FDA Approves Process Co-Developed by Codexis to Produce Sitagliptin API

Codexis (Redwood City, CA) says that the U.S. FDA has approved a new process co-developed by Codexis for the manufacture of sitagliptin, the active pharmaceutical ingredient (API) in Merck & Co.’s (Whitehouse Station, NJ) Januvia, for the treatment of type 2 diabetes. The approved process indicates the potential for improving the overall increase in yield of sitagliptin, while significantly decreasing waste byproducts, Codexis says. Codexis develops industrial enzymes to enable the cost advantaged production of biofuels, bio-based chemicals, and...

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