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Metformin diabetes medicines and N-nitrosodimethylamine (NDMA) – a probable human carcinogen

  • 7 декабря 2019
  • acceptable, active substance, AI, API, authority, cancer, carcinogen, CEP, daily, diabetes, drug, drug product, EDQM, EMA, EU, FDA, GMP, HCl, HSA, human, hydrochloride, ICH M7, impurity, intake, investigation, manufacturing process, market, medicinal product, medicines, metformin, N-nitrosodimethylamine, NDMA, nitrosamine, recall, root cause, Streuli Pharma AG, Swissmedic, type 2, withdrawal,
  EMA is aware that trace amounts of an impurity, N-nitrosodimethylamine (NDMA), have been found in a small number of metformin diabetes medicines outside the EU. At this point, there are no data indicating that EU metformin medicines are affected. Authorities in the EU are in the process of working with companies to test EU
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