Pseudoephedrine

Symptoms such as nasal congestion and mucosal congestion caused by upper respiratory tract infection, allergic rhinitis and other diseases have long affected the daily work and life of patients. As a sympathomimetic adrenergic drug, pseudoephedrine selectively contracts the capillaries of the upper respiratory tract to eliminate mucosal congestion and swelling in the nasopharynx. Meanwhile, its effects on systemic blood vessels, heart rate and central nervous system are significantly weaker than those of ephedrine, making it one of the core components of compound cold preparations and rhinitis therapeutic drugs. It is applicable to adults and children with related indications, with decades of clinical application history, and its safety and efficacy have been widely verified.

The current global market size of pseudoephedrine is approximately USD 1.2 billion, with a compound annual growth rate of around 3.2%. The downstream demand is concentrated in two major fields: compound cold medicine and specialized rhinitis medication. China is the world's largest producer and exporter of pseudoephedrine, with its production capacity accounting for more than 70% of the global total. Affected by the volume-based procurement policy in the domestic market, the average price reduction of compound preparations containing pseudoephedrine has reached 46%, further driving the steady growth of demand for upstream API. At present, there are 11 enterprises in China with the production qualification of pseudoephedrine API, the market concentration is relatively high, and the share of leading enterprises accounts for more than 60%.

The original research enterprise of pseudoephedrine is Boehringer Ingelheim of Germany, and the original research brand name is Sudafed. The core compound patent expired globally in 1982. The current mainstream dosage forms include tablets, sustained-release capsules and oral solutions, and conventional specifications include 30mg, 60mg and 120mg sustained-release dosage forms. The original preparation has been included in the FDA Orange Book Reference Listed Drug Catalog, and also included in China's *Catalogue of Reference Preparations for Chemical Drugs (Third Batch)*. At present, the pseudoephedrine APIs of 8 domestic enterprises have obtained A-status registration numbers through CDE registration, and another 12 compound preparation varieties containing pseudoephedrine have been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the quality research and compliance declaration needs of pseudoephedrine API, CATO provides a full set of impurity reference standards for this API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. The products fully comply with the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can effectively help enterprises shorten the R&D cycle and reduce the declaration risk.