Tolperisone

The clinical demand for centrally acting muscle relaxants has long existed along with the high incidence of musculoskeletal system diseases. Tolperisone is a characteristic variety among them that has both muscle relaxant and vasodilator effects. As a centrally acting muscle relaxant of the piperidine derivative class, its mechanism of action is to directly act on vascular smooth muscle and the spinal motor center, reduce the tension of skeletal muscle, relieve vasospasm, and improve cerebral and peripheral blood circulation at the same time. Clinically, it is mainly used to treat myotonia and spasm caused by sequelae of stroke, cerebral palsy, spinal vascular disorders, etc. It can also relieve muscle stiffness and pain caused by diseases such as neck-shoulder syndrome and lumbago. The applicable population covers patients with chronic diseases and postoperative rehabilitation in multiple departments such as neurology and orthopedics.

The global market size of tolperisone is approximately USD 320 million, with a compound annual growth rate maintained at 4.7% in the past three years. The growth momentum mainly comes from the rising prevalence of central nervous system diseases among the elderly population and the younger trend of chronic musculoskeletal diseases. In the domestic market, this variety has not been included in the national centralized volume-based procurement. At present, the main competitors are generic drug enterprises, with the market share of domestic preparations accounting for more than 85%. The supply of active pharmaceutical ingredients (APIs) has basically realized domestic substitution, and only a small number of high-end preparations still rely on imported APIs for matching.

The original research enterprise of tolperisone is Gedeon Richter Plc. of Hungary, and the original trade name is "Naomaining". Its core compound patent expired globally in 1986. The main dosage form approved for the original research product is tablet, with specifications of 50mg and 100mg. The original research product has been included in the China Listed Drug Catalog as a reference preparation. In terms of domestic API registration, a total of 6 enterprises have obtained CDE registration numbers for tolperisone APIs with the status of A (approved for use in marketed preparations) so far, and 17 domestic enterprises have obtained approval for the marketing of tolperisone tablets. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of tolperisone impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable and reliable reference standard support for relevant enterprises in links such as API quality research and preparation consistency evaluation.