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Last week’s round-up, 10-14 February 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud   NDMA in Metformin: FDA Finds Low Levels in Only 2 of 10 Tested Products 14 February 2020 The FDA has tested several Metformin drug product and active substance samples for the potentially carcinogenic impurity NDMA. Most of the metformin drug product samples did not show any […]

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The EPO

Real Generics’ Regulatory News Digest For Generics – 24 November 2015

Planned changes to intellectual property protection in Europe Towards the end of October 2015, the European Commission published a working document entitled A Single Market Strategy for Europe – Analysis and Evidence. The document suggests a number of changes in intellectual property protection that would have a positive and significant impact on manufacturers of existing […]

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Elemental impurities

Real Generics’ Regulatory News Digest For Generics – 10 August 2015

Draft ICH Guidelines for Consultation Mutagenic impurities ICH has released a draft addendum to ICH Guideline M7 on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. The addendum summarises known mutagenic impurities commonly found or used in drug synthesis (e.g. aniline, dimethyl sulfate, ethyl chloride, hydroxylamine), providing acceptable […]

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