FDA approvals drop 8% in 2025, with fewer blockbusters; Brinsupri, Rhapsido make it to first-in-class list

DATA COMPILATION
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Pipeline Prospector February 2026 highlights: Gilead buys Arcellx for US$ 7.8 bn; FDA okays Vanda’s psychotic pill

Stock Recap
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ACETASOL HC

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ACTIVE PHARMA INGREDIENTS

82 API Suppliers, 29 USDMF, 14 CEP/COS, 6 JDMF, 9 EU WC, 10 KDMF, 39 NDC API, 1 VMF, 32 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

53 Drugs in Development

53 Drugs in Development

FINISHED DOSAGE FORMULATIONS

594 FDF Dossiers, 237 FDA Orange Book, 285 Europe, 14 Canada, 8 Australia, 28 South Africa, 22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%, CREAM;TOPICAL - 5%;1%, OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 1%, LOTION;TOPICAL - 2%, TABLET;ORAL - 10MG, TABLET;ORAL - 20MG, TABLET;ORAL - 5MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 4 Rochem International Inc, 8 SPI Pharma, 1 Pharm-RX Chemical, 7 Gangwal Healthcare, 24 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 4 Pfanstiehl, 23 Kirsch Pharma, 22 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 42 BASF, 3 BioSpectra, 4 CD Formulation, 1 Clariant, 15 Corel Pharma Chem, 7 DFE Pharma, 3 Esteem Industries, 6 Finar, 16 Gangwal Chemicals, 4 Gloria Interchem, 2 Hayashibara, 2 Ideal Cures, 4 Ingredion Pharma Solutions, 19 Kerry, 3 Keval Exports, 9 Lubrizol Life Science Health, 17 Microlex e.U, 3 Nanjing Bold Chemical, 2 Neelkanth MineChem, 2 Nippon Fine Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 33 Roquette, 21 Seppic, 2 Shandong Focus Biotechnology Co., Ltd, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 5 Silverline Chemicals, 1 Symrise, 2 Valens Pharmachem, 5 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

83 Topical, 61 Thickeners and Stabilizers, 59 Solubilizers, 55 Parenteral, 51 Fillers, Diluents & Binders, 36 Direct Compression, 34 Emulsifying Agents, 33 Granulation, 27 Disintegrants & Superdisintegrants, 25 Coating Systems & Additives, 24 Surfactant & Foaming Agents, 23 Controlled & Modified Release, 23 Lubricants & Glidants, 20 Film Formers & Plasticizers, 18 Taste Masking, 15 Co-Processed Excipients, 12 Chewable & Orodispersible Aids, 7 Rheology Modifiers, 6 API Stability Enhancers, 1 Soft Gelatin

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 54 News #PharmaBuzz

GLOBAL SALES INFORMATION

38 US Medicaid Prescriptions, 54 Regulatory FDF Prices, 1 Annual Reports

MARKET PLACE

39 APIs, 17 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 1 US Exclusivities, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 3 JP, 27 Others

ANALYTICAL

2 BioAnalytical Methods, 4 Analytical Methods

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
27/02/2026	Curia	U.S.A	CURIA SPAIN SAU	33002	HYDROCORTISONE MICRONIZED	2018-07-31	Active	II	Complete	2019-01-07	2018-09-18
27/02/2026	Pfizer CentreOne	U.S.A	PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INC	1413	HYDROCORTISONE MICRONIZED AND NON-MICRONIZED	1969-09-02	Active	II	Complete	2013-02-26	2013-02-13

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

ACETASOL HC

ACETASOL HC

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

82 API Suppliers

29 USDMF

14 CEP/COS

6 JDMF

9 EU WC

10 KDMF

39 NDC API

1 VMF

32 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

53 Drugs in Development

FINISHED DOSAGE FORMULATIONS

594 FDF Dossiers

237 FDA Orange Book

285 Europe

14 Canada

8 Australia

28 South Africa

22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%

CREAM;TOPICAL - 5%;1%

OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CREAM;TOPICAL - 1%

LOTION;TOPICAL - 2%

TABLET;ORAL - 10MG

TABLET;ORAL - 20MG

TABLET;ORAL - 5MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI

4 Rochem International Inc

8 SPI Pharma

1 Pharm-RX Chemical

7 Gangwal Healthcare

24 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

4 Pfanstiehl

23 Kirsch Pharma

22 Actylis

1 Aeon Procare

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

42 BASF

3 BioSpectra

4 CD Formulation

1 Clariant

15 Corel Pharma Chem

7 DFE Pharma

3 Esteem Industries

6 Finar

16 Gangwal Chemicals

4 Gloria Interchem

2 Hayashibara

2 Ideal Cures

4 Ingredion Pharma Solutions

19 Kerry

3 Keval Exports

9 Lubrizol Life Science Health

17 Microlex e.U

3 Nanjing Bold Chemical

2 Neelkanth MineChem

2 Nippon Fine Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

7 Pluviaendo

4 Prachin Chemical

33 Roquette

21 Seppic

2 Shandong Focus Biotechnology Co., Ltd

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

10 Sigachi Industries

OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons