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  • MFDS to wait and see self-test results on metformin
  • by Chon, Seung-Hyun | translator Byun Kyung A | Dec 13, 2019 06:34am
MFDS hasn¡¯t made official order to pharmaceutical companies about metformin contamination
Basically encouraging self-investigation, applying new contamination risk management initiative
Full investigation could be ordered in case impurity found on exceeding level
 ¡ã Ministry of Food and Drug Safety (MFDS)

The government seems to have decided to encourage pharmaceutical companies to run their own impurity contamination test on metformin drugs. Unlike the ranitidine and nizatidine incidents, the government means to wait and see the companies¡¯ self-investigation results, rather than to take an action by itself. Basically, metformin would be the first substance to be applied with the recently unveiled impurity risk management initiative. However, the possibility still exists for the government to immediately call for sales ban and other follw-up measures, when a exceeding level of impurity is found in a product, either in Korea or overseas.

According to the industry source on Dec. 12, Korea¡¯s Ministry of Food a
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