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It is reported that one patient died of OMM after 63 months of misdiagnosed premalignant atypical melanocytic hyperplasia as a benign lentigo simplex (50)

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Reflecting the relevance of the concentration of impurities on immunogenicity, impurities that are unique to the generic product and present at a concentration between 0.1% and 0.5% of the API must be evaluated for immunogenic risk potential relative to the API

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