Guerbet USA, the U.S. affiliate of French contrast developer Guerbet, announced the opening of a manufacturing site that has been approved by the U.S. Food and Drug Administration (FDA) for its Lipiodol Ultra Fluid (ethiodized oil) contrast agent.
Guerbet's site for Lipiodol will package the contrast agent in new glass vials designed to reduce the risk of breakage and cracking commonly associated with glass ampoules.
The announcement coincides with the end of Lipiodol's temporary importation status. The first delivery of Lipiodol from the site is scheduled for the week of April 1, Guerbet said.
