Andy Teasdale - Waters
Andy Teasdale
Andy Teasdale

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The Evolving Regulations Guiding Nitrosamines

By October 19, 2020

In July 2018, the European Medicines Agency (EMA) reported the recall of a number of products containing the active pharmaceutical ingredient (API) valsartan due to contamination with a known carcinogen, dimethyl nitrosamine, also referred to… Read more >

Categories: Pharmaceutical
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Mutagenic Impurity Risk Assessment Throughout the Development and Manufacturing Process

By September 15, 2020

Since the early 2000s and the advent of the first guidance relating to mutagenic impurities developed by the European Medicines Agency (EMA), it has been necessary to assess the risk posed by mutagenic impurities.  Although… Read more >

Categories: Pharmaceutical
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