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API Makers Must Control Dangerous Impurities Better, FDA Compliance Official Says

 
• By Joanne S. Eglovitch

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.

Manufacturers of active pharmaceutical ingredients must control the risk posed by dangerous impurities before they are released to the public, Donald Ashley, director of the Office of Compliance in US FDA’s Center for Drug Evaluation and Research, told the Parenteral Drug Association/FDA conference in Washington Sept. 25.

Noting that one supplier’s failure to control genotoxic impurities in valsartan API have led to numerous recalls and posed possible...

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Novo, Lilly Ad Challenges Cause Discontinued Claims For Compounded GLP-1s

 
• By Sue Sutter

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