Vetter’s European Clinical Site Receives Permanent Manufacturer’s Authorization

Vetter Development Service Rankweil successfully completes re-inspection

• Successful inspection completed at clinical site
• Inspectors were impressed with systems and processes
• Austrian site supports manufacturing and quality control of Human Investigational Medicinal Products

Vetter, a leading global Contract Development and Manufacturing Organization (CDMO), has received the permanent Manufacturer’s Authorization for its clinical development site in Rankweil, Austria. Operational for nearly two years, the responsible national regulatory authority, the Austrian Agency for Health and Food Safety (AGES) again inspected the site for issuance of a permanent Manufacturer’s Authorization. Before commissioning the site, the authority had already carried out an initial inspection at the end of 2021, which resulted in a temporary Manufacturer’s Authorization for two years, as is customary in Austria.

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High quality standards in aseptic production at Vetter’s clinical site in Vorarlberg, Austria. (Photo: Business Wire)

The AGES inspectors gained deep insights into Vetter’s methods of work at the site during the three-day inspection. The focus was on the verification of the processes and the documentation in the production and quality control as well as on the systems for quality assurance. The inspectors were impressed with the premises, systems and processes on site.

"We are very happy and proud of the result of this comprehensive inspection conducted by the AGES. Our state-of-the-art facility in Austria features structured and modern systems and processes and our staff members bring high expertise,” says Wolfgang Weikmann, Vetter’s Senior Vice President Quality. “This allows us to provide clinical trial materials of consistently high quality to our customers worldwide, helping to develop life-enhancing medication for patients in need.”

Vetter Development Service Rankweil represents the company’s European counterpart to its clinical manufacturing site near Chicago. “Our Austrian site allows us to further expand our capacity and service offering to our customer base in the crucial field of process development and clinical manufacturing of Phase I and II injectables,” says Dr. Claus Feussner, Vetter’s Senior Vice President of Development Service. “The site's successful re-inspection and the receipt of the permanent Manufacturer's Authorization is yet another important milestone in our strategic company development."

© Vetter Pharma International GmbH: High quality standards in aseptic production at Vetter’s clinical site in Vorarlberg, Austria.

Find the Vetter press kit and more background information here.

About Vetter

Vetter is a leading Contract Development and Manufacturing Organization (CDMO) with headquarters in Ravensburg, Germany, and production facilities in Germany, Austria, and the U.S. As a global player, the pharmaceutical service provider is also present with its own sales locations in the Asia-Pacific markets of Japan, China, South Korea and Singapore. Around the world, small and large renowned pharma and biotech companies rely on the decades of experience, high quality, modern technologies, reliability, and commitment of more than 6,000 employees. In close partnership with its customers, the Vetter team supplies patients all over the world with medicines, many of which are vital. The CDMO provides support from drug product development through clinical and commercial filling to a wide range of assembly and packaging services for vials, syringes, and cartridges. With innovative solutions, Vetter develops prefilled drug-delivery systems together with its customers to continuously improve patient safety, comfort, and compliance. The company is a pioneer in the industry when it comes to sustainability, and acts as a socially and ethically responsible corporate citizen. The CDMO is a member of the UN Global Compact, has received multiple CDMO Leadership Awards and was awarded several times as Best Managed Company. Founded in Ravensburg in 1950, the company remains family-owned to this day. Learn more at www.vetter-pharma.com.

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