Fudosteine

Chronic respiratory diseases are chronic conditions with high incidence globally, and expectorant therapy is one of the core links to relieve airway obstruction and reduce the risk of acute exacerbations. Fudosteine is an expectorant of the cysteine derivative class. It inhibits the excessive proliferation of airway goblet cells, reduces the excessive secretion of mucin, and simultaneously breaks the disulfide bonds of mucin to lower sputum viscosity, with certain antioxidant and anti-inflammatory activities. Clinically, it is mainly used for expectorant treatment of respiratory diseases such as bronchial asthma, chronic bronchitis, bronchiectasis and tuberculosis, and is suitable for patients of all age groups with thick sputum and difficulty in expectoration. Compared with traditional expectorants, it has better tolerance and good safety for long-term use.

At present, the market size of expectorants continues to expand. Fudosteine occupies a stable market share in the segment with its unique multiple mechanism of action. In 2023, the sales volume of fudosteine at the terminal of domestic public medical institutions was approximately RMB 320 million, and the compound annual growth rate in the past three years has remained at around 7%. The domestic preparation market is dominated by generic drugs. More than 20 enterprises have obtained approval for fudosteine oral preparations, among which tablets and capsules have been included in the national centralized procurement. The winning bid price has dropped by more than 80% compared with the original research product, and the demand of downstream preparation enterprises for high-cost-effective and compliant API continues to rise.

The original research enterprise of fudosteine is Japan's S.S Pharmaceutical Co., Ltd., and the original trade name is "Fluimucil" (Note: This needs to be verified. Some data show that the original trade name is Cleactil, and Fluimucil is the trade name of acetylcysteine. It is recommended to refer to official information for confirmation). Its core compound patent expired around 2009 in major markets such as Japan and the United States. The original dosage form is mainly 200mg tablets, which has been included in the Japanese Orange Book and the Chinese List of Reference Preparations for Chemical Drugs. In China, nearly 30 enterprises have obtained A status for their fudosteine API through CDE registration, which can be associated with preparation declaration or marketed for sale. The domestically approved preparation dosage forms cover three categories: tablets, capsules and granules. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the demand for impurity reference standards in the process of generic drug R&D and quality control of fudosteine, CATO provides a full set of impurity reference standards for this API. Most of the products are in stock, and orders for in-stock products 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 directly support API quality research, impurity profile analysis and generic drug consistency evaluation declaration work.