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



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

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

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

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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