Azelastine

The recurrent attacks of allergic diseases such as allergic rhinitis and urticaria have long affected the quality of life of more than 20% of the global population, and antihistamines are the first-line treatment option for such diseases. As a second-generation H1 antihistamine, azelastine has the dual mechanisms of mast cell stabilization and histamine receptor antagonism, which can effectively inhibit the release of allergic mediators and reduce inflammatory responses. It is clinically used for the treatment of allergic rhinitis, allergic conjunctivitis, acute and chronic urticaria and other diseases, with the applicable population covering adults and children over 6 years old. The local administration method can greatly reduce the incidence of adverse reactions such as central sedation, making it a classic drug with both safety and effectiveness in the field of allergy.

The global market size of azelastine preparations maintains a steady growth, with the market size reaching approximately USD 480 million in 2023, among which nasal spray dosage forms account for more than 60%. In terms of the domestic market, the sales of azelastine preparations at the terminal of public medical institutions exceeded RMB 320 million in 2024, with a compound annual growth rate of approximately 7.2%. The current competitive landscape is dominated by generic drugs. More than 10 domestic enterprises have obtained approval for azelastine nasal sprays, tablets and other dosage forms. The price of winning products after centralized procurement has dropped by more than 45%, which puts forward higher requirements for the stability of API supply and cost control.

The original manufacturer of azelastine is Meda Pharma of Germany, with the original brand name "Azep". Its core compound patents in major markets such as Europe and the United States expired around 2011, and the Chinese compound patent also expired in 2011. The originally marketed dosage forms include azelastine hydrochloride nasal spray (10ml:10mg, 0.14mg per spray), azelastine hydrochloride eye drops (0.05%) and oral tablets (1mg, 2mg). Among them, the original nasal spray has been included in the China Listed Drug Catalogue as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. Up to now, there are 12 registration entries of azelastine hydrochloride API on the API registration platform of China CDE, among which 7 are in activated status (Status A). Three types of preparations, namely azelastine hydrochloride nasal spray, tablets and eye drops, have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for azelastine API, which can meet the impurity research needs of different process routes. All products comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are available in stock, and in-stock products ordered before 16:00 can be shipped on the same day, which can fully help pharmaceutical enterprises shorten the impurity research cycle and accelerate the registration and declaration progress.