IN FORCE Advance Authorisation

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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/Nov/202425/10 DATED: 22/11/2024

Please Note

I. For information of exporters, Norms Committee - III handles all cases pertaining to fixation/ratification of norms for Export Products falling under ITC (HS) Chapter 29, 30 .Communications in respect of cases/pertaining to NC- III may be sent to email address: nc3.dgft@nic.in
II. The Norms Committee has taken decision only with respect to technical aspect/wastage norms. While redeeming the applications, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure including those in Policy Circulars issued from time to time or any other provisions under FTP/HBP for EODC.
III. Wherever the Committee has fixed Norms, the concerned RA may ensure that AA is issued on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less.
IV. RAs shall ensure compliance of SION, General Notes and Chapter Notes wherever applicable.
V. RAs shall also ensure that authorisation is issued or redeemed based on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less. In this regard full compliance of the provisions of Para 4.12 of FTP, Para 4.16; Para 4.21; and Pra 4.51 of HBP shall be made.

tee or as per wastages claimed in the application, whichever is less. In this regard full compliance of the provisions of Para 4.12 of FTP, Para 4.16; Para 4.21; and Pra 4.51 of HBP shall be made.

Meeting No. NC/3/MEET/Nov/202425/10 dated 22/11/2024 of Norms Committee - III for the year 2024-25 was held on 22/11/2024 under the Chairmanship of Shri Rakesh Kumar,Additional DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2023.

The following members were present in the meeting:-

S.No.	Name and Designation of Representatives	Department
1	Shri Rakesh Kumar, Addl. DGFT	DGFT(HQ)

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2	Shri Raman Kumar,Deputy DGFT	DGFT(HQ)
3	Shri Dinesh Narain Mathur, Technical Expert	Consultant (Pharma)
4	Shri Shaish Kumar, Technical Expert	Consultant (Chemical)
5	Shri Nand Lal, Technical Expert	Consultant (Chemical)
6	Shri Uttam Dey Sarkar, ASO	DGFT (HQ)

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Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	ADSILA ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00002270AM25
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>Decision:The committee considered the request of firm for review/fixation of ad-hoc norms and as per<br>the advice of the TE, it was decided to call for following information/documents from the firm:-<br>DML for 718 mg. Fish Oil Capsule.

Case No.	2 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	TROIKAA PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00002512AM25
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Copy of DML showing approved composition of export item.<br>1.<br>Master-Batch Formula shoing net content of all inputs.<br>2.<br>Export quantity in numbers of injections.<br>3.

Case No.	3 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	VINDHYA ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00002820AM25

|---| |Case Status|Case Deferred| |Party Name|VINDHYA ORGANICS PRIVATE LIMITED| |Meeting Number and Date|NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024| |HQ File Number|HQRNORM APPLY 00002820AM25|

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RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Complete technical details as per Annexure to Appendix-4.

Case No.	Case No.	4 / NC/3/MEET/Nov/202425/10	4 / NC/3/MEET/Nov/202425/10	4 / NC/3/MEET/Nov/202425/10	4 / NC/3/MEET/Nov/202425/10	4 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		ZYDUS LIFESCIENCES LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00003140AM25
RA File Number		NA
Licence No and Date		NA
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 AZITHROMYCIN DIHYDRATE USP 330.12 mg. AZITHROMYCIN ORAL SUSPENSION USP 100MG/5ML (300MG/15ML BOTTLE) ((ACTIVE INGREDIENT: AZITHROMYCIN DIHYDRATE USP EQUIVALENT TO AZITHROMYCIN USP - NET WT. 132.597 KGS)) 1 Number 2 SUCROSE NF FINE GRADE (COMPRESSUC PS) 11616.00 mg. 3 AZITHROMYCIN DIHYDRATE USP 660.24 mg. AZITHROMYCIN ORAL SUSPENSION USP 200MG/5ML (600MG/15ML BOTTLE) ((ACTIVE INGREDIENT: AZITHROMYCIN DIHYDRATE USP EQUIVALENT TO 1 Number 4 SUCROSE NF FINE GRADE (COMPRESSUC PS) 11616.00 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||AZITHROMYCIN ORAL SUSPENSION USP 100MG/5ML (300MG/15ML BOTTLE) ((ACTIVE INGREDIENT: AZITHROMYCIN DIHYDRATE USP EQUIVALENT TO AZITHROMYCIN USP - NET WT. 132.597 KGS))||1 Number|1|AZITHROMYCIN DIHYDRATE USP|330.12 mg.| |||||2|SUCROSE NF FINE GRADE (COMPRESSUC PS)|11616.00 mg.| ||AZITHROMYCIN ORAL SUSPENSION USP 200MG/5ML (600MG/15ML BOTTLE) ((ACTIVE INGREDIENT: AZITHROMYCIN DIHYDRATE USP EQUIVALENT TO||1 Number|3|AZITHROMYCIN DIHYDRATE USP|660.24 mg.| |||||4|SUCROSE NF FINE GRADE (COMPRESSUC PS)|11616.00 mg.|

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USP|660.24 mg.| |||||4|SUCROSE NF FINE GRADE (COMPRESSUC PS)|11616.00 mg.|

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AZITHROMYCIN USP - NET<br>WT. 530.382 KGS))
AZITHROMYCIN ORAL<br>SUSPENSION USP 200MG/5ML<br>(900MG/22.5ML BOTTLE)<br>((ACTIVE INGREDIENT:<br>AZITHROMYCIN DIHYDRATE<br>USP<br>EQUIVALENT<br>TO<br>AZITHROMYCIN USP - NET<br>WT. 278.973 KGS))	1 Number	5	AZITHROMYCIN<br>DIHYDRATE USP	990.36 mg.
		6	SUCROSE NF FINE GRADE<br>(COMPRESSUC PS)	17424.00 mg.
AZITHROMYCIN ORAL<br>SUSPENSION USP 200MG/5ML<br>(1200MG/30ML BOTTLE)<br>((ACTIVE INGREDIENT:<br>AZITHROMYCIN DIHYDRATE<br>USP<br>EQUIVALENT<br>TO<br>AZITHROMYCIN USP - NET<br>WT.

PS)|17424.00 mg.| ||AZITHROMYCIN ORAL SUSPENSION USP 200MG/5ML (1200MG/30ML BOTTLE) ((ACTIVE INGREDIENT: AZITHROMYCIN DIHYDRATE USP EQUIVALENT TO AZITHROMYCIN USP - NET WT. 2174.778 KGS))|1 Number|7|AZITHROMYCIN DIHYDRATE USP|1320.48 mg.| ||||8|SUCROSE NF FINE GRADE (COMPRESSUC PS)|23232.00 mg.|

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

Case No.	5 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00003176AM25
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>Decision:The committee considered the case as per agenda and it was decided to fix ad-hoc<br>norms as perSION A-1294.

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Case No.	6 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	KEVA FRAGRANCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	018205000499AM20
RA File Number	039404000373 AM20
Licence No and<br>Date	0310830887/07/08/2019
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

umber|039404000373 AM20| |Licence No and Date|0310830887/07/08/2019| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	7 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	HIKAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00004443AM23
RA File Number	34AX04000759 AM23
Licence No and<br>Date	3411003012/18/11/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it has been observed that the firm has still<br>not furnished the following documents/information as sought by the committee in its meeting held on<br>24/03.2023. Therefore, it was decided to give last change to the firm to furnish the said<br>documents/information:-<br>Comploete chemical reactions and molecular weights along with sgtage wise percentage yields<br>on molar basis.<br>i.<br>Requirement and recovery of solvent at each step.<br>ii.

i. Comploete chemical reactions and molecular weights along with sgtage wise percentage yields on molar basis.

Case No.	8 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED

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25/10| |---|---| |Case Status|Case Approved| |Party Name|MANKIND PHARMA LIMITED|

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Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00004891AM23
RA File Number	05AX04002651 AM23
Licence No and<br>Date	0511016260/08/12/2022
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Jan/202324/20 dated 18/01/2024against<br>advance authorizationNo. 0511018497 dated 25/04/2023, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Ofloxacin Otic Solution, 5ml<br>(Having net content of 6.63 kg of<br>Bulk Drug)<br>1 Number<br>1<br>OFLOXACIN USP<br>15.30 mg.<br>Ofloxacin Otic Solution, 10ml<br>(Having net content of 6.63 kg of<br>Bulk Drug)<br>1 Number<br>2<br>OFLOXACIN USP<br>30.60 mg.<br>Ofloxacin Ophthalmic Solution,<br>USP, 5ml (Having net content of<br>9.69 kg of Bulk Drug)<br>1 Number<br>3<br>OFLOXACIN USP<br>15.30 mg.<br>RA concerned may take further necessary action as per above decision of NC.

olution, USP, 5ml (Having net content of 9.69 kg of Bulk Drug) 1 Number 3 OFLOXACIN USP 15.30 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	9 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	DELTA FINOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00004995AM23
RA File Number	03AX04004505 AM23
Licence No and<br>Date	0311019991/15/12/2022

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Norms Committee Decision:

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

To give balance chemical reaction indicating molecular weight of both reactants and products.
To give the correct formula of 2 Amino Pyridine and accordingly, to correct the chemical reaction at B1 and 2 of Technical details.

Current production consumption data duly certified by Chartered Accountant.

Case No.	10 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	MEGHMANI INDUSTRIES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00005857AM23
RA File Number	08AX04001681 AM23
Licence No and Date	0811007072/21/01/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.<br>1<br>Dichloropinacoline<br>1.0 kg.<br>1,2,4 TRIAZINONE<br>1 kg.<br>2<br>Thiocarbahydrazide<br>0.569 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	11 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED

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ecessary action as per above decision of NC.||

Case No.	11 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED

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Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00005897AM23
RA File Number	34AX04000965 AM23
Licence No and<br>Date	3411003278/24/01/2023
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Copy of Master-Batch Formula showing net content of all inputs in the export product.

Case No.	12 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	SANJIVANI PHARMA
Meeting Number and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00005920AM23
RA File Number	34AX04000896 AM23
Licence No and Date	3411003302/25/01/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>METHYL COBALAMINE<br>1 kg.<br>1<br>CYNOCOBALAMINE<br>0.869 kg.<br>RA concerned may take further necessary action as per above decision of NC.

l. No.** Import Items Qty. allowed. METHYL COBALAMINE 1 kg. 1 CYNOCOBALAMINE 0.869 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	13 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	AUROBINDO PHARMA LTD
Meeting Number	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024

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and Date	and Date
HQ File Number		HQRNORM APPLY 00005943AM23
RA File Number		09AX04000960 AM23
Licence No and<br>Date		0911004371/27/01/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Jan/202324/20 dated 18/01/2024against<br>advance authorizationNo. 0911003411 dated 27/07/2022, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 6-Amino Penicillanic Acid (6-APA) 0.5139 kg. 2 Carbon Enoanticromos (Activated Carbon) 0.063 kg. 3 D(-) Alpha Phenyl Glycine Base (PG Base) 0.4015 kg. 4 lsopropyl Alcohol (IPA) 0.320 kg. 5 Methanol (Methyl Alcohol) 0.778 kg. 6 Methylene Chloride 2.810 kg. 7 Pivaloyl Chloride 0.3058 kg. 8 Potassium Carbonate (Anhydrous) 0.1838 kg. 9 4-Ethyl-2, 3 Dioxo Piperazine (EDP) 0.4113 kg. 10 Trimethyl Chlorosilane 0.3778 kg. Piperacillin Hydrate 1 kg. 11 Triphosgene 0.3154 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Piperacillin Hydrate||1 kg.|1|6-Amino Penicillanic Acid (6-APA)|0.5139 kg.| |||||2|Carbon Enoanticromos (Activated Carbon)|0.063 kg.| |||||3|D(-) Alpha Phenyl Glycine Base (PG Base)|0.4015 kg.| |||||4|lsopropyl Alcohol (IPA)|0.320 kg.| |||||5|Methanol (Methyl Alcohol)|0.778 kg.| |||||6|Methylene Chloride|2.810 kg.| |||||7|Pivaloyl Chloride|0.3058 kg.| |||||8|Potassium Carbonate (Anhydrous)|0.1838 kg.| |||||9|4-Ethyl-2, 3 Dioxo Piperazine (EDP)|0.4113 kg.| |||||10|Trimethyl Chlorosilane|0.3778 kg.| |||||11|Triphosgene|0.3154 kg.|

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assium Carbonate (Anhydrous)|0.1838 kg.| |||||9|4-Ethyl-2, 3 Dioxo Piperazine (EDP)|0.4113 kg.| |||||10|Trimethyl Chlorosilane|0.3778 kg.| |||||11|Triphosgene|0.3154 kg.|

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Case No.	Case No.	14 / NC/3/MEET/Nov/202425/10	14 / NC/3/MEET/Nov/202425/10	14 / NC/3/MEET/Nov/202425/10	14 / NC/3/MEET/Nov/202425/10	14 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		INTAS PHARMACEUTICALS LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00005991AM23
RA File Number		08AX04001832 AM23
Licence No and Date		0811007126/31/01/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>ALENDRONATE SODIUM<br>TABLETS 5 MG(EACH<br>UNCOATED TABLET<br>CONTAINS: ALENDRONATE<br>SODIUM TRIHYDRATE EP<br>6.53 MG EQ. TO ALENDRONIC<br>ACID 5 MG)<br>1<br>Number<br>Tablet<br>1<br>ALENDRONATE SODIUM<br>TRIHYDRATE EP / BP / IP<br>/ USP / PH. EUR.<br>6.661 mg.<br>ALENDRONATE SODIUM<br>TABLETS 10 MG(EACH<br>UNCOATED TABLET<br>CONTAINS: ALENDRONATE<br>SODIUM TRIHYDRATE EP<br>13.05 MG EQ. TO<br>ALENDRONIC ACID 10 MG)<br>1 Number<br>Tablet<br>2<br>ALENDRONATE SODIUM<br>TRIHYDRATE EP / BP / IP<br>/ USP / PH.

NCOATED TABLET CONTAINS: ALENDRONATE SODIUM TRIHYDRATE EP 13.05 MG EQ. TO ALENDRONIC ACID 10 MG) 1 Number Tablet 2 ALENDRONATE SODIUM TRIHYDRATE EP / BP / IP / USP / PH. EUR. 13.311 mg. ALENDRONATE SODIUM TABLETS 70 MG(EACH UNCOATED TABLET CONTAINS: ALENDRONATE SODIUM TRIHYDRATE EP 1 Number Tablet 3 ALENDRONATE SODIUM TRIHYDRATE EP / BP / IP / USP / PH. EUR. 93.197 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||ALENDRONATE SODIUM TABLETS 5 MG(EACH UNCOATED TABLET CONTAINS: ALENDRONATE SODIUM TRIHYDRATE EP 6.53 MG EQ. TO ALENDRONIC ACID 5 MG)||1 Number Tablet|1|ALENDRONATE SODIUM TRIHYDRATE EP / BP / IP / USP / PH. EUR.|6.661 mg.| ||ALENDRONATE SODIUM TABLETS 10 MG(EACH UNCOATED TABLET CONTAINS: ALENDRONATE SODIUM TRIHYDRATE EP 13.05 MG EQ. TO ALENDRONIC ACID 10 MG)||1 Number Tablet|2|ALENDRONATE SODIUM TRIHYDRATE EP / BP / IP / USP / PH. EUR.|13.311 mg.| ||ALENDRONATE SODIUM TABLETS 70 MG(EACH UNCOATED TABLET CONTAINS: ALENDRONATE SODIUM TRIHYDRATE EP||1 Number Tablet|3|ALENDRONATE SODIUM TRIHYDRATE EP / BP / IP / USP / PH. EUR.|93.197 mg.|

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91.37 MG EQ. TO ALENDRONIC ACID 70 MG [IN WHICH ACTIVE INGREDIENT ALENDRONATE SODIUM TRIHYDRATE USED IS 77.673 KGS.])

DRATE EP / BP / IP / USP / PH. EUR.|93.197 mg.|

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91.37 MG EQ. TO ALENDRONIC ACID 70 MG [IN WHICH ACTIVE INGREDIENT ALENDRONATE SODIUM TRIHYDRATE USED IS 77.673 KGS.])

