The inspection took place on the 9th and 10th January 2013 from which the regulatory body concluded that the Pennsylvania based site is fully compliant with Good Manufacturing Practices, with no 483 issued.
Commenting on the inspection, Ian Markwell, Vice President of Quality, said: “We are very pleased with the outcome of our inspection, as it marks the establishment of our US commercial packaging operations with FDA approval for bottle, blister, wallet and vial labeling/packaging.”
Jim McGibbon, US Director of Business Development explained “We are now able to meet the growing market demand for quality led, flexible commercial packaging solutions in the US. Now having been successfully inspected by the FDA, we are ready to commence operations for our first client.”
Almac’s first US commercial packaging client, a US-based diversified healthcare company, is an existing long term client partner of its UK operations for both formulation development and contract commercial manufacture services. Initially Almac will supply three commercial products with bulk tablet and capsule manufacture taking place in Almac’s EMA and FDA approved commercial facility in the UK, with final bottle and blister packaging taking place in Audubon.
“This is a significant first contract for the Audubon facility filling in excess of 4M finished packs per annum, so it’s proving a busy start to the year!” added McGibbon.
Almac’s new FDA approved, US commercial packaging facility in Audubon, PA, offers flexible packaging solutions from primary packaging of solid oral dosage forms to customized secondary labelling and packaging of sterile biopharmaceutical products for both established US products and niche/orphan drug launches alike.