人福醫藥(600079.SH):控股子公司通過英國GMP符合性檢查
格隆匯8月5日丨人福醫藥(600079.SH)公佈,近日,控股子公司宜昌人福收到英國藥品與健康產品管理局(簡稱MHRA)頒發的編號為“UKGMP48442InspGMP48442/33381169-0003”的GMP證書,本次認證所涉及的生產線為宜昌人福位於宜昌市東臨路517號全球總部基地的最終滅菌小容量注射劑生產線,年設計產能為5億支小容量注射劑,於2023年10月接受了MHRA的GMP(藥品生產質量管理規範)符合性檢查,累計投入約為人民幣5億元,該生產線目前生產的主要產品為枸櫞酸芬太尼注射液、枸櫞酸舒芬太尼注射液等。宜昌人福枸櫞酸芬太尼注射液2023年度實現銷售收入約為人民幣6,500萬元,枸櫞酸舒芬太尼注射液2023年度實現銷售收入約為人民幣18億元。
截至目前,宜昌人福境外業務實現營業收入不超過其總營業收入的10%,最終滅菌小容量注射劑生產線相關產品尚未在英國實現銷售。本次宜昌人福最終滅菌小容量注射劑生產線通過英國GMP符合性檢查標誌着英國規範市場對宜昌人福生產體系的認可和肯定,將對其拓展英國仿製藥市場帶來積極的影響。
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