Case No.	Case No.	15 / NC/3/MEET/Nov/202425/10	15 / NC/3/MEET/Nov/202425/10	15 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00005992AM23
RA File Number		05AX04003132 AM23
Licence No and<br>Date		0511017077/31/01/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo. NC/3/MEET/Jul/202425/7 dated 06/08/2024against<br>Hqr. File No. HQRNORMAPPLY00001755AM25, it was decided to fix ad-hoc norms under Para 4.07<br>of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>TIMOLOL MALEATE<br>17.94 mg.<br>Latanoprost and Timolol<br>Maleate Ophthalmic Solution<br>0.005% w/v/0.5% w/v,<br>2.5ml(Each ml contains<br>Latanoprost 0.05 mg<br>(Equivalent to 6.250 Gram of<br>Bulk Drug) and Timolol<br>Maleate 6.83 mg = Timolol 5<br>mg (Equivalent to 853.750<br>1 Number<br>2<br>LATANOPROST<br>0.1275 mg.
	Export Product		Qty.	**Sl.

valent to 6.250 Gram of Bulk Drug) and Timolol Maleate 6.83 mg = Timolol 5 mg (Equivalent to 853.750 1 Number 2 LATANOPROST 0.1275 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Latanoprost and Timolol Maleate Ophthalmic Solution 0.005% w/v/0.5% w/v, 2.5ml(Each ml contains Latanoprost 0.05 mg (Equivalent to 6.250 Gram of Bulk Drug) and Timolol Maleate 6.83 mg = Timolol 5 mg (Equivalent to 853.750||1 Number|1|TIMOLOL MALEATE|17.94 mg.| |||||2|LATANOPROST|0.1275 mg.|

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Gram of Bulk Drug))

Case No.	16 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	FDC LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00006001AM23
RA File Number	03AX04005245 AM23
Licence No and Date	0311021062/31/01/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.<br>AZELASTINE EYE DROPS 8<br>ML((NET CONTAINS<br>AZELASTINE<br>HYDROCHLODRIDE 0.5 MG<br>PER VIAL OF 8<br>ML NET WT OF BULK<br>DRUG IS 144 GRAMS))<br>1 Vial<br>1<br>AZELASTINE<br>HYDROCHLORIDE<br>0.51 mg/vial<br>RA concerned may take further necessary action as per above decision of NC.

VIAL OF 8 ML NET WT OF BULK DRUG IS 144 GRAMS)) 1 Vial 1 AZELASTINE HYDROCHLORIDE 0.51 mg/vial RA concerned may take further necessary action as per above decision of NC.||

Case No.	17 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved

UDIN00500956AM25

Party Name	FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00006022AM23
RA File Number	05AX04003065 AM23
Licence No and<br>Date	0511017109/01/02/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Jul/202324/7 dated 06/08/2024against<br>advance authorizationNo. 0511013693 dated 11/07/2022, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Ropivacaine Hydrochloride<br>Anhydrous (API)<br>1 kg<br>1<br>(S)-2',6' Pipecoloxylidide OR(S)-<br>N-(2,6-dimethy<br>phenyl-2-<br>piperidinecarboxamide)<br>0.923 kg.<br>RA concerned may take further necessary action as per above decision of NC.

kg 1 (S)-2',6' Pipecoloxylidide OR(S)- N-(2,6-dimethy phenyl-2- piperidinecarboxamide) 0.923 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	18 / NC/3/MEET/Nov/202425/10	18 / NC/3/MEET/Nov/202425/10	18 / NC/3/MEET/Nov/202425/10	18 / NC/3/MEET/Nov/202425/10	18 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		CLAROID PHARMACEUTICALS PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00006027AM23
RA File Number		08AX04001720 AM23
Licence No and Date		0811007147/01/02/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items<br>	Qty. allowed.

UDIN00500956AM25

ERYTHROMYCIN 500 MG	1 Number	1	ERYTHROMYCINSTEARATE	706 mg/Tablet
(85,00,000 TABLETS)
(ERYTHROMYCIN
STEARATE 706 MG IS
EQUILENT TO
ERYTHROMYCIN 500 MG)

Note:

NC also decided to revise the SION A-222 for above products based on revised ad-hoc norms. 2. For other variation of export item, norms may be worked-out on pro-rata basis.

Case No.	Case No.	19 / NC/3/MEET/Nov/202425/10	19 / NC/3/MEET/Nov/202425/10	19 / NC/3/MEET/Nov/202425/10	19 / NC/3/MEET/Nov/202425/10	19 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		CONNEX PHARMA PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00001735AM24
RA File Number		26AX04000033 AM24
Licence No and Date		2611000980/16/06/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>METHYL<br>CHLOROFORMATE<br>0.885 kg.<br>CHLOROMETHYL<br>ISOPROPYL<br>CARBONATE<br>1 kg.<br>2<br>ISOPROPYL ALCOHOL<br>0.492 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	CHLOROMETHYL<br>ISOPROPYL<br>CARBONATE		1 kg.	1	METHYL<br>CHLOROFORMATE	0.885 kg.
				2	ISOPROPYL ALCOHOL	0.492 kg.

Export Product**||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||CHLOROMETHYL ISOPROPYL CARBONATE||1 kg.|1|METHYL CHLOROFORMATE|0.885 kg.| |||||2|ISOPROPYL ALCOHOL|0.492 kg.|

Case No.	Case No.	19 / NC/3/MEET/Nov/202425/10	19 / NC/3/MEET/Nov/202425/10	19 / NC/3/MEET/Nov/202425/10	19 / NC/3/MEET/Nov/202425/10	19 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		CONNEX PHARMA PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00001735AM24
RA File Number		26AX04000033 AM24
Licence No and Date		2611000980/16/06/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>METHYL<br>CHLOROFORMATE<br>0.885 kg.<br>CHLOROMETHYL<br>ISOPROPYL<br>CARBONATE<br>1 kg.<br>2<br>ISOPROPYL ALCOHOL<br>0.492 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	CHLOROMETHYL<br>ISOPROPYL<br>CARBONATE		1 kg.	1	METHYL<br>CHLOROFORMATE	0.885 kg.
				2	ISOPROPYL ALCOHOL	0.492 kg.

UDIN00500956AM25

|**Sl. No. **|Import Items|Qty. allowed.| ||CHLOROMETHYL ISOPROPYL CARBONATE||1 kg.|1|METHYL CHLOROFORMATE|0.885 kg.| |||||2|ISOPROPYL ALCOHOL|0.492 kg.|

UDIN00500956AM25

Case No.	20 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	KAVALIFE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00005806AM24
RA File Number	07AX04000908 AM24
Licence No and<br>Date	0711009260/21/09/2023
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.<br>Natural Caffeine Anhydrous<br>(NLT 98.5%)<br>1 kg.<br>1<br>Natural Caffeine Powder<br>98.5%<br>1.0 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	21 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	AKUMS DRUGS AND PHARMACEUTICALS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00006789AM24
RA File Number	05AX04002288 AM24
Licence No and Date	0511022010/09/11/2023

UDIN00500956AM25

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. allowed.
UTERONE 200 (Progesterone<br>BP 200 mg)(Each soft gelatin<br>capsule contains Progesterone<br>BP 200 mg<br>( Naturally Micronized )<br>Excipients ( Methylparaben<br>BP & Propylparaben BP used<br>as preservative))	1 Number	1	PROGESTERONE<br>MICRONISED<br>(STANDARD:BP)	204 mg.
PROSTAR 200 (Progesterone<br>BP 200 mg )	1 Number	2	PROGESTERONE<br>MICRONISED<br>(STANDARD:BP)	204 mg.

Case No.	22 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008450AM24
RA File Number	03AX04005000 AM24
Licence No and Date	0311030997/09/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

UDIN00500956AM25

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:-||

UDIN00500956AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Hexoral Tabs Express/<br>Hexoraletten N Lozenges Sugar<br>Free. Each Lozenge contains (i)<br>Chlorhexidine Dihydrochloride<br>- 5<br>mg((ii) Benzocaine - 1.50 mg<br>(iii) Isomalt - 2289.65 mg.	1 Number	1	Chlorhexidine<br>Dihydrochloride	5.1 mg.
		2	Benzocaine	1.53 mg.
		3	Isomalt	2289.65 mg

ine Dihydrochloride - 5 mg((ii) Benzocaine - 1.50 mg (iii) Isomalt - 2289.65 mg.|1 Number|1|Chlorhexidine Dihydrochloride|5.1 mg.| ||||2|Benzocaine|1.53 mg.| ||||3|Isomalt|2289.65 mg|

Case No.	Case No.	23 / NC/3/MEET/Nov/202425/10	23 / NC/3/MEET/Nov/202425/10	23 / NC/3/MEET/Nov/202425/10	23 / NC/3/MEET/Nov/202425/10	23 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		JUBILANT INGREVIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00008464AM24
RA File Number		05AX04003559 AM24
Licence No and<br>Date		0511023876/09/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Apr/202425/1 dated 10/04/2024against<br>advance authorizationNo.0311008815 dated 24/11/2021, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>2-Hydroxy Ethyl<br>Methacrylate<br>0.640 kg.<br>2-Acetoacetoxy<br>Ethyl<br>Methacrylate<br>1 kg.<br>2<br>Glacial Acetic Acid<br>0.755 kg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	2-Acetoacetoxy<br>Ethyl<br>Methacrylate		1 kg.	1	2-Hydroxy Ethyl<br>Methacrylate	0.640 kg.
				2	Glacial Acetic Acid	0.755 kg.

||Qty.|Sl. No.|Import Items|Qty. allowed.| ||2-Acetoacetoxy Ethyl Methacrylate||1 kg.|1|2-Hydroxy Ethyl Methacrylate|0.640 kg.| |||||2|Glacial Acetic Acid|0.755 kg.|

UDIN00500956AM25

Case No.	24 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	ELPPE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008471AM24
RA File Number	03AX04004959 AM24
Licence No and<br>Date	0311031032/09/02/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Chemical name of IE AT32P & PYRIDOXAL 5 FOSFAT and to enclose catalogue and to<br>indicate calculation of requirement the chemicals.<br>1.<br>To indicate indigenous item in Appendix-4E, to use in the process.<br>2.<br>The commercial value of by-product Acetone supported by Invoices.<br>3.<br>End use of export item and percentage yield of the reaction with justification, giving<br>stoichiometic material balance on molar basis.<br>4.

t Acetone supported by Invoices.** 3. End use of export item and percentage yield of the reaction with justification, giving stoichiometic material balance on molar basis. 4.||

Case No.	25 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	SMILAX LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008518AM24
RA File Number	09AX04000984 AM24
Licence No and<br>Date	0911006732/12/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

19 This document has been digitally signed by Raman Kumar, Deputy DGFT on 17-12-2024 16:53:22.

UDIN00500956AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Norfloxacin	1 kg.	1	3-Chloro-4-Fluoroaniline	0.95 kg.
		2	Diethyl Ethoxy Methylene Malonate	1.41 kg.
		3	Toluene	2.96 kg.
		4	Methanol	3.53 kg.
		5	Piperazine Anhydrous	0.665 kg.

| ||Norfloxacin|1 kg.|1|3-Chloro-4-Fluoroaniline|0.95 kg.| ||||2|Diethyl Ethoxy Methylene Malonate|1.41 kg.| ||||3|Toluene|2.96 kg.| ||||4|Methanol|3.53 kg.| ||||5|Piperazine Anhydrous|0.665 kg.|

Case No.	26 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	CATION PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008519AM24
RA File Number	52AX04000341 AM24
Licence No and<br>Date	5211007357/12/02/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Complete chemistry, Molecular weight and percentage yield on molar basis.

Case No.	27 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	ATUL LIMITED
Meeting Number	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024

UDIN00500956AM25

and Date
HQ File Number	HQRNORM APPLY 00008531AM24
RA File Number	08AX04002041 AM24
Licence No and<br>Date	0811010749/13/02/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Chemical reaction indicating molecular weight of reactants and products indicating yield of the<br>reaction with justification.<br>1.<br>2.End use of the Export Item.

m the firm:- Chemical reaction indicating molecular weight of reactants and products indicating yield of the reaction with justification. 1. 2.End use of the Export Item.||

Case No.	Case No.	28 / NC/3/MEET/Nov/202425/10	28 / NC/3/MEET/Nov/202425/10	28 / NC/3/MEET/Nov/202425/10	28 / NC/3/MEET/Nov/202425/10	28 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		MANKIND PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00008554AM24
RA File Number		05AX04003657 AM24
Licence No and<br>Date		0511023947/13/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Jan/202324/20 dated 18/01/2024against<br>advance authorizationNo.0511018497 dated 25/04/2023, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Ofloxacin Otic Solution, 5ml (Having net content of 29.35 kg of Bulk Drug (filling volume 5.4 ml in each number)) 1 Number 1 OFLOXACIN USP 15.30 mg. Ofloxacin Otic Solution, 10ml (Having net content of 24.46 kg of Bulk Drug (filling volume 10.65 ml in each Number) 1 Number 2 OFLOXACIN USP 30.60 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||Ofloxacin Otic Solution, 5ml (Having net content of 29.35 kg of Bulk Drug (filling volume 5.4 ml in each number))||1 Number|1|OFLOXACIN USP|15.30 mg.| ||Ofloxacin Otic Solution, 10ml (Having net content of 24.46 kg of Bulk Drug (filling volume 10.65 ml in each Number)||1 Number|2|OFLOXACIN USP|30.60 mg.|

UDIN00500956AM25

15.30 mg.| ||Ofloxacin Otic Solution, 10ml (Having net content of 24.46 kg of Bulk Drug (filling volume 10.65 ml in each Number)||1 Number|2|OFLOXACIN USP|30.60 mg.|

UDIN00500956AM25

Ofloxacin Ophthalmic Solution, USP, 5ml<br>(Having net content of 61.68 kg of Bulk<br>Drug (filling volume 5.4 ml in<br>each number))<br>1 Number<br>3<br>OFLOXACIN USP<br>15.30 mg.<br>Ofloxacin Ophthalmic Solution, USP,<br>10ml (Having net content of 7.16 kg of<br>Bulk Drug (filling volume 10.65 ml in<br>each number))<br>1 Number<br>4<br>OFLOXACIN USP<br>30.60 mg.<br>RA concerned may take further necessary action as per above decision of NC.	Ofloxacin Ophthalmic Solution, USP, 5ml<br>(Having net content of 61.68 kg of Bulk<br>Drug (filling volume 5.4 ml in<br>each number))	1 Number	3	OFLOXACIN USP	15.30 mg.
	Ofloxacin Ophthalmic Solution, USP,<br>10ml (Having net content of 7.16 kg of<br>Bulk Drug (filling volume 10.65 ml in<br>each number))	1 Number	4	OFLOXACIN USP	30.60 mg.

|---|---|---|---|---| ||Ofloxacin Ophthalmic Solution, USP, 10ml (Having net content of 7.16 kg of Bulk Drug (filling volume 10.65 ml in each number))|1 Number|4|OFLOXACIN USP|30.60 mg.|

Case No.	Case No.	29 / NC/3/MEET/Nov/202425/10	29 / NC/3/MEET/Nov/202425/10	29 / NC/3/MEET/Nov/202425/10	29 / NC/3/MEET/Nov/202425/10	29 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		FDC LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00008564AM24
RA File Number		03AX04005181 AM24
Licence No and Date		0311031166/14/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>CHLORAMPHENICOL<br>(VANMYCETIN) EYE DROPS<br>10 ML (CLORAH EYE DROPS<br>10 ML AND OPTIPHEN<br>OPHTHALMIC SOLUTIONS 5<br>mg/ml 10ML )((EACH VIAL<br>CONTAINS<br>CHLORAMPHENICOL<br>MICRONIZED 0.050 GM NET<br>297000<br>Vials<br>1<br>CHLORAMPHENICOL<br>MICRONIZED<br>15.145 kg.
	Export Product		Qty.	Sl. No.	Import Items	**Qty.

