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Alendronate, Sodium, Trihydrate

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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

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

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TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 70MG BASE, TABLET;ORAL - EQ 70MG BASE;2,800 IU, TABLET;ORAL - EQ 70MG BASE;5,600 IU

RELATED EXCIPIENT COMPANIES

4 Rochem International Inc, 17 SPI Pharma, 6 DKSH, 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

79 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 Film Formers & Plasticizers, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 25 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 120 Finished Drug Prices, 5 Annual Reports

MARKET PLACE

10 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

1 US Patents, 17 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 4 JP, 1 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/01/2025	Polpharma	Poland	ZAKLADY FARMACEUTYCZNE POLPHARMA SA	16962	SODIUM ALENDRONATE	2003-11-17	Active	II	Complete	2014-12-16	2014-11-28
28/01/2025	TAPI Technology & API Services	Israel	TEVA PHARMACEUTICAL INDUSTRIES LTD	20443	SODIUM ALENDRONATE	2007-04-17	Inactive	II	N/A

Alendronate, Sodium, Trihydrate

Alendronate, Sodium, Trihydrate

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Browse all information

CHEMISTRY

Discover Molecule Insights

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

DEVELOPMENTS

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

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

RELATED EXCIPIENT COMPANIES

4 Rochem International Inc

17 SPI Pharma

6 DKSH

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

79 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

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