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

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Alendronate Sodium Trihydrate
Australia

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pharmacompass-2-m-2025-11-03

Alendronate Sodium Trihydrate

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

57 API Suppliers, 24 USDMF, 13 CEP/COS, 6 JDMF, 12 EU WC, 4 KDMF, 12 NDC API, 21 Listed Suppliers, $ API Reference Price

57 API Suppliers
24 USDMF
13 CEP/COS
6 JDMF
12 EU WC
4 KDMF
12 NDC API
21 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

21 Drugs in Development

21 Drugs in Development

FINISHED DOSAGE FORMULATIONS

268 FDF Dossiers, 64 FDA Orange Book, 137 Europe, 23 Canada, 14 Australia, 3 South Africa, 27 Listed Dossiers

268 FDF Dossiers
64 FDA Orange Book
137 Europe
23 Canada
14 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TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 70MG BASE, TABLET;ORAL - EQ 70MG BASE;2,800 IU, TABLET;ORAL - EQ 70MG BASE;5,600 IU

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 3 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 3 Kirsch Pharma, 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, 5 Ingredion Pharma Solutions, 15 Kerry, 3 Keval Exports, 3 Lonza Capsugel, 12 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 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, 10 Sigachi Industries, 4 Silverline Chemicals, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

60 Fillers, Diluents & Binders, 33 Direct Compression, 29 Disintegrants & Superdisintegrants, 24 Granulation, 24 Taste Masking, 19 Thickeners and Stabilizers, 17 Chewable & Orodispersible Aids, 14 Lubricants & Glidants, 14 Co-Processed Excipients, 8 Parenteral, 8 Empty Capsules, 6 Coating Systems & Additives, 4 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

60 Fillers, Diluents & Binders
33 Direct Compression
29 Disintegrants & Superdisintegrants
24 Granulation
24 Taste Masking
19 Thickeners and Stabilizers
17 Chewable & Orodispersible Aids
14 Lubricants & Glidants
14 Co-Processed Excipients
8 Parenteral
8 Empty Capsules
6 Coating Systems & Additives
4 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

13 US Medicaid Prescriptions, 77 Regulatory FDF Prices

13 US Medicaid Prescriptions
77 Regulatory FDF Prices

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, 4 JP, 2 Others

2 EDQM
4 JP
2 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 217 Xls

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14 All

01 8Alphapharm Pty Ltd

02 2Apotex Pty Ltd

03 2Sandoz Pty Ltd

04 2WAGNER PHARMACEUTICALS PTY LTD

filter Active Ingredients Reset all filters

14 All

01 8Alendronate

02 6Alendronate + colecalciferol

filter Dosage Form Reset all filters

14 All

01 6Tablet

02 8tablet

filter Brand Name Reset all filters

14 All

01 2ALENDRONATE-WGR

02 2APO-Alendronate

03 2Alendronate Sandoz

04 2Fonat

05 3Fosamax Plus

06 3Fosamax Plus 70 mg/140 mcg

Alendronate Sodium

List of Suppliers

Product Main Page

01

Alphapharm Pty Ltd

AES

Not Confirmed

Alphapharm Pty Ltd

AES

Not Confirmed

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Digital Content

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Alphapharm Pty Ltd

AES

Not Confirmed

Alphapharm Pty Ltd

AES

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

Alendronate + colecalciferol

Brand Name : Fosamax Plus 70 mg/140 mcg

Dosage Form : Tablet

Dosage Strength : 70MG

Packaging : 4

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Alphapharm Pty Ltd

AES

Not Confirmed

Alphapharm Pty Ltd

AES

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

Alendronate + colecalciferol

Brand Name : Fosamax Plus

Dosage Form : Tablet

Dosage Strength : 70MG

Packaging : 4

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Alphapharm Pty Ltd

AES

Not Confirmed

Alphapharm Pty Ltd

AES

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

Alendronate + colecalciferol

Brand Name : Fosamax Plus

Dosage Form : Tablet

Dosage Strength : 70MG

Packaging : 4

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Alphapharm Pty Ltd

AES

Not Confirmed

Alphapharm Pty Ltd

AES

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

Alendronate + colecalciferol

Brand Name : Fosamax Plus 70 mg/140 mcg

Dosage Form : Tablet

Dosage Strength : 70MG

Packaging : 4

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Alphapharm Pty Ltd

AES

Not Confirmed

Alphapharm Pty Ltd

AES

Not Confirmed

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Digital Content

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Apotex Pty Ltd

AES

Not Confirmed

Apotex Pty Ltd

AES

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Digital Content

Regulatory Info :

Registration Country : Australia

Alendronate

Brand Name : APO-Alendronate

Dosage Form : tablet

Dosage Strength : 70 mg

Packaging : 4

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Sandoz Pty Ltd

AES

Not Confirmed

Sandoz Pty Ltd

AES

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

Alendronate

Brand Name : Alendronate Sandoz

Dosage Form : tablet

Dosage Strength : 70 mg

Packaging : 4

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Sandoz Pty Ltd

AES

Not Confirmed

Sandoz Pty Ltd

AES

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

Alendronate

Brand Name : Alendronate Sandoz

Dosage Form : tablet

Dosage Strength : 70 mg

Packaging : 4

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

WAGNER PHARMACEUTICALS PTY LTD

Country

AES

Not Confirmed

WAGNER PHARMACEUTICALS PTY LTD

Country

AES

Not Confirmed

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Country

Virtual Booth

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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

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

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