Fortrea, Emery Pharma Partner for Rapid MNP Testing in Rifampin, Enables FDA-Compliant DDI Studies

Fortrea Holdings Inc. (NASDAQ:FTRE) is one of the best low priced pharma stocks to buy now. On June 24, Fortrea announced a collaboration with Emery Pharma, which is an analytical and bioanalytical CRO. The partnership aims to provide rapid, lot-by-lot testing for 1-methyl-4-nitrosopiperazine/MNP in rifampin. The goal is to ensure that MNP impurities are below the Acceptable Intake/AI Limit set by US FDA guidelines, thereby enabling the continued use of rifampin in drug-drug interaction/DDI studies.

Rifampin is a commonly used antibiotic and has historically been a preferred agent in DDI studies due to its safety and tolerability profile, particularly for inducing the CYP3A4 isoenzyme.

Fortrea, Emery Pharma Partner for Rapid MNP Testing in Rifampin, Enables FDA-Compliant DDI Studies

An executive team in a boardroom discussing the launch of a new drug trial.

In 2021, the FDA discovered that all tested batches of rifampin contained some levels of MNP that exceeded accepted limits. Then later in 2023, the FDA updated its guidance and raised the acceptable MNP limit for rifampin.

Fortrea Holdings Inc. (NASDAQ:FTRE) is a contract research organization that provides biopharmaceutical product and medical device development solutions to pharmaceutical, biotechnology, and medical device customers worldwide.

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Disclosure: None. This article is originally published at Insider Monkey.