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The higher doses and costs are justified by accelerated timelines in appropriate contexts

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"It is therefore recommended that higher thresholds are proposed for fermentation products which can be used for the US market." "In the European market the EMA guideline on setting specifications for related impurities in antibiotics (EMA/CHMP/CVMP/QWP/199250/2009 corr) published 30 June 2012, includes a special threshold for fermentation products," the company added

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