FDA approves new Definity manufacturing site

Diagnostic imaging agent developer Lantheus Medical Imaging has received approval from the U.S. Food and Drug Administration (FDA) for Jubilant HollisterStier to be a new manufacturing site for its Definity ultrasound contrast imaging agent.

Jubilant HollisterStier, a subsidiary of Jubilant Life Sciences, is an integrated pharmaceutical contrast manufacturer with locations in Salisbury, MD; Spokane, WA; Montreal; and Roorkee, India. It will become the lead supplier of Definity for Lantheus, the company said.

Definity is used in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border, Lantheus said. It is currently manufactured by Ben Venue Laboratories, which plans to exit the contract manufacturing services business.

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