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Naltrexone HCl
Europe

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Naltrexone HCl

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

73 API Suppliers, 9 USDMF, 8 CEP/COS, 2 EU WC, 8 KDMF, 55 NDC API, 18 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

30 Drugs in Development

30 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

44 FDF Dossiers, 23 FDA Orange Book, 11 Europe, 4 Canada, 2 South Africa, 4 Listed Dossiers

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CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Surfactant & Foaming Agents, 5 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Chewable & Orodispersible Aids

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 Surfactant & Foaming Agents
5 API Stability Enhancers
5 Coloring Agents
4 Vegetarian Capsules
4 Chewable & Orodispersible Aids

DIGITAL CONTENT

49 News #PharmaBuzz

49 News #PharmaBuzz

GLOBAL SALES INFORMATION

12 US Medicaid Prescriptions, 14 Regulatory FDF Prices

12 US Medicaid Prescriptions
14 Regulatory FDF Prices

MARKET PLACE

17 APIs, 3 FDF Dossiers

17 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

85 US Patents, 4 Health Canada Patents

85 US Patents
4 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 7 Others

2 EDQM
7 Others

$ API Ref.Price (USD/KG) : 6,845 Xls

Filters

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filter Applicant Reset all filters

11 All

01 1ACCORD HEALTHCARE LIMITED

02 1Accord Healthcare Slu

03 1Bristol-Myers Squibb

04 1MOLTENI & C. F.LLI ALITTI SpA

05 2Orexigen Therapeutics Ireland Limited

06 1Orexigen Therapeutics Ireland Limited (1)

07 1POA Pharma Scandinavia AB

08 1SIRTON MEDICARE Srl

09 2ZAMBON ITALIA Srl

filter Active Ingredients Reset all filters

11 All

01 1Bupropion Hydrochloride; Naltrexone Hydrochloride

02 1Naltreksonhydrochloride; Bupropionhydrochloride

03 8Naltrexone Hydrochloride

04 1Naltrexone Hydrochloride; Bupropion Hydrochloride

filter Dosage Form Reset all filters

11 All

01 1Antic-calc Tablet, Film Coated

02 1Depot tablet

03 1Extended-Release Tablet

04 2Film Coated Tablet

05 2Naltrexone 50Mg 10 Units Oral Use

06 3Naltrexone 50Mg 14 Joined' Oral Use

07 1Tablet

filter Country Reset all filters

11 All

01 5Italy

02 2Norway

03 3Spain

04 1Sweden

filter Brand Name Reset all filters

11 All

01 2Antaxone

02 3Mysimba

03 1Nalorex

04 1Naltrexone

05 1Naltrexone POA Pharma

06 1Narcoral

07 1Revia Coated Tablets

08 1Tranalex

Naltrexone Hydrochloride

List of Suppliers

Product Main Page

01

ACCORD HEALTHCARE LIMITED

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ACCORD HEALTHCARE LIMITED

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Regulatory Info :

Registration Country : Italy

Naltrexone Hydrochloride

Brand Name : Naltrexone

Dosage Form : Naltrexone 50Mg 14 Joined' Oral Use

Dosage Strength : 14 cpr riv 50 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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02

Bristol-Myers Squibb

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Bristol-Myers Squibb

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Regulatory Info : Authorized

Registration Country : Spain

Naltrexone Hydrochloride

Brand Name : Revia Coated Tablets

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 2004-11-18

Application Number : 3417516

Regulatory Info : Authorized

Registration Country : Spain

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03

MOLTENI & C. F.LLI ALITTI SpA

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MOLTENI & C. F.LLI ALITTI SpA

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Regulatory Info :

Registration Country : Italy

Naltrexone Hydrochloride

Brand Name : Nalorex

Dosage Form : Naltrexone 50Mg 14 Joined' Oral Use

Dosage Strength : 14 cpr riv 50 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

ZAMBON ITALIA Srl

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ZAMBON ITALIA Srl

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Regulatory Info :

Registration Country : Italy

Naltrexone Hydrochloride

Brand Name : Antaxone

Dosage Form : Naltrexone 50Mg 14 Joined' Oral Use

Dosage Strength : 14 cps 50 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

ZAMBON ITALIA Srl

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ZAMBON ITALIA Srl

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Regulatory Info :

Registration Country : Italy

Naltrexone Hydrochloride

Brand Name : Antaxone

Dosage Form : Naltrexone 50Mg 10 Units Oral Use

Dosage Strength : os soluz 10 vials 50 mg 10 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

SIRTON MEDICARE Srl

Country

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SIRTON MEDICARE Srl

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Regulatory Info :

Registration Country : Italy

Naltrexone Hydrochloride

Brand Name : Narcoral

Dosage Form : Naltrexone 50Mg 10 Units Oral Use

Dosage Strength : 10 CPR 50 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

POA Pharma Scandinavia AB

Country

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POA Pharma Scandinavia AB

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Regulatory Info :

Registration Country : Norway

Naltrexone Hydrochloride

Brand Name : Naltrexone POA Pharma

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 50 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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08

Orexigen Therapeutics Ireland Limited (1...

Country

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Orexigen Therapeutics Ireland Limited (1...

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Regulatory Info :

Registration Country : Norway

Naltreksonhydrochloride; Bupropionhydrochloride

Brand Name : Mysimba

Dosage Form : Depot tablet

Dosage Strength : 8mg/90mg

Packaging : Blisterpakning 112item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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09

Orexigen Therapeutics Ireland Limited

Country

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Orexigen Therapeutics Ireland Limited

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Regulatory Info : Approved

Registration Country : Sweden

Bupropion Hydrochloride; Naltrexone Hydrochloride

Brand Name : Mysimba

Dosage Form : Tablet

Dosage Strength : 8mg;90mg

Packaging :

Approval Date : 26/03/2015

Application Number : 20131031000012

Regulatory Info : Approved

Registration Country : Sweden

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10

Orexigen Therapeutics Ireland Limited

Country

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Orexigen Therapeutics Ireland Limited

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Regulatory Info : Authorized

Registration Country : Spain

Naltrexone Hydrochloride; Bupropion Hydrochloride

Brand Name : Mysimba

Dosage Form : Extended-Release Tablet

Dosage Strength : 8MG; 90 MG

Packaging :

Approval Date : 2016-10-10

Application Number : 114988001

Regulatory Info : Authorized

Registration Country : Spain

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