CONTAINS CHLORAMPHENICOL MICRONIZED 0.050 GM NET 297000 Vials 1 CHLORAMPHENICOL MICRONIZED 15.145 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||CHLORAMPHENICOL (VANMYCETIN) EYE DROPS 10 ML (CLORAH EYE DROPS 10 ML AND OPTIPHEN OPHTHALMIC SOLUTIONS 5 mg/ml 10ML )((EACH VIAL CONTAINS CHLORAMPHENICOL MICRONIZED 0.050 GM NET||297000 Vials|1|CHLORAMPHENICOL MICRONIZED|15.145 kg.|

Case No.	Case No.	29 / NC/3/MEET/Nov/202425/10	29 / NC/3/MEET/Nov/202425/10	29 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		FDC LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00008564AM24
RA File Number		03AX04005181 AM24
Licence No and Date		0311031166/14/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>CHLORAMPHENICOL<br>(VANMYCETIN) EYE DROPS<br>10 ML (CLORAH EYE DROPS<br>10 ML AND OPTIPHEN<br>OPHTHALMIC SOLUTIONS 5<br>mg/ml 10ML )((EACH VIAL<br>CONTAINS<br>CHLORAMPHENICOL<br>MICRONIZED 0.050 GM NET<br>297000<br>Vials<br>1<br>CHLORAMPHENICOL<br>MICRONIZED<br>15.145 kg.
	Export Product		Qty.	**Sl.

br>mg/ml 10ML )((EACH VIAL CONTAINS CHLORAMPHENICOL MICRONIZED 0.050 GM NET 297000 Vials 1 CHLORAMPHENICOL MICRONIZED 15.145 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||CHLORAMPHENICOL (VANMYCETIN) EYE DROPS 10 ML (CLORAH EYE DROPS 10 ML AND OPTIPHEN OPHTHALMIC SOLUTIONS 5 mg/ml 10ML )((EACH VIAL CONTAINS CHLORAMPHENICOL MICRONIZED 0.050 GM NET||297000 Vials|1|CHLORAMPHENICOL MICRONIZED|15.145 kg.|

UDIN00500956AM25

WT OF BULK DRUG IS 14.850 KGS))

Case No.	30 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008566AM24
RA File Number	05AX04003666 AM24
Licence No and<br>Date	0511023953/14/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Jun/202324/8 dated 30/06/2023against<br>advance authorizationNo.0911004779 dated 29/03/.2023, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Nitroglycerin Sublingual Tablets USP, 0.3mg 1 Number 1 DILUTED NITROGLYCERIN USP (2% W/W) 15.70 mg. Nitroglycerin Sublingual Tablets USP, 0.4mg 1 Number 2 DILUTED NITROGLYCERIN USP (2% W/W) 20.93 mg. Nitroglycerin Sublingual Tablets USP, 0.6mg 1 Number 3 DILUTED NITROGLYCERIN USP (2% W/W) 31.40 mg. RA concerned may take further necessary action as per above decision of NC.||

UDIN00500956AM25

Case No.	31 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	BASIL DRUGS AND PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008570AM24
RA File Number	03AX04005041 AM24
Licence No and<br>Date	0311031186/14/02/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Complete chemistry, molecular weight and percentage yield on molar basis for each export<br>item.<br>1.<br>Past production/consumption data duly certified by CA.<br>2.

the firm:- Complete chemistry, molecular weight and percentage yield on molar basis for each export item. 1. Past production/consumption data duly certified by CA. 2.||

Case No.	Case No.	32 / NC/3/MEET/Nov/202425/10	32 / NC/3/MEET/Nov/202425/10	32 / NC/3/MEET/Nov/202425/10	32 / NC/3/MEET/Nov/202425/10	32 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		VERGO PHARMA RESEARCH LABORATORIES PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00008616AM24
RA File Number		03AX04005267 AM24
Licence No and Date		0311031276/16/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Procyclidine 5mg Tablets<br>1 Number<br>1<br>Procyclidine<br>Hydrochloride<br>5.10 mg.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	Procyclidine 5mg Tablets		1 Number	1	Procyclidine<br>Hydrochloride	5.10 mg.

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0 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Procyclidine 5mg Tablets||1 Number|1|Procyclidine Hydrochloride|5.10 mg.|

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Case No.	Case No.	33 / NC/3/MEET/Nov/202425/10	33 / NC/3/MEET/Nov/202425/10	33 / NC/3/MEET/Nov/202425/10	33 / NC/3/MEET/Nov/202425/10	33 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		VIDACARE MEDICA PRIVATE LIMITED
Meeting Number and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00008647AM24
RA File Number		03AX04005005 AM24
Licence No and Date		0311031320/19/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>TETRACYCLLINE HCL CAPSULE<br>BP 250 MG EACH CAPSULE<br>CONTAINS:TETRACYCLLINE HCL<br>BP 250MG 400000 X 10X10 C)<br>40000000<br>Numbers<br>1<br>TETRACYCLINE HCL<br>BP/USP/EP<br>10200 kg.<br>DEVITHRO- 500 TABLETS<br>ERYTHROMYCIN STEARATE<br>TABLETS BP 500 MG EACH FILM<br>COATED TABLET CONTAINS:<br>ERYTHROMYCIN STEARATE BP<br>( 693.789 MG) EQ.

TETRACYCLINE HCL BP/USP/EP 10200 kg. DEVITHRO- 500 TABLETS ERYTHROMYCIN STEARATE TABLETS BP 500 MG EACH FILM COATED TABLET CONTAINS: ERYTHROMYCIN STEARATE BP ( 693.789 MG) EQ. TO ERYTHROMYCIN BP 500 MG 111006.24 X 10 X 10 T) 11100624 Numbers 2 ERYTHROMYCIN STEARATE BP/USP/EP 5661.31 kg. DEVITHRO- 250 TABLETS ERYTHROMYCIN STEARATE TABLETS BP 250 MG EACH FILM COATED TABLET CONTAINS : ERYTHROMYCIN STEARATE BP ( 346.89 MG) EQ. TO 9798671 Numbers 3 ERYTHROMYCIN STEARATE BP/USP/EP 2498.66 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||TETRACYCLLINE HCL CAPSULE BP 250 MG EACH CAPSULE CONTAINS:TETRACYCLLINE HCL BP 250MG 400000 X 10X10 C)||40000000 Numbers|1|TETRACYCLINE HCL BP/USP/EP|10200 kg.| ||DEVITHRO- 500 TABLETS ERYTHROMYCIN STEARATE TABLETS BP 500 MG EACH FILM COATED TABLET CONTAINS: ERYTHROMYCIN STEARATE BP ( 693.789 MG) EQ. TO ERYTHROMYCIN BP 500 MG 111006.24 X 10 X 10 T)||11100624 Numbers|2|ERYTHROMYCIN STEARATE BP/USP/EP|5661.31 kg.| ||DEVITHRO- 250 TABLETS ERYTHROMYCIN STEARATE TABLETS BP 250 MG EACH FILM COATED TABLET CONTAINS : ERYTHROMYCIN STEARATE BP ( 346.89 MG) EQ. TO||9798671 Numbers|3|ERYTHROMYCIN STEARATE BP/USP/EP|2498.66 kg.|

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ERYTHROMYCIN BP 250 MG 97986.71 X 10 X 10 T)

: ERYTHROMYCIN STEARATE BP ( 346.89 MG) EQ. TO||9798671 Numbers|3|ERYTHROMYCIN STEARATE BP/USP/EP|2498.66 kg.|

UDIN00500956AM25

ERYTHROMYCIN BP 250 MG 97986.71 X 10 X 10 T)

Case No.	34 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008661AM24
RA File Number	07AX04001821 AM24
Licence No and<br>Date	0711010591/21/02/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Chemical reaction indicating molecular weight of reactants and products, giving yield of the<br>reaction with justification.<br>1.<br>End use of the export item.<br>2.<br>A copy of minutes of meeting, if the norms have been approved for the item, in the past.<br>3.

Case No.	35 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008671AM24
RA File Number	07AX04001818 AM24
Licence No and<br>Date	0711010595/21/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

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

UDIN00500956AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
MAGNESIUM OROTATE	1 MT	1	OROTIC ACID (Monohydrate)	0.990 MT
CALCIUM OROTATE	1 MT	2	OROTIC ACID (Monohydrate)	0.948 MT
POTASSIUM OROTATE	1 MT	3	OROTIC ACID (Monohydrate)	0.944 MT
ZINC OROTATE	1 MT	4	OROTIC ACID (Monohydrate)	0.890 MT
FERROUS OROTATE	1 MT	5	OROTIC ACID (Monohydrate)	0.872 MT

Case No.	Case No.	36 / NC/3/MEET/Nov/202425/10	36 / NC/3/MEET/Nov/202425/10	36 / NC/3/MEET/Nov/202425/10	36 / NC/3/MEET/Nov/202425/10	36 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00008680AM24
RA File Number		08AX04002108 AM24
Licence No and<br>Date		0811010830/21/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Cupric Chloride Injection USP, 0.4 mg/mL (10 mL) 1 Number 1 Copper (II) chloride dihydrate GMP 11.77 mg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Cupric Chloride Injection USP, 0.4 mg/mL (10 mL)||1 Number|1|Copper (II) chloride dihydrate GMP|11.77 mg.|

UDIN00500956AM25

Case No.	37 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	SPAR PHARMA LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008685AM24
RA File Number	09AX04000988 AM24
Licence No and<br>Date	0911006814/21/02/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Complete chemistry, molecular weight and percentage yield on molar basis for entire process.

dvice of the TE, it was decided to call for following information/documents from the firm:- Complete chemistry, molecular weight and percentage yield on molar basis for entire process.||

Case No.	Case No.	38 / NC/3/MEET/Nov/202425/10	38 / NC/3/MEET/Nov/202425/10	38 / NC/3/MEET/Nov/202425/10	38 / NC/3/MEET/Nov/202425/10	38 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00008696AM24
RA File Number		03AX04005309 AM24
Licence No and<br>Date		0311031390/22/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export<br>product/import item in meetingNo.NC/3/MEET/Apr/202425/2 dated 30/04/2024against advance authorization<br>No.0311024276 dated 06/06/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00500956AM25

Export Product* Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

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|1 Carbamazepine 102.00 mg. 2 Cellulose Acetate (CA 320S) Eastman 29.20 mg. Carbamazepine Extended-Release Tablets USP 100 mg. Each tablet contains (i) Carbamazepine 100 mg.((ii) Cellulose Acetate (CA- 320S) -Eastman 35.04mg. (iii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 5.28 mg. 1 Number 3 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 4.40 mg. 4 Carbamazepine 204.00 mg. 5 Cellulose Acetate (CA 320S) Eastman 29.20 mg. Carbamazepine Extended-Release Tablets USP 200 mg. Each tablet contains (i) Carbamazepine 200 mg.((ii) Cellulose Acetate (CA- 320S) -Eastman 35.04mg. (iii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 5.28 mg 1 Number 6 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 4.40 mg. 7 Carbamazepine 408.00 mg. 8 Cellulose Acetate (CA 320S) Eastman 29.20 mg. Carbamazepine Extended-Release Tablets USP 400 mg. Each tablet contains (i) Carbamazepine 400 mg.((ii) Cellulose Acetate (CA- 320S) -Eastman 26.28mg. (iii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 3.96 mg 1 Number 9 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 4.40 mg. RA concerned may take further necessary action as per above decision of NC.|Carbamazepine Extended-Release Tablets USP 100 mg.

Carbamazepine Extended-Release<br>Tablets USP 100 mg. Each tablet<br>contains (i) Carbamazepine 100<br>mg.((ii) Cellulose Acetate (CA-<br>320S) -Eastman 35.04mg. (iii)<br>Eastman (TM Cellulose Acetate<br>(CA 398-10NF/EP)- 5.28 mg.	<br> <br> <br> <br> <br>1 Number	1	Carbamazepine	102.00 mg.
		2	Cellulose Acetate (CA 320S)<br>Eastman	29.20 mg.
		3	EASTMAN (TM)<br>CELLULOSE ACETATE (CA<br>398-10NF/EP)	4.40 mg.
Carbamazepine Extended-Release<br>Tablets USP 200 mg. Each tablet<br>contains (i) Carbamazepine 200<br>mg.((ii) Cellulose Acetate (CA-<br>320S) -Eastman 35.04mg. (iii)<br>Eastman (TM Cellulose Acetate<br>(CA 398-10NF/EP)- 5.28 mg	<br> <br> <br> <br> <br>1 Number	4	Carbamazepine	204.00 mg.
		5	Cellulose Acetate (CA 320S)<br>Eastman	29.20 mg.
		6	EASTMAN (TM)<br>CELLULOSE ACETATE (CA<br>398-10NF/EP)	4.40 mg.
Carbamazepine Extended-Release<br>Tablets USP 400 mg. Each tablet<br>contains (i) Carbamazepine 400<br>mg.((ii) Cellulose Acetate (CA-<br>320S) -Eastman 26.28mg. (iii)<br>Eastman (TM Cellulose Acetate<br>(CA 398-10NF/EP)- 3.96 mg	<br> <br> <br> <br> <br>1 Number	7	Carbamazepine	408.00 mg.
		8	Cellulose Acetate (CA 320S)<br>Eastman	29.20 mg.
		9	EASTMAN (TM)<br>CELLULOSE ACETATE (CA<br>398-10NF/EP)	4.40 mg.

3.96 mg| 1 Number|7|Carbamazepine|408.00 mg.| ||||8|Cellulose Acetate (CA 320S) Eastman|29.20 mg.| ||||9|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)|4.40 mg.|

Case No.	39 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	HIND PHARMA
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008700AM24
RA File Number	56AX04000681 AM24
Licence No and<br>Date	5611002746/22/02/2024

UDIN00500956AM25

Norms Committee Decision:

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

Copy of DML for each export item showing approved composition.

Case No.	40 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	MEONE HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008751AM24
RA File Number	04AX04001035 AM24
Licence No and<br>Date	0411006998/26/02/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Copy of DML for the export product showing approved composition.<br>i.<br>CoA of import item from foreign supplier.<br>ii.<br>Complete calculation sheet to arrive at applied norms.<br>iii.

Case No.	41 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008755AM24
RA File Number	05AX04003663 AM24
Licence No and<br>Date	0511023926/26/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

30 This document has been digitally signed by Raman Kumar, Deputy DGFT on 17-12-2024 16:53:22.

UDIN00500956AM25

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

30 This document has been digitally signed by Raman Kumar, Deputy DGFT on 17-12-2024 16:53:22.

UDIN00500956AM25

Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>VIREXIM 1GM INJECTION<br>(CEFTRIAXONE<br>INJECTION<br>USP 1 GM)<br>1 Number<br>1<br>STERILE CEFTRIAXONE<br>SODIUM IP<br>1.16 gm.<br>CEFTRIAXONE<br>1GM<br>INJECTION<br>(CEFTRIAXONE<br>INJECTION<br>USP<br>FOR<br>INJECTION 1GM)<br>1 Number<br>2<br>STERILE CEFTRIAXONE<br>SODIUM IP<br>1.16 gm.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	VIREXIM 1GM INJECTION<br>(CEFTRIAXONE<br>INJECTION<br>USP 1 GM)	<br> <br>1 Number	1	STERILE CEFTRIAXONE<br>SODIUM IP	1.16 gm.
	CEFTRIAXONE<br>1GM<br>INJECTION<br>(CEFTRIAXONE<br>INJECTION<br>USP<br>FOR<br>INJECTION 1GM)	<br> <br> <br>1 Number	2	STERILE CEFTRIAXONE<br>SODIUM IP	1.16 gm.

Case No.	42 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008761AM24
RA File Number	03AX04005401 AM24
Licence No and<br>Date	0311031503/27/02/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

umber|03AX04005401 AM24| |Licence No and Date|0311031503/27/02/2024| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	43 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	S KANT CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008762AM24
RA File Number	03AX04005393 AM24
Licence No and<br>Date	0311031505/27/02/2024

UDIN00500956AM25

Norms Committee Decision:

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Jan/202324/21 dated 24/01/2024 against advance authorization No.0811008267 dated 24/05/2023 , it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
DEXAMETHASONE IP	1 kg.	1	16ALPHA-METHYL EPOXIDE<br>(8DM)	0.811 kg.

irm, whichever is less:-

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
DEXAMETHASONE IP	1 kg.	1	16ALPHA-METHYL EPOXIDE<br>(8DM)	0.811 kg.

Case No.	44 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	PRIVI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008765AM24
RA File Number	03AX04005326 AM24
Licence No and<br>Date	0311031507/27/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the request of firm for fixation of ad-hoc norms and it appears that item of<br>export under license is perfumery compounds and same comes under para 4.11(b) of FTP, 2023, and the said para states<br>that “For export of perfumes, perfumery compounds and various feed ingredients containing vitamins, no authorisation<br>shall be issued by Regional Authority under para 4.07 of HBP and applicants shall be required to apply under para 4.06<br>of HBP to the Norms Committee”.<br>The Committee decided that a clarification in this regard may be furnished by the firm as well by RA<br>concerned.<br>1.

The Committee decided that a clarification in this regard may be furnished by the firm as well by RA concerned.

Case No.	45 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved

UDIN00500956AM25

d that a clarification in this regard may be furnished by the firm as well by RA concerned.

