Fosamax | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Fosamax
South Africa

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Fosamax

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

49 API Suppliers, 24 USDMF, 13 CEP/COS, 6 JDMF, 10 EU WC, 13 KDMF, 11 NDC API, 20 Listed Suppliers, $ API Reference Price

49 API Suppliers
24 USDMF
13 CEP/COS
6 JDMF
10 EU WC
13 KDMF
11 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

FINISHED DOSAGE FORMULATIONS

232 FDF Dossiers, 64 FDA Orange Book, 107 Europe, 25 Canada, 6 Australia, 3 South Africa, 27 Listed Dossiers

232 FDF Dossiers
64 FDA Orange Book
107 Europe
25 Canada
6 Australia
3 South Africa
27 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 70MG BASE, TABLET;ORAL - EQ 70MG BASE;2,800 IU, TABLET;ORAL - EQ 70MG BASE;5,600 IU

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 70MG BASE
TABLET;ORAL - EQ 70MG BASE;2,800 IU
TABLET;ORAL - EQ 70MG BASE;5,600 IU

RELATED EXCIPIENT COMPANIES

4 Rochem International Inc, 17 SPI Pharma, 6 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 2 Actylis, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 7 BASF, 1 Bioplus Life Sciences, 7 DFE Pharma, 5 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 26 Kerry, 3 Lonza Capsugel, 12 Microlex e.U, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qualicaps, 18 Roquette, 1 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

79 Fillers, Diluents & Binders, 36 Direct Compression, 27 Disintegrants & Superdisintegrants, 23 Taste Masking, 20 Thickeners and Stabilizers, 20 Co-Processed Excipients, 19 Granulation, 15 Lubricants & Glidants, 14 Chewable & Orodispersible Aids, 8 Empty Capsules, 7 Coating Systems & Additives, 6 Controlled & Modified Release, 6 Parenteral, 4 API Stability Enhancers, 3 Emulsifying Agents, 2 Solubilizers, 2 Topical, 2 Rheology Modifiers, 1 Film Formers & Plasticizers, 1 Surfactant & Foaming Agents

79 Fillers, Diluents & Binders
36 Direct Compression
27 Disintegrants & Superdisintegrants
23 Taste Masking
20 Thickeners and Stabilizers
20 Co-Processed Excipients
19 Granulation
15 Lubricants & Glidants
14 Chewable & Orodispersible Aids
8 Empty Capsules
7 Coating Systems & Additives
6 Controlled & Modified Release
6 Parenteral
4 API Stability Enhancers
3 Emulsifying Agents
2 Solubilizers
2 Topical
2 Rheology Modifiers
1 Film Formers & Plasticizers
1 Surfactant & Foaming Agents

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 25 NEWS #PharmaBuzz

5 DATA COMPILATION #PharmaFlow
25 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 120 Finished Drug Prices, 5 Annual Reports

4 US Medicaid Prescriptions
120 Finished Drug Prices
5 Annual Reports

MARKET PLACE

10 APIs, 1 FDF Dossiers

10 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

1 US Patents, 17 Health Canada Patents

1 US Patents
17 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 4 JP, 1 Others

2 EDQM
1 USP
4 JP
1 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 182 Xls

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3 All

01 2Accord Healthcare (Pty) Ltd

02 1Organon South Africa (Pty) Ltd

filter Active Ingredients Reset all filters

3 All

01 3Alendronate Sodium

filter Dosage Form Reset all filters

3 All

01 3TAB

filter Brand Name Reset all filters

3 All

01 1Fosavance 5 600

02 1Ostena 10

03 1Ostena 70

Alendronate Sodium

List of Suppliers

Product Main Page

01

Accord Healthcare (Pty) Ltd

Antibody Engineering

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Accord Healthcare (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Alendronate Sodium

Brand Name : Ostena 10

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Accord Healthcare (Pty) Ltd

Antibody Engineering

Not Confirmed

Accord Healthcare (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Alendronate Sodium

Brand Name : Ostena 70

Dosage Form : TAB

Dosage Strength : 70mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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Digital Content

Corporate PDF

03

Organon South Africa (Pty) Ltd

Country

Antibody Engineering

Not Confirmed

Organon South Africa (Pty) Ltd

Country

Antibody Engineering

Not Confirmed

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Country

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Regulatory Info : Originator

Registration Country : South Africa

Alendronate Sodium

Brand Name : Fosavance 5 600

Dosage Form : TAB

Dosage Strength : 70mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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