Zydus Lifesciences Ltd., the global healthcare group known for its focus on innovation-driven therapies, has announced a significant step forward in its US oncology pipeline. The company has entered into an exclusive licensing and commercialization partnership with US-based RK Pharma Inc for a novel sterile injectable supportive care product being developed through the 505(b)(2) regulatory pathway.
Under this arrangement, RK Pharma will take charge of manufacturing and supplying the finished product, while Zydus will handle the NDA submission as well as commercialization once approved. The product is expected to be filed with the USFDA in 2026 and has been designed to reduce dosing errors and improve compliance among healthcare professionals, making it a potentially important advancement in supportive oncology treatment.
Speaking about the collaboration, Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, said that the partnership marks another milestone in Zydus’ commitment to delivering high-quality, accessible therapies. He highlighted that working with RK Pharma will help bring an innovative and much-needed option to patients in the US.
Dr. Ravishanker Kovi, Founder and Executive Chairman of RK Pharma, noted that this product reflects RK Pharma’s strong capabilities in formulation science and sterile injectable manufacturing. He emphasized that Zydus’ regulatory expertise and commercial reach in the US market make the collaboration well-positioned to ensure timely availability of the therapy to patients who need it.
The commercial potential of this product is notable, with IQVIA data (MAT September 2025) estimating a total addressable US market of 6.2 million units. With supportive care being a critical part of the oncology treatment cycle, the upcoming injectable could play a meaningful role in enhancing safety and ease of use across healthcare settings.
