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  • MFDS & FDA have different NDMA¡¯s follow-up measures
  • by Lee, Jeong-Hwan | translator Choi HeeYoung | Jun 2, 2020 09:13pm
The MFDS, order to prohibit sales and verify manufacturing process
Pharmaceutical industry "FDA allows inspection per batch, minimize damage by pincette regulation"
The domestic pharmaceutical industry has pointed out that the MFDS and the US Food and Drug Administration (FDA) have made unusually different follow-up measures over NDMA detection Metformin.

The MFDS caused an immediate and irreversible damage to pharmaceutical companies by disposing of manufacturing and sales prohibition along with the full recovery of items before the detection of impurities exceeding the standards, but FDA did not enforce the prohibition of sales other than the recovery of the existing distribution volumes. Some pharmaceuticals explain that there are aspects that minimize damage to the pharmaceutical industry through delicate regulation.

In particular, about the cause of NDMA detection, the MF
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