Alendronate Sodium | Australian Register of Therapeutic Goods | Australia | PharmaCompass.com

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Alendronate Sodium
Australia

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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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Alendronate Sodium

ACCESS ALL DATA, CHEMISTRY

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TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 70MG BASE, TABLET;ORAL - EQ 70MG BASE;2,800 IU, TABLET;ORAL - EQ 70MG BASE;5,600 IU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

02 2Apotex Pty Ltd

03 2Sandoz Pty Ltd

04 2WAGNER PHARMACEUTICALS PTY LTD

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01 2ALENDRONATE-WGR

02 2APO-Alendronate

03 2Alendronate Sandoz

04 2Fonat

Alendronate Sodium

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Alphapharm Pty Ltd

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Alphapharm Pty Ltd

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Regulatory Info :

Registration Country : Australia

alendronate

Brand Name : Fonat

Dosage Form : tablet

Dosage Strength : 70 mg

Packaging : 4

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Alphapharm Pty Ltd

PharmScience R&D

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Regulatory Info :

Registration Country : Australia

alendronate

Brand Name : Fonat

Dosage Form : tablet

Dosage Strength : 70 mg

Packaging : 4

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Regulatory Info :

Registration Country : Australia

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03

Apotex Pty Ltd

PharmScience R&D

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Apotex Pty Ltd

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Regulatory Info :

Registration Country : Australia

alendronate

Brand Name : APO-Alendronate

Dosage Form : tablet

Dosage Strength : 70 mg

Packaging : 4

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Regulatory Info :

Registration Country : Australia

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Apotex Pty Ltd

PharmScience R&D

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Regulatory Info :

Registration Country : Australia

alendronate

Brand Name : APO-Alendronate

Dosage Form : tablet

Dosage Strength : 70 mg

Packaging : 4

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Registration Country : Australia

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Sandoz Pty Ltd

PharmScience R&D

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Regulatory Info :

Registration Country : Australia

alendronate

Brand Name : Alendronate Sandoz

Dosage Form : tablet

Dosage Strength : 70 mg

Packaging : 4

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Registration Country : Australia

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Sandoz Pty Ltd

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alendronate

Brand Name : Alendronate Sandoz

Dosage Form : tablet

Dosage Strength : 70 mg

Packaging : 4

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Registration Country : Australia

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WAGNER PHARMACEUTICALS PTY LTD

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PharmScience R&D

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Registration Country : Australia

alendronate

Brand Name : ALENDRONATE-WGR

Dosage Form : tablet

Dosage Strength : 70 mg

Packaging : 4

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WAGNER PHARMACEUTICALS PTY LTD

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PharmScience R&D

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Regulatory Info :

Registration Country : Australia

alendronate

Brand Name : ALENDRONATE-WGR

Dosage Form : tablet

Dosage Strength : 70 mg

Packaging : 4

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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