Zent2U is happy to announce that based on a successful finalization of the product development with vertically integrated active substance we’ll file for a registration in EU in order to obtain a Marketing Authorizations for a generic version of Brintellix® 5mg, 10mg, 15mg, 20mg film coated tablets (H. Lundbeck A/S®). 🌍
The eCTD dossier will be ready for registration submission in February 2025. 📅
Knowing that Vortioxetine active substance is sensitive for nitrosamine impurity contamination, we developed our product with controlled nitrosamine impurities content. 🧪
Vortioxetine is indicated for the treatment of major depressive episodes in adults. 💊
Having the newly developed dossier in place allows our potential partners to enrich their portfolio of antidepressants with a new generic product and offer 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
#Pharmaceuticals #HealthcareInnovation #MentalHealth #Antidepressants #GenericDrugs #PharmaNews #Healthcare #Partnerships #Vortioxetine #Zent2U #Zentiva #B2B
