Shine submits drug master file for Lu-177

Medical isotope firm Shine Technologies has submitted a drug master file with the U.S. Food and Drug Administration (FDA) for its non-carrier-added lutetium-177 (Lu-177) chloride radiopharmaceutical.

The submission provides confidential and detailed information about facilities, procedures, or articles used in the manufacturing, processing, and storing of drugs, according to the vendor. Shine noted that several companies have requested letters of authorization to access the drug master file in order to support clinical trials underway for cancer treatments.