Codexis receives FDA approval for sitagliptin manufacturing process

Codexis, Inc. (Nasdaq:CDXS), a developer of industrial enzymes to enable the cost advantaged production of biofuels, bio-based chemicals, and pharmaceutical intermediates, today announced that the FDA has approved a new process co-developed by Codexis for the manufacture of sitagliptin, the active pharmaceutical ingredient in Merck's Januvia®.    

"FDA approval of this manufacturing process is a major milestone for Codexis," said Peter Strumph, Interim Chief Executive Officer. "This is another example of how our directed evolution technology can deliver well controlled, cost advantaged commercial pharmaceutical, biofuel, or bio-based chemical production processes."

The approved process, which won the Presidential Green Chemistry Award in 2010, is a more environmentally friendly and efficient production process than those used in the past. Specifically, it indicates the potential for improving the overall increase in yield of sitagliptin, while significantly decreasing waste byproducts.