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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Aggrenox

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ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 19 USDMF, 9 CEP/COS, 6 JDMF, 4 EU WC, 7 NDC API, 10 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

8 Drugs in Development

8 Drugs in Development

FINISHED DOSAGE FORMULATIONS

121 FDF Dossiers, 52 FDA Orange Book, 48 Europe, 2 Canada, 5 South Africa, 14 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

6 Evonik, 2 Rochem International Inc, 7 SPI Pharma, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Capital Farma, 4 Kirsch Pharma, 4 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 31 BASF, 1 CD Formulation, 1 Clariant, 15 Corel Pharma Chem, 6 DFE Pharma, 13 DKSH, 1 Esteem Industries, 2 Finar, 12 Gangwal Chemicals, 14 Ideal Cures, 3 Ingredion Pharma Solutions, 26 Kerry, 2 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 19 Roquette, 14 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 2 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

77 Coating Systems & Additives, 59 Fillers, Diluents & Binders, 42 Controlled & Modified Release, 35 Thickeners and Stabilizers, 32 Solubilizers, 30 Granulation, 30 Direct Compression, 22 Topical, 21 Film Formers & Plasticizers, 19 Lubricants & Glidants, 19 Disintegrants & Superdisintegrants, 16 Parenteral, 15 Taste Masking, 11 Emulsifying Agents, 11 Co-Processed Excipients, 10 Rheology Modifiers, 9 Empty Capsules, 9 API Stability Enhancers, 7 Chewable & Orodispersible Aids, 5 Coloring Agents, 5 Surfactant & Foaming Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

13 News #PharmaBuzz

13 News #PharmaBuzz

GLOBAL SALES INFORMATION

13 US Medicaid Prescriptions, 16 Regulatory FDF Prices

MARKET PLACE

10 APIs, 4 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM, 7 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Labeler	NDC Package Code	Non Proprietary Name	Start Marketing Date	End Marketing Date	Category Code	Dosage Form (Strength)
29/01/2026	AGC Pharma Chemicals Europe	Spain	AGC Pharma Chemicals Europe, S.L.U.	65404-005	DIPYRIDAMOLE	1999-01-01	2026-12-31	BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING	POWDER (1mg/mg)
29/01/2026	Cohance Lifesciences	India	COHANCE LIFESCIENCES LIMITED	17511-122	Dipyridamole	2020-01-20	2026-12-31	BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING	POWDER (1kg/kg)

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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.

Aggrenox

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

36 API Suppliers

19 USDMF

9 CEP/COS

6 JDMF

4 EU WC

7 NDC API

10 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

8 Drugs in Development

FINISHED DOSAGE FORMULATIONS

121 FDF Dossiers

52 FDA Orange Book

48 Europe

2 Canada

5 South Africa

14 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

6 Evonik

2 Rochem International Inc

7 SPI Pharma

1 Pharm-RX Chemical

1 Boai NKY Pharmaceuticals Ltd

4 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 Capital Farma

4 Kirsch Pharma

4 ACG Worldwide

7 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

31 BASF

1 CD Formulation

1 Clariant

15 Corel Pharma Chem

6 DFE Pharma

13 DKSH

1 Esteem Industries

2 Finar

12 Gangwal Chemicals

14 Ideal Cures

3 Ingredion Pharma Solutions

26 Kerry

2 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

15 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

3 Pharmatrans-Sanaq

5 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

19 Roquette

14 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

3 Silverline Chemicals

3 The Dow Chemical Company

2 Valens Pharmachem

3 Vasa Pharmachem

1 Vertellus

EXCIPIENTS BY APPLICATIONS

TABLET;ORAL - 25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 25MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons