Zydus, RK Pharma partner for oncology supportive care product in US

Zydus Lifesciences Ltd. announced today, November 26, 2025, an exclusive licensing and commercialization agreement with RK Pharma Inc. for a novel sterile injectable 505(b)(2) oncology supportive care product targeting the U.S. market. RK Pharma will manufacture and supply the product, while Zydus will handle NDA submission and commercialization in the U.S. The product, developed via the 505(b)(2) pathway, is anticipated to be filed in 2026.

This innovative product aims to reduce dosing errors and enhance compliance for healthcare professionals. Dr. Sharvil Patel, managing director of Zydus Lifesciences, emphasized the partnership's role in delivering high-quality, affordable medicines and improving patient care in the U.S.

The novel 505(b)(2) product addresses a substantial commercial opportunity in the U.S. market. According to IQVIA data from MAT September 2025, the estimated total addressable market is 6.2 million units.