Case No.	45 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved

UDIN00500956AM25

Party Name	SWISS PARENTERALS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008773AM24
RA File Number	08AX04002087 AM24
Licence No and Date	0811010888/27/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.<br>ISOFLURANE USP/BP/IP/CEP/EP/ChP<br>250ML (LIQUID FOR INHALATION)<br>EACH<br>BOTTLE<br>CONTAINS<br>ISOFLURANE<br>USP<br>250ML<br>EQUIVALENT TO 372.96GMS)<br>10000<br>Numbers<br>1<br>ISOFLURANE<br>3729.6 kg.<br>ISOFLURANE USP/BP/IP/CEP/EP/ChP<br>100ML (LIQUID FOR INHALATION)<br>EACH<br>BOTTLE<br>CONTAINS<br>ISOFLURANE<br>USP<br>100ML<br>EQUIVALENT TO 149.48GMS)<br>12000<br>Numbers<br>2<br>ISOFLURANE<br>1793.76 kg.<br>ISOFLURANE USP/BP/IP/CEP/EP/ChP<br>30ML (LIQUID FOR INHALATION)<br>EACH<br>BOTTLE<br>CONTAINS<br>ISOFLURANE<br>USP<br>30ML<br>EQUIVALENT TO 45.88GMS)<br>2000<br>Number<br>3<br>ISOFLURANE<br>91.76 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	46 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	PIRAMAL PHARMA LIMITED

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

Case No.	46 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	PIRAMAL PHARMA LIMITED

UDIN00500956AM25

Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008780AM24
RA File Number	03AX04005442 AM24
Licence No and<br>Date	0311031542/27/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Aug/202425/8 dated 28/08/2024against<br>advance authorizationNo.0311033003 dated 15/04/2024, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Vibegron (Gemtesa)Tablets 75 mg<br>1 Number<br>1<br>Vibegron<br>76.50 mg/Tablet<br>RA concerned may take further necessary action as per above decision of NC.

ort Items** Qty. allowed. Vibegron (Gemtesa)Tablets 75 mg 1 Number 1 Vibegron 76.50 mg/Tablet RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	Case No.	47 / NC/3/MEET/Nov/202425/10	47 / NC/3/MEET/Nov/202425/10
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number			HQRNORM APPLY 00008783AM24
RA File Number			03AX04005399 AM24
Licence No and<br>Date			0311031475/28/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the request of firm in details and also discussed report of factory<br>visit. The committee found that in the above mention case export product is in form of Gel not a<br>cream/Ointments and accordingly decided to fix the ad-hoc norms as under :-<br>Sl.<br>No<br>Export Product<br>Quantity
	Sl.<br>No	Export Product		Quantity

br>cream/Ointments and accordingly decided to fix the ad-hoc norms as under :- Sl. No Export Product Quantity||||| ||Sl. No|Export Product||Quantity|

Case No.	Case No.	Case No.	47 / NC/3/MEET/Nov/202425/10	47 / NC/3/MEET/Nov/202425/10
Case Status			Case Approved
Party Name			ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number			HQRNORM APPLY 00008783AM24
RA File Number			03AX04005399 AM24
Licence No and<br>Date			0311031475/28/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the request of firm in details and also discussed report of factory<br>visit. The committee found that in the above mention case export product is in form of Gel not a<br>cream/Ointments and accordingly decided to fix the ad-hoc norms as under :-<br>Sl.<br>No<br>Export Product<br>Quantity
	Sl.<br>No	Export Product		Quantity

UDIN00500956AM25

(i)	Medical Cream and Ointment(Azelaic Acid 15% Gel 50 Gm Tot WT 7,500Kgs.	1 Number
	(Net Cont :Azelaic 1,125Kgs, Benzoic 7.50Kg, Edetate Dis 7.50 Kgs, Carbopol
	75Kgs, Polysorbate 112.5 Kgs, Propylene 900 Kgs))

Sl. No.	Import Items	Quantity allowed.
1	Relevant Bulk Drugs	Net content in the export product plus 2% wastage.
2	Relevant Excipients	Net content in the export product plus 2% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy and General Notes.

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

Case No.	Case No.	48 / NC/3/MEET/Nov/202425/10	48 / NC/3/MEET/Nov/202425/10	48 / NC/3/MEET/Nov/202425/10	48 / NC/3/MEET/Nov/202425/10	48 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00008792AM24
RA File Number		08AX04002148 AM24
Licence No and<br>Date		0811010899/28/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00500956AM25

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

UDIN00500956AM25

Phenylephrine<br>Hydrochloride<br>Injection USP, 10 mg/mL (5 mL)<br>1 Vial<br>1<br>Phenylephrine HCl<br>USP/Ph.Eur<br>55 mg/Vial<br>Phenylephrine<br>Hydrochloride<br>Injection USP, 10 mg/mL (10 mL)<br>1 Vial<br>2<br>Phenylephrine HCl<br>USP/Ph.Eur<br>110 mg/Vial<br>RA concerned may take further necessary action as per above decision of NC.	Phenylephrine<br>Hydrochloride<br>Injection USP, 10 mg/mL (5 mL)<br>Phenylephrine<br>Hydrochloride<br>Injection USP, 10 mg/mL (10 mL)	<br>1 Vial	1	Phenylephrine HCl<br>USP/Ph.Eur	55 mg/Vial
		<br>1 Vial	2	Phenylephrine HCl<br>USP/Ph.Eur	110 mg/Vial

Case No.	Case No.	49 / NC/3/MEET/Nov/202425/10	49 / NC/3/MEET/Nov/202425/10	49 / NC/3/MEET/Nov/202425/10	49 / NC/3/MEET/Nov/202425/10	49 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		RUBICON RESEARCH LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00008801AM24
RA File Number		03AX04005270 AM24
Licence No and<br>Date		0311031579/28/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>**Sl.

per agenda and it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 Buspirone HCl USP 5.10 mg. 2 Lactose Monohydrate NF 80.0 mg. Buspirone HCI Tablet 5mg 1 Number 3 Croscarmellose Sodium USP-NF (Ac-Di-Sol) 0.50 mg. 4 Buspirone HCl USP 7.65 mg. 5 Lactose Monohydrate NF 120.0 mg. Buspirone HCI Tablet 7.5mg 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Buspirone HCI Tablet 5mg||1 Number|1|Buspirone HCl USP|5.10 mg.| |||||2|Lactose Monohydrate NF|80.0 mg.| |||||3|Croscarmellose Sodium USP-NF (Ac-Di-Sol)|0.50 mg.| ||Buspirone HCI Tablet 7.5mg||1 Number|4|Buspirone HCl USP|7.65 mg.| |||||5|Lactose Monohydrate NF|120.0 mg.|

Case No.	Case No.	49 / NC/3/MEET/Nov/202425/10	49 / NC/3/MEET/Nov/202425/10	49 / NC/3/MEET/Nov/202425/10	49 / NC/3/MEET/Nov/202425/10	49 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		RUBICON RESEARCH LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00008801AM24
RA File Number		03AX04005270 AM24
Licence No and<br>Date		0311031579/28/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol.

nd Date||0311031579/28/02/2024||||| |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. allowed. 1 Buspirone HCl USP 5.10 mg. 2 Lactose Monohydrate NF 80.0 mg. Buspirone HCI Tablet 5mg 1 Number 3 Croscarmellose Sodium USP-NF (Ac-Di-Sol) 0.50 mg. 4 Buspirone HCl USP 7.65 mg. 5 Lactose Monohydrate NF 120.0 mg. Buspirone HCI Tablet 7.5mg 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Buspirone HCI Tablet 5mg||1 Number|1|Buspirone HCl USP|5.10 mg.| |||||2|Lactose Monohydrate NF|80.0 mg.| |||||3|Croscarmellose Sodium USP-NF (Ac-Di-Sol)|0.50 mg.| ||Buspirone HCI Tablet 7.5mg||1 Number|4|Buspirone HCl USP|7.65 mg.| |||||5|Lactose Monohydrate NF|120.0 mg.|

UDIN00500956AM25

|||||3|Croscarmellose Sodium USP-NF (Ac-Di-Sol)|0.50 mg.| ||Buspirone HCI Tablet 7.5mg||1 Number|4|Buspirone HCl USP|7.65 mg.| |||||5|Lactose Monohydrate NF|120.0 mg.|

UDIN00500956AM25

		6	Croscarmellose Sodium USP-NF<br>(Ac-Di-Sol)	0.75 mg.
Buspirone HCI Tablet 10 mg	1 Number	7	Buspirone HCl USP	10.2 mg
		8	Lactose Monohydrate NF	160.0 mg
		9	Croscarmellose Sodium USP-NF<br>(Ac-Di-Sol)	1.00 mg.
Buspirone HCI Tablet 15 mg	1 Number	10	Buspirone HCl USP	15.30 mg.
		11	Lactose Monohydrate NF	240.0 mg
		12	Croscarmellose Sodium USP-NF<br>(Ac-Di-Sol)	1.50 mg.
Buspirone HCI Tablet 30 mg	1 Number	13	Buspirone HCl USP	30.6 mg.
		14	Lactose Monohydrate NF	480.0 mg.
		15	Croscarmellose Sodium USP-NF<br>(Ac-Di-Sol)	3.00 mg.
Acetazolamide<br>Tab<br>USP<br>125mg	<br>1 Number	16	Acetazolamide USP	127.50 mg.
		17	Lactose Monohydrate NF	51.10 mg.
		18	Sodium Starch Glycolate NF	7.50 mg.
Acetazolamide Tab USP 250<br>mg	<br>1 Number	19	Acetazolamide USP	255.0 mg.
		20	Lactose Monohydrate NF	102.30 mg.
		21	Sodium Starch Glycolate NF	15.00 mg.
Metoprolol Tartrate Tablets<br>25 mg	<br>1 Number	22	Metoprolol Tartrate USP	25.50 mg.
		23	Lactose Monohydrate NF	26.0 mg.

UDIN00500956AM25

|21|Sodium Starch Glycolate NF|15.00 mg.| ||Metoprolol Tartrate Tablets 25 mg| 1 Number|22|Metoprolol Tartrate USP|25.50 mg.| ||||23|Lactose Monohydrate NF|26.0 mg.|

UDIN00500956AM25

		24	Sodium Starch Glycolate NF	10.00 mg.
Metoprolol Tartrate Tablets<br>37.50mg	<br>1 Number	25	Metoprolol Tartrate USP	38.25 mg.
		26	Lactose Monohydrate NF	39.00 mg.
		27	Sodium Starch Glycolate NF	15.00 mg.
Metoprolol Tartrate Tablets<br>50mg	<br>1 Number	28	Metoprolol Tartrate USP	51.0 mg.
		29	Lactose Monohydrate NF	78.0 mg.
		30	Sodium Starch Glycolate NF	20.0 mg.
Metoprolol Tartrate Tablets<br>75mg	<br>1 Number	31	Metoprolol Tartrate USP	76.5 mg.
		32	Lactose Monohydrate NF	78.0 mg.
		33	Sodium Starch Glycolate NF	30.0 mg.
Metoprolol Tartrate Tablets<br>100mg	<br>1 Number	34	Metoprolol Tartrate USP	102.0 mg.
		35	Lactose Monohydrate NF	104.0 mg.
		36	Sodium Starch Glycolate NF	40.0 mg.
Oxybutynin Chloride ER Tab<br>USP 5mg	<br>1 Number	37	Oxybutynin Chl USP	5.10 mg.
		38	Lactose Monohydrate NF	15.33 mg.
Oxybutynin Cl ER Tab USP<br>10mg	<br>1 Number	39	Oxybutynin Chl USP	10.20 mg.
		40	Lactose Monohydrate NF	30.65 mg.
Oxybutynin Chloride ER Tab<br>USP 15mg	<br>1 Number	41	Oxybutynin Chl USP	15.30 mg.
		42	Lactose Monohydrate NF	25.75 mg.

UDIN00500956AM25

| ||||40|Lactose Monohydrate NF|30.65 mg.| ||Oxybutynin Chloride ER Tab USP 15mg| 1 Number|41|Oxybutynin Chl USP|15.30 mg.| ||||42|Lactose Monohydrate NF|25.75 mg.|

UDIN00500956AM25

Case No.	50 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	MAXMED LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008802AM24
RA File Number	05AX04003602 AM24
Licence No and<br>Date	0511024076/28/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Nov/202425/10 dated 22/11/2024against<br>advance authorizationNo.0511024076 dated 28/02/2024, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Amoxycillin oral suspension<br>(Amoxycillin Syrup) 250 mg/5 ml,<br>60 ml Bottle (Each 5 ml contains<br>Amoxycillin Trihydrate equivalent to<br>250 mg of Amoxycillin))<br>1500000<br>Numbers<br>1<br>Amoxycillin<br>Trihydrate<br>5423.0 kg.<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	51 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024

se No.	51 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024

UDIN00500956AM25

HQ File Number	HQRNORM APPLY 00008814AM24
RA File Number	05AX04003827 AM24
Licence No and<br>Date	0511024211/29/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Nov/202425/10 dated 22/11/2024against<br>advance authorizationNo.0511024211 dated 29/02/2024, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>VANCOMYCIN HYDROCHLORIDE<br>( STERILE)<br>1 kg<br>1<br>Vancomycin HCL<br>(Non Sterile)<br>1.01 kg.<br>RA concerned may take further necessary action as per above decision of NC.

y. allowed.** VANCOMYCIN HYDROCHLORIDE ( STERILE) 1 kg 1 Vancomycin HCL (Non Sterile) 1.01 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	52 / NC/3/MEET/Nov/202425/10	52 / NC/3/MEET/Nov/202425/10	52 / NC/3/MEET/Nov/202425/10	52 / NC/3/MEET/Nov/202425/10	52 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00008824AM24
RA File Number		34AX04000861 AM24
Licence No and<br>Date		3411004655/29/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl.<br>No.	Import Items	Qty. allowed.

UDIN00500956AM25

t** Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

UDIN00500956AM25

Dorzolamide<br>Hydrochloride<br>and<br>Timolol<br>Maleate<br>Ophthalmic<br>Solution, USP 2% & 0.5% - 10 ML<br>1 Number<br>1<br>Timolol Maleate USP<br>69.67 mg.<br>Brimonidine Tartrate and Timolol<br>Maleate Ophthalmic solution 0.2%<br>& 0.5% - 5 ML<br>1 Number<br>2<br>Timolol Maleate USP<br>34.68 mg.<br>Brimonidine Tartrate and Timolol<br>Maleate Ophthalmic solution 0.2%<br>& 0.5% -10 ML<br>1 Number<br>3<br>Timolol Maleate USP<br>69.36 mg.<br>Brimonidine Tartrate and Timolol<br>Maleate Ophthalmic solution 0.2%<br>& 0.5% - 15 ML<br>1 Number<br>4<br>Timolol Maleate USP<br>104.04 mg.<br>Timolol Maleate Ophthalmic Gel<br>Forming Solution, 0.5% - 5 ML<br>1 Number<br>5<br>Timolol Maleate USP<br>34.68 mg.<br>Timolol Maleate Ophthalmic Gel<br>Forming Solution, 0.25% - 5 ML<br>1 Number<br>6<br>Timolol Maleate USP<br>17.34 mg.<br>RA concerned may take further necessary action as per above decision of NC.	Dorzolamide<br>Hydrochloride<br>and<br>Timolol<br>Maleate<br>Ophthalmic<br>Solution, USP 2% & 0.5% - 10 ML	<br> <br>1 Number	1	Timolol Maleate USP	69.67 mg.
	Brimonidine Tartrate and Timolol<br>Maleate Ophthalmic solution 0.2%<br>& 0.5% - 5 ML	<br> <br>1 Number	2	Timolol Maleate USP	34.68 mg.
	Brimonidine Tartrate and Timolol<br>Maleate Ophthalmic solution 0.2%<br>& 0.5% -10 ML	<br> <br>1 Number	3	Timolol Maleate USP	69.36 mg.

5% - 5 ML| 1 Number|2|Timolol Maleate USP|34.68 mg.| ||Brimonidine Tartrate and Timolol Maleate Ophthalmic solution 0.2% & 0.5% -10 ML| 1 Number|3|Timolol Maleate USP|69.36 mg.| ||Brimonidine Tartrate and Timolol Maleate Ophthalmic solution 0.2% & 0.5% - 15 ML| 1 Number|4|Timolol Maleate USP|104.04 mg.| ||Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% - 5 ML| 1 Number|5|Timolol Maleate USP|34.68 mg.| ||Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% - 5 ML| 1 Number|6|Timolol Maleate USP|17.34 mg.|

Case No.	53 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	RUBICON RESEARCH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00008826AM24
RA File Number	03AX04005194 AM24
Licence No and<br>Date	0311031599/29/02/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-

UDIN00500956AM25

1. Copy of Master Batch Formula.

Copy of Drug Manufacturing Licence (DML).

Case No.	Case No.	54 / NC/3/MEET/Nov/202425/10	54 / NC/3/MEET/Nov/202425/10	54 / NC/3/MEET/Nov/202425/10	54 / NC/3/MEET/Nov/202425/10	54 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		TORRENT PHARMACEUTICALS LTD
Meeting Number and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00008831AM24
RA File Number		08AX04002140 AM24
Licence No and Date		0811010931/29/02/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Aug/202425/8 dated 28/08/2024against<br>advance authorizationNo.0811011227 dated 04/04/2024, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 2 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 8.719 KG IN EXPORT ITEM) 1 Number 1 CANDESARTAN CILEXETIL PH.EUR 2.04 mg. CANDESARTAN CILEXETIL 4 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 4 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 21.797 KG IN EXPORT ITEM) 1 Number 2 CANDESARTAN CILEXETIL PH.EUR 4.08 mg. CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 8 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 196.468 KG IN EXPORT ITEM) 1 Number 3 CANDESARTAN CILEXETIL PH.EUR 8.16 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|**Qty.

