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绿叶制药(02186.HK):棕榈酸帕利哌酮缓释混悬注射液(LY03010)生产场地零“483”通过美国FDA PAI检查

JRJ Finance ·  Jun 27 09:54

绿叶制药(02186.HK)发布公告,集团收到美国食品药品监督管理局(FDA)的正式检查报告,显示集团用于生产棕榈酸帕利哌酮缓释混悬注射液(LY03010)的生产场地以无需采取整改(No Action Indicated, NAI,零“483”)成功通过美国FDA的上市批准前检查(Pre-Approval Inspection,“PAI”)。

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