Bionpharma Secures FDA Nod for Generic Etravirine Tablets

Bengaluru-based STEERLife, the life sciences division of STEER World, and Bionpharma, a US-headquartered pharmaceutical company, have announced the US FDA approval for Bionpharma’s generic Etravirine tablets. This is a significant milestone to the two firms in the pharmaceutical industry.

Approved under the proprietary FragMelt continuous processing platform by STEERLife, the approval lends credence to the capability of the platform to generate sustainable production that is solvent-free and that is strictly bioequivalent to the reference drug, INTELENCE. This success shows that the companies are committed to offering affordable, high quality and green therapy.

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It is a tribute of the strength of science and state-of-the-art engineering on the first day of the business that resulted in this ANDA approval, said Venkat Krishnan, CEO of Bionpharma. The partnership with STEERLife has taken a product that was very difficult to work with technically and transformed it into a scalable and high quality product that is now fit to compete in the US market.

The second-line antiretroviral medication of etravirine is a very essential drug but has posed a major challenge in manufacturing because it is highly sensitive to heat and shear. The teams were able to overcome these difficulties collaboratively by combining the regulatory skills of Bionpharma with the engineering skills of STEERLife to end up with a regulatory-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 enables Bionpharma to expand access to affordable, high-quality treatment options for patients living with HIV/AIDS in the US.