Amerigen at a Glance

Amerigen at a Glance

Amerigen is a privately held

company that was founded in 2007 by a group of healthcare investors. The Company has a focus on the development, manufacture and sale of high quality generic pharmaceutical products for two of the most important markets in the world…the U.S. and China…

Amerigen has unique integrated development, regulatory and manufacturing capabilities, with a focus is on complex oral products with formulation challenges and/or other barriers to entry; and first generic opportunities.

Our U.S. and Corporate office is located in Northern New Jersey. In addition to executive management, this location also houses staff in the following functions for the U.S. market: product and business development, finance, regulatory affairs, and commercial operations. Product development is being undertaken at various locations around the world under the supervision of Amerigen’s experienced formulation, analytical, quality and regulatory leaders.

Our main facility is in China and located in Suzhou, Jiangsu Province, near Shanghai. The Suzhou facility houses executive and local management for the Chinese market and is a U.S. FDA and Chinese FDA (CFDA) approved finished dose manufacturing site. Also on the Suzhou site is a substantial, highly capable product development team that develops many of Amerigen’s products. The Suzhou facility was first successfully inspected by the U.S. FDA in 2009, and has been regularly inspected with positive outcomes since then, most recently in late 2016.

Amerigen launched its first product on the U.S. market in 2014 following the approval of an ANDA for carbidopa 25mg tablets, then the first generic equivalent to Valeant’s Lodosyn®. The Company now manufactures, from its site in Suzhou, multiple oral finished dose products that are commercialized under an Amerigen label in the U.S. and China markets. In addition, Amerigen has a rich pipeline of filed ANDA’s and advanced development projects.