BWXT Medical Submits Drug Master File for Actinium-225 API to U.S. Food and Drug Administration
BWXT Medical Ltd. has submitted a Drug Master File (DMF) to the U.S. Drug and Food Administration (FDA) for No Carrier Added (n.c.a.)
- BWXT Medical Ltd. has submitted a Drug Master File (DMF) to the U.S. Drug and Food Administration (FDA) for No Carrier Added (n.c.a.)
- One such technology is high-energy proton spallation of thorium targets that are produced and irradiated in collaboration with TRIUMF.
- Irradiation at high energy favors the production of Ra-225, which can be isolated and loaded onto a generator.
- Jonathan Cirtain, president and chief executive officer of BWXT Medical, stated, “Our submission of a Drug Master File to the FDA marks a significant milestone for our company.