Amphotericin B

The clinical fatality rate of invasive fungal diseases is as high as 40%~90%, which is an important cause of death in critically ill patients with immunodeficiency, organ transplantation, hematological malignancies and other conditions. As a classic representative of polyene antifungal drugs, amphotericin B exerts broad-spectrum antifungal activity by binding to ergosterol on the fungal cell membrane, changing membrane permeability and leading to leakage of cell contents. It has a powerful killing effect on a variety of pathogenic fungi such as Candida, Aspergillus and Cryptococcus, and is currently a basic drug for the clinical treatment of deep fungal infections, especially suitable for severely infected populations who do not respond to other antifungal drugs.

The global market size of amphotericin B was approximately USD 1.27 billion in 2023, and it is expected to grow to USD 1.93 billion by 2028, with a compound annual growth rate of approximately 8.7%. The growth momentum mainly comes from the expansion of the immunocompromised population and the increase in the detection rate of invasive fungal diseases. In terms of the domestic market, common amphotericin B for injection has been included in the national centralized procurement, and the quotations of selected enterprises have dropped by more than 90% compared with those before the centralized procurement. As a high-end preparation, the liposome dosage form still maintains a high market share. At present, domestic API manufacturers are dominated by local manufacturers, and the supply is relatively stable.

The original research enterprise of amphotericin B is X-Gen Pharmaceuticals, and the original research brand name is Fungizone. Its core compound patent expired globally around 1990. The main dosage form of the original research is powder for injection, with a specification of 50 mg/vial, which has been included in the FDA Reference Listed Drug Catalog, and the original research reference listed drug has not been imported into China. Up to now, there are 6 pieces of amphotericin B API registration information on the domestic CDE API registration platform, 3 of which have obtained Class A status and can be used as compliant sources to supply preparation production. A number of domestic enterprises have obtained marketing approval for amphotericin B for injection and amphotericin B liposome. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for amphotericin B, covering all key impurities in the synthesis process and degradation process. All products meet the requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products are in stock, and stock orders placed before 16:00 can be shipped on the same day, which can quickly match the use needs of pharmaceutical enterprises in different stages such as R&D, quality research and consistency evaluation.