What Are Nitrosamines and Why Is The Industry Concerned?
Since 2018, the pharmaceutical industry has been closely monitoring nitrosamines, especially NDMA, following their discovery in certain batches of Valsartan, a high blood pressure treatment produced by Zhejiang Huahai Pharmaceutical (ZHP). Valsartan, an angiotensin II receptor blocker, helps regulate blood pressure by inhibiting these receptors, which leads to the relaxation and widening of blood vessels, coupled with a decrease in sodium retention. This discovery ultimately led the European Medicines Agency (EMA) and the FDA to broaden their scrutiny of pharmaceutical manufacturing processes and products with the aim of enhancing patient safety by evaluating contamination levels and ensuring impurity levels remain within acceptable limits. Since the presence of hazardous substances is not limited to inherently risky products but also extends to those that should not contain these dangerous elements, this situation has led to calls for more rigorous quality control measures by regulatory bodies to safeguard patients.