The Dipharma Group is a privately owned Contract Development and Manufacturing Organization (CDMO) with a global footprint, and is a leading manufacturer of Active Pharmaceutical Ingredients (APIs), New Chemical Entities (NCEs), and advanced intermediates for both the worldwide generic and contract manufacturing markets. The Group operates with robust quality systems that meet the rigorous standards set by the global regulatory authorities demonstrated by our inspection records from the FDA, AIFA, PMDA, KFDA and, more recently, ANVISA.
With decades of experience in chemical process development, regulatory compliance, and reliable supply chain management, Dipharma has established itself as a trusted partner for the most important pharmaceutical companies worldwide. Its portfolio of high-quality APIs and comprehensive CDMO services reflects a proactive response to evolving market needs, grounded in solid technical know-how and an agile operational capability from discovery to commercial.
Founded in 1949 and headquartered in Milan, Italy, the Group operates four manufacturing sites and two R&D centers across Europe and North America.
One of its key subsidiaries is Dipharma Inc., formerly Kalexsyn, Inc. The site, founded in Kalamazoo, Michigan, in 2003, was acquired by the Dipharma Group in 2018 to enhance the Group's presence in North America.
To explore Dipharma Inc.’s role within the Group and its contribution to accelerating customer projects, we interviewed the company’s CEO, Dr. Brian Eklov.
Q: Since joining the Dipharma Group, Dipharma Inc. has significantly expanded its scope. How has the company evolved in terms of infrastructure and capabilities?
A: Since its acquisition seven years ago, Dipharma Inc. has undergone a significant transformation, both in terms of technical capabilities and strategic alignment with the Group’s global objectives, enhancing its range of services from that of a world-class contract research organization (CRO) to much more of a full-service CDMO. One of the key milestones has been the implementation of Current Good Manufacturing Practices (CGMP), which allows us to leverage our world-class chemistry services for our clients’ clinical-phase projects. This process has been closely tied to a major investment in our Kalamazoo site, most notably the installation of a two-line CGMP Kilolab, designed to accommodate API release for Phase 1 and Phase 2 clinical trials, as well as for small commercial volumes. This suite is supported by a state-of-the-art Quality Control laboratory, designed and equipped to the latest pharmaceutical quality standards, with full 21CFR Part 11 compliance for Data Integrity management.
This transformation culminated in a successful FDA preapproval inspection in January 2024 and receipt of the commercial manufacturing approval in 2025.
Concurrently, we are enhancing Analytical and Solid-State Development capabilities to offer integrated, science-driven solutions that meet evolving customer needs. These investments strengthen our position in the North America market, which represents approximately 40% of the Group’s overall turnover, and reflects our commitment to providing comprehensive CDMO services from pre-clinical and Phase I/II support from Kalamazoo, back integration with our Italian sites, and supporting Phase III and commercial launches from any of the four plants in the Group’s portfolio. We operate the Group as a single, unified international team, enabling higher quality and faster project execution—benefits achievable only through this unified approach. Moreover, our close integration into client teams fosters strong connections that translate into long-term, repeated successes built on scientific rigor and transparency.
