|[February 06, 2013]
Almac Launches US Commercial Packaging Operations with Successful FDA Inspection and New Client Partnership
CRAIGAVON, Northern Ireland --(Business Wire)--
today announces 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 9th and
10th January 2013 from which the regulatory body concluded
that the Pennsylvania based site is fully compliant with Good
Manufacturing Practices, with no 483 issued.
Commenting on the inspection, Ian Markwell, Vice President of Quality,
said: "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."
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
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 (News - Alert) 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 4M 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 customized secondary
labelling and packaging of sterile
biopharmaceutical products for both established US products and
niche/orphan drug launches alike.
Notes to Editors
Group provides a broad range of services from R&D,
discovery and development, API
trial supply and IXRS®
technology (IVRS/IWRS), to commercial-scale
manufacture. Almac provides services to more than 600 companies,
including all the world leaders in the pharmaceutical and biotech
sectors. The company
employs over 3,300 individuals and is headquartered in Craigavon,
Northern Ireland. US operations are based in Pennsylvania, North
Carolina and California.
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