🔬Zent2U is happy to announce that we successfully completed pivotal bioequivalence trial carried out on Vortioxetine 20mg film-coated tablet (Zentiva) and Brintellix® 20mg film-coated tablets (Lundbeck) and our endpoints perfectly matched necessary bioequivalence parameters. Having study completed we reached significant development milestone and we‘ll progress into manufacturing of registration batches and compilation of EU dossier, available for review in October 2024.
🔜We believe that having dossier in place this year grants Zent2U and its partners the great position to register the dossier in all major EU markets at earliest possible time and launch the product indicated for major depressive disorders at day 1 after patent expiry.
🚦Our product is vertically integrated and its unique composition controls nitrosamine impurities content.
Partner up now and connect with our team today!
Thomas Koene (thomas.koene@zentiva.com) – Head of Growth Partnerships
Tomas Pilarcik (tomas.pilarcik@zentiva.com) – Head of B2B Europe
Rahul Padhye (rahul.padhye@zentiva.com) – Head of B2B International
Nina Fuentes de Tienda (nina.fuentes@zentiva.com) – Key Account Manager B2B Europe
ℹ️Disclaimer: Vortioxetine which is subject to patent protection is currently not offered or made available in countries where patents are in force.
