Alcami Launches API Center Of Excellence

Alcami, a contract development and manufacturing organization for active pharmaceutical ingredients (API) and drug products, has launched a Center of Excellence at its API development and manufacturing facility in Germantown, Wisconsin.

Previously announced capability extensions in controlled substances and highly potent API (HPAPI) will be serviced by the Center of Excellence. In June 2017, the company received US Drug Enforcement Administration bulk manufacturer registration. HPAPI capability implementation is in its final phase with two current good manufacturing practice production suites equipped with engineering controls designed to meet the established occupational exposure limit of minimally 0.03 micrograms per cubic meter. The company initiated process development for its first HPAPI program in the second quarter of 2017 and plans to begin manufacturing in the fourth quarter of 2017 with a pipeline of programs to follow.