浙江醫藥(600216.SH):下屬生產企業新昌製藥廠通過英國遠程符合性檢查
格隆匯1月11日丨浙江醫藥(600216.SH)公佈,公司下屬生產企業新昌製藥廠(“新昌製藥”)於2021年7月26日-8月3日接受了英國醫藥和健康產品管理局(簡稱“MHRA”)的遠程GMP(藥品生產質量管理規範)符合性檢查,該檢查範圍涵蓋了口服固體制劑的質量體系、物料、生產、包裝與標籤、設備設施、實驗室控制六大系統。
近日,新昌製藥收到MHRA頒發的編號為“UK GMP27485 Insp GMP 27485/992430-0001”GMP證書,證書有效期3年,標誌着新昌製藥通過英國GMP認證,符合英國藥品質量體系要求。
通過MHRA遠程符合性檢查的口服固體制劑車間檢查品種為左氧氟沙星片(規格:0.25g,0.5g)、鹽酸環丙沙星片(規格:0.25g,0.5g),生產線設計產能為3億片/年,累計研發投入3963萬元。
左氧氟沙星屬於喹諾酮類抗菌素,按照仿製藥註冊申請,適用於敏感菌所致的呼吸系統感染、泌尿系統感染、生殖系統感染、皮膚軟組織感染、腸道感染及其它感染。米內數據查詢顯示,2020年左氧氟沙星片國內銷售額為13.99億元。
鹽酸環丙沙星為第三代喹諾酮類抗菌藥物,按照仿製藥註冊申請,適用於治療成年人革蘭氏陰性菌引起的下呼吸道感染、囊性纖維化或支氣管擴張中的支氣管肺部感染、肺炎、慢性化膿性中耳炎、尿路感染、複雜的尿路感染等。米內數據查詢顯示,2020年鹽酸環丙沙星片國內銷售額為1016.92萬元。
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