Tobramycin for Inhalation solution 60 mg / ml<br>(300 mg / 5 ml)||1 Number||1|||Tobramycin Sulfate||370.20 mg| ||Tobramycin for Inhalation solution 75 mg / ml<br>||1 Number||2|||Tobramycin Sulfate||370.20 mg| |||||||||||| ||(300 mg / 4 ml)|||||||||| |||||||||||| |||||||||||| |||||||||||| |RA concerned ma||take further necessar action as er above decision of NC||||||||| |||y y p .||||||||| |||||||||||| |Case No.||56 / NC/3/MEET/Jul/202324/9||||||||| |||||||||||| |Case Status||Case Deferred||||||||| |||||||||||| |Party Name||SUDEEP PHARMA PRIVATE LIMITED|||||||||

Case No. 56 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name SUDEEP PHARMA PRIVATE LIMITED

43

UDIN00233900AM24

y Name||SUDEEP PHARMA PRIVATE LIMITED|||||||||

Case No. 56 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name SUDEEP PHARMA PRIVATE LIMITED

43

UDIN00233900AM24

Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00122419AM22
RA File Number 34AA04003768 AM22
Licence No and<br>Date 3411000762/23/06/2021
Norms Committee Decision:
We may call sample shipping bills from the firm and call the comments of TE..
Case No. 57 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name HIKAL LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00001127AM24
RA File Number NA
Licence No and<br>Date 3411000771/28/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.

Committee Decision:|| |The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.|| |Hence, the Committee decided torejectthe case.||

Case No.<br>58 / NC/3/MEET/Jul/202324/9 Case No.<br>58 / NC/3/MEET/Jul/202324/9
Case Status<br>Case Approved
Party Name<br>LYRUS LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number<br>HQRNORM REVIW00003920AM23
RA File Number<br>07AA04005177 AM22
Licence No and<br>Date<br>0711001417/06/07/2021
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
Vol. I as per details given below or as applied by the firm, whichever is less: -
Export Product Qty. Sl. No. Import Items Qty.
BEZAFIBRATE Tablet 200 mg 1500000.0 Numbers 1 BEZAFIBRATE 306 kg.

r details given below or as applied by the firm, whichever is less: -||||||| |Export Product|Qty.|Sl. No.|Import Items||Qty.|| |BEZAFIBRATE Tablet 200 mg|1500000.0 Numbers|1|BEZAFIBRATE||306 kg.||

Case No.<br>58 / NC/3/MEET/Jul/202324/9 Case No.<br>58 / NC/3/MEET/Jul/202324/9
Case Status<br>Case Approved
Party Name<br>LYRUS LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number<br>HQRNORM REVIW00003920AM23
RA File Number<br>07AA04005177 AM22
Licence No and<br>Date<br>0711001417/06/07/2021
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
Vol. I as per details given below or as applied by the firm, whichever is less: -
Export Product Qty. Sl. No. Import Items Qty.
BEZAFIBRATE Tablet 200 mg 1500000.0 Numbers 1 BEZAFIBRATE 306 kg.

44

UDIN00233900AM24

BEZAFIBRATE Tablet 400 mg 2100000.0 Numbers 2 BEZAFIBRATE 650 kg.

.|Sl. No.|Import Items||Qty.|| |BEZAFIBRATE Tablet 200 mg|1500000.0 Numbers|1|BEZAFIBRATE||306 kg.||

44

UDIN00233900AM24

BEZAFIBRATE Tablet 400 mg 2100000.0 Numbers 2 BEZAFIBRATE 650 kg.

Case No. 59 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00137048AM22
RA File Number 34AA04005105 AM22
Licence No and<br>Date 3411000838/12/07/2021
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and committee has observed that
information furnished by the firm is incomplete and it was decided to call for following information/documents
from the firm:-
Copy of Drugs Manufacturing License (DML).<br>1.
Complete chemistry, Molecular weight and percentage yield on molar basis.<br>2.
Certificate<br>3. of Analysis (CoA) of export product.
We may call sample shipping bills from the firm and call the comments of TE.<br>4.

ercentage yield on molar basis.**<br>2.|| |Certificate<br>3.|of Analysis (CoA) of export product.| |We may call sample shipping bills from the firm and call the comments of TE.<br>4.||

Case No. Case No. 60 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00137496AM22
RA File Number 02AA04013191 AM22
Licence No and<br>Date 0211000929/13/07/2021
Norms Committee Decision:
T
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.

45

UDIN00233900AM24

Benzene (from olefinic complex) 1 MT 1 Light Naphtha 1.194 MT

r as applied by the firm, whichever is less:-|||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.||

45

UDIN00233900AM24

Benzene (from olefinic complex) 1 MT 1 Light Naphtha 1.194 MT

Case No. 61 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00139649AM22
RA File Number 02AA04013519 AM22
Licence No and<br>Date 0211000948/15/07/2021
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.<br>Import Items<br>Qty.<br>Benzene (from olefinic complex)<br>1 MT<br>1<br>Light Naphtha<br>1.194 MT<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 62 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00143924AM22
RA File Number 07AA04016516 AM22
Licence No and<br>Date 0711001521/21/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.

Case No. 63 / NC/3/MEET/Jul/202324/9

46

UDIN00233900AM24

genda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.||

Case No. 63 / NC/3/MEET/Jul/202324/9

46

UDIN00233900AM24

Case Status<br>Case Approved
Party Name<br>BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number<br>HQRNORM REVIW00004039AM23
RA File Number<br>34AA04005924 AM22
Licence No and<br>Date<br>3411000924/02/08/2021
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.
Hexyl Salicylate 1 kg. 1 n-Hexanol (Lorol C 6/ Nacol 6-99) 0.510 kg.
((n-Hexyl-ortho-Hydroxy Benzoate))
2 Salicylic Acid 0.682 kg.
RA concerned may take further necessary action as per above decision of NC

(Lorol C 6/ Nacol 6-99)||0.510 kg.|| |((n-Hexyl-ortho-Hydroxy Benzoate))||||||| |||2|Salicylic Acid||0.682 kg.|| |RA concerned may take further necessary action as per above decision of NC|||||||

Case No. 64 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00004041AM23
RA File Number 34AA04005925 AM22
Licence No and<br>Date 3411000923/02/08/2021
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.
Benzyl Acetone (Jastone)(( 4-phenyl-butan-2-one )) 1 kg. 1 Benzaldehyde 0.895 kg.

47

UDIN00233900AM24

Case No. 65 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name MEHK CHEMICALS PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00004318AM23
RA File Number 03AA04061020 AM22
Licence No and<br>Date 0311006197/16/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.

Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.||

Case No. 66 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name SRF LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00177182AM22
RA File Number 05AA04076110 AM22
Licence No and<br>Date 0511004515/06/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply.<br>Hence, the Committee decided torejectthe case.
Case No. 67 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00178872AM22
RA File Number 34AA04007161 AM22
Licence No and<br>Date 3411001079/07/09/2021
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: -

48

UDIN00233900AM24

Export Product Qty. Sl. No. Import Items Qty.
Dimethyl Benzyl Carbinyl Butyrate 1 kg 1 N BUTYRIC ANHYDRIDE 0.80 kg.
((1-Cyclohexyl-2-methylpropan-2-yl butanoate))
Export Product Qty. Sl. No. Import Items Qty.
Dimethyl Benzyl Carbinyl Butyrate 1 kg 1 N BUTYRIC ANHYDRIDE 0.80 kg.
((1-Cyclohexyl-2-methylpropan-2-yl butanoate))
Case No. 68 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name SRF LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00007301AM23
RA File Number 05AA04061713 AM22
Licence No and<br>Date 0511004657/10/09/2021
Norms Committee Decision:
The committee considered the request of firm for review/fixation of ad-hoc norms and it was decided to call for
following information/documents from the firm:-
Technical Literature in support of yield at step –I and III.<br>i.
Details of byproducts, their quantity and documented sale value.<br>ii.
Requirement and recovery of solvents at each step.<br>iii.
Past production/consumption data for 2020-21, 2021-22 and 2022-23 duly certified by Central taxes and<br>iv.
GST Authorities.
Sample of shipping bills and bill of entry of the export products along with statement of Input-output as<br>v.
per export documents of the said authorization.
  • iv. Past production/consumption data for 2020-21, 2021-22 and 2022-23 duly certified by Central taxes and GST Authorities.

br>v.|| |per export|documents of the said authorization.|

  • iv. Past production/consumption data for 2020-21, 2021-22 and 2022-23 duly certified by Central taxes and GST Authorities.
Case No. 69 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name SWATI MENTHOL AND ALLIED CHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00184658AM22
RA File Number 05AA04081685 AM22
Licence No and<br>Date 0511004757/15/09/2021
Norms Committee Decision:

49

UDIN00233900AM24

The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence, the Committee decided to reject the case.

