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  • Is MFDS going to suspend sales on nizatidine with no NDMA?
  • by Chon, Seung-Hyun | Nov 6, 2019 08:59am
Industry urges sales suspension to be more selective based on NDMA level
MFDS orders nizatidine usage record by each DMF number
Nizatidine with NDMA found in Japan and the U.S.
Pharmaceutical industry is walking on thin ice as the government initiated impurity investigation on stomach ulcer medicine. Now that the U.S. detected impurity in nizatidine, following a case in Japan, probability of finding impurity in nizatidine has gotten higher in Korea.

The industry is on high alert against the government¡¯s possible order to suspend sales of nizatidine drug without detecting any impurity, which was the case with ranitidine.

According to an industry insider, Ministry of Food and Drug Safety (MFDS) ordered pharmaceutical companies to submit complete nizatidine product manufacturing record and to test active pharmaceutical ingredient (API) chemically similar to the ingredient.

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