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Ash Stevens Approved as API Manufacturer for Ixazomib Citrate, 3rd Approval in 24 Months

Ash Stevens, Inc. (ASI), a leading provider of global contract pharmaceutical chemical development and API (Active Pharmaceutical Ingredient) manufacturing services, announced in late 2015 U.S Food and Drug Administration (FDA) approval for their Riverview, Michigan facility to manufacture the API Ixazomib, an oral proteasome inhibitor indicated in combination with leanlidomide and dexamethasone for the treatment of patients with 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.” Two other recent approvals for Ash Stevens were for Amotosalen (2015) for ex vivo preparation of pathogen- reduced plasma and platelet components, and for Ponatinib (2013) an oncology API.

Ash Stevens Inc. is a full service pharmaceutical Contract Development and Manufacturing Organization (CDMO) 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. 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.

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