PRESS RELEASE: Minerva Imaging receives GMP certification from Danish Medicines Agency
Minerva received GMP certification from Danish Medicines Agency for manufacture of radiopharmaceutical drugs and tracers at the new site
Ølstykke, Denmark – September 1st 2023
18 months after first ground was broken, Minerva today obtained approval from the Danish Medicines Agency for the manufacture of radiopharmaceutical drugs for clinical use in the highly specialized radiopharmaceutical manufacturing facilities.
Carsten H. Nielsen, CEO and co-founder:
“We are extremely grateful for all the hard work and dedication from employees, contractors, partners and authorities, who have made this extraordinary achievement possible. With the GMP certification, we have taken a big step forward with our vision of offering best–in–industry fully integrated radiopharmaceutical research, drug development and manufacturing services– all under one roof.”
Process validations and other preparations for manufacturing are starting immediately for partner projects, who are signed up for clinical manufacturing activities.
Click here to have more insight into radioisotopes handled / manufactured on site, contract development, manufacturing activities and other contract services provided by Minerva Imaging.
Manufacturing and development activities for 2024, 2025 and 2026 are currently being booked and we encourage partners to engage early in clinical manufacturing planning, due to general capacity constraints in the industry.