Nuvisan awarded GMP certificate

Nuvisan received the GMP certification for the manufacturing of radiolabeled APIs

To support the development program of our partners, Nuvisan has been consistently expanding its 50-year experience in isotope chemistry. Over time, we developed a strong expertise and state-of-the-art platform dedicated to the synthesis of isotope labeled APIs including radioactive (14C, 3H) and stable isotopes (D, 13C, 15N).

Mostly used for drug metabolism and pharmacokinetics (DMPK) studies, we are now also able to offer 14C-API manufacturing and quality control in compliance with EU GMP Part-II guidelines. Our solutions include, but are not limited to, chemical synthesis, purification, testing, release, and storage (-80 °C – room temperature) of 14C-APIs for clinical studies in dedicated GMP premises using a fit-for-purpose quality management system.

We would like to pay a tribute to the ongoing efforts of our team members who are consistently working toward expanding our portfolio of solutions.