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认证:健康元无菌美罗培南制剂获欧盟认证 发布时间: 2013-03-28 12:22 点击:

 

认证:健康元无菌美罗培南制剂获欧盟认证
Certification: jiankangyuan sterile meropenem preparation by the EU certification
健康元旗下全资子公司深圳市海滨制药有限公司,近日接受德国GMP认证机构对其无菌美罗培南制剂(注射用粉末)生产车间现场检查,并收到认证机构颁发的欧盟EU-GMP 认证证书
A wholly owned subsidiary of Joincare under Shenzhen Haibin pharmaceutical limited company, recently accepted the German GMP certification of the sterile meropenem preparation (powder for injection) production workshop on-site inspection, and received EU-GMP certification issued by the certification institution.
昨天,记者了解到,这是国内首家无菌美罗培南制剂(注射用粉末)通过欧盟EU-GMP认证的企业。
Yesterday, the reporter understands, this is the first domestic meropenem (sterile powder for injection preparation) through the EU EU-GMP certification enterprises.
美罗培南作为抗生素,是迄今为止抗菌谱最广、抗菌活性甚强的一种,扮演着抗临床重症感染最后一道防线的重要角色,因此有着抗生素王牌的素称。由于工艺难度较大,目前国内生产该药的厂家相比胜少。
Meropenem as antibiotics, is so far the most widely, antibacterial spectrum antibacterial activity is very strong, plays an important role in the last line of defense against clinical severe infection, therefore has a trump card in antibiotic. Because the process is difficult, the current domestic production of the drug manufacturers won less than.
去年11月,海滨公司无菌美罗培南(原料药)获得欧盟EU-GMP认证证书,截至目前为止,海滨公司成为国内唯一同时获得无菌美罗培南原料药及无菌制剂(注射用粉末)欧盟EU-GMP认证证书的生产厂家。
Last November, the beach, sterile meropenem (API) obtained from the European EU-GMP certification, so far, the seaside company became the only obtain aseptic meropenem API and sterile preparations (powder for injection) EU EU-GMP certification of the production factory.
健康元旗下海滨公司以生产抗生素药物为主,经营范围包括化学原料药和制剂、抗生素、心脑血管类药等,致力于打造国内最大的抗生素生产基地。2001年,健康元首次IPO融资上市,就将美罗培南作为重点投资项目,计划打造专业的美罗培南生产链条。
Beach, health yuan flag with production of antibiotics, including the scope of business of chemical raw material medicine and preparation, antibiotics, cardiovascular drugs, is committed to creating the largest domestic production base of antibiotics. In 2001, health yuan first IPO financing market, will meropenem as a key investment projects, plans to build a professional production chain for meropenem.
时至今日,海滨公司美罗培南原料药及其制剂,占据了国内需求近50%的市场,同时,还远销非洲、南美、南亚、东南亚、东欧等地,海占据非欧美市场总量的60%,2010年仅仅美罗培南就为健康元贡献净利润将近2亿。
Today, meropenem drugs beach company, occupied the domestic demand of nearly 50% of the market, at the same time, but also exported to Africa, South America, South Asia, Southeast Asia, Eastern Europe, occupying the sea than in Europe and the United States market 60% of the total, in 2010 only meropenem for Joincare contribution to net profit of nearly 200000000.
认证:健康元无菌美罗培南制剂获欧盟认证
Certification: jiankangyuan sterile meropenem preparation by the EU certification