The U.S. Food and Drug Administration (FDA) issued a warning letter to an Indian manufacturer, Lantech Pharmaceuticals, for detecting N-Nitrosodiethylamine (NDEA) and N-Nitrosodimethylamine (NDMA) impurities in the Valsartan Active Pharmaceutical Ingredient (API), in an investigation convoyed recently.
Although the investigation focused on NDEA, there were NDMA samples that were collected from its equipment. Lantech acts as a contract solvent recovery facility for Valsartan Active Pharmaceutical Ingredient (API) manufacturers and has also failed to incorporate receiving and charging tanks for non-dedicated storage used in its solvent recovery operations.