Case No. 70 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name GANGWAL CHEMICALS PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00187865AM22
RA File Number 03AA04083531 AM22
Licence No and<br>Date 0311007077/20/09/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case

s Committee Decision:|| |The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.|| |Hence, the Committee decided torejectthe case||

Case No. 71 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name CHEMPLAST SANMAR LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00006805AM23
RA File Number 04AA04015436 AM22
Licence No and<br>Date 0411001511/22/09/2021
Norms Committee Decision:
We may call sample shipping bills from the firm and call the comments of TE.
Case No. 72 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name FDC LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00005815AM23
RA File Number 03AA040106163 AM22
Licence No and<br>Date 0311007214/25/09/2021
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: -

50

UDIN00233900AM24

Export Product Qty. Sl. No. Import Items Qty.
AZELASTINE EYE DROPS 8ML <br>1 Number 1 AZELASTINE HYDROCLORIDE 4.08 mg.
(Each ML contains Azelastine HCL
0.004 gm)
ort Product Qty. Sl. No. Import Items Qty.
AZELASTINE EYE DROPS 8ML <br>1 Number 1 AZELASTINE HYDROCLORIDE 4.08 mg.
(Each ML contains Azelastine HCL
0.004 gm)
RA Export Product Export Product Export Product Qty. Sl. N o. Impor Impor Impor t Items Qty. Qty.
AZELASTINE EYE DROPS 8ML<br>(Each ML contains Azelastine HCL<br>0.004 gm) <br> <br>1 Nu mber 1 AZEL ASTINE HYDROCL ORI DE 4.08 mg.
concerned may take further necessary action as per abo ve decis ion of NC.
Cas e No. 73 / NC/3/MEET/Jul/20 324/9
C Stt C Ad
ase aus ase pprove
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number
NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
and Date
HQ File Number HQRNORM APPLY 00195013AM22
RA File Number 09AA04004969 AM22
Licence No and 0911001626/27/09/2021
Date
Norms Committee Decision:
The Committee c<br>Vol.

No and||0911001626/27/09/2021|||||||||||||||| ||||||||||||||||||| |Date|||||||||||||||||| |Norms Committee||Decision:|||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| |The Committee c<br>Vol. I as per detai||onsidered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>ls given below or as applied by the firm, whichever is less:-|||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||Export Product||Q||ty.|||Sl. No.||||Import Items|||||Qty.| ||||||||||||||||||| ||Ceftazidime<br>powder<br>for||<br>312500||Numbers|||1||||Ceftazidime for Injection Bulk|||||400 kg.| ||preparation<br>of<br>solution<br>for|||||||||||Sterile (containing NLT 118 m|||g||| ||Intramuscular<br>|and<br>Intravenous<br>||||||||||Sodium carbonate)|||||| ||administration|1 gram|||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||Ceftazidime<br>preparation|powder<br>for<br>of<br>solution<br>for|<br> <br>39063<br>||||2|||||Ceftazidime for Injection Bulk<br>Sterile (containing NLT 232 mg|||||100 kg.| ||Intramuscular|and<br>Intravenous|<br>Numbers|||||||||sodium carbonate)|||||| ||administration|2 gram|||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| |RA concerned ma||y take further necessary action as per above decision of NC.|||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| |Case No||74 / NC/3/MEET/Jul/202324/9|||||||||||||||| |.|||||||||||||||||| |||||||||||||||||||

Case No. 74 / NC/3/MEET/Jul/202324/9

51

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||||||||||||||| ||||||||||||||||||| |Case No||74 / NC/3/MEET/Jul/202324/9|||||||||||||||| |.|||||||||||||||||| |||||||||||||||||||

Case No. 74 / NC/3/MEET/Jul/202324/9

51

UDIN00233900AM24

Case Status Case Deferred
Party Name NATURAL AND ESSENTIAL OILS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00196404AM22
RA File Number 07AA04026654 AM22
Licence No and<br>Date 0711002016/28/09/2021
Norms Committee Decision:
We may call sample shipping bills from the firm and call the comments of TE
Case No.<br>75 / NC/3/MEET/Jul/202324/9
Case Status<br>Case Approved
Party Name<br>FDC LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number<br>HQRNORM REVIW00005837AM23
RA File Number<br>03AA040106642 AM22
Licence No and<br>Date<br>0311007268/28/09/2021
Norms Committee Decision:
T
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less: -
Export Product<br>Qty. Sl. No. Import Items Qty.
BRIMONIDINE Tartrate Eye Drop,<br>1 Number 1 BRIMONIDINE L TARTRATE 10.2 mg.
0.2% w/v, 5 ml vial.
RA concerned may take further necessary action as per above decision of NC.

|Qty.|| |BRIMONIDINE Tartrate Eye Drop,<br>1 Number|1|BRIMONIDINE L TARTRATE|10.2 mg.|| |0.2% w/v, 5 ml vial.||||| |RA concerned may take further necessary action as per above decision of NC.|||||

Case No. 76 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00198447AM22
RA File Number 09AA04014674 AM22
Licence No and 0911001659/30/09/2021

52

UDIN00233900AM24

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.
Heparin sodium Solution for intravenous and 1 Number 1 Heparin Sodium 27.50 mg
subcutaneous administration 5000 IU / ml - (5000 IU/
1ml) (Each ml contains Heparin Sodium 5000 IU)
Heparin<br>sodium<br>Solution<br>for<br>intravenous and <br>1 Number 2 Heparin Sodium 55.00 mg
subcutaneous administration 5000 IU / ml - (10000 IU/
2 ml)(Each ml contains Heparin Sodium 5000 IU)
Heparin sodium Solution for intravenous and 1 Number 3 Heparin Sodium 137.50 mg
subcutaneous administration 5000 IU / ml - (25000 IU/
5 ml)(Each ml contains Heparin Sodium 5000 IU)

in sodium Solution for intravenous and||1 Number|3|Heparin Sodium|137.50 mg| |subcutaneous administration 5000 IU / ml - (25000 IU/|||||| |5 ml)(Each ml contains Heparin Sodium 5000 IU)||||||

Case No. 77 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name VACHICHEM INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00003902AM23
RA File Number 07AA04028991 AM22
Licence No and<br>Date 0711002024/30/09/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.
Case No. 78 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00201651AM22

53

UDIN00233900AM24

RA File Number 07AA04031322 AM22
Licence No and<br>Date 0711002073/04/10/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.

Committee Decision:|| |The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.|| |Hence, the Committee decided torejectthe case.||

Case No. 79 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00201659AM22
RA File Number 07AA04034939 AM22
Licence No and<br>Date 0711002076/04/10/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.
Case No. 80 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name GLAND PHARMA LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00206565AM22
RA File Number 09AA04010507 AM22
Licence No and<br>Date 0911001380/08/10/2021
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.

se 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.|| |Heparin Injection BP, 5000IU/5ml, 5ml Vial(Each||1 Number|1|Heparin Sodium|27.5 mg.|| |ml contains, Heaprin Sodium BP 1000IU, Benzyl||||||| |Alcohol BP 0.95 percent w/v, Water for Injection BP<br>q.s.)|||2|Glass Vials|1.02 Numbers|| ||||3|Rubber Stoppers|1.01 Numbers||

54

UDIN00233900AM24

4<br>Flip off Seals<br>1.01 Numbers<br>5<br>Heparin Sodium<br>137.5 mg.<br>6<br>Glass Vials<br>1.02 Numbers<br>7<br>Rubber Stoppers<br>1.01 Numbers<br>Heparin Injection BP, 25000IU/5ml, 5ml Vial(Each<br>ml contins, Heaprin Sodium BP 5000IU, Benzyl<br>Alcohol BP 0.95 percent w/v, Water for Injection BP<br>q.s.)<br>1 Number<br>8<br>Flip off Seals<br>1.01 Numbers<br>RA concerned may take further necessary action as per above decision of NC. 4 Flip off Seals 1.01 Numbers
Heparin Injection BP, 25000IU/5ml, 5ml Vial(Each<br>ml contins, Heaprin Sodium BP 5000IU, Benzyl<br>Alcohol BP 0.95 percent w/v, Water for Injection BP<br>q.s.) <br>1 Number 5 Heparin Sodium 137.5 mg.
6 Glass Vials 1.02 Numbers
7 Rubber Stoppers 1.01 Numbers
8 Flip off Seals 1.01 Numbers

