Zent2U is pleased to announce that we successfully completed the clinical development of a generic version of Brintellix® 5mg, 10mg, 15mg, 20mg film coated tablets (H. Lundbeck A/S®), based on successful results of bioequivalence studies. 📊
Registration batches of the product are manufactured as well as final development steps are ongoing with a target to compile eCTD dossier within December 2024. 📅
Vortioxetine active substance is sensitive for nitrosamine impurity contamination, and we developed our finished drug product with nitrosamine impurity content under control. Vortioxetine is indicated for the treatment of major depressive episodes in adults. 💊
Having the new dossier in place allows our potential partners to enrich their portfolio of antidepressants with a new generic product, offering efficient and cost-effective treatment to the patients. 🤝
Partner up now and connect with our team today! 📧
thomas.koene@zentiva.com - Thomas Koene - Head of Zent2U
tomas.pilarcik@zentiva.com – Tomas Pilarcik – Head of B2B Europe
rahul.padhye@zentiva.com – Rahul Padhye – Head of B2B International
nina.fuentes@zentiva.com – Nina Fuentes de Tienda – Key Account Manager B2B Europe
yuliyana.manolova@zentiva.com – Yuliyana Manolova – Head of Distribution and Clinical Trials
Zent2U innovation HealthcareAdvancements depression anxiety B2B generics partnership
