FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Blocks Aurobindo Pharma From Supplying Irbesartan

Oct. 23, 2018
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The European Medicines Agency has barred Indian drugmaker Aurobindo Pharmaceuticals from selling irbesartan in the EU as part of its ongoing review of impurities in sartan products used as active pharmaceutical ingredients in that pose a contamination risk to medicines that use them as ingredients.

The Aurobindo ban stems from the discovery of low levels of N-nitrosodiethylamine (NDEA), a carcinogenic organic compound, in the firm’s irbesartan.

EU authorities have increased scrutiny of Chinese API maker Zhejiang Huahai, the valsartan manufacturer linked to the original contamination of APIs used in blood pressure drugs. Specifically, they are increasing inspections of the company’s Linhai site to monitor its corrective measures.

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