Noscapine

Among respiratory disease medications, peripherally acting antitussives have no central inhibitory side effects, so their demand in the symptomatic treatment of chronic cough and mild respiratory infections continues to rise. Noscapine is an isoquinoline alkaloid class of peripherally acting antitussive. It exerts an antitussive effect by inhibiting the pulmonary stretch reflex and relieving bronchial smooth muscle spasm, with a duration of efficacy of 4 hours. It is non-addictive, does not inhibit respiration, and does not cause drug dependence. It is suitable for dry cough patients of different age groups, especially drivers, high-altitude workers and elderly patients who need to avoid central sedative side effects.

Public data shows that in 2023, the size of China's retail market for antitussive drugs exceeded 8.7 billion yuan, among which the market share of peripherally acting antitussives has risen to 22%, with an annual growth rate of 14%, which is higher than the overall market growth rate of antitussives. In terms of competitive landscape, currently domestic noscapine preparations are mainly generic drugs, and the market share of original research products is less than 15%. The supply of active pharmaceutical ingredients (APIs) has long been dominated by domestic enterprises. With the steady release of market demand for OTC drugs for cold and cough, the annual demand for noscapine API maintains a steady growth range of around 7%.

The original research enterprise of noscapine is Abbott, with the original research trade name Noscapine. The core compound patent expired globally in 1990, and there are currently no valid core patent restrictions in major global markets. The main dosage form of the original research product is tablet, with a specification of 10 mg per tablet. The original research tablet has been included in the reference listed drug catalog published by the FDA, and has not yet been included in the China Listed Drug Catalog. As of now, there are a total of 6 noscapine API registration entries on the CDE API registration platform, 3 of which are in Status A and can be used in association with domestic preparation declarations. The approved noscapine preparation products marketed in China are mainly noscapine tablets, all of which are domestic generic drugs. (Data as of June 2025, please refer to the official CDE website for the latest information)

In the process of generic drug consistency evaluation and API production of noscapine, impurity research is the core link to ensure the compliance of product quality. CATO provides a full set of impurity reference standards for noscapine API, most of which are available from stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of enterprises for impurity qualitative and quantitative research and quality standard establishment.