Following an inspection earlier this year at the contract manufacturer’s facility in Audubon, Pennsylvania, the US Food and Drug Administration (FDA) has concluded that the site is fully compliant with Good Manufacturing Practice (GMP).
The nod from the FDA ties in with the commencement of Almac’s first US client who has signed a contract with the CMO for an order of more than four million blisterpacks per year.
A spokeswoman from Almac told Outsourcing-Pharma that due to legal reasons the client could not be identified, though it is a US-based healthcare company who has already partnered Almac at its UK manufacturing operations in Craigavon, Northern Ireland.
She added that Almac were currently in early negotiations with a number of other US clients.
The facility is equipped with a variety of packaging and labeling equipment of both solid oral dose drug products and sterile biopharmaceutical presentations.
Almac initially invested $100m (€74m) in the facility, in order to take on the US market and have since invested a further $10m in capacity at the packaging site, adding technology which included a high-speed blister line, a bottling line, walleting presses and a vial ampoule labeling line.
US Director of Business Development at Almac, Jim McGibbon, said that: “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.”