The European Medicines Agency has signed off on WuXi PharmaTech's cGMP drug production and analytical testing facilities in Shanghai. The manufacturing plant produces solid oral dosage forms for use in clinical trials. The test facility is used for developing and validating methods of API and formulated drug analysis for potency, purity and solubility.
The facility approvals are another score for China's drug industry, and evidence that the government meant what it said about raising pharma industry quality to the standards observed in most developed countries.
It's at once a bootstrap tale and a comeback story. The People's Republic ranked third among the 20 countries filing patents for aseptic applications in 2008. Its 21 submissions towered over its 2003 accomplishment of just one.
Demand for Chinese APIs, however, dropped in 2009 following high-profile quality problems, as we've reported. But efforts to beef up quality controls, and the adoption of GMP methods, appear to be reversing the trend. Consultancy JZ Med expects 5 percent to 8 percent growth in 2010, with the rate accelerating through 2015.
- here's the WuXi announcement