Cloperastine

Against the background of high incidence of respiratory diseases, the clinical selection of antitussive drugs always focuses on the balance between efficacy and safety. Cloperastine is a non-addictive central antitussive drug, which mainly exerts its effect by inhibiting the cough center, and also has weak antihistamine and bronchial smooth muscle relaxation effects. It does not inhibit respiration and has no addiction risk. Clinically, it is mainly used to treat dry cough symptoms caused by colds, bronchitis, pneumonia and other diseases, and its applicable population covers adults and children without contraindications. It is one of the commonly used options for clinical symptomatic treatment of mild to moderate dry cough.

In the current domestic antitussive drug market, the proportion of central non-addictive varieties is increasing year by year. In 2023, the market size of the relevant market segment was about 1.87 billion yuan, and the compound annual growth rate remained at around 7.2%. With the advantages of low adverse reactions and no addiction, the penetration rate of cloperastine in primary medical institutions and OTC channels continues to rise. At present, there are no imported original research preparations in the domestic market, and the production side is dominated by domestic generic drug enterprises. The overall competitive pattern is relatively scattered, there are no obvious leading monopoly enterprises, and the supply and demand of API are stable.

There is no verifiable information related to clear overseas original research enterprises and original research trade names of cloperastine. The domestically approved preparation formulations are mainly tablets, with a common specification of 10mg. At present, this variety has not been included in the National Reference Preparation Catalogue, and there is no valid A-status registration number available for public notification on the CDE API Registration Platform. All cloperastine preparations marketed in China are generic varieties produced by domestic enterprises. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of cloperastine impurity reference standards. Most products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the full-scenario needs of pharmaceutical enterprises in API research and development, quality research and routine production quality control.