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華北製藥:先泰公司獲氨苄西林及苄星青黴素《藥品GMP證書》
格隆匯 02-10 16:53

格隆匯2月10日丨華北製藥(600812.SH)公佈,近日,公司下屬子公司華北製藥集團先泰藥業有限公司(以下簡稱“先泰公司”)收到河北省藥品監督管理局頒發的《藥品GMP證書》。本次認證的兩條生產線中,801車間化學法生產線為證書到期後的復認證,808車間生產線為車間改造後的首次認證。總計投入資金2952萬元,主要用於對廠房、主要設備設施的改造、維修、維護等。

氨苄西林是β-內酰胺類、廣譜半合成抗生素,屬於氨基青黴素類的一種,跟阿莫西林的作用相似。通過抑制細菌細胞壁的合成,使細菌迅速破裂溶解,毒性極低。可以治療多種細菌感染,比如呼吸道感染(上呼吸道感染、中耳炎鼻竇炎等)、下呼吸道感染(肺炎急性支氣管炎、慢性支氣管炎急性發作)。泌尿系統的感染,如腦膜炎、沙門氏菌感染症以及心內膜炎。

根據中國化學制藥工業協會2015-2017年統計數據,國內氨苄西林年產量為3600噸/年左右,波動幅度在8-10%。主要生產企業有珠海聯邦、石藥集團、先泰公司等。2017年先泰公司市場份額約佔22%,2018年先泰公司該產品銷售收入13212萬元。

苄星青黴素是一種長效的青黴素類抗生素,主要用來治療對青黴素敏感致病菌感染。尤其是用於預防和治療風濕熱和風濕性心臟病、梅毒、淋病等低度感染但需要長期用藥的疾病。

根據中國化學制藥工業協會2015-2018年統計數據,國內苄星青黴素年產量為200-400噸/年左右。主要生產企業有江西東風、先泰公司、石藥中諾等。先泰公司該原料藥主要用於出口,在國內市場份額佔比較小,2018年該產品銷售量佔據我國該產品出口總量的份額約50%,2018年銷售收入共計2751萬元。

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