Natamycin

Ocular fungal infectious diseases such as fungal keratitis and blepharitis have an insidious onset and a high disability rate. For a long time, there has been a lack of local medication options with both broad-spectrum antifungal activity and low ocular toxicity in clinical practice. Natamycin is a polyene antifungal antibiotic. It exerts a bactericidal effect by binding to ergosterol on the fungal cell membrane and changing the permeability of the cell membrane, leading to the leakage of important intracellular substances. It is currently the only first-line topical antifungal drug approved for clinical ophthalmology. It has good activity against most ocular pathogenic fungi such as Aspergillus, Fusarium and Candida, is suitable for patients with fungal ocular infections of all age groups, and is also a commonly used first-aid standby drug for people at high risk of corneal fungal infection.

The global natamycin market size was approximately USD 180 million in 2023, with a compound annual growth rate of 6.2% from 2019 to 2023. The main driving factors for the growth are the increasing prevalence of fungal ocular infections and the rising consultation rate of corneal infections caused by agricultural trauma. The current market is dominated by generic drugs. China is the core supplier of natamycin API in the world, with its production capacity accounting for about 72% of the global total. The domestic preparation market has completed the coverage of provincial-level centralized procurement, and the price of the selected products has dropped by about 61% compared with the original research product, greatly improving the accessibility.

The original research enterprise of natamycin is Alcon Laboratories, Inc. in the United States, and the original research trade name is Natacyn. Its US compound patent expired in 2000, and the core Chinese preparation patent expired in 2014. The main dosage form of the original research product is 5% natamycin ophthalmic suspension, with the specification of 15ml:0.75g, which has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs (Third Batch)*. Up to now, there are a total of 6 natamycin API registration entries on China's CDE API Registration Platform, among which 4 are in status A (approved for use in marketed preparations). In China, 8 enterprises have obtained marketing approval for natamycin ophthalmic suspension. (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 natamycin API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully support the full-process needs of API R&D, quality research and routine production quality control.