Almac launches US commercial packaging operations

Published: 6-Feb-2013

Successful FDA inspection and new client partnership get 2013 off to a busy start


Almac has undergone the successful inspection of its new US Commercial Packaging operations located in Audubon, PA by the Food and Drug Administration (FDA). The inspection took place on the 9–10 January 2013, from which the regulatory body concluded that the Pennsylvania site is fully compliant with Good Manufacturing Practices, with no 483 issued.

‘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,’ said Ian Markwell, Vice President of Quality.

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 4 million 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 customised secondary labelling and packaging of sterile biopharmaceutical products for both established US products and niche/orphan drug launches alike.

You may also like