Zydus Lifesciences has entered into an exclusive licensing and commercialisation agreement with RK Pharma, a US based company, for a new sterile injectable oncology supportive care product that is intended for the United States market. This strategic partnership marks a significant step for Zydus in expanding its presence in the US oncology segment.
Under the terms of the agreement, RK Pharma will be responsible for the manufacturing and supply of the finished drug, ensuring consistent quality and availability. Zydus, on the other hand, will manage the regulatory pathway, including the submission of the new drug application (NDA) to the US Food and Drug Administration, as well as oversee the commercialisation of the product across the US. This division of responsibilities allows both companies to leverage their respective expertise in manufacturing, regulatory compliance, and market access.
The product is planned for filing with the US FDA in 2026. According to the company, it is designed to reduce dosing errors and improve compliance for healthcare professionals, offering a safer and more reliable option for patients undergoing oncology supportive care. The innovation in the formulation and delivery of the drug reflects Zydus’s ongoing commitment to addressing unmet needs in oncology treatment and enhancing patient outcomes.
Zydus estimates that the total addressable market for this drug in the US could reach approximately 6.2 million units. The company sees the agreement with RK Pharma as a critical step toward meeting the growing demand for effective oncology supportive care treatments and expanding its footprint in the global pharmaceutical landscape.
