Risedronate

For osteoporosis, a degenerative bone disease with high incidence among middle-aged and elderly populations, bisphosphonate drugs are currently the first-line clinical bone resorption inhibitors. Risedronic acid is a third-generation nitrogen-containing bisphosphonate. It specifically binds to hydroxyapatite in bone tissue, inhibits osteoclast activity, reduces the bone resorption process, thereby increasing bone mineral density and reducing the risk of vertebral and non-vertebral fractures. It is mainly used clinically to treat osteoporosis in postmenopausal women and osteoporosis in men, and can also be used for glucocorticoid-induced osteoporosis. The safety and tolerability of long-term medication have been verified by multiple large-scale clinical studies.

The global market size of risedronic acid-related preparations has maintained steady growth in recent years, with the market size reaching approximately USD 870 million in 2023, of which generic drugs account for more than 75%. In terms of the domestic market, with the year-on-year increase in the prevalence of osteoporosis and the advancement of centralized procurement policies, the clinical penetration rate of risedronic acid preparations continues to rise. In 2023, the terminal sales of domestic public medical institutions were approximately RMB 210 million, a year-on-year increase of 12.3%. At present, multiple domestic enterprises have passed the consistency evaluation of generic drugs, and market competition is gradually tilting towards the stability of the API supply chain and quality compliance.

Risedronic acid was originally developed jointly by Procter & Gamble and Sanofi, with the original brand name "Actonel" (Chinese brand name "安妥良"). Its core compound patent in the United States expired in 2013, and the core patent in China also expired in 2014. The main dosage forms approved for the original drug include tablets, with specifications of 5mg, 30mg, 35mg, 75mg and 150mg. They have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and are also reference preparations recognized by the FDA. At present, the risedronic acid APIs of multiple domestic enterprises have been registered with the CDE with the status of A (usable in marketed drugs), and multiple risedronate sodium preparation varieties have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of risedronic acid impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the impurity reference standard needs of pharmaceutical enterprises in the whole process of API R&D, quality research, consistency evaluation, etc.