Dragon produces EPO through its wholly-owned subsidiary, Nanjing Huaxin Biopharmaceutical Co. Ltd, which is located in Nanjing, China. This 90,000 ft2, fully-integrated manufacturing facility incorporates cell culture, purification, formulation, vialing, packaging, water treatment, quality assurance and quality control capabilities.
Our production facility was certified in 2000 as being in conformance with Chinese Good Manufacturing Practices (GMP), in accordance with World Health Association (WHO) standards. This internationally accepted validation of Dragon’s production facilities and processes has been key to our ability to expand EPO registrations and sales beyond China and into international markets.
To leverage the cost advantages of our high-yield cell line, we have integrated state-of-the-art bioreactor fermentation technology into our Nanjing facility and are continuously working to maximize the efficiencies of our down-stream production processes.
Our current manufacturing facility has a potential annual production capacity of 15 to 20 million doses of EPO, a capacity which we believe positions Dragon to be one of the leading global producers of EPO. In preparation for our entry into the European Union EPO market, we are now in the process of planning for the acquisition of construction of an additional, FDA-certified manufacturing facility.