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.
Breckenridge Pharmaceutical partners with sterile injectable manufacturer Maiva Pharma
Breckenridge Pharmaceutical launches Pomalidomide Capsules in US market
Cipla launches generic liraglutide injection in the US
Arna Pharma signs MOU with Slate Run Pharmaceuticals
STADA and Bio-Thera Solutions receive European marketing authorisation for Gotenfia (golimumab)
DifGen Pharmaceuticals' Fluorometholone Ophthalmic Suspension, 0.1% receives FDA approval
Viatris names new chief legal officer
Alvotech signs biosimilar supply and commercialisation deals with Sandoz
InSysBio agrees new collaborative project with BeOne Medicines