Zhejiang Medicine's subsidiary passes FDA inspection

Zhejiang Medicine Co., Ltd. [SSE:600216] announced that its subsidiary, Zhejiang Innovation Biopharmaceutical Co., Ltd. (InnoBio), successfully completed an FDA CGMP inspection of its Vancomycin Hydrochloride injection production facility, the inspection took place from October 30, 2024, to November 8, 2024. The FDA confirmed that the inspection was complete, signifying that InnoBio's quality management system meets U.S. standards. The inspected facility has an annual design capacity of 10 million vials of Vancomycin Hydrochloride injection. Vancomycin is a glycopeptide antibiotic used to treat infections caused by methicillin-resistant Staphylococcus aureus and other bacteria. In January 2023, InnoBio received FDA approval for its Vancomycin Hydrochloride injection via the 505(b)(2) pathway. The company views this successful inspection as a boost to its international competitiveness, setting the stage for future global expansion.