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14 Jan 2026
Admin
News Article

Bionpharma Secures US FDA ANDA Approval for Generic Etravirine Tablets

Bionpharma Inc. has received US FDA approval for its Abbreviated New Drug Application (ANDA) for generic etravirine tablets, in collaboration with STEERLife.

The approval clears the path for commercialization of a more affordable HIV treatment in the US market.

A Technically Complex HIV Drug, Successfully Simplified

Etravirine is a second-line antiretroviral therapy used in the treatment of HIV/AIDS.

However, developing a generic version is not straightforward.

The API is extremely sensitive to heat and shear
Conventional batch manufacturing often fails to ensure stability
Maintaining bioequivalence adds another layer of complexity

This made etravirine a challenging candidate for generic development.

FragMelt: The Core Technology Behind the Approval

The product was developed using STEERLife’s proprietary FragMelt continuous processing platform. Key advantages of FragMelt include:

Solvent-free manufacturing, improving sustainability
Continuous processing, reducing variability
Precise handling of heat- and shear-sensitive APIs
Consistent bioequivalence to the reference drug, Intelence

This approach overcomes limitations commonly seen in traditional batch processes.

A Model Collaboration Between Engineering and Regulation

The approval reflects a tightly aligned partnership.

Bionpharma led regulatory strategy and ANDA execution
STEERLife contributed engineering, formulation expertise, and process innovation
Together, they converted a fragile molecule into a stable, scalable, FDA-compliant product

The result is a robust generic suitable for competitive US markets.

Leadership Perspective

Venkat Krishnan, CEO of Bionpharma, said the approval demonstrates what is possible when science and engineering align early.

“This collaboration converted a technically challenging product into a scalable, high-quality medicine ready for the US market.”

Indu Bhushan, CEO and Director of STEERLife, emphasized platform validation.

“FragMelt was built to solve complex formulation challenges. This approval validates both the technology and the collaborative development model.”

Why This ANDA Approval Matters?

This milestone delivers value on multiple fronts.

Patients gain access to a lower-cost HIV therapy
Manufacturers see proof that continuous manufacturing can handle complex APIs
The industry gets a real-world example of sustainable, solvent-free production

It also reinforces continuous processing as a viable path for difficult generics.

What Comes Next?

With ANDA approval secured:

Bionpharma will lead US commercialization and distribution
Both companies are exploring future collaborations
The focus will be on complex generics requiring advanced processing technologies

This approval is not just a product launch. It’s a signal that next-generation manufacturing is ready for mainstream generic pharma.

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