The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have reported the presence of a second impurity in valsartan products.
The new impurity is called N-Nitrosodiethylamine (NDEA) and it has been found in several batches of drugs with valsartan as the active pharmaceutical ingredient (API).
Both the European and US regulatory authorities recalled certain valsartan drugs in July this year after finding traces of a potential human carcinogen, N-nitrosodimethylamine (NDMA) in the products.
NDEA is also a known animal and suspected human carcinogen. The FDA discovered this impurity in three lots of Torrent Pharmaceuticals鈥� recalled valsartan products.
In addition, Zhejiang Huahai Pharmaceuticals (ZHP) reported the presence of NDEA in multiple batches of its valsartan API.
The FDA said it would re-test all valsartan API and products, including the recalled products and those being marketed in the US. NDEA was observed in select ZHP valsartan API, and in 160mg and 320mg tablets made by Torrent using ZHP鈥檚 API.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataHowever, not all products formulated using the ZHP valsartan API contain the NDEA impurity.
EMA is also assessing whether NDEA is an impurity in valsartan products marketed in Europe.
FDA commissioner Scott Gottlieb said: 鈥淎s we continue to investigate the root cause of the impurities found in products that contain valsartan, our scientists are testing these products to better understand these impurities and to ensure they鈥檙e not present in other products.
鈥淲e鈥檒l also continue to work with global regulatory agencies to learn as much as we can about how these impurities came about and how they may affect patients鈥� health around the globe.鈥�
According to EMA, the life-time risk of cancer in patients who used affected valsartan drugs is low. People who have taken lower doses or used the medicine for shorter duration are considered to be at an even lower risk.
