Almac Group Receives Product Approval from FDA, MHRA and Health Canada

Global contract development and manufacturing organization, Almac Group, announced that after successful pre-approval inspection (PAI) of its pharmaceutical services operations located in Audubon, Pennsylvania by the Food and Drug Administration (FDA) of the United States, the site has received product approval from the US FDA, the UK Medicines and Health Products Regulatory Agency (MHRA) and Health Canada.

The PAI, conducted by three FDA investigators last month, resulted in the approval of the three products 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 packaging (sachets), an innovative new process introduced at the Audubon plant. The three product portfolios were thoroughly examined for 11 days by the investigators without any results related to these products.

This is a significant milestone for the Almac Pharma Services Audubon site since its initial FDA approval in 2013 and demonstrates the company’s confidence in the continued growth of Almac Pharma Services as a global provider of solutions for the pharmaceutical and biotechnology industries.

Ian Markwell, vice president of quality at Almac Pharma Services, said, “It’s good to see that the FDA’s successful inspection earlier this year paves the way for Audubon’s site to be approved to supply products to other markets.

Almac Pharma Services’ Audubon site offers a range of solutions for blister packs, stickpacks and kits. The site’s capabilities include a semi-automated packaging system that offers a streamlined and efficient semi-automated process for packaging complex medical kit components. These bespoke technologies are available to meet the needs of the US market and provide global supply.