Mylan warned by US regulator over Indian facility

14 November 2019

The US Food and Drug Administration has sent a warning letter to Netherlands-incorporated drugmaker Mylan (Nasdaq: MYL) over procedures at an Indian manufacturing facility.

The letter comes in the wake of a recall of several drug products containing the active ingredient valsartan, which is used to treat high blood pressure and heart failure, due to an impurity, N-nitrosodimethylamine (NDMA).

Other firms have also been warned by the regulator following concerns over valsartan, including Aurobindo Pharma (BSE: 524804). In July, the FDA said the Indian firm was using solvents to produce drugs that with high levels of NDMA.

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