ISOTOPIA MOLECULAR IMAGING LTD
Overview
ISOTOPIA MOLECULAR IMAGING LTD is an active pharmaceutical ingredient (API) supplier with 2 active FDA Type II Drug Master Files, covering LUTETIUM CHLORIDE CARRIER ADDED (LU 177 C.A.) SOLUTION; LUTETIUM CHLORIDE NON CARRIER ADDED (LU 177 N.C.A.) SOLUTION.
API / Drug Master Files
ISOTOPIA MOLECULAR IMAGING LTD holds 2 active (2 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.
- LUTETIUM CHLORIDE CARRIER ADDED (LU 177 C.A.) SOLUTIONActive2023-07-24
- LUTETIUM CHLORIDE NON CARRIER ADDED (LU 177 N.C.A.) SOLUTIONActive2020-08-14
FDA compliance signals
No FDA recalls, Warning Letters, or Form 483 observations are linked to ISOTOPIA MOLECULAR IMAGING LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.
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