FDA, EMA report presence of new impurity in valsartan produced at Huahai

By PharmaCompass

2018-09-20

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The valsartan contamination saga continues to rock the world of pharmaceuticals. In July this year, blood pressure drug valsartan, produced by China's Zhejiang Huahai Pharmaceutical Co. Ltd, was found to contain traces of N-nitrosodimethylamine (NDMA), a probable human carcinogen, due to a production change in 2012. The findings have prompted recalls in more than 50 countries.

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The US Food and Drug Administration’s (FDA) latest testing of products shows an additional unexpected impurity in three lots of Torrent Pharmaceuticals’ recalled valsartan drug products.

This second impurity — N-Nitrosodiethylamine (NDEA) — is a known animal and suspected human carcinogen. These Torrent products were included in the company’s recall on August 23, 2018.

NDEA has been detected in valsartan made by Huahai using its previous manufacturing process, before changes were introduced in 2012. Both NDEA and NDMA belong to the class of nitrosamines.

EMA is now assessing the impact of NDEA, in addition to assessing the impacts of NDMA. It is also looking for NDEA that had been detected in products produced before 2012.

“Data on levels of NDEA are currently very limited, and EMA will provide further information on whether its presence impacts the risk assessment once more information becomes available,” EMA said in a statement.

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