EXETIL SHOULD NOT BE LESS THAN 196.468 KG IN EXPORT ITEM) 1 Number 3 CANDESARTAN CILEXETIL PH.EUR 8.16 mg.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 2 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 8.719 KG IN EXPORT ITEM)|| 1 Number|1|CANDESARTAN CILEXETIL PH.EUR|2.04 mg.| ||CANDESARTAN CILEXETIL 4 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 4 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 21.797 KG IN EXPORT ITEM)|| 1 Number|2|CANDESARTAN CILEXETIL PH.EUR|4.08 mg.| ||CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 8 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 196.468 KG IN EXPORT ITEM)|| 1 Number|3|CANDESARTAN CILEXETIL PH.EUR|8.16 mg.|

UDIN00500956AM25

TIL PH. EUR 8 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 196.468 KG IN EXPORT ITEM)|| 1 Number|3|CANDESARTAN CILEXETIL PH.EUR|8.16 mg.|

UDIN00500956AM25

CANDESARTAN CILEXETIL 16 MG<br>TABLETS(EACH UNCOATED TABLET<br>CONTAINS : CANDESARTAN CILEXETIL PH.<br>EUR 16 MG NET CONTENT OF<br>CANDESARTAN CILEXETIL SHOULD NOT BE<br>LESS THAN 435.949 KG IN EXPORT ITEM)	<br>1 Number	4	CANDESARTAN<br>CILEXETIL PH.EUR	16.32 mg.
CANDESARTAN CILEXETIL 32 MG<br>TABLETS(EACH UNCOATED TABLET<br>CONTAINS : CANDESARTAN CILEXETIL PH.<br>EUR 32 MG NET CONTENT OF<br>CANDESARTAN CILEXETIL SHOULD NOT BE<br>LESS THAN 674.268 KG IN EXPORT ITEM)	<br>1 Number	5	CANDESARTAN<br>CILEXETIL PH.EUR	32.64 mg.
CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZID E TABLETS 8<br>MG +12.5 MG(EACH UNCOATED TABLET<br>CONTAINS CANDESARTAN CILEXETIL<br>PH. EUR 8 MG AND<br>HYDROCHLOROTHIAZIDE PH. EUR. 12.5<br>MG NET CONTENT OF CANDESARTAN<br>CILEXETIL SHOULD NOT BE LESS THAN<br>8.138 KG IN EXPORT ITEM)	1 Number	6	CANDESARTAN<br>CILEXETIL PH.EUR	8.16 mg
CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZID E TABLETS 16<br>MG +12.5 MG(EACH UNCOATED TABLET<br>CONTAINS CANDESARTAN CILEXETIL PH.<br>EUR 16 MG AND<br>HYDROCHLOROTHIAZIDE PH. EUR.

.EUR|8.16 mg| ||CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZID E TABLETS 16 MG +12.5 MG(EACH UNCOATED TABLET CONTAINS CANDESARTAN CILEXETIL PH. EUR 16 MG AND HYDROCHLOROTHIAZIDE PH. EUR. 12.5 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 34.876 KG IN EXPORT ITEM)|1 Number|7|CANDESARTAN CILEXETIL PH.EUR|16.32 mg.| ||CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZID E TABLETS 32 MG +12.5 MG(EACH UNCOATED TABLET CONTAINS CANDESARTAN CILEXETIL PH. EUR 32 MG AND HYDROCHLOROTHIAZIDE PH. EUR. 12.5 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 20.926 KG IN EXPORT ITEM)|1 Number|8|CANDESARTAN CILEXETIL PH.EUR|32.64 mg.| ||CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZID E TABLETS 32 MG +25 MG(EACH UNCOATED TABLET|1 Number|9|CANDESARTAN CILEXETIL PH.EUR|32.64 mg.|

UDIN00500956AM25

CONTAINS CANDESARTAN CILEXETIL PH. EUR 32 MG AND HYDROCHLOROTHIAZIDE PH EUR. 25 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 41.851 KG IN EXPORT ITEM)

UDIN00500956AM25

CONTAINS CANDESARTAN CILEXETIL PH. EUR 32 MG AND HYDROCHLOROTHIAZIDE PH EUR. 25 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 41.851 KG IN EXPORT ITEM)

Case No.	Case No.	Case No.	Case No.	Case No.	55 / NC/3/MEET/Nov/202425/10	55 / NC/3/MEET/Nov/202425/10	55 / NC/3/MEET/Nov/202425/10
Case Status					Case Approved
Party Name					ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date					NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number					HQRNORM APPLY 00000504AM25
RA File Number					03AX04000497 AM25
Licence No and<br>Date					0311033495/01/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the request of firm in details and also discussed report of factory<br>visit. The committee found that in the above mention case export product is in form of Gel not a<br>cream/Ointments and accordingly decided to fix the ad-hoc norms as under :-<br>Sl.<br>No<br>Export Product<br>Quantity<br>(i)<br>Medical Cream & Onitment(Mesalamine Rectal Suspension, USP Enema 4.0<br>g/ 60 ml (Tot Wt: 73944 Kgs(Net Cont: Mesalamine 5028.19 Kgs,<br>POTASSIUM METABISULFITE NF 347.54 , POTASSIUM ACETATE<br>303.17 kgs LDPE Bottle 1200000 Nos, Enema Applictor 1200000 Nos.))<br>1 Number<br>**Sl.

Tot Wt: 73944 Kgs(Net Cont: Mesalamine 5028.19 Kgs, POTASSIUM METABISULFITE NF 347.54 , POTASSIUM ACETATE 303.17 kgs LDPE Bottle 1200000 Nos, Enema Applictor 1200000 Nos.)) 1 Number Sl. No. Import Items Quantity allowed.|||||||| ||Sl. No||Export Product||||Quantity| ||(i)||Medical Cream & Onitment(Mesalamine Rectal Suspension, USP Enema 4.0 g/ 60 ml (Tot Wt: 73944 Kgs(Net Cont: Mesalamine 5028.19 Kgs, POTASSIUM METABISULFITE NF 347.54 , POTASSIUM ACETATE 303.17 kgs LDPE Bottle 1200000 Nos, Enema Applictor 1200000 Nos.))||||1 Number| ||||||||| |||Sl. No.||Import Items||Quantity allowed.||

44 This document has been digitally signed by Raman Kumar, Deputy DGFT on 17-12-2024 16:53:22.

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1	Relevant Bulk Drugs	Net content in the export product plus 2% wastage.
2	Relevant Excipients	Net content in the export product plus 2% wastage.
3	Relevant Packaging Material	Relevant as per Packing Policy and General Notes.

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

Case No.	Case No.	56 / NC/3/MEET/Nov/202425/10	56 / NC/3/MEET/Nov/202425/10	56 / NC/3/MEET/Nov/202425/10	56 / NC/3/MEET/Nov/202425/10	56 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		NAPROD LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00000508AM25
RA File Number		03AX04000230 AM25
Licence No and<br>Date		0311033504/01/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Nov/202425/10 dated 22/11/2024against<br>advance authorizationNo.0311033504 dated 01/05/2024, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>NAPROLAT-CARBOPLATIN BP 10<br>MG/ML INJ. ( 1x15ML ) 150 MG.<br>1 Vial<br>1<br>Carboplatin IP/ BP/ USP<br>157.5 mg/Vial<br>NAPROLAT-CARBOPLATIN BP 10<br>MG/ML INJ. ( 1x45ML ) 450 MG.<br>1 Vial<br>2<br>Carboplatin IP/ BP/ USP<br>472.50 mg/Vial
	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.
	NAPROLAT-CARBOPLATIN BP 10<br>MG/ML INJ.

) 450 MG. 1 Vial 2 Carboplatin IP/ BP/ USP 472.50 mg/Vial||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||NAPROLAT-CARBOPLATIN BP 10 MG/ML INJ. ( 1x15ML ) 150 MG.|| 1 Vial|1|Carboplatin IP/ BP/ USP|157.5 mg/Vial| ||NAPROLAT-CARBOPLATIN BP 10 MG/ML INJ. ( 1x45ML ) 450 MG.|| 1 Vial|2|Carboplatin IP/ BP/ USP|472.50 mg/Vial|

Case No.	Case No.	56 / NC/3/MEET/Nov/202425/10	56 / NC/3/MEET/Nov/202425/10	56 / NC/3/MEET/Nov/202425/10	56 / NC/3/MEET/Nov/202425/10	56 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		NAPROD LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00000508AM25
RA File Number		03AX04000230 AM25
Licence No and<br>Date		0311033504/01/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Nov/202425/10 dated 22/11/2024against<br>advance authorizationNo.0311033504 dated 01/05/2024, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>NAPROLAT-CARBOPLATIN BP 10<br>MG/ML INJ. ( 1x15ML ) 150 MG.<br>1 Vial<br>1<br>Carboplatin IP/ BP/ USP<br>157.5 mg/Vial<br>NAPROLAT-CARBOPLATIN BP 10<br>MG/ML INJ.

port Items** Qty. allowed. NAPROLAT-CARBOPLATIN BP 10 MG/ML INJ. ( 1x15ML ) 150 MG. 1 Vial 1 Carboplatin IP/ BP/ USP 157.5 mg/Vial NAPROLAT-CARBOPLATIN BP 10 MG/ML INJ. ( 1x45ML ) 450 MG. 1 Vial 2 Carboplatin IP/ BP/ USP 472.50 mg/Vial||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.| ||NAPROLAT-CARBOPLATIN BP 10 MG/ML INJ. ( 1x15ML ) 150 MG.|| 1 Vial|1|Carboplatin IP/ BP/ USP|157.5 mg/Vial| ||NAPROLAT-CARBOPLATIN BP 10 MG/ML INJ. ( 1x45ML ) 450 MG.|| 1 Vial|2|Carboplatin IP/ BP/ USP|472.50 mg/Vial|

UDIN00500956AM25

Case No.	57 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000517AM25
RA File Number	08AX04000152 AM25
Licence No and<br>Date	0811011425/02/05/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>CoA of import item from Foreign Supplier.<br>1.<br>Copy of Drug Manufacturing License (DML).<br>2.<br>Vial size of export item in ML.<br>3.

g information/documents from the firm:- CoA of import item from Foreign Supplier. 1. Copy of Drug Manufacturing License (DML). 2. Vial size of export item in ML. 3.||

Case No.	58 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	SANPRAS HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000523AM25
RA File Number	31AX04000022 AM25
Licence No and<br>Date	3111003394/02/05/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Composition of export item and wastage claimed in each step of manufacturing process.<br>1.<br>CoA of export item.<br>2.<br>CoA of import item from Foreign Supplier.<br>3.

46 This document has been digitally signed by Raman Kumar, Deputy DGFT on 17-12-2024 16:53:22.

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Copy of Batch-Log Sheet for previous three consequitive batches.

3.||

46 This document has been digitally signed by Raman Kumar, Deputy DGFT on 17-12-2024 16:53:22.

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Copy of Batch-Log Sheet for previous three consequitive batches.

Case No.	Case No.	59 / NC/3/MEET/Nov/202425/10	59 / NC/3/MEET/Nov/202425/10	59 / NC/3/MEET/Nov/202425/10	59 / NC/3/MEET/Nov/202425/10	59 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00000534AM25
RA File Number		03AX04000479 AM25
Licence No and<br>Date		0311033556/03/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Nov/202425/10 dated 22/11/2024against<br>advance authorizationNo.0311033556 dated 03/05/2024, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>SENTRY POLYOX WSR<br>COAGULANT NF<br>56.8 mg.<br>2<br>EASTMAN (TM)<br>CELLULOSE ACETATE<br>(CA 398-10NF/EP)<br>33.12 mg.<br>Nifedipine Extended-Release<br>Tablets 30mg.

* Qty. allowed. 1 SENTRY POLYOX WSR COAGULANT NF 56.8 mg. 2 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 33.12 mg. Nifedipine Extended-Release Tablets 30mg. Each tablet contains (i) Sentry Polyox WSR Coagulant NF - 56.80 mg((ii) Eastman (TM Cellulose Acetate (CA 398- 10NF/EP)- 33.12 mg (iii) SENTRY POLYOX WSR N80 FP NF - 118.40 mg. 1 Number 3 SENTRY POLYOX WSR N80 FP NF 118.40 mg. 4 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 113.60 mg. 5 EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP) 42.32 mg. Nifedipine Extended-Release Tablets 60mg. Each tablet contains (i) Sentry Polyox WSR Coagulant NF - 113.60 mg((ii) Eastman (TM Cellulose Acetate (CA 398- 10NF/EP)- 42.32 mg (iii) SENTRY POLYOX WSR N80 FP NF - 236.80 mg. 1 Number||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||Nifedipine Extended-Release Tablets 30mg. Each tablet contains (i) Sentry Polyox WSR Coagulant NF - 56.80 mg((ii) Eastman (TM Cellulose Acetate (CA 398- 10NF/EP)- 33.12 mg (iii) SENTRY POLYOX WSR N80 FP NF - 118.40 mg.||1 Number|1|SENTRY POLYOX WSR COAGULANT NF|56.8 mg.| |||||2|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)|33.12 mg.| |||||3|SENTRY POLYOX WSR N80 FP NF|118.40 mg.| ||Nifedipine Extended-Release Tablets 60mg.

WSR COAGULANT NF|56.8 mg.| |||||2|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)|33.12 mg.| |||||3|SENTRY POLYOX WSR N80 FP NF|118.40 mg.| ||Nifedipine Extended-Release Tablets 60mg. Each tablet contains (i) Sentry Polyox WSR Coagulant NF - 113.60 mg((ii) Eastman (TM Cellulose Acetate (CA 398- 10NF/EP)- 42.32 mg (iii) SENTRY POLYOX WSR N80 FP NF - 236.80 mg.||1 Number|4|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)|113.60 mg.| |||||5|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)|42.32 mg.| ||||||||

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6<br>SENTRY POLYOX WSR<br>N80 FP NF<br>236.80 mg.<br>7<br>SENTRY POLYOX WSR<br>COAGULANT NF<br>162.9 mg.<br>8<br>EASTMAN (TM)<br>CELLULOSE ACETATE<br>(CA 398-10NF/EP)<br>64.80 mg.<br>Nifedipine Extended-Release<br>Tablets 90mg. Each tablet contains<br>(i) Sentry Polyox WSR Coagulant<br>NF - 162.90 mg((ii) Eastman (TM<br>Cellulose Acetate (CA 398-<br>10NF/EP)- 64.80 mg (iii) SENTRY<br>POLYOX WSR N80 FP NF -<br>369.90 mg.<br>1 Number<br>9<br>SENTRY POLYOX WSR<br>N80 FP NF<br>369.90 mg.<br>RA concerned may take further necessary action as per above decision of NC.			6	SENTRY POLYOX WSR<br>N80 FP NF	236.80 mg.
	Nifedipine Extended-Release<br>Tablets 90mg.

		6	SENTRY POLYOX WSR<br>N80 FP NF	236.80 mg.
Nifedipine Extended-Release<br>Tablets 90mg. Each tablet contains<br>(i) Sentry Polyox WSR Coagulant<br>NF - 162.90 mg((ii) Eastman (TM<br>Cellulose Acetate (CA 398-<br>10NF/EP)- 64.80 mg (iii) SENTRY<br>POLYOX WSR N80 FP NF -<br>369.90 mg.	1 Number	7	SENTRY POLYOX WSR<br>COAGULANT NF	162.9 mg.
		8	EASTMAN (TM)<br>CELLULOSE ACETATE<br>(CA 398-10NF/EP)	64.80 mg.
		9	SENTRY POLYOX WSR<br>N80 FP NF	369.90 mg.

Case No.	60 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	RUBICON RESEARCH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000535AM25
RA File Number	03AX04000486 AM25
Licence No and<br>Date	0311033558/03/05/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Copy of Drug Manufacturing License.<br>1.<br>Copy of Master-Batch Formula.<br>2.

Case No.	61 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	UMEDICA LABORATORIES PRIVATE LIMITED

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*Copy of Master-Batch Formula.** 2.||

Case No.	61 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	UMEDICA LABORATORIES PRIVATE LIMITED

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Meeting Number and Date	Meeting Number and Date	Meeting Number and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number			HQRNORM APPLY 00000560AM25
RA File Number			03AX04000294 AM25
Licence No and Date			0311033608/06/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 407 of HBP Vol I as per details given below or as applied b the firm whichever is less:-
	.	. y ,



	Export	Product		Qty.	Sl. No.	Import Items	Qty.<br>allowed
							.
				<br>
	ROSUVAST<br>BP / USP 20	ATIN TABLET<br>MG.((Each		<br>47135000<br>Numbers	1	Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-<br>fluorophenyl)-6-isopropyl-2-(N-	1299.4 kg.
	Tablet contains Rosuvastatin<br>Calcium 20.800 mg) Eq. to<br>Rosuvastatin 20 mg.					methylmethylsulfonamido)pyrimidin-<br>5-yl)vinyl)-2,2-dimethyl-1,3-dioxan-<br>4-yl)acetate

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

mg.|||||methylmethylsulfonamido)pyrimidin- 5-yl)vinyl)-2,2-dimethyl-1,3-dioxan- 4-yl)acetate|| ||||||||| |RA concerned may take further necessary action as per above decision of NC.||||||||



Case No		62 / NC/3/MEET/No/202425/10
.		v
Case Status		Case Aroed
		ppv
Party Name		CDYMAX (INDIA) PHARMA PRIVATE LIMITED

Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024

HQ File Number		HQRNORM APPLY 00000561AM25

RA File Number		07AX04000123 AM25

Licence No and<br>Date		0711011233/06/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.

