The Maltese facilities of Spain's Medichem S.A. have been classified as acceptable by the US Food and Drug Administration (FDA) after the agency inspected them for the first time. A full FDA inspection was performed covering quality, facilities and equipment, production and laboratory control systems.

Medichem's Malta plant was engineered and built from scratch in 2004 / 2005 and started regular production in November 2005. It obtained both the GMP certification from the Maltese National Health Authority and the ISO 9001:2000 certification in February 2007.

Medichem has been selling in the US from its Spanish production site since 1986. Now exports to the US can also be made from the Maltese plant.

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