North China Pharmaceutical announced on Sep 15, 2011 that its gene recombinant human albumin had obtained Drug Manufacturing Certificate from Hebei Food and Drug Administration, symbolizing the acquired ability in the industrialization of recombinant human albumin. Currently, the products can be launched in the market once the company finishes the clinical trials as well as receives Production Approval.
As the most consumed blood product in China, there is a large shortage in human albumin supply. In recent year, the proportion of imported human albumin increases gradually, reaching 48.4% (by lot release volume) in 2010. Being the substitute of human albumin without restriction from blood source, recombinant human albumin is no doubt another effective way to ease the intense supply in China.
Its first-phase recombinant human albumin project of 150,000 tons has now been in the commissioning stage, is expected to put into operation this year.
Ratio of Domestic and Imported Human Albumin in China, 2007-2010 (by Lot Release Volume)
Source: NICPBP; ResearchInChina