山东新华制药股份(00719)：盐酸苄丝肼获得化学原料药上市申请批准通知书

智通财经05-08

智通财经APP讯，山东新华制药股份(00719)发布公告，近日，山东新华制药股份有限公司(以下简称“新华制药”或“本公司”)收到国家药品监督管理局核准签发的盐酸苄丝肼(以下简称“本品”)《化学原料药上市申请批准通知书》。2024年9月，新华制药向国家药品监督管理局CDE递交盐酸苄丝肼境内生产化学原料药上市申请注册申报资料并获受理， 2026年5月获得《化学原料药上市申请批准通知书》，审评结论为批准...

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