新天地(301277.SZ):原料藥鹽酸莫西沙星通過藥品GMP符合性檢查
格隆匯2月21日丨新天地(301277.SZ)公佈,公司於近日收到由河南省藥品監督管理局頒發的《河南省藥品監督管理局藥品GMP檢查結果吿知書》。檢查範圍為原料藥(鹽酸莫西沙星)。經審查,該企業基本符合《藥品生產質量管理規範(2010年修訂)》要求。
鹽酸莫西沙星為喹諾酮類抗生素,用於治療對本品敏感病原體引起的感染性疾病,如細菌性鼻竇炎、細菌性慢性支氣管炎急性發作、社區獲得性肺炎、單純性皮膚及皮膚組織感染、複雜性腹腔內感染、複雜性皮膚及皮膚組織感染等。
公司原料藥鹽酸莫西沙星通過藥品GMP符合性檢查,表明公司相關產品和生產線符合GMP要求,有利於推動該產品在國內生產並上市銷售,有望提升公司業績,促進公司持續、健康發展。
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