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# FDA OKs Xellia Pharma Cleveland Sterile Drug Plant
- URL: https://www.fdaweb.com/fda-oks-xellia-pharma-cleveland-sterile-drug-plant/
- Published: 2020-03-26T12:00:00.000Z
- Updated: 2026-09-14T16:08:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146425

FDA has approved Xellia Pharmaceuticals’ Cleveland, OH manufacturing site to make anti-infective drug products for the U.S. market. The specialty pharmaceutical company says it acquired the site in 2015 and subsequently upgraded the facility. In January, FDA conducted a comprehensive GMP inspection at the facility, and this month the company says it was notified by the agency about the inspection’s satisfactory outcome and the approval to start product manufacturing. The company has an existing sterile injectable production plant in Copenhagen, Denmark.  
  
Xellia says it will use the facility to maximize aseptic injectables production. “The increased capacity will be used to grow and scale Xellia’s own pipeline with dedicated production lines for its established and innovative anti-infective injectable drug products,” it says. The company will also use the site to widen its offering of contract-manufacturing services for third-party injectables.