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

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Fosamax
South Africa

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SPI Pharma has been solving formulation challenges using superior functional materials.

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Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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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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Fosamax

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

47 API Suppliers, 24 USDMF, 13 CEP/COS, 6 JDMF, 10 EU WC, 13 KDMF, 11 NDC API, 19 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

FINISHED DOSAGE FORMULATIONS

233 FDF Dossiers, 64 FDA Orange Book, 107 Europe, 24 Canada, 8 Australia, 3 South Africa, 27 Listed Dossiers

233 FDF Dossiers
64 FDA Orange Book
107 Europe
24 Canada
8 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TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 70MG BASE, TABLET;ORAL - EQ 70MG BASE;2,800 IU, TABLET;ORAL - EQ 70MG BASE;5,600 IU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, 18 SPI Pharma, 6 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 8 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

75 Fillers, Diluents & Binders, 29 Disintegrants & Superdisintegrants, 28 Direct Compression, 24 Taste Masking, 19 Granulation, 19 Thickeners and Stabilizers, 17 Co-Processed Excipients, 15 Chewable & Orodispersible Aids, 14 Lubricants & Glidants, 8 Empty Capsules, 7 Coating Systems & Additives, 6 Parenteral, 5 Controlled & Modified Release, 3 API Stability Enhancers, 3 Solubilizers, 3 Emulsifying Agents, 2 Topical, 2 Rheology Modifiers, 1 Film Formers & Plasticizers, 1 Surfactant & Foaming Agents

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

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 25 NEWS #PharmaBuzz

1 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) : 179 Xls

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01 2Accord Healthcare (Pty) Ltd

02 1MSD(Pty) Ltd

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3 All

01 3Alendronate Sodium

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01 3TAB

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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

The Generic Rx Session

Not Confirmed

Accord Healthcare (Pty) Ltd

The Generic Rx Session

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

The Generic Rx Session

Not Confirmed

Accord Healthcare (Pty) Ltd

The Generic Rx Session

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

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Product Web Link

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Corporate PDF

03

MSD(Pty) Ltd

Country

The Generic Rx Session

Not Confirmed

MSD(Pty) Ltd

Country

The Generic Rx Session

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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