FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

Data Compilation
#PharmaFlow

Stock Recap
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AC-941

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ACTIVE PHARMA INGREDIENTS

93 API Suppliers, 37 USDMF, 29 CEP/COS, 10 JDMF, 18 EU WC, 9 KDMF, 34 NDC API, 48 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

99 Drugs in Development

99 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

502 FDF Dossiers, 41 FDA Orange Book, 298 Europe, 22 Canada, 69 Australia, 31 South Africa, 41 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

OINTMENT;TOPICAL - 0.1%, CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, LOTION;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, AEROSOL, METERED;INHALATION - 0.05MG/INH, AEROSOL, METERED;INHALATION - 0.10MG/INH, AEROSOL, METERED;INHALATION - 0.20MG/INH, SPRAY, METERED;NASAL - 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER;INHALATION - 0.11MG/INH, POWDER;INHALATION - 0.22MG/INH, AEROSOL, METERED;INHALATION - 0.005MG/INH;0.05MG/INH, AEROSOL, METERED;INHALATION - 0.005MG/INH;0.1MG/INH, AEROSOL, METERED;INHALATION - 0.005MG/INH;0.2MG/INH

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Rochem International Inc, 1 SPI Pharma, 2 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 6 Kirsch Pharma, 6 Actylis, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 4 BASF, 1 CD Formulation, 3 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 1 Ideal Cures, 5 Kerry, 2 Keval Exports, 1 Kima Chemical, 6 Microlex e.U, 1 Nanjing Bold Chemical, 1 Nitika Pharmaceutical Specialities, 1 Pharmatrans-Sanaq, 1 Pluviaendo, 1 Prachin Chemical, 9 Roquette, 6 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 8 Sigachi Industries, 1 Silverline Chemicals, 1 The Dow Chemical Company, 1 Valens Pharmachem, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

20 Solubilizers, 18 Thickeners and Stabilizers, 17 Parenteral, 16 Fillers, Diluents & Binders, 16 Direct Compression, 10 Topical, 9 Film Formers & Plasticizers, 9 Granulation, 8 Co-Processed Excipients, 7 Coating Systems & Additives, 5 Disintegrants & Superdisintegrants, 5 Emulsifying Agents, 4 Taste Masking, 4 Rheology Modifiers, 3 Controlled & Modified Release, 3 Chewable & Orodispersible Aids, 3 Surfactant & Foaming Agents, 2 Lubricants & Glidants, 1 API Stability Enhancers

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 52 News #PharmaBuzz

GLOBAL SALES INFORMATION

14 US Medicaid Prescriptions, 29 Regulatory FDF Prices, 16 Annual Reports

MARKET PLACE

17 APIs, 4 FDF Dossiers

PATENTS & EXCLUSIVITIES

23 US Patents, 1 US Exclusivities, 34 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 1 USP, 2 Others

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Registrant Name	MF Registration No.	Classification	Initial Date of Reg.	Latest Date of Reg.	Registrant's Address
02/02/2026	Hovione	Portugal	HOVIONE FARMACIENCIA SA	307MF10155	Mometasone furoate hydrate	2025-12-23	2025-12-23	Sete Casas 2674-506 Loures PORTUGAL
29/01/2026	MSD INTL GMBH	Singapore	MSD International GmbH (Singapore Branch)	218MF10890	Mometasone furoate	2006-11-10	2008-06-30	50 Tuas West Drive Singapore 638408

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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.

AC-941

AC-941

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

93 API Suppliers

37 USDMF

29 CEP/COS

10 JDMF

18 EU WC

9 KDMF

34 NDC API

48 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

99 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

502 FDF Dossiers

41 FDA Orange Book

298 Europe

22 Canada

69 Australia

31 South Africa

41 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

OINTMENT;TOPICAL - 0.1%

CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

LOTION;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

AEROSOL, METERED;INHALATION - 0.05MG/INH

AEROSOL, METERED;INHALATION - 0.10MG/INH

AEROSOL, METERED;INHALATION - 0.20MG/INH

SPRAY, METERED;NASAL - 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

POWDER;INHALATION - 0.11MG/INH

POWDER;INHALATION - 0.22MG/INH

AEROSOL, METERED;INHALATION - 0.005MG/INH;0.05MG/INH

AEROSOL, METERED;INHALATION - 0.005MG/INH;0.1MG/INH

AEROSOL, METERED;INHALATION - 0.005MG/INH;0.2MG/INH

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Rochem International Inc

1 SPI Pharma

2 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

6 Kirsch Pharma

6 Actylis

1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

4 BASF

1 CD Formulation

3 DFE Pharma

2 Finar

7 Gangwal Chemicals

1 Ideal Cures

5 Kerry

2 Keval Exports

1 Kima Chemical

6 Microlex e.U

1 Nanjing Bold Chemical

1 Nitika Pharmaceutical Specialities

1 Pharmatrans-Sanaq

1 Pluviaendo

1 Prachin Chemical

9 Roquette

6 Seppic

1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

8 Sigachi Industries

1 Silverline Chemicals

1 The Dow Chemical Company

1 Valens Pharmachem

1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

20 Solubilizers

18 Thickeners and Stabilizers

17 Parenteral

16 Fillers, Diluents & Binders

16 Direct Compression

10 Topical

CREAM;TOPICAL - 0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

LOTION;TOPICAL - 0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY, METERED;NASAL - 0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons