Alendronic acid sodium salt | Australian Register of Therapeutic Goods | Australia | PharmaCompass.com

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Alendronic Acid Sodium Salt
Australia

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Alendronic acid sodium salt

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

59 API Suppliers, 24 USDMF, 13 CEP/COS, 6 JDMF, 9 EU WC, 13 KDMF, 10 NDC API, 20 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

FINISHED DOSAGE FORMULATIONS

237 FDF Dossiers, 64 FDA Orange Book, 104 Europe, 24 Canada, 14 Australia, 3 South Africa, 28 Listed Dossiers

237 FDF Dossiers
64 FDA Orange Book
104 Europe
24 Canada
14 Australia
3 South Africa
28 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TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 70MG BASE, TABLET;ORAL - EQ 70MG BASE;2,800 IU, TABLET;ORAL - EQ 70MG BASE;5,600 IU

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 10 Sigachi Industries, 4 Silverline Chemicals, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

74 Fillers, Diluents & Binders, 29 Disintegrants & Superdisintegrants, 27 Direct Compression, 24 Taste Masking, 22 Co-Processed Excipients, 19 Granulation, 18 Thickeners and Stabilizers, 15 Chewable & Orodispersible Aids, 14 Lubricants & Glidants, 8 Empty Capsules, 7 Coating Systems & Additives, 6 Parenteral, 5 Controlled & Modified Release, 3 Emulsifying Agents, 3 API Stability Enhancers, 3 Solubilizers, 2 Topical, 2 Rheology Modifiers, 1 Surfactant & Foaming Agents, 1 Film Formers & Plasticizers

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

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 25 News #PharmaBuzz

1 Data Compilation #PharmaFlow
25 News #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 117 Regulatory FDF Prices, 5 Annual Reports

4 US Medicaid Prescriptions
117 Regulatory FDF 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, 4 JP, 1 Others

2 EDQM
4 JP
1 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 218 Xls

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01 6Alphapharm PTY Ltd

02 2Alphapharm Pty Ltd

03 2Apotex Pty Ltd

04 2Sandoz Pty Ltd

05 2WAGNER PHARMACEUTICALS PTY LTD

filter Active Ingredients Reset all filters

14 All

01 8Alendronate

02 6Alendronate; Colecalciferol

filter Dosage Form Reset all filters

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01 6Tablet

02 8tablet

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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

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01

Alphapharm Pty Ltd

IOPC

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Alphapharm Pty Ltd

IOPC

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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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02

Alphapharm PTY Ltd

IOPC

Not Confirmed

Alphapharm PTY Ltd

IOPC

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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

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03

Alphapharm PTY Ltd

IOPC

Not Confirmed

Alphapharm PTY Ltd

IOPC

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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

IOPC

Not Confirmed

Alphapharm PTY Ltd

IOPC

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

IOPC

Not Confirmed

Alphapharm PTY Ltd

IOPC

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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

IOPC

Not Confirmed

Alphapharm Pty Ltd

IOPC

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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

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07

Apotex Pty Ltd

IOPC

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Apotex Pty Ltd

IOPC

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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

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08

Sandoz Pty Ltd

IOPC

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Sandoz Pty Ltd

IOPC

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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

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Digital Content

09

Sandoz Pty Ltd

IOPC

Not Confirmed

Sandoz Pty Ltd

IOPC

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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

Product Web Link

Digital Content

10

WAGNER PHARMACEUTICALS PTY LTD

Country

IOPC

Not Confirmed

WAGNER PHARMACEUTICALS PTY LTD

Country

IOPC

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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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