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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Methotrexate, Rheumatrex, Trexall), Abitrexate

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ACTIVE PHARMA INGREDIENTS

59 API Suppliers, 25 USDMF, 8 CEP/COS, 4 JDMF, 3 EU WC, 12 NDC API, 30 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

108 Drugs in Development

108 Drugs in Development

INTERMEDIATES

8 Intermediate Suppliers

8 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

934 FDF Dossiers, 128 FDA Orange Book, 614 Europe, 62 Canada, 59 Australia, 13 South Africa, 58 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 100MG BASE/VIAL, INJECTABLE;INJECTION - EQ 1GM BASE/VIAL, INJECTABLE;INJECTION - EQ 1GM BASE/40ML (EQ 25MG BASE/ML), INJECTABLE;INJECTION - EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML), INJECTABLE;INJECTION - EQ 2.5MG BASE/ML, INJECTABLE;INJECTION - EQ 20MG BASE/VIAL, INJECTABLE;INJECTION - EQ 20MG BASE/2ML (EQ 10MG BASE/ML), INJECTABLE;INJECTION - EQ 25MG BASE/ML, INJECTABLE;INJECTION - EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 50MG BASE/VIAL, INJECTABLE;INJECTION - EQ 50MG BASE/2ML (EQ 25MG BASE/ML), SOLUTION;SUBCUTANEOUS - 10MG/0.4ML (10MG/0.4ML), SOLUTION;SUBCUTANEOUS - 12.5MG/0.5ML (12.5MG/0.5ML), SOLUTION;SUBCUTANEOUS - 15MG/0.6ML (15MG/0.6ML), SOLUTION;SUBCUTANEOUS - 17.5MG/0.7ML (17.5MG/0.7ML), SOLUTION;SUBCUTANEOUS - 20MG/0.8ML (20MG/0.8ML), SOLUTION;SUBCUTANEOUS - 22.5MG/ML (22.5MG/ML), SOLUTION;SUBCUTANEOUS - 25MG/1ML (25MG/1ML), SOLUTION;SUBCUTANEOUS - 7.5MG/0.3ML (7.5MG/0.3ML), TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 4 SPI Pharma, 5 DKSH, 1 Pharm-RX Chemical, 5 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 4 Kirsch Pharma, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 3 Finar, 9 Gangwal Chemicals, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 24 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 17 Roquette, 13 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

42 Coating Systems & Additives, 41 Fillers, Diluents & Binders, 27 Direct Compression, 24 Granulation, 24 Thickeners and Stabilizers, 20 Controlled & Modified Release, 18 Solubilizers, 18 Topical, 17 Disintegrants & Superdisintegrants, 16 Parenteral, 15 Lubricants & Glidants, 12 Taste Masking, 11 Film Formers & Plasticizers, 11 Co-Processed Excipients, 8 Chewable & Orodispersible Aids, 8 Emulsifying Agents, 6 Rheology Modifiers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Coloring Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 134 News #PharmaBuzz

GLOBAL SALES INFORMATION

26 US Medicaid Prescriptions, 97 Regulatory FDF Prices

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23 APIs, 24 FDF Dossiers

PATENTS & EXCLUSIVITIES

145 US Patents

145 US Patents

REF. STANDARDS & IMPURITIES

6 EDQM, 4 JP, 2 Others

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Certificate Holder	Certificate No.	Substance	Issue Date	Status	Type	End Date	Substance No.
29/01/2026	Fermion Oy	Finland	FERMION OY Espoo FI	CEP 2001-145 - Rev 05	Methotrexate	2025-01-22	Valid	Chemical		560
29/01/2026	Fareva	Luxembourg	EXCELLA GMBH & CO. KG Feucht DE	R1-CEP 2000-024 - Rev 10	Methotrexate	2020-02-21	Valid	Chemical		560

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Methotrexate, Rheumatrex, Trexall), Abitrexate

Methotrexate, Rheumatrex, Trexall), Abitrexate

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

59 API Suppliers

25 USDMF

8 CEP/COS

4 JDMF

3 EU WC

12 NDC API

30 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

108 Drugs in Development

INTERMEDIATES

8 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

934 FDF Dossiers

128 FDA Orange Book

614 Europe

62 Canada

59 Australia

13 South Africa

58 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 100MG BASE/VIAL

INJECTABLE;INJECTION - EQ 1GM BASE/VIAL

INJECTABLE;INJECTION - EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

INJECTABLE;INJECTION - EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML)

INJECTABLE;INJECTION - EQ 2.5MG BASE/ML

INJECTABLE;INJECTION - EQ 20MG BASE/VIAL

INJECTABLE;INJECTION - EQ 20MG BASE/2ML (EQ 10MG BASE/ML)

INJECTABLE;INJECTION - EQ 25MG BASE/ML

INJECTABLE;INJECTION - EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 50MG BASE/VIAL

INJECTABLE;INJECTION - EQ 50MG BASE/2ML (EQ 25MG BASE/ML)

SOLUTION;SUBCUTANEOUS - 10MG/0.4ML (10MG/0.4ML)

SOLUTION;SUBCUTANEOUS - 12.5MG/0.5ML (12.5MG/0.5ML)

SOLUTION;SUBCUTANEOUS - 15MG/0.6ML (15MG/0.6ML)

SOLUTION;SUBCUTANEOUS - 17.5MG/0.7ML (17.5MG/0.7ML)

SOLUTION;SUBCUTANEOUS - 20MG/0.8ML (20MG/0.8ML)

SOLUTION;SUBCUTANEOUS - 22.5MG/ML (22.5MG/ML)

SOLUTION;SUBCUTANEOUS - 25MG/1ML (25MG/1ML)

SOLUTION;SUBCUTANEOUS - 7.5MG/0.3ML (7.5MG/0.3ML)

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

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

4 SPI Pharma

5 DKSH

1 Pharm-RX Chemical

5 Gangwal Healthcare

5 Nanjing Well Pharmaceutical

4 Kirsch Pharma

1 ACG Worldwide

9 Actylis

1 Aeon Procare

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

17 BASF

1 Bioplus Life Sciences

1 CD Formulation

1 Clariant

10 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

3 Finar

9 Gangwal Chemicals

4 Ideal Cures

3 Ingredion Pharma Solutions

24 Kerry

2 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

INJECTABLE;INJECTION - EQ 500MG BASE/20ML (EQ 25MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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