MilliporeSigma opened a facility in Mollet des Vallès, Spain, dedicated to the manufacture of meglumine, an FDA-approved excipient for pharmaceuticals and a component of medical imaging contrast media.
The facility, validated by the FDA, is the only location in Europe that manufactures meglumine, an amino sugar derived from glucose. The facility in Spain is solely dedicated to the production of meglumine, thereby ensuring continuity of supply to customers as well as meeting increasing demand for the excipient, said Andrew Bulpin, head of process solutions strategic marketing and innovation at MilliporeSigma. As an excipient, meglumine interacts directly with active pharmaceutical ingredients to increase solubility. Therefore, the manufacture of meglumine must meet the same stringent regulatory and quality requirements as active pharmaceutical ingredients (APIs), he added.
“Our new facility was optimized around the manufacturing process to achieve greater efficiencies and meets the most stringent quality standards for manufacturing meglumine,” continued Bulpin “The result is a high level of confidence in quality and security of supply for our customers.”