Isis Pharmaceuticals, Inc. (ISIS) announced that it has successfully completed a pre-approval inspection of its manufacturing facility located in Carlsbad, California.
As part of the inspection, the European Medicines Agency (EMA) conducted an extensive review of Isis' manufacturing facility and processes and Isis' Good Manufacturing Practices (GMP) Quality systems to ensure product manufactured is of appropriate and reliable quality.
The EMA's approval of the Isis manufacturing facility allows Isis to supply Genzyme with Kynamro drug substance to support commercial launch in Europe.
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