China Isotope & Radiation (HKG:1763) said its subsidiary Chengdu Gaotong Isotope has successfully completed the U.S. Food and Drug Administration filing process for its lutetium-177, or Lu-177, active pharmaceutical ingredient DMF, according to a Tuesday Hong Kong bourse filing.
The company said the filing clearance will streamline the drug registration process for downstream manufacturers by eliminating the need to submit supporting documentation for the API separately, potentially reducing review time and application costs.