苏州爱美津制药有限公司又一次成功地通过了美国FDA 的现行药品生产质量管理规范(cGMP)检查

2017年10月26日

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中国江苏苏州,2017年10月26日消息,苏州爱美津制药有限公司(苏州爱美津)宣布:苏州工厂又一次成功通过US FDA的现行药品生产质量管理规范(cGMP)常规检查。10月23日至10月26日,美国FDA对苏州爱美津进行了一次常规检查,并确认了苏州工厂持续按照美国FDA cGMP的要求进行生产。美国FDA对苏州爱美津的多次检查是对苏州爱美津人员执行满足美国法规要求和期望的流程的全面验证。此次检查审核了数百份文件、询问了所有相关部门的人员。再一次,苏州爱美津管理团队很高兴地宣布这一积极成果。

Suzhou Jiangsu, P.R.C. Oct 26, 2017, Suzhou Amerigen Pharmaceuticals Co., Ltd. (Suzhou Amerigen) announces that the facility successfully passed another US FDA’s General cGMP inspection. On Oct 23 to Oct 26, US FDA conducted its routine inspection of Suzhou Amerigen’s facility and confirmed that the facility continues to operate in compliance with US FDA cGMP requirements. These inspections of Suzhou Amerigen's facility are in depth verifications that Amerigen’s personnel perform procedures which are consistent with US Regulatory requirements and expectations.  The inspection includes review of hundreds of documents and various personnel in all relevant departments. Once again, the Suzhou Amerigen management team is pleased to report this positive outcome. 


关于爱美津 About Amerigen

Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the US and China. The group is controlled by Amerigen Pharmaceuticals Limited. The US regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc., based in Lyndhurst, NJ, USA. The group's Chinese subsidiary, Suzhou Amerigen Pharmaceutical Company Limited, is located in Suzhou, Jiangsu Province. The group has products on the market currently in both the US and China plus an active portfolio of products under development, filed, or intended for filing, as ANDA's with the US FDA and the Chinese CFDA. Amerigen's focus is orally delivered products that are potential first generics, challenging to develop, require specialized technologies or high containment to manufacture, and present complex regulatory and intellectual property obstacles to bring to market. All Amerigen's products are developed and manufactured by the company or its partners around the world to meet the highest quality standards, including the US FDA.

爱美津制药致力于仿制药所涉及到的全部阶段的业务,是一家包括美国和中国多成员企业的集团公司。集团由爱美津制药控股。美国市场的注册和商业活动由位于新泽西州,林赫斯特的美国爱美津负责;集团的中国分公司,苏州爱美津制药有限公司,位于中国江苏省苏州市。爱美津制药集团目前在美国以及中国均有药品上市和销售,同时,我们拥有活跃的在研产品组,面向美国食品药品监督管理局(FDA)注册和已申报若干个仿制药品种(ANDA),并且计划开展向中国食品药品监督管理局(CFDA)注册和申报产品的工作。爱美津从事开发的口服制剂产品,是开发难度高,需要专门的技术,或生产要求高度严格管理控制,以及法规复杂,需要规避或挑战专利的仿制药。爱美津集团旗下公司或合作方开发和生产的所有产品,都满足高质量标准,包括美国FDA。