Furosemide

The prevalence of diseases such as chronic heart failure and nephrotic syndrome continues to rise globally. As a common accompanying symptom of these diseases, edema seriously affects patients' quality of life and disease prognosis. Furosemide belongs to the class of loop diuretics. It exerts a rapid and potent diuretic effect by specifically inhibiting the Na+-K+-2Cl- cotransporter in the thick ascending limb of the renal tubular medullary loop, reducing the reabsorption of sodium ions and chloride ions. Clinically, it is mainly used for the treatment of edematous diseases, hypertension, prevention of acute renal failure, hyperkalemia, hypercalcemia and other conditions. It is a first-line core medication for the intervention of acute and severe edema, and the applicable population covers adults, children and some elderly patients requiring diuretic intervention.

At present, the global furosemide preparation market size is stably around 1.5 billion US dollars, with a compound annual growth rate maintained at 2.3%, showing a significant rigid market demand characteristic. For the domestic market, furosemide is a variety listed in the National Essential Medicines List and is included in the Class A medical insurance catalog. In 2023, the terminal preparation sales of furosemide in domestic public medical institutions exceeded 1.2 billion yuan. As the core patents have long expired, the current market is dominated by generic drugs. More than 40 domestic enterprises have obtained production approvals for furosemide preparations, and the supply pattern of APIs is relatively scattered, with more than 15 domestic API enterprises obtaining registration approvals. After the implementation of centralized procurement, the price of preparations dropped by more than 70%, and the requirements for cost control and impurity compliance of upstream APIs have been further enhanced.

The original developer of furosemide is Sanofi, with the original brand name Lasix®. Its core compound patent expired in the 1960s. The main dosage forms approved for the original product include tablets and injections, among which the tablet specifications are 20mg, 40mg and 80mg, and the injection specifications are 10mg/1ml and 20mg/2ml. The original product has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also included in the FDA Reference Preparation Catalogue. Up to now, there are more than 20 furosemide API registration records on the API registration platform of China CDE, most of which are in status A and can be associated with domestic preparation applications. The domestic approved furosemide preparations cover multiple dosage forms such as tablets, injections and furosemide for injection. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for furosemide API, covering all types such as synthetic process impurities and degradation impurities. Most of the products are in stock. In-stock products ordered before 16:00 can be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of various scenarios of API enterprises, including quality research, registration and declaration, and routine release testing.