Why is Metformin’s investigation expanded?
By Lee, Tak-Sun | translator Choi HeeYoung
20.06.10 06:20:42
가나다라
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Detects NDMA below the standard value in imported finished products without domestic raw materials
It was difficult because there were a lot of lot numbers
▲Namsu Kim, the chief explains the progress of NDMA in Metformin investigation in a briefing with reporters held at the MFDS in Osong on the 9th
The "detection of NDMA in metformin preparations" published by the MFDS is different from the previous cases. In particular, the difference is that NDMA was not detected in the raw materials.ertain raw materials were a problem in the case of Valsartan or Nizatidine. And, NDMA was also detected in raw materials in the case of Ranitidine.
However, in the case of Metformin, Nothing was found among 970 commercially available raw materials. Nevertheless, the MFDS prohibits the manufacture and sale of 31 drug products that have been detected in excess of NDMA by investigating the drugs.
In response, a briefing with reporters held at the Osong headquarters on the 9th, Nam-soo K
Lee, Tak-Sun(hooggasi2@dailypharm.com)
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