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FDA approves new production process to manufacture Merck sitagliptin tablets

The FDA has approved a new production process co-developed by Codexis for the manufacture of sitagliptin, the active pharmaceutical ingredient in Merck's Januvia.

The production process is an environmentally friendly and indicates the potential for improving the overall increase in yield of sitagliptin, while decreasing waste byproducts, Codexis said.

Codexis interim chief executive officer Peter Strumph said, "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."

Codexis is a developer of industrial enzymes to enable the production of biofuels, biobased chemicals and pharmaceutical intermediates.