Global service provider Almac has passed FDA inspection of its new U.S. commercial packaging operations located in Audubon, Penn. The inspection took place on Jan. 9 and 10, 2013, from which the regulatory body concluded that the 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 U.S. commercial packaging operations with FDA approval for bottle, blister, wallet and vial labeling/packaging,” said Ian Markwell, vice president of quality, Almac.
Jim McGibbon, U.S. director of business development, Almac, said, “We are now able to meet the growing market demand for quality led, flexible commercial packaging solutions in the U.S. Now having been successfully inspected by the FDA, we are ready to commence operations for our first client.”
Almac’s first U.S. commercial packaging client, a U.S.-based diversified healthcare company, is an existing long term client partner of its U.K. 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 U.K., with final bottle and blister packaging taking place in Audubon.
“This is a significant first contract for the Audubon facility filling in excess of 4M finished packs per annum, so it’s proving a busy start to the year!” added McGibbon.
Almac’s new facility, offers flexible packaging solutions from primary packaging of solid oral dosage forms to customized secondary labelling and packaging of sterile biopharmaceutical products for both established US products and niche/orphan drug launches alike.