Almac has cleared the FDA inspection and begun US commercial packaging operations in Audubon, Pennsylvania.
The FDA concluded that the site is compliant with good manufacturing practices, with no 483 issued. Almac quality vice president Ian Markwell 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.”
The packaging facility offers packaging solutions such as primary packaging of solid oral dosage forms, customized secondary labelling and packaging of sterile biopharmaceutical products for both established US products and niche/orphan drug launches.
Initially Almac will supply three commercial products to an undisclosed US-based diversified healthcare company.
Bulk tablet and capsule manufacturing will be carried out at Almac’s UK commercial facility while final bottle and blister packaging will be carried in Audubon.
Almac business development US director Jim McGibbon said, “We are now able to meet the growing market demand for quality led, flexible commercial packaging solutions in the US.”