Cook Pharmica has received approval from the FDA for the manufacture of commercial product. The approval follows an inspection by the FDA’s Center for Biologics Evaluation and Research covering the company’s new filling line, lyophilization capabilities, and quality systems.
“This FDA decision marks a very important milestone for our company,” said Tedd Green, president of Cook Pharmica. “This first commercial manufacturing approval opens Cook Pharmica’s doors to access the vibrant biopharmaceutical industry as it generates breakthroughs for patients in the U.S. and worldwide.”
The company’s parenteral manufacturing business unit contains both vial and prefilled syringe manufacturing lines under barrier isolation, as well as secondary packaging to ready products for distribution. The company is capable of filling 15 million vials and 70 million prefilled syringes annually.