The Quality Lowdown: The More Things Change …
FDA on Zhejiang Huahai valsartan; EMA on Hetero Drugs and other sartans; Micro brew lab; Fagron API; FDA's Mexican soap aria
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.
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FDA Warning Letters Hit Three Repackers For Failing To Identify Original API Makers
The US FDA’s concerns about the transparency of the pharmaceutical supply chain surfaced in three recent drug GMP warning letters to drug repackers of active pharmaceutical ingredients who failed to disclose the names of the API manufacturers to their customers. Janet Woodcock, director of the agency's drug center, called such lack of transparency a "real threat" to public health that must be addressed quickly.
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.
The Quality Lowdown: A Week Of International Intrigue
Or perhaps it's been a week of intriguing international events in global drug quality, as an international group works to ratchet up global standards, regulators aim to ease the coming UK/EU divorce and the US and China play their hands in a tariff poker match. Meanwhile, US FDA looks to avert labeler code crisis, Quebec API firm comes clean about missing identity testing, and US firm recalls drug product based on FDA’s API supplier inspection findings.