UDIN00500956AM25

Capecitabine	1	kg.	1	2, 3-Di-O-ACETYL-5-DEOXY-5-	1.00 kg.
				FLUOROCYTIDINE

*||Qty.|Sl. No.|Import Items|Qty. allowed.|

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Capecitabine	1	kg.	1	2, 3-Di-O-ACETYL-5-DEOXY-5-	1.00 kg.
				FLUOROCYTIDINE

Case No.	63 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	HEMA DYECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000568AM25
RA File Number	03AX04000390 AM25
Licence No and<br>Date	0311033616/06/05/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>1.Chemical reaction indicating molecular weight of reactants and products with stage wise<br>yield.<br>2.Calculation of requirement of raw materials, (both imported and indigenous) with<br>justification of yield of the reaction.<br>3.To indicate indigenous items in Appendix- 4E with technical details of the annexure.

Case No.	64 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000569AM25
RA File Number	03AX04000513 AM25
Licence No and<br>Date	0311033617/06/05/2024
Norms Committee Decision:

UDIN00500956AM25

and 22/11/2024| |HQ File Number|HQRNORM APPLY 00000569AM25| |RA File Number|03AX04000513 AM25| |Licence No and Date|0311033617/06/05/2024| |Norms Committee Decision:||

UDIN00500956AM25

Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
AZELAIC ACID GEL 15 percent<br>(Pack Size 50 Grams) (Net Wt. of<br>Azelaic Acid is 1425.00 Kgs.)	<br> <br>190000<br>Numbers	1	Azelaic Acid	1453.50 kg.

Case No.	65 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	DEEPAK CHEM TECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000594AM25
RA File Number	34AX04000083 AM25
Licence No and<br>Date	3411004899/08/05/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>1.

cision:**The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was decided to call for following information/documents from the firm:- 1. Chemical reaction indicating molecular weight of reactants and products with stage wise yield. 2.Calculation of requirement of raw materials, (both imported and indigenous) with justification of yield of the reaction. 3.To indicate indigenous items in Appendix-4E with technical details of the annexure. 4.Stoichiometric material balance on a molar basis. 5.In the process flow chart do not use abbreviations, instead to give full names||

UDIN00500956AM25

Case No.	66 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	DEEPAK CHEM TECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000595AM25
RA File Number	34AX04000021 AM25
Licence No and<br>Date	3411004900/08/05/2024

|Meeting Number and Date|NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024| |HQ File Number|HQRNORM APPLY 00000595AM25| |RA File Number|34AX04000021 AM25| |Licence No and Date|3411004900/08/05/2024| |Norms Committee Decision: Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice of the TE, it was decided to call for following information/documents from the firm:- 1.Chemical reaction indicating molecular weight of reactants and products with stage wise yield. 2.Calculation of requirement of raw materials, (both imported and indigenous) with justification of yield of the reaction. 3.To indicate indigenous items in Appendix-4E with technical details of the annexure. 4.Stoichiometric material balance on a molar basis. 5.In the process flow chart do not use abbreviations, instead to give full names.||

Case No.	67 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000598AM25
RA File Number	03AX04000571 AM25
Licence No and<br>Date	0311033662/08/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

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

52 This document has been digitally signed by Raman Kumar, Deputy DGFT on 17-12-2024 16:53:22.

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Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Cetylpyridinium Chloride And<br>Benzydamine<br>Hydrochloride<br>Antiseptic<br>Lozenges<br>Sugar<br>Free.(Each lozenge contains (i)<br>Cetylpyridinium Chloride- 1<br>mg<br>(ii)<br>Benzydamine<br>Hydrochloride - 3 mg (iii)<br>lsomalt ST-M - 2471.285 mg.	<br> <br> <br> <br> <br> <br> <br>1 Number	1	Cetylpyridinium<br>Chloride	1.00 mg/Lozen
		2	Benzydamine<br>Hydrochloride	3.06 mg/Lozen
		3	Isomalt ST-M	2471.285 mg/Lozen

ST-M - 2471.285 mg.| 1 Number|1|Cetylpyridinium Chloride|1.00 mg/Lozen| ||||2|Benzydamine Hydrochloride|3.06 mg/Lozen| ||||3|Isomalt ST-M|2471.285 mg/Lozen|

Case No.	68 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000608AM25
RA File Number	03AX04000430 AM25
Licence No and<br>Date	0311033683/08/05/2024
Norms Committee Decision:<br>Decision:The case is under consideration and TE was requested to expedite his comments.

Case No.	69 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000616AM25
RA File Number	08AX04000190 AM25
Licence No and<br>Date	0811011469/09/05/2024
Norms Committee Decision:

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Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
Benzylpenicillin sodium 3mg (5mui)	<br>1 Number	1	Benzylpenicillin	3.042 mg.
injection			sodium

xport Product**	Qty.	Sl. No.	Import Items	Qty. allowed.
Benzylpenicillin sodium 3mg (5mui)	<br>1 Number	1	Benzylpenicillin	3.042 mg.
injection			sodium

Case No.<br>70 / NC/3/MEET/Nov/202425/10	Case No.<br>70 / NC/3/MEET/Nov/202425/10
Case Status<br>Case Approved
Party Name<br>AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number<br>HQRNORM APPLY 00000626AM25
RA File Number<br>08AX04000176 AM25
Licence No and<br>Date<br>0811011484/09/05/2024
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. allowed.
Ropivacaine Hydrochloride Inj 200	<br>1 Vial	1	Ropivacaine	210 mg/Vial
mg/100 mL
Ropivacaine Hydrochloride Inj 400	<br>1 Vial	2	Ropivacaine	420 mg/Vial
mg/200 mL
Ropivacaine Hydrochloride Inj 500	<br>1 Vial	3	Ropivacaine	525 mg/Vial
mg/100 mL

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e Hydrochloride Inj 400| 1 Vial|2|Ropivacaine|420 mg/Vial|| |mg/200 mL|||||| |Ropivacaine Hydrochloride Inj 500| 1 Vial|3|Ropivacaine|525 mg/Vial|| |mg/100 mL||||||

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Case No.		71 / NC/3/MEET/Nov/202425/10

Case Status		Case Approved

Party Name		NAPROD LIFE SCIENCES PRIVATE LIMITED
Meeting Number		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
and Date

HQ File Number		HQRNORM APPLY 00000642AM25

RA File Number		03AX04000610 AM25
Licence No and		0311033714/09/05/2024
Date
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Apr/202425/2 dated 30/04/2024against<br>advance authorizationNo.0311024666 dated 19/06/2023, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-

	Export Product		Qty.	Sl. No.	Import Items	Qty. allowed.


	NAPROLAT-	CARBOPLATIN BP<br>1	<br>Number Vial	1	Carboplatin IP/ BP/	472.50 mg/45 ml.
	10 MG/ML I	NJ.

Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| |||||||| |||||||| ||NAPROLAT-|CARBOPLATIN BP 1| Number Vial|1|Carboplatin IP/ BP/|472.50 mg/45 ml.| ||10 MG/ML I|NJ. ( 1x45ML ) 450|||USP/EP|Injection| ||MG.|||||| |||||||| |||||||| |||||||| |RA concerned m||ay take further necessary action as per above decision of NC.||||| |||||||| |Case No.||72 / NC/3/MEET/Nov/202425/10||||| |Case Status||Case Approved||||| |Party Name||JUBILANT GENERICS LIMITED||||| |Meeting Number and Date||NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024||||| |HQ File Number||HQRNORM APPLY 00000653AM25|||||

Case No.	72 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	JUBILANT GENERICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000653AM25

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RA File Number

05AX04000387 AM25

Licence No and Date

0511025423/10/05/2024

Norms Committee Decision: Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo.NC/3/MEET/Sep/202324/14 dated 27/09/2023against advance authorizationNo.0511020697 dated 29/08/2023, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items **Qty.

to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Losartan Potassium 25 mg 1 Tablet 1 Losartan Potassium Ph.Eur (UK) 25.50 mg. Losartan Potassium 50 mg 1 Tablet 2 Losartan Potassium Ph.Eur (UK) 51.00 mg. Losartan Potassium 100 mg 1 Tablet 3 Losartan Potassium Ph.Eur (UK) 102.00 mg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	73 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	K.P.MANISH GLOBAL INGREDIENTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000654AM25
RA File Number	04AX04000110 AM25
Licence No and<br>Date	0411007398/10/05/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-

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Molecular weight not given in the reaction.
Whether export item is Pseudomonic Acid A only and confirm to which Pharmacoepia?
Copy of CoA of Export item.
CoA of import item from Foreign Supplier.
Percentage yield for purification.

m is Pseudomonic Acid A only and confirm to which Pharmacoepia?**

Copy of CoA of Export item.
CoA of import item from Foreign Supplier.
Percentage yield for purification.

Case No.	74 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	NECTAR LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000693AM25
RA File Number	30AX04000069 AM25
Licence No and<br>Date	3011005168/13/05/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	75 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	PRIGIV SPECIALTIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000698AM25
RA File Number	03AX04000618 AM25
Licence No and<br>Date	0311033818/14/05/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	76 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED

57 This document has been digitally signed by Raman Kumar, Deputy DGFT on 17-12-2024 16:53:22.

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57 This document has been digitally signed by Raman Kumar, Deputy DGFT on 17-12-2024 16:53:22.

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Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000700AM25
RA File Number	08AX04000215 AM25
Licence No and<br>Date	0811011547/14/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>Propofol Injectable Emulsion, USP 200 mg<br>per 20 mL (10 mg per mL)<br>1 Vial<br>1<br>Propofol<br>210 mg/Vial<br>Propofol Injectable Emulsion, USP 500 mg<br>per 50 mL (10 mg per mL)<br>1 Vial<br>2<br>Propofol<br>525 mg/Vial<br>Propofol Injectable Emulsion, USP 1,000<br>mg per 100 mL (10 mg per mL)<br>1 Vial<br>3<br>Propofol<br>1050 mg/Vial<br>RA concerned may take further necessary action as per above decision of NC.

Propofol Injectable Emulsion, USP 1,000 mg per 100 mL (10 mg per mL) 1 Vial 3 Propofol 1050 mg/Vial RA concerned may take further necessary action as per above decision of NC.||

Case No.	77 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000703AM25
RA File Number	05AX04000448 AM25
Licence No and<br>Date	0511025482/14/05/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-

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Justification for low yield of 69.2%

Case No.	78 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000706AM25
RA File Number	05AX04000432 AM25
Licence No and Date	0511025488/14/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>Moxifloxacin<br>Hydrochloride<br>2575.125 gram<br>Moxifloxacin HCL and<br>Dexamethasone Sodium Phosphate<br>Eye Drops 0.5%w/v, 0.1% w/v, 5ml<br>((Each ml contain Moxifloxacin<br>Base 5mg. equi. to Moxifloxacin<br>HCL 5.45mg. & Dexamethasone<br>Phosphate 1mg equi. to<br>Dexamethasone Sodium Phosphate<br>1.1mg (Equi.to 2452.500gm<br>Moxifloxacin HCL and 495.000gm<br>Dexamethasone Sodium Phosphate<br>Bulk Drug))<br>90000<br>Numbers<br>2<br>Dexamethasone<br>Sodium Phosphate<br>519.75 gram<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	79 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred

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

Case No.	79 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred

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Party Name	S KANT HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000712AM25
RA File Number	03AX04000705 AM25
Licence No and<br>Date	0311033849/14/05/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	80 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	JALAQUA INTERNATIONAL LLP
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000722AM25
RA File Number	52AX04000032 AM25
Licence No and<br>Date	5211008159/15/05/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>1.Chemical reaction indicating molecular weight of reactants and products with yield.<br>2.Calculation of requirement of raw materials, (both imported and indigenous) with<br>justification of yield of the reaction.<br>3.To indicate indigenous items in Appendix-4E with technical details of the annexure.<br>4.Stoichiometric material balance on a molar basis and commercial value of byproduct, if<br>any.

.To indicate indigenous items in Appendix-4E with technical details of the annexure.** 4.Stoichiometric material balance on a molar basis and commercial value of byproduct, if any.||

Case No.	81 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024

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and Date
HQ File Number	HQRNORM APPLY 00000729AM25
RA File Number	03AX04000711 AM25
Licence No and<br>Date	0311033871/15/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the request of firm in details and also discussed report of factory<br>visit. The committee found that in the above mention case export product is in form of Gel not a<br>cream/Ointments and accordingly decided to fix the ad-hoc norms as under :-<br>Sl.<br>No<br>Export Product<br>Quantity<br>(i)<br>Medical Creams & Ointments(TRIAMCINOLONE ACETO OINT USP, 0.1%<br>454G Tot Wt. 40860 Kgs (Net Cont: Triamcinolone 40.86Kgs, Plastic Jars 90000<br>Nos, Plastic Caps 90000 Nos))<br>1 Number<br>**Sl.

Medical Creams & Ointments(TRIAMCINOLONE ACETO OINT USP, 0.1% 454G Tot Wt. 40860 Kgs (Net Cont: Triamcinolone 40.86Kgs, Plastic Jars 90000 Nos, Plastic Caps 90000 Nos)) 1 Number Sl. No. Import Items Quantity allowed. 1 Relevant Bulk Drugs Net content in the export product plus 2% wastage. 2 Relevant Excipients Net content in the export product plus 2% wastage. 3 Relevant Packaging Material Relevant as per Packing Policy and General Notes. Note: The firm will declare net weight of import items (Relevant Bulk Drugs and Excipients) in export to the RA concerned for redemption. RA concerned may take further necessary action as per above decision of NC.||

Case No. 82 / NC/3/MEET/Nov/202425/10

61 This document has been digitally signed by Raman Kumar, Deputy DGFT on 17-12-2024 16:53:22.

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Case Status	Case Deferred
Party Name	ASHISH LIFE SCIENCE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000731AM25
RA File Number	03AX04000559 AM25
Licence No and<br>Date	0311033874/15/05/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

r|03AX04000559 AM25| |Licence No and Date|0311033874/15/05/2024| |Norms Committee Decision: Decision: The case is under consideration and TE was requested to expedite his comments.||

Case No.	83 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000733AM25
RA File Number	03AX04000685 AM25
Licence No and<br>Date	0311033879/15/05/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Complete chemistry is not given to arrive at API.<br>1.<br>Percentage yield on molar basis for each step.<br>2.<br>Imort item No.2 should be specified as per the CoA of import item from Foreign Supplier.<br>3.<br>Molecular weight of step 2 output is not matching with step 3 input.<br>4.

Case No.	84 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	S KANT HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000736AM25
RA File Number	03AX04000697 AM25
Licence No and<br>Date	0311033882/15/05/2024

62 This document has been digitally signed by Raman Kumar, Deputy DGFT on 17-12-2024 16:53:22.

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Norms Committee Decision:

M25| |Licence No and Date|0311033882/15/05/2024|

62 This document has been digitally signed by Raman Kumar, Deputy DGFT on 17-12-2024 16:53:22.

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Norms Committee Decision:

Decision: The case is under consideration and TE was requested to expedite his comments.

Case No.	85 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000737AM25
RA File Number	34AX04000120 AM25
Licence No and<br>Date	3411004931/15/05/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Commercial value of low Boiler /High Boiler and residue alongwith invoices.

Case No.	Case No.	86 / NC/3/MEET/Nov/202425/10	86 / NC/3/MEET/Nov/202425/10	86 / NC/3/MEET/Nov/202425/10	86 / NC/3/MEET/Nov/202425/10	86 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00000745AM25
RA File Number		03AX04000666 AM25
Licence No and<br>Date		0311033901/16/05/2024

and Date||NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024||||| |HQ File Number||HQRNORM APPLY 00000745AM25||||| |RA File Number||03AX04000666 AM25||||| |Licence No and Date||0311033901/16/05/2024||||| |Norms Committee Decision: Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo.NC/3/MEET/Nov/202425/10 dated 22/11/2024against advance authorizationNo.0311033901 dated 16/05/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|**Sl. No. **|Import Items|Qty. allowed.|

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|1 Mometasone Furoate BP ( Micronized) 11475 gram Mometasone Furoate & Azelastine Hydrochloride Nasal Spray (150MD) / (DIRNELID AZ / MOMATE AZ) 150 MDI(( Each Spray Deliver Mometasone Furoate 50mcg and Azelastine Hydrochloride 140 mcg) ( Net Wt. of Import Sr. No. 1 is 11250 Grams and Import Sr. No.2 is 31500 Grams)) 1500000 Numbers 2 Azelastine Hydrochloride BP 32130 gram 3 Mometasone Furoate BP ( Micronized) 4590 gram Mometasone Furoate & Azelastine Hydrochloride Nasal Spray (75MD) / (DIRNELID AZ / MOMATE AZ) 75 MDI(( Each Spray Deliver Mometasone Furoate 50mcg and Azelastine Hydrochloride 140 mcg) ( Net Wt. of Import Sr. No.

