Our K-DMF for Gadobutrol has already been through a formulation-linked technical review with Korea's MFDS

A quiet milestone, but a useful one for anyone registering an MRI contrast agent in Korea. First filed in March 2025, last updated October 2026, current status 정상 (valid).

Gadobutrol sits alongside Gadoterate Meglumine and Calcobutrol in our contrast media API range. For teams building or transferring an MRI contrast product for the Korean market, our regulatory team can walk you through the documentation package.

If Korea is on your registration roadmap for 2027, message us and we'll start with the paperwork.