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

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Abbott Brand of Procetofen

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

93 API Suppliers, 25 USDMF, 17 CEP/COS, 3 JDMF, 13 EU WC, 25 KDMF, 17 NDC API, 46 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

18 Drugs in Development

18 Drugs in Development

INTERMEDIATES

8 Intermediate Suppliers

8 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

341 FDF Dossiers, 133 FDA Orange Book, 90 Europe, 12 Canada, 34 Australia, 3 South Africa, 69 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 160MG, CAPSULE;ORAL - 150MG, CAPSULE;ORAL - 50MG, TABLET;ORAL - 145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 130MG, CAPSULE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 43MG, CAPSULE;ORAL - 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 105MG, TABLET;ORAL - 35MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 2 Rochem International Inc, 20 SPI Pharma, 14 DKSH, 1 PMC Isochem, 1 Pharm-RX Chemical, 8 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 2 Kewpie Corporation, 14 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 3 Kirsch Pharma, 1 Panvo Organics, 4 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 35 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 2 Clariant, 14 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 2 Esteem Industries, 2 Finar, 14 Gangwal Chemicals, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 3 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 31 Roquette, 15 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 3 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

80 Fillers, Diluents & Binders, 53 Solubilizers, 52 Thickeners and Stabilizers, 51 Coating Systems & Additives, 49 Direct Compression, 48 Disintegrants & Superdisintegrants, 40 Granulation, 31 Taste Masking, 31 Controlled & Modified Release, 30 Topical, 26 Lubricants & Glidants, 23 Parenteral, 22 Chewable & Orodispersible Aids, 22 Film Formers & Plasticizers, 18 Emulsifying Agents, 16 Co-Processed Excipients, 11 Rheology Modifiers, 10 API Stability Enhancers, 9 Empty Capsules, 8 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 65 News #PharmaBuzz

GLOBAL SALES INFORMATION

61 US Medicaid Prescriptions, 38 Regulatory FDF Prices

MARKET PLACE

27 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

20 US Patents, 10 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 4 USP, 9 Others

ANALYTICAL

1 BioAnalytical Methods

1 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	IOL Chemicals and Pharmaceuticals	India	IOL CHEMICALS AND PHARMACEUTICALS LTD	36535	FENOFIBRATE USP	2022-01-05	Active	II	Complete	2024-02-05	2023-12-22
29/01/2026	Seqens	France	VANAMALI ORGANICS PVT LTD	11194	FENOFIBRATE	1994-11-09	Active	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.

Abbott Brand Of Procetofen

Abbott Brand of Procetofen

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

93 API Suppliers

25 USDMF

17 CEP/COS

3 JDMF

13 EU WC

25 KDMF

17 NDC API

46 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

18 Drugs in Development

INTERMEDIATES

8 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

341 FDF Dossiers

133 FDA Orange Book

90 Europe

12 Canada

34 Australia

3 South Africa

69 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 160MG

CAPSULE;ORAL - 150MG

CAPSULE;ORAL - 50MG

TABLET;ORAL - 145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 130MG

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

CAPSULE;ORAL - 43MG

CAPSULE;ORAL - 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 105MG

TABLET;ORAL - 35MG

RELATED EXCIPIENT COMPANIES

1 Minakem

1 Evonik

2 Rochem International Inc

20 SPI Pharma

14 DKSH

1 PMC Isochem

1 Pharm-RX Chemical

8 Boai NKY Pharmaceuticals Ltd

8 Gangwal Healthcare

2 Kewpie Corporation

14 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

3 Kirsch Pharma

1 Panvo Organics

4 ACG Worldwide

7 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

35 BASF

1 Bioplus Life Sciences

1 CD Formulation

2 Clariant

14 Corel Pharma Chem

7 DFE Pharma

1 Doshion Polyscience

2 Esteem Industries

2 Finar

14 Gangwal Chemicals

5 Ideal Cures

5 Ingredion Pharma Solutions

26 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

15 Microlex e.U

3 Nanjing Bold Chemical

3 Nitika Pharmaceutical Specialities

TABLET;ORAL - 145MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 48MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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

CAPSULE;ORAL - 90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons