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Almac Completes FDA Inspection at Charnwood, UK Facilities

Pre-approval inspection was related to a solid oral dose product which the site will manufacture for a global pharmaceutical company.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Almac Pharma Services has successfully completed its first U.S. FDA inspection of its commercial manufacturing facility in Charnwood, England.

The pre-approval inspection was related 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.

Almac Pharma Services’ facility, which is set within the Charnwood Campus in Loughborough, provides a wide range of oral dose development and manufacturing specializing 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, complementing existing FDA-approved facilities in Craigavon, Northern Ireland, Dundalk, Ireland, and its U.S. facility in Audubon, PA.

Almac Pharma Services’ Vice President, Quality, Ian Markwell said, “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.”

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