Zent2U is pleased to announce a successful finalization of the harmonized part of the registration procedure with European authorities for Ibuprofen IR / SR 400 mg tablets as per Article 10(3) – hybrid application.
At the moment, national parts of the procedure have been pending in order to obtain Marketing Authorization across European countries.
Ibuprofen is indicated for treatment of mild to moderate pain, such as headache, back pain, toothache, neuralgia, muscle and joint pain and postoperative pain, cold and flu symptoms and fever associated with common flu.
The novel formulation containing ibuprofen in an immediate and a sustained release layers in the same tablet offers a combination of fast onset of action and sustained therapeutic effect. Dosing one tablet every 8 hours allows for uninterrupted daily activities and overnight rest.
Having this innovative formulation in their pain relief portfolio will help our potential partners to differentiate from those offering the standard treatment as well as to provide their patients with a clearly added value product.
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
b2b innovation Zent2U Zentiva painmanagement