EU DMF readiness
US DMF readiness
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.
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).
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.