API Makers Must Control Dangerous Impurities Better, FDA Compliance Official Says
The compliance chief for FDA’s center for drugs said API makers need to do a better job of testing their products for impurities to avoid exposing patients to safety risks, as has occurred with at least one supplier’s valsartan API.
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FDA official says OTC firms that have not been inspected before and have limited to no knowledge of US GMP requirements appear to be driving the upward surge in drug GMP warning letters issued by the agency since January. One especially “scary” warning letter trend is manufacturers not testing incoming ingredient for diethylene glycol (DEG) or ethylene glycol (EG). Over the years, DEG contamination in pharmaceuticals has resulted in lethal poisoning incidents around the world.
US FDA inspection offers hints that Zhejiang Huahai’s genotoxic valsartan impurity could have been caught earlier, while EMA expands its quality review to other sartans that contain the same trouble-prone tetrazole ring. A micro lab will have to jettison its microbrewery, and compounding supplier Fagron must ID its API sources.
Lupin’s Tarapur API site for ‘sartans’, including valsartan, has been cleared of NDMA concerns by the US FDA, and the Indian firm has also provided analytical reports to EU authorities to affirm its case. The FDA inspection, though, did end with a lone observation at the site.