Nystatin

Fungal infection is a long-term challenge in the global public health field, especially in the diagnosis and treatment of deep fungal diseases and mucosal fungal infections, and there is a rigid demand for antifungal drugs with high efficacy and low toxicity. Nystatin is a polyene antifungal antibiotic. It exerts a bactericidal effect by binding to ergosterol on the fungal cell membrane, changing the permeability of the cell membrane, and leading to the leakage of important intracellular substances. It has particularly prominent activity against Candida species, and is mainly used clinically to treat mucosal Candida infections in the oral cavity, digestive tract, vagina and other sites, and can also be used for the local treatment of skin fungal infections. The applicable population covers patients with common infections and high-risk infected people with low immune function. Because it is not easily absorbed orally and has few systemic adverse reactions, it is a commonly used basic antifungal drug in primary clinical settings.

At present, the global market size of antifungal drugs maintains steady growth. Among them, polyene drugs, as a classic category of antifungal products, have a continuously increasing demand in primary medical care and infection prevention scenarios. The global annual market size of nystatin is approximately US$320 million, with a compound annual growth rate of 4.1% in the past three years. In terms of the domestic market, nystatin is included in the Category A of the National Medical Insurance Catalog, and its clinical use penetration rate is increasing year by year. In 2023, the domestic sales of its preparations exceeded RMB 1.2 billion. The competitive landscape is dominated by generic drugs, with domestic enterprises accounting for more than 90% of the market share. The production concentration of active pharmaceutical ingredients (APIs) is relatively high, and the production capacity of leading domestic manufacturers can cover nearly 60% of the global demand.

The original research enterprise of nystatin is Bristol-Myers Squibb, with the original brand name Mycostatin, and the core compound patent expired globally in 1960. At present, the main dosage forms approved by the original research company include oral suspension, vaginal suppository and ointment, among which the specification of oral suspension is 100,000 units/ml, and the specification of vaginal suppository is 100,000 units per piece. Relevant dosage forms have been included in the FDA Reference Listed Drug Catalog, and the original research preparations have not been introduced into China yet. In terms of domestic API registration, at present, 7 enterprises have obtained A-status registration numbers for nystatin APIs after passing the review and public announcement of the Center for Drug Evaluation (CDE). The domestically approved and marketed preparations cover multiple dosage forms such as tablets, vaginal effervescent tablets, ointments and suppositories, which can fully meet the use needs of different clinical scenarios. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the demand for quality research and compliance declaration of nystatin, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can support enterprises to complete the full life cycle quality control of APIs and preparations.