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Alendronate sodium

CAS No.

121268-17-5

Reference product

FOSAMAX/MSD

Polymorphic form

Trihydrate

Therapeutic Area

Musculo-skeletal system

Status

commercial

EU DMF readiness

US DMF readiness

016962

CEP

Other documentation

Japanese DMF
Korean DMF
Canadian DMF

💉 Available also
in injectable form

Drug description:

Alendronate sodium is indicated for the treatment of post-menopausal osteoporosis; reduces the risk of vertebral and hip fractures. Alendronate sodium is indicated for the treatment of osteoporosis in men at increased risk of fracture. A reduction in the incidence of vertebral, but not of non-vertebral fractures has been demonstrated. Alendronate sodium is used in the prophylaxis of glucocorticoid-induced osteoporosis.
It is formulated as tablets for oral route of administration.

Mechanism of action:

Alendronate sodium is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation. Preclinical studies have shown preferential localization of alendronate sodium to sites of active resorption. Activity of osteoclasts is inhibited, but recruitment or attachment of osteoclasts is not affected. The bone formed during treatment with alendronate sodium is of normal quality.

Disclaimer
Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).
Polpharma’s strategic investment in HPAPI facility
We have launched an investment in a specialized facility
for the R&D and Production of highly active substances
with an OEL value of 10 ng/m3 (OEB 6).

The HP API investment includes separate process
laboratories (PDL), analytical laboratories (ADL)
with the possibility of performing Quality Control
analyses, and a GMP kilo-lab production line with
volume up to 1.5 kg with potential volume increase.

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