CRO Frontage and Fanghui Pharma launch collaboration
An emerging Chinese pharmaceutical company just launched a new globalization strategy by tapping the pharmaceutical R&D, manufacturing, registration and marketing expertise of global CRO Frontage Laboratories.
Luohe Fanghui Pharmaceuticals of Henan Province, China, signed a $10 million agreement with Frontage after seeking assistance in growth strategies from a variety of sources. “We selected Frontage based on its success in helping many Chinese pharmaceutical companies develop products for international markets,” said Fanghui Chairman Xiyuan Zhao.
“We are pleased to participate as a strategic resource in Fanghui’s enterprise globalization efforts,” said Song Li, founder and CEO of Frontage. “This agreement furthers our own plans to provide more infrastructure development, GMP and regulatory guidance, and facility construction consultation to Chinese pharmaceutical companies.”
Frontage will first serve as general strategic consultant for construction of new facilities. This includes equipment selection and process validation to support Fanghui’s product pipeline, coordination of third-party engineering and architectural contractors and ensuring the facilities meet international regulatory standards. Frontage also will help establish a solid dosage manufacturing platform for generic and new products compliant with current good manufacturing practices.
The agreement also guides the process of establishing new quality systems that meet Chinese and international GXP guidelines, and the filing of generic and new drug applications simultaneously in the U.S. and China. Finally, Frontage will help Fanghui conduct international market research to identify suitable and potentially profitable products for its pipeline.
Frontage Laboratories operates in the U.S. and China, running two phase I clinical units in China and one in Hackensack, N.J. It also operates a preclinical animal facility and bioanalytical and CMC facilities in Pennsylvania, and bioanalytical and CMC facilities in China.
Fanghui Pharmaceuticals was founded in 1969 in central China. Fanghui owns more than 100 products approved by the Chinese State Food and Drug Administration (SFDA).