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立方製藥(003020.SZ):非洛地平緩釋片通過一致性評價
格隆匯 08-03 11:48

格隆匯8月3日丨立方製藥(003020.SZ)公佈,近日,公司收到國家藥監局核准簽發的關於非洛地平緩釋片《藥品補充申請批准通知書》(通知書編號:2022B03112)。公司非洛地平緩釋片通過仿製藥質量和療效一致性評價。

非洛地平緩釋片主要用於治療高血壓、穩定性心絞痛。公司該產品於2004年獲得藥品註冊生產批件,批准文號為國藥準字H20040773,規格為5mg。公司2021年8月向國家藥品監督管理局藥品審評中心遞交非洛地平緩釋片的一致性評價補充申請,於2021年8月30日獲受理。

截至該公吿日,除原研外,國內共有4家企業非洛地平緩釋片仿製品種通過/視同通過質量與療效一致性評價。

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