ITM MEDICAL ISOTOPES GMBH

Overview

ITM MEDICAL ISOTOPES GMBH is an active pharmaceutical ingredient (API) supplier with 2 active FDA Type II Drug Master Files, covering LU-177 N.C.A. PRECURSOR RADIOPHARMACEUTICAL PRECURSOR SOLUTION; LUTETIUM (177LU) SOLUTION FOR RADIOLABELING.

API / Drug Master Files

ITM MEDICAL ISOTOPES GMBH holds 2 active (3 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• LU-177 N.C.A. PRECURSOR RADIOPHARMACEUTICAL PRECURSOR SOLUTIONActive2020-09-21
• LUTETIUM (177LU) SOLUTION FOR RADIOLABELINGActive2017-11-01
• 68GE/68GA GENERATORInactive2020-07-10

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to ITM MEDICAL ISOTOPES GMBH in our records. PharmaTek screens the full directory against live FDA enforcement data.