SHINE Files Drug Master File With FDA

by Taylor Kennedy

SHINE Medical Technologies logo

SHINE Technologies has submitted a Drug Master File (DMF) with the U.S. Food and Drug Administration for non-carrier-added lutetium-177 (Lu-177) chloride, the company announced recently.

According to a release, the DMF submission provides confidential detailed information about facilities, procedures or articles used in the manufacturing, processing and storing of drugs.

“We’ve been producing lutetium-177 that meets or exceeds customer specifications for some time now, and the DMF submittal represents the next step in getting our product into regular commercial use,” SHINE Technologies CEO Greg Piefer said in a statement.

Lu-177 is a cancer-killing radioisotope that is paired with a cancer-seeking molecule to form a compound that targets and attacks cancer cells.