[Reporter’s view] We must prepare for the post impurity era
By Kim, Jin-Gu | translator Choi HeeYoung
20.05.27 06:10:14
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The situation wasn't the worst. Unlike Ranitidine, not all Metformin sales have been stopped. It is expected that the confusion of patients and the potential damage of pharmaceutical companies will not be greater than in the case of the Valsartan·Ranitidine crisis.
The MFDS decided to stop selling 31 of the 288 finished Metformin products in Korea on the 25th. The reason was the same as in the previous situation. N-nitrosodimethylamine (NDMA) was detected above the provisional management criteria.
As a result, the case of impurities, starting from Valsartan and Ranitidine to Metformin, has been closed. At present, there are no other ingredients that raise concerns about impurities.
Kim, Jin-Gu(kjg@dailypharm.com)
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