P 0.95 percent w/v, Water for Injection BP<br>q.s.)|<br>1 Number|5|Heparin Sodium|137.5 mg.| ||||6|Glass Vials|1.02 Numbers| ||||7|Rubber Stoppers|1.01 Numbers| ||||8|Flip off Seals|1.01 Numbers|

Case No. 81 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name LUPIN LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00215795AM22
RA File Number 03AA040109357 AM22
Licence No and<br>Date 0311007760/18/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm applied under para-4.18 of HBP<br>Vol.2 (Non Infringing Process) applicable for Pharmaceutical product manufacture which does not require for fixation<br>of ad-hoc norms. Hence, the Committee decided toWithdrawnthe case.
Case No. 82 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00226895AM22
RA File Number 02AA04031501 AM22
Licence No and<br>Date 0211001401/26/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to 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:-

55

UDIN00233900AM24

Export Product Qty. Sl. No. Import Items Qty.
Benzene (from olefinic complex) 1 MT 1 Light Naphtha 1.194 MT

the firm, whichever is less:-||

55

UDIN00233900AM24

Export Product Qty. Sl. No. Import Items Qty.
Benzene (from olefinic complex) 1 MT 1 Light Naphtha 1.194 MT

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

Case No. 83 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00227901AM22
RA File Number 02AA04030895 AM22
Licence No and<br>Date 0211001406/27/10/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Benzene (from olefinic complex)<br>1 MT<br>1<br>Light Naphtha<br>1.194 MT<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 84 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name BAZAYAN ENTERPRISES LLP
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00003373AM23
RA File Number 03AA04078009 AM22
Licence No and<br>Date 0311008047/29/10/2021
Norms Committee Decision:

56

UDIN00233900AM24

The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply. Hence, the Committee decided to reject the case.

56

UDIN00233900AM24

The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply. Hence, the Committee decided to reject the case.

Case No. 85 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name AUROBINDO PHARMA LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00006964AM23
RA File Number 09AA04016788 AM22
Licence No and<br>Date 0911001796/29/10/2021
Norms Committee Decision:
We may call sample shipping bills from the firm and call the comments of TE.
Case No. 86 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00239769AM22
RA File Number 09AA04001389 AM22
Licence No and<br>Date 0911001808/02/11/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to refer the case toDeptt. of Bio-Technologyfor
obtaining their comments.

1808/02/11/2021| |Norms Committee Decision:|| |The Committee considered the case as per agenda and it was decided to refer the case toDeptt. of Bio-Technologyfor|| |obtaining their comments.||

Case No. 87 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name LUPIN LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00246330AM22
RA File Number 03AA040117679 AM22
Licence No and<br>Date 0311008378/09/11/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm applied under para4.18 of HBP
Vol.2 (Non Infringing Process) applicable for Pharmaceutical product manufacture which does not require for fixation
of ad-hoc norms. Hence, the Committee decided toWithdrawnthe case.

57

UDIN00233900AM24

Case No. 88 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name AMINES AND PLASTICIZERS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00004678AM23
RA File Number 03AA040113998 AM22
Licence No and<br>Date 0311008443/11/11/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.

Committee Decision:|| |The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.|| |Hence, the Committee decided torejectthe case.||

Case No. Case No. Case No. 88 / NC/3/MEET/Jul/202324/9 88 / NC/3/MEET/Jul/202324/9 88 / NC/3/MEET/Jul/202324/9 88 / NC/3/MEET/Jul/202324/9 88 / NC/3/MEET/Jul/202324/9 88 / NC/3/MEET/Jul/202324/9 88 / NC/3/MEET/Jul/202324/9 88 / NC/3/MEET/Jul/202324/9 88 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name AMINES AND PLASTICIZERS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00004678AM23
RA File Number 03AA040113998 AM22
Lic<br>Dat ence No and<br> 0311008443/11/11/2021
e
Nor<br>The<br>He ms Committee Decision:
Committee considered the case as per agen<br>nce, the Committee decided torejectthe cas da and it was<br>e. observed that the firm has still not furn ished its reply.
Cas e No. 89 / NC/3/MEET/Jul/202324/9
Cas e Status Case Approved
Par ty Name AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number
<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00255683AM22
RA File Number 09AA04016606 AM22
Licence No and<br>Date 0911001869/17/11/2021
Norms Committee Decision:

Number|||HQRNORM APPLY 00255683AM22||||||||| |RA File Number|||09AA04016606 AM22||||||||| |Licence No and<br>Date|||0911001869/17/11/2021||||||||| |Norms Committee|||Decision:||||||||| ||||||||||||| |The Committee co<br>Vol. I as per detai|||nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>ls given below or as applied by the firm, whichever is less:||||||||| ||||||||||||| ||Export product|||Qty.||Sl. No.|Import items||||Qty.| ||||||||||||| ||Dronedarone HC||L|1 kg||1|Salicylaldehyde||||1.00 kg| ||htil||dt||||||||| ||||||||||||| ||(parmaceuca||prouc)|||2|Dimethyl formamide||||1.00 kg| ||||||||||||| ||||||||||||| |||||||3|Methylenedichloride||||15.00 kg| ||||||||||||| ||||||||||||| |||||||4|Iso propyl Alcohol||||4.60 kg| |||||||5|Di-n-butylamine||||0.667 kg| |||||||6|Methyl-2-bromo hexanoate||||1.32 kg| |||||||||||||

58

UDIN00233900AM24

Case No. 90 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00257369AM22
RA File Number 09AA04017800 AM22
Licence No and<br>Date 0911001879/18/11/2021
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.

e case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>Heparin sodium Solution for intravenous and<br>subcutaneous administration 5000 IU / ml - (5000 IU/<br>1 ml)(Each ml contains Heparin Sodium 5000 IU)<br>1 Number<br>1<br>Heparin Sodium<br>27.50 mg<br>Heparin sodium Solution for intravenous and<br>subcutaneous administration 5000 IU / ml - (10000 IU/<br>2 ml)(Each ml contains Heparin Sodium 5000 IU)<br>1 Number<br>2<br>Heparin Sodium<br>55.00 mg<br>Heparin sodium Solution for intravenous and<br>subcutaneous administration 5000 IU / ml - (25000<br>IU/ 5 ml)(Each ml contains Heparin Sodium 5000 IU)<br>1 Number<br>3<br>Heparin Sodium<br>137.50 mg<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. 91 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023

59

UDIN00233900AM24

EET/Jul/202324/9| |---|---| |Case Status|Case Approved| |Party Name|JODAS EXPOIM PRIVATE LIMITED| |Meeting Number<br>and Date|NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023|

59

UDIN00233900AM24

HQ File Number HQ File Number HQRNORM APPLY 00261552AM22 HQRNORM APPLY 00261552AM22 HQRNORM APPLY 00261552AM22 HQRNORM APPLY 00261552AM22 HQRNORM APPLY 00261552AM22 HQRNORM APPLY 00261552AM22
RA File Number 09AA04017897 AM22
Licence No and 0911001904/22/11/2021
Date
Norms Committee Decision:
The Committee co<br>l di nsidered the case as per agenda and it was decided to fix ad-hoc norms un<br>i bl lid b h fi hih i l der Para 4.07 of HBP
Vo. I as per etas gven eow or as appe y te rm, wcever s ess:-<br>Export Product<br>Qty<br>Sl No<br>Import
Export Product Qty Sl No Import Items Qty
. . . .
Heparin sodiu<br> m Solution for intravenous<br> and<br> <br> 1 Number 1 Heparin Sodi um 27.50 mg
subcutaneous<br>ml)(Each ml c administration 5000 IU / m<br>ntains Hearin Sodium 50 - (5000 IU/ 1<br>00 IU)
p
Heparin sodiu m Solution for intravenous and<br> 1 Number 2 Heparin Sodi um 55.00 mg
subcutaneous a<br> dministration 5000 IU / ml<br> - (10000 IU/<br>
2 ml)(Each ml contains Heparin Sodium 5 000 IU)

