Zydus and RK Pharma sign exclusive licensing and commercialisation deal for a novel 505(b)(2) supportive oncology treatment in the US market
Wednesday, November 26, 2025
Zydus Lifesciences Ltd. (including its subsidiaries and affiliates), a global innovation-driven healthcare company, has announced that it has signed an exclusive licensing and commercialisation agreement with RK Pharma Inc, USA, for a novel sterile injectable 505(b)(2) oncology supportive care product for the US market.
Under the agreement, RK Pharma will manufacture and supply the finished product, while Zydus will handle the NDA submission and commercialisation in the US. The product, developed under the 505(b)(2) pathway, is expected to be filed in 2026 and is designed to help reduce dosing errors and support better compliance among healthcare professionals.
Dr Sharvil Patel, Managing Director of Zydus Lifesciences, said, “We are pleased to collaborate with RK Pharma to bring this innovative product to patients in the US. This partnership strengthens our commitment to delivering high-quality, affordable medicines and improving patient care.”
Dr Ravishanker Kovi, Founder and Executive Chairman of RK Pharma, added, “This novel 505(b)(2) supportive oncology product demonstrates RK Pharma’s strong capabilities in formulation and manufacturing, especially in specialised areas such as sterile injectables and complex generics. Working with Zydus, a company with strong regulatory expertise and a solid commercial presence, will ensure this important treatment option reaches patients efficiently. Together, we remain committed to improving access to high-quality healthcare in the US.”
The product addresses a significant commercial opportunity in the US, with a total addressable market (TAM) of 6.2 million units, according to IQVIA MAT September 2025 data.
Source: zyduslife.com
