Mebhydrolin

As a classic variety of antihistamine drugs, mebhydrolin belongs to the first-generation H1 receptor antagonists. By competitively blocking the binding of histamine to H1 receptors, it inhibits pathological processes such as capillary dilation and smooth muscle spasm caused by allergic reactions. Clinically, it is mainly used for the symptomatic treatment of allergic diseases such as allergic rhinitis, urticaria and hay fever, and can also relieve non-specific allergic symptoms such as skin pruritus. The applicable population covers adults and children without contraindications. Compared with some second-generation antihistamines, it has unique clinical application value in the rapid relief of acute allergic symptoms, and is an important part of the primary allergy treatment medication system.

At present, the global market size of antihistamine drugs has exceeded 10 billion US dollars. Among them, first-generation antihistamines maintain stable demand in primary medical care and generic drug markets due to their cost-effectiveness advantage. As a segmented variety, mebhydrolin accounts for approximately 1.2% of the primary medication market in parts of Eastern Europe and Asia, with a compound annual growth rate of around 3.7% in the past three years. Currently, this variety is mainly supplied by generic drugs globally, and no original manufacturer has formed a monopoly pattern in core markets. There is no record of relevant varieties included in centralized procurement in China.

The original research enterprise of mebhydrolin is Gedeon Richter Plc. of Hungary, with the original brand name Diazon. Its core compound patent expired globally in the 1980s. The original dosage form is mainly tablets, with a conventional specification of 50 mg per tablet, which has been listed as the reference listed drug by many EU countries. Up to now, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China has not included the API registration information of this variety, and there is no approved mebhydrolin preparation product marketed in China either. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for mebhydrolin API. Most products are available in stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet various reference standard needs of pharmaceutical enterprises in the stages of API R&D, quality research and registration declaration.