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Identification of nitrosamine impurities, probable carcinogen, in multiple medicinal drug products has prompted manufacturers to recall and cause disruptions for physicians and tens of millions of patients around the world. The presence of nitrosamine impurities intrigued, FDA and other international regulators to conduct a detailed analysis of these impurities in affected active ingredients and medicines. Agencies suggested that the manufacturers should assess their medicinal products for nitrosamine impurities content and take proper steps to mitigate risks. In the meantime, European Agency has suggested to marketing authorisation holders to submit a risk evaluation report within 2021. Since the agencies have strict standards for safety, effectiveness, and quality, manufacturers should follow strictly good manufacturing process during manufacturing and should perform the risk assessment and mitigation. Further they should work on formulation so that no nitrosamine impurities can be present in medicine. Overall, agencies, patients, and manufacturers are evaluating risks and chemistry of the medicinal products to find a solution.Keyword:
Nitrosamine impurities, ranitidine, valsartan, metformin, Food and Drug Administration (FDA), nitrosodimethylamine (NAMA), carcinogenic, health regulatory authorities
Journal: Medical Glory Vol 5, Issue No 1, January-March, 2021
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