Alendronic Acid

As a classic third-generation bisphosphonate bone metabolism regulator, alendronic acid specifically binds to hydroxyapatite in bone tissues, inhibits osteoclast activity, and reduces the bone resorption process, making it one of the core drugs for clinical prevention and treatment of osteoporosis at present. Its indications include postmenopausal women's osteoporosis, male osteoporosis, glucocorticoid-induced osteoporosis and Paget's disease, which can effectively reduce the risk of fractures in the vertebral body, hip and other parts. The applicable population covers patients of all ages with abnormal bone mass and diagnosed osteoporosis. It has been clinically applied for more than 20 years, and its safety and efficacy have been fully verified.

The global market size of alendronic acid-related preparations is stable at around 1.8 billion US dollars, among which the annual growth rate of the Chinese market is maintained at around 5%, and the overall market pattern has entered a mature stage. As the core patents have long expired, generic drugs dominate the market. There are more than 30 domestic preparation enterprises that have passed the consistency evaluation. In multiple rounds of national centralized drug procurement, the price of related preparations has dropped by more than 90%, and the clinical accessibility has been greatly improved, which has also driven the continuous and stable growth of upstream API demand, and the domestic annual API production capacity has exceeded 200 tons.

The original research enterprise of alendronic acid is Merck Sharp & Dohme, whose original research product is marketed under the trade name Fosamax®. Its core compound patent expired in the United States in 2004, and the Chinese compound patent also expired in 2004. The mainstream dosage form of the original research product is tablet, with two specifications of 10mg and 70mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and also listed in the FDA Reference Preparation Catalogue. In the current API registration platform of China CDE, there are nearly 40 registration entries of alendronic acid APIs, among which more than 20 are in A status and can be legally supplied to preparation manufacturers. The domestically approved alendronate sodium preparation varieties have covered multiple dosage forms such as tablets, enteric-coated tablets and capsules. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs of alendronic acid, CATO provides a full set of impurity reference standards for this API. Most of the products are in stock, and stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the needs of impurity reference substances in the whole process of API production, preparation R&D, quality testing, etc.