The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have named Torrent Pharmaceuticals and Zhejiang Tianyu, respectively, as part of wider action to limit the spread of contaminated valsartan.
For Torrent Pharmaceuticals, the FDA announced it had issued a voluntary recall for 14 lots of valsartan/amlodipine and valsartan/amlodipine/hydrochlorothiazide tablets. The active pharmaceutical ingredient (API) used in its products was supplied by Zhejiang Huahai.
Zhejiang Huahai was at the centre of the global recall of valsartan products last month, after EMA inspectors discovered that the company’s API contained an impurity known as N-nitrosodimethylamine (NDMA). This particular chemical has been listed as a probable carcinogenic.
Earlier this month, it came to light that Zhejiang Huagai had received two Form 483s from the US regulator, in 2016 and 2017
The FDA announced that Torrent had not received any reports of adverse events related to the recall, but was instead a precautionary measure.
At the time of publishing, Torrent Pharmaceuticals had not responded to a request for comment.
Another Chinese company involved
Widening the possible sources of the contaminated API is the EMA’s announcement that Zhejiang Tianyu is no longer authorised to manufacture the same ingredient. This decision was reached after the EMA concluded that the company had also produced the valsartan active substance with NDMA contamination.
However, the Agency noted that levels of NDMA were “considerably lower than levels found in the active substance from Zhejiang Huahai”. Despite this, the Agency was concerned enough to suspend the company’s certificate by the European Directorate for the Quality of Medicines and Healthcare.