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.