已受理,完成质量复核,转CDE。采用我们原料的制剂即将在欧洲上市。自2004年上市至2008年,在美国的净销售额累计超过10亿美元,原研厂的2007年销售额为4.63亿美元,2008年为5.97亿美元(IMS数据)。
安森博有近二十年进口药品注册经验,80多个进口药品成功注册案例。
业务范围:1、进口药品代理;2、进口药品注册委托服务;3、寻找进口制剂国内销售合作伙伴。
如您对我们的进口原料药感兴趣,只需采购即可,我们负责进口原料药注册等。目前我公司已有近30个进口原料药在CDE排队待审,50多个进口原料药的资料在整理中。已有60多家国内制剂厂采购我们的原料药。
我们代理的进口制剂,已经在欧美已经或即将上市销售,质量可靠,期待与您合作。
We are a trade company. We are very strong in registration and promotion of import drugs in China, with decades of registration experience and over 86 Licenses procured successfully.
We submitted about 10 import drug applications per year since 2011;
Our knowledge, experience and good working relationship with the regulatory department help us to speed up regulatory approvals and to provide sound support for our formulation customers.
We procured 5 new IDLs in 2010, among which one license was obtained within 10 months and another was obtained within 12 months.
We do not manufacture API and formulation, only focus on registration and promotion of import drug in China.