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ANDA impurities guidance

This article was originally published in The Tan Sheet

Executive Summary

Draft document provides guidance on including in ANDAs and drug master files information on "identification and qualification of impurities in drug substances" for monograph and nonmonograph drugs. Impurities are classified in the July 24 document as either chemistry- or safety-related; the document provides guidance on "qualifying impurities" in the ANDA product compared to the "related USP monograph, the scientific literature or innovator material" -- specifically, when impurities in the ANDA products are at higher or lower levels than these benchmarks or are not found in the references at all -- and provides "threshold levels, below which qualification is not needed." Comments on the draft guidance are due within 60 days of publication...

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