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Probable Carcinogen Found Haunting More Firms’ Valsartan API

 
• By Bowman Cox

As Zhejiang Huahai works to rid its valsartan API manufacturing process of NDMA impurity, two competitors also have launched recalls after discovering the probable carcinogen in their valsartan API. Meanwhile, US FDA confronts Huahai over handling of impurities that visited chromatograms in the form of ghost peaks.

Southeastern China rock formations shrouded in fog
Zhejiang Huahai was not the only API maker visited by unexpected peaks • Source: Wikimedia Commons

Recalls of valsartan blood pressure medication are spreading as additional manufacturers of the active pharmaceutical ingredient are detecting the probable carcinogen N-nitrosodimethylamine (NDMA) in their products.

Recalls could broaden even further as US FDA investigates whether NDMA appears in other types of angiotensin II receptor blockers.

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