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

September 29, 2018 By fiercepharma

The European Medicines Agency has piled onto China’s Zhejiang Huahai, finding its manufacturing out of compliance for the valsartan API that has been recalled globally after being found to contain a suspected carcinogen.

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

The action was posted Friday, the same day the FDA announced it has finally put the Chinese company on import alert, meaning it products are now banned from the U.S. The company primarily makes APIs and intermediates for of valsartan, which is used to make blood pressure drugs. 

A September inspection by the Italian Medicines Agency found essentially the same issues laid out in an FDA Form 483: that Huahai did not carefully evaluate the risks of changes to its manufacturing processes that led to the formation of the impurity. N-nitrosodimethylamine, a suspected cancer-causing agent, was discovered in Huahai’s APIs this summer.

When out-of-spec results were found by Huahai, it explained the results away and shipped products anyway. EU regulators said nine “Major” and eight “Other” deviations were identified.

The discovery has led to a global recall of more than half of all valsartan products on the market (PDF). The FDA said patients can still find untainted products (PDF) from other producers. While the levels of NDMA in ZHP’s valsartan API were trace amounts, they were considered unacceptable, the FDA has said.

The report said the joint inspection by the EMA and the European Directorate for the Quality of Medicines (EDQM) “was initiated as for-cause inspection in the context of the NDMA/NDEA Valsartan contamination issue. Nine “Major” and eight “Other” deviations were identified.”

It said Huahai’s APIs have already been banned from the EU, but that countries should consider banning its intermediates as well.

After the initial recall, the FDA started looking into the chemical class of “genotoxic impurities,” into which valsartan falls, and recently said it uncovered a second and unexpected cancer-causing impurity in three batches of the blood pressure medicine valsartan that were sold by Torrent Pharmaceuticals. The regulatory agency said the newest impurity to be found was N-Nitrosodiethylamine (NDEA), which is a known animal and suspected human carcinogen. The products tested were included in Torrent’s recall last month.

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