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Impurity data on schizophrenia and asthma drugs submitted

By Chon, Seung-Hyun | translator Alice Kang

22.06.08 06:20:10

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Companies submit data on possibility of quetiapine impurities by May 27th

To submit data on distributed products by July¡¦ no products were recalled due to excess impurities

Companies also complete submitting test results on Montelukast ¡¦ MFDS ¡°Will make follow-up measures after review¡±


Pharmaceutical companies are submitting results of their impurity inspections on the schizophrenia treatment ¡®Quetiapine¡¯ and asthma and allergic rhinitis treatment ¡®Montelukast¡¯ one after another. As of now, no product has been recalled due to excessive impurities, and the health authorities plan to take follow-up measures after reviewing the drug companies' impurity inspection data.

According to industry sources on the 7th, pharmaceutical companies submitted data on their schizophrenia treatment ¡®Quetiapine¡¯ to the Ministry of Food and Safety by May 27th. The data contained the companies¡¯ evaluation of the possibility N-Nitroso-Aryl Piperazine (NNAP) impurities, process safety review data, pro

Chon, Seung-Hyun(1000@dailypharm.com)
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