【圣诺生物:全资子公司圣诺制药被列入FDA 66-40名单并暂停对美销售】圣诺生物公告,全资子公司圣诺制药于2026年8月20日至2026年8月22日、2026年8月24日及2026年8月27日接受FDA现场检查,FDA于2026年8月27日签发Form FDA 483,载明8项观察项。公司已于2026年9月17日提交初始回复及整改措施;圣诺制药于2026年9月19日被列入第66-40号进口禁令名单,但尚未收到OAI结论或FDA警告信。解除相关警示前,公司将全面停止所有多肽原料药对美国市场的销售与发运。
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