Risedronate 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

Risedronate sodium

CAS No.

329003-65-8

Reference product

Actonel, Benet/ACCORD

Polymorphic form

Form A

Therapeutic Area

Musculo-skeletal system

Status

commercial

EU DMF readiness

✓

US DMF readiness

020384

CEP

✓

Other documentation

Japanese DMF
Korean DMF
Canadian DMF
Brazilian DMF

Drug description:

Risedronate sodium is a pyridines derivative drug which belongs to the class of bone density conservation agents.
Risedronate sodium is indicated for treatment and prevention of osteoporosis in postmenopausal women, glucocorticoid-induced osteoporosis in men and women and treatment of osteoporosis in men, and also used for treatment of Paget’s disease of bone.
It is formulated as tablets, film-coated tablet for oral route of administration.

Mechanism of action:

Risedronate sodium is a pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption. The bone turnover is reduced while the osteoblast activity and bone mineralization is preserved.

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).