复星医药(02196.HK)子公司制剂生产线通过美国FDA现场检查
格隆汇7月15日丨复星医药(02196.HK)公布,公司控股子公司江苏万邦生化医药集团有限责任公司于2019年5月6日至2019年5月10日接受了美国食品药品监督管理局(以下简称“美国FDA”)的cGMP(即现行药品生产质量管理规范)现场检查。
本次检查的车间为制剂五车间,本次认证所涉产品为江苏万邦受托生产产品孟鲁司特钠片,制剂五车间的片剂的设计产能为20亿片/年。本次认证累计投入人民币约29万元(未经审计)。
公司称,本次通过现场检查表明江苏万邦的制剂五车间符合美国FDAcGMP标准,其受托生产产品孟鲁司特钠片可进行商业化生产。本次通过检查不会对集团现阶段业绩产生重大影响。
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