Contract services provider in Northern Ireland, Almac, has announced the launch of its US commercial packaging operations in Audubon, Pennsylvania, following successful inspection of its facility by the Food and Drug Administration (FDA).
Post inspection, the regulatory body concluded that the site is fully compliant with good manufacturing practices, with no 483 issued.
The outcome of the company's inspection is expected to mark the establishment of its commercial packaging operations in the US with FDA approval for bottle, blister, wallet and vial labelling / packaging.
Almac business development US Director Jim McGibbon said the company will now be able to meet the growing market demand for led, flexible commercial packaging solutions in the country.
"Now having been successfully inspected by the FDA, we are ready to commence operations for our first client," McGibbon said.
Almac's new FDA approved, commercial packaging facility in Audubon, Pennsylvania offers flexible packaging solutions.
As part of its first contract with a US-based diversified healthcare company, Almac will supply three commercial products with bulk tablet and capsule manufacture taking place in its UK facility, and final bottle and blister packaging will take place in Audubon.
The solutions will range from primary packaging of solid oral dosage forms to customised secondary labelling and packaging of sterile biopharmaceutical products for US products as well as niche / orphan drug launches.
The company, which has its US operations in Pennsylvania, North Carolina and California, provides services to pharmaceutical and biotech sectors.
Image: Almac's US commercial packaging facility in Audubon, Pennsylvania offers flexible packaging solutions. Credit: Almac.