亞太藥業(002370.SZ):頭孢氨苄膠囊通過仿製藥質量和療效一致性評價
格隆匯 10 月 26日丨亞太藥業(002370.SZ)公佈,公司於近日收到國家藥品監督管理局核准簽發的關於頭孢氨苄膠囊的《藥品補充申請批準通知書》,公司頭孢氨苄膠囊通過仿製藥質量和療效一致性評價。
頭孢氨苄屬第一代頭孢菌素,適用於敏感菌所致的急性扁桃體炎、咽峽炎、中耳炎、鼻竇炎、支氣管炎、肺炎等呼吸道感染、尿路感染及皮膚軟組織感染等,經研究結果表明,該產品質量穩定,其關鍵質量屬性與參比製劑一致,體內與參比製劑等效。
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