Chlorphenamine

As a category of chronic diseases with high global incidence, allergic diseases trouble more than 20% of the population all year round, and antihistamines are the core medications for clinical control of allergic symptoms. Chlorpheniramine belongs to the first-generation alkylamine H1 receptor antagonist. By competitively blocking the binding of histamine to H1 receptors on effector cells, it inhibits pathological reactions such as capillary dilatation, increased permeability and smooth muscle contraction caused by histamine, and can effectively relieve runny nose and nasal congestion caused by allergic rhinitis, itching and redness and swelling caused by skin allergies such as urticaria and eczema, as well as related symptoms of drug or food allergy. Due to its rapid onset of action and prominent cost-effectiveness, it is a common basic drug for symptomatic treatment of allergies in adults and children, and is also widely used as a core component of compound cold preparations.

At present, the global market size of chlorpheniramine API is stable at around USD 180 million, and the domestic market size is approximately RMB 230 million, with the compound annual growth rate maintained in a stable range of 3%-4%. As the compound patent has long expired, the market is dominated by generic drug supply. Domestic manufacturers are concentrated in East China and Central China, with leading enterprises accounting for nearly 60% of the market share. In addition to meeting the demand of domestic preparation production, more than 40% of the production capacity is supplied to overseas markets. Affected by the implementation of centralized procurement of cold and allergy drugs in recent years, the stability of the demand side of API has continued to improve, and cost control ability has become the core competitive element of enterprises.

The original research enterprise of chlorpheniramine is Bayer, with the original research trade name Chlor-Trimeton. The core compound patent expired globally in 1971. At present, the main commercially available dosage forms include tablets and injections. The common oral tablet specification is 4mg, and the injection specification is 1ml:10mg. The original preparation of this variety has been included in the FDA reference preparation catalog, and imported original research products can be selected as domestic reference preparations. Up to now, there are more than 30 registration information of chlorpheniramine on the CDE API registration platform, of which more than 20 are in status A (activated). Dozens of chlorpheniramine single-agent and compound preparations have been approved for marketing in China. (Data as of May 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for chlorpheniramine API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs of the whole process of API research and development, quality research, registration and declaration, etc.