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

Data Compilation
#PharmaFlow

Pipeline Prospector 2025 highlights: FDA approves pill version of Novo’s Wegovy; BioMarin acquires Amicus for US$ 4.8 bn

Stock Recap
#PipelineProspector

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ACTIVE PHARMA INGREDIENTS

94 API Suppliers, 36 USDMF, 29 CEP/COS, 9 JDMF, 18 EU WC, 9 KDMF, 34 NDC API, 49 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

99 Drugs in Development

99 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

447 FDF Dossiers, 41 FDA Orange Book, 243 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OINTMENT;TOPICAL - 0.1%, CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, LOTION;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, AEROSOL, METERED;INHALATION - 0.05MG/INH, AEROSOL, METERED;INHALATION - 0.10MG/INH, AEROSOL, METERED;INHALATION - 0.20MG/INH, SPRAY, METERED;NASAL - 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER;INHALATION - 0.11MG/INH, POWDER;INHALATION - 0.22MG/INH, AEROSOL, METERED;INHALATION - 0.005MG/INH;0.05MG/INH,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, 5 DKSH, 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

21 Solubilizers, 20 Thickeners and Stabilizers, 17 Parenteral, 16 Fillers, Diluents & Binders, 16 Direct Compression, 11 Topical, 9 Coating Systems & Additives, 9 Film Formers & Plasticizers, 9 Granulation, 8 Co-Processed Excipients, 6 Rheology Modifiers, 5 Emulsifying Agents, 5 Disintegrants & Superdisintegrants, 4 Taste Masking, 3 Controlled & Modified Release, 3 Chewable & Orodispersible Aids, 3 Surfactant & Foaming Agents, 2 Coloring 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

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Certificate Holder	Certificate No.	Substance	Issue Date	Status	Type	End Date	Substance No.
29/01/2026	Symbiotec Pharmalab	India	SYMBIOTEC PHARMALAB PRIVATE LIMITED Indore IN	CEP 2007-194 - Rev 04	Mometasone furoate, Micronised	2025-06-02	Valid	Chemical		1449
29/01/2026	Coral Drugs Private Limited	India	CORAL DRUGS PRIVATE LIMITED New Delhi IN	CEP 2024-282 - Rev 00	Mometasone furoate monohydrate, Micronised	2024-10-17	Valid	Chemical		2858

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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.

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ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

94 API Suppliers

36 USDMF

29 CEP/COS

9 JDMF

18 EU WC

9 KDMF

34 NDC API

49 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

99 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

447 FDF Dossiers

41 FDA Orange Book

243 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

5 DKSH

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

21 Solubilizers

20 Thickeners and Stabilizers

17 Parenteral

16 Fillers, Diluents & Binders

16 Direct Compression

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