苏州爱美津制药有限公司成功续证药品GMP证书

2017年9月19日

及时发布,请联系:
美国: (732) 993-9821
中国: +86-512-6745-1085 分机 101
info@amerigenpharma.com


中国江苏苏州,2017年9月19日消息,苏州爱美津制药有限公司(苏州爱美津)宣布:江苏省食品药品监督管理局向苏州爱美津制药有限公司(苏州爱美津)发放药品GMP证书。2017年5月,江苏省食品药品监督管理局对苏州爱美津进行了GMP续证的现场检查和审核,确认苏州爱美津符合《药品生产质量管理规范》(2010年修订),并于2017年9月19日颁发了药品GMP证书。

Suzhou Jiangsu, P.R.C. September 19, 2017 – Suzhou Amerigen Pharmaceuticals Ltd., Co. (Suzhou Amerigen) announces that Jiangsu Food and Drug Administration (FDA) has granted the certificate of Good Manufacturing Practices (GMP) for Pharmaceutical Products to Suzhou Amerigen. In May, 2017, Jiangsu FDA conducted an on-site inspection and audit in Suzhou Amerigen for the GMP certificate renewal. In final, JSFDA confirmed that Suzhou Amerigen complies with the requirements of Chinese Good Manufacturing Practices (2010 Revision) for Pharmaceutical products, and granted the GMP certificate for Pharmaceutical Products to Suzhou Amerigen on September 19, 2017.


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。