Dipharma Francis S.r.l. (Dipharma), a global CDMO and leading manufacturer of Active Pharmaceutical Ingredients and advanced Intermediates, announced today the completion of the second phase of expansion of its American site, Dipharma Inc., located in Kalamazoo, MI. (US).
The new investment provides additional CGMP, Quality Control laboratory and warehouse spaces, increasing the capability of the American site to support and expand its CDMO services.
The state-of-the-art QC laboratory is designed and equipped according to the latest pharmaceutical quality standards, with full 21CFR Part 11 compliance for Electronic Data Integrity, and the new warehouses are fully-climate controlled and allow enhanced material storage with increased material segregation.
This expansion follows the 2020 opening of the dedicated CGMP Kilolab and QC laboratory.
The third phase of the project is ongoing and will expand the current Kilolab by adding a second CGMP line. The new line will be capable of running larger-scale reactions, up to 85 L while also expanding our cryogenic reaction and solid isolation capabilities.
The third phase is expected to be completed by the 2nd quarter of 2023.
“Expanding and upgrading our US operations enhances Dipharma’s CDMO portfolio, allowing us to offer a wider and more customized set of solutions designed to meet the most stringent customer requirements — said Jorge Nogueira, Chief Executive Officer of Dipharma Francis S.r.l. — These activities compliment strategic investments underway at our Italian facilities, including doubling our pilot plant capacity and others with the aim to further strengthen Dipharma’s capacity and support the growing demand from our worldwide partners at all phases of development”.
