智通财经APP获悉，海普瑞(09989)午前涨超3%，截至发稿，涨3.09%，报5.33港元，成交额872.01万港元。
消息面上，海普瑞发布公告，公司近日收到欧洲药品管理局(EMA)签发的关于依诺肝素钠注射液新增生产商的批准通知。批准涉及的药品为依诺肝素钠注射液，商品名为Inhixa，剂型为注射液，规格包括20mg/0.2ml, 40mg/0.4ml, 60mg/0.6ml, 80mg/0.8ml, 100mg/1ml, 120mg/0.8ml, 150mg/1ml。
据介绍，海普瑞坪山园区新建预灌封制剂生产线项目于2022年正式启动，首期新建三条预灌封生产线设计产能为3.3亿支╱年，其按照中国、欧美药品法规标准设计建造，用于生产依诺肝素钠预灌封注射液。该项目已完成建设并通过欧盟《药品生产质量管理规范》认证。此次公司坪山园区预灌封制剂生产线获得EMA的许可，标志着公司坪山园区生产的依诺肝素钠注射液已获得在欧洲经济区(EEA)实现商业化的资格，此次获批将为公司进一步推进制剂国际化战略提供更加充足的产能保障，切实提高公司市场竞争力。
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