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

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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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Gen-Glybe

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 15 USDMF, 9 CEP/COS, 4 JDMF, 8 EU WC, 1 KDMF, 7 NDC API, 16 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

13 Drugs in Development

13 Drugs in Development

INTERMEDIATES

9 Intermediate Suppliers

9 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

185 FDF Dossiers, 83 FDA Orange Book, 29 Europe, 7 Canada, 2 Australia, 19 South Africa, 45 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 1.25MG, TABLET;ORAL - 2.5MG, TABLET;ORAL - 5MG, TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik, 7 SPI Pharma, 8 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Kirsch Pharma, 1 ACG Worldwide, 5 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 1 Avesta Pharma, 27 BASF, 2 Clariant, 14 Corel Pharma Chem, 7 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 24 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

65 Fillers, Diluents & Binders, 43 Coating Systems & Additives, 37 Direct Compression, 31 Controlled & Modified Release, 31 Granulation, 29 Solubilizers, 27 Disintegrants & Superdisintegrants, 24 Thickeners and Stabilizers, 19 Film Formers & Plasticizers, 19 Topical, 18 Lubricants & Glidants, 14 Co-Processed Excipients, 13 Parenteral, 11 Taste Masking, 10 Chewable & Orodispersible Aids, 8 Emulsifying Agents, 6 Surfactant & Foaming Agents, 6 API Stability Enhancers, 5 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 2 Coloring Agents

DIGITAL CONTENT

26 News #PharmaBuzz

26 News #PharmaBuzz

GLOBAL SALES INFORMATION

9 US Medicaid Prescriptions, 21 Regulatory FDF Prices

MARKET PLACE

15 APIs, 5 FDF Dossiers

REF. STANDARDS & IMPURITIES

4 EDQM, 6 Others

$ 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	Aurobindo Pharma Limited	India	Aurobindo Pharma Limited	65862-318	Glyburide	2023-11-15	2026-12-31	BULK INGREDIENT	POWDER (50kg/50kg)
29/01/2026	Cambrex Corporation	U.S.A	Cambrex Profarmaco Milano Srl	12828-0066	Glyburide	1993-02-01	2026-12-31	BULK INGREDIENT	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.

Gen-Glybe

Gen-Glybe

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

32 API Suppliers

15 USDMF

9 CEP/COS

4 JDMF

8 EU WC

1 KDMF

7 NDC API

16 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

13 Drugs in Development

INTERMEDIATES

9 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

185 FDF Dossiers

83 FDA Orange Book

29 Europe

7 Canada

2 Australia

19 South Africa

45 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 1.25MG

TABLET;ORAL - 2.5MG

TABLET;ORAL - 5MG

TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik

7 SPI Pharma

8 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 Kirsch Pharma

1 ACG Worldwide

5 Actylis

2 Aeon Procare

1 Alcedo Pharmachem

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

1 Avesta Pharma

27 BASF

2 Clariant

14 Corel Pharma Chem

7 DFE Pharma

1 Esteem Industries

2 Finar

11 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

5 Ideal Cures

4 Ingredion Pharma Solutions

24 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

3 Pharmatrans-Sanaq

6 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

18 Roquette

13 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

11 Sigachi Industries

4 Silverline Chemicals

2 The Dow Chemical Company

2 Ulanqab Kema New Material

TABLET;ORAL - 1.25MG;250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 2.5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons