(17beta)-17-Hydroxyandrost-4-en-3-one | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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(17beta)-17-Hydroxyandrost-4-en-3-one
South Africa

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(17beta)-17-Hydroxyandrost-4-en-3-one

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 22 USDMF, 8 CEP/COS, 6 EU WC, 43 NDC API, 17 Listed Suppliers, $ API Reference Price

36 API Suppliers
22 USDMF
8 CEP/COS
6 EU WC
43 NDC API
17 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

9 Drugs in Development

9 Drugs in Development

FINISHED DOSAGE FORMULATIONS

126 FDF Dossiers, 60 FDA Orange Book, 39 Europe, 7 Canada, 7 Australia, 8 South Africa, 5 Listed Dossiers

126 FDF Dossiers
60 FDA Orange Book
39 Europe
7 Canada
7 Australia
8 South Africa
5 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM, EXTENDED RELEASE;TRANSDERMAL - 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FILM, EXTENDED RELEASE;TRANSDERMAL - 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL, METERED;NASAL - 5.5MG/0.122GM ACTUATION, GEL, METERED;TRANSDERMAL - 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TRANSDERMAL - 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TRANSDERMAL - 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TRANSDERMAL - 50MG/5GM PACKET, TABLET, EXTENDED RELEASE;BUCCAL - 30MG, GEL, METERED;TRANSDERMAL - 1.62% (20.25MG/1.25GM ACTUATION), GEL;TRANSDERMAL - 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION, METERED;TRANSDERMAL - 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FILM, EXTENDED RELEASE;TRANSDERMAL - 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
FILM, EXTENDED RELEASE;TRANSDERMAL - 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
GEL, METERED;NASAL - 5.5MG/0.122GM ACTUATION
GEL, METERED;TRANSDERMAL - 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
GEL;TRANSDERMAL - 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
GEL;TRANSDERMAL - 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
GEL;TRANSDERMAL - 50MG/5GM PACKET
TABLET, EXTENDED RELEASE;BUCCAL - 30MG
GEL, METERED;TRANSDERMAL - 1.62% (20.25MG/1.25GM ACTUATION)
GEL;TRANSDERMAL - 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION, METERED;TRANSDERMAL - 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 2 Seqens, 2 DKSH, 1 Jai Radhe Sales, 6 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 23 BASF, 1 BioSpectra, 2 Clariant, 15 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 7 Lubrizol Life Science Health, 14 Microlex e.U, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

75 Fillers, Diluents & Binders, 44 Coating Systems & Additives, 35 Topical, 32 Direct Compression, 30 Controlled & Modified Release, 25 Thickeners and Stabilizers, 21 Granulation, 20 Disintegrants & Superdisintegrants, 19 Lubricants & Glidants, 19 Co-Processed Excipients, 16 Film Formers & Plasticizers, 15 Solubilizers, 13 Parenteral, 7 Taste Masking, 6 Emulsifying Agents, 6 Chewable & Orodispersible Aids, 6 API Stability Enhancers, 5 Empty Capsules, 4 Rheology Modifiers, 4 Vegetarian Capsules, 2 Coloring Agents

75 Fillers, Diluents & Binders
44 Coating Systems & Additives
35 Topical
32 Direct Compression
30 Controlled & Modified Release
25 Thickeners and Stabilizers
21 Granulation
20 Disintegrants & Superdisintegrants
19 Lubricants & Glidants
19 Co-Processed Excipients
16 Film Formers & Plasticizers
15 Solubilizers
13 Parenteral
7 Taste Masking
6 Emulsifying Agents
6 Chewable & Orodispersible Aids
6 API Stability Enhancers
5 Empty Capsules
4 Rheology Modifiers
4 Vegetarian Capsules
2 Coloring Agents

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 120 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
120 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

7 US Medicaid Prescriptions, 36 Finished Drug Prices, 12 Annual Reports

7 US Medicaid Prescriptions
36 Finished Drug Prices
12 Annual Reports

MARKET PLACE

8 APIs, 2 FDF Dossiers

8 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

41 US Patents, 8 Health Canada Patents

41 US Patents
8 Health Canada Patents

REF. STANDARDS & IMPURITIES

10 EDQM, 1 USP, 6 Others

10 EDQM
1 USP
6 Others

ANALYTICAL

2 Analytical Methods

2 Analytical Methods

$ API Ref.Price (USD/KG) : 440 Xls

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01 1Pharmacare Limited, Woodmead

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03 1Depo-testosterone 100mg

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05 1Sustanon 250mg

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07 1TestaForte

08 1Testosterone

Aspen Testosterone

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Pharmacare Limited, Woodmead

Medlab Asia & Asia Health

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Regulatory Info : Originator

Registration Country : South Africa

Testosterone

Brand Name : Sustanon 250mg

Dosage Form : INJ

Dosage Strength : 250mg/ml

Packaging : 1X1mg/ml

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Registration Country : South Africa

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Adcock Ingram Healthcare (Pty) Ltd

Medlab Asia & Asia Health

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Medlab Asia & Asia Health

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Brand Name : Androxon

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Adcock Ingram Limited

Medlab Asia & Asia Health

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Adcock Ingram Limited

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Regulatory Info : Originator

Registration Country : South Africa

Testosterone

Brand Name : Sustanon

Dosage Form : INJ

Dosage Strength : 250mg/ml

Packaging : 6X1mg/ml

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Adcock Ingram Limited

Medlab Asia & Asia Health

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Adcock Ingram Limited

Medlab Asia & Asia Health

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Regulatory Info : Originator

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Testosterone

Brand Name : Testosterone

Dosage Form : IMP

Dosage Strength : 25mg

Packaging : 1X1mg

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Medi Challenge

Medlab Asia & Asia Health

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Medi Challenge

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Testosterone

Brand Name : Androgel

Dosage Form : SAC

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Pfizer Laboratories (Pty) Ltd

Medlab Asia & Asia Health

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Pfizer Laboratories (Pty) Ltd

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Registration Country : South Africa

Testosterone

Brand Name : Depo-testosterone 100mg

Dosage Form : INJ

Dosage Strength : 100mg/ml

Packaging : 10X1mg/ml

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Pharmacorp (Pty) Ltd

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Medlab Asia & Asia Health

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Regulatory Info : Generic

Registration Country : South Africa

Testosterone

Brand Name : TestaFeme

Dosage Form : CRE

Dosage Strength : 10mg/ml

Packaging : 50X1mg/ml

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Regulatory Info : Generic

Registration Country : South Africa

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Pharmacorp (Pty) Ltd

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Medlab Asia & Asia Health

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Pharmacorp (Pty) Ltd

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Regulatory Info : Generic

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Brand Name : TestaForte

Dosage Form : CRE

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