Acta Scientific Pharmaceutical Sciences (ISSN: 2581-883X)

Perspective Volume 4 Issue 6

Nitrosamine Impurities in Pharmaceutical Drugs

Tabrez Shaikh*

Lab Manager at Indoco Research Centre, Navimumbai, Maharashtra, India

*Corresponding Author: Tabrez Shaikh, Lab Manager at Indoco Research Centre, Navimumbai, Maharashtra, India.

Received: January 28, 2020; Published: June 01, 2020


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.





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


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