Dipharma
Empowering your Journey from Molecule to Market

When driving innovation in the pharmaceutical industry, accelerating the drug development process is crucial. Dipharma is here to simplify this journey. As a global CDMO and a leading manufacturer of active pharmaceutical ingredients and intermediates, Dipharma turns challenges into opportunities. Instead of juggling multiple CDMOs, Dipharma supports customers as a one-stop partner from pre-IND to market, ensuring seamless compliance in every market. This holistic approach shortens timelines, optimises resources and allows clients to focus on what matters most: delivering life-changing therapies to patients.

How does Dipharma make it happen?

Its four facilities, strategically located across the U.S. and Europe, are built to satisfy customers’ needs while adhering to the strictest regulatory standards. The three facilities in Italy, certified by Agenzia Italiana del Farmaco (AIFA) on behalf of the European Medicines Agency (EMA), have also earned approval from major regulatory agencies worldwide, most notably the FDA since 1970, the Japanese PMDA, the Korean KFDA and the Brazilian Anvisa.

In the U.S., the Kalamazoo-based former Kalexsyn Inc., a world-class contract research organisation (CRO) founded in Michigan in 2003, was acquired by Dipharma in 2018 and underwent a thorough transformation into a small-scale GMP site, culminating in a successful FDA preapproval inspection at early 2024. This harmonised and impeccable compliance track record guarantees every molecule produced at Dipharma’s facilities meets the highest global standards.

Transparency Built to Last

At Dipharma, client communication is key. They assure every client is always engaged and well-informed.

The dedicated team provides daily updates and weekly video calls, fostering seamless communication and collaboration throughout the CDMO project. The core team, including a Project Manager, a Technical Manager and Subject Matter Experts, oversees every phase, maintaining consistency and smooth transitions. The commitment to transparency reflects Dipharma’s dedication to client satisfaction, distinguishing it in the industry as a partner that truly values open collaboration.

“We manage intricate projects with agility, adjusting to changing demands and timelines. This balance of scale and flexibility positions us as a preferred partner in the industry,” says Andrea Confetti, Exclusive Synthesis BU leader.

Dipharