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May 28, 2021 / 2021
Zent2U announces successful development completion of Metformin with controlled NDMA content
May 28, 2021: is happy to announce its successful development of a Metformin finished drug product with significantly controlled NDMA content.
Zent2U’s development of innovative manufacturing processes to control impurities, including N-nitrosodimethylamine (NDMA), is completed and the opportunity is now offered to you. Zentiva‘s improved processes have been successfully implemented into industrial use and Zentiva has related intellectual property rights. Application concerning worldwide patent rights is pending.
Solving this complex task, which is closely observed by global regulators, allows Zentiva to offer complete EU dossiers to partners. We believe that having a Metformin finished drug product with controlled nitrosamine impurity content will bring significant advantages to millions of diabetes patients. Further, this innovation will advantage our potential business partners in overcoming nitrosamine impurity issues and allow the launch of the improved product quickly, with critical NMDA reduction and benefiting from Zentiva’s proprietary technology.
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Tomas Pilarcik
Key Account Managertomas.pilarcik@zentiva.com
Thomas Koene
Head of Growth Partnershipsthomas.koene@zentiva.com
Mihai Stoian
Key Account Managermihai.stoian@zentiva.com
Rahul Padhye
Key Account Managerrahul.padhye@zentiva.com
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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