Amerigen To Develop Generics With Ningbo Menovo
By C. Rajan, contributing writer
Amerigen Pharmaceuticals Limited announced last week that it has entered into a collaboration agreement with the Ningbo Menovo Pharmaceutical for the development of generic pharmaceuticals, primarily targeting the United States market.
Amerigen’s President & CEO, John Lowry, said, “This collaboration enables each party to leverage its respective strengths and will broaden Amerigen’s product pipeline. Our first product opportunity leverages formulation work already undertaken by Amerigen at its Suzhou facility and Menovo’s leading position with the corresponding Active Pharmaceutical Ingredient (API).”
Under the terms of the agreement, the two companies will jointly develop the generic drugs. Amerigen will commercialize the products in the U.S, while Menovo will be responsible for manufacturing the APIs and the finished products. Amerigen will take responsibility for the clinical, regulatory, and commercial activities in the U.S., and will also provide support and assistance to Menovo in obtaining U.S. FDA approval for their finished dose manufacturing site in Daxie, China.
Adam Yao, Menovo’s CEO, said, “By partnering with Amerigen, who is an existing supplier of finished product from China into the United States market from their US FDA and CFDA approved facility in Suzhou, we look forward to accelerating our strategic objective of growing our international business in API’s and integrating this into self-manufactured finished product of the highest quality”.
Amerigen also recently announced that its Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Co. Ltd., received Chinese Food and Drug Administration (CFDA) approval. The company then launched its generic Mecobalamin tablets into the China domestic market. The CFDA approval of Mecobalamin is the first for Amerigen and marks its entry into the Chinese generics market.
Earlier this year, Amerigen received U.S. FDA approval for its ANDA for Carbidopa 25mg tablet, which is a generic equivalent of Valeant’s Lodosyn that has been launched under an Amerigen Pharmaceuticals label.
Amerigen Pharmaceuticals is focused on developing oral generic drugs. With many of the major drugs losing patent protection between 2010 and 2020, the generics business is currently booming. China and India are the major hubs for generics development and commercialization, and many U.S. based pharma companies are tying up with Chinese and Indian companies to enter the huge generics market.
The Amerigen group of companies has operations in the U.S. and China, and is developing generics for both the U.S. and Chinese markets. Amerigen has entered collaborations with several companies over the past couple of years to develop and market its generic products in the U.S. and China. Along with its Chinese subsidiary, Suzhou, Amerigen has entered tie-ups with Forest Laboratories, Viwa Pharmaceuticals, UPM, and the Shanghai Fosun Omni Pharmaceutical company.