Korean drug manufacturers are taking voluntary action by recalling or suspending the sales of tamsulosin, citing potential NDSRI impurity, N-Nitroso-tamsulosin concern

Nitrosamines in the News
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https://www.koreabiomed.com/news/articleView.html?idxno=21377

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Any knowledge of the limit that manufactures have been working against?
Prof @ymleefn any insights?

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EMA CMDh requested to NcWP for N-nitroso tamsulosin AI limit derivation in its April 2023 meeting. So its AI is in progress work…

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In Australia, the TGA has set a limit of 18ng per day

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Health Canada published a limit of 18ng per day.

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@Rafa @hgajjar Thank you for the AI update

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Additionally ANVISA also include Nitroso tamsulosine in its recently updated (Version 3) guidance on Control of Nitrosoamine impurities with same AI i.e 18 ng/day as like health Canada and TGA

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