奥锐特药业股份有限公司关于 公司通过美国FDA现场检查的公告

Group 1 - The company successfully passed the FDA cGMP inspection at its Badu factory from March 17 to March 21, 2025, indicating compliance with quality management systems and production environment standards required by the FDA [1][4] - The inspection covered six major systems: quality system, materials, production, packaging and labeling, facilities, and laboratory controls [1] - The FDA issued an Establishment Inspection Report (EIR) confirming that the company met the necessary requirements, which supports the company's efforts to expand into international markets [1] Group 2 - The inspection results were classified as NAI (No Action Indicated), which is a favorable outcome for the company [4] - The products involved in the inspection include active pharmaceutical ingredients such as Ipratropium, Abiraterone Acetate, and Pregabalin [4] - The successful inspection is expected to have a positive impact on the company's ability to enter and grow in global regulated markets [1]