Almac Pharma Services Announces Successful FDA Inspection at Charnwood, UK Facilities

Almac Pharma Services, a member of the privately owned Almac Group providing innovative pharmaceutical development, manufacture and commercial services to global pharmaceutical and biotech organisations, is delighted to announce the successful completion of its first US Food and Drug Administration (FDA) inspection of its commercial manufacturing facility in Charnwood, England.

The pre-approval inspection which took place over the course of five days was in relation to a solid oral dose product which the site will manufacture for a global pharmaceutical company. On completion, the inspector concluded the facility, systems and practices comply with FDA requirements with no Form 483 observations or comments reported.

Since its acquisition in 2015, Almac Pharma Services’ facility, which is set within the Charnwood Campus in Loughborough, has experienced significant growth and now employs over 250 highly skilled and experienced individuals.  The site provides a wide range of oral dose development and manufacturing specialising in high potency and age-appropriate treatment options.

This successful FDA inspection marks a significant milestone as it represents the final Almac Pharma Services’ site to receive FDA approval. This achievement now complements the existing FDA-approved facilities at the company’s global headquarters in Craigavon, Northern Ireland, Dundalk, Ireland, and its US facility in Audubon, Pennsylvania. It also further reinforces the company’s commitment to upholding the highest standards of quality as it experiences significant growth across its product development, manufacture and commercialisation services to meet ongoing client needs.

Almac Pharma Services’ Vice President, Quality, Ian Markwell commented: “This milestone underscores our commitment to maintaining the highest quality standards and regulatory compliance enabling us to consistently deliver best-in-class services to our clients. With this achievement, we continue to strengthen our position as a trusted, reliable and stable partner as we work together to advance human health for the sake of patients in need.”