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

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Naltrexone Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

73 API Suppliers, 8 USDMF, 8 CEP/COS, 2 EU WC, 8 KDMF, 55 NDC API, 21 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

18 Drugs in Development

18 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

45 FDF Dossiers, 23 FDA Orange Book, 12 Europe, 4 Canada, 2 South Africa, 4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG, CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Evonik, 1 SPI Pharma, 10 DKSH, 4 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 5 Kirsch Pharma, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 1 CD Formulation, 1 Clariant, 18 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 1 Finar, 10 Gangwal Chemicals, 8 Ideal Cures, 1 Ingredion Pharma Solutions, 23 Kerry, 2 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 10 Roquette, 12 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

59 Coating Systems & Additives, 38 Fillers, Diluents & Binders, 36 Controlled & Modified Release, 28 Thickeners and Stabilizers, 24 Granulation, 22 Direct Compression, 19 Solubilizers, 14 Parenteral, 14 Lubricants & Glidants, 14 Disintegrants & Superdisintegrants, 13 Topical, 12 Film Formers & Plasticizers, 11 Taste Masking, 9 Co-Processed Excipients, 9 Empty Capsules, 7 Emulsifying Agents, 7 Rheology Modifiers, 5 Coloring Agents, 5 Surfactant & Foaming Agents, 5 API Stability Enhancers, 4 Chewable & Orodispersible Aids, 4 Vegetarian Capsules

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 49 News #PharmaBuzz

GLOBAL SALES INFORMATION

12 US Medicaid Prescriptions, 12 Regulatory FDF Prices

MARKET PLACE

18 APIs, 3 FDF Dossiers

PATENTS & EXCLUSIVITIES

85 US Patents, 4 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 7 Others

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Certificate Holder	Certificate No.	Substance	Issue Date	Status	Type	End Date	Substance No.
30/12/2025	Siegfried AG	Switzerland	SIEGFRIED LTD. Zofingen CH	R1-CEP 2009-352 - Rev 03	Naltrexone hydrochloride	2023-02-15	Valid	Chemical		1790
30/12/2025	EUROAPI	France	FRANCOPIA Paris FR	CEP 2009-287 - Rev 04	Naltrexone hydrochloride	2025-10-20	Valid	Chemical		1790

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Naltrexone Hydrochloride

Naltrexone Hydrochloride

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

73 API Suppliers

8 USDMF

8 CEP/COS

2 EU WC

8 KDMF

55 NDC API

21 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

18 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

45 FDF Dossiers

23 FDA Orange Book

12 Europe

4 Canada

2 South Africa

4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG

CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Evonik

1 SPI Pharma

10 DKSH

4 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

1 Pfanstiehl

5 Kirsch Pharma

4 ACG Worldwide

8 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

17 BASF

1 CD Formulation

1 Clariant

18 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

1 Finar

10 Gangwal Chemicals

8 Ideal Cures

1 Ingredion Pharma Solutions

23 Kerry

2 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

1 Novo Excipients

1 Pharmatrans-Sanaq

4 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

10 Roquette

12 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

3 Silverline Chemicals

3 The Dow Chemical Company

1 Valens Pharmachem

3 Vasa Pharmachem

1 Vertellus

EXCIPIENTS BY APPLICATIONS

CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons