华润医药(03320.HK) 宣布,集团旗下“湘中制药”收到国家药品监督管理局颁发的左乙拉西坦口服溶液《药品注册证书》,并视同通过一致性评价。同时,集团旗下“天东制药”获得山东省药品监督管理局颁发的《药品GMP符合性检查告知书》,通过药品GMP符合性检查。
左乙拉西坦口服溶液是一种用于成人、儿童及一个月以上婴幼儿癫痫患者部分性发作的加用治疗药物。
天东制药的GMP检查范围包括以下生产线:肝素钠原料药生产线及那屈肝素钙原料药生产线。本次药品GMP符合性检查,是肝素钠原料药新工艺、那屈肝素钙原料药上市前的首次药品GMP符合性检查。(su/a)(港股报价延迟最少十五分钟。沽空资料截至 2025-03-03 16:25。)
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