Marking a significant milestone in the global effort to expand access to advanced HIV therapies, STEERLife (the life sciences division of STEER World), and Bionpharma Inc. recently announced Bionpharma has received Abbreviated New Drug Application (ANDA) approval from the US FDA for its generic Etravirine tablets.

Developed using STEERLife’s proprietary FragMelt continuous processing platform, this approval represents a breakthrough in pharmaceutical manufacturing. The platform enables a sustainable, solvent-free manufacturing route while maintaining strict bioequivalence to the reference product, INTELENCE. The partnership underscores a shared commitment to delivering high-quality, cost-effective, and environmentally conscious medical solutions to patients.

This approval allows Bionpharma to commercialize the product in the United States, expanding patient access to a high-quality, more affordable treatment option for HIV/AIDS.

Etravirine is an important second-line antiretroviral therapy for the treatment of HIV/AIDS. Its development posed significant technical challenges due to its extreme sensitivity to heat and shear.  Through a focused partnership, Bionpharma’s regulatory expertise and STEERLife’s engineering depth, formulation capabilities, and continuous processing technologies combined to overcome these barriers, converting a complex molecule into a stable, reproducible, and regulatory-compliant product.

A key enabler of this success was STEERLife’s proprietary FragMelt platform, which integrates advanced engineering and pharmaceutical sciences to enable continuous, solvent-free processing of heat- and shear-sensitive APIs. This approach allowed efficient solubilization and stabilization of the API while ensuring it meets stringent USFDA quality standards – an outcome that is often difficult to achieve using conventional batch manufacturing methods.

“This ANDA approval is a testament to the power of aligning scientific insight with advanced engineering from day one,” said Mr Venkat Krishnan, CEO of Bionpharma. “Our collaboration with STEERLife has converted a technically challenging product into a scalable, high-quality product ready for the competitive US 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 success of this program highlights several key advantages of STEERLife’s continuous manufacturing approach:

• Precision engineering:  FragMelt enables processing of heat-sensitive materials while meeting stringent USFDA quality expectations.
• Scalability and speed: Continuous processing ensures highly reproducible formulations and a rapid transition from development to commercial readiness.
• Sustainability: The solvent-free process reduces environmental impact while simplifying manufacturing operations.

With ANDA approval secured, Bionpharma will lead the commercialization and distribution of Etravirine tablets in the United States. Both organizations view this achievement as a solid foundation for future collaborations on complex generics that require advanced processing solutions to reach global markets.

 This milestone reflects Bionpharma’s commitment to expanding patient access to high-quality generics and STEERLife’s focus on advancing smarter, greener continuous pharmaceutical manufacturing. The collaboration demonstrates how integrated development – aligning formulation science, engineering, and manufacturing – can accelerate time to market for challenging drug products while meeting regulatory expectations.

BionPharma Inc. is a US-based pharmaceutical company specializing in high-quality generic prescription and OTC medicines. A leading supplier of soft-gel capsules, it supports R&D, manufacturing and commercialization through global affiliates, serving 40+ countries. BionPharma focuses on affordable, regulatory-compliant medicines and partners on product development, in-licensing and market entry.

STEERLife, the Life Sciences arm of STEER World, pioneers continuous, solvent-free pharmaceutical processing with proprietary platforms such as FragMelt, PureMelt, and INTEGRAAL. As India’s first to transition from batch to continuous processing, STEERLife delivers scalable, regulatory-ready solutions for complex generics in critical areas like Oncology and Antiretroviral therapies. Combining formulation science with engineering expertise, STEERLife offers end-to-end drug development, scale-up and tech transfer, prioritizing quality, efficiency, and patient-centricity.