The FDA says a combination of conditions, including certain chemicals, processing conditions and production steps, can lead to the formation of the NDMA impurity during manufacturing. (FDA)
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.
In an update on the global recall of the contaminated ingredient, the FDA says Prinston Pharmaceuticals contacted the FDA June 19 to report it had stopped making its blood pressure medicines after detecting N-nitrosodimethylamine (NDMA) in the API manufactured by Zhejiang Huahai Pharmaceutical (ZHP).