2月3日,白云山星群药业收到国家药品监督管理局核准签发的关于“阿法骨化醇软胶囊”(商品名:奥司惠)的《药品补充申请批准通知书》,确认该药品0.25μg与0.5μg两种规格均成功通过仿制药质量和疗效一致性评价。星群药业成为该品种目前同时双规格过评的厂家,并且是首家过评0.5μg规格的厂家。这标志着星群在该药品的研发、生产与质量控制体系全链条达到了行业领先水平,也为临床治疗提供更灵活、精准、优质的用药...
Source Link2月3日,白云山星群药业收到国家药品监督管理局核准签发的关于“阿法骨化醇软胶囊”(商品名:奥司惠)的《药品补充申请批准通知书》,确认该药品0.25μg与0.5μg两种规格均成功通过仿制药质量和疗效一致性评价。星群药业成为该品种目前同时双规格过评的厂家,并且是首家过评0.5μg规格的厂家。这标志着星群在该药品的研发、生产与质量控制体系全链条达到了行业领先水平,也为临床治疗提供更灵活、精准、优质的用药...
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