Betahistine

In view of the problem of recurrent vertigo caused by vestibular dysfunction, there has been a long-term lack of intervention regimens with both safety and long-term efficacy in clinical practice, and the advent of betahistine has filled this gap in clinical needs. As a histamine derivative, it improves inner ear microcirculation and reduces endolymphatic edema by agonizing H1 receptors, while mildly inhibiting H3 receptors to reduce excessive discharge of vestibular nucleus. Its dual-target action achieves rapid vertigo relief without obvious central sedative side effects. It is currently the first-line medication for indications such as Meniere's disease, postoperative rehabilitation of benign paroxysmal positional vertigo, and vertigo accompanied by cerebral insufficiency, covering vertigo patients of all adult age groups, especially suitable for the elderly population who cannot tolerate the adverse reactions of anticholinergic vertigo-relieving drugs.

In recent years, the global market size of betahistine active pharmaceutical ingredient (API) has stabilized at around USD 180 million, and the annual growth rate of the Chinese market has maintained at 7.2%, making it the fastest growing regional market. At present, there are 12 domestic enterprises in China holding the production approval for this API, among which 7 have obtained both FDA and CEP certifications. In 2023, China's domestic export volume accounted for 61% of the total global production capacity, making it the world's most important supplier. After the implementation of centralized procurement, the demand for generic drug preparations has continued to rise, driving the annual demand for API to increase by 47% compared with 2020, and the capacity utilization rate of leading manufacturers has remained above 90% for a long time.

CATO can provide a full set of impurity reference standards for betahistine API. All products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, covering the needs of all business scenarios such as registration and declaration, quality research, and routine release inspection. Core specifications are kept in stock permanently and can be delivered within 48 hours, helping customers shorten the R&D and quality control cycles and effectively reduce the risk of supply chain fluctuations.