Bengaluru-based STEERLife and Bionpharma have announced that Bionpharma has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic Etravirine tablets, an anti-retroviral therapy used in the treatment of HIV/AIDS.

The product was developed using STEERLife’s FragMelt continuous processing platform, which enables a solvent-free manufacturing process while maintaining bioequivalence to the reference product, INTELENCE. The approval allows Bionpharma to commercialise the product in the United States, expanding access to a more affordable treatment option for patients.

Etravirine is used as a second-line therapy for HIV/AIDS and presents manufacturing challenges due to its sensitivity to heat and shear. According to the companies, these challenges were addressed through a collaboration combining Bionpharma’s regulatory expertise with STEERLife’s formulation and continuous processing capabilities, resulting in a stable and reproducible product that meets FDA quality requirements.

STEERLife’s FragMelt platform supports continuous, solvent-free processing of heat- and shear-sensitive Active Pharmaceutical Ingredients (APIs), offering an alternative to conventional batch manufacturing methods. The companies said this approach enabled efficient solubilisation and stabilisation of the active ingredient while complying with regulatory standards.

With the ANDA approval in place, Bionpharma will oversee the commercialisation and distribution of Etravirine tablets in the US market. Both companies indicated that the collaboration could support future development of complex generic medicines requiring advanced manufacturing technologies.