常山藥業(300255.SZ)子公司獲得枸櫞酸西地那非片補充申請批件
格隆匯12月18日丨常山藥業(300255.SZ)公佈,公司子公司常山生化藥業(江蘇)有限公司於近日收到國家藥品監督管理局核准簽發的藥品補充申請批件,主要具體信息如下:
藥品名稱:枸櫞酸西地那非片;劑型:片劑;規格:50mg;原藥品批准文號:國藥準字H20171004;藥品標準:YBH05682017;藥品生產企業:常山生化藥業(江蘇)有限公司;申請內容:枸櫞酸西地那非片生產所用原料藥“枸櫞酸西地那非”的生產工藝發生變更,申請採用生產工藝變更後的原料藥作為該製劑生產所用原料藥。審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,同意本品採用生產工藝變更後的原料藥作為本製劑生產所用原料藥。關聯原料藥枸櫞酸西地那非登記號:Y20180001559。本品質量標準除含量限度收緊為93.0%~107.0%,其他項目均執行YBH05682017。其他照原批件內容執行。
枸櫞酸西地那非原料藥在變更工藝後,優化了生產過程,能夠大幅提高產能。此次公司獲得枸櫞酸西地那非片補充申請批件,可以提升公司枸櫞酸西地那非片的產量,有利於該產品的銷售。
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