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The Reaction To Valsartan Impurities: More Scrutiny, More Testing And Tighter Limits

Potent Carcinogens Stir Up Anxieties Over Unknown Unknowns In Pharmaceutical Process Chemistry

 
• By Bowman Cox

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.

man in a white robe and mask makes notes standing in the shop

The regulatory consequences of last year’s discovery that carcinogenic impurities called nitrosamines tainted a major supplier’s active ingredient for a popular blood pressure medication are becoming clear.

There will be greater scrutiny, more testing and tighter limits not only for that medication, valsartan, but also for other...

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