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

Data Compilation
#PharmaFlow

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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Trexan

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

73 API Suppliers, 8 USDMF, 8 CEP/COS, 2 EU WC, 8 KDMF, 55 NDC API, 21 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

18 Drugs in Development

18 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

45 FDF Dossiers, 23 FDA Orange Book, 12 Europe, 4 Canada, 2 South Africa, 4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG, CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Evonik, 1 SPI Pharma, 4 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 5 Kirsch Pharma, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 1 CD Formulation, 1 Clariant, 18 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 1 Finar, 10 Gangwal Chemicals, 8 Ideal Cures, 1 Ingredion Pharma Solutions, 23 Kerry, 2 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 10 Roquette, 12 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

57 Coating Systems & Additives, 36 Controlled & Modified Release, 34 Fillers, Diluents & Binders, 24 Granulation, 22 Thickeners and Stabilizers, 22 Direct Compression, 19 Solubilizers, 14 Parenteral, 14 Lubricants & Glidants, 14 Disintegrants & Superdisintegrants, 13 Topical, 12 Film Formers & Plasticizers, 11 Taste Masking, 9 Co-Processed Excipients, 9 Empty Capsules, 6 Emulsifying Agents, 5 Rheology Modifiers, 5 Surfactant & Foaming Agents, 5 API Stability Enhancers, 4 Chewable & Orodispersible Aids, 4 Vegetarian Capsules, 2 Coloring Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 49 News #PharmaBuzz

GLOBAL SALES INFORMATION

12 US Medicaid Prescriptions, 12 Regulatory FDF Prices

MARKET PLACE

18 APIs, 3 FDF Dossiers

PATENTS & EXCLUSIVITIES

85 US Patents, 4 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 7 Others

$ 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	Siegfried AG	Switzerland	SIEGFRIED LTD	23214	NALTREXONE HYDROCHLORIDE	2009-10-21	Active	II	Complete	2014-07-16	2013-01-28
29/01/2026	EUROAPI	France	FRANCOPIA A EUROAPI CO	20623	NALTREXONE HYDROCHLORIDE	2007-06-20	Active	II	Complete	2013-03-17	2013-03-11

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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.

Trexan

Trexan

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

73 API Suppliers

8 USDMF

8 CEP/COS

2 EU WC

8 KDMF

55 NDC API

21 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

18 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

45 FDF Dossiers

23 FDA Orange Book

12 Europe

4 Canada

2 South Africa

4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG

CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Evonik

1 SPI Pharma

4 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

1 Pfanstiehl

5 Kirsch Pharma

4 ACG Worldwide

8 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

17 BASF

1 CD Formulation

1 Clariant

18 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

1 Finar

10 Gangwal Chemicals

8 Ideal Cures

1 Ingredion Pharma Solutions

23 Kerry

2 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

1 Novo Excipients

1 Pharmatrans-Sanaq

4 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

10 Roquette

12 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

3 Silverline Chemicals

3 The Dow Chemical Company

1 Valens Pharmachem

3 Vasa Pharmachem

1 Vertellus

EXCIPIENTS BY APPLICATIONS

57 Coating Systems & Additives

CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons