German pharmaceuticals, chemicals and life sciences company Merck KGaA has opened a new plant in Mollet des Vallès, Spain dedicated solely to the manufacture of meglumine, an FDA-approved excipient for pharmaceuticals and a component of medical imaging contrast media.

The Merck facility, which has been validated by the US Food and Drug Administration (FDA) is claimed to be the only one in Europe that manufactures meglumine, an amino sugar derived from glucose. Its dedicated production, the German company said, ensures continuity of supply to customers as well as meeting increasing demand for the excipient. As meglumine interacts directly with active pharmaceutical ingredients to increase solubility, its production must meet the same stringent regulatory and quality requirements as APIs.

“Our new facility was optimized around the manufacturing process to achieve greater efficiencies and meets the most stringent quality standards for manufacturing meglumine,” said Andrew Bulpin, head of Process Solutions Strategic Marketing & Innovation, Life Science. “The result,” it said, “is a high level of confidence in quality and security of supply for our customers.”