Subsidiary of Zhejiang Medicine (stock code 600216.SH), Innovate Biopharmaceuticals, passed the on-site inspection by the US FDA.

Zhejiang Medicine (600216.SH) announced that its controlling subsidiary Zhejiang Innovate Biotech Co., Ltd. (referred to as "Innovate Biotech") underwent an on-site inspection for Current Good Manufacturing Practices (CGMP) by the U.S. Food and Drug Administration (FDA) from October 30 to November 8, 2024. This inspection was for the routine supervision of the production of gentamicin sulfate injection. Recently, Innovate Biotech received the Establishment Inspection Report (EIR) and a letter from the FDA regarding the inspection. Based on the requirements of the U.S. Code of Federal Regulations Title 21, the FDA has confirmed the completion of the inspection. The letter indicated that Innovate Biotech's production quality management system meets the CGMP requirements of the FDA, and Innovate Biotech successfully passed the routine supervision inspection by the FDA.