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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ACTIVE PHARMA INGREDIENTS

17 API Suppliers, 10 USDMF, 2 CEP/COS, 4 JDMF, 5 EU WC, 5 NDC API, 5 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

54 FDF Dossiers, 18 FDA Orange Book, 17 Europe, 1 South Africa, 18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Rochem International Inc, 18 SPI Pharma, 8 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 1 Kirsch Pharma, 1 Panvo Organics, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 31 BASF, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 1 Finar, 12 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 22 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 20 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

73 Fillers, Diluents & Binders, 46 Coating Systems & Additives, 45 Disintegrants & Superdisintegrants, 41 Direct Compression, 34 Granulation, 27 Solubilizers, 27 Controlled & Modified Release, 22 Thickeners and Stabilizers, 21 Chewable & Orodispersible Aids, 21 Lubricants & Glidants, 19 Taste Masking, 14 Parenteral, 13 Topical, 13 Co-Processed Excipients, 12 Film Formers & Plasticizers, 6 Emulsifying Agents, 6 API Stability Enhancers, 5 Empty Capsules, 4 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 2 Coloring Agents

DIGITAL CONTENT

7 News #PharmaBuzz

7 News #PharmaBuzz

GLOBAL SALES INFORMATION

7 US Medicaid Prescriptions

7 US Medicaid Prescriptions

MARKET PLACE

1 APIs

1 APIs

PATENTS & EXCLUSIVITIES

6 Health Canada Patents

6 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 4 JP, 10 Others

$ 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)
29/01/2026	Unichem Laboratories Limited	India	Unichem Laboratories Limited, India	53747-052	Nateglinide	2014-12-30	2026-12-31	BULK INGREDIENT	POWDER (1kg/kg)
29/01/2026	Unichem Laboratories Limited	India	Unichem Laboratories Limited, India	53747-020	Nateglinide	2008-03-25	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

17 API Suppliers

10 USDMF

2 CEP/COS

4 JDMF

5 EU WC

5 NDC API

5 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

54 FDF Dossiers

18 FDA Orange Book

17 Europe

1 South Africa

18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

1 Rochem International Inc

18 SPI Pharma

8 Boai NKY Pharmaceuticals Ltd

7 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

1 Pfanstiehl

1 Kirsch Pharma

1 Panvo Organics

1 ACG Worldwide

5 Actylis

1 Aeon Procare

2 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

31 BASF

10 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

1 Finar

12 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

5 Ideal Cures

5 Ingredion Pharma Solutions

22 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

15 Microlex e.U

1 Nanjing Bold Chemical

3 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

5 Novo Excipients

5 Pharmatrans-Sanaq

7 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

20 Roquette

13 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

4 Silverline Chemicals

2 The Dow Chemical Company

1 Ulanqab Kema New Material

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

73 Fillers, Diluents & Binders

46 Coating Systems & Additives

45 Disintegrants & Superdisintegrants

TABLET;ORAL - 120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons