Ash Stevens to Manufacture Amotosalen API
PTSM: Pharmaceutical Technology Sourcing and Management
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
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
Drug Solutions Podcast: Emerging Methods of Vaccine Administration and Distribution
June 20th 2023Michael Schrader, CEO and co-founder of Vaxess, discusses the latest on vaccine administration and different ways the pharmaceutical industry can distribute these products with Pharmaceutical Technology editor Jill Murphy.
FDA Grants Full Approval for Symptomatic Tenosynovial Giant Cell Tumor Treatment
February 18th 2025Tenosynovial giant cell tumor (TGCT) is rare and non-malignant, forming in or near joints, but which if left untreated can cause damage to joints and surrounding tissue, potentially leading to significant disability.
