Merck opens production facility exclusively for meglumine
Regulatory compliant, FDA-audited facility based in Mollet des Vallès, Spain.
Merck has opened new, ICH Q7-compliant facility dedicated to the production of meglumine, a unique pharmaceutical excipient and component of contrast imaging media. The new facility is based in Mollet des Vallès, Spain.
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. As an excipient, meglumine interacts directly with APIs to increase solubility. Therefore, the manufacture of meglumine 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 is a high level of confidence in quality and security of supply for our customers."
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