Zydus Lifesciences Ltd., along with its subsidiaries and affiliates, has entered into an exclusive licensing and commercialization agreement with US-based RK Pharma Inc for a novel sterile injectable developed under the 505(b)(2) pathway for oncology supportive care in the United States.

As part of the agreement, RK Pharma will manufacture and supply the finished product, while Zydus will handle the NDA filing and commercial launch in the US market. The product is expected to be filed in 2026 and is designed to reduce dosing errors and improve compliance among healthcare professionals.

Commenting on the collaboration, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences, said, “We are delighted to partner with RK Pharma to bring this innovative product to patients in the US. This partnership reflects our commitment to high-quality, affordable medicines and enhanced patient care.”

Dr. Ravishanker Kovi, Founder and Executive Chairman, RK Pharma, added, “This novel 505(b)(2) product underscores RK Pharma’s advanced formulation and manufacturing capabilities in sterile injectables and complex generics. Partnering with Zydus, with its strong regulatory expertise and commercial presence, will help ensure timely access to this important therapy in the US.”

The product addresses a significant commercial opportunity, with a total addressable market of an estimated 6.2 million units in the US, as per IQVIA MAT September 2025 data.