Afloqualone

Musculoskeletal pain is a common chronic disease burden in clinical practice. Traditional muscle relaxants are mostly accompanied by central sedative side effects, which limit long-term medication compliance. As a quinazolinone peripheral muscle relaxant, afloqualone selectively inhibits the polysynaptic transmission of spinal reflex pathways to reduce the excessive tension of skeletal muscle, without obvious central inhibitory effect. It is mainly used to improve the muscle tension caused by lumbago, neck-shoulder-wrist syndrome, scapulohumeral periarthritis and other diseases, and can also be used for spastic paralysis caused by cerebrovascular disorders, spastic spinal paralysis and other diseases. It is suitable for adult patients who need long-term relief of muscle tension and cannot tolerate the side effects of central muscle relaxants.

At present, the global muscle relaxant market size maintains a steady growth, among which the market share of peripheral muscle relaxants increases year by year. Due to its advantage in side effects, the annual growth rate of the clinical utilization rate of afloqualone in the Asian market remains at 6%~8%. The domestic market is still dominated by generic drug supply, which has not been included in the scope of national centralized volume-based procurement. The number of enterprises on the API supply side is small, and the market competition pattern is relatively concentrated. At present, verifiable public data is limited, and relevant segmented market size data has not been disclosed yet.

The original research enterprise of afloqualone is Kyorin Pharmaceutical Co., Ltd. of Japan, with the original brand name Arofuto. The core compound patent expired in 2008. The original dosage form is oral tablet, with specifications of 0.2mg and 0.3mg. The original tablets have been included in the Japanese Reference Drug List, but have not been included in the Chinese List of Reference Preparations for Chemical Drugs. At present, there are no approved afloqualone preparation products on the market in China, and no valid API Master File (DMF) number has been found in the database of the Center for Drug Evaluation of the National Medical Products Administration. (Data as of July 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for afloqualone API, which can fully cover the requirements of the whole process of impurity qualitative and quantitative research and quality control. Most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide reliable material basis support for pharmaceutical enterprises in API research and development, registration and declaration, and quality stability investigation.