Mometasone Furoate & Azelastine<br>Hydrochloride Nasal Spray<br>(150MD) / (DIRNELID AZ /<br>MOMATE AZ) 150 MDI(( Each<br>Spray Deliver Mometasone Furoate<br>50mcg and Azelastine<br>Hydrochloride 140 mcg) ( Net Wt.<br>of Import Sr. No. 1 is 11250 Grams<br>and Import Sr. No.2 is 31500<br>Grams))	1500000<br>Numbers	1	Mometasone Furoate BP<br>( Micronized)	11475 gram
		2	Azelastine Hydrochloride<br>BP	32130 gram
Mometasone Furoate & Azelastine<br>Hydrochloride Nasal Spray (75MD) /<br>(DIRNELID AZ / MOMATE AZ) 75<br>MDI(( Each Spray Deliver<br>Mometasone Furoate 50mcg and<br>Azelastine Hydrochloride 140 mcg)<br>( Net Wt. of Import Sr. No. 1 is 4500<br>Grams and Import Sr.<br>No.2 is 12600 Grams))	1200000<br>Numbers	3	Mometasone Furoate BP (<br>Micronized)	4590 gram
		4	Azelastine Hydrochloride<br>BP	12852 gram

f Import Sr. No. 1 is 4500 Grams and Import Sr. No.2 is 12600 Grams))|1200000 Numbers|3|Mometasone Furoate BP ( Micronized)|4590 gram| ||||4|Azelastine Hydrochloride BP|12852 gram|

Case No.	87 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000747AM25
RA File Number	07AX04000241 AM25
Licence No and<br>Date	0711011310/16/05/2024
Norms Committee Decision:<br>Decision:The committee considered the request of the firm for fixation of ad-hoc norms and it has been<br>observed that the export item is Opipramol Dihydrochloride whereas the entire chemistry and norms<br>working is given for Opipramol Hydrochloride, therefore, the committee decided that no norms can be<br>proposed under the present details, given by the firm. Accordingly, the committee decided to seek a

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detailed reply from the firm on the matter.

that no norms can be proposed under the present details, given by the firm. Accordingly, the committee decided to seek a||

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detailed reply from the firm on the matter.


detailed reply fro		m the firm on the matter.






Case No.		88 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved

Party Name		J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00000751AM25
RA File Number		03AX04000709 AM25
Licence No and<br>Date		0311033876/16/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/May/202425/4 dated 06/06/2024against<br>advance authorizationNo0311024069 dated 31/05/2023it was decided to fix ad-hoc norms under Para
<br>4.07 of HBP Vo		.,<br>l. I as per details given below or as applied by the firm whichever is less:-
				,



	Export P	roduct	Qty.	Sl. No.	Import Items	Qty. allowed.

	Nifedipine Exten	ded-Release Tablets 30mg.	<br>1 Number	1	SENTRY POLYOX WSR	568 m
	<br>Each tablet contains (i) Sentry Polyox WSR<br>Coagulant NF - 56.80 mg (ii) Eastman (TM<br>Cellulose Acetate (CA 398-10NF/EP)- 33.12 mg<br>(iii) SENTRY POLYOX WSR N80 FP NF -<br>118.40 mg.

68 m| || Each tablet contains (i) Sentry Polyox WSR Coagulant NF - 56.80 mg (ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 33.12 mg (iii) SENTRY POLYOX WSR N80 FP NF - 118.40 mg. Net content (i) 770 Kgs (ii) 448.99 Kgs (iii) 1605.07 Kgs.|| ||COAGULANT NF|. g.| |||||2|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)|33.12 mg| |||||3|SENTRY POLYOX WSR N80 FP NF|118.40 mg.| ||Nifedipine Extended-Release Tablets 60mg. Each tablet contains (i) Sentry Polyox WSR Coagulant NF - 113.60 mg (ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 42.32 mg || 1 Number|4|SENTRY POLYOX WSR COAGULANT NF|113.60 mg.| ||||||EASTMAN (TM) CELLULOSE|| ||(iii) SENTRY PO 23680 mg Net c|LYOX WSR N80 FP NF - ntent (i) 400 Kgs (ii) 14901| |5| ACETATE (CA 398-10NF/EP)|42.32 mg.| ||. . Kgs (iii) 833.80 K|. gs||||| |||||||| |||||6|SENTRY POLYOX WSR N80 FP NF|23680 mg| |||||||. .| |||||||| ||Nifedipine Exten|ded-Release Tablets 90mg.|1 Number|7|SENTRY POLYOX WSR COAGULANT NF|162.9 mg.| ||||||||

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|6|SENTRY POLYOX WSR N80 FP NF|23680 mg| |||||||. .| |||||||| ||Nifedipine Exten|ded-Release Tablets 90mg.|1 Number|7|SENTRY POLYOX WSR COAGULANT NF|162.9 mg.| ||||||||

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	Each tablet conta<br>	<br>	8	EASTMAN (TM) CELLULOSE<br>ACETATE (CA 39810NF/EP)	64.80 mg.
-<br>Coagulant NF - 162.90 mg (ii) Eastman (TM<br>Cellulose Acetate (CA 398-10NF/EP)- 64.80 mg<br>(iii) SENTRY POLYOX WSR N80 FP NF -<br>369.90 mg. Net content (i) 370.01 Kgs (ii)<br>147.19 Kgs (iii) 840.19 Kgs<br>9<br>SENTRY POLYOX WSR N80 FP NF<br>369.90 mg.<br>	Coagulant NF - 162.90 mg (ii) Eastman (TM<br>Cellulose Acetate (CA 398-10NF/EP)- 64.80 mg<br>(iii) SENTRY POLYOX WSR N80 FP NF -<br>369.90 mg. Net content (i) 370.01 Kgs (ii)<br>147.19 Kgs (iii) 840.19 Kgs	<br> <br> <br>		-
			9	SENTRY POLYOX WSR N80 FP NF	369.90 mg.
RA concerned may take further necessary action as per above decision of NC.

.01 Kgs (ii) 147.19 Kgs (iii) 840.19 Kgs|| ||-|| |||||9|SENTRY POLYOX WSR N80 FP NF|369.90 mg.| |RA concerned may take further necessary action as per above decision of NC.|||||||



Case No		89 / NC/3/MEET/Nov/202425/10
.
Case Status		Case Aroved
		pp
Party Name		J B CHEMICALS AND PHARMACEUTICALS LIMITED

Meeting Number<br>and Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024

HQ File Number		HQRNORM APPLY 00000752AM25

RA File Number		03AX04000708 AM25

Licence No and<br>Date		0311033875/16/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/May/202425/4 dated 06/06/2024against<br>advance authorizationNo.0311024069 dated 31/05/2023, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-


	Export P	roduct	Qty.	Sl. No.	Import Items	Qty. allowed.


	Nifedipine Ex<br>30mg.

ven below or as applied by the firm, whichever is less:-||||||| |||||||| |||||||| ||Export P|roduct|Qty.|Sl. No.|Import Items|Qty. allowed.| |||||||| |||||||| ||Nifedipine Ex 30mg. Each ta|tended-Release Tablets blet contains (i) Sentry| 1 Number|1|SENTRY POLYOX WSR COAGULANT NF| 56.8 mg.| || Polyox WSR| Coagulant NF - 56.80| |||| || mg(ii) East| man (TM Cellulose| |||| ||Acetate (CA mg (iii) SEN|398-10NF/EP)- 33.12 TRY POLYOX WSR| |2|EASTMAN (TM) CELLULOSE ACETATE | 33.12 mg| || N80 FP NF - 118.40 mg. Net content (i) 770 Kgs (ii) 448.99 Kgs (iii) 1605.07 Kgs.|| ||(CA 398-10NF/EP)|| |||||3|SENTRY POLYOX WSR N80 FP NF| 118.40 mg.|

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Nifedipine Extended-Release Tablets	<br>1 Number	4	SENTRY POLYOX WSR	<br>113.60 mg.
60mg. Each tablet contains (i) Sentry			COAGULANT NF
Polyox WSR Coagulant NF - 113.60
mg(ii)<br>Eastman<br>(TM<br>Cellulose<br>Acetate (CA 398-10NF/EP)- 42.32<br>mg (iii) SENTRY POLYOX WSR<br>N80 FP NF - 236.80 mg. Net content	<br> <br> <br>	5	EASTMAN (TM)<br>CELLULOSE ACETATE<br>(CA 398-10NF/EP)	<br>42.32 mg.
(i) 400 Kgs (ii) 149.01 Kgs (iii)
833.80 Kgs		6	SENTRY POLYOX WSR	<br>236.80 mg.
			N80 FP NF
Nifedipine Extended-Release Tablets	<br>1 Number	7	SENTRY POLYOX WSR	<br>162.9 mg.
90mg.

.| |(i) 400 Kgs (ii) 149.01 Kgs (iii)||||| |833.80 Kgs||6|SENTRY POLYOX WSR| 236.80 mg.| ||||N80 FP NF|| |Nifedipine Extended-Release Tablets| 1 Number|7|SENTRY POLYOX WSR| 162.9 mg.| |90mg. Each tablet contains (i) Sentry|||COAGULANT NF|| |Polyox WSR Coagulant NF - 162.90||||| |mg(ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 64.80 mg (iii) SENTRY POLYOX WSR N80 FP NF - 369.90 mg. Net content| |8|EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)| 64.80 mg.| |(i) 370.01 Kgs (ii) 147.19 Kgs (iii)||||| |840.19 Kgs||9|SENTRY POLYOX WSR| 369.90 mg.| ||||N80 FP NF||

Case No.	90 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	PRIGIV SPECIALTIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000772AM25
RA File Number	03AX04000620 AM25
Licence No and<br>Date	0311033931/16/05/2024
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:-

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

67 This document has been digitally signed by Raman Kumar, Deputy DGFT on 17-12-2024 16:53:22.

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Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>Cis-3-Hexenol<br>0.653 kg.<br>Luzernyl Butyrate<br>1 kg.<br>2<br>Butyric acid<br>0.575 kg.<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import Items	Qty. allowed.
	Luzernyl Butyrate	1 kg.	1	Cis-3-Hexenol	0.653 kg.
			2	Butyric acid	0.575 kg.

Case No.	Case No.	91 / NC/3/MEET/Nov/202425/10	91 / NC/3/MEET/Nov/202425/10	91 / NC/3/MEET/Nov/202425/10	91 / NC/3/MEET/Nov/202425/10	91 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		COVALENT LABORATORIES PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00000773AM25
RA File Number		09AX04000101 AM25
Licence No and Date		0911007242/17/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms<br>under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. 1 7-Phenylacetamideo-3- Chloromethyl Cephalosporonic Acid Para Methoxybenzyl Ester (GCLE) 2.672 kg. 2 Acetone 8.85 kg. 3 Methylene Chloride 5.70 kg. 4 Methanol 5.70 kg. 7-AMINO-3-VINYL-3- CEPHEM-4-CARBOXYLIC ACID (7-AVCA)(API) 1 kg.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||7-AMINO-3-VINYL-3- CEPHEM-4-CARBOXYLIC ACID (7-AVCA)(API)||1 kg.|1|7-Phenylacetamideo-3- Chloromethyl Cephalosporonic Acid Para Methoxybenzyl Ester (GCLE)|2.672 kg.| |||||2|Acetone|8.85 kg.| |||||3|Methylene Chloride|5.70 kg.| |||||4|Methanol|5.70 kg.|

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	5	Activated Carbon	0.100 kg.
	6	Triphenyl Phosphine	1.26 kg.

Case No.	92 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	VINS BIOPRODUCTS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000776AM25
RA File Number	09AX04000030 AM25
Licence No and<br>Date	0911007243/17/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to refer the case toDeptt.<br>of Bio-Technologyfor obtaining their comments.

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

Decision: The Committee considered the case as per agenda and it was decided to refer the case to Deptt. of Bio-Technology for obtaining their comments.

Case No.	93 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	KLJ PLASTICIZERS LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000784AM25
RA File Number	05AX04000474 AM25
Licence No and<br>Date	0511025589/17/05/2024
Norms Committee Decision:<br>Decision: The case is under consideration and TE was requested to expedite his comments.

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Case No.	94 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	MOREPEN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000787AM25
RA File Number	05AX04000479 AM25
Licence No and<br>Date	0511025590/17/05/2024
Norms Committee Decision:
Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice
of the TE, it was	decided to call for following information/documents from the firm:-
Complete chemical description of export item alongwith copy of Shipping Bill in support of it.<br>1.
CoA of Export Item.<br>2.

ll for following information/documents from the firm:-| |Complete chemical description of export item alongwith copy of Shipping Bill in support of it. 1.|| |CoA of Export Item. 2.||

Case No.	95 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	PRIGIV SPECIALTIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000797AM25
RA File Number	03AX04000605 AM25
Licence No and<br>Date	0311033967/17/05/2024
Norms Committee Decision:
Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice
of the TE, it was	decided to call for following information/documents from the firm:-
Manufactur process endorsed is for other product i.e. Luzernyl Butyrate.

Case No.	96 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	TORRENT PHARMACEUTICALS LTD
Meeting Number and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000852AM25
RA File Number	08AX04000258 AM25
Licence No and Date	0811011655/22/05/2024

70 This document has been digitally signed by Raman Kumar, Deputy DGFT on 17-12-2024 16:53:22.

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Norms Committee Decision:

8 AM25| |Licence No and Date|0811011655/22/05/2024|

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Norms Committee Decision:

Decision: The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meeting No.NC/3/MEET/Aug/202425/8 dated 28/08/2024 against advance authorization No.0811011227 dated 04/04/2024 , 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:-

|Norms Committee Decision: Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo.NC/3/MEET/Aug/202425/8 dated 28/08/2024against advance authorizationNo.0811011227 dated 04/04/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 2 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 17.800 KG IN EXPORT ITEM) 1 Number 1 CANDESARTAN CILEXETIL PH.EUR 2.04 mg. CANDESARTAN CILEXETIL 4 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH.

THAN 17.800 KG IN EXPORT ITEM) 1 Number 1 CANDESARTAN CILEXETIL PH.EUR 2.04 mg. CANDESARTAN CILEXETIL 4 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 4 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 23.600 KG IN EXPORT ITEM) 1 Number 2 CANDESARTAN CILEXETIL PH.EUR 4.08 mg. CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 8 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 204.00 KG IN EXPORT ITEM) 1 Number 3 CANDESARTAN CILEXETIL PH.EUR 8.16 mg. CANDESARTAN CILEXETIL 16 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 16 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 408 KG IN EXPORT ITEM) 1 Number 4 CANDESARTAN CILEXETIL PH.EUR 16.32 mg. CANDESARTAN CILEXETIL 32 MG TABLETS(EACH UNCOATED TABLET 1 Number 5 CANDESARTAN CILEXETIL PH.EUR 32.64 mg.|Norms Committee Decision: Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo.NC/3/MEET/Aug/202425/8 dated 28/08/2024against advance authorizationNo.0811011227 dated 04/04/2024, 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.

04/04/2024**, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 2 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 17.800 KG IN EXPORT ITEM) 1 Number 1 CANDESARTAN CILEXETIL PH.EUR 2.04 mg. CANDESARTAN CILEXETIL 4 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 4 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 23.600 KG IN EXPORT ITEM) 1 Number 2 CANDESARTAN CILEXETIL PH.EUR 4.08 mg. CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 8 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 204.00 KG IN EXPORT ITEM) 1 Number 3 CANDESARTAN CILEXETIL PH.EUR 8.16 mg. CANDESARTAN CILEXETIL 16 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 16 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 408 KG IN EXPORT ITEM) 1 Number 4 CANDESARTAN CILEXETIL PH.EUR 16.32 mg. CANDESARTAN CILEXETIL 32 MG TABLETS(EACH UNCOATED TABLET 1 Number 5 CANDESARTAN CILEXETIL PH.EUR 32.64 mg.|Norms Committee Decision: **Decision:**The Committee considered the case as per agenda and taking cue from the earlier

OATED TABLET 1 Number 5 CANDESARTAN CILEXETIL PH.EUR 32.64 mg.|Norms Committee Decision: Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo.NC/3/MEET/Aug/202425/8 dated 28/08/2024against advance authorizationNo.0811011227 dated 04/04/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 2 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 17.800 KG IN EXPORT ITEM) 1 Number 1 CANDESARTAN CILEXETIL PH.EUR 2.04 mg. CANDESARTAN CILEXETIL 4 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 4 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 23.600 KG IN EXPORT ITEM) 1 Number 2 CANDESARTAN CILEXETIL PH.EUR 4.08 mg. CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH.

THAN 23.600 KG IN EXPORT ITEM) 1 Number 2 CANDESARTAN CILEXETIL PH.EUR 4.08 mg. CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 8 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 204.00 KG IN EXPORT ITEM) 1 Number 3 CANDESARTAN CILEXETIL PH.EUR 8.16 mg. CANDESARTAN CILEXETIL 16 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 16 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 408 KG IN EXPORT ITEM) 1 Number 4 CANDESARTAN CILEXETIL PH.EUR 16.32 mg. CANDESARTAN CILEXETIL 32 MG TABLETS(EACH UNCOATED TABLET 1 Number 5 CANDESARTAN CILEXETIL PH.EUR 32.64 mg.|Norms Committee Decision: Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo.NC/3/MEET/Aug/202425/8 dated 28/08/2024against advance authorizationNo.0811011227 dated 04/04/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH.

r>Export Product Qty. Sl. No. Import Items Qty. allowed. CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 2 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 17.800 KG IN EXPORT ITEM) 1 Number 1 CANDESARTAN CILEXETIL PH.EUR 2.04 mg. CANDESARTAN CILEXETIL 4 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 4 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 23.600 KG IN EXPORT ITEM) 1 Number 2 CANDESARTAN CILEXETIL PH.EUR 4.08 mg. CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 8 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 204.00 KG IN EXPORT ITEM) 1 Number 3 CANDESARTAN CILEXETIL PH.EUR 8.16 mg. CANDESARTAN CILEXETIL 16 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 16 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 408 KG IN EXPORT ITEM) 1 Number 4 CANDESARTAN CILEXETIL PH.EUR 16.32 mg. CANDESARTAN CILEXETIL 32 MG TABLETS(EACH UNCOATED TABLET 1 Number 5 CANDESARTAN CILEXETIL PH.EUR 32.64 mg.|Norms Committee Decision: Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo.NC/3/MEET/Aug/202425/8 dated 28/08/2024against advance authorization**No.0811011227 dated

er agenda and taking cue from the earlier decision for same export product/import item in meetingNo.NC/3/MEET/Aug/202425/8 dated 28/08/2024against advance authorizationNo.0811011227 dated 04/04/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 2 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 17.800 KG IN EXPORT ITEM) 1 Number 1 CANDESARTAN CILEXETIL PH.EUR 2.04 mg. CANDESARTAN CILEXETIL 4 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 4 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 23.600 KG IN EXPORT ITEM) 1 Number 2 CANDESARTAN CILEXETIL PH.EUR 4.08 mg. CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH.

THAN 23.600 KG IN EXPORT ITEM) 1 Number 2 CANDESARTAN CILEXETIL PH.EUR 4.08 mg. CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 8 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 204.00 KG IN EXPORT ITEM) 1 Number 3 CANDESARTAN CILEXETIL PH.EUR 8.16 mg. CANDESARTAN CILEXETIL 16 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 16 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 408 KG IN EXPORT ITEM) 1 Number 4 CANDESARTAN CILEXETIL PH.EUR 16.32 mg. CANDESARTAN CILEXETIL 32 MG TABLETS(EACH UNCOATED TABLET 1 Number 5 CANDESARTAN CILEXETIL PH.EUR 32.64 mg.|Norms Committee Decision: Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for same export product/import item in meetingNo.NC/3/MEET/Aug/202425/8 dated 28/08/2024against advance authorizationNo.0811011227 dated 04/04/2024, it was decided to fix ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH.

r>Export Product Qty. Sl. No. Import Items Qty. allowed. CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 2 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 17.800 KG IN EXPORT ITEM) 1 Number 1 CANDESARTAN CILEXETIL PH.EUR 2.04 mg. CANDESARTAN CILEXETIL 4 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 4 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 23.600 KG IN EXPORT ITEM) 1 Number 2 CANDESARTAN CILEXETIL PH.EUR 4.08 mg. CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 8 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 204.00 KG IN EXPORT ITEM) 1 Number 3 CANDESARTAN CILEXETIL PH.EUR 8.16 mg. CANDESARTAN CILEXETIL 16 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 16 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 408 KG IN EXPORT ITEM) 1 Number 4 CANDESARTAN CILEXETIL PH.EUR 16.32 mg. CANDESARTAN CILEXETIL 32 MG TABLETS(EACH UNCOATED TABLET 1 Number 5 CANDESARTAN CILEXETIL PH.EUR 32.64 mg.| |---|---|---|---|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.| ||CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH.

--|---|---| ||Export Product|Qty.|Sl. No.|Import Items|Qty. allowed.| ||CANDESARTAN CILEXETIL 2 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 2 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 17.800 KG IN EXPORT ITEM)|1 Number|1|CANDESARTAN CILEXETIL PH.EUR|2.04 mg.| ||CANDESARTAN CILEXETIL 4 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 4 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 23.600 KG IN EXPORT ITEM)|1 Number|2|CANDESARTAN CILEXETIL PH.EUR|4.08 mg.| ||CANDESARTAN CILEXETIL 8 MG TABLETS(EACH UNCOATED TABLET CONTAINS: CANDESARTAN CILEXETIL PH. EUR 8 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 204.00 KG IN EXPORT ITEM)|1 Number|3|CANDESARTAN CILEXETIL PH.EUR|8.16 mg.| ||CANDESARTAN CILEXETIL 16 MG TABLETS(EACH UNCOATED TABLET CONTAINS : CANDESARTAN CILEXETIL PH. EUR 16 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 408 KG IN EXPORT ITEM)|1 Number|4|CANDESARTAN CILEXETIL PH.EUR|16.32 mg.| ||CANDESARTAN CILEXETIL 32 MG TABLETS(EACH UNCOATED TABLET|1 Number|5|CANDESARTAN CILEXETIL PH.EUR|32.64 mg.|

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)|1 Number|4|CANDESARTAN CILEXETIL PH.EUR|16.32 mg.| ||CANDESARTAN CILEXETIL 32 MG TABLETS(EACH UNCOATED TABLET|1 Number|5|CANDESARTAN CILEXETIL PH.EUR|32.64 mg.|

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CONTAINS : CANDESARTAN<br>CILEXETIL PH. EUR 32 MG NET<br>CONTENT OF CANDESARTAN<br>CILEXETIL SHOULD NOT BE LESS<br>THAN 608.00 KG IN EXPORT ITEM)
CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZID E<br>TABLETS 8 MG +12.5 MG (EACH<br>UNCOATED TABLET CONTAINS<br>CANDESARTAN CILEXETIL PH. EUR 8<br>MG AND HYDROCHLOROTHIAZIDE<br>PH. EUR. 12.5 MG NET CONTENT OF<br>CANDESARTAN CILEXETIL SHOULD<br>NOT BE LESS THAN 10.400 KG IN<br>EXPORT ITEM)	1 Number	6	CANDESARTAN<br>CILEXETIL PH.EUR	8.16 mg.
CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZID E<br>TABLETS 16 MG +12.5 MG(EACH<br>UNCOATED TABLET CONTAINS<br>CANDESARTAN CILEXETIL PH. EUR<br>16 MG AND HYDROCHLOROTHIAZIDE<br>PH. EUR. 12.5 MG NET CONTENT OF<br>CANDESARTAN CILEXETIL SHOULD<br>NOT BE LESS THAN 22.400 KG IN<br>EXPORT ITEM)	1 Number	7	CANDESARTAN<br>CILEXETIL PH.EUR	16.32 mg.
CANDESARTAN CILEXETIL AND<br>HYDROCHLOROTHIAZID E<br>TABLETS 32 MG +12.5 MG(EACH<br>UNCOATED TABLET CONTAINS<br>CANDESARTAN CILEXETIL PH. EUR<br>32 MG AND HYDROCHLOROTHIAZIDE<br>PH. EUR.

SARTAN CILEXETIL AND HYDROCHLOROTHIAZID E TABLETS 32 MG +12.5 MG(EACH UNCOATED TABLET CONTAINS CANDESARTAN CILEXETIL PH. EUR 32 MG AND HYDROCHLOROTHIAZIDE PH. EUR. 12.5 MG NET CONTENT OF CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 27.200 KG IN EXPORT ITEM)|1 Number|8|CANDESARTAN CILEXETIL PH.EUR|32.64 mg.| ||CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZID E TABLETS 32 MG +25 MG(EACH UNCOATED TABLET CONTAINS CANDESARTAN CILEXETIL PH. EUR 32 MG AND HYDROCHLOROTHIAZIDE PH EUR. 25 MG NET CONTENT OF|1 Number|9|CANDESARTAN CILEXETIL PH.EUR|32.64 mg.|

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CANDESARTAN CILEXETIL SHOULD NOT BE LESS THAN 27.200 KG IN EXPORT ITEM)

Case No.	97 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	AMNEAL PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000853AM25
RA File Number	08AX04000275 AM25
Licence No and<br>Date	0811011659/22/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and taking cue from the earlier decision for<br>same export product/import item in meetingNo.NC/3/MEET/Aug/202425/8 dated 28/08/2024against<br>advance authorizationNo.0811011114 dated 27/03/2024, it was decided to fix ad-hoc norms under Para<br>4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. Tranexamic Acid Injection 100mg/mL (10mL) 1 Number 1 Tranexamic acid (Injectable grade, US FDA approved) 1.05 gm/100 ml. Vial RA concerned may take further necessary action as per above decision of NC.||

Case No.	98 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved

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Party Name	HONOUR LAB LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000864AM25
RA File Number	09AX04000065 AM25
Licence No and Date	0911007285/22/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.<br>1<br>2-Acetoxybenzoic acid<br>0.894 kg.<br>NITAZOXANIDE(Diloxanide<br>furoate, Cimetidine, Oxyclozanide,<br>Famotidine:)<br>1 kg.<br>2<br>5-Nitrothiazol-2-amine<br>0.59 kg.<br>RA concerned may take further necessary action as per above decision of NC.

iloxanide furoate, Cimetidine, Oxyclozanide, Famotidine:) 1 kg. 2 5-Nitrothiazol-2-amine 0.59 kg. RA concerned may take further necessary action as per above decision of NC.||

Case No.	Case No.	99 / NC/3/MEET/Nov/202425/10	99 / NC/3/MEET/Nov/202425/10	99 / NC/3/MEET/Nov/202425/10	99 / NC/3/MEET/Nov/202425/10	99 / NC/3/MEET/Nov/202425/10
Case Status		Case Approved
Party Name		LEBEN LABORATORIES PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number		HQRNORM APPLY 00000865AM25
RA File Number		03AX04000768 AM25
Licence No and Date		0311033991/22/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty. allowed.
	Export Product		Qty.	Sl.<br>No.	Import Items	Qty. allowed.

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t** Qty. Sl. No. Import Items Qty. allowed.||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.|

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	MOXILEB-250DT . AMOXICILLIN<br>TABLET 250MG.((EACH TABLET<br>CONTAINING AMOXICILLIN<br>TRYHYDRATE EQUIVALENT TO<br>250MG OF AMOXICILLIN) . NET<br>CONTENT OF IMPORT/EXEMPT<br>MATERIAL USED IN EXPORT<br>PRODUCT<br>1)<br>AMOXICILLIN<br>TRYHYDRATE BP (COMPACTD) -<br>157.850KGS<br>(EXCLUDING<br>2%<br>WASTAGE))	<br> <br>550000<br>Numbers<br>Tablets	1	AMOXICILLIN<br>TRYHYDRATE BP<br>COMPACTED	160.95 kg.
	MOXILEB-250 CAPSULE.<br>AMOXICILLIN CAPSULE 250MG<br>.((EACH CAPSULE CONTAINING<br>AMOXICILLIN TRYHYDRATE<br>EQUIVALENT TO 250MG OF<br>AMOXICILLIN). NET CONTENT OF<br>IMPORT/EXEMPT MATERIAL<br>USED IN EXPORT PRODUCT 1)<br>AMOXICILLIN TRYHYDRATE BP<br>(COMPATED)-2658.927KGS<br>(EXCLUDING 2% WASTAGE))	9264554<br>Numbers<br>Capsules	2	AMOXICILLIN<br>TRYHYDRATE BP<br>COMPACTED	2711.17 kg.
	MOXILEB-500 CAPSULE.<br>AMOXICILLIN CAPSULE<br>500MG.((EACH CAPSULE<br>CONTAINING AMOXICILLIN<br>TRYHYDRATE EQUIVALENT TO<br>500MG OF AMOXICILLIN).

CILLIN TRYHYDRATE BP COMPACTED|2711.17 kg.| ||MOXILEB-500 CAPSULE. AMOXICILLIN CAPSULE 500MG.((EACH CAPSULE CONTAINING AMOXICILLIN TRYHYDRATE EQUIVALENT TO 500MG OF AMOXICILLIN). NET CONTENT OF IMPORT/EXEMPT MATERIAL USED IN EXPORT PRODUCT 1) AMOXICILLIN TRYHYDRATE BP (COMPACTED) - 1722.00KGS (EXCLUDING 2% WASTAGE))| 3000000 Numbers Capsules|3|AMOXICILLIN TRYHYDRATE BP COMPACTED|1755.84 kg.| ||MOXILEB ORAL SUSPENSION. AMOXICILLIN ORAL SUSPENSION (AMOXICILLIN SYRUP) 125MG/100ML BOTTLE ((EACH 5ML CONTAINS AMOXICILLIN TRYHYDRATE|126545 Numbers Bottles|4|AMOXICILLIN TRYHYDRATE BP COMPACTED|370.45 kg.|

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EQUIVALENT TO 125MG OF AMOXICILLIN). NET CONTENT OF IMPORT/EXEMPT MATERIAL USED IN EXPORT PRODUCT 1) AMOXICILLIN TRYHYDRATE BP (COMPACTED) - 363.184 KGS ( EXCLUDING 2% WASTAGE))

Case No.	100 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	MICRO LABS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000879AM25
RA File Number	07AX04000179 AM25
Licence No and<br>Date	0711011361/24/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>**Qty.

ad-hoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:- Export Product Qty. Sl. No. Import Items Qty. allowed. RAMELTEON 8MG TABLETS 1 Number 1 RAMELTEON 8.16 mg/Tablet RA concerned may take further necessary action as per above decision of NC.||

UDIN00500956AM25

Case No.	101 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	NEOGEN CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000901AM25
RA File Number	03AX04000936 AM25
Licence No and<br>Date	0311034124/27/05/2024
Norms Committee Decision:<br>Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice<br>of the TE, it was decided to call for following information/documents from the firm:-<br>Percentage of export and import item with CoA.

for fixation of ad-hoc norms and as per the advice of the TE, it was decided to call for following information/documents from the firm:- Percentage of export and import item with CoA.||

Case No.	102 / NC/3/MEET/Nov/202425/10
Case Status	Case Approved
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000905AM25
RA File Number	08AX04000290 AM25
Licence No and Date	0811011668/27/05/2024
Norms Committee Decision:<br>Decision:The Committee considered the case as per agenda and it was decided to fix ad-hoc norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty.<br>allowed.<br>Benzathine Benzylpenicillin 1.44g (2.4MU)<br>Injection<br>(BENZATHINE<br>BENZYLPENICILLIN)<br>1 Number<br>1<br>Benzathine<br>Benzylpencillin<br>Sterile BP<br>1.512 mg.<br>RA concerned may take further necessary action as per above decision of NC.

UDIN00500956AM25

YLPENICILLIN) 1 Number 1 Benzathine Benzylpencillin Sterile BP 1.512 mg. RA concerned may take further necessary action as per above decision of NC.||

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Case No.	103 / NC/3/MEET/Nov/202425/10
Case Status	Case Deferred
Party Name	MELOG SPECIALITY CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number	HQRNORM APPLY 00000920AM25
RA File Number	03AX04000829 AM25
Licence No and<br>Date	0311034133/27/05/2024
Norms Committee Decision:
Decision:The committee considered the request of firm for fixation of ad-hoc norms and as per the advice
of the TE, it was	decided to call for following information/documents from the firm:-
Quantity and value of by-product i.e. Isobutylene PTBP and Polymer of butylated hydrocarbon.

Case No.<br>104 / NC/3/MEET/Nov/202425/10	Case No.<br>104 / NC/3/MEET/Nov/202425/10
Case Status<br>Case Approved
Party Name<br>USV PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202425/ 10 and 22/11/2024
HQ File Number<br>HQRNORM APPLY 00000921AM25
RA File Number<br>03AX04000940 AM25
Licence No and<br>Date<br>0311034134/27/05/2024
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.

agenda and it was decided to fix|||ad-hoc norms under|| |Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:-|||||| |Export Product|Qty.|**Sl. No. **|Import Items|Qty. allowed.|| |Acetazolamide ER capsules 500|1 Number|1|Acetazolamide USP|510 mg/Capsule|| |MG 100 S, US((10,200 Bottles X|||||| |100 Capsules Per Bottles =|||||| |10,20,000 Capsules) (Total|||||| |Weight of Export Product =|||||| |510.000 Kgs) (Net Content||||||

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weight of Import Product = 563.091 kgs))

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