Febuxostat

In the clinical long-term management of hyperuricemia and gout, there has long been a pain point of limited options for uric acid-lowering drugs. As a new-generation selective xanthine oxidase, febuxostat binds to the molybdopterin center of xanthine oxidase with high specificity to block the conversion of hypoxanthine to uric acid. Compared with allopurinol, a traditional drug, it does not interfere with other enzyme pathways in purine and metabolism, with lower risk of adverse reactions. At present, it is mainly used in clinical practice for the long-term treatment of hyperuricemia in patients with, and is not recommended for people with asymptomatic hyperuricemia. It is especially suitable for gout patients who are intolerant to allopurinol or have positive HLA-B*5801, and is a first-line uric acid-lowering drug recommended by guidelines in many countries.

The domestic market size of febuxostat had exceeded 3.5 billion yuan in 2022. With the逐年 increase in the prevalence of hyperuricemia and the younger age of the affected population, the compound annual growth rate of the market has remained at around 12% in the past 3 years. After the implementation of centralized procurement, the market share of the original drug has dropped to less than 15%, and domestic generic drugs account for more than 80% of the market. At present, more than 30 domestic enterprises have obtained the production approval for febuxostat API. The industry competition focuses on process purity, impurity control and compliance, and the demand for supporting impurity reference from downstream preparation enterprises continues to rise.

In response to the needs of qualitative and quantitative detection of in the R&D and quality control of febuxostat, CATO can provide a full set of impurity reference for this API. All products are in stock, and meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can directly support multiple scenarios such as API registration and declaration, daily quality release and stability studies.