仙琚製藥(002332.SZ):取得戊酸雌二醇片境內生產藥品註冊證書
格隆匯7月5日丨仙琚製藥(002332.SZ)公佈,公司於近日收到國家藥品監督管理局核准簽發的關於戊酸雌二醇片的《藥品註冊證書》(證書編號:2024S01558),公司戊酸雌二醇片被批准註冊。
戊酸雌二醇片原研(商品名:補佳樂)已於1997年在中國獲得進口註冊許可,規格1mg。本次浙江仙琚製藥股份有限公司申報的戊酸雌二醇片(1mg)規格與原研已批准上市的規格一致,按化學藥品4類進行申報。
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