药明生物近日宣布,其五个生产基地在药品上市批准前检查(PLI)中,均以零关键发现项和零数据完整性问题通过美国食品药品监督管理局(FDA)审查。这一成果体现了企业在质量管理与合规生产方面的高标准,也为相关药品的商业化进程扫清关键障碍。此次顺利通过检查,进一步巩固了药明生物在全球生物制药合同开发与制造领域的竞争力。
Source Link药明生物近日宣布,其五个生产基地在药品上市批准前检查(PLI)中,均以零关键发现项和零数据完整性问题通过美国食品药品监督管理局(FDA)审查。这一成果体现了企业在质量管理与合规生产方面的高标准,也为相关药品的商业化进程扫清关键障碍。此次顺利通过检查,进一步巩固了药明生物在全球生物制药合同开发与制造领域的竞争力。
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