Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Manufacturing Change OK’ed for Januvia, Glactiv to Address Nitrosamine Impurities
The Japanese health ministry has approved regulatory changes to the manufacturing method of the DPP-4 inhibitor Januvia/Glactiv (sitagliptin) to hold down nitrosamine impurities called Nitroso-STG-19 (NTTP) below the acceptable intake limit. MSD and Ono Pharmaceutical, the manufacturing authorization holders of…
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