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潤都股份(002923.SZ):單硝酸異山梨酯緩釋膠囊通過仿製藥一致性評價
格隆匯 11-23 15:56

格隆匯 11 月 23日丨潤都股份(002923.SZ)公佈,近日,公司通過國家藥品監督管理局網站獲悉,公司藥品“單硝酸異山梨酯緩釋膠囊”(規格:50mg、規格:40mg)已通過仿製藥質量和療效一致性評價。

該藥品“單硝酸異山梨酯緩釋膠囊”的臨牀適應症為:冠心病的長期治療;心絞痛(包括心肌梗死後)的長期治療和預防;與洋地黃及/或利尿劑合用治療慢性充血性心力衰竭。

公司於2019年6月17日向國家藥品監督管理局藥品審評中心遞交了單硝酸異山梨酯緩釋膠囊(規格:50mg)補充申請,並於2019年6月24日獲得受理;公司於2019年9月24日向國家藥品監督管理局藥品審評中心遞交了單硝酸異山梨酯緩釋膠囊(規格:40mg)補充申請,並於2019年9月30日獲得受理。截至公告披露日,公司生產的單硝酸異山梨酯緩釋膠囊為國內該品種(膠囊劑)首家通過仿製藥質量和療效一致性評價。

公司單硝酸異山梨酯緩釋膠囊通過仿製藥質量和療效一致性評價,有利於提高市場競爭力,併為公司後續產品開展仿製藥一致性評價工作積累寶貴經驗。

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