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Cardinal Facility Gets FDA Approval To Manufacture Ovation Drug

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Cardinal Health, Inc. and Ovation Pharmaceuticals, Inc. received an approval letter from the FDA for Cardinal Health’s new sterile facility in North Raleigh, NC to manufacture Panhemati, an Ovation biologic therapy used to treat acute porphyria, a rare genetic disorder. The new facility currently has 82 employees and is expected to grow to 200 jobs for the Raleigh area when it reaches full capacity.

Jeffrey S. Aronin, president and chief executive officer of Ovation Pharmaceuticals said, “We felt it was important to invest in sustaining ongoing supply of this life-saving medication. This new, state-of-the-art manufacturing facility will ensure that patients suffering from this rare enzymatic disease get the treatment they need. With Ovation’s commitment to this underserved patient population and Cardinal Health’s sterile manufacturing expertise, we are well positioned to provide patients with an uninterrupted supply of Panhematin well into the future.”

“Ovation is leveraging multiple capabilities within Cardinal Health to simplify the manufacturing and packaging processes and get Panhematin into the hands of those who need it,” said Shawn Gallagher, vice president and general manager of Cardinal Health’s North Raleigh facility. “Panhematin is the first commercial drug to be manufactured at the new facility in North Raleigh, and this helps prepare the site for additional commercialization of products. The facility has capacity to support production of a range of other biopharmaceutical products.”

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