I. General Information
Recently, Tianjin Lisheng Pharmaceutical Co., Ltd. (hereinafter referred to as "the Company") received the Notice of Approval for Marketing Application of Chemical Active Pharmaceutical Ingredients for Febuxostat API (Approval No.: 2023YS00313) issued by the National Medical Products Administration (NMPA). The product has passed the marketing application for chemical active pharmaceutical ingredients.
II. Basic Information of the Product
Generic Name: Febuxostat
English Name: Febuxostat
Chemical Name: 2-[3-cyano-4-(2-methylpropoxy)phenyl]-4-methylthiazole-5-carboxylic acid
Molecular Weight: 316.37
Molecular Formula: C₁₆H₁₆N₂O₃S
CAS No.: 144060-53-7
Manufacturer: Tianjin Lisheng Pharmaceutical Co., Ltd.
Application Content: Marketing application for chemical active pharmaceutical ingredient
Acceptance No.: CYHS2160527
Approval Conclusion: Approved for marketing as a chemical active pharmaceutical ingredient
III. Relevant Information of the Product
Febuxostat is a 2-arylthiazole derivative and a xanthine oxidase (XO) inhibitor. It reduces serum uric acid concentration by inhibiting uric acid synthesis and promoting uric acid excretion.It is indicated for the chronic treatment of hyperuricemia in patients with gout. It is not recommended for asymptomatic hyperuricemia.At conventional therapeutic concentrations, it does not inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism. Clinical studies have demonstrated that febuxostat tablets are safe and effective in the treatment of patients with gout and hyperuricemia.
