Ahmedabad, India and Nijmegen, Netherlands, February 14, 2025

Zydus Lifesciences Ltd. (including its subsidiaries and affiliates), a global innovation-driven healthcare company announced that it has signed an exclusive development, licensing, supply,, and commercialization 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 commercialization 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 are intended to provide reduced pill burden, flexibility for dose adjustment, and enhanced patient compliance.

Speaking on the development, Managing Director of Zydus Lifesciences Ltd., Dr. Sharvil Patel said, “We are pleased to partner with Synthon for the commercialization of this complex drug product in the US market. The partnership will bring access to a high unmet-need therapy area. We are certain that by pooling our resources and knowledge, we will meetthe  critical needs of patients and stakeholders.”

Anish Mehta, CEO of Synthon BV, stated, “This 505(B)(2) product is another example of Synthon’s superior complex product development capabilities and represents a strategic move toward more complex and clinically differentiated products. We are excited to strengthen our partnership with Zydus, who will bring this critical medicine to market to provide patients with important treatment alternatives for this extremely challenging condition.”