Naltrexone Hydrochloride | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Naltrexone Hydrochloride
South Africa

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Faran Shimi Naltrexone Hydrochloride

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Naltrexone Hydrochloride

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FAMAR CDMO- From early development to commercial manufacturing.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Naltrexone Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 9 USDMF, 8 CEP/COS, 2 EU WC, 7 KDMF, 46 NDC API, 19 Listed Suppliers, $ API Reference Price

26 API Suppliers
9 USDMF
8 CEP/COS
2 EU WC
7 KDMF
46 NDC API
19 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

14 Drugs in Development

14 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

48 FDF Dossiers, 23 FDA Orange Book, 14 Europe, 4 Canada, 2 South Africa, 5 Listed Dossiers

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CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or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

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, 2 Seqens, 8 DKSH, 4 Faran Shimi Pharmaceutical, 4 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

63 Coating Systems & Additives, 52 Fillers, Diluents & Binders, 41 Controlled & Modified Release, 24 Thickeners and Stabilizers, 19 Granulation, 19 Solubilizers, 17 Direct Compression, 14 Disintegrants & Superdisintegrants, 14 Lubricants & Glidants, 13 Film Formers & Plasticizers, 12 Topical, 12 Parenteral, 11 Taste Masking, 9 Co-Processed Excipients, 9 Empty Capsules, 7 Emulsifying Agents, 5 API Stability Enhancers, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 3 Chewable & Orodispersible Aids

63 Coating Systems & Additives
52 Fillers, Diluents & Binders
41 Controlled & Modified Release
24 Thickeners and Stabilizers
19 Granulation
19 Solubilizers
17 Direct Compression
14 Disintegrants & Superdisintegrants
14 Lubricants & Glidants
13 Film Formers & Plasticizers
12 Topical
12 Parenteral
11 Taste Masking
9 Co-Processed Excipients
9 Empty Capsules
7 Emulsifying Agents
5 API Stability Enhancers
5 Coloring Agents
5 Rheology Modifiers
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

2 US Medicaid Prescriptions
17 Finished Drug Prices

MARKET PLACE

16 APIs, 3 FDF Dossiers

16 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

88 US Patents

88 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 7 Others

2 EDQM
7 Others

$ API Ref.Price (USD/KG) : 6,831 Xls

Filters

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filter Applicant Reset all filters

2 All

01 1Accord Healthcare (Pty) Ltd

02 1Litha Pharma (Pty) Ltd

filter Active Ingredients Reset all filters

2 All

01 1Naltrexone Hydrochloride

02 1Naltrexone hydrochloride

filter Dosage Form Reset all filters

2 All

01 1TAB

02 1Tab

filter Brand Name Reset all filters

2 All

01 1Contrave

02 1Naltima

List of Suppliers

Product Main Page

01

Accord Healthcare (Pty) Ltd

PharmScience R&D

Not Confirmed

Accord Healthcare (Pty) Ltd

PharmScience R&D

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Naltrexone hydrochloride

Brand Name : Naltima

Dosage Form : TAB

Dosage Strength : 50mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Litha Pharma (Pty) Ltd

BioAsia

Not Confirmed

Litha Pharma (Pty) Ltd

BioAsia

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Naltrexone Hydrochloride

Brand Name : Contrave

Dosage Form : Tab

Dosage Strength : 8mg

Packaging : 112X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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