Bumetanide

For patients with cardiovascular disease, kidney disease and liver cirrhosis complicated by refractory edema, loop diuretics with strong natriuretic and diuretic effects and controllable adverse reactions are the core choice for clinical treatment. As a new generation of potent loop diuretic, bumetanide specifically inhibits the Na+-K+-2Cl- cotransporter in the thick ascending limb of the renal medullary loop, and blocks the reabsorption of sodium ions and chloride ions. Its diuretic effect is 20 to 60 times that of furosemide, and the incidence of adverse reactions such as ototoxicity and hypokalemia is lower. In addition to being used for various edematous diseases in clinical practice, it can also be used for adjuvant treatment of critical and severe diseases such as hypertensive crisis, acute renal failure, hyperkalemia and hypercalcemia, and is especially suitable for tolerant populations who have poor response to furosemide.

At present, the global market size of bumetanide is stable at around USD 180 million, and the annual growth rate of the Chinese market remains at 7% to 9%. In 2023, the sales revenue in domestic sample hospitals exceeded RMB 230 million. The competitive landscape is dominated by generic drugs, and the concentration of domestic API manufacturers is relatively high, with the top 3 enterprises accounting for more than 80% of the market share. This product has been included in the national centralized volume-based procurement, and the price of winning preparations has dropped by more than 70%, which further improves clinical accessibility and drives the continuous rise of upstream API demand.

The original research enterprise of bumetanide is Roche, with the original brand name Bumex, and its core compound patent in the United States expired in 1983. The main dosage forms approved for the original research product are tablets and injections. The specifications of tablets are 0.5mg, 1mg and 2mg, and the specifications of injections are 0.25mg/ml and 0.5mg/2ml. It has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. As of now, more than 15 domestic enterprises have obtained CDE registration numbers (status A) for bumetanide APIs, and more than 20 enterprises have obtained marketing approval for bumetanide tablets and injections. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the R&D and quality control needs of bumetanide APIs, CATO provides a full set of impurity reference standards for this API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can help enterprises quickly complete the whole process of impurity research, quality standard establishment and registration declaration.