USFDA Approves Bionpharma's Generic HIV Drug Etravirine
The product was developed using STEERLife's FragMelt continuous processing platform, which enables solvent-free manufacturing while maintaining bioequivalence to the reference product.
New Delhi: Bionpharma Inc. has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Etravirine Tablets, an antiretroviral drug used in the treatment of HIV-1 infection.
The generic Etravirine tablets were developed in collaboration with STEERLife, the life sciences division of STEER World, using its proprietary continuous processing technology. The approval allows Bionpharma to commercialise the product in the United States as a therapeutically equivalent version of INTELENCE®, the reference listed drug.
Etravirine is a key second-line antiretroviral therapy for HIV-1 patients, particularly those who have developed resistance to earlier treatments. However, the drug presents significant formulation challenges due to its sensitivity to heat and shear, making conventional batch manufacturing difficult.
According to the companies, the product was developed using STEERLife’s FragMelt™ continuous processing platform, which enables solvent-free manufacturing while maintaining bioequivalence to the reference product. The platform allows improved process control, scalability and sustainability compared to traditional batch processes.
With the USFDA approval in place, Bionpharma will lead the commercialisation and distribution of Etravirine tablets in the US market, expanding access to a more affordable HIV treatment option.
Commenting on the approval, Venkat Krishnan, CEO of Bionpharma, said, “This ANDA approval is a testament to the power of aligning scientific insight with advanced engineering from day one. Our collaboration with STEERLife has converted a technically challenging product into a scalable, high-quality product ready for the competitive U.S. market.”
Indu Bhushan, CEO and Director of STEERLife, added, “FragMelt™ and our continuous processing approach were engineered specifically to solve complex formulation challenges such as these. This approval not only validates our platform but also reinforces the immense value of collaborative development and technology transfer in the generic pharmaceutical space.”
The companies highlighted that continuous manufacturing offers advantages such as enhanced reproducibility, faster transition from development to commercial scale, and reduced environmental impact due to solvent-free processing.
Etravirine tablets add to Bionpharma’s expanding portfolio of USFDA-approved generic medicines, while the approval also marks a regulatory milestone for STEERLife’s continuous pharmaceutical manufacturing technologies in regulated markets.
