白云山(00874.HK)收到普卢利沙星药品再注册批件
格隆汇10月14日丨白云山(00874.HK)公布,公司分公司广州白云山医药集团股份有限公司白云山化学制药厂近日收到广东省药品监督管理局核准签发的《药品再注册批件》。
经审查,同意普卢利沙星再注册。由于本品长期未生产,恢复生产时,须向省药监局提出现场检查申请,经省药监局现场检查并抽验一批产品合格后,方可上市销售。
据悉,普卢利沙星为化学制药厂原料药品种,2008年3月18日由化学制药厂获得新药证书,并取得批准文号,属化学药品3.1类新药。普卢利沙星主要适用于对普卢利沙星敏感的浅表性皮肤感染,深层皮肤感染症;外伤和烫伤以及手术创伤等浅表性继发性感染;急性上呼吸道感染、慢性呼吸系统疾病的继发性感染和肺炎等。目前化学制药厂未生产和销售该原料药。根据药智网数据,除化学制药厂外,国内共有9家企业生产该原料药,公司亦无法从公开数据查询到市场上其他企业该原料药的生产和销售情况。
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