FDA OKs Ash Stevens’ Facility for Amotosalen Production
Ash Stevens, Inc. (ASI), a provider of contract pharmaceutical drug substance development and active pharmaceutical ingredient (API) manufacturing services, reports that the US Food and Drug Administration (FDA) has approved ASI’s manufacturing facility in Riverview, Michigan for the manufacture of amotosalen, the API in Cerus Corporation’s Intercept Blood System. The Intercept Blood System recently received FDA approval for ex vivo preparation of pathogen-reduced plasma and platelet components in order to reduce the risk of transfusion-transmitted infection.
Source: Ash Stevens
