華森製藥(002907.SZ):獲得奧美拉唑碳酸氫鈉膠囊藥品補充申請批准通知書暨成為藥品上市許可持有人
格隆匯10月20日丨華森製藥(002907.SZ)公佈,公司於2018年6月28日與北京百奧藥業有限責任公司(“北京百奧”)簽訂了關於奧美拉唑碳酸氫鈉膠囊(規格:20mg:1100mg)的《技術開發及轉讓合同》,百奧藥業於2021年5月取得了國家藥品監督管理局(“國家藥監局”)核准簽發的《藥品註冊證書》(證書編號:2021S00512)(第3類)。具體內容詳見公司分別於2018年6月30日和2021年5月26日披露的《關於簽訂<技術開發及轉讓合同>的公吿》(公吿編號:2018-032)和《關於合作方取得奧美拉唑碳酸氫鈉膠囊藥品註冊證書的公吿》(公吿編號:2021-032)。公司隨即開展該產品的上市許可持有人變更工作,持有人變更完成後該產品即進行上市銷售。
公司於近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的關於奧美拉唑碳酸氫鈉膠囊的《藥品補充申請批准通知書》,標誌着該產品已完成藥品上市許可持有人變更工作,公司已成為其藥品上市許可持有人,公司將儘快開展市場營銷工作。
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