Shandong Xinhua Pharmaceutical (000756.SZ): Tramadol hydrochloride sustained-release tablets passed the evaluation of generic drugs consistency.

Shandong Xinhua Pharmaceutical (000756.SZ) announced recently that the company has received the approval notice for the supplementary application of the controlled-release tramadol hydrochloride tablets (referred to as "the product") issued by the National Medical Products Administration. The product has passed the generic drug quality and efficacy consistency evaluation (generic drug consistency evaluation). Shandong Xinhua Pharmaceutical is the first domestic company to pass the generic drug consistency evaluation for this product. The product is a central nervous system opioid analgesic used for moderate to severe pain. As an opioid drug, the controlled-release tramadol tablets belong to the Class B varieties of the National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug List (2024). According to relevant data, the sales of tramadol formulations in public medical institutions in China in 2023 amounted to approximately RMB 913 million.