MILAN, Italy—Dipharma Francis S.r.l., a contract development and manufacturing organization for the pharmaceutical industry, announced the completion of the new cGMP Quality Control laboratory and c-GMP kilolab at its Kalamazoo location, the former Kalexsyn Inc.
The new manufacturing suite strengthens Dipharma’s CDMO offering and completes the range of exclusive 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.
With an engineering batch already scheduled for production, Dipharma is currently assembling all documents required by FDA for Drug Establishment Registration.
Dipharma has annual revenue of approximately €120 million, with offices in Italy, the United States, and China. Dipharma purchased Kalexsyn in 2018 through its American subsidiary Dipharma Inc.
Founded in 2003 by Robert Gadwood and David Zimmermann, Kalexsyn provides chemistry services for drug discovery, including custom synthesis, stable label synthesis, process impurity synthesis, and process route improvement work.