Erdosteine

Chronic respiratory diseases have a prolonged and easily recurrent course, and mucous sputum obstructing the airway is the core inducement that aggravates infection and reduces pulmonary function. Mucolytic drugs occupy an irreplaceable clinical position in long-term management. Erdosteine is a new type of cysteine derivative expectorant, and its mechanism of action is different from that of traditional expectorants: on the one hand, it reduces sputum viscosity by breaking the disulfide bonds of mucin; on the other hand, it exerts a mucosal repair effect by inhibiting the production of free radicals and protecting α1-antitrypsin. Meanwhile, it does not affect the hepatic CYP enzyme system, so the risk of drug interaction is lower. Clinically, it is mainly used for the symptoms of thick sputum and difficult expectoration caused by acute and chronic bronchitis, emphysema and other diseases. The applicable population covers adult patients with respiratory tract infections and people receiving long-term management of chronic airway diseases, especially elderly patients with underlying diseases who need to use multiple drugs in combination.

The global market size of erdosteine has maintained steady growth in recent years, with the overall market size reaching approximately USD 180 million in 2023. The growth rate of the domestic market is higher than the global average, and the compound annual growth rate is maintained at around 7%. At present, there are 11 domestic erdosteine API manufacturers that have been approved for marketing. The preparation products have been included in the National Medical Insurance Catalog (Class B). Since 2021, the inter-provincial alliance centralized procurement of many provinces has included erdosteine oral regular-release dosage forms in the scope, and the price reduction of the selected products has exceeded 60%, which has driven the continuously rising demand of downstream preparation enterprises for cost-effective and compliant APIs.

CATO can provide a full set of impurity reference standards for erdosteine API. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, with sufficient spot reserves, which can quickly respond to the application needs of the whole process such as API R&D, quality research, and consistency evaluation, effectively shortening the project cycle of customers and reducing compliance risks.