Vetter, a global 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. Prior to commissioning the site, the authority had carried out an initial inspection at the end of 2021, which resulted in a temporary Manufacturer’s Authorization for the customary two years.
 
The AGES inspectors focused on the verification of the processes and the documentation in the production and quality control as well as on the systems for quality assurance. 
 
“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,” said 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 is 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,” said 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.”