The FDA’s Center for Biologics Evaluation and Research conducted a pre-approval inspection of Cook Pharmica in February 2012, which covered the company’s new vial filling line, lyophilization capabilities and facility-wide quality systems.
Cook Pharmica president Tedd Green said, "This first commercial manufacturing approval opens Cook Pharmica’s doors to the vibrant biopharmaceutical industry as it generates breakthroughs for patients in the United States and worldwide."
"This approval demonstrates Cook Pharmica’s ability and commitment to manufacture high- quality drug products within the FDA’s stringent regulatory standards and practices," Green said.
The parenteral manufacturing business unit of Cook Pharmica contains both vial and prefilled syringe manufacturing lines under barrier isolation, in addition to secondary packaging to prepare products for distribution.
Cook Pharmica’s manufacturing business unit is available to fill the shortage of domestic drug product manufacturing in the US and support federal efforts to eliminate drug shortages.