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Impurity detected Cozaar is excluded from recovery

By Lee, Tak-Sun | translator Choi HeeYoung

21.12.07 16:01:42

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Generic risk and exposure

Difference in the raw material process, such as whether to use Azide or not

It's hard to interpret the difference in quality between original and generic


In the case of a single drug in Losartan formulation where impurities were detected, it is interpreted that only the original drug was excluded from recovery, exposing the risk of domestic generics again.

It is analyzed that the reason why the original drug was excluded from the collection list is because the raw material process is different. The MFDS announced on the 7th that it will recover 295 items (98 companies) of Losartan drugs that have been excessively detected with Azido-based impurities.

The majority of the 306 (99 companies) items in circulation are included. As impurities were confirmed to be within the daily intake allowance, 11 items were excluded from the collection, 5 it

Lee, Tak-Sun(hooggasi2@dailypharm.com)
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