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

Data Compilation
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Stock Recap
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ACTIVE PHARMA INGREDIENTS

56 API Suppliers, 27 USDMF, 14 EU WC, 2 KDMF, 21 NDC API, 36 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

50 Drugs in Development

50 Drugs in Development

INTERMEDIATES

23 Intermediate Suppliers

23 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

183 FDF Dossiers, 58 FDA Orange Book, 97 Europe, 2 Canada, 3 South Africa, 23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GRANULES, EXTENDED RELEASE;ORAL - 1GM, GRANULES, EXTENDED RELEASE;ORAL - 500MG

RELATED EXCIPIENT COMPANIES

2 Evonik, 1 SPI Pharma, 3 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Kirsch Pharma, 1 ACG Worldwide, 2 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 BASF, 1 Clariant, 13 Corel Pharma Chem, 4 DFE Pharma, 10 Gangwal Chemicals, 9 Ideal Cures, 21 Kerry, 1 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 9 Roquette, 12 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 2 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

57 Coating Systems & Additives, 32 Fillers, Diluents & Binders, 26 Controlled & Modified Release, 14 Solubilizers, 14 Direct Compression, 13 Granulation, 12 Thickeners and Stabilizers, 12 Lubricants & Glidants, 12 Film Formers & Plasticizers, 10 Parenteral, 9 Co-Processed Excipients, 7 Topical, 6 Disintegrants & Superdisintegrants, 6 Taste Masking, 5 API Stability Enhancers, 5 Emulsifying Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Rheology Modifiers, 4 Chewable & Orodispersible Aids, 2 Coloring Agents

DIGITAL CONTENT

27 News #PharmaBuzz

27 News #PharmaBuzz

GLOBAL SALES INFORMATION

19 US Medicaid Prescriptions, 18 Regulatory FDF Prices, 8 Annual Reports

MARKET PLACE

18 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents

4 US Patents

REF. STANDARDS & IMPURITIES

10 Others

10 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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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	Metrochem API Private Limited	India	METROCHEM API PRIVATE LIMITED	42765-048	RANOLAZINE	2022-07-27	2026-12-31	BULK INGREDIENT	POWDER (25kg/25kg)
29/01/2026	Virupaksha Organics	India	Virupaksha Organics Limited	51686-0015	Ranolazine	2025-12-27	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

56 API Suppliers

27 USDMF

14 EU WC

2 KDMF

21 NDC API

36 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

50 Drugs in Development

INTERMEDIATES

23 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

183 FDF Dossiers

58 FDA Orange Book

97 Europe

2 Canada

3 South Africa

23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GRANULES, EXTENDED RELEASE;ORAL - 1GM

GRANULES, EXTENDED RELEASE;ORAL - 500MG

RELATED EXCIPIENT COMPANIES

2 Evonik

1 SPI Pharma

3 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

1 Kirsch Pharma

1 ACG Worldwide

2 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

6 BASF

1 Clariant

13 Corel Pharma Chem

4 DFE Pharma

10 Gangwal Chemicals

9 Ideal Cures

21 Kerry

1 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

10 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

2 Novo Excipients

1 Pharmatrans-Sanaq

2 Pluviaendo

2 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

9 Roquette

12 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

9 Sigachi Industries

2 Silverline Chemicals

2 The Dow Chemical Company

1 Valens Pharmachem

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

57 Coating Systems & Additives

32 Fillers, Diluents & Binders

26 Controlled & Modified Release

14 Solubilizers

14 Direct Compression

13 Granulation

12 Thickeners and Stabilizers

12 Lubricants & Glidants

12 Film Formers & Plasticizers

10 Parenteral

9 Co-Processed Excipients

7 Topical

TABLET, EXTENDED RELEASE;ORAL - 1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons