FDA and EMA in mid of June 2018 became aware of the presence of Nitrosamine impurity in generic drug substances and drug product, valsartan an angiotensin II receptor blockers (ARBs) or ‘Sartans’ class medicines which is used to treat patients with hypertension (high blood pressure) and heart. Later, various Nitrosamine impurities were detected in other sartan and non-sartan drug substances and drug products. This announcement leads to voluntarily recall hundreds of batches of these generic versions by pharmaceutical distributor worldwide.

References

Citation

Citation: Tabrez Shaikh. “Nitrosamine Impurities in Pharmaceutical Drugs".Acta Scientific Pharmaceutical Sciences 4.6 (2020): 27.

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Copyright: © 2020 Tabrez Shaikh. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.