Meclizine

As a classic variety of antihistamine drugs, meclizine exerts its effect by competitively blocking histamine H1 receptors, and also has central inhibitory and anticholinergic activities. It can effectively inhibit the excitability of vestibular nerves and reduce the signal transduction of the vestibular center, making it a common choice for clinical prevention and treatment of motion sickness. Its indications cover nausea, vomiting and vertigo symptoms caused by car sickness, sea sickness and air sickness, and can also be used to relieve vertigo discomfort caused by Meniere's disease, vestibular neuritis and other diseases. The applicable population covers adults and children over 6 years old. Since its duration of action can reach 12-24 hours, it is more suitable for long-distance travel scenarios compared with short-acting motion sickness drugs.

The global market size of motion sickness drugs is approximately USD 1.8 billion, with a compound annual growth rate maintained at around 4.2%, among which antihistamine drugs account for more than 60%. Meclizine, with its characteristics of long action and low drowsiness, occupies nearly 12% of this market share. In terms of the domestic market, this variety has not been included in the national centralized volume-based procurement at present, and there are fewer than 5 local generic drug manufacturers. There has been a long-term space for import substitution in the API supply side. The market demand growth rate is stable at above 5%, and there is no clear market leading enterprise, so the industry competition pattern is relatively scattered.

The original research enterprise of meclizine is Pfizer, with the original brand name Antivert, and the core compound patent expired globally in 1987. The main dosage form approved for the original drug is tablet, with specifications including 12.5mg and 25mg, which has been included in the FDA Reference Listed Drug Catalog. Up to now, no enterprise in China has obtained the A status registration number of meclizine API, and no domestic meclizine preparation has been approved for marketing, so clinical application temporarily relies on the supply of imported products. (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 meclizine API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can provide stable impurity reference standard support for the whole process of API R&D, quality research and generic drug declaration.