Lamotrigine tablets from Hunan Sanjin Pharmaceutical Co., Ltd. of Sanjin Group was approved to be marketed by SFDA on December 6, sFDA announced.
The research on the human bioequivalence of this variety is completed by Duzheng Biological "one-stop" clinical research: hunan Brain Hospital, a strategic cooperative unit, is responsible for clinical practice, Serong Intelligence is responsible for recruitment, Leading Medicine is responsible for SMO service, and weight ke data execution data management and statistical analysis. Clinical and analysis of this product are exempt from on-site verification.
Lamotrigine tablets, developed by GlaxoSmithKline for the treatment of epilepsy, were marketed in the United States in 1994 and approved domestically in 1999. According to statistics, the global market sales volume of lamotrigine preparations (including all preparation forms) in 2018 was about 1.46 billion US dollars; In the first three quarters of 2019, the sales volume of Lamotrigine tablets (including tablets and dispersive tablets) in nationwide hospitals was about 203 million yuan.
Duzheng Bio focuses on providing one-stop service for clinical research of innovative drugs and generic drugs, and has significant advantages in early clinical research of innovative drugs, clinical research of improved new drugs, PPI drugs and other difficult preparation BE research fields. Through scientific and reliable scheme design, efficient recruitment and management of subjects, rich clinical resources, strict quality management and risk control system, and perfect information system guarantee, we help pharmaceutical enterprises solve clinical pain points, highlight clinical value, and help pharmaceutical industry innovation and development.