Ash Stevens to Make Amotosalen API for Cerus

Jan. 29, 2015

Ash Stevens Inc., a provider of global contract pharmaceutical drug substance development and Active Pharmaceutical Ingredient (API) manufacturing services, announced that the FDA has approved its 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 (TTI).

“We are proud to be Cerus Corporation’s outsourcing partner for the development and manufacture of this important API," says Dr. Stephen Munk, president and CEO of Ash Stevens Inc. "We have had a collaborative and highly productive relationship with Cerus for many years and we are excited to help provide this innovative product to patients.”

This represents Ash Stevens Inc.’s 12th manufacturing approval for an innovator or NCE (New Chemical Entity) drug.