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苑東生物(688513.SH):格隆溴銨注射液獲得藥品註冊證書
格隆匯 11-05 16:40

格隆匯 11 月 5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《藥品註冊證書》。

藥品名稱:格隆溴銨注射液;劑型:注射劑;規格:1ml:0.2mg,2ml:0.4mg;註冊分類:化學藥品3類;藥品有效期:24個月;受理號:CYHS1800352國,CYHS1800353國;證書編號:2020S00687,2020S00688;藥品批准文號:國藥準字H20203545,國藥準字H20203546。

格隆溴銨注射液是一種抗膽鹼能藥物。當逆轉非去極化肌鬆藥誘導的神經肌肉阻滯時,該藥品可用於防止抗膽鹼酯酶藥如新斯的明的外周毒蕈鹼作用(如心動過緩)。

格隆溴銨注射液由Baxter Healthcare公司開發,1975年2月在美國獲批上市銷售,商品名為Robinul®,規格為0.2mg/ml,目前格隆溴銨注射液在英國、加拿大、澳大利亞等國家已批准上市。根據國家藥監局網站數據查詢,截止公告日,公司為國內繼江蘇恆瑞後第二家獲得該產品藥品註冊證書的廠家。此外,還有江蘇海岸、廣東嘉博、廣東中潤3家公司提交ANDA申請。

2018年10月11日,公司向國家藥監局提交的格隆溴銨注射液註冊申請獲得受理。截止公告日,該產品累計已投入研發費用人民幣約1938萬元。

格隆溴銨注射液的藥品註冊分類為化學藥品3類。根據國家藥監局《關於仿製藥質量和療效一致性評價工作有關事項的公告》(2017年第100號)文件相關規定,該藥品視為通過仿製藥質量和療效一致性評價。格隆溴銨注射液獲批標誌着公司具備在國內市場銷售該藥品的資格,進一步豐富了公司麻醉鎮痛領域的產品線,有助於提升公司產品的市場競爭力,對公司經營發展也具有一定的積極作用。

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