人福醫藥(600079.SH):鹽酸左布比卡因注射液獲藥品註冊批件
格隆匯12月10日丨人福醫藥(600079.SH)公佈,公司控股子公司宜昌人福藥業有限責任公司(“宜昌人福”,公司持有其67%的股權)近日收到國家藥品監督管理局核准簽發的鹽酸左布比卡因注射液的《藥品註冊批件》。
藥品名稱:鹽酸左布比卡因注射液;批件號:2019S00630、2019S00631;劑型:注射劑;規格:按C18H28N2O計5ml:37.5mg、按C18H28N2O計10ml:50mg;註冊分類:原化學藥品第6類;藥品有效期:12個月;申請事項:國產藥品註冊;藥品批准文號:國藥準字H20193347、國藥準字H20193348;藥品批准文號有效期:至2024年11月27日;藥品生產企業:宜昌人福藥業有限責任公司;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,批准註冊,發給藥品批准文號。
宜昌人福於2015年6月向國家藥品監督管理局提交鹽酸左布比卡因注射液的註冊申請並獲得受理,截至目前累計研發投入約為300萬元人民幣。鹽酸左布比卡因注射液用於外科硬膜外阻滯麻醉。根據米內網數據統計,2018年鹽酸左布比卡因注射液在我國城市、縣級及鄉鎮三大終端公立醫院的銷售額約為9,500萬元人民幣,主要生產廠家包括珠海潤都製藥股份有限公司、江蘇恆瑞醫藥股份有限公司、江蘇奧賽康藥業有限公司等。
此次鹽酸左布比卡因注射液獲批後,宜昌人福將根據市場需求情況,着手安排生產上市並儘快完成該產品的一致性評價工作。該產品充實了公司麻醉類藥品的產品線,其上市銷售將對公司帶來積極的影響。
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