Up-to-date Information on Nitrosamine Contamination in APIs at the APIC Conference

After high blood pressure medicine valsartan and other sartan preparations were discovered to be contaminated with nitrosamine, further cases keep emerging. Just recently, nitrosamine was discovered in several batches containing pioglitazone (diabetes sentisizer) or ranitidine (stomach acid blocker) as the active ingredient. A few days ago, a number of ranitidine preparations were recalled from the market. In an announcement made on 16 September, EDQM stated that they would, together with the European Medicines Agency EMA, set up a number of measures to deal with the nitrosamine issue.

At the 22nd APIC/CEFIC Conference in Prague from 23-25 October, EMA and EDQM speakers will present the most recent developments in GMP and authorisation regarding active pharmaceutical ingredients, also broaching the issue of nitrosamine contamination. You will receive first-hand information on measures which have already been planned or put into practice in order to prevent nitrosamine contamination. Further information on the event can be found on the APIC/CEFIC Conference website.

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