LONDON--(BUSINESS WIRE)-- NextPharma is pleased to announce that the US Food and Drug Administration (FDA) has completed a successful inspection of NextPharma’s centre of excellence for hormonal drug development and manufacturing in Waltrop, Germany. The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practice (GMP), and no Form 483 observations were issued. The US FDA authorities inspected the facility from 20th to 24th January, 2014 having originally inspected and approved the site in 2008.
Andrew Kelley, Chief Operating Officer, commented, “This latest successful FDA inspection is an extremely satisfying result for our dedicated NextPharma Waltrop team and for our customers. It supports our track record of outstanding regulatory compliance as we continue to commit resources to maintain the highest quality standards.”
Franck Latrille, Chief Executive Officer, added, “Our FDA readiness programme is of strategic importance across all of NextPharma’s development and manufacturing locations. This latest positive endorsement by the FDA supports our vision of partnering customers on a global basis and we are planning for FDA inspections to follow at our Göttingen (Germany) and Bielefeld (Germany) facilities during 2014.”
Notes to Editors:
NextPharma, headquartered in the UK and founded in 2000, is a world class outsourcing partner to the pharmaceutical and biotechnology industry. The company:
NextPharma Technologies Holding Limited (www.nextpharma.com)
Executive Vice President Corporate Development
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