[February 03, 2014] |
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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."
Frank 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."
-Ends-
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:
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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.
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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.
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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.
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