Betahistine

As a core drug for clinically improving vestibular circulation and relieving vertigo symptoms, betahistine is a histamine derivative. Its mechanism of action combines weak H1 receptor agonist activity and strong H3 receptor antagonist activity. It can specifically dilate blood vessels of the inner ear, brain and vertebrobasilar artery, improve inner ear microcirculation disturbance, reduce endolymphatic edema, and meanwhile inhibit the excitability of vestibular nucleus, so as to relieve symptoms such as vertigo, tinnitus and hearing loss. It is clinically mainly used for vertigo and tinnitus associated with Ménière's disease, Ménière's syndrome and vertigo disorders, and its applicable population covers patients with recurrent vestibular dysfunction of all age groups. With high safety and few adverse reactions, it is a first-line drug recommended by domestic and foreign vertigo diagnosis and treatment guidelines.

The global betahistine market size has exceeded US$700 million, and the compound annual growth rate from 2023 to 2029 is expected to remain at 4.8%. Among them, the growth rate of the Chinese market is significantly higher than the global average, with a compound annual growth rate of 6.2%. At present, generic drugs account for more than 90% of the domestic market, and betahistine has been included in multiple batches of national centralized drug procurement. The price of the winning preparations has dropped by more than 70% compared with that before the centralized procurement, which has greatly reduced the medication burden of patients, and also promoted the continuous and stable growth of the demand for upstream API. Domestic API manufacturers are mainly local manufacturers, and the production capacity of leading enterprises accounts for more than 60% of the total national supply.

The original developer of betahistine is Merck KGaA, Germany, and the original brand name is Serc. Its core compound patent expired in 1998 in major global markets. The main dosage form approved for the original drug is tablet, with specifications including 6mg, 16mg and 24mg. Among them, the 6mg and 16mg specifications have been included in the *Catalogue of Chemical Medicines* of China, and are also listed as reference listed drugs by the FDA. Up to now, more than 10 Chinese enterprises have obtained CDE registration numbers (Status A) for betahistine APIs. The domestically approved marketed preparation varieties include betahistine hydrochloride tablets, betahistine mesilate tablets and injections, and the pass rate of generic drug consistency evaluation exceeds 80%. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for betahistine API. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the needs of various scenarios such as drug development, quality research and daily inspection.