Zydus Lifesciences Ltd., along with its subsidiaries and affiliates, a global healthcare company focused on innovation, has announced an exclusive licensing and commercialization agreement with RK Pharma Inc. of the United States for a new sterile injectable 505(b)(2) oncology supportive care product aimed at the U.S. market. Under the terms of the partnership, RK Pharma will handle the manufacturing and supply of the finished product, while Zydus will take responsibility for the NDA submission and commercialization in the U.S. The product, developed through the 505(b)(2) regulatory pathway, is expected to be filed in 2026 and is designed to reduce dosing errors and improve compliance among healthcare professionals.
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Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, expressed enthusiasm for the collaboration, noting that it reflects the company’s dedication to providing high-quality and affordable medicines while enhancing patient care in the United States. He highlighted that working with RK Pharma allows Zydus to bring an innovative treatment to patients efficiently and reinforces their commitment to advancing healthcare solutions.
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Dr. Ravishanker Kovi, Founder and Executive Chairman of RK Pharma, emphasized that the novel 505(b)(2) oncology supportive care product showcases the company’s expertise in formulation and manufacturing, particularly for complex sterile injectables and generics. He added that partnering with Zydus, which brings regulatory strength and a strong commercial presence, ensures that this important therapeutic option reaches patients effectively, furthering their joint mission to improve access to high-quality healthcare in the U.S.
The product is expected to address a significant commercial opportunity in the U.S., targeting an estimated total addressable market of 6.2 million units based on IQVIA data MAT September 2025. This collaboration between Zydus and RK Pharma combines advanced manufacturing capabilities, regulatory expertise, and market reach to bring an innovative supportive oncology treatment to U.S. patients while aiming to enhance safety and treatment compliance.
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