Japan relies almost entirely on China for the APIs of β-lactam antibiotics. These drugs are essential for treating infectious diseases…
REGULATORY
MHLW to Set AI Limit for Atomoxetine’s Nitrosamine Impurities at 100 ng/Day
Japan will set an acceptable intake (AI) limit of 100 ng per day for N-nitroso-atomoxetine, a potentially carcinogenic nitrosamine, for the ADHD drug atomoxetine after the substance was found in some of the API used in a product marketed by…
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