Chloropyramine

As allergic diseases are among the chronic diseases with high incidence globally, antihistamines are the core medication option for relieving related symptoms. Chloropyramine belongs to the first-generation ethylenediamine class H1 receptor antagonists. By competitively blocking the binding of histamine to H1 receptors on effector cells, it inhibits the pathological reactions induced by histamine such as capillary dilation, increased permeability, and smooth muscle spasm. It can effectively relieve symptoms such as itching, redness and swelling, and runny nose caused by allergic diseases including allergic rhinitis, urticaria, and contact dermatitis. It can also be used as a component of compound preparations for the symptomatic treatment of colds, and the applicable population covers adults and children with clear medication indications.

At present, the global market size of antihistamines has exceeded 10 billion US dollars. Among them, first-generation antihistamines still occupy a stable market share in OTC and primary medical care scenarios due to their cost-effectiveness advantage. As a mature variety that has been clinically applied for many years, the annual growth rate of global market demand for chloropyramine remains at 2%-3%, with Europe and Southeast Asia being the main consumption regions. Currently, this variety is still in the market introduction stage in China. The number of approved and marketed preparations is relatively small, sufficient competition has not yet formed on the API supply side, and verifiable public data on the domestic market size has not been queried.

The original research enterprise of chloropyramine is Sanofi, and the original brand name is Suprastin. Its core compound patent has expired globally. At present, the mainstream dosage forms of the original product are 25mg tablets and 20mg/1ml injections. The original tablets have been listed as reference preparations by many countries and regions such as the European EMA and Russia, and have not yet been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the NMPA of China. At present, there is no A-status registration number for the approved marketing of chloropyramine API in China, and no public information on the approval of domestic enterprises to produce preparations of this variety has been queried. (Data as of September 2024, please refer to the official website of CDE for the latest information.)

CATO can provide a full set of impurity reference standards for chloropyramine API, most of which are directly available from stock. Spot orders paid 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 the needs of pharmaceutical enterprises in the whole process of API R&D, quality research and registration.