Is Nitrosamine Impurities Posing the Regulatory Threat?
The pharmaceutical industry is no stranger to challenges around quality, safety, and compliance. In recent years, nitrosamine impurities have emerged as a significant regulatory concern, drawing global attention and leading to recalls, scrutiny, and tightening of quality control mechanisms. As regulatory agencies such as the US FDA, EMA, and CDSCO intensify their oversight, the industry … Read more