News

News // Emery Pharma Offers Support to Pharmaceutical Companies Following FDA’s Duloxetine Recall Due to Nitrosamine Impurities

Emery Pharma Offers Support to Pharmaceutical Companies Following FDA’s Duloxetine Recall Due to Nitrosamine Impurities

In light of the recent FDA recall of duloxetine, a widely used antidepressant, due to the detection of nitrosamine impurities, Emery Pharma is offering its expertise to pharmaceutical companies facing similar challenges. Nitrosamines, classified as probable human carcinogens, have been found in numerous drug products in recent years, prompting increased scrutiny from global regulatory bodies.

As reported in USA Today, the recall was triggered by concerns over the potential health risks associated with long-term exposure to nitrosamines. Emery Pharma has been at the forefront of nitrosamine detection and analysis, offering comprehensive services to trace the root causes of contamination, assess risks, and ensure that products meet the latest regulatory standards.

“Our team at Emery Pharma has deep expertise in identifying and managing nitrosamine impurities in pharmaceuticals,” said Dr. Ron Najafi, CEO of Emery Pharma. “With our advanced analytical capabilities, we are ready to assist companies in navigating this complex issue and ensuring the safety and integrity of their products.”

Emery Pharma provides a wide range of services designed to address nitrosamine contamination, including:

  • Advanced analytical testing using cutting-edge technologies such as LC-MS/MS and GC-MS
  • Root cause analysis to identify contamination sources
  • Comprehensive risk assessments and mitigation strategies
  • Compliance with FDA and EMA guidelines for nitrosamine levels in drug products

With a proven track record of success in supporting pharmaceutical companies with nitrosamine-related challenges, Emery Pharma is well-positioned to help manufacturers resolve issues quickly and efficiently, reducing the risk of product recalls and regulatory action.

To learn more about Emery Pharma’s services and how we can help your company with nitrosamine testing and risk mitigation, visit our nitrosamine webpage or contact us directly at bd@emerypharma.com.

 

Emery Pharma

Emery Pharma is a full-service contract research laboratory, specializing in analytical, bioanalytical chemistry, microbiology & cell biology services, custom synthesis, and general R&D and cGMP/GLP support.