EU expands look at Zhejiang Huahai as impurities show up in other 'sartans'

The European Medicines Agency is expanding its investigation into APIs made by China's Zhejiang Huahai Pharmaceuticals. (xUnionManx/CC BY 2.0)

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.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

RELATED: EU regulators blast China’s Zhejiang Huahai over valsartan API mess

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.

RELATED: Actually, it's just one site: FDA corrects previous word on embattled valsartan maker's ban

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.

Suggested Articles

Industry watchers have been speculating about just how high Novartis would price gene therapy Zolgensma. And now, they have an answer.

The WHO’s role in part is to provide prescribing guidance without an eye on profits. What happens when that guidance is tainted by private money?

After 19 sales reps left Amgen to help Karyopharm launch a rival multiple myeloma drug, Amgen sued. Now Karyopharm wants the suit thrown out.