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FDA has approved the Ash Steven’s manufacturing facility in Riverview, MI for the manufacture of Amotosalen.
Ash Stevens, a provider of global contract pharmaceutical drug substance development and API manufacturing services, announced that FDA has approved the company’s manufacturing facility in Riverview, MI 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 pathogenreduced plasma and platelet components in order to reduce the risk of transfusion-transmitted infection.
This represents ASI’s twelfth manufacturing approval for an innovator or new chemical entity drug.
Source: Ash Stevens