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Alendronate, Sodium, Trihydrate

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ACTIVE PHARMA INGREDIENTS

53 API Suppliers, 24 USDMF, 13 CEP/COS, 6 JDMF, 9 EU WC, 3 KDMF, 11 NDC API, 20 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

21 Drugs in Development

21 Drugs in Development

FINISHED DOSAGE FORMULATIONS

231 FDF Dossiers, 64 FDA Orange Book, 104 Europe, 24 Canada, 8 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TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 70MG BASE, TABLET;ORAL - EQ 70MG BASE;2,800 IU, TABLET;ORAL - EQ 70MG BASE;5,600 IU

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 Co-Processed Excipients, 14 Lubricants & Glidants, 8 Empty Capsules, 8 Parenteral, 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

GLOBAL SALES INFORMATION

13 US Medicaid Prescriptions, 117 Regulatory FDF Prices

MARKET PLACE

10 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

1 US Patents, 17 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 4 JP, 1 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Name of the Firm	Written Confirmation No.	Product Name	Issue Date	Valid Till	Address of the Firm
04/06/2025	Apex Healthcare Limited	India	M/s Apex Healthcare limited	WC-0409	Sodium Alendronate BP/EP/USP	2024-03-01	2026-12-31	4710, 4711, 4707-A/8, 4707-A/9, GIDC, Industrial Estate, Ankleshwar, Dist.Bharuch-393002, Gujarat, India
06/09/2025	Aurobindo Pharma Limited	India	M/s. Apitoria Pharma Private Limited	WC-0023	Alendronate Sodium Ph.Eur	07-11-2025	25-06-2028	Sy. No’s. 52,53,58,59,61 to 78, 127 & 128,Pydibhimavaram Village & Sy. No’s. 1,2,4 to 9,11,29,30,31 & 32,Chittivalasa Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, India, PIN: 532409

Alendronate, Sodium, Trihydrate

Alendronate, Sodium, Trihydrate

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

53 API Suppliers

24 USDMF

13 CEP/COS

6 JDMF

9 EU WC

3 KDMF

11 NDC API

20 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

21 Drugs in Development

FINISHED DOSAGE FORMULATIONS

231 FDF Dossiers

64 FDA Orange Book

104 Europe

24 Canada

8 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

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 Co-Processed Excipients

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