📣We refer to the recent notification issued by the European Medicines Agency on Friday 15th December 2023 following a Good Clinical Practice (GCP) inspection of the CRO that uncovered irregularities in study data, inadequacies in study documentation and deficiencies in computer systems and procedures for managing study data and raised serious concerns about the validity and reliability of the data from bioequivalence studies with respect to more than 100 generic molecules and impacting more than 200 MA holders & applicants.
💊At Zentiva, we maintain the highest Good Clinical Practice standards. We are pleased to assure our partners that Zent2U portfolio has not been affected by this suspension in any way and we can offer the following products (as well as many other products) with compliant clinical data:
Abacavir + Lamivudine
Amlodipine
Atazanavir
Atorvastatin
Dapagliflozin + Metformin
Deferasirox
Ibuprofen
Lacosamide
Linagliptin
Metformin
Sertraline
Sitagliptin
Sitagliptin + Metformin
Solifenacin
Vildalgiptin
📞 Call to Action:
We invite our partners to contact our Zent2U licensing team Tomas Pilarcik, Nina Fuentes de Tienda, Rahul Padhye and Thomas Koene for detailed information on our product offerings.
Reference: https://lnkd.in/eUeVS8aq
Photo: © European Union, 1995-2023
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