Scilex announces successful FDA audit of enhanced ZTlido manufacturing facility

Scilex announced the successful completion of a Good Manufacturing Practices, GMP, inspection by the U.S. Food and Drug Administration, FDA, of the enhanced manufacturing facility of Oishi Koseido for ZTlido located in Tosu, Saga, Japan. This successful audit allows Scilex to continue commercializing ZTlido product manufactured at 250kg scale at Oishi’s facility. This facility is also the manufacturing site for SP-103 that recently completed trials in acute back pain and neck pain. “This successful FDA GMP inspection highlights the GMP and quality assurance of our partner Oishi’s manufacturing facility in Japan, which is essential as we scale the commercial production of ZTlido(R),” said Jaisim Shah, Chief Executive Officer and President of Scilex. “The successful FDA inspection for this enhanced manufacturing site marks an important milestone for Scilex that will enable us to increase our capacity to meet the growing demand for ZTlido.”