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

Data Compilation
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Stock Recap
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ACTIVE PHARMA INGREDIENTS

24 API Suppliers, 14 USDMF, 7 EU WC, 7 NDC API, 12 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

8 Intermediate Suppliers

8 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

57 FDF Dossiers, 20 FDA Orange Book, 16 Europe, 6 Canada, 5 South Africa, 10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 3 Boai NKY Pharmaceuticals Ltd, 3 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 9 BASF, 3 Clariant, 10 Corel Pharma Chem, 4 DFE Pharma, 1 Esteem Industries, 1 Finar, 8 Gangwal Chemicals, 5 Ideal Cures, 21 Kerry, 1 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 9 Roquette, 6 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 9 Sigachi Industries, 2 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

43 Coating Systems & Additives, 38 Fillers, Diluents & Binders, 22 Controlled & Modified Release, 16 Thickeners and Stabilizers, 16 Lubricants & Glidants, 15 Topical, 14 Direct Compression, 14 Granulation, 10 Film Formers & Plasticizers, 10 Co-Processed Excipients, 8 Solubilizers, 6 Disintegrants & Superdisintegrants, 6 API Stability Enhancers, 5 Parenteral, 5 Empty Capsules, 4 Taste Masking, 4 Emulsifying Agents, 4 Chewable & Orodispersible Aids, 4 Vegetarian Capsules, 3 Rheology Modifiers, 2 Coloring Agents, 2 Surfactant & Foaming Agents

DIGITAL CONTENT

12 News #PharmaBuzz

12 News #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 2 Annual Reports

MARKET PLACE

2 APIs, 4 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 Health Canada Patents

6 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 Others

4 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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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	TAPI Technology & API Services	Israel	TAPI NL BV	22206	DARIFENACIN HYDROBROMIDE	2008-11-21	Active	II	Complete	2013-08-28	2013-08-14
29/01/2026	Unimark Remedies	India	UNIMARK REMEDIES LTD	26419	DARIFENACIN HYDROBROMIDE	2012-09-27	Inactive	II	N/A

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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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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

24 API Suppliers

14 USDMF

7 EU WC

7 NDC API

12 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

INTERMEDIATES

8 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

57 FDF Dossiers

20 FDA Orange Book

16 Europe

6 Canada

5 South Africa

10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma

3 Boai NKY Pharmaceuticals Ltd

3 Gangwal Healthcare

5 Nanjing Well Pharmaceutical

1 ACG Worldwide

3 Actylis

1 Aeon Procare

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Avesta Pharma

9 BASF

3 Clariant

10 Corel Pharma Chem

4 DFE Pharma

1 Esteem Industries

1 Finar

8 Gangwal Chemicals

5 Ideal Cures

21 Kerry

1 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

10 Microlex e.U

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

2 Novo Excipients

1 Pharmatrans-Sanaq

2 Pluviaendo

2 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

9 Roquette

6 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

9 Sigachi Industries

2 Silverline Chemicals

2 The Dow Chemical Company

1 Ulanqab Kema New Material

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

43 Coating Systems & Additives

38 Fillers, Diluents & Binders

22 Controlled & Modified Release

16 Thickeners and Stabilizers

16 Lubricants & Glidants

15 Topical

14 Direct Compression

14 Granulation

10 Film Formers & Plasticizers

10 Co-Processed Excipients

8 Solubilizers

6 Disintegrants & Superdisintegrants

6 API Stability Enhancers

TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons