Health authorities have prepared new standards for managing impurities in Januvia, a diabetes treatment. Prior to the release of Januvia generics, pharmaceutical companies were requested to only ship products within the newly set standard. Pharmaceutical companies are busy with quality control by presenting a standard that is seven times stricter than the temporary acceptance standard applied at the time of the recall of Januvia impurity products. According to the industry on the 25th, the Ministry of Food and Drug Safety recently sent an official letter to pharmaceutical companies with instructions on safety measures and information on nitrosamine impurities in drugs containing ‘sitagliptin’.

The MF