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Five Years Later, Legacy Biologics Still Face ‘Next Heparin’ Risks

This article was originally published in The Gold Sheet

Executive Summary

Several factors continue to slow efforts to modernize legacy biologics’ compendial monographs against fake ingredients like the ones someone put in heparin in 2008. Hyaluronate, the ‘poster child’ for monograph modernization; New NDAs for pancreatin create new modernization challenges; Heparin maker vertically integrates to prevent adulteration.

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