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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Zetia , Ezetrol, Ezetimibe

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

147 API Suppliers, 32 USDMF, 11 JDMF, 19 EU WC, 90 KDMF, 18 NDC API, 48 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

59 Drugs in Development

59 Drugs in Development

INTERMEDIATES

31 Intermediate Suppliers

31 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1189 FDF Dossiers, 71 FDA Orange Book, 805 Europe, 20 Canada, 141 Australia, 49 South Africa, 103 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 10MG, TABLET;ORAL - 10MG;10MG, TABLET;ORAL - 10MG;20MG, TABLET;ORAL - 10MG;40MG, TABLET;ORAL - 10MG;80MG

RELATED EXCIPIENT COMPANIES

2 Minakem, 6 SPI Pharma, 6 DKSH, 5 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 3 Kirsch Pharma, 1 Panvo Organics, 1 ACG Worldwide, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 19 BASF, 2 CD Formulation, 10 Corel Pharma Chem, 7 DFE Pharma, 8 Gangwal Chemicals, 4 Ideal Cures, 4 Ingredion Pharma Solutions, 24 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 3 Nitika Pharmaceutical Specialities, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

51 Fillers, Diluents & Binders, 42 Coating Systems & Additives, 40 Disintegrants & Superdisintegrants, 34 Direct Compression, 32 Granulation, 22 Lubricants & Glidants, 20 Thickeners and Stabilizers, 19 Controlled & Modified Release, 12 Chewable & Orodispersible Aids, 10 Co-Processed Excipients, 10 Taste Masking, 9 Solubilizers, 8 Film Formers & Plasticizers, 7 Parenteral, 6 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Emulsifying Agents, 2 Topical, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

119 News #PharmaBuzz

119 News #PharmaBuzz

GLOBAL SALES INFORMATION

28 US Medicaid Prescriptions, 160 Regulatory FDF Prices, 65 Annual Reports

MARKET PLACE

25 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

21 US Patents, 3 US Exclusivities, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 USP, 4 Others

ANALYTICAL

6 BioAnalytical Methods

6 BioAnalytical Methods

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
29/01/2026	Neuland Laboratories	India	NEULAND LABORATORIES LTD	25543	EZETIMIBE USP (FORM-X)	2011-11-30	Active	II	Complete	2018-08-14	2018-07-05
29/01/2026	TAPI Technology & API Services	Israel	TAPI NL BV	20039	EZETIMIBE	2006-12-13	Active	II	Complete	2013-04-17	2013-04-04

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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.

Zetia , Ezetrol, Ezetimibe

Zetia , Ezetrol, Ezetimibe

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

147 API Suppliers

32 USDMF

11 JDMF

19 EU WC

90 KDMF

18 NDC API

48 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

59 Drugs in Development

INTERMEDIATES

31 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1189 FDF Dossiers

71 FDA Orange Book

805 Europe

20 Canada

141 Australia

49 South Africa

103 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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

TABLET;ORAL - EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 10MG

TABLET;ORAL - 10MG;10MG

TABLET;ORAL - 10MG;20MG

TABLET;ORAL - 10MG;40MG

TABLET;ORAL - 10MG;80MG

RELATED EXCIPIENT COMPANIES

2 Minakem

6 SPI Pharma

6 DKSH

5 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

3 Kirsch Pharma

1 Panvo Organics

1 ACG Worldwide

1 Aeon Procare

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

19 BASF

2 CD Formulation

10 Corel Pharma Chem

7 DFE Pharma

8 Gangwal Chemicals

4 Ideal Cures

4 Ingredion Pharma Solutions

24 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

3 Nitika Pharmaceutical Specialities

3 Novo Excipients

5 Pharmatrans-Sanaq

6 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

18 Roquette

7 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

11 Sigachi Industries

4 Silverline Chemicals

2 The Dow Chemical Company

1 Ulanqab Kema New Material

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

51 Fillers, Diluents & Binders

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

TABLET;ORAL - EQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 80MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons