US-based contract research, development and manufacturing organisation Frontage Laboratories has reinforced its already substantial presence in the Chinese market through a US$10 million partnership with Luohe Fanghui Pharmaceuticals, an emerging drug company based in Henan Province.
Fanghui is launching its globalisation strategy by tapping Frontage’s expertise in pharmaceutical research and development, manufacturing, registration and marketing. It chose Frontage as a partner “based on its success in helping many Chinese pharmaceutical companies develop products for international markets”, noted Fanghui chairman Xiyuan Zhao.
Frontage runs two Phase I clinical research units in China – in Zhengzhou, Henan Province and Changchun, Jilin Province respectively – in addition to its US Phase I facility in Hackensack, New Jersey. The company’s late-phase services are based both in Exton, US and Beijing, China, while it has bioanalytical and CMC (chemistry, manufacturing and controls) facilities in Shanghai and Beijing respectively.
Frontage’s first task under the agreement with Fanghui will be to serve as general strategic consultant for the construction of new facilities.
This will include equipment selection and process validation to support Fanghui’s product pipeline, co-ordination of third-party engineering and architectural contractors, and ensuring the facilities meet international regulatory standards.
In addition, Frontage will help Fanghui to establish a solid-dosage manufacturing platform for generic and new products in compliance with current Good Manufacturing Practices.
The partnership also includes setting up new quality systems that meet Chinese and international GXP (best practice) guidelines, filing generic and new drug applications simultaneously in the US and China, and helping Fanghui to conduct international market research aimed at identifying suitable products for its future pipeline.