FDA’s Latest Nitrosamine Guidance Reinforces the need for a more Proactive Risk Management for Drug Developers and CDMOs
Alameda, California – August 3, 2026 – Emery Pharma today underscored the importance of the U.S. Food and Drug Administration’s July 24, 2026 update to its guidance on nitrosamine drug substance-related impurities (NDSRIs). The revision adds new API-specific entries, including mitapivat and several dalbavancin related NDSRIs, while continuing the FDA’s steady expansion of acceptable intake (AI) recommendations that began in earlier guidance updates.
The latest revision reinforces an important message for the pharmaceutical industry: nitrosamine risk assessment is no longer a reactive exercise. It is an expected part of modern drug development and manufacturing.
For drug developers, the guidance means sponsors should be prepared to provide comprehensive nitrosamine risk assessments, scientific rationale, confirmatory analytical data, control strategies, product specifications, and stability data. Where scientifically justified, FDA also provides a pathway for alternative acceptable intake limits supported by toxicological data or enhanced Ames testing.
While many widely used APIs were incorporated through previous FDA updates, the July 2026 revision expands the Agency’s growing database and further establishes nitrosamine risk management as a routine regulatory expectation for both innovator and generic drug manufacturers.
“Nitrosamine testing is no longer simply about detecting impurities,” said Ron Najafi, Ph.D., Founder and CEO of Emery Pharma. “The key is understanding how these impurities form, identifying the root cause, and implementing control strategies early in development.”
Emery Pharma has been engaged in nitrosamine science since the earliest investigations into ranitidine (Zantac). The company’s work on NDMA formation helped advance the scientific understanding of nitrosamine formation mechanisms and established Emery Pharma as a leader in nitrosamine risk assessment, root cause analysis, and ultra-trace analytical testing.
Today, Emery Pharma supports pharmaceutical companies worldwide with nitrosamine risk assessments, root cause investigations, LC-MS/MS and high-resolution mass spectrometry testing, method development and validation, stability studies, and regulatory support.
About Emery Pharma
Emery Pharma is an FDA-registered and FDA-inspected analytical CRO headquartered in Alameda, California. The company provides GLP and GMP-compliant analytical services, including mass spectrometry, bioanalysis, microbiology, CMC analytical support, nitrosamine testing, and regulatory consulting for pharmaceutical and biotechnology companies worldwide.
Media Contact
Ron Najafi, Ph.D.
Founder & CEO
Emery Pharma
Alameda, California
www.emerypharma.com
