SHANDONG XINHUA(00719): Tramadol hydrochloride sustained-release tablets pass the generic consistency evaluation.

Shandong Xinhua (00719) announced that the company has received the approval notice for the supplementary application of the production of Tramadol Hydrochloride Extended-Release 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 enterprise to pass the generic drug consistency evaluation for this product. The product is a central nervous system opioid analgesic indicated for moderate to severe pain. As an opioid drug, Tramadol Hydrochloride Extended-Release Tablets belongs to the Class B variety in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2024). According to relevant data, the sales of Tramadol formulations in public medical institutions in China reached approximately 913 million yuan in 2023. The Tramadol Hydrochloride Extended-Release Tablets of Shandong Xinhua Pharmaceutical passed the generic drug quality and efficacy consistency evaluation in January 2025, which will help further enhance the market competitiveness of the product.