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  • [FOCUS]We expect the MFDS to act wisely on impurity measures
  • by Chon, Seung-Hyun | translator Choi HeeYoung | Apr 22, 2020 06:02am
At the end of September last year, when the MFDS decided to stop selling all products of the anti-ulcer drug ¡°Ranitidine,¡± the pharmaceutical industry reacted strongly.

The MFDS decided to withdraw because Ranitidine has unstable properties and is always exposed to the risk of carcinogenic substance 'N-nitrosodimethylamine (NDMA)'. The pharmaceutical industry complained strongly about tough measures in Korea, saying that we have not yet concluded whether or not the drug is harmful, and it is reasonable for NDMA to recover only the products in question that have been overdetected.

At the time, in the United States and the EU, only the manufacturing number of products exceeding NDMA was recovered. Nevertheless,
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