Eperisone

Muscle tension increase and spasticity caused by diseases such as chronic musculoskeletal pain and cerebrovascular disorders have long been important clinical problems that affect patients' daily activity ability and reduce their quality of life. Eperisone is a centrally acting muscle relaxant that can act on the central nervous system and vascular smooth muscle simultaneously. By inhibiting spinal cord reflexes, reducing the sensitivity of muscle spindles, and dilating blood vessels to improve blood flow, it blocks the vicious cycle of "hypermyotonia - local circulation disorder - pain" through multiple targets. It is not only suitable for improving the myotonia state of diseases such as cervical-shoulder-arm syndrome, scapulohumeral periarthritis and lumbago, but also can be used for spastic paralysis caused by cerebrovascular disorders, spastic spinal paralysis, cervical spondylosis, postoperative sequelae, traumatic sequelae, etc. It is a commonly used clinical drug that takes both pain relief and motor function improvement into account.

At present, the global eperisone market maintains a steady growth trend. In 2023, the market size was approximately USD 420 million, with a compound annual growth rate of about 4.3%. The Chinese market accounts for approximately 28%, making it the second largest single market in the world. With the intensification of domestic population aging and the rising prevalence of chronic musculoskeletal diseases, it is expected that the growth rate of the domestic market in the next three years will be higher than the global average, maintaining an annual growth rate of 5%-6%. At present, the domestic market is dominated by generic drugs. More than 20 enterprises have been approved to produce eperisone-related preparations, and the localization rate of API exceeds 90%. After the implementation of the centralized procurement policy, the price of related dosage forms has dropped by approximately 62%, and the clinical accessibility has been significantly improved.

The original research enterprise of eperisone is Eisai Co., Ltd. of Japan, and the original research trade name is "Myonal". Its core compound patent expired in 2001, and all core patents in China have also expired. At present, the main dosage forms approved for the original research include tablets and granules. The specification of the tablets is 50 mg, and the specification of the granules is 1g:20mg. Both dosage forms have been included in the Chinese Listed Drugs Catalogue, and are the reference preparations for domestic generic drug research and development. As of October 2024, there have been 17 eperisone API registration entries on the API registration platform of China CDE, among which 12 are in the status of "A" (approved for use in marketed preparations). More than 15 eperisone oral preparation varieties have been approved for marketing in China. (The data is as of October 2024, please refer to the official website of CDE for the latest information.)

In response to the demand for impurity research in the process of eperisone generic drug research and development and quality control, CATO provides a full set of impurity reference standards for this API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. Meanwhile, all products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of various R&D scenarios such as impurity qualitative and quantitative research and stability investigation.