The infusion of funds in the Halle/Westfalen, Germany manufacturing complex is intended to help meet growing global demand for injectable pharmaceuticals.
Akorn received a warning letter from the FDA on January 4, relating to the inspection of its manufacturing facility in Decatur, Illinois, in April and May 2018.
The US FDA’s New Inspection Protocol Project represents an “improvement process step” towards a risk-based site selection model, according to the Swedish CDMO.
The 5,000-square-foot expansion responds to client demand, says president Robert Lee: “The market for services is growing, yet the supply of CMOs interested in taking on these complex drug products is not.”
Pfizer has revealed it will invest $5bn to support operations in the US, with the first step being the construction of a 400,000-square-foot production facility, costing $465m.
