Amerigen Pharmaceuticals is a multinational company with established development and manufacturing platforms aimed at providing high-quality generic pharmaceutical products. Its headquarter is based at New Jersey, US.爱美津制药是一家集研发和制造于一体的跨国公司,旨在向美国提供高质量的仿制药品。总部位于美国新泽西州。With pharmaceutical assets and science-based expertise in the United States and abroad, Amerigen is able to provide quality products at competitive prices along with unmatched customer service.凭借在美国和海外的制药资产和技术专家队伍,爱美津致力于提供高品质产品、有竞争力的价格和无以匹敌的客户服务。At the end of 2007, Amerigen has successfully completed the acquisition of an oral solid dose manufacturing facility in Suzhou Industrial Park, China and established Suzhou Amerigen Pharmaceutical Co., Ltd.2007年底,爱美津完成了在中国苏州工业园区的口服固体制剂生产厂的收购,并成立了苏州爱美津制药有限公司。 The milestones of Suzhou Amerigen are as follows:苏州爱美津制药的里程碑如下:2007 Suzhou Amerigen was established
苏州爱美津成立2008 First US regulatory filing
首次获得美国法规文件受理2009 First US FDA PAI & General Inspection
首次美国食品药品监督管理局上市批准和常规检查2010 Received US FDA approval for bulk tablet manufacturing
获得美国食品药品监督管理局的批准生产大包装片剂2012 Passed CFDA Re-Inspection (GMP 2010 version)
通过中国食品药品监督管理局再次检查-新版GMP (2010版)2013 Passed US FDA Inspection –Recommended approvals on four ANDAs
通过美国食品药品监督管理局检查- 4个简化新药被推荐批准2014 Launched US Product and re-introduced China Products
产品在美国市场上市, 中国市场产品恢复生产。2015 Passed US FDA Inspection on Data Integrity
通过美国食品药品监督管理局针对数据完整性的专项检查
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