Frontage and Fanghui Pharma Launch $10M Collaboration
Strategic agreement to guide R&D, manufacturing, registration, and marketing
An emerging Chinese pharmaceutical company just launched a new globalization strategy by tapping the pharmaceutical research and development, manufacturing, registration and marketing expertise of Frontage Laboratories, Inc., a global contract research organization.
Luohe Fanghui Pharmaceuticals Co., Ltd. of Henan Province, China, signed the $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.”
Under the new agreement, 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 will also help establish a solid dosage manufacturing platform for generic and new products that is 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 US and China. Finally, Frontage will help Fanghui to conduct international market research to identify suitable and potentially profitable products for its future pipeline.
Frontage Laboratories, Inc. is a global contract research, development and manufacturing organization, offering a full range of pharmaceutical R&D services. Frontage operates in the US and China, using one seamless GXP platform. Frontage runs three Phase 1 Clinical units, a 72-bed Phase 1 Unit in Hackensack, NJ, a 120-bed Phase 1 Unit in Zhengzhou, Henan Province China, and a-80 bed Phase 1 Unit in Changchun, Jiling Province China. Frontage has an AALAC certified preclinical animal facility in Pennsylvania, where it also maintains bioanalytical and CMC facilities. In Shanghai and Beijing, China, the company also operates bioanalytical and CMC facilities. As a rapidly expanding CRO with ten years of success providing high-quality GXP services, Frontage has established an international standard in pharmaceutical product research, development, quality and management systems.
Fanghui Pharmaceuticals, Co., Ltd. was founded in 1969 and is located in the City of Luohe, Henan Province, in central China. Fanghui obtained its GMP certification after major improvements were made in 2003. Now Fanghui owns more than 100 products that have been approved by Chinese State Food and Drug Administration (SFDA). Based on current production trends, Fanghui set globalization as its future development strategy to manufacture drugs for Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA) to supply North American and European markets with products having appropriate regulatory certification. Fanghui has set a goal to develop an advanced organization that will conduct new facility construction, quality system, regulatory certification, pharmaceutical research, manufacturing, and international marketing over the next 5-7 years.