【纪实】凯莱英化学大分子基地顺利通过美国FDA批准前检查

同花顺09-21

凯莱英（HK6821）化学大分子基地生产的某原料药（884143）项目，于2026年6月底至7月初完成了美国食品药品监督管理局(FDA)的批准前检查(PAI)，并于8月底收到FDA签发的工厂检查报告(EIR)，标志着公司合规能力再次获得美国药监体系权威认可。此次FDA PAI检查，是公司化学大分子基地首次接受FDA检查，标志着已具备采用成熟、合规的先进工艺开展规模化生产与常态化运营的能力，能够对标...

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