Nitrosamine Impurities in Medicinal Products

In 2018, the unexpected discovery of nitrosamine (probable human carcinogen) impurities in several angiotensin receptor blockers (ARBs) triggered a series of regulatory actions across the EU, US and other international partners through the form of immediate measures to protect public health (e.g. product recalls) and subsequent review of drugs at risk.  The Kinapse team has recently published an article ‘Nitrosamine impurities in Medicinal Products’ detailing the root causes, lessons learnt and recommendations for the industry based on the current developments across EMA, FDA and other international partners.

Follow the link to the complete article published in the December edition of PharmTech

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