India, Feb. 12 -- India-based Zydus Lifesciences (including its subsidiaries and affiliates), has signed an exclusive development, licensing, supply and commercialisation agreement with Synthon BV of the Netherlands for a novel 505(B)(2) oncology product for an undisclosed target.
Under the terms of this agreement, Synthon will be responsible for the development, manufacturing and supply of the finished product. Zydus will be responsible for the NDA submission and commercialisation of the product in the US. This 505(B)(2) oncology product will likely be filed in 2026 and will be offering additional strengths that is intended to provide reduced pill burden, flexibility for dose adjustment and enhanced patient compliance.
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