兆科眼科(06622.HK)候選藥通過藥監局藥品註冊現場檢查
兆科眼科(06622.HK)公布,候選藥阿達帕林鹽酸克林黴素複方凝膠(ACCG)已通過國家藥監局食品藥品審核查驗中心之藥品註冊現場檢查,為公司繼今年5月通過貝美素(口塞)嗎洛爾滴眼液及鹽酸依匹斯汀滴眼液之現場檢查後,於本年度通過之第三項現場檢查,為最終審批ACCG之重要一步。
公司亦已通過廣東省藥品監督管理局對藥品生產質量管理規範GMP實施情況進行之外用凝膠生產線合規檢查。檢查結果確認公司已落實GMP管理框架、核心團隊、全套分析工具、設備及設施、妥善文件管理系統以及生產及質量系統妥善運作。此亦為公司通過GMP檢查之第二條生產線。
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