苑东生物(688513.SH)子公司硕德药业通过美国FDA现场检查

Core Viewpoint - The company, Yuandong Biotech (688513.SH), announced that its wholly-owned subsidiary, Chengdu Shode Pharmaceutical Co., Ltd., successfully passed FDA inspections for its naloxone nasal spray, receiving zero deficiencies in the reports [1] Group 1 - The FDA conducted current Good Manufacturing Practice (cGMP) inspections and Bioresearch Monitoring (BIMO) inspections from May 6 to May 9 and May 16 to May 22, 2025 [1] - The inspections were part of the approval process for the naloxone nasal spray [1] - Chengdu Shode Pharmaceutical received two Establishment Inspection Reports (EIR) from the FDA, indicating compliance with regulatory standards [1]