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

Data Compilation
#PharmaFlow

Stock Recap
#PipelineProspector

Eranz

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

144 API Suppliers, 33 USDMF, 11 CEP/COS, 17 JDMF, 28 EU WC, 78 KDMF, 20 NDC API, 43 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

67 Drugs in Development

67 Drugs in Development

INTERMEDIATES

32 Intermediate Suppliers

32 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

745 FDF Dossiers, 104 FDA Orange Book, 459 Europe, 42 Canada, 32 Australia, 28 South Africa, 80 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 5MG, TABLET, ORALLY DISINTEGRATING;ORAL - 10MG, TABLET, ORALLY DISINTEGRATING;ORAL - 5MG, TABLET;ORAL - 23MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 5 Evonik, 5 Rochem International Inc, 19 SPI Pharma, 2 Pharm-RX Chemical, 8 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 1 Capital Farma, 4 Kirsch Pharma, 1 Panvo Organics, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 1 Avesta Pharma, 35 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 2 Clariant, 15 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 14 Ideal Cures, 5 Ingredion Pharma Solutions, 22 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 21 Roquette, 14 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

77 Fillers, Diluents & Binders, 70 Coating Systems & Additives, 46 Disintegrants & Superdisintegrants, 42 Controlled & Modified Release, 40 Solubilizers, 37 Direct Compression, 34 Granulation, 31 Thickeners and Stabilizers, 27 Taste Masking, 25 Parenteral, 25 Lubricants & Glidants, 24 Topical, 22 Chewable & Orodispersible Aids, 21 Film Formers & Plasticizers, 15 Co-Processed Excipients, 11 Emulsifying Agents, 9 Empty Capsules, 8 API Stability Enhancers, 7 Surfactant & Foaming Agents, 6 Rheology Modifiers, 4 Vegetarian Capsules, 2 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 66 News #PharmaBuzz

GLOBAL SALES INFORMATION

27 US Medicaid Prescriptions, 107 Regulatory FDF Prices, 9 Annual Reports

MARKET PLACE

16 APIs, 3 FDF Dossiers

PATENTS & EXCLUSIVITIES

51 US Patents, 4 US Exclusivities, 8 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 7 JP, 17 Others

ANALYTICAL

3 BioAnalytical Methods, 9 Analytical Methods

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Certificate Holder	Certificate No.	Substance	Issue Date	Status	Type	End Date	Substance No.
29/01/2026	Alembic Pharmaceuticals Limited	India	ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN	CEP 2022-079 - Rev 01	Donepezil hydrochloride monohydrate, Monohydrate	2023-12-18	Valid	Chemical		3067
29/01/2026	Aurobindo Pharma Limited	India	APITORIA PHARMA PRIVATE LIMITED Hyderabad IN	CEP 2020-132 - Rev 01	Donepezil hydrochloride monohydrate, Monohydrate	2023-12-15	Valid	Chemical		3067

Privacy policy
Terms and conditions
Disclaimers
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.

Eranz

Eranz

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

144 API Suppliers

33 USDMF

11 CEP/COS

17 JDMF

28 EU WC

78 KDMF

20 NDC API

43 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

67 Drugs in Development

INTERMEDIATES

32 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

745 FDF Dossiers

104 FDA Orange Book

459 Europe

42 Canada

32 Australia

28 South Africa

80 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG

TABLET;ORAL - 5MG

TABLET, ORALLY DISINTEGRATING;ORAL - 10MG

TABLET, ORALLY DISINTEGRATING;ORAL - 5MG

TABLET;ORAL - 23MG

RELATED EXCIPIENT COMPANIES

1 Minakem

5 Evonik

5 Rochem International Inc

19 SPI Pharma

2 Pharm-RX Chemical

8 Boai NKY Pharmaceuticals Ltd

8 Gangwal Healthcare

10 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

1 Capital Farma

4 Kirsch Pharma

1 Panvo Organics

4 ACG Worldwide

8 Actylis

1 Aeon Procare

2 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

3 Ashland

1 Avesta Pharma

35 BASF

1 Bioplus Life Sciences

1 CD Formulation

2 Clariant

15 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

2 Finar

13 Gangwal Chemicals

14 Ideal Cures

5 Ingredion Pharma Solutions

22 Kerry

3 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

14 Microlex e.U

1 Nanjing Bold Chemical

3 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

4 Novo Excipients

5 Pharmatrans-Sanaq

8 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

21 Roquette