Shandong Sihuan Pharmaceutical Co.,Ltd.
EU expands look at Zhejiang Huahai as impurities show up in other 'sartans'
A global recall may get expanded beyond valsartan as regulators continue to find potentially cancer-causing impurities in other “sartan” products. European regulators say they have found the same impurity discovered in valsartan in both losartan made by Hetero Labs and now irbesartan by Aurobindo Pharma.
The European Medicines Agency (EMA) said on Monday that low levels of N-nitrosodimethylamine (NDMA) were found earlier this month in the irbesartan made by Aurobindo. EU authorities suspended import of the Indian company’s irbesartan products and said they are considering whether to recall them from pharmacies as a precaution.
The global recall of valsartan began this summer when the FDA and EU learned that the valsartan API made by China’s Zhejiang Huahai Pharmaceuticals contained potential carcinogens NDMA and N-nitrosodiethylamine. The agency and Huahai had attributed the impurities to a manufacturing process change the company made years ago.
EU authorities extended their look into candesartan, irbesartan, losartan and olmesartan after discovering an impurity in the losartan made by Hetero Labs but didn't say where it originated. While the two impurities have so far been found only in Huahai’s valsartan API, the EU said it is going back to take a closer look at the Chinese maker's other APIs.
The FDA has banned APIs coming out of Huahai’s manufacturing site in Chuannan. The ban came after FDA officials turned up shortcomings in the company’s manufacturing process at Chuannan during an inspection from July 23 to Aug. 3. The FDA lambasted the company in an 11-observation Form 483 for making the manufacturing process changes without conducting proper risk assessments. The FDA has also extended its probe into other APIs that might contain impurities.