Elemental impurity risk management can help biomanufacturers to maintain regulatory alignment and ensure patient safety.

FDA inspectors last month spent two weeks inspecting the plant of the Chinese API maker after learning its valsartan contained an impurity that is a suspected carcinogen. Inspectors had been in the ...

The global recall of valsartan has now extended to Pfizer and to Japan, via Mylan and India. According to a translated copy of its announcement, Pfizer’s Tokyo-based Japanese subsidiary said it is ...