Probable Carcinogen Found Haunting More Firms’ Valsartan API
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.
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Some filling lines and API plants fared poorly in post-pandemic inspections, with shortfalls identified in sterility assurance and impurity control. Zhejiang Tianyu and System Kosmetik got warning letters. Alvotech, Cipla and Aurobindo got Form 483 reports posted on the FDA website.
Sartans Recalled In UK As Further Impurity Is Confirmed
Certain batches of two angiotensin II receptor blockers, or sartans, are being recalled in the UK after an impurity that can potentially increase the risk of cancer over time was detected.
US FDA Warning Letter Hits Huahai For Failure To Prevent Valsartan Contamination
Zhejiang Huahai should have realized its valsartan API was tainted by the probable carcinogen NDMA, FDA says in warning letter, despite earlier statement from agency leadership to the contrary.