Alendronate Sodium | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Alendronate Sodium
South Africa

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Alendronate Sodium

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

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

50 API Suppliers
24 USDMF
13 CEP/COS
6 JDMF
11 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TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 70MG BASE, TABLET;ORAL - EQ 70MG BASE;2,800 IU, TABLET;ORAL - EQ 70MG BASE;5,600 IU

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Jai Radhe Sales, 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

80 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 Surfactant & Foaming Agents, 1 Film Formers & Plasticizers

80 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 Surfactant & Foaming Agents
1 Film Formers & Plasticizers

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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01 2Accord Healthcare (Pty) Ltd

02 1Organon South Africa (Pty) Ltd

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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

euroPLX 86 Munich

Not Confirmed

Accord Healthcare (Pty) Ltd

euroPLX 86 Munich

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Accord Healthcare (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

Accord Healthcare (Pty) Ltd

euroPLX 86 Munich

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

Product Web Link

Digital Content

Corporate PDF

03

Organon South Africa (Pty) Ltd

Country

euroPLX 86 Munich

Not Confirmed

Organon South Africa (Pty) Ltd

Country

euroPLX 86 Munich

Not Confirmed

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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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