Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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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