華北製藥(600812.SH):華民公司頭孢氨苄膠囊(0.25g)獲仿製藥一致性評價
格隆匯11月26日丨華北製藥(600812.SH)公佈,近日,華北製藥股份有限公司下屬全資子公司華北製藥河北華民藥業有限責任公司(以下簡稱“華民公司”)收到國家藥品監督管理局核准簽發頭孢氨苄膠囊(0.25g)的《藥品補充申請批件》,該藥品通過仿製藥質量和療效一致性評價。
頭孢氨苄膠囊適用於敏感菌所致的急性扁桃體炎、咽喉炎、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。頭孢氨苄屬於第一代口服頭孢菌素類抗生素藥物,最早由美國EliLilly公司於1967年合成,目前國內外有片劑、膠囊劑、幹混懸劑以及顆粒劑等劑型,是一種臨牀應用比較廣泛的抗感染類藥物。
開展一致性評價工作以來,華民公司該藥品(0.25g)累計研發投入985萬元人民幣(未經審計)。
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