双峰格雷斯海姆是一家为医药企业专业提供高端医药玻璃包装和技术服务的中德合资公司,是中国医药包装协会常务理事单位,江苏省医药包装药用辅料协会副会长单位,江苏药品质量协会常务理事单位。
公司的核心产品是药用玻璃管制注射剂瓶、安瓿、卡式瓶、生命科学小瓶,产品具备良好的耐水性和耐冷冻性,品质符合YBB、ISO、EP、USP标准,是各种生物制剂、冻干粉针、疫苗、血液制剂等药品的包装首选。
在药品与药包材关联审批的实施要求下,公司在国家药品监督管理局药品审评中心(CDE)平台登记并公示品种达40多个,其中20多个品种处于激活状态。在美国FDA,公司各种规格产品拥有激活状态下的DMF15209登记号。
Gerresheimer Shuangfeng is a Sino-German Joint Venture company specialized in providing high level pharmaceutical glass packaging and technical service for Pharmaceutical companies, which is the standing director unit of China Pharmaceutical Packaging Association, vice chairman unit of Jiangsu Pharmaceutical Packaging & Excipients Association, and standing director unit of Jiangsu Medical Quality Association.
Gerresheimer Shuangfeng’s core products are pharmaceutical tubular injection vials, ampoules, cartridges, and scientific vials with ideal hydrolytic resistance and freezing resistance. The product quality fits for YBB, ISO, EP and USP standard, it is the first choice of pharmaceutical packaging for biologics, lyophilization, vaccines and blood preparation.
Under the implementation requirements of the related approval of drugs and packaging materials, the company has registered and publicized more than 40 ranges on the center for drug evaluation (CDE) platform, among which more than 20 ranges are active. We also have active DMF number in FDA, DMF number is 15209.