đź“ŁZent2U announces completion of development and final compilation of EU dossier of Bisoprolol 0.5 mg/ml ready-to-use oral solution.
Zent2U is happy to announce that based on a successful results of bioequivalence studies conducted on Concor Cor® 10mg tablets (Merck®) and Bisoprolol 0.5 mg/ml oral solution (Zentiva). In the year 2023 we successfully finalized all subsequent development steps to compile the eCTD dossier for Bisoprolol oral suspension. The dossier is ready for a filing procedure with regulatory authorities in EU as per Article 10(3) – hybrid application.
Bisoprolol is indicated for treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, diuretics, and optionally cardiac glycosides, treatment of hypertension and angina. Bisoprolol remains the largest beta blocker with over 9 billion tablets sold (MAT Q2 2023) as per IQVIA (EU27+UK).
“Dosage in the range of 1.25 - 10mg can be easily administered via oral syringe to patients with swallowing difficulties or nasogastric tube. The product can be used as a substitution for tablets to enhance patient compliance as well as to lower pill burden”, describes Jan Zajic, Head of Portfolio Zent2U.
Having the new dossier in place will help our potential partners to enrich their cardiovascular portfolio with a specifically targeted generic product to bring new added-value treatment to patients.
đź“žPartner 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
#bisoprolol #zent2u #innovation #HealthcareAdvancements
