智通财经APP讯，白云山(00874)发布公告，近日，该公司分公司广州白云山医药集团股份有限公司白云山制药总厂(以下简称“白云山制药总厂”)收到国家药品监督管理局核准签发关于他达拉非片(10mg)的《药品注册证书》。
他达拉非是磷酸二酯酶5(PDE5)抑制剂，主要用于治疗男性勃起功能障碍(ED)。原研为美国礼来公司，分别于2002年11月、2003年11月在欧盟、美国获批，于2004年12月在中国获批上市。
公告称，本次获得他达拉非片（10mg）的《药品注册证书》后，白云山制药总厂拥有该药品两个品规（20mg、10mg）的《药品注册证书》,进一步丰富了白云山制药总厂男性用药产品的种类，有利于提升本公司在男性用药领域市场的竞争力。白云山制药总厂将按照相关要求和市场需求开展生产。
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