Erdosteine

One of the core pathological features of respiratory diseases such as chronic obstructive pulmonary disease and bronchitis is airway mucus hypersecretion. Viscous sputum blocking the airway will not only aggravate dyspnea, but also increase the risk of secondary infection, so expectorant therapy has become an important part of symptomatic intervention for these diseases. Erdosteine is a mucolytic expectorant drug, and its mechanism of action is different from that of traditional expectorants. The free sulfhydryl groups in its molecule can directly break the disulfide bonds of mucin to reduce sputum viscosity, and at the same time inhibit lipid peroxidation and reduce the release of airway inflammatory mediators, with both mucus regulation and mucosal protection effects. It is clinically mainly used for viscous sputum and difficulty in expectoration caused by diseases such as acute and chronic bronchitis and obstructive emphysema, and the applicable population includes adult patients and elderly patients with respiratory diseases who meet the medication indications.

The global expectorant market size continues to grow steadily. Among them, erdosteine, with its better safety and multiple action advantages, has seen its clinical utilization rate increase year by year in Europe, Asia and other regions. In 2023, the global market size of erdosteine preparations has exceeded US$320 million, with a compound annual growth rate remaining at around 6%. In terms of the Chinese market, erdosteine has been included in the Category B of the National Medical Insurance Catalog. With the increase in the penetration rate of chronic disease management for respiratory diseases, the compound annual growth rate of the domestic preparation market in the past 3 years has reached 8.2%. At present, generic drugs dominate the market, and nearly 20 enterprises have been approved to produce erdosteine-related preparations. The main suppliers of API are Chinese and Indian pharmaceutical companies, and the competitive pattern is relatively fragmented.

The original research enterprise of erdosteine is Edmond Pharma, an Italian company, with the original trade name Mucofor. The core compound patent expired in Europe in 2003, and the compound patent in China also expired in 2003. The main dosage forms of the original research include capsules (150mg, 300mg) and granules (150mg per sachet), among which the original 150mg capsules have been included in the Reference Preparation Catalog of China NMPA. Up to now, there are more than 20 registration information of erdosteine API on the API registration platform of China CDE, most of which are in status A (approved for use in marketed preparations). A variety of erdosteine preparations such as capsules, tablets, dispersible tablets and granules have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for erdosteine API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the R&D and production needs of pharmaceutical enterprises in different scenarios such as impurity research, quality control, and generic drug consistency evaluation.