Breaking News

Almac Audubon Facility Passes FDA Inspection

February 6, 2013

U.S. commercial packaging operations underway

Almac’s new commercial packaging operations in Audubon, PA have successfully passed an FDA inspection. The FDA concluded that the site is GMP-compliant with no 483 issued. Ian Markwell, Almac’s vice president of Quality, said, “We are very pleased with the outcome of our inspection, as it marks the establishment of our U.S. commercial packaging operations with FDA approval for bottle, blister, wallet and vial labeling/packaging.”
Jim McGibbon, U.S. director of business development for Almac, added, “We are now able to meet the growing market demand for quality led, flexible commercial packaging solutions in the U.S. Now having been successfully inspected by the FDA, we are ready to commence operations for our first client.”
For its first U.S. commercial packaging client, Almac will supply three commercial products, with bulk tablet and capsule manufacture taking place at its commercial facility in the UK, with final bottle and blister packaging taking place in Audubon.
The Audubon facility offers packaging solutions from primary packaging of solid oral dosage forms to customized secondary labelling and packaging of sterile biopharmaceutical products for both established U.S. products and niche/orphan drug launches.

Related Contract Manufacturing:

Related Packaging:

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