USFDA finds second impurity

October 15, 2018 0 By CH Unnikrishnan

The US FDA has found an additional unexpected impurity N-Nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient (API) valsartan.

NDEA, a known animal and suspected human carcinogen, was found in three lots of Torrent Pharmaceuticals’ recalled valsartan drug products, the USFDA said while updating the public on the agency’s ongoing investigation surrounding the recent voluntary recall of several drug products containing valsartan API. These Torrent products were included in the company’s recall on August 23, 2018

Like N-Nitrosodimethylamine (NDMA), which was found in the recalled valsartan products, NDEA is also formed from a specific sequence of manufacturing steps and chemical reactions.

In addition to the FDA’s testing, the agency will post a preliminary method for detecting NDEA. Manufacturers and global regulators can use this method to screen other products for the potential presence of this impurity.