February 16, 2021: Zent2U is happy to announce successful completion of the development on ACE inhibitor Perindopril Arginine. Following positive results of pivotal bioequivalence study performed at Canadian CRO with Coversum Arginine® reference product by Servier® and complying stability data generated on registration batches of the product, we compiled EU CTD dossier which is available for review now.
Having all studies completed and our dossier compiled we’re targeting to file registration at the earliest possible slot. We believe that having a dossier in place now grants Zent2U and its partners the great position to register in all relevant European markets at the earliest possible time, and therefore launch the product as soon as exclusivity expires.
Disclaimer: Perindopril Arginine which is subject to patent protection is currently not offered or made available in countries where patents are in force
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Tomas PilarcikKey Account Manager
Thomas KoeneHead of Growth Partnerships
Head of Communications
ZENTIVA GROUP, a.s.
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