2018年6月7日
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Lyndhurst NJ, June 7, 2018 – Amerigen Pharmaceuticals Limited (“Amerigen”) today announced the commercial launch of its generic bexarotene 75mg capsules following the recent approval of the Company’s corresponding Abbreviated New Drug Application (“ANDA”) by the U.S. Food and Drug Administration. Amerigen’s bexarotene product is a generic equivalent to Valeant Pharmaceuticals’ Targretin® Capsules. Amerigen’s generic bexarotene capsules are marketed by Amerigen’s U.S. affiliate, Amerigen Pharmaceuticals, Inc.
2018年6月7日,美國新澤西州林德赫斯特消息 – 愛美津制藥有限公司(愛美津)今天宣布:公司的仿制藥產品貝沙羅汀膠囊75mg的簡略新藥申請,在獲得了美國食品和藥物管理局的批準后上市。愛美津的貝沙羅汀產品是與Valeant制藥公司的Targretin®膠囊等效的仿制藥產品。愛美津的貝沙羅汀膠囊由愛美津在美國的隸屬機構-愛美津制藥股份有限公司進行銷售。
關于愛美津 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.
愛美津制藥致力于仿制藥所涉及到的全部階段的業務,是一家包括美國和中國多成員企業的集團公司。集團由愛美津制藥控股。美國市場的注冊和商業活動由位于新澤西州,林赫斯特的美國愛美津負責;集團的中國分公司,蘇州愛美津制藥有限公司,位于中國江蘇省蘇州市。愛美津制藥集團目前在美國以及中國均有藥品上市和銷售,同時,我們擁有活躍的在研產品組,面向美國食品藥品監督管理局(FDA)注冊和已申報若干個仿制藥品種(ANDA),并且計劃開展向中國食品藥品監督管理局(CFDA)注冊和申報產品的工作。愛美津從事開發的口服制劑產品,是開發難度高,需要專門的技術,或生產要求高度嚴格管理控制,以及法規復雜,需要規避或挑戰專利的仿制藥。愛美津集團旗下公司或合作方開發和生產的所有產品,都滿足高質量標準,包括美國FDA。