Almac Pharma Services Audubon site receives first product approval by MHRA and Health Canada
November 15, 2022
Global contract development and manufacturing organization, Almac Group, has announced that after the successful pre-approval inspection (PAI) of its Pharma Services’ operations located in Audubon, Pennsylvania by the US Food and Drug Administration (FDA), the site has received product approval from the US FDA, UK Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada.
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: “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.
About Almac Pharma Services
Tailormade pharmaceutical development and commercial solutions
With over 50 years’ experience, Almac Pharma Services is a world leading outsourcing partner to the global pharmaceutical and biotechnology industry.
With facilities located in Europe and the US, we provide tailored, quality-led and timely solutions from early and late phase pharmaceutical development, commercial drug product manufacture, product launch, commercial packaging through to global storage & distribution.
About Almac Group
A unique culture delivering exceptional solutions
The Almac Group is an established contract development and manufacturing organization providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.
Its innovative services range from R&D, biomarker discovery development and commercialization, API manufacture, analytical services, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organization which has grown organically over the past five decades now employing over 6,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.