DUTASTERIDE [WHO-DD] | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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DUTASTERIDE [WHO-DD]
South Africa

Evonik

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Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

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xyz-pharma-m-2025-04-21

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.

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xyz-pharma-m-2025-04-14

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DUTASTERIDE [WHO-DD]

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

70 API Suppliers, 17 USDMF, 9 CEP/COS, 8 JDMF, 5 EU WC, 27 KDMF, 20 NDC API, 29 Listed Suppliers, $ API Reference Price

70 API Suppliers
17 USDMF
9 CEP/COS
8 JDMF
5 EU WC
27 KDMF
20 NDC API
29 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

153 FDF Dossiers, 25 FDA Orange Book, 66 Europe, 17 Canada, 8 Australia, 6 South Africa, 31 Listed Dossiers

153 FDF Dossiers
25 FDA Orange Book
66 Europe
17 Canada
8 Australia
6 South Africa
31 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 0.5MG, CAPSULE;ORAL - 0.5MG;0.4MG

CAPSULE;ORAL - 0.5MG
CAPSULE;ORAL - 0.5MG;0.4MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 4 Evonik, 2 Rochem International Inc, 7 SPI Pharma, 13 DKSH, 3 Faran Shimi Pharmaceutical, 4 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 12 Corel Pharma Chem, 2 DFE Pharma, 3 Finar, 8 Gangwal Chemicals, 10 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 17 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 5 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 24 Roquette, 16 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 1 Silverline Chemicals, 1 Symrise, 3 The Dow Chemical Company, 1 Valens Pharmachem, 1 Vasa Pharmachem, 2 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

62 Coating Systems & Additives, 41 Fillers, Diluents & Binders, 35 Controlled & Modified Release, 31 Thickeners and Stabilizers, 26 Solubilizers, 24 Film Formers & Plasticizers, 21 Topical, 18 Parenteral, 17 Taste Masking, 17 Direct Compression, 14 Granulation, 10 Co-Processed Excipients, 9 Empty Capsules, 9 Disintegrants & Superdisintegrants, 9 Rheology Modifiers, 8 Chewable & Orodispersible Aids, 8 Emulsifying Agents, 6 Surfactant & Foaming Agents, 5 Lubricants & Glidants, 5 Coloring Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 1 Soft Gelatin

62 Coating Systems & Additives
41 Fillers, Diluents & Binders
35 Controlled & Modified Release
31 Thickeners and Stabilizers
26 Solubilizers
24 Film Formers & Plasticizers
21 Topical
18 Parenteral
17 Taste Masking
17 Direct Compression
14 Granulation
10 Co-Processed Excipients
9 Empty Capsules
9 Disintegrants & Superdisintegrants
9 Rheology Modifiers
8 Chewable & Orodispersible Aids
8 Emulsifying Agents
6 Surfactant & Foaming Agents
5 Lubricants & Glidants
5 Coloring Agents
4 Vegetarian Capsules
4 API Stability Enhancers
1 Soft Gelatin

DIGITAL CONTENT

34 News #PharmaBuzz

34 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 60 Regulatory FDF Prices, 10 Annual Reports

3 US Medicaid Prescriptions
60 Regulatory FDF Prices
10 Annual Reports

MARKET PLACE

25 APIs, 3 FDF Dossiers

25 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 3 Others

2 EDQM
3 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 11,027 Xls

Filters

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6 All

01 1Adcock Ingram Limited

02 1Cipla Medpro (Pty) Ltd

03 2GlaxoSmithKline South Africa (Pty) Limited

04 1Pharma Dynamics (Pty) Ltd

05 1Zydus Healthcare SA (Pty) Ltd

filter Active Ingredients Reset all filters

6 All

01 6Dutasteride

filter Dosage Form Reset all filters

6 All

01 6CAP

filter Brand Name Reset all filters

6 All

01 1Avodart

02 1Duodart

03 1Duozaq 0,5 mg/0,4 mg

04 1Swifsul

05 1Uromax Co

06 1Zedrast

List of Suppliers

Product Main Page

01

Adcock Ingram Limited

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Adcock Ingram Limited

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Dutasteride

Brand Name : Swifsul

Dosage Form : CAP

Dosage Strength : 0.5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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Corporate PDF

02

Cipla Medpro (Pty) Ltd

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Cipla Medpro (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Dutasteride

Brand Name : Uromax Co

Dosage Form : CAP

Dosage Strength : 0,5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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Corporate PDF

03

GlaxoSmithKline South Africa (Pty) Limit...

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GlaxoSmithKline South Africa (Pty) Limit...

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Dutasteride

Brand Name : Avodart

Dosage Form : CAP

Dosage Strength : 0.5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

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04

GlaxoSmithKline South Africa (Pty) Limit...

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GlaxoSmithKline South Africa (Pty) Limit...

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Dutasteride

Brand Name : Duodart

Dosage Form : CAP

Dosage Strength : 0.5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

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Corporate PDF

05

Pharma Dynamics (Pty) Ltd

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Pharma Dynamics (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Dutasteride

Brand Name : Duozaq 0,5 mg/0,4 mg

Dosage Form : CAP

Dosage Strength : 0,5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Product Web Link

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06

Zydus Healthcare SA (Pty) Ltd

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Zydus Healthcare SA (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Dutasteride

Brand Name : Zedrast

Dosage Form : CAP

Dosage Strength : 0.5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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