RIVERVIEW, Mich., Nov., 23, 2015 /PRNewswire/ -- Ash Stevens, Inc. (ASI), a leading provider of global contract pharmaceutical chemical development and API (Active Pharmaceutical Ingredient) manufacturing services, is pleased to announce the U.S Food and Drug Administration (FDA) has approved ASI’s facility in Riverview, Michigan for the manufacture of the API ixazomib, an oral proteasome inhibitor indicated in combination with leanlidomide and dexamethasone for the treatment of patients multiple myeloma who have received at least one prior therapy.
“Ixazomib is a novel, orally active drug, giving hope to certain patients suffering from multiple myeloma,” said Dr. Stephen Munk, CEO and President of Ash Stevens. “The rapid approval by FDA to manufacture this important drug validates our mission to use chemistry to improve the quality of life for people suffering from a variety of conditions. We are extremely proud to be manufacturing a second, novel API for Takeda.”
About Ash Stevens, Inc.
Ash Stevens Inc. is a full service pharmaceutical Contract Manufacturing Organization (CMO) offering comprehensive small-molecule drug substance development and cGMP manufacturing services. Founded in 1962 and headquartered in Riverview, Michigan, Ash Stevens has extensive experience developing and manufacturing Active Pharmaceutical Ingredients (APIs) for Life Science companies that develop innovator small-molecule therapeutics. Ash Stevens is a long-time provider of contract research services to the National Institutes of Health including the National Cancer Institute, and has participated in the development of many important drugs through these Government agencies. To date, Ash Stevens has received over a dozen FDA manufacturing approvals for innovator APIs, including four fast-track manufacturing approvals for the active ingredients in the drugs Velcade®, Vidaza®, Clolar® and Iclusig® as well as the API for the INTERCEPT Blood System. Services offered by Ash Stevens include process development and scale-up; cGMP manufacturing; development and cGMP manufacture of a variety of classes of APIs including highly potent APIs (HPAPIs) using barrier-isolation technology. In addition, Ash Stevens provides comprehensive analytical capabilities (including method development and qualification, stability studies and qualification of reference standards); and regulatory support for all phases of drug development and manufacturing. Ash Stevens facilities include capabilities from a recent plant expansion including vessels as large as 4,000 liters with a capacity to produce batches as large as 250 kilos.
For more information, visit www.ashstevens.comor contact Dr. James Hamby, Vice President of Business Development (jhamby@ashstevens.com).
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SOURCE Ash Stevens, Inc.
