華北製藥(600812.SH):頭孢呋辛酯片通過仿製藥一致性評價
格隆匯12月11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呋辛酯片(0.125g)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。
本品為第二代頭孢菌素類抗生素,主要適用於溶血性鏈球菌、金黃色葡萄球菌(耐甲氧西林株除外)及流感嗜血桿菌、大腸埃希菌、肺炎克雷伯菌、奇異變形桿菌等腸桿菌科細菌敏感菌株所致成人急性咽炎或扁桃體炎、急性中耳炎、上頜竇炎、慢性支氣管炎急性發作、急性支氣管炎、單純性尿路感染、皮膚軟組織感染及無併發症淋病奈瑟菌性尿道炎和宮頸炎;兒童咽炎或扁桃體炎、急性中耳炎及膿皰病等。頭孢呋辛酯由Glaxo Smith Kline開發成功,1987年在英國、愛爾蘭、德國和意大利首先上市,商品名為Zinnat;1988年在美國上市,商品名為Ceftin,劑型為片劑和幹混懸劑,規格為500mg、250mg、125mg。
開展一致性評價工作以來,華民公司該藥品研發投入約1400萬元人民幣(未經審計)。
目前,包括華民公司在內國內有12家公司擁有頭孢呋辛酯片批准文號,其中0.25g批准文號10家,0.5g批准文號2家,0.125g批准文號8家,華民公司為該品種(0.125g)第四家通過一致性評價的企業。華民公司該產品2018年銷售收入為543萬元。
工信部數據顯示2017年頭孢呋辛酯片(0.125g)全國產量為35641萬片,其中華民公司產量為2381萬片。
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