ECA新闻：缬沙坦：什么导致了污染？

 翻译：JULIA  来源：Julia法规翻译25.07.2018Valsartan: what caused the contamination?缬沙坦：什么导致了污染？After the recent supply shortages of medicinal products containing the API ibuprofen, there are now massive problems with Valsartan products.继最近的含API布洛芬的药品供应短缺事件之后，现在缬沙坦药品又面临大问题。What's known so far is that the API has been contaminated with N-nitrosodimethylamine (NDMA) during production. This concerns the deliveries by the Chinese manufacturer Zhejiang Huahai Pharmaceutical. Apress release by the German Federal Institute for Drugs and MedicalDevices (BfArM) states that the WHO's and EU's International Agency for Research on Cancer classified the substance as "potentially carcinogenic for humans".截止目前已知的是该API在生产过程中被N-二甲基亚硝胺（NDMA）污染 ………………………………