DRAXIS Manufacturing Facilities Pass FDA Inspection
DRAXIS Health has received notification from the US Food and Drug Administration that the company's manufacturing operations in Montreal continue to maintain their classification as acceptable facilities.
The successful inspection was conducted primarily with regard to two additional products manufactured on behalf of clients in the DRAXIS Pharma sterile lyophilization (freeze-drying) production facility.
There were no Form 483 Inspectional Observations issued during the FDA evaluation of DRAXIS systems. The FDA inspections also involved evaluations in DRAXIS Health's radiopharmaceutical business unit, DRAXIMAGE. The inspections form part of each client's FDA regulatory application to authorize DRAXIS to manufacture products for distribution in the United States.
"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. We are focused on maintaining and exceeding good manufacturing practices to further improve our record of regulatory excellence as we increase our offering of value-added lyophilized and sterile production services to the pharmaceutical and biotechnology communities."
DRAXIS Pharma expanded lyophilization capacity in its Montreal facility in late 2005 with the addition of a second, in-line integrated lyophilization unit. Today, the company has a total of 374 square feet (35 square metres) of lyophilization shelf space capacity. Additional sterile product manufacturing capabilities allow the company to produce injectable liquids in vials and ampoules as well as sterile ophthalmic products, creams and ointments. Current clients include major international pharmaceutical companies, mid-sized and emerging pharmaceutical customers and innovative biotechnology firms.