Amerigen Pharmaceuticals

Founded in 2007, Amerigen Pharmaceuticals operates as a developer, manufacturer, and distributor of generic pharmaceutical products, with a strategic focus on the U.S. and Chinese markets. The company's U.S. headquarters in Lyndhurst, New Jersey, manages executive functions, business development, finance, regulatory affairs, and commercial operations. A key component of its operational structure is its manufacturing and R&D facility in Suzhou, China, which is approved by both the U.S. Food and Drug Administration (FDA) and the China Food and Drug Administration (CFDA). This dual compliance allows Amerigen to uniquely position itself to supply high-quality, affordable medicines to both major markets.

The company was established through the purchase of a facility from Tang Pharmaceutical Co. LTD, which included nine existing Chinese product licenses that Amerigen began to re-validate and reintroduce to the market. John Lowry was appointed President & CEO in 2010, bringing nearly three decades of experience from leadership roles at pharmaceutical and medical device companies like Catalent Pharma Solutions, Cardinal Health, and Becton Dickinson. His background includes a Bachelor of Science in Mechanical Engineering from Villanova University. Under his leadership, Amerigen focused on developing orally delivered products that are challenging to formulate, require specialized manufacturing, or face complex regulatory and intellectual property hurdles.

Amerigen's business model revolves around the development, manufacturing, and sale of generic pharmaceuticals. The company generates revenue through the commercialization of its product portfolio, which includes both internally developed drugs and those acquired through partnerships. A significant milestone was the acquisition of its U.S. portfolio of 23 commercial and pipeline generic products by ANI Pharmaceuticals in January 2020. The company has a history of successfully bringing 'first-to-market' generics, such as the generic equivalent to West-Ward's cyclophosphamide capsules and Bausch Health's Cuprimine®. Other notable approvals include generic versions of Shire's Adderall XR® and Actelion's Zavesca®.

Keywords: generic pharmaceuticals, pharmaceutical manufacturing, US FDA approved, CFDA certified, Abbreviated New Drug Application, ANDA, oral solid dosage, pharmaceutical development, US pharmaceutical market, China pharmaceutical market, John Lowry, ANI Pharmaceuticals, Suzhou manufacturing, cyclophosphamide, penicillamine, miglustat, Adderall XR generic, controlled release, drug commercialization, pharmaceutical distribution