Dipharma Completes Second Stage of US Facility Expansion
Investment expected to establish additional cGMPs, expand CDMO services.
Dipharma Francis SRL, a contract development and manufacturing organization (CDMO) and producer of active pharmaceutical ingredients (APIs), has finished the second stage of expansion of its US facility, located in Kalamazoo, Mich. The extension will reportedly provide current good manufacturing practices (cGMPs), a quality control laboratory, and warehouse spaces, increasing its capability to support and grow its CDMO services. Phase III—which features the addition of a second cGMP line—is expected to be complete by Q2 of this year.
According to the company, the new laboratory is designed and equipped according to the latest pharmaceutical quality standards, with full 21 CFR Part 11 compliance for electronic data integrity (EDI). The new warehouses are fully climate-controlled and allow for material segregation.
“… These [expansion] 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,” says Jorge Nogueira, the company’s CEO.
