Bengaluru-based STEERLife, the life sciences arm of STEER World, and US-headquartered Bionpharma have secured US FDA approval for Bionpharma’s generic version of the HIV drug Etravirine tablets.
The generic was developed using STEERLife’s proprietary FragMelt continuous processing platform, which enables a sustainable, solvent-free manufacturing process while ensuring strict bioequivalence with the reference drug, INTELENCE. The collaboration underscores a focus on delivering high-quality, cost-effective, and environmentally conscious therapies.
Etravirine, a critical second-line antiretroviral therapy, is highly sensitive to heat and shear, making its manufacturing complex. The partnership combined Bionpharma’s regulatory expertise with STEERLife’s engineering, formulation capabilities, and continuous processing technologies to overcome these challenges, resulting in a stable, reproducible, and FDA-compliant product.
With US FDA approval in hand, Bionpharma can now commercialize Etravirine in the United States, providing patients living with HIV/AIDS access to an affordable and high-quality treatment option.
The approval also marks a significant milestone in applying advanced continuous processing technology to complex generic pharmaceutical manufacturing.
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