CDMO Dipharma Francis S.r.l. has completed its new cGMP Quality Control laboratory and c-GMP kilolab at its CDMO site located in Kalamazoo (MI), US.
The new cGMP manufacturing suite strengthens Dipharma’s CDMO offering and completes its range of services, ensuring continuity across the whole lifecycle of customers’ molecules, from preclinical to commercial stage.
The QC laboratory is designed and equipped according to latest pharmaceutical quality standards, with full CFR21 compliance for Data Integrity management. There is also a D grade classified finishing room
“Dipharma Group is now able to cover the whole pharmaceutical chemistry services spectrum, from discovery to marketed drugs,” explained Jorge Nogueira, CEO of Dipharma. “Furthermore, I am pleased to highlight that, with the construction of the new kilolab, Dipharma implements cGMP capability at its American subsidiary Kalexsyn, enhancing its range of exclusive services from CRO to CDMO.”
With an engineering batch already scheduled for production, Dipharma is currently assembling all documents required by FDA for Drug Establishment Registration.
