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The manufacturer is a global CDMO and GMP manufacturer operating since 2020. It functions as a CTD dossier owner and manufacturer, offering full drug-product services and acting as a CTD dossier owner and manufacturer. With approximately 500–1,000 employees worldwide, it maintains manufacturing sites in Europe, Japan, and North America and sells products across those regions. As a GMP manufacturer, it holds GMP approvals for sterile and non-sterile production. Its production lines cover sterile liquids (IV bags, ampoules, vials using BFS), non-sterile liquids, semi-solids (creams, ointments, gels), oral solids, suppositories, and more. The site in Leipzig features multiple semi-solid lines plus three non-sterile liquid production lines; recently, a new liquid filling and cartoning line was added, boosting capacity significantly. As CTD dossier owner and manufacturer, it manages regulatory dossiers and production, and as CTD dossier owner and manufacturer, it ensures compliance across development and manufacturing.
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