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Cook Pharmica Gains Commercial Manufacturing Approval

FDA inspection covers new filling line lyophilization capabilities, and quality systems

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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 biopharmaceu...

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