Aptuit LLC has expanded its existing 1600L scale API capability and commercial GMP API license, investing in scale and capabilities in formulation development, analytics and clinical manufacturing to serve Phase III and beyond, as well as a commercial GMP license for drug product.
 
Aptuit has added lab scale nanomilling; hot melt extrusion, and spray drying equipment including SEDDS/SMEDDS technology. The Phase II GMP production scale will increase to Phase III and commercial levels, with additional shift cycles, capsuling machines, and a new pan-coating machine.
 
Aptuit’s Dr. Goldman said, “Customers have noted our unique single source high quality fully integrated solution for API and drug product up to Phase II scale. They wish to maintain consistency of scientific excellence, and avoid risk of technology transfer at a critical phase in product development.  We have now received many requests to support programs to Phase III and beyond NDA filing to product launch.  The expansion of capacity, numerous capital investments and adding GMP license is part of our strategy to leverage our core competency of integrated early Phase CMC to fully integrated CMC at commercial scale. We will deliver these services from our fully integrated CMC facilities in Verona, Italy , and Oxford, UK .”