The firm announced US FDA approval for its analytical lab at its Craigavon headquarters in Northern Ireland earlier today, explaining that the award followed a three-day inspection of the facility, including its mass spec units.
Almac told Outsourcing-pharma.com that: “The US FDA audited Almac on behalf of our client who was entering commercial phase with two different products, a respiratory inhaler and irritable bowel treatment.”
The contract services firm did not provide specific details of the two products in question, but did explain the wide range of services that are available to customers seeking to test drugs they plan to launch in the US.
“The analytical labs at Almac Sciences routinely test both API and drug products throughout all phases of a product lifecycle, from development through to commercial materials. As such, Almac Sciences is named on a number of customer product licences as an analytical contract laboratory.
“As well as standard physical and chemical testing, Almac Sciences has a number of specialist analytical laboratories such as mass spectroscopy, NMR and XRPD, all being carried out in compliance with GMP regulatory requirements.”
While supporting a specific US focused customer may have prompted Almac to open its lab to US FDA scrutiny, gaining approval will allow the Northern Ireland contract services firm to test products being developed by others seeking to access the US market.