Full Text:
Implementing and maintaining GMP can amount to a significant percentage of a company's operating costs, European API producers say, and many do so because they supply the U.S. market, where adherence to GMP is mandatory. But in selling to Europe, other suppliers have kept their costs down by not following such standards. This situation has changed with a European Union directive now being implemented by the member countries: As of Oct. 30, 2005, all APIs going into drugs sold in Europe must be from GMP-compliant sources.
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