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華森製藥(002907.SZ):503車間硬膠囊劑生產線(茶愈膠囊)通過GMP符合性檢查
格隆匯 04-07 18:14

格隆匯4月7日丨華森製藥(002907.SZ)公佈,公司重慶市榮昌區昌州街道板橋路143號503車間硬膠囊劑生產線,茶愈膠囊於2022年接受並順利通過了重慶市藥品監督管理局(簡稱“市藥監局”)組織的藥品生產質量管理規範符合性檢查(簡稱“GMP符合性檢查”),並於近日收到市藥監局核准簽發的上述相關生產線的《關於藥品生產質量管理規範符合性檢查結果的通知》,檢查結果為符合《藥品生產質量管理規範》的有關規定。

茶愈膠囊是由治療支氣管痙攣經典藥物茶鹼和祛痰經典藥物愈創木酚甘油醚組成的獨家複方改良製劑,是支氣管炎、慢性支氣管炎的重要基礎治療藥物,國內老齡化趨勢下該類型患者人數日益增長,茶愈膠囊具有良好的市場空間。

公司於2021年成為茶愈膠囊的藥品上市許可持有人,該次獲得藥品GMP符合性檢查結果,表明公司相關生產線符合GMP要求,茶愈膠囊可以正式在公司生產並上市銷售,有利於公司的可持續發展。

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