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苑東生物(688513.SH):枸櫞酸咖啡因注射液通過一致性評價
格隆匯 02-24 15:53

格隆匯 2 月 24日丨苑東生物(688513.SH)公佈,公司於近日收到國家藥品監督管理局核准簽發的化學藥品“枸櫞酸咖啡因注射液”的《藥品補充申請批准通知書》。

藥品名稱:枸櫞酸咖啡因注射液;劑型:注射劑;規格:1ml:20mg(相當於C8H10N4O210mg)、3ml:60mg(相當於C8H10N4O230mg);申請內容:一致性評價申請,處方工藝有變更;註冊分類:化學藥品;原藥品批准文號:國藥準字H20163401、國藥準字H20184023;上市許可持有人:成都苑東生物製藥股份有限公司;審批結論:根據《中華人民共和國藥品管理法》、《國務院關於改革藥品醫療器械審評審批制度的意見》(國發〔2015〕44號)、《關於仿製藥質量和療效一致性評價工作有關事項的公吿》(2017年第100號)和《國家藥監局關於開展化學藥品注射劑仿製藥質量和療效一致性評價工作的公吿》(2020年第62號)的規定,經審查,本品通過仿製藥質量和療效一致性評價。同時同意變更處方及生產工藝。生產工藝、質量標準和説明書照所附執行,標籤相關內容應與説明書保持一致。有效期為24個月。

公司枸櫞酸咖啡因注射液通過一致性評價,有利於提高市場競爭力,對公司未來的經營業績產生積極的影響,同時為公司後續一致性評價產品研究工作積累了寶貴經驗。該產品通過仿製藥一致性評價對公司業務不構成重大影響。

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