Cetirizine

Allergic diseases fall into the category of chronic diseases with high global incidence, and antihistamines have always been the core option for clinical symptomatic treatment. Cetirizine is a second-generation H1 antihistamine, which can block peripheral histamine H1 receptors with high selectivity and inhibit histamine-mediated allergic reactions. Meanwhile, it has no obvious central sedative effect, and its safety is superior to that of first-generation antihistamines. Its clinical indications cover seasonal allergic rhinitis, perennial allergic rhinitis, allergic conjunctivitis, as well as pruritus and urticaria caused by allergies. It is applicable to adults and children over 2 years old, and is a commonly used first-line drug for the treatment of allergic diseases.

The global cetirizine market size is stable at around USD 2.8 billion, with a compound annual growth rate of approximately 2.3%. The market size in China exceeds RMB 1.5 billion, with a growth rate higher than the global average. Since the core patents have long expired, this category has entered a stage of full competition, with the market share of domestic generic drugs exceeding 90%. Among them, cetirizine hydrochloride tablets, drops and other dosage forms have been included in the national centralized drug procurement, with the price cut of winning bids exceeding 80%, and clinical accessibility has been greatly improved. At present, domestic API manufacturers are concentrated in East China and South China, and the production capacity of leading enterprises accounts for more than 65% of the total domestic supply.

The original developer of cetirizine is UCB, with the original brand name Zyrtec. Its core compound patent in the United States expired in 2007, and the Chinese compound patent also expired in 2007. The main dosage forms approved for the original product include tablets (10mg), drops (10mg/ml), and syrup (1mg/ml), which have been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and the FDA reference preparation catalogue. Up to now, there are more than 30 cetirizine-related registration numbers on the API registration platform of China's CDE, most of which are in status A and can be used for associated preparation declaration. More than 50 domestic enterprises have obtained approval for the marketing of cetirizine oral preparations. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of cetirizine impurity reference standards. Most products are available from stock, and stock orders placed before 16:00 can be shipped on the same day. The products simultaneously meet the requirements of pharmacopoeias of China, FDA and other national drug regulatory regulations, and can provide stable reference material support for API R&D, quality research and consistency evaluation work.