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Vetter’s Newest Facility Successfully Completes FDA Inspection



  Vetter’s Newest Facility Successfully Completes FDA Inspection

Center for visual inspection and logistics sets high safety and control
standards

Business Wire

RAVENSBURG, Germany -- March 28, 2013

Vetter, a leading contract development and manufacturing organization (CDMO),
announced today that its new center for visual inspection and logistics passed
its first GMP inspection by the U.S. Food and Drug Administration (FDA). The
inspection was conducted March 11 through 14 to ensure the facility is in
compliance with good manufacturing practices. The facility was already granted
manufacturing approval and cGMP certification for Europa from the RP
Tuebingen, Germany in 2012.

The 18,000-square-meter facility, known as Ravensburg Vetter West (RVW), began
operations in April 2012. The site provides high-bay warehousing for cold
storage and room-temperature products, as well as visual inspection. Featuring
state-of-the-art technology, which helps adapted to the needs of the separate
supply and manufacturing processes, RVW also harnesses extensive use of
renewable energy sources, including photovoltaic and geothermal.

“We’re pleased with the outcome of Ravensburg Vetter West’s first FDA GMP
inspection,” said managing director Thomas Otto. “We at Vetter work diligently
to meet regulatory requirements. Maintaining high quality standards is a job
we take seriously to be a reliable and efficient partner for our customers.”

About Vetter:

Vetter is a leading contract development and manufacturing organization (CDMO)
that specializes in the aseptic filling of syringes, cartridges and vials. The
company has extensive experience with biologics and other complex compounds,
including monoclonal antibodies, peptides, interferons and vaccines. Its
clientele includes the world’s top 10 pharma/biotech firms and emerging
companies alike. A full-service provider, Vetter supports products throughout
their lifecycles, from preclinical development through global market supply.
Through its U.S. and European facilities, Vetter Development Service provides
state-of-the-art support for early-stage products, with seamless transfer at
Phase III to Vetter Commercial Manufacturing for large-scale production. The
company is the originator of dual-chamber technology, which enables easier,
safer lyophilized-drug administration; and is a leader in the use of RABS
technology in cleanrooms, which mitigates risk of product contamination during
the manufacturing process. Vetter has won numerous awards for innovation and
quality, including top prize at the 2012 European Outsourcing Awards for its
new high-speed filling line. Headquartered in Ravensburg, Germany, the company
employs approximately 3,000 staff across Europe and the United States. For
more information about Vetter, visit www.vetter-pharma.com

Contact:

Vetter Pharma International GmbH
Oskar Gold
Phone: +49 (0)751-3700-3023
Fax: +49 (0)751-3700-7707
E-mail: PRnews@vetter-pharma.com
www.vetter-pharma.com
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