Nitrosamine Impurities Deadline: Are Your Products Compliant?
ADARE PHARMA SOLUTIONS SPONSORED CONTENT

Nitrosamine Impurities Deadline: Are Your Products Compliant?

In August 2023, the FDA released its guidance on nitrosamine contamination, Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs). This guidance set a November 1, 2023, deadline for risk assessment updates and an August 1, 2025, deadline for all drug manufacturers and market authorization holders to comply fully with the NDSRI limits set.

This article highlights how the nitrosamine mitigation experts at Adare can provide you with informed and quantifiable options to help you find the right path forward and resolve your nitrosamine issues quickly and efficiently.

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