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Granules India receives US FDA approval for Trazodone Hydrochloride Tablets and plans to launch in Q1.
Granules India Limited secured US FDA approval for its ANDA application of Trazodone Hydrochloride Tablets, equivalent to Pragma Pharmaceuticals' Desyrel Tablets for treating major depressive disorder in adults.
This marks Granules' 65th ANDA approval, and the current US market for Trazodone tablets is $128m annually.
The company plans to launch the product this quarter, aiming for steady market growth.
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Granules India recibe la aprobación de la FDA de los EE.UU. para tabletas de clorhidrato de Trazodone y planea lanzarlo en el primer trimestre.