Bumetanide

### BumetanideFor edema symptoms caused by congestive heart failure, cirrhotic ascites and other diseases, the clinical value of potent diuretics has always been irreplaceable. As a representative drug of loop diuretics, bumetanide exerts a rapid diuretic and detumescent effect by inhibiting the reabsorption of sodium and chloride ions in the thick ascending limb of the renal tubule medullary loop. Its potency is 20-60 times that of furosemide, and the incidence of adverse reactions such as hypokalemia is lower. In addition to conventional edema treatment, it is also suitable for patients with renal insufficiency who are intolerant to furosemide, and is widely used in emergency, cardiovascular, nephrology and other departments.

In 2023, the domestic market size of bumetanide preparations was approximately RMB 870 million, with a compound annual growth rate of 6.2% in the past three years. The demand side is driven by the rising prevalence of chronic diseases and the expansion of the elderly population to maintain steady growth. At present, there are 12 domestic enterprises that have been approved for bumetanide API, with local manufacturers accounting for more than 90% of the production capacity, among which 4 enterprises have obtained FDA certification for their products. Meanwhile, this variety has been included in the seventh batch of national centralized procurement, with an average price reduction of 68% for the selected products. The demand of downstream preparation enterprises for cost-effective and compliant APIs and supporting impurity reference substances continues to rise.

CATO can provide a full set of impurity reference standards for bumetanide API. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, with complete structural confirmation data and sufficient stock reserves. They can directly meet the full-process scenario needs of pharmaceutical enterprises in impurity research, quality control, registration and declaration, and greatly shorten the R&D cycle.