海外CDMO质量问题频出 药明康德以高质量“护城河”持续收获客户信任

乐居财经
Oct 15, 2025

10月13日,再生元官方确认,为其代工的CDMO厂商Catalent位于印第安纳工厂收到了FDA的OAI信函。该信函是基于FDA在今年7月进行的一次现场检查结果发出的。FDA的检查分类通常分为三类,而OAI代表该设施处于“不可接受的合规状态”,属于其中程度最严重的一级,对依赖该工厂大规模生产药物的药企影响也最为致命。实际上,两个月之前再生元就曾透露,由于该工厂制造设施存在问题,FDA已延长了原定于...

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