After Huahai’s valsartan, Aurobindo stopped from supplying irbesartan into Europe

By PharmaCompass

2018-10-18

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The detection of impurities – N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) – in valsartan from Zhejiang Huahai Pharmaceuticals over the last few months has led to an EU-wide review of all valsartan medicines. The review was subsequently extended to other ‘sartan’ medicines when very low levels of NDEA were found in losartan made by Hetero Labs in India.

European regulators say they have found the same impurity discovered in valsartan in both losartan made by Hetero Labs and now irbesartan manufactured by Aurobindo Pharma.

Irbesartan is the third sartan to be found with low levels of NDEA. On October 8, 2018, the European Directorate for the Quality of Medicines & HealthCare (EDQM) suspended Aurobindo Pharma’s CEP (Certificate of Suitability), effectively stopping the supply in the EU of medicines containing irbesartan from this company.

National authorities in the EU are also considering whether to recall medicines containing Aurobindo Pharma’s irbesartan from pharmacies as a precaution.

“The review into the presence of impurities in sartans and their potential effects in patients is ongoing. EMA will continue working with national authorities, international partners and EDQM and will provide updates as more information becomes available,” an EMA statement said.

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