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Naltrexone Hydrochloride

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ACTIVE PHARMA INGREDIENTS

25 API Suppliers, 9 USDMF, 8 CEP/COS, 2 EU WC, 6 KDMF, 44 NDC API, 18 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

14 Drugs in Development

14 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

48 FDF Dossiers, 23 FDA Orange Book, 14 Europe, 4 Canada, 2 South Africa, 5 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CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

2 Evonik, 1 SPI Pharma, 2 Seqens, 8 DKSH, 2 Jai Radhe Sales, 4 Faran Shimi Pharmaceutical, 9 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 1 Clariant, 18 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 10 Gangwal Chemicals, 9 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 35 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 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, 11 Sigachi Industries, 3 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

61 Coating Systems & Additives, 56 Fillers, Diluents & Binders, 42 Controlled & Modified Release, 25 Thickeners and Stabilizers, 24 Direct Compression, 19 Solubilizers, 19 Granulation, 15 Lubricants & Glidants, 15 Disintegrants & Superdisintegrants, 13 Co-Processed Excipients, 12 Topical, 12 Parenteral, 12 Film Formers & Plasticizers, 11 Taste Masking, 9 Empty Capsules, 7 Emulsifying Agents, 5 Rheology Modifiers, 5 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 3 Chewable & Orodispersible Aids

DIGITAL CONTENT

47 NEWS #PharmaBuzz

47 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 17 Finished Drug Prices

MARKET PLACE

16 APIs, 3 FDF Dossiers

PATENTS & EXCLUSIVITIES

88 US Patents

88 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 7 Others

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/10/2024	EUROAPI	France	FRANCOPIA A EUROAPI CO	20623	NALTREXONE HYDROCHLORIDE	2007-06-20	Active	II	Complete	2013-03-17	2013-03-11
28/10/2024	Veranova	U.S.A	MACFARLAN SMITH LTD	21590	NALTREXONE HYDROCHLORIDE	2008-04-29	Active	II	Complete	2012-12-27	2012-11-30

Naltrexone Hydrochloride

Naltrexone Hydrochloride

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Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

25 API Suppliers

9 USDMF

8 CEP/COS

2 EU WC

6 KDMF

44 NDC API

18 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

14 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

48 FDF Dossiers

23 FDA Orange Book

14 Europe

4 Canada

2 South Africa

5 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

2 Evonik

1 SPI Pharma

2 Seqens

8 DKSH

2 Jai Radhe Sales

4 Faran Shimi Pharmaceutical

9 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

1 Pfanstiehl

4 ACG Worldwide

8 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

17 BASF

1 Clariant

18 Corel Pharma Chem

6 DFE Pharma

1 Finar

10 Gangwal Chemicals

9 Ideal Cures Pvt Ltd

1 Ingredion Pharma Solutions

35 Kerry

4 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

1 Nanjing Bold Chemical

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

11 Sigachi Industries

3 The Dow Chemical Company

1 Valens Pharmachem

3 Vasa Pharmachem

1 Vertellus

EXCIPIENTS BY APPLICATIONS

61 Coating Systems & Additives

56 Fillers, Diluents & Binders

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