Mylan Warning Letter Exposes Challenges In Valsartan Supply Chain Chemistry

Nitrosamines taint Mylan’s valsartan API solvent recovery, whether outsourced or in-house; firm mulls US FDA's request for ‘material systems review.’

Warning Rubber Stamp
The US FDA warns its way into the pharma supply chain.

A warning letter to Mylan NV is yet another indication that in response to last year’s discovery of carcinogenic nitrosamines in active pharmaceutical ingredients for certain blood pressure medications, US Food and Drug Administration investigators are turning their attention further up the pharmaceutical supply chain.

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