CDMO Almac Group’s Audubon, Pennsylvania site has received product approval from the US FDA, UK Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada.
This comes after the successful pre-approval inspection (PAI) of the company’s pharma services’ operations.
The PAI, conducted by three FDA Investigators last month, resulted in the approval of all three products that were covered by the inspection. The scope of the inspection included both the blistering of a multi-product blister pack as well as two products using stickpack (sachets) packaging which is an innovative new process introduced to the Audubon facility.
All three product portfolios were extensively reviewed for 11 days by the investigators with no findings related to these products.
This is a significant milestone for Almac Pharma Services’ Audubon site since its initial FDA site approval in 2013 and is testimony to the company’s confidence that Almac Pharma Services will continue to grow as the global solution provider to the pharmaceutical and biotech industries.
Ian Markwell, VP of Quality at Almac Pharma Services, said: “It is good to see that the successful FDA inspection earlier this year is paving the way for the approval of the Audubon site to supply products for other markets.”
Almac Pharma Services’ Audubon site provides a range of solutions for blister packs, stickpacks, and kitting. Site capabilities include a semi-automated packaging system which offers a streamlined and efficient semi-automated process for the packaging of complex medical kit components. These bespoke technologies are available to meet the needs in the U.S. market and provide worldwide supply.
