Carbocisteine

Patients with chronic respiratory diseases are often troubled by thick sputum and difficulty in expectoration, which may even block the respiratory tract and cause asphyxia risk in severe cases. Carbocisteine is a commonly used mucoregulator targeting such symptoms. As a mucolytic drug, it can reduce sputum viscosity by breaking the disulfide bonds of mucin secreted by bronchial glands, and at the same time promote the ciliary movement of respiratory mucosa to improve the efficiency of sputum clearance. Clinically, it is mainly used for symptoms such as thick sputum, difficulty in expectoration and sputum obstruction of trachea caused by chronic bronchitis, bronchial asthma and other diseases. It can also be used to prevent and treat postoperative expectoration difficulty and pneumonia complications, and the applicable population covers adults and pediatric patients who meet the dosage requirements.

At present, the global carbocisteine market size maintains a steady growth trend. In 2023, the overall market size has exceeded USD 320 million, with a compound annual growth rate of around 4.7%. In the domestic market, due to the rising prevalence of chronic respiratory diseases and the increasing penetration of primary diagnosis and treatment, the market size reached RMB 780 million in 2023, with a growth rate higher than the global average. In terms of competition pattern, the patent of this variety has expired for many years, and generic drugs account for more than 95% of the market. The concentration of domestic manufacturers is relatively high, with the top 3 enterprises occupying nearly 60% of the API market share. The product has been selected into the national centralized procurement catalog for many times, and the terminal price tends to be stable.

The original research enterprise of carbocisteine is Sanofi, France, with the original brand name Mucodyne, and its core compound patent expired worldwide in 1985. The current mainstream dosage forms include three categories: tablets, oral solutions and granules, with common specifications of 250mg for tablets, 10ml:200mg for oral solutions, and 0.5g per bag for granules. The original research product has been included in the FDA Reference Listed Drug Catalog, and most of the reference listed drugs for domestic generic drugs also select this original research variety. In terms of domestic API registration, 12 enterprises have obtained CDE registration numbers for carbocisteine APIs, among which 8 are in A status and can be legally supplied for the production of marketed preparations, and the number of approved oral preparation varieties in China has exceeded 60. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for carbocisteine, most of which are available from stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can meet the reference substance use needs of the whole process including API R&D, quality research, registration and declaration, etc.