Xcelience announced the opening of a 3,000-square-foot facility in Birmingham, UK, making it the first small to mid-sized American CDMO to launch international operations. The new plant will become a gateway for the Florida-based company’s clinical packaging and distribution services in the UK, Europe and abroad.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has fully inspected the new facility on June 4, 2014. This facility offers storage, secondary packaging, labeling and clinical trial distribution operations. Other capabilities include qualified person (QP) release and lab services. The new building also houses a qualified 2-8°C walk in cold storage chamber.
“The market for pharmaceutical products is global, and our clients have been asking us to go global with them. This facility is our first step toward meeting that need,” says Derek Hennecke, president and CEO. “Now our clients have a central hub which can be used to package and distribute throughout the UK and European markets.”
Xcelience corporate Standard Operating Procedures (SOPs) have been revised to include the new UK/EU operations. Several Xcelience clients have begun to schedule EU distribution of clinical materials for the third quarter of 2014.
No other American CDMO with revenue under $1 billion has made the move to service clients internationally, Hennecke says.
The Xcelience facility in Birmingham is the first step in the company’s multi-stage plan to develop and license several international hubs in places where clients most need them, Mr. Hennecke says. Xcelience is actively working towards setting up partner depot facilities in four locations in Latin America, one in the Middle East and one in Russia.