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New drug plant gets USFDA approval

Published by Steve Coleman on May 15, 2012

Bristol-Myers Squibb Company has received approval from the US Food and Drug Administration to start producing a new rheumatoid arthritis medication at its Devens, Mass. site.

The drug maker says it plans to start producing ORENCIA at the facility, a state-of-the-art bulk biologics plant that employs an estimated 300 workers, including scientists, engineers and bioprocess operators.

"The approval of our Devens site is an important milestone for Bristol-Myers Squibb as part of our strategic focus on delivering innovative biologic medicines for patients with serious disease," said Lou Schmukler, president, Global Manufacturing & Supply, Bristol-Myers Squibb in a news release. "The increased manufacturing capacity from the Devens site will support market demand for ORENCIA and positions us well for future production of additional biologic medicines."

Bristol-Myers Squibb currently manufactures its biologic medicines in a company-owned facility in Syracuse, NY and through third party suppliers. The drugs are finished and packaged at a plant in Manati, Puerto Rico. The firm plans to turn Syracuse into a center of excellence in process development and early product launch for its biologic medicines.

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