Merck announced the opening of a new, ICH Q7-compliant facility dedicated to the production of meglumine, a unique pharmaceutical excipient and component of contrast imaging media.
Darmstadt/Germany — Merck announced the opening of 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. As an excipient, meglumine interacts directly with active pharmaceutical ingredients to increase solubility, the company claims. Therefore, the manufacture of meglumine had to 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 is a high level of confidence in quality and security of supply for our customers."