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“The company has already instituted additional quality controls and expects to be able to consistently reduce NTTP levels to meet the long-term acceptable daily intake level this year,” Merck said.
After a potential carcinogen, Nitroso-STG-19 (NTTP), was found in samples of Merck’s sitagliptin-containing diabetes drugs, the New Jersey drugmaker says it has identified the root cause of the nitrosamine impurity and hopes to fix the issue this year.