Benproperine

As a commonly used non-narcotic antitussive in clinical practice, benproperine is an antitussive drug with dual mechanisms of action, both peripheral and central. It can block the pulmonary vagus nerve reflex generated by the stretch receptors of the lung-pleura, and directly inhibit the cough center at the same time. It also has papaverine-like smooth muscle antispasmodic effect, and its antitussive efficacy is 2 to 4 times stronger than that of codeine. It has no addiction, no respiratory depression effect, and will not cause biliary and duodenal spasm or constipation. It is suitable for irritating dry cough caused by various reasons such as acute bronchitis, acute exacerbation of chronic bronchitis, upper respiratory tract infections (such as pharyngitis, rhinitis), smoking and allergy. It covers dry cough人群 of all age groups including adults and children, and is a first-line recommended drug for clinical mild to moderate dry cough symptoms.

At present, the global market size of antitussive drugs exceeds 18 billion US dollars. Among them, benproperine, as one of the core varieties of over-the-counter antitussives, accounts for about 7.2% of the oral antitussive market. Driven by factors such as the fluctuation of the incidence rate of respiratory tract infections and the improvement of clinical recognition of non-narcotic antitussives in recent years, its compound annual growth rate has remained at about 6.8%. In terms of the domestic market, benproperine preparations have been included in the Class B medical insurance catalog, and there is no original research patent restriction. The manufacturers are mainly generic pharmaceutical enterprises. At present, more than 20 enterprises hold preparation approval documents. The supply pattern of API is relatively scattered, and no absolute leading enterprise has been formed. The overall market supply and demand is in a tight balance.

Benproperine was originally developed by Japan Kaken Pharmaceutical Co., Ltd., with the trade name "咳福乐". Its core compound patent expired globally in 1989, and there is no valid patent restriction at present. The main dosage forms of benproperine already marketed in China include tablets, sustained-release tablets, capsules and oral solutions, with a common specification of 20mg (calculated as benproperine). The preparation products of the original research and multiple domestic enterprises have been included in the *Catalog of Reference Preparations for Chemical Drugs* issued by the National Medical Products Administration. Up to now, the CDE API registration platform has included 12 benproperine API registration numbers, of which 8 have been approved through the associated review with preparations. More than 20 benproperine preparation varieties have been approved for marketing in China, covering multiple dosage forms such as oral immediate-release dosage forms, sustained-release dosage forms and oral solutions. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for benproperine. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable impurity reference standard support for API R&D, quality research and preparation consistency evaluation.