Emedastine

Allergic conjunctivitis is a high-incidence allergic disease in ophthalmology. Conventional mast cell stabilizers or antihistamines often have shortcomings such as slow onset of action and single mechanism of action. The advent of emedastine has filled this clinical gap. As a second-generation highly selective H1 receptor antagonist, it can simultaneously inhibit histamine release and mast cell degranulation, blocking the progression of allergic reactions through dual pathways. It not only avoids the central sedative side effects of first-generation antihistamines, but also rapidly relieves typical symptoms such as ocular itching, conjunctival congestion and lacrimation. Clinically, it is mainly used for the symptomatic treatment of allergic conjunctivitis in adults and children over 3 years old, and is currently a first-line treatment option in the field of ophthalmic allergy.

The global market size of ophthalmic allergy drugs has maintained steady growth in recent years. In 2023, the overall market size exceeded 8.5 billion US dollars, among which antihistamine ophthalmic drugs accounted for nearly 32%. With higher safety for children, emedastine has a market growth rate higher than the average level of its sub-category, with a compound annual growth rate of 6.2%. At present, the original research products still occupy the dominant share in the global market. Domestic generic preparations have been successively approved for marketing since 2019. After the coverage of centralized procurement, the terminal price has dropped by about 48%, and the accessibility of the primary market has been significantly improved, driving the annual growth rate of API demand to remain above 15%.

The original research enterprise of emedastine is Novartis, and the original brand name is "Emadine". Its core compound patent in the United States expired in 2010, and the compound patent in China expired in 2009. The main dosage form of the original product is 0.05% emedastine fumarate eye drops, with a conventional specification of 5ml:2.5mg. This dosage form has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by NMPA, and is also a reference preparation designated by FDA. Up to now, more than 10 domestic enterprises have obtained A status for their emedastine fumarate APIs through CDE registration, and another 7 generic eye drop products have been approved for marketing, among which 3 have passed the consistency evaluation. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of emedastine impurity reference standards, covering all categories of synthetic process impurities, degradation impurities and isomer impurities. Most products are in stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the various needs of API R&D, quality research and routine release testing.