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

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ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 15 USDMF, 3 CEP/COS, 5 JDMF, 7 KDMF, 3 NDC API, 9 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

127 FDF Dossiers, 65 FDA Orange Book, 32 Europe, 4 Canada, 2 Australia, 13 South Africa, 11 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 40MG, TABLET;ORAL - 5MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, TABLET;ORAL - 37.5MG;20MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 4 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 13 BASF, 11 Corel Pharma Chem, 6 DFE Pharma, 9 DKSH, 1 Esteem Industries, 1 Finar, 9 Gangwal Chemicals, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 24 Kerry, 2 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 19 Roquette, 13 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

48 Fillers, Diluents & Binders, 43 Coating Systems & Additives, 29 Thickeners and Stabilizers, 27 Direct Compression, 24 Granulation, 21 Controlled & Modified Release, 17 Disintegrants & Superdisintegrants, 16 Lubricants & Glidants, 15 Solubilizers, 12 Film Formers & Plasticizers, 12 Topical, 11 Co-Processed Excipients, 10 Taste Masking, 9 Empty Capsules, 8 Chewable & Orodispersible Aids, 8 Parenteral, 8 Emulsifying Agents, 5 Rheology Modifiers, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

9 News #PharmaBuzz

9 News #PharmaBuzz

GLOBAL SALES INFORMATION

16 US Medicaid Prescriptions, 21 Regulatory FDF Prices

MARKET PLACE

13 APIs, 4 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM

2 EDQM

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Registrant Name	Registration No.	Compound	Registration Date	Manufacturer	Manufacturer's Country	Manufacturer's Address
29/01/2026	Dipharma	Italy	Erison Pharmaceutical Co., Ltd.	20221214-209-J-1421	Isosorbide dinitrate	2022-12-14	DIPHARMA FRANCIS srl	Italy	Via XXIV Maggio 40, 33036 Mereto di Tomba (UD) Italy
29/01/2026	Dipharma	Italy	Bukwang Pharmaceutical Co., Ltd.	20211207-209-J-1172	Isosorbide dinitrate	2021-12-07	Dipharma Francis Srl@Adare Pharmaceuticals srl	Italy	33036, Via XXIV Maggio, 40, Mereto di Tomba (UD), Italy@Via Martin Luther King, 13 20042 Pessano con Bornago (MI), Italy

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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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Isodinit

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

31 API Suppliers

15 USDMF

3 CEP/COS

5 JDMF

7 KDMF

3 NDC API

9 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

127 FDF Dossiers

65 FDA Orange Book

32 Europe

4 Canada

2 Australia

13 South Africa

11 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 40MG

TABLET;ORAL - 5MG

CAPSULE, EXTENDED RELEASE;ORAL - 40MG

TABLET;ORAL - 37.5MG;20MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma

4 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Pfanstiehl

3 Kirsch Pharma

4 ACG Worldwide

6 Actylis

1 Aeon Procare

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

13 BASF

11 Corel Pharma Chem

6 DFE Pharma

9 DKSH

1 Esteem Industries

1 Finar

9 Gangwal Chemicals

4 Ideal Cures

3 Ingredion Pharma Solutions

24 Kerry

2 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

3 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

19 Roquette

13 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

3 Silverline Chemicals

3 The Dow Chemical Company

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

48 Fillers, Diluents & Binders

43 Coating Systems & Additives

29 Thickeners and Stabilizers

27 Direct Compression

24 Granulation

21 Controlled & Modified Release

17 Disintegrants & Superdisintegrants

TABLET;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons