Bionpharma wins FDA approval for Etravirine as STEERLife’s FragMelt proves regulatory-ready
Bionpharma Inc. has secured Abbreviated New Drug Application (ANDA) approval from the United States Food and Drug Administration for its generic version of Etravirine tablets, a second-line treatment for HIV-1. Developed in partnership with STEERLife, the formulation leverages the proprietary FragMelt continuous manufacturing platform to overcome the heat- and shear-sensitivity of the active pharmaceutical ingredient.