天壇生物(600161.SH):下屬企業獲得《藥品GMP符合性檢查吿知書》
格隆匯6月24日丨天壇生物(600161.SH)公佈,近日,北京天壇生物製品股份有限公司下屬成都蓉生藥業有限責任公司(以下簡稱“成都蓉生”)收到四川省藥品監督管理局頒發的《藥品GMP
符合性檢查吿知書》。
目前,成都蓉生“皮下注射人免疫球蛋白”已完成Ⅲ期臨牀試驗,遞交上市許可申請並獲得受理,本次成都蓉生獲得《藥品GMP符合性檢查吿知書》,表明成都蓉生血液製品生產車間符合國家GMP要求,待取得“皮下注射人免疫球蛋白”註冊證書和最終生產許可後,可實現該產品的生產。
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