Hybio Pharmaceuticals’ subsidiary, Pingshan Branch, completed an on-site inspection by the United States Food and Drug Administration (FDA) for current Good Manufacturing Practices (cGMP)

Hybio Pharmaceuticals’ subsidiary, Pingshan Branch, completed an on-site inspection by the United States Food and Drug Administration (FDA) for current Good Manufacturing Practices (cGMP) on August 8, 2023. Recently, they received the FDA’s Establishment Inspection Report (EIR) for the Pingshan Branch. The report indicates that the Pingshan Branch’s quality management system complies with the requirements of the FDA’s cGMP, signifying that the Pingshan Branch’s formulation production base has passed the FDA’s on-site inspection. This cGMP inspection covered one workshop and three workshops, with products including Cetrorelix Acetate injections and Liraglutide injections.

The successful completion of the FDA’s on-site inspections demonstrates that the company’s pharmaceutical production quality management system and production facilities have reached international advanced levels. This achievement is conducive to expediting the approval progress of the company’s previously submitted Abbreviated New Drug Application (ANDA) products in the United States. It also strengths the foundation for the company’s internationalization strategy of “Based in China, with a global outlook,” creating necessary conditions for the company’s future expansion of international cooperation. This development has a positive impact on the company’s presence in the international market and further enhances the company’s core competitiveness.