On June 24, 2025, Fortrea Holdings Inc. announced a strategic collaboration with Emery Pharma to provide rapid, lot-by-lot testing of rifampin for 1-methyl-4-nitrosopiperazine (MNP) impurities. This partnership ensures that rifampin, a preferred drug for drug-drug interaction (DDI) studies, meets the updated U.S. Food and Drug Administration (FDA) Acceptable Intake Limit for MNP.
This collaboration enables Fortrea to confidently offer rifampin as an inducing agent for the CYP3A4 isoenzyme in DDI studies, which is crucial for de-risking early-phase trials, accelerating timelines, and enhancing data quality. The FDA updated its guidance in 2023, raising the acceptable MNP limit for rifampin, making this testing capability vital.
The partnership leverages Emery Pharma's strong capabilities in analytical and bioanalytical testing, combined with Fortrea's industry-leading clinical conduct. This strengthens Fortrea's ability to generate high-quality data for clinical pharmacology trials, benefiting both sponsors and patients worldwide.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.