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Top first-in-class drug candidates of 2025: Ionis’ donidalorsen, Sanofi’s fitusiran, Cytokinetics’ aficamten await FDA approval

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Pipeline Prospector Feb 2025: Bain buys Mitsubishi Tanabe for US$ 3.4 bn; Japan’s Ono gets FDA nod for rare joint tumor drug

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ACTIVE PHARMA INGREDIENTS

17 API Suppliers, 10 USDMF, 6 CEP/COS, 4 NDC API, 7 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

64 FDF Dossiers, 40 FDA Orange Book, 18 Canada, 3 South Africa, 3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

DIGITAL CONTENT

13 NEWS #PharmaBuzz

13 NEWS #PharmaBuzz

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1 APIs

1 APIs

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 3 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
24/02/2025	Sanofi	France	SANOFI CHIMIE	2364	NORGESTERAL ACETATE OXIME	1974-11-26	Inactive	II	N/A
24/02/2025	TAPI Technology & API Services	Israel	TEVA PHARMACEUTICAL INDUSTRIES LTD	14241	NORGESTIMATE BULK DRUG SUBSTANCE	1999-06-25	Active	II	N/A

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ACTIVE PHARMA INGREDIENTS

17 API Suppliers

10 USDMF

6 CEP/COS

4 NDC API

7 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

64 FDF Dossiers

40 FDA Orange Book

18 Canada

3 South Africa

3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL-28 - 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

DIGITAL CONTENT

13 NEWS #PharmaBuzz

MARKET PLACE

1 APIs

REF. STANDARDS & IMPURITIES

2 EDQM

2 USP

3 Others

ANALYTICAL

1 BioAnalytical Methods

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