Mumbai, Nov. 26 -- 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. ...