1 Number||2|Heparin Sodi||um|55.00 mg| ||subcutaneous a<br>|dministration 5000 IU / ml<br>|- (10000 IU/<br>|||||||| |||||||||||| ||2 ml)(Each ml|contains Heparin Sodium 5|000 IU)|||||||| |||||||||||| ||Heparin sodium Solution for intravenous<br>subcutaneous administration 5000 IU / ml<br>5 ml)(Each ml contains Heparin Sodium 5||and<br>- (25000 IU/<br>000 IU)<br>|||||||| |||||1 Number||3|Heparin Sodi||um|137.50 mg| |||||||||||| |RA concerned may take further necessary action as per above decision of NC.||||||||||| |||||||||||| |||||||||||| |Case No.||92 / NC/3/MEET/Jul/202324/9||||||||| |Case Status||Case Rejected||||||||| |Party Name||LAXMI ORGANIC INDUSTRIES LIMITED||||||||| |Meeting Number||NC/ 3/ MEET/ Jl/ 202324/ 9 d 28/07/2023||||||||| |and Date||u an||||||||| |HQ File Number||HQRNORM APPLY 00262564AM22||||||||| |RA File Number||03AA04013560 AM22||||||||| |Licence No and<br>Date||0311008775/23/11/2021||||||||| |Norms Committee Decision:<br>The Committee considered the case as er aenda and it as obsered that the firm has still||||||||ot frnished its rel||| |p g w v u py.<br>Hence the Committee decided torejectthe case||||||||||| |,||.||||||||| |||||||||||| |Case No.||93 / NC/3/MEET/Jul/202324/9||||||||| |Case Status||Case Approved||||||||| |Party Name||JODAS EXPOIM PRIVATE LIMITED|||||||||

torejectthe case||||||||||| |,||.||||||||| |||||||||||| |Case No.||93 / NC/3/MEET/Jul/202324/9||||||||| |Case Status||Case Approved||||||||| |Party Name||JODAS EXPOIM PRIVATE LIMITED|||||||||

Case No. 92 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00262564AM22
RA File Number 03AA04013560 AM22
Licence No and<br>Date 0311008775/23/11/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.
Case No. 93 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name JODAS EXPOIM PRIVATE LIMITED

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UDIN00233900AM24

Meeting Number<br>and Date Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023 NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023 NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023 NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023 NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023 NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023 NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023 NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023 NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023 NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023 NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023 NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00265144AM22

C/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023|NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023| |---|---|---|---|---|---|---|---|---|---|---|---|---|---| |HQ File Number||HQRNORM APPLY 00265144AM22|||||||||||| |RA File Number||09AA04017903 AM22|||||||||||| |Licence No and<br>Date||0911001933/25/11/2021|||||||||||| |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.<br>Heparin sodium Solution for intravenous and<br>subcutaneous administration 5000 IU / ml - (5000 IU/ 1<br>ml)(Each ml contains Heparin Sodium 5000 IU)<br>1 Number<br>1<br>Heparin Sodium<br>27.50 mg<br>Heparin sodium Solution for intravenous and<br>subcutaneous administration 5000 IU / ml - (10000 IU/<br>2 ml)(Each ml contains Heparin Sodium 5000 IU)<br>1 Number<br>2<br>Heparin Sodium<br>55.00 mg<br>Heparin sodium Solution for intravenous and<br>1 Number<br>3<br>Heparin Sodium<br>137.50 mg|||||||||||||| ||Export Product||||Qty.||Sl.

dium 5000 IU)<br>1 Number<br>2<br>Heparin Sodium<br>55.00 mg<br>Heparin sodium Solution for intravenous and<br>1 Number<br>3<br>Heparin Sodium<br>137.50 mg|||||||||||||| ||Export Product||||Qty.||Sl. No.|||Import Items||Qty.|| ||||||||||||||| ||Heparin sodium Solution for intravenous and||||1 Nu|ber|1|||Heparin Sodium||2750 mg|| ||<br>subcutaneous administration 5000 IU / ml - (5<br>ml)(Each ml contains Heparin Sodium 5000 I||000 IU/ 1<br>U)|||||||||.|| ||Heparin sodium Solution for intravenous and||||1 Nu|mber|2|||Heparin Sodium||55.00 mg|| ||subcutaneous administration 5000 IU / ml - (10000 IU/<br>2 ml)(Each ml contains Heparin Sodium 5000 IU)||||||||||||| ||Heparin sodium Solution for intravenous and||||1 Number||3|||Heparin Sodium||137.50 mg|| ||<br>subcutaneous administration 5000 IU / ml - (25000 IU/||||||||||||| ||<br>5 ml)(Each ml|<br>contains Heparin Sodium 5000 IU)|||||||||||| ||||||||||||||| ||||||||||||||| ||||||||||||||| |RA concerned may||take further necessary action as per above decision of NC.|||||||||||| ||||||||||||||| ||||||||||||||| ||||||||||||||| ||||||||||||||| |Case No.||94 / NC/3/MEET/Jul/202324/9|||||||||||| |Case Status||Case Approved|||||||||||| |Party Name||JODAS EXPOIM PRIVATE LIMITED|||||||||||| |Meeting Number<br>and Date||NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023|||||||||||| |HQ File Number||HQRNORM APPLY 00274252AM22|||||||||||| |RA|File Number|09AA04018274 AM22|||||||||||| |Lic<br>Dat|ence No and||||||||||||| ||<br>e|0911001996/03/12/2021|||||||||||| |Nor<br>Th<br>Vo|ms Committee Decision:|||||||||||||

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.|| |Benzene (from olefinic complex)|1 MT|1|Light Naphtha|1.194 MT|| |RA concerned may take further necessary action as per above decision of NC.||||||

64

UDIN00233900AM24

Case No. 102 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00345828AM22
RA File Number 09AX04000205 AM22
Licence No and<br>Date 0911002465/07/02/2022
Norms Committee Decision:
We may call sample shipping bills from the firm and call the comments of TE.
Case No. 103 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name ARKRAY HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00347493AM22
RA File Number 52AX04000059 AM22
Licence No and<br>Date 5211001995/08/02/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.

Committee Decision:|| |The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.|| |Hence, the Committee decided torejectthe case.||

Case No. 104 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name LAURUS SYNTHESIS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00351303AM22
RA File Number 09AX04000191 AM22
Licence No and<br>Date 0911002504/11/02/2022
Norms Committee Decision:
We may call sample shipping bills from the firm and call the comments of TE.
Case No. 105 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name PIL PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023

65

UDIN00233900AM24

HQ File Number HQRNORM APPLY 00356272AM22
RA File Number 05AX04000849 AM22
Licence No and<br>Date 0511008550/15/02/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.

Committee Decision:|| |The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.|| |Hence, the Committee decided torejectthe case.||

Case No. 106 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00356332AM22
RA File Number 08AX04000424 AM22
Licence No and<br>Date 0811004069/15/02/2022
Norms Committee Decision:
We may call sample shipping bills from the firm and call the comments of TE.
Case No.<br>107 / NC/3/MEET/Jul/202324/9 Case No.<br>107 / NC/3/MEET/Jul/202324/9
Case Status<br>Case Approved
Party Name<br>AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number<br>HQRNORM APPLY 00367304AM22
RA File Number<br>09AX04000261 AM22
Licence No and<br>Date<br>0911002566/25/02/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:-
Export Product<br>Qty.<br>Sl.

s per agenda and it was decided to fix ad-hoc norms under Para|||4.07 of HBP||| |Vol. I as per details given below or as applied by the firm, whichever is less:-|||||| ||Export Product<br>Qty.<br>Sl. No.|Import Items||Qty.|| ||1<br>Nirmatrelvir<br>1 kg.|(AS, 3S)-A-((tert-butyloxycarbonyl) amino)-2-oxo-3-||1.25 kg.|| |||pyrrolinepropanoic acid methyl ester (60-8)|||| ||(Pharmaceutical product)||||| ||2|(1R,2S,5S)-Methyl 6,6-dimethyl-3-azabicyclo[3.1.0]||1.58 kg.|| |||hexane-2-carboxylate hydrochloride (77-1)||||

66

UDIN00233900AM24

3 BOC-tertbutyl-Leucine (35-9) 1.98 kg.

Case No. 108 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name MISTAIR HEALTH AND HYGIENE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00375016AM22
RA File Number 03AX04001352 AM22
Licence No and<br>Date 0311012252/04/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply.<br>Hence, the Committee decided torejectthe case.

Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply.<br>Hence, the Committee decided torejectthe case.||

Case No. 109 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name ANANTA MEDICARE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00378768AM22
RA File Number 05AX04001194 AM22
Licence No and<br>Date 0511010747/07/03/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.
Case No. 110 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name INTAS PHARMACEUTICALS LIMITED
Meeting Number and<br>Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00379532AM22
RA File Number 08AX04000605 AM22
Licence No and Date 0811004316/08/03/2022
Norms Committee Decision:<br>T

67

UDIN00233900AM24

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: -

M24

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.
DOXYCYCLINE DISPERSIBLE 1 Number 1 DOXYCYCLINE 102.908 mg.
TABLETS 100 MG (EACH MONOHYDRATE
UNCOATED DISPERSIBLE
TABLET CONTAINS: EP / BP / IP / USP / PH. EUR.
DOXYCYCLINE
MONOHYDRATE PH.EUR. EQ.
TO DOX YCYCLINE 100 MG [IN
WHICH ACTIVE INGREDIENT
DOXYCYCLINE
MONOHYDRATE USED IS 53.000
KGS.])
Case No. 111 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name SHIVA BIO CHEM INDUSTRIES
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00382075AM22
RA File Number 50AX04000031 AM22
Licence No and<br>Date 5011000413/10/03/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing
before Norms Committee to explain its case with the following information/documents:
COA of import and export item indicating percentage purity.<br>i.
If any, By-Product obtained, please furnish details of quantity and value of such By-Product.<br>ii.
End use of<br>iii. Export Product.
We may call sample shipping bills from the firm and call the comments of TE.<br>iv.
Case No. 112 / NC/3/MEET/Jul/202324/9
Case Status Case Approved

68

port Product.**| |We may call sample shipping bills from the firm and call the comments of TE.<br>iv.||

Case No. 112 / NC/3/MEET/Jul/202324/9
Case Status Case Approved

68

UDIN00233900AM24

Party Name<br>HALDIA PETROCHEMICALS LIMITED Party Name<br>HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number<br>HQRNORM APPLY 00386453AM22
RA File Number<br>02AX04000187 AM22
Licence No and<br>Date<br>0211002100/14/03/2022
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.
Benzene (from olefinic complex) 1 MT 1 Light Naphtha 1.194 MT
RA concerned may take further necessary action as per above decision of NC

|Export Product|Qty.|Sl. No.|Import Items|Qty.|| |Benzene (from olefinic complex)|1 MT|1|Light Naphtha|1.194 MT|| |RA concerned may take further necessary action as per above decision of NC||||||

Case No.<br>113 / NC/3/MEET/Jul/202324/9
Case Status<br>Case Approved
Party Name<br>HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number<br>HQRNORM APPLY 00389089AM22
RA File Number<br>02AX04000201 AM22
Licence No and<br>Date<br>0211002113/16/03/2022
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.
Benzene (from olefinic complex) 1 MT 1 Light Naphtha 1.194 MT

69

UDIN00233900AM24

pplied by the firm, whichever is less: -|||||| |Export Product|Qty.|Sl. No.|Import Items|Qty.|| |Benzene (from olefinic complex)|1 MT|1|Light Naphtha|1.194 MT|| |||||||

69

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Case No.<br>114 / NC/3/MEET/Jul/202324/9
Case Status<br>Case Approved
Party Name<br>HALDIA PETROCHEMICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number<br>HQRNORM APPLY 00390945AM22
RA File Number<br>02AX04000207 AM22
Licence No and<br>Date<br>0211002128/17/03/2022
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.
Benzene (from olefinic complex) 1 MT 1 Light Naphtha 1.194 MT
RA concerned may take further necessary action as per above decision of NC.
Case No. 115 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00409480AM22
RA File Number 34AX04000458 AM22
Licence No and<br>Date 3411002061/31/03/2022
Norms Committee Decision:
We may call sample shipping bills from the firm and call the comments of TE.

| |RA File Number|34AX04000458 AM22| |Licence No and<br>Date|3411002061/31/03/2022| |Norms Committee Decision:|| |We may call sample shipping bills from the firm and call the comments of TE.||

Case No. 116 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name MANGALAM DRUGS AND ORGANICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00000438AM23

70

UDIN00233900AM24

RA File Number 03AX04001990 AM22
Licence No and<br>Date 0311014190/26/04/2022
Norms Committee Decision:
We may call sample shipping bills from the firm and call the comments of TE.
Case No. 117 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00000485AM23
RA File Number 03AX04000399 AM23
Licence No and<br>Date 0311014263/29/04/2022
Norms Committee Decision:
We may call sample shipping bills from the firm and call the comments of TE.

| |RA File Number|03AX04000399 AM23| |Licence No and<br>Date|0311014263/29/04/2022| |Norms Committee Decision:|| |We may call sample shipping bills from the firm and call the comments of TE.||

Case No.<br>118 / NC/3/MEET/Jul/202324/9
Case Status<br>Case Deferred
Party Name<br>SAINOR LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number<br>HQRNORM APPLY 00000500AM23
RA File Number<br>09AX04000372 AM22
Licence No and<br>Date<br>0911002924/29/04/2022
Norms Committee Decision:
The committee considered the request of firm for fixation of ad-hoc norms and it was decided to call for following
information/documents from the firm: -
Percentage of Tetrahydrofuran in export product.<br>1.
Recovery of Tetrahydrofuran if used as a solvent.<br>2.
We may call sample shipping bills from the firm and call the comments of TE.<br>3.
Case No. 119 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00000703AM23
RA File Number 09AX04000059 AM23

71

UDIN00233900AM24

Licence No and 0911002979/11/05/2022 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: -

on:

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.
Heparin sodium Solution for intravenous and<br>subcutaneous administration 5000 IU / ml - (5000 IU/ 1<br>ml)(Each ml contains Heparin Sodium 5000 IU) 1 Number 1 Heparin Sodium 27.50 mg
Heparin sodium Solution for intravenous and<br>subcutaneous administration 5000 IU / ml - (10000 IU/ 2<br>ml)(Each ml contains Heparin Sodium 5000 IU) 1 Number 2 Heparin Sodium 55.00 mg
Heparin sodium Solution for intravenous and<br>subcutaneous administration 5000 IU / ml - (25000 IU/ 5<br>ml)(Each ml contains Heparin Sodium 5000 IU) 1 Number 3 Heparin Sodium 137.50 mg
Case No. Case No. 120 / NC/3/MEET/Jul/202324/9 120 / NC/3/MEET/Jul/202324/9 120 / NC/3/MEET/Jul/202324/9 120 / NC/3/MEET/Jul/202324/9 120 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name INNOVARE LABS PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00000708AM23
RA File Number 26AX04000007 AM23
Licence No and Date 2611000574/11/05/2022
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.

case as per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>ADENINE<br>0.85 kg<br>(R)-9-[2-(Phosphonomethoxy)-<br>1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||(R)-9-[2-(Phosphonomethoxy)-||1 kg.|1|ADENINE|0.85 kg|

Case No. Case No. 120 / NC/3/MEET/Jul/202324/9 120 / NC/3/MEET/Jul/202324/9 120 / NC/3/MEET/Jul/202324/9 120 / NC/3/MEET/Jul/202324/9 120 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name INNOVARE LABS PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00000708AM23
RA File Number 26AX04000007 AM23
Licence No and Date 2611000574/11/05/2022
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.<br>1<br>ADENINE<br>0.85 kg<br>(R)-9-[2-(Phosphonomethoxy)-<br>1 kg.
Export Product Qty. Sl. No. Import Items Qty.
(R)-9-[2-(Phosphonomethoxy)- 1 kg. 1 ADENINE 0.85 kg

72

UDIN00233900AM24

INE<br>0.85 kg<br>(R)-9-[2-(Phosphonomethoxy)-<br>1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty.| ||(R)-9-[2-(Phosphonomethoxy)-||1 kg.|1|ADENINE|0.85 kg|

72

UDIN00233900AM24

2<br>R-(+)-PROPYLENE<br>CARBONATE<br>0.79 kg.<br>propyl]<br>adenine<br>monohydrate<br>or<br>Tenofovir Fumarate (TCX) II<br>3<br>DIETHYL P TOLUENE<br>SULFONYLOXYMETHYL<br>1.00 kg.<br>RA concerned may take further necessary action as per above decision of NC. propyl]<br>adenine<br>monohydrate<br>or<br>Tenofovir Fumarate (TCX) II 2 R-(+)-PROPYLENE<br>CARBONATE 0.79 kg.
3 DIETHYL P TOLUENE<br>SULFONYLOXYMETHYL 1.00 kg.
Case No. 121 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name ASTEC LIFESCIENCES LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00000715AM23
RA File Number 03AX04000356 AM23
Licence No and Date 0311014646/11/05/2022
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.

se 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>1<br>2 FLURO A NILINE<br>0.66 kg.<br>2<br>ETHYL CHLOROFORMATE<br>0.55 kg.<br>3<br>DI METHYL FORMAMIDE<br>Deleted (not given in<br>production/consumption data<br>& also not a main reactant<br>4<br>ETHYL 3 AMINO 4 4 4<br>TRIFLUROCROTONATE<br>0.66 kg.<br>PDSH(PDSH TECHNICAL)<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||

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Case No. 122 / NC/3/MEET/Jul/202324/9 122 / NC/3/MEET/Jul/202324/9 122 / NC/3/MEET/Jul/202324/9 122 / NC/3/MEET/Jul/202324/9 122 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name ADCOCK INGRAM LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00000741AM23
RA File Number 07AX04000110 AM23
Licence No and<br>Date 0711003978/13/05/2022
Norms Committee Decision:<br>Committee considered the case as per agenda and taking cue from earlier decision for same export product/import<br>item in Meeting No.NC/3/MEET/Mar/20202223/24 dated 13/04/2023against advance authorization No.<br>0711002880 dated 16/01/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

em in Meeting No.NC/3/MEET/Mar/20202223/24 dated 13/04/2023against advance authorization No.<br>0711002880 dated 16/01/2022, 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:|||||| |Export product<br>Neulin 125mg Tablets -Theophylline 125 Mg<br>+Guar gum 4.375 Mg(9142857 No. of<br>Tabs)(Theop-1142.857 +GUAR.GUM<br>40.000KGS)<br>Neulin 200mg Tablets -Theophylline 200 Mg<br>+Guar gum 7.00Mg(9142857 No. of<br>Tabs)(Theop- 1828.571+GUAR.GUM<br>64.000 KGS<br>Neulin 250mg Tablets -Theophylline 250 Mg<br>+Guar gum 8.750 Mg(9142857 No. of<br>Tabs)(Theop-2285.714+GUAR.GUM<br>80.000 KGS)<br>Neulin 300mg Tablets -Theophylline 300 Mg<br>+Guar gum 10.5 Mg(9142857 No. of<br>Tabs)(Theop-2742.857+GUAR.GUM||Qty.|Sl. No.|Import items|Qty.| |||1 no. of<br>Tablet|1|Theophylline BP / EP / USP /<br>PH.EURAnhydrous Powder|127.5 mg| ||||2|Guar Gum IH (BP / EP / USP /<br>PH.EUR)|4.375 mg| |||1 no. of<br>Tablet|1|Theophylline BP / EP / USP /<br>PH.EURAnhydrous Powder|204.0 mg| ||||2|Guar Gum IH (BP / EP / USP /<br>PH.EUR)|7.00 mg| |||1 no. of<br>Tablet|1|Theophylline BP / EP / USP /<br>PH.EURAnhydrous Powder|255.0 mg| ||||2|Guar Gum IH (BP / EP / USP /<br>PH.EUR)|8.75 mg| |||1 no. of|1|Theophylline BP / EP / USP /<br>PH.EURAnhydrous Powder|306.0 mg|

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96.000 KGS) Tablet 2 Guar Gum IH (BP / EP / USP /
PH.EUR)
10.5 mg

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

00233900AM24

96.000 KGS) Tablet 2 Guar Gum IH (BP / EP / USP /
PH.EUR)
10.5 mg

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

Case No. 123 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name AMI ORGANICS LIMITED
Meeting Number and<br>Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00000753AM23
RA File Number 52AX04000039 AM23
Licence No and Date 5211002485/13/05/2022
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>1<br>MALONONITRILE<br>0.571 kg.<br>2<br>"GUANIDINE HCL "<br>0.826 kg.<br>5-NITROSO-2,4,6-<br>TRIAMINOPYRIMIDINE<br>1 kg.<br>3<br>"N,N DIMETHYL FORMAMIDE 99. 5%<br>(Tech. Spec. Liquid)"<br>0.632 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 124 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name UNITED BIOTECH PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00000757AM23
RA File Number 05AX04000267 AM23

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H PRIVATE LIMITED| |Meeting Number<br>and Date|NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023| |HQ File Number|HQRNORM APPLY 00000757AM23| |RA File Number|05AX04000267 AM23|

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Licence No and 0511012548/13/05/2022 Date Norms Committee Decision: The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply. Hence, the Committee decided to reject the case.

Case No. 125 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name SHIVA BIO CHEM INDUSTRIES
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00000856AM23
RA File Number 50AX04000018 AM23
Licence No and<br>Date 5011000486/18/05/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing<br>before Norms Committee to explain its case with the following information/documents:<br>COA of import and export item indicating percentage purity.<br>i.<br>If any, By-Product obtained, please furnish details of quantity and value of such By-Product.<br>ii.<br>End use of Export Product.<br>iii.<br>We may call sample shipping bills from the firm and call the comments of TE.<br>iv.

details of quantity and value of such By-Product.**<br>ii.<br>End use of Export Product.<br>iii.<br>We may call sample shipping bills from the firm and call the comments of TE.<br>iv.|||

Case No. 126 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name JODAS EXPOIM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00000912AM23
RA File Number 09AX04000058 AM23
Licence No and<br>Date 0911003033/20/05/2022
Norms Committee Decision:<br>We may call sample shipping bills from the firm and call the comments of TE.
Case No. 127 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name MICRO LABS LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00000918AM23
RA File Number 07AX04000117 AM23

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Licence No and Date 0711004046/21/05/2022

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.
PROCHLORPERZINE MALEATE 1 Number 1 PROCHLORPERAZINE 3.06 kg.
BUCCAL TABLETS MALEATE
3MG(PROCHLORPERZINE
MALEATE BUCCAL
TABLETS<br>3MG BP/EP/USP/IP
13.50KG)

---| |PROCHLORPERZINE|MALEATE|1 Number|1|PROCHLORPERAZINE|3.06 kg.| |BUCCAL TABLETS||||MALEATE|| |3MG(PROCHLORPERZINE|||||| |MALEATE BUCCAL|||||| |TABLETS<br>3MG|BP/EP/USP/IP||||| |13.50KG)||||||

Case No. 128 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name HETERO DRUGS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00000975AM23
RA File Number 09AX04000080 AM23
Licence No and<br>Date 0911003042/25/05/2022
Norms Committee Decision:
We may call sample shipping bills from the firm and call the comments of TE.
Case No. 129 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00001183AM23
RA File Number 52AX04000220 AM23
Licence No and<br>Date 5211002594/03/06/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply.

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Hence, the Committee decided to reject the case.

Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply.||

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Hence, the Committee decided to reject the case.

Case No. 130 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00000271AM24
RA File Number 03AX04001018 AM23
Licence No and<br>Date 0311015240/03/06/2022
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>Justification of low yield of 65.35%<br>1.<br>We may call sample shipping bills from the firm and call the comments of TE.<br>2.
Case No. 131 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name CIPLA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00001239AM23
RA File Number 03AX04000947 AM23
Licence No and<br>Date 0311015309/07/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case..

Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case..||

Case No. 132 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00001260AM23
RA File Number 05AX04000587 AM23
Licence No and<br>Date 0511013087/08/06/2022
Norms Committee Decision:

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We may call sample shipping bills from the firm and call the comments of TE.

Case No. 133 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name AROCHEMA INGREDIENTS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00001332AM23
RA File Number 26AX04000018 AM23
Licence No and<br>Date 2611000615/13/06/2022
Norms Committee Decision:<br>**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.<br>I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>1<br>7-OCTENAL<br>1.999 kg.<br>2<br>INHERENT UC 12 ME<br>(9-Methyl Dodecenate)<br>2.69 kg.<br>3<br>ULTRACAT<br>0.000089 kg.<br>4<br>SNATCHCAT<br>0.000104 kg.<br>AMBRETTOLIDE<br>VEG<br>(Perfumery Compound)<br>1 kg.<br>5<br>GREEN CAT<br>Not Imported.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 134 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name MANKIND PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00001345AM23
RA File Number 05AX04000761 AM23
Licence No and 0511013170/13/06/2022

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Date

Norms Committee Decision:

We may call sample shipping bills from the firm and call the comments of TE.

000761 AM23| |Licence No and|0511013170/13/06/2022|

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Date

Norms Committee Decision:

We may call sample shipping bills from the firm and call the comments of TE.

Case No. 135 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name MANKIND PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00001346AM23
RA File Number 05AX04000760 AM23
Licence No and<br>Date 0511013171/13/06/2022
Norms Committee Decision:<br>We may call sample shipping bills from the firm and call the comments of TE.
Case No. 136 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00001355AM23
RA File Number 03AX04000821 AM23
Licence No and<br>Date 0311015467/13/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply.<br>Hence, the Committee decided torejectthe case.

Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply.<br>Hence, the Committee decided torejectthe case.||

Case No. 137 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00001357AM23
RA File Number 03AX04001138 AM23
Licence No and<br>Date 0311015469/13/06/2022
Norms Committee Decision:<br>The firm vide e-mail dated09.08.2023has informed that they have surrendered their above license. In view of e-mail<br>of firm, the Committee decided towithdrawthe case.

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Case No. 138 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
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 firm vide e-mail dated09.08.2023has requested to give at least 60 days for submitting of documents as sought by<br>DL. In view of e-mail of firm, the Committee decided to defer the case.

he firm vide e-mail dated09.08.2023has requested to give at least 60 days for submitting of documents as sought by<br>DL. In view of e-mail of firm, the Committee decided to defer the case.||

Case No. 139 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name STERLING AUXILIARIES PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00001673AM23
RA File Number 03AX04001934 AM23
Licence No and<br>Date 0311015879/27/06/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.
Case No. 140 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00001720AM23
RA File Number 33AX04000021 AM23
Licence No and<br>Date 3311000772/28/06/2022
Norms Committee Decision:<br>We may call sample shipping bills from the firm and call the comments of TE.
Case No. 141 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name SRF LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023

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No. 141 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name SRF LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023

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HQ File Number HQRNORM APPLY 00001911AM23
RA File Number 05AX04001017 AM23
Licence No and<br>Date 0511013648/07/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case
Case No. 142 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name SALVI CHEMICAL INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00001938AM23
RA File Number 03AX04001943 AM23
Licence No and<br>Date 0311016208/08/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.
Case No. 143 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name APEX DRUG HOUSE
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00002007AM23
RA File Number 03AX04002053 AM23
Licence No and<br>Date 0311016315/13/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.

Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.||

Case No. 144 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name SRF LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00002026AM23
RA File Number 05AX04001011 AM23
Licence No and<br>Date 0511013749/13/07/2022

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Norms Committee Decision:

The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply. Hence, the Committee decided to reject the case.

Case No. 145 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name FREESIA CHEMICALS
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00002037AM23
RA File Number 03AX04002018 AM23
Licence No and<br>Date 0311016342/14/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.

Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.||

Case No. Case No. 146 / NC/3/MEET/Jul/202324/9 146 / NC/3/MEET/Jul/202324/9 146 / NC/3/MEET/Jul/202324/9 146 / NC/3/MEET/Jul/202324/9 146 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name BELCHEM INDUSTRIES (INDIA) PVT LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00002202AM23
RA File Number 03AX04002190 AM23
Licence No and<br>Date 0311016511/22/07/2022
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 Vol. I as per<br>details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>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.
Export Product Qty. Sl. No. Import Items Qty.
BELGUARD PBSA<br>(Phenylbenzimidazole Sulfonic Acid). 1 kg. 1 Ortho Phenylene Diamine 0.4925 kg.
concerned may take further necessary action as per above decision of NC.
Case No. 147 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected

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25 kg.| ||concerned may take further necessary action as per above decision of NC.||||||

Case No. 147 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected

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Party Name SRF LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00002213AM23
RA File Number 05AX04001131 AM23
Licence No and<br>Date 0511013929/22/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case
Case No. 148 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name CANPEX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00002216AM23
RA File Number 31AX04000115 AM23
Licence No and<br>Date 3111001583/22/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.

Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.||

Case No. 149 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00002265AM23
RA File Number 03AX04002336 AM23
Licence No and<br>Date 0311016601/26/07/2022
Norms Committee Decision:<br>The committee considered the request of firm for fixation of ad-hoc norms and it was decided to furnish the following<br>clarification: -<br>Requirement of Raw Material is more than as asked for. Please clarify.<br>1.<br>We may call sample shipping bills from the firm and call the comments of TE.<br>2.
Case No. 150 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name ASCENT FINECHEM PRIVATE LIMITED
Meeting Number NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023

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/ NC/3/MEET/Jul/202324/9| |---|---| |Case Status|Case Approved| |Party Name|ASCENT FINECHEM PRIVATE LIMITED| |Meeting Number|NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023|

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and Date
HQ File Number HQRNORM APPLY 00002286AM23
RA File Number 08AX04000679 AM23
Licence No and<br>Date 0811005628/26/07/2022
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.<br>Import Items<br>Qty.<br>1<br>O CHLOROBENZYL CYANIDE<br>1.59 kg.<br>Indoline<br>1 kg.<br>2<br>TOLUENE<br>0.56 kg.<br>RA concerned may take further necessary action as per above decision of NC.
Case No. 151 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name ASMEE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00002335AM23
RA File Number 03AX04002471 AM23
Licence No and<br>Date 0311016692/29/07/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.

Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.||

Case No. 152 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name GUJARAT FLUOROCHEMICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00002374AM23
RA File Number 34AX04000340 AM23
Licence No and<br>Date 3411002592/29/07/2022
Norms Committee Decision:

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UDIN00233900AM24

We may call sample shipping bills from the firm and call the comments of TE.

Case No. 153 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00002443AM23
RA File Number 07AX04000653 AM23
Licence No and<br>Date 0711004832/03/08/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case
Case No.<br>154 / NC/3/MEET/Jul/202324/9
Case Status<br>Case Approved
Party Name<br>TIDE INDUSTRIES
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number<br>HQRNORM APPLY 00002532AM23
RA File Number<br>34AX04000447 AM23
Licence No and<br>Date<br>3411002627/08/08/2022
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export
product/import item in Meeting No.NC/3/MEET/Mar/20202223/24 dated 13/04/2023against advance
authorization No.0711002880dated 16/01/2022, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I
as per details given below or as applied by the firm, whichever is less:
Export Product<br>Qty. Sl.

2880dated 16/01/2022**, it was decided to fix ad-hoc norms under Para 4.07|||of HBP Vol. I|| |as per details given below or as applied by the firm, whichever is less:||||| |Export Product<br>Qty.|Sl. No.|Import Items|Qty.|| |Aldehyde C9 (Purity 98%)<br>1 Kg|1|N Nonanal|1.24 kg|| |RA concerned may take further necessary action as per above decision|of NC.||||

Case No. 155 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED

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UDIN00233900AM24

Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00002548AM23
RA File Number 03AX04002511 AM23
Licence No and<br>Date 0311017048/10/08/2022
Norms Committee Decision:<br>We may call sample shipping bills from the firm and call the comments of TE.
Case No. 156 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00002634AM23
RA File Number 03AX04002522 AM23
Licence No and<br>Date 0311017151/12/08/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply.<br>Hence, the Committee decided torejectthe case.

Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply.<br>Hence, the Committee decided torejectthe case.||

Case No. 157 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name ASMEE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00002687AM23
RA File Number 03AX04002781 AM23
Licence No and<br>Date 0311017314/18/08/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply.<br>Hence, the Committee decided torejectthe case.
Case No. 158 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00002742AM23
RA File Number 34AX04000462 AM23
Licence No and 3411002662/23/08/2022

87

UDIN00233900AM24

Date

Norms Committee Decision:

The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence, the Committee decided to reject the case.

Case No. 159 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00002838AM23
RA File Number 34AX04000490 AM23
Licence No and<br>Date 3411002712/29/08/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.
Case No. 160 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name SRF LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00003157AM23
RA File Number 05AX04001704 AM23
Licence No and<br>Date 0511014859/16/09/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case..

Committee Decision:|| |The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.|| |Hence, the Committee decided torejectthe case..||

Case No. 161 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name INDO AMINES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00003360AM23
RA File Number 03AX04003351 AM23
Licence No and<br>Date 0311018148/25/09/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.

88

UDIN00233900AM24

Hence, the Committee decided to reject the case.

Case No. 162 / NC/3/MEET/Jul/202324/9
Case Status Case Approved
Party Name ZENITH DYEINTERMEDIATES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM REVIW00007108AM23
RA File Number 03AX04003199 AM23
Licence No and<br>Date 0311018319/03/10/2022
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. 5/82-ALC4/2019dated02/08/2019against advance authorizationNo. 0310828945dated10/05/2019, it was
decided to fix ad-hoc norms under Para 4.07 of HBP Vol.

|||| |in meetingNo. 5/82-ALC4/2019dated02/08/2019against advance authorizationNo.||||0310828945dated10/05/2019, 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.|| |NAS-5((2-Diazo -1-Napthol-5-Sulfonic Acid, Sodium Salt))||1 kg.|1||Tobias Acid|1.618 kg.|| ||||||(Purity 97%)||| |RA concerned may take further necessary action as per above decision of NC.||||||||

Case No. 163 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name SHREE MAHADEV INTERMEDIATE
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00003525AM23
RA File Number 34AX04000640 AM23
Licence No and<br>Date 3411002862/04/10/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply.
Hence, the Committee decided torejectthe case.
Case No. 164 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name NAVIN FLUORINE INTERNATIONAL LIMITED

89

UDIN00233900AM24

mittee decided torejectthe case.||

Case No. 164 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name NAVIN FLUORINE INTERNATIONAL LIMITED

89

UDIN00233900AM24

Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00003558AM23
RA File Number 03AX04003496 AM23
Licence No and<br>Date 0311018391/06/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case
Case No. 165 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name NAVIN FLUORINE ADVANCED SCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00003759AM23
RA File Number 03AX04003669 AM23
Licence No and<br>Date 0311018602/16/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.

Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.||

Case No. 166 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name MISTAIR HEALTH AND HYGIENE PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00003866AM23
RA File Number 03AX04003730 AM23
Licence No and<br>Date 0311018761/21/10/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case.
Case No. 167 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name SRF LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00003982AM23
RA File Number 05AX04002096 AM23

90

UDIN00233900AM24

Licence No and 0511015534/31/10/2022 Date Norms Committee Decision: The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply. Hence, the Committee decided to reject the case.

e Norms Committee Decision: The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply. Hence, the Committee decided to reject the case.

Case No. 168 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name SHIVA BIO CHEM INDUSTRIES
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00004047AM23
RA File Number 50AX04000064 AM23
Licence No and<br>Date 5011000667/03/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call the firm for attending Personal Hearing<br>before Norms Committee to explain its case with the following information/documents:<br>COA of import and export item indicating percentage purity.<br>i.<br>If any, By-Product obtained, please furnish details of quantity and value of such By-Product.<br>ii.<br>End use of Export Product.<br>iii.<br>We may call sample shipping bills from the firm and call the comments of TE.<br>iv.

h details of quantity and value of such By-Product.**<br>ii.<br>End use of Export Product.<br>iii.<br>We may call sample shipping bills from the firm and call the comments of TE.<br>iv.|||

Case No. 169 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name SALICYLATES & CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00004216AM23
RA File Number 09AX04000689 AM23
Licence No and<br>Date 0911003913/09/11/2022
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply.<br>Hence, the Committee decided torejectthe case.
Case No. 170 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name SRF LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023

91

UDIN00233900AM24

HQ File Number HQRNORM APPLY 00004249AM23
RA File Number 05AX04002217 AM23
Licence No and<br>Date 0511015715/09/11/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply.
Hence, the Committee decided torejectthe case

s Committee Decision:|| |The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply.|| |Hence, the Committee decided torejectthe case||

Case No. 171 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name ASTEC LIFESCIENCES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00004440AM23
RA File Number 03AX04004060 AM23
Licence No and<br>Date 0311019325/18/11/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply.
Hence, the Committee decided torejectthe case
Case No. 172 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name ASSOCIATED DYESTUFF PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00004521AM23
RA File Number 08AX04001207 AM23
Licence No and<br>Date 0811006504/22/11/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.
Case No. 173 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name AMI ORGANICS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00004863AM23
RA File Number 52AX04001711 AM23
Licence No and<br>Date 5211003710/07/12/2022

92

UDIN00233900AM24

Norms Committee Decision:

The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply. Hence, the Committee decided to reject the case

Case No. 174 / NC/3/MEET/Jul/202324/9
Case Status Case Deferred
Party Name MANKIND PHARMA LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00004891AM23
RA File Number 05AX04002651 AM23
Licence No and<br>Date 0511016260/08/12/2022
Norms Committee Decision:
We may call sample shipping bills from the firm and call the comments of TE.
Case No. 175 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name LAVINIA LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00005002AM23
RA File Number 03AX04004301 AM23
Licence No and<br>Date 0311020004/15/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case

s Committee Decision:|| |The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.|| |Hence, the Committee decided torejectthe case||

Case No. 176 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name SHREE GANESH REMEDIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00005087AM23
RA File Number 34AX04000836 AM23
Licence No and<br>Date 3411003129/19/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.

93

UDIN00233900AM24

Case No. 177 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00005141AM23
RA File Number 34AX04000846 AM23
Licence No and<br>Date 3411003139/20/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.

Committee Decision:|| |The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.|| |Hence, the Committee decided torejectthe case.||

Case No. 178 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00005250AM23
RA File Number 05AX04002812 AM23
Licence No and<br>Date 0511016521/23/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.
Case No.<br>179 / NC/3/MEET/Jul/202324/9 Case No.<br>179 / NC/3/MEET/Jul/202324/9
Case Status<br>Case Approved
Party Name<br>LYRUS LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number<br>HQRNORM APPLY 00005325AM23
RA File Number<br>07AX04001423 AM23
Licence No and<br>Date<br>0711006029/27/12/2022
Norms Committee Decision:
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.
LISINOPRIL<br>DIHYDRATE<br>2.5MG <br>285714.0 Units 1 Lisinopril Dihydrate Ph.Eur 728.57 gm
TABLETS

e firm, whichever is less:-||||||| |Export Product|Qty.|Sl. No.|Import Items||Qty.|| |LISINOPRIL<br>DIHYDRATE<br>2.5MG|<br>285714.0 Units|1|Lisinopril Dihydrate Ph.Eur||728.57 gm|| |TABLETS|||||||

Case No.<br>179 / NC/3/MEET/Jul/202324/9 Case No.<br>179 / NC/3/MEET/Jul/202324/9
Case Status<br>Case Approved
Party Name<br>LYRUS LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number<br>HQRNORM APPLY 00005325AM23
RA File Number<br>07AX04001423 AM23
Licence No and<br>Date<br>0711006029/27/12/2022
Norms Committee Decision:
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.
LISINOPRIL<br>DIHYDRATE<br>2.5MG <br>285714.0 Units 1 Lisinopril Dihydrate Ph.Eur 728.57 gm
TABLETS

94

UDIN00233900AM24

||||||| |Export Product|Qty.|Sl. No.|Import Items||Qty.|| |LISINOPRIL<br>DIHYDRATE<br>2.5MG|<br>285714.0 Units|1|Lisinopril Dihydrate Ph.Eur||728.57 gm|| |TABLETS|||||||

94

UDIN00233900AM24

LISINOPRIL<br>DIHYDRATE<br>5.0<br>MG<br>TABLETS<br>42857.0 Units<br>2<br>Lisinopril Dihydrate Ph.Eur<br>2185.712 gm<br>LISINOPRIL<br>DIHYDRATE<br>10.0<br>MG<br>TABLETS<br>214285.0 Units<br>3<br>Lisinopril Dihydrate Ph.Eur<br>2185.707 gm<br>LISINOPRIL<br>DIHYDRATE<br>20.0<br>MG<br>TABLETS<br>285714.0 Units<br>4<br>Lisinopril Dihydrate Ph.Eur<br>5828.566 gm<br>RA concerned may take further necessary action as per above decision of NC. LISINOPRIL<br>DIHYDRATE<br>5.0<br>MG<br>TABLETS <br>42857.0 Units 2 Lisinopril Dihydrate Ph.Eur 2185.712 gm
LISINOPRIL<br>DIHYDRATE<br>10.0<br>MG<br>TABLETS <br>214285.0 Units 3 Lisinopril Dihydrate Ph.Eur 2185.707 gm
LISINOPRIL<br>DIHYDRATE<br>20.0<br>MG<br>TABLETS <br>285714.0 Units 4 Lisinopril Dihydrate Ph.Eur 5828.566 gm
Case No. 180 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00005430AM23
RA File Number 03AX04004553 AM23
Licence No and<br>Date 0311020346/30/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.

Committee Decision:|| |The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.|| |Hence, the Committee decided torejectthe case.||

Case No. 181 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00005431AM23
RA File Number 03AX04004543 AM23
Licence No and<br>Date 0311020347/30/12/2022
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.
Hence, the Committee decided torejectthe case.
Case No. 182 / NC/3/MEET/Jul/202324/9
Case Status Case Rejected
Party Name ZEOLITES AND ALLIED PRODUCTS PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Jul/ 202324/ 9 and 28/07/2023
HQ File Number HQRNORM APPLY 00005510AM23

95

UDIN00233900AM24

RA File Number 03AX04004898 AM23
Licence No and<br>Date 0311020475/04/01/2023
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm has still not furnished its reply.<br>Hence, the Committee decided torejectthe case

96

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