Draxis Health reports that it received notification from FDA that its manufacturing operations in Montreal continue to maintain their classification as acceptable facilities following an inspection by the agency in January of all six production and quality systems at Draxis Pharma, the firm’s contract manufacturing division.
The inspection was conducted primarily with regard to two additional products manufactured on behalf of clients in the sterile lyophilization production facility.
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 sq. ft. of lyophilization shelf space capacity. Additional sterile product manufacturing capabilities allow the company to produce injectable liquids in vials and ampules as well as sterile ophthalmic products, creams, and ointments.