Bavarian Nordic A/S’ Kvistgård Facility Approved by Authorities
Bavarian Nordic A/S announced today that its production facility in Kvistgård has been granted Manufacturing Authorisation according to the Medicines Act by the Danish Medicines Agency (Lægemiddelstyrelsen). In continuation of previous authorisations, the authorisation enables Bavarian Nordic to manufacture, analyze and release sterile vaccines for use in humans on the Kvistgård production facility in accordance with full EU cGMP requirements.
The authorisation applies to manufacturing, analysis and release of vaccines for use in clinical trials and emergency situations. Thus it covers Bavarian Nordic’s need for manufacturing of smallpox vaccine for the RFP-III order and other markets for emergency use of smallpox vaccines.
Bavarian Nordic can now begin its commercial manufacturing of vaccines.
Peter Wulff, President and CEO of Bavarian Nordic commented, “The authorisation of our Kvistgård facility is an important milestone for Bavarian Nordic in our efforts to initiate large-scale commercial production of smallpox vaccines.”
