Valsartan probe teaches FDA lesson about impurities in manufacturing

31st August 2018 Uncategorised 0

It was a U.S. drugmaker that first alerted the FDA that the valsartan API it got from a Chinese ingredient maker contained a potentially dangerous impurity. And in the process of investigating, the FDA learned something it hadn’t known: that a combination of manufacturing conditions could lead to formation of the NDMA impurity in an API.

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Source: fierce