Amerigen History 爱美津历史

In 2007, Amerigen Inc., the US Corporate Headquarters of Amerigen LTD were founded.  Also in 2007,  Amerigen LTD purchased the facility at 58 Qun Xing Yi Lu from Tang Pharmaceutical Co. LTD and founded the Suzhou Amerigen Company Limited.  The original Senior Management team was primarily experts in the US Generic Pharmaceutical market and product development for US targeted generic products was undertaken.  In 2009, Suzhou Amerigen received US FDA site approval for GMP pharmaceutical products manufacture.

2007年，爱美津公司，即爱美津有限公司美国公司总部正式成立。同样在2007年，爱美津有限公司收购了唐氏药业有限公司位于群星一路的工厂，并成立了苏州爱美津制药有限公司。原始的高级管理团队，主要是由在美国仿制药市场和针对美国仿制药进行产品开发的专家组成。2009年，苏州爱美津获得美国药监局关于GMP药品生产的审批。

Since that time four oral solid dosage product (US ANDAs) have been completely developed, manufactured, and tested at Suzhou Amerigen (SAPCL).   Additionally, products which could not be developed at Suzhou Amerigen for strategic business reasons were supported (both formulation and analytical) by Suzhou Amerigen though manufactured at contractors.

自此以后，苏州爱美津（SAPCL）已经自行开发、制造、测试4个口服固体制剂产品（美国简化新药申请）。此外，由于战略业务的原因而不能在苏州爱美津开发的产品（包括处方和分析），由承包商来制造。

During periods in 2011-2012, and again in 2015, strategic capital equipment investments and upgrades were made to ensure that Suzhou Amerigen can manufacture more complicated pharmaceutical process products at the highest quality. 

在2011-2012年期间，随后又在2015年，苏州爱美津进行了战略性固定设备投资和升级，以确保在最高质量要求下，制造具有更复杂制药工艺的产品。

In 2012, the CFDA inspected the facility and granted the facility approval against the 2010 GMP regulations.  The site was among the first facilities locally approved to the new regulations.  In 2013, Suzhou Amerigen received another positive US FDA Inspection.   Positive feedback from the investigators included “when I enter into this facility, I no longer feel like I’m in China.”  Business visitors often comment that “from a compliance perspective, this facility’s among the best in China.”

2012年，中国药监局对工厂进行了现场检查，并依据2010新版GMP法规授予批准证书。苏州爱美津是根据中国新版GMP获批的首批工厂。2013年，苏州爱美津接受了美国药监局的另一次检查。检察官的正面反馈中包括：“当我进入到这个工厂，我不再觉得我在中国。”商务访客常常评论说：“从合规的角度来看，这家工厂在中国是名列前茅的。”

In March 2014, Amerigen received US FDA first generic approval for the form of Carbidopa Tablets which is manufactured at Suzhou Amerigen.

2014年3月，美国药监局批准在苏州爱美津制造的卡比多巴片剂是首仿药。

The purchase of the Suzhou Amerigen facility included 9 China Domestic Product Licenses.  In 2014, Suzhou Amerigen started the process of reintroduction of the “Tang” products, after re-validating them to a standard consistent with U.S. expectations.   This action led to the reintroductions of Mecobalamin Tablets, 0.5mg, Metoprolol Tartrate Tablets, 25 and 50 mg, and in 2015, Itopride Tablets, 50mg.  The other five product licenses for China are still available for distribution partnerships and remain in the evaluation phase for reintroduction. 

苏州爱美津的收购中包括9个产品的中国国内生产许可证。2014年，苏州爱美津开始着手唐氏产品工艺再造，通过再验证使之满足美国标准。这一行动决定了甲钴胺片0.5mg，酒石酸美托洛尔片25和50毫克的再生产，并在2015年，再生产了伊托必利片50毫克。对于中国市场的其他五个产品许可证仍然可以与分销商进行合作，仍然处于再生产评估阶段。

Suzhou Amerigen welcomes strategic business development arrangements that can be mutually beneficial.  With Business Development teams based both in the US and in China, and with experience in both markets, Suzhou Amerigen and Amerigen Inc. are positioned to deliver.  

苏州爱美津欢迎可以互惠互利的企业发展战略合作。苏州爱美津和爱美津公司位于中美两国的业务开发团队，并在这两个市场的经验为基础的商业开发团队将竭诚提供服务。