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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alanine, 3-(3,4-dihydroxyphenyl)-, L-

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

48 API Suppliers, 22 USDMF, 13 CEP/COS, 4 JDMF, 3 EU WC, 9 KDMF, 12 NDC API, 17 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

71 Drugs in Development

71 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

855 FDF Dossiers, 141 FDA Orange Book, 531 Europe, 33 Canada, 88 Australia, 14 South Africa, 48 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG;100MG, TABLET;ORAL - 25MG;100MG, TABLET;ORAL - 25MG;250MG, TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 23.75MG;95MG, CAPSULE, EXTENDED RELEASE;ORAL - 36.25MG;145MG, CAPSULE, EXTENDED RELEASE;ORAL - 48.75MG;195MG, CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG, TABLET;ORAL - 12.5MG;200MG;50MG, TABLET;ORAL - 18.75MG;200MG;75MG, TABLET;ORAL - 25MG;200MG;100MG, TABLET;ORAL - 31.25MG;200MG;125MG, TABLET;ORAL - 37.5MG;200MG;150MG, TABLET;ORAL - 50MG;200MG;200MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 4 Evonik, 4 Rochem International Inc, 21 SPI Pharma, 8 DKSH, 8 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 1 Capital Farma, 4 Kirsch Pharma, 1 Panvo Organics, 1 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 29 BASF, 1 CD Formulation, 12 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 1 Finar, 12 Gangwal Chemicals, 9 Ideal Cures, 5 Ingredion Pharma Solutions, 22 Kerry, 4 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 17 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, 1 Qualicaps, 29 Roquette, 13 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 4 The Dow Chemical Company, 2 Ulanqab Kema New Material, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

78 Fillers, Diluents & Binders, 59 Coating Systems & Additives, 46 Disintegrants & Superdisintegrants, 37 Direct Compression, 37 Thickeners and Stabilizers, 34 Granulation, 34 Solubilizers, 33 Controlled & Modified Release, 27 Taste Masking, 24 Parenteral, 23 Chewable & Orodispersible Aids, 22 Lubricants & Glidants, 22 Film Formers & Plasticizers, 15 Topical, 15 Co-Processed Excipients, 10 Rheology Modifiers, 8 API Stability Enhancers, 8 Emulsifying Agents, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

4 Data Compilation #PharmaFlow, 104 News #PharmaBuzz

GLOBAL SALES INFORMATION

28 US Medicaid Prescriptions, 69 Regulatory FDF Prices, 27 Annual Reports

MARKET PLACE

24 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

315 US Patents, 4 US Exclusivities, 9 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 8 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Registrant Name	MF Registration No.	Classification	Initial Date of Reg.	Latest Date of Reg.	Registrant's Address
29/01/2026	Ajinomoto Company	Japan	Ajinomoto Co., Inc.	302MF10140	L-DIHYDROXYPHENYLALANINE	2020-11-26	2020-11-26	1-15-1 Kyobashi, Chuo-ku, Tokyo
29/01/2026	Ajinomoto Company	Japan	Ajinomoto Co., Inc.	221MF10284	Japanese Pharmacopoeia Levodopa (for manufacturing purp...	2009-12-22	2009-12-22	1-15-1 Kyobashi, Chuo-ku, Tokyo

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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.

Alanine, 3-(3,4-dihydroxyphenyl)-, L-

alanine, 3-(3,4-dihydroxyphenyl)-, L-

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

48 API Suppliers

22 USDMF

13 CEP/COS

4 JDMF

3 EU WC

9 KDMF

12 NDC API

17 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

71 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

855 FDF Dossiers

141 FDA Orange Book

531 Europe

33 Canada

88 Australia

14 South Africa

48 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG;100MG

TABLET;ORAL - 25MG;100MG

TABLET;ORAL - 25MG;250MG

TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 23.75MG;95MG

CAPSULE, EXTENDED RELEASE;ORAL - 36.25MG;145MG

CAPSULE, EXTENDED RELEASE;ORAL - 48.75MG;195MG

CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG

TABLET;ORAL - 12.5MG;200MG;50MG

TABLET;ORAL - 18.75MG;200MG;75MG

TABLET;ORAL - 25MG;200MG;100MG

TABLET;ORAL - 31.25MG;200MG;125MG

TABLET;ORAL - 37.5MG;200MG;150MG

TABLET;ORAL - 50MG;200MG;200MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Minakem

4 Evonik

4 Rochem International Inc

21 SPI Pharma

8 DKSH

8 Boai NKY Pharmaceuticals Ltd

8 Gangwal Healthcare

5 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

1 Capital Farma

4 Kirsch Pharma

1 Panvo Organics

1 ACG Worldwide

8 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

3 Ashland

29 BASF

1 CD Formulation

12 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

1 Finar

12 Gangwal Chemicals

9 Ideal Cures

5 Ingredion Pharma Solutions

22 Kerry

4 Keval Exports

5 Kima Chemical

6 Lonza Capsugel

17 Microlex e.U

1 Nanjing Bold Chemical

3 Nitika Pharmaceutical Specialities

TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons