Zent2U announces completion of development and submission of Ibuprofen 170mg IR / 230mg SR tablets for registration in Europe. ☑️
“We are happy to announce that based on a successful finalization of the development process we have filed a registration procedure with regulatory authorities in EU as per Article 10(3) – hybrid application to obtain a Marketing Authorization for our Ibuprofen 170mg IR / 230mg SR bilayer tablets,” says Head of Zent2U Thomas Koene and continues: “The eCTD dossier is based on successful results of bioequivalence studies conducted with the reference product Nurofen® 200mg tablets (Reckitt Benckiser Healthcare®).”
Our bi-layer tablet contains 400 mg of ibuprofen (170 mg as immediate release and 230 mg as sustained release). The immediate release layer dissolves quickly to allow for fast absorption. The second layer is designed to slowly release a drug in the body over an extended period.
“Having this innovative formulation in the 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,” adds Thomas Koene. 💫
Partner up now and connect with our team today:
thomas.koene@zentiva.com – Thomas Koene – Head of Strategic Growth Partnerships
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
#b2b #innovation #Zent2U #painmanagement
