亨迪药业(301211.SZ)：百科药物通过美国FDA现场检查

智通财经2025-05-16

智通财经APP讯，亨迪药业(301211.SZ)公告，公司全资子公司武汉百科药物开发有限公司(简称“百科药物”)于2025年3月10日-14日接受了来自美国食品药品监督管理局(简称“FDA”)的cGMP(现行药品生产质量管理规范)日常监管的现场检查。近日百科药物收到FDA出具的现场检查报告(EIR)，按照美国21CFR法规(美国联邦法规第21章)的规定，FDA确认本次检查已结束，百科药物通过本次...

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