Enforcement Actions Against Sartan Manufacturers

BARBARA W. UNGE | October 31, 2019

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Health authorities worldwide have overseen the recall of many ‘sartan’ products in the past few years.  These recalls began in the US as early as 2013 with a recall of product by Teva Pharmaceuticals.  Authorities in the US, EMA, Canada, and Australia, just to name a few, have taken enforcement actions and implemented drug product recalls. Because the impurity originated with the API, and because the generic version of the drug(s) in question are manufactured by a variety of firms, this impacts many products from many companies.  While the initial problem began with a valsartan API, studies have demonstrated that this may include many other ‘sartan’ products and other related nitrosamine impurities.

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Shasun

Shasun Pharmaceutical Division develops & manufactures formulations for solid dosage products. Shasun is a vertically integrated formulations partner for the pharmaceutical industry and is focused on Europe, North America, Japan and other regulated markets. Its services include formulation research & development activities, analytical method development and validation, scale-up & technology transfer, clinical supplies manufacturing to full scale commercial manufacturing of oral solid dosage forms.

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