Under the terms of the agreement, RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization in the US. The product, developed under the 505(b)(2) pathway, is expected to be filed in 2026 and is designed to reduce dosing errors and enhance compliance among healthcare professionals.
The novel product targets a significant commercial opportunity in the US market, with an estimated total addressable market (TAM) of 6.2 million units, according to IQVIA MAT September 2025 data.
Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, said, “We are delighted to collaborate with RK Pharma to bring this innovative product to patients in the US. This partnership reinforces our commitment to delivering high-quality, affordable medicines and improving patient care.”
Dr. Ravishanker Kovi, Founder and Executive Chairman of RK Pharma, stated, “This novel 505(b)(2) product of supportive oncology treatment highlights RK Pharma’s testament to advanced capabilities in formulation and manufacturing, particularly in specialized areas like sterile injectables and complex generics. Our collaboration with Zydus, a company with robust regulatory expertise and a powerful commercial footprint, ensures that this important therapeutic option reaches patients efficiently, reinforcing our shared mission to improve access to high-quality healthcare in the USA.”
The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life-sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27000 people worldwide and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives.
Zydus Lifesciences reported a 38.12% jump in consolidated net profit to Rs 1,258.60 crore in Q2 FY26, compared with Rs 911.2 crore posted in Q2 FY25. Revenue from operations increased 18.07% year on year (YoY) to Rs 6,037.9 crore in Q2 FY26.