BLOOMINGTON, Ind. – In a decision that paves the way for greater pharmaceutical industry use of the company’s contract manufacturing services, Cook Pharmica LLC has received its first approval from the U.S. Food and Drug Administration (FDA) to manufacture commercial product. The product approval for commercial manufacturing came from the FDA’s Center for Biologics Evaluation and Research following a rigorous pre-approval inspection of Cook Pharmica in February. The inspection covered the company’s new vial filling line, lyophilization capabilities and facility-wide 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 the vibrant biopharmaceutical industry as it generates breakthroughs for patients in the United States and worldwide.”
Company executives noted that the FDA’s approval of its vial filling line and lyophilization (freeze-drying) capabilities has already generated widespread industry interest in its full manufacturing and packaging capabilities, with inquiries coming from many leading biopharmaceutical companies. The rigorous preapproval inspection is a prerequisite for commercial manufacturing of clients’ drug product.
“This approval demonstrates Cook Pharmica’s ability and commitment to manufacture high- quality drug products within the FDA’s stringent regulatory standards and practices. Everyone at Cook Pharmica is very pleased to have the opportunity and responsibility to ensure that we deliver a dependable commercial drug-product supply for our clients and ultimately to patients,” Green said.
The parenteral manufacturing business unit of Cook Pharmica contains both vial and prefilled syringe manufacturing lines under barrier isolation, as well as secondary packaging to prepare products for distribution. Capable of filling 15 million vials and 70 million prefilled syringes annually, Cook Pharmica’s assets are available to fill the shortage of domestic drug product manufacturing in the United States and support federal efforts to eliminate dangerous drug shortages domestically. Based on other client projects at Cook Pharmica, the company expects to receive similar approvals to manufacture drug products for overseas markets as well.
About Cook Pharmica LLC
Cook Pharmica is an integrated contract development and manufacturing organization that provides the pharmaceutical and biopharmaceutical industries with drug substance manufacturing from mammalian cell culture; analytical and formulation development; parenteral manufacturing in vials and prefilled syringes; lyophilization; and secondary packaging. Operating with more than 400 employees in a 900,000-square-foot, $200 million facility in Bloomington, Ind., Cook Pharmica’s mission is to consolidate and simplify clients’ contract manufacturing into one source at one location. Founded in 2004, Cook Pharmica, the biopharmaceutical manufacturing division of Cook Medical, is a privately held, wholly owned subsidiary of parent company Cook Group. For more information, visit www.cookpharmica.com. Follow Cook Medical on Twitter @cookmedicalpr.