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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

 
• By Bowman Cox

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.

A US FDA inspection report provides hints about why a change in the manufacturing process at a Chinese pharmaceutical company six years ago may have escaped scrutiny that could have alerted the company and its customers years ago to the presence of a genotoxic impurity in valsartan active pharmaceutical ingredient.

The situation comes to light unfortunately just as industry is working to convince regulatory authorities to agree to an International Council on Harmonization Q12 guideline that would let manufacturers handle...

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