振東製藥(300158.SZ):頭孢克肟膠囊通過一致性評價
格隆匯6月8日丨振東製藥(300158.SZ)宣佈,近日,公司全資子公司山西振東泰盛製藥有限公司(簡稱“泰盛製藥”)收到國家藥監局簽發的關於頭孢克肟膠囊50mg規格的《藥品補充申請批准通知書》(通知書編號:2021B01679),該藥品通過仿製藥質量和療效一致性評價。
頭孢克肟膠囊適用於對頭孢克肟敏感的鏈球菌屬(腸球菌除外)、肺炎球菌、淋球菌、卡他布蘭漢球菌、大腸桿菌、克雷伯桿菌屬、沙雷菌屬、變形桿菌屬及流感桿菌等引進的下列細菌感染性疾病:1、支氣管炎、支氣管擴張症(感染時),慢性呼吸系統感染疾病的繼發感染,肺炎;2、腎盂腎炎、膀胱炎、淋球菌性尿道炎;3、膽囊炎、膽管炎;4、猩紅熱;5、中耳炎、副鼻竇炎。
根據米內網數據顯示,2020年我國頭孢克肟膠囊全終端總體銷售規模約為12.6億元。目前共有6家頭孢克肟膠囊生產商通過一致性評價,包括石藥集團歐意藥業有限公司、華北製藥河北華民藥業有限責任公司、齊魯製藥有限公司、成都倍特藥業股份有限公司、廣州白雲山醫藥集團股份有限公司白雲山製藥總廠以及泰盛製藥。
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