FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Mylan’s Valsartan Blocked From EU Medicines Due to NDEA Impurity

Nov. 26, 2018

The EU restricted the use of Mylan’s valsartan in EU medicines, after discovering NDEA impurities in product batches manufactured at the company’s Hyderabad, India facility.

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has suspended the drugmaker’s certificate of compliance with European quality standards, barring the use of valsartan product from the Hyderabad facility in EU medicines.

National EU authorities have also begun to recall impacted batches that contain the valsartan in question and are testing for contamination. Companies that market sartan medicines in the EU have been asked to test their products for impurities.

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