Alendronate sodium

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We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs), that is proceeding with a $45-million manufacturing expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from 2024 with full completion scheduled for Q3 2024.

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Polpharma API CDMO (Contract Development and Manufacturing Organization) supports emerging and large pharmaceutical customers in the development and commercialization of their small-molecule APIs clinical candidates thanks to +70 years of experience in process development, scale-up, and cGMP manufacturing of small molecule APIs in volumes ranging from kilos to tens of tons.

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We manufacture our products by following our customers' and health authorities' most stringent requirements. DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD), and FDA (US DMF). Material and product testing is performed in line with the European and United States Pharmacopeias.

Technologies Cryogenic High Potent Capabilities
 

We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs) that is proceeding with a $35-million facility expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from Q1 2024, with full completion scheduled for Q3 2024.

Our products

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).