DETROIT, MI (May 24, 2004) – Ash Stevens Inc. received approval from the U.S. Food & Drug Administration (FDA) to manufacture the bulk drug substance 5-Azacitidine for Pharmion Corp.’s Vidaza, a treatment for patients suffering from Myelodysplastic Syndromes (MDS), the company said last week.
The FDA approved Vidaza for treatment of all five MDS subtypes.
The manufacturing of 5-Azacitidine will commence immediately at Ash’s Riverview, Michigan, plant, the company said. The 30,000-square-foot facility includes reaction vessels with capacities up to 500 gallons and a variety of product isolator systems, including a Walker-Carlisle containment isolator for high potency drug substances, the company said.
Ash Stevens, headquartered in Detroit, is a pharmaceutical chemical research organization.
