Carbinoxamine

As a chronic disease with high global prevalence, allergic diseases have always made antihistamines the core choice for clinical symptomatic treatment. Carbinoxamine is a first-generation ethylenediamine H1 receptor antagonist. By competitively blocking the binding of histamine to H1 receptors on effector cells, it inhibits pathological reactions such as histamine-induced capillary dilation, increased permeability and smooth muscle spasm. It can effectively relieve symptoms such as itching, runny nose, redness and swelling caused by allergic rhinitis, urticaria, hay fever, allergic conjunctivitis and other diseases, and can also be used to relieve catarrhal symptoms caused by common cold. The applicable population covers adults and children over 2 years old.

The global market size of antihistamines is growing steadily. Among them, first-generation antihistamines maintain stable demand in primary care and OTC markets due to their cost-effectiveness advantage. As a classic variety, carbinoxamine has a global annual market size of approximately USD 120 million, with a compound annual growth rate of 2.7% in the past three years. In terms of competitive landscape, the European and American markets are dominated by the original research manufacturer and a small number of generic drug enterprises, while the domestic market has not yet formed large-scale competition. At present, there are only a small amount of imported API and preparations supplied, and it has not been included in the national centralized procurement scope, leaving sufficient space for generic drug development.

The original research enterprise of carbinoxamine is Johnson & Johnson, with the original brand name Polyhistine. The core compound patent expired globally in 1986. The main marketed dosage forms of the original product include oral solution (0.4mg/ml) and tablets (4mg), which have been included in the FDA Reference Listed Drug Catalog. In terms of the domestic market, there is no approved domestic carbinoxamine API registration number at present, only 2 enterprises' imported carbinoxamine API are in status A. Imported carbinoxamine oral solution has been approved for marketing in China, but it has not yet been included in the Chinese Reference Listed Drug Catalog. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for carbinoxamine API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They are compliant with multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process requirements of generic drug research and development, quality research and post-marketing quality control.