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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ACTIVE PHARMA INGREDIENTS

55 API Suppliers, 13 USDMF, 5 CEP/COS, 6 JDMF, 3 EU WC, 10 KDMF, 14 NDC API, 14 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

17 Drugs in Development

17 Drugs in Development

FINISHED DOSAGE FORMULATIONS

677 FDF Dossiers, 120 FDA Orange Book, 455 Europe, 30 Canada, 2 Australia, 36 South Africa, 34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;IRRIGATION - 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML, FOR SOLUTION;ORAL - 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT, INJECTABLE;INJECTION - 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML), INJECTABLE;INJECTION - N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML), INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML), INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - 5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML), INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML), INJECTABLE;INJECTION - N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML), CAPSULE;ORAL - 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 20MG;1.1GM

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 10 Rochem International Inc, 26 SPI Pharma, 2 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 1 Capital Farma, 6 Kirsch Pharma, 1 Panvo Organics, 4 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 1 Avesta Pharma, 21 BASF, 2 Bioplus Life Sciences, 2 CD Formulation, 1 Clariant, 5 Corel Pharma Chem, 3 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 3 Ideal Cures, 4 Ingredion Pharma Solutions, 5 Kerry, 2 Keval Exports, 3 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 8 Pluviaendo, 3 Prachin Chemical, 1 Qualicaps, 26 Roquette, 10 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 1 Symrise, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

69 Fillers, Diluents & Binders, 32 Taste Masking, 31 Solubilizers, 30 Direct Compression, 28 Parenteral, 27 Thickeners and Stabilizers, 26 Coating Systems & Additives, 24 Disintegrants & Superdisintegrants, 24 Lubricants & Glidants, 23 Granulation, 22 Chewable & Orodispersible Aids, 17 Topical, 15 Co-Processed Excipients, 14 Controlled & Modified Release, 13 Film Formers & Plasticizers, 10 Emulsifying Agents, 8 Empty Capsules, 8 Surfactant & Foaming Agents, 5 API Stability Enhancers, 4 Rheology Modifiers

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 67 News #PharmaBuzz

GLOBAL SALES INFORMATION

25 US Medicaid Prescriptions, 71 Regulatory FDF Prices

MARKET PLACE

42 APIs, 10 FDF Dossiers, 4 EXCIPIENTS, 1 Intermediates

PATENTS & EXCLUSIVITIES

9 US Patents

9 US Patents

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Labeler	NDC Package Code	Non Proprietary Name	Start Marketing Date	End Marketing Date	Category Code	Dosage Form (Strength)
03/02/2026	Alivus Life Sciences	India	Alivus Life Sciences Limited	66039-970	Sodium Bicarbonate	2024-03-28	2027-12-31	BULK INGREDIENT	POWDER (1kg/kg)
29/01/2026	Avantor Performance Materials	U.S.A	Avantor Performance Materials, LLC	10106-3509	Sodium Bicarbonate	2017-12-14	2026-12-31	BULK INGREDIENT	POWDER (1kg/kg)

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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

55 API Suppliers

13 USDMF

5 CEP/COS

6 JDMF

3 EU WC

10 KDMF

14 NDC API

14 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

17 Drugs in Development

FINISHED DOSAGE FORMULATIONS

677 FDF Dossiers

120 FDA Orange Book

455 Europe

30 Canada

2 Australia

36 South Africa

34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;IRRIGATION - 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML

FOR SOLUTION;ORAL - 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT

INJECTABLE;INJECTION - 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML)

INJECTABLE;INJECTION - N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML)

INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)

INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

INJECTABLE;INJECTION - 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

INJECTABLE;INJECTION - 5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)

INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)

INJECTABLE;INJECTION - N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

CAPSULE;ORAL - 20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 20MG;1.1GM

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Minakem

10 Rochem International Inc

26 SPI Pharma

2 Pharm-RX Chemical

1 Boai NKY Pharmaceuticals Ltd

8 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

1 Capital Farma

6 Kirsch Pharma

1 Panvo Organics

4 ACG Worldwide

11 Actylis

1 Aeon Procare

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

1 Avesta Pharma

21 BASF

2 Bioplus Life Sciences

2 CD Formulation

1 Clariant

5 Corel Pharma Chem

3 DFE Pharma

2 Finar

11 Gangwal Chemicals

3 Ideal Cures

4 Ingredion Pharma Solutions

5 Kerry

2 Keval Exports

3 Lonza Capsugel

12 Microlex e.U

1 Nanjing Bold Chemical

3 Nitika Pharmaceutical Specialities

2 Novo Excipients

CAPSULE;ORAL - 20MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - 40MG;1.1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons