FDA approves Merck & Codexis’ Januvia API production process
The FDA has approved a process co-developed by Merck & Co and Codexis for manufacturing the Januvia API, sitagliptin.
US Food and Drug Administration (FDA) approval allows Merck to use the process it designed with Codexis for efficient, environmentally friendly active pharmaceutical ingredient (API) production.
“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”, Peter Strumph, interim-CEO at Codexis, said.
By using the process Codexis claims Merck can increase yield while cutting waste by-products.
