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  • Pharmaceuticals are focusing on domestic actions for NDMA
  • by Chon, Seung-Hyun | translator Choi HeeYoung | Feb 6, 2020 06:30am
NDMA was detected in 2 of 10 items, all below baseline
The MFDS, "under investigation"
Investigations have shown that Metformin's impurity content is safe in the US and EU. In Korea, the Ministry of Food and Drug Safety has also begun inspections after deriving the test method.

The US Food and Drug Administration (FDA) announced on the website that some of the Metformin products sold under the FDA approval and carcinogenic substance 'N-nitrosodimethylamine (NDMA)' was detected, but the daily intake (96 ng) was not exceeded.

Of the 10 products examined, NDMA was detected only in six lots of two Metformin 1000mg ER & Metformin 500mg ER products by Actavis. Detection amount was 0.01 ~ 0.02 microgram (mcg) per tablet.

 ¡ã NDMA test results of 10 Metformin products conducted by FDA (Source: FDA)

The FDA said that the test did not confirm a sample of Metformin with NDMA det
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