From Reuters:
Apotex Inc faces a ban on products entering the United States after the U.S. Food and Drug Administration warned the Canadian drugmaker about a number of manufacturing breaches at a Toronto factory, according to an industry analyst.
The action, which affects new product, follows a June 25 warning letter and a late 2008 inspection of the Etobicoke facility, which cited a number of deviations from U.S. manufacturing codes.
Neither the privately held generic drugmaker, which is a significant supplier to the U.S. market, nor the FDA immediately responded to requests for comment. ...more
Tuesday, September 08, 2009
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