STEERLife, the life sciences division of India-based STEER World, and Bionpharma Inc, a US-based pharmaceutical company, announced on Tuesday that Bionpharma has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic Etravirine tablets.
The product, a second-line antiretroviral therapy for the treatment of HIV/AIDS, was developed using STEERLife's proprietary FragMelt continuous processing platform which enables a sustainable, solvent-free manufacturing route while maintaining strict bioequivalence to the reference product, INTELENCE.
This approval enables Bionpharma to commercialise the product in the United States, expanding patient access to a high-quality, more affordable treatment option for HIV/AIDS.
Viatris names new chief legal officer
Alvotech signs biosimilar supply and commercialisation deals with Sandoz
InSysBio agrees new collaborative project with BeOne Medicines
MS Pharma enters strategic partnership with Hetero Group
Apiject to open new generic injectable drug manufacturing facility in Apex, NC
Bionpharma and STEERLife's Etravirine tablets approved by US FDA
ScinoPharm Taiwan secures first US FDA approval for complex multiple sclerosis generic
ScinoPharm Taiwan's Glatiramer Acetate Injection approved by US FDA
Accord Healthcare launches Clomiphene tablets in US market
Zentiva receives ESG Transparency Award 2025
Galmed Pharmaceuticals reports topline results for combination of Aramchol, Stivarga and metformin
Ingenus Pharmaceuticals' generic equivalent to Premarin receives US FDA approval
EirGenix signs second global exclusive licensing deal with Sandoz