2018年6月7日
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info@amerigenpharma.com
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(guó)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(chǎn)品貝沙羅汀膠囊75mg的簡(jiǎn)略新藥申請(qǐng),在獲得了美國(guó)食品和藥物管理局的批準(zhǔn)后上市。愛美津的貝沙羅汀產(chǎn)品是與Valeant制藥公司的Targretin®膠囊等效的仿制藥產(chǎn)品。愛美津的貝沙羅汀膠囊由愛美津在美國(guó)的隸屬機(jī)構(gòu)-愛美津制藥股份有限公司進(jìn)行銷售。
關(guān)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(yè)務(wù),是一家包括美國(guó)和中國(guó)多成員企業(yè)的集團(tuán)公司。集團(tuán)由愛美津制藥控股。美國(guó)市場(chǎng)的注冊(cè)和商業(yè)活動(dòng)由位于新澤西州,林赫斯特的美國(guó)愛美津負(fù)責(zé);集團(tuán)的中國(guó)分公司,蘇州愛美津制藥有限公司,位于中國(guó)江蘇省蘇州市。愛美津制藥集團(tuán)目前在美國(guó)以及中國(guó)均有藥品上市和銷售,同時(shí),我們擁有活躍的在研產(chǎn)品組,面向美國(guó)食品藥品監(jiān)督管理局(FDA)注冊(cè)和已申報(bào)若干個(gè)仿制藥品種(ANDA),并且計(jì)劃開展向中國(guó)食品藥品監(jiān)督管理局(CFDA)注冊(cè)和申報(bào)產(chǎn)品的工作。愛美津從事開發(fā)的口服制劑產(chǎn)品,是開發(fā)難度高,需要專門的技術(shù),或生產(chǎn)要求高度嚴(yán)格管理控制,以及法規(guī)復(fù)雜,需要規(guī)避或挑戰(zhàn)專利的仿制藥。愛美津集團(tuán)旗下公司或合作方開發(fā)和生產(chǎn)的所有產(chǎn)品,都滿足高質(zhì)量標(biāo)準(zhǔn),包括美國(guó)FDA。