苏州爱美津制药有限公司
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
公司地址: 苏州工业园区群星一路58号
No. 58, Qunxing Yi Lu, SIP, Suzhou
邮政编码: 215006
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