Feb. 3, 2014 09:00 UTC

NextPharma Completes Successful US FDA Inspection with No Observations

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.”

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Notes to Editors:

About NextPharma

NextPharma, headquartered in the UK and founded in 2000, is a world class outsourcing partner to the pharmaceutical and biotechnology industry. The company:

  • Offers a full range of services from early phase product development, through clinical trial packaging (Phases I through III), to high volume commercial manufacturing. The company is a world leader in modified release technologies and in specialist product manufacturing including hormones, penicillins, and cephalosporins, in addition to providing manufacturing and packaging services for conventional product forms. Additionally, NextPharma offers integrated logistics solutions tailored to meet the needs of the global pharmaceutical industry.
  • Operates globally with six product development centres, six manufacturing plants and six temperature controlled storage and distribution sites across Europe (production facilities in France and Germany), supplying customers in North America, Europe and the rest of the world.
  • Has 1,000 employees dedicated to serving over 150 customers worldwide. Its customer base includes many of the world’s leading pharmaceutical, specialty pharma and biotech companies.

Contacts

NextPharma Technologies Holding Limited (www.nextpharma.com)
Alan Dodsworth
Executive Vice President Corporate Development
Tel: +44 (0) 1483 479 120


Source: NextPharma