Breaking News

Cook Pharmica Gains Commercial Manufacturing Approval

June 19, 2012

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

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.

Related Contract Manufacturing:

Related Packaging:

Related Compliance:

blog comments powered by Disqus
  • Staying Ahead in the Small Molecule Space

    Staying Ahead in the Small Molecule Space

    Dr. Matthew Moorcroft, VP Global Marketing, Cambrex||September 8, 2016
    Understand what is happening in the market and react accordingly

  • FDA & Drug Development

    FDA & Drug Development

    Rachelle Du2019Souza, Regulatory Heights Inc.||September 8, 2016
    You must perform the necessary due diligence to stay on top of regulatory developments

  • Patent Law  and Contract Manufacturing

    Patent Law and Contract Manufacturing

    Beverly W. Lubit, Member of the Firm, Chiesa Shahinian & Giantomasi||September 8, 2016
    Analyzing the impact of The Medicines Co. vs. Hospira Inc. decision