美国FDA 向苏州爱美津发布了美格鲁特胶囊100mg的EIR

2017年9月29日

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中国江苏苏州,2017年9月29日消息,苏州爱美津制药有限公司(苏州爱美津)宣布:美国FDA 向苏州爱美津发布了美格鲁特胶囊100mg的EIR.  苏州爱美津最近一次成功通过美国FDA的批准前检查是2016年11月8日到11日。美国FDA在2017年9月25日发布了EIR来支持批准苏州爱美津工厂可以进行美格鲁特胶囊100mg的生产,从而正式结束了此次检查。该EIR再一次证明了苏州工厂持续地符合美国现行GMP的要求,能够进行口服固体制剂药品的生产、包装和检测处理。

Suzhou Jiangsu, P.R.C. September 29, 2017, Suzhou Amerigen Pharmaceuticals Ltd., Co. (Suzhou Amerigen) announces that US FDA released the Establishment Inspection Report(EIR) for Miglustat Capsules 100mg. The most recent US FDA Pre-Approval Inspection (PAI) of Suzhou Amerigen was conducted on November 8 to 11, 2016 with a successful outcome.  US FDA has officially closed this inspection with the issuance of the Establishment Inspection Report on September 25, 2017 in support of approving this facility for the manufacture of Miglustat Capsules 100mg.  This reconfirms that our Suzhou facility remains compliant to the US cGMP requirements which pertain to the manufacture, packaging, testing, and handling of oral solid dose drug products.


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。