Draxis Passes FDA Inspection

Draxis Pharma, the CMO division of Draxis Health Inc., recently received word from the FDA that its Montreal facilities passed inspection. FDA conducted inspections of all six production and quality systems at Draxis Pharma in January 2007. The inspection was conducted primarily with regard to two products manufactured on behalf of clients in the Draxis Pharma sterile lyophilization  production site.

According to Draxis, there were no Form 483 Inspectional Observations issued during the evaluation. The FDA inspections also involved evaluations in Draxis’ radiopharmaceutical business unit, DRAXIMAGE. The inspections were part its clients’ FDA regulatory applications to authorize Draxis to manufacture products for distribution in the U.S.

“The achievement of this positive inspection of our facilities and systems is a tangible result of our strong commitment to providing the highest level of quality and regulatory compliance for our clients and their products,” said Dr. Martin Barkin, president and chief executive officer of Draxis Health, Inc. “By continually meeting the increasingly stringent standards established by the FDA and other international regulators, we have been able to grow our contract manufacturing business by more than 300% over the past five years.”

Draxis Pharma expanded the lyo capacity in its Montreal facility in late 2005 with the addition of a second, in-line integrated lyo unit. Today, the company has a total of 374 square feet of lyo shelf space capacity.