智通财经APP讯，山东新华制药股份(00719)发布公告，近日，该公司收到国家药品监督管理局核准签发的枸橼酸西地那非口崩片(以下简称“本品”)《药品注册证书》。
2024年4月，新华制药向国家药品监督管理局药品审评中心(CDE)递交枸橼酸西地那非口崩片境内生产药品上市许可注册申报资料并获受理，2025年9月获得《药品注册证书》，审评结论为批准注册。
枸橼酸西地那非口崩片用于治疗勃起功能障碍。根据相关统计数据，2024年中国公立医疗机构西地那非相关制剂销售额约为人民币52亿元。
新华制药的枸橼酸西地那非口崩片于2025年9月取得药品注册证书，有利于本公司开拓新的市场领域，提高市场竞争力。
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