Dexchlorpheniramine

Allergic diseases belong to the category of chronic diseases with high global incidence, and antihistamines have long been the core option for clinical symptomatic treatment. Dexchlorpheniramine is the dextrorotatory isomer of the first-generation antihistamines. By highly selectively blocking histamine H1 receptors, it inhibits pathological reactions such as capillary dilatation and smooth muscle spasm caused by allergic mediators. Compared with racemic chlorpheniramine, it has a faster onset of action and a lower incidence of central adverse reactions such as sedation. It is mainly used clinically for symptom relief of allergic diseases such as allergic rhinitis, urticaria and allergic conjunctivitis, and can meet the conventional treatment needs of adult and pediatric allergic patients.

In recent years, the global market size of dexchlorpheniramine-related preparations has stabilized at around USD 420 million, with a compound annual growth rate of approximately 2.8%. The growth mainly comes from the expanded demand for pediatric allergy medications and compound cold preparations. In the domestic market, this variety is a common component of OTC compound cold preparations. At present, more than 20 enterprises have been approved to produce relevant oral preparations. The supply of APIs is mainly dominated by domestic manufacturers, and the price fluctuates in the range of 10%-15% affected by upstream chemical raw materials, with no relevant records of national centralized procurement yet.

The original research enterprise of dexchlorpheniramine is Bayer, with the original trade name Chlor-Trimeton, and its core compound patent expired globally in 1972. The main dosage form approved by the original research is 4mg oral tablet, which has been included in the FDA Reference Listed Drug Catalog. At present, there is no imported original preparation on the market in China. There are a total of 7 registered domestic API registration numbers, all of which have been activated and can be used for associated preparation declaration. The domestically approved preparation varieties are mainly oral tablets, sustained-release capsules and compound preparations. (Data as of May 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for dexchlorpheniramine API, and most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and fully satisfy the reference substance needs in the whole process of API R&D, quality research and registration declaration.