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福安药业精氨酸原料药药品注册申请未通过批准
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福安药业精氨酸原料药药品注册申请未通过批准
2017年4月12日,福安药业(集团)股份有限公司(福安药业)公布了一份关于收到 药品审批意见通知件的公告。公告内容显示,福安药业国家食品药品监督管理总局下发的药品审批意见通知件,福安药业申请的精氨酸原料药不符合药品注册要求,注册申请不予批准。除了精氨酸原料药之外,福安药业正在申请生产批件的精氨酸酮洛芬(包括注射液)也已撤回申请。 福安药业主营业务包括原料药和中间体、制剂、药品的生产与销售,涉及领域主要包括抗生素类、抗肿瘤类、呼吸系统类等领域。2016年福安药业营业收入12.97亿元(USD11...
Amino Acids China E-News 201704(Chinese version)
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