Guerbet receives regulatory boost for Dotarem

By AuntMinnieEurope.com staff writers

April 22, 2020 -- Contrast developer Guerbet has received approval from the U.S. Food and Drug Administration (FDA) to manufacture its Dotarem MRI contrast agent in the U.S.

Until the approval, Dotarem was manufactured exclusively outside the U.S. Now, Guerbet will manufacture the agent at a facility in Raleigh, NC.

The plant will produce Dotarem for U.S.-based customers, according to the company's goal of supplying its U.S. customers with products made in the U.S. Guerbet's line of contrast power injectors and urology systems are made and/or assembled in Cincinnati, OH.


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