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

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

Stock Recap
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Pulmaxan turbohaler

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

89 API Suppliers, 25 USDMF, 27 CEP/COS, 5 JDMF, 8 EU WC, 17 KDMF, 37 NDC API, 46 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

239 Drugs in Development

239 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1259 FDF Dossiers, 54 FDA Orange Book, 1012 Europe, 23 Canada, 75 Australia, 39 South Africa, 56 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 9MG, AEROSOL, FOAM;RECTAL - 2MG/ACTUATION, SPRAY, METERED;NASAL - 0.032MG/SPRAY, SUSPENSION;INHALATION - 0.25MG/2ML, SUSPENSION;INHALATION - 0.5MG/2ML, SUSPENSION;INHALATION - 1MG/2ML, CAPSULE, DELAYED RELEASE;ORAL - 6MG, CAPSULE, DELAYED RELEASE;ORAL - 9MG, CAPSULE, DELAYED RELEASE;ORAL - 3MG, AEROSOL, METERED;INHALATION - 0.08MG/INH;0.0045MG/INH, AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0045MG/INH

RELATED EXCIPIENT COMPANIES

4 Evonik, 1 Rochem International Inc, 5 SPI Pharma, 13 DKSH, 3 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 9 Kirsch Pharma, 4 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 23 BASF, 1 CD Formulation, 1 Clariant, 14 Corel Pharma Chem, 4 DFE Pharma, 3 Doshion Polyscience, 1 Esteem Industries, 2 Finar, 10 Gangwal Chemicals, 8 Ideal Cures, 2 Ingredion Pharma Solutions, 20 Kerry, 2 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 18 Roquette, 14 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 2 Silverline Chemicals, 4 The Dow Chemical Company, 2 Valens Pharmachem, 2 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

64 Coating Systems & Additives, 53 Fillers, Diluents & Binders, 42 Thickeners and Stabilizers, 35 Controlled & Modified Release, 25 Solubilizers, 23 Granulation, 23 Direct Compression, 20 Parenteral, 20 Film Formers & Plasticizers, 20 Taste Masking, 19 Topical, 18 Lubricants & Glidants, 11 Co-Processed Excipients, 10 Rheology Modifiers, 10 Emulsifying Agents, 9 Empty Capsules, 9 Disintegrants & Superdisintegrants, 8 Chewable & Orodispersible Aids, 5 Surfactant & Foaming Agents, 5 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 2 Stock Recap #PipelineProspector, 146 News #PharmaBuzz

GLOBAL SALES INFORMATION

34 US Medicaid Prescriptions, 91 Regulatory FDF Prices, 51 Annual Reports

MARKET PLACE

20 APIs, 17 FDF Dossiers, 1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

39 US Patents, 4 US Exclusivities, 16 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 21 USP, 15 Others

ANALYTICAL

3 BioAnalytical Methods

3 BioAnalytical Methods

$ 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	Vamsi Labs	India	VAMSI LABS LIMITED Solapur IN	CEP 2024-441 - Rev 00	Budesonide, Micronised	2025-12-10	Valid	Chemical		1075
29/01/2026	Coral Drugs Private Limited	India	CORAL DRUGS PRIVATE LIMITED New Delhi IN	CEP 2016-020 - Rev 01	Budesonide	2026-01-06	Valid	Chemical		1075

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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.

Pulmaxan Turbohaler

Pulmaxan turbohaler

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

89 API Suppliers

25 USDMF

27 CEP/COS

5 JDMF

8 EU WC

17 KDMF

37 NDC API

46 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

239 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1259 FDF Dossiers

54 FDA Orange Book

1012 Europe

23 Canada

75 Australia

39 South Africa

56 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 9MG

AEROSOL, FOAM;RECTAL - 2MG/ACTUATION

SPRAY, METERED;NASAL - 0.032MG/SPRAY

SUSPENSION;INHALATION - 0.25MG/2ML

SUSPENSION;INHALATION - 0.5MG/2ML

SUSPENSION;INHALATION - 1MG/2ML

CAPSULE, DELAYED RELEASE;ORAL - 6MG

CAPSULE, DELAYED RELEASE;ORAL - 9MG

CAPSULE, DELAYED RELEASE;ORAL - 3MG

AEROSOL, METERED;INHALATION - 0.08MG/INH;0.0045MG/INH

AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0045MG/INH

RELATED EXCIPIENT COMPANIES

4 Evonik

1 Rochem International Inc

5 SPI Pharma

13 DKSH

3 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 Pfanstiehl

9 Kirsch Pharma

4 ACG Worldwide

11 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

23 BASF

1 CD Formulation

1 Clariant

14 Corel Pharma Chem

4 DFE Pharma

3 Doshion Polyscience

1 Esteem Industries

2 Finar

10 Gangwal Chemicals

8 Ideal Cures

2 Ingredion Pharma Solutions

20 Kerry

2 Keval Exports

5 Kima Chemical

6 Lonza Capsugel

16 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

1 Novo Excipients

1 Pharmatrans-Sanaq

5 Pluviaendo

2 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

18 Roquette