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FDA Approves Ash Stevens as API Manufacturer for Takeda’s Multiple Myeloma Drug

November 26, 2015
Pharmaceutical Technology Editors

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-12-02-2015, Volume 11, Issue 12

Ash Stevens has received FDA’s approval to manufacture Takeda’s multiple myeloma drug, ixazomib, at its facility in Riverview, Michigan.

CMO Ash Stevens announced that it has received FDA’s approval to manufacture Takeda’s multiple myeloma drug, ixazomib, at its facility in Riverview, Michigan. Ixazomib is an oral proteasome inhibitor used in combination with leanlidomide and dexamethasone for the treatment of multiple myeloma. According to the company’s CEO and president, Stephen Munk, this is the second novel API that Ash Stevens is manufacturing for Takeda.

The CMO has received more than a dozen FDA manufacturing approvals for innovator APIs to date, 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. Its portfolio includes process development and scale-up; cGMP manufacturing; development and cGMP manufacture of a range of APIs including highly potent APIs using barrier-isolation technology. Ash Stevens also provides analytical services-such as method development and qualification, stability studies, and qualification of reference standards-and regulatory support for all phases of drug development and manufacturing.

Source: Ash Stevens