海普瑞(09989.HK)依諾肝素鈉注射液獲EMA新增生產商批准
海普瑞(09989.HK)公布,收到歐洲藥品管理局(EMA)簽發的關於Inhixa(依諾肝素鈉注射液)新增生產商的批准通知。
公司指,海普瑞坪山園區新建預灌封製劑生產線項目於2022年正式啟動,首期新建三條預灌封生產線設計產能為每年3.3億支,其按照中國、歐美藥品法規標準設計建造,用於生產依諾肝素鈉預灌封注射液。該項目已完成建設並通過歐盟《藥品生產質量管理規範》認證。
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