Don't Use Recycled Raw Materials In Valsartan And Other ARBs, US FDA Says
US FDA officials told manufacturers to beware of using reused solvents and catalysts to avoid carcinogenic impurities such as nitrosamines from leaching into valsartan and other ARBs used to treat high blood pressure. FDA has identified 40 nitrosamine-free ARBs to provide alternatives to patients and health care providers experiencing shortages caused by recent recalls of these products.
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Lantech’s solvent recovery operations expected to meet US drug GMP requirements due to risk of carcinogens in blood pressure medications.
The saga of tainted valsartan has taken another turn with an online pharmacy that tests its medications before dispensing them finding yet another probable carcinogen in lots of the blood pressure medication from multiple manufacturers. The pharmacy filed a citizen petition asking the US FDA to tighten its globally harmonized limit for the residual solvent.
In the months since US and EU authorities restricted Zhejiang Huahai’s market access over the discovery of nitrosamine impurities in its valsartan API, the broader regulatory consequences for drug manufacturers are coming into focus.