The deal fits with Siegfried’s experience of manufacturing controlled substances and capacity to perform exclusive synthesis. Process transfer and manufacture will occur at Siegfried’s site on Pennsville, New Jersey, US.
Production is expected to begin after Siegfried has gained approvals from the US Drug Enforcement Administration (DEA) and US Food and Drug Administration. Also, the manufacturing process needs to be transferred from Jazz’s current supplier.
Xyrem is an FDA approved treatment for excessive daytime sleepiness and cataplexy in adult patients with narcolepsy.