The valsartan nitrosamine contamination issue was probably the most significant quality issue to hit the pharmaceutical industry in a decade. Here, Dave Elder outlines how agencies and manufacturers are dealing with the problem and indicates the knowledge gaps that might be concealing future complications.
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The new general chapter (2.5.42) outlines three procedures for the analysis of N-nitrosamine impurities in active substances.
Product recalls due to contamination issues can be extremely costly for companies, in addition to the associated health implications. In this article, Marc Baiget Francesch explores the potential risks associated with N-nitrosodimethylamine (NDMA) contamination, why is it such a frequent contaminant and how to detect and eliminate the risks.
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
The Food and Drug Administration has released a list of 40 drugs used to treat hypertension and heart failure that don’t contain any known carcinogens...
The MHRA have announced another sartan-containing drug product over fears that it is contaminated with the carcinogen N‑nitrosodiethylamine...
“Our finding of reduced aortic dilatation with irbesartan, over and above standard medical therapy, suggests an important clinical effect that may prevent complications and ultimately delay or obviate the need for surgical intervention in patients with Marfan syndrome,” said Dr Mullen.