Zent2U is happy to announce the successful results of pivotal bioequivalence studies for Dolutegravir 50 mg film coated tablets. The eCTD dossier is being compiled to be ready for submission to European regulatory authorities soon.
Dolutegravir is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg.
Having the newly developed dossier in place allows our potential partners to enrich their portfolio of antiretrovirals with a new generic product, to offer treatment to growing pool of patients and launch the product in the first wave after patent expiry.
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
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