August 12, 2021: Zent2U announces successful completion of Sertraline pivotal bioequivalence study.

Zent2U is happy to announce that we successfully completed a new pivotal bioequivalence trial that was conducted under fasting conditions. Our trial was carried out on Sertraline 100 mg film-coated tablets (Zentiva) and Zoloft® 100 mg film-coated tablets (Pfizer) and our endpoints perfectly matched necessary bioequivalence parameters.

Having BE study completed we reached a significant development milestone and we‘ll progress into a generation of stability data on registration batches and compilation of the European dossier for 50 mg and 100 mg Sertraline film-coated tablets, available for review in January 2022. Brand new dossier on this well-established product will allow registration filing according to the latest EU registration requirements & guidelines. We believe that having an updated dossier for Sertraline in place will help our potential partners to expand or refresh their CNS portfolio and allow the smooth registration and launch of this attractive product.

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Media Contact

Mounira Lemoui
Head of Communications
ZENTIVA GROUP, a.s.
U kabelovny 529/16, Dolní Měcholupy, 102 00 Prague 10
Mobil: (+420) 727 873 159
E-mail: mounira.lemoui@zentiva.com