Bengaluru-based STEERLife, the life sciences arm of STEER World, and US-headquartered Bionpharma have announced that the latter has received US FDA nod for its generic HIV drug -- Etravirine tablets.

 

Developed using STEERLife’s proprietary FragMelt continuous processing platform, the approval marks a major breakthrough in pharmaceutical manufacturing. The platform enables a sustainable, solvent-free production process while maintaining strict bioequivalence with the reference drug, INTELENCE. The partnership highlights a shared mission to provide high-quality, cost-effective, and environmentally conscious therapies.

 

“This ANDA approval is a testament to the power of aligning scientific insight with advanced engineering from day one,” said Mr. Venkat Krishnan, CEO of Bionpharma. “Our collaboration with STEERLife has converted a technically challenging product into a scalable, high-quality product ready for the competitive US market.”

 

Etravirine, a critical second-line antiretroviral therapy, presents significant manufacturing challenges due to its extreme sensitivity to heat and shear. By combining Bionpharma’s regulatory expertise with STEERLife’s engineering, formulation capabilities, and continuous processing technologies, the teams overcame these hurdles, producing a stable, reproducible, and USFDA-compliant product.

 

“FragMelt and our continuous processing approach were engineered specifically to solve complex formulation challenges such as these,” said Indu Bhushan, CEO and Director of STEERLife. “This approval not only validates our platform but also reinforces the immense value of collaborative development and technology transfer in the generic pharmaceutical space.”

 

With this approval, Bionpharma can now commercialize Etravirine in the US, expanding access to an affordable, high-quality treatment option for patients living with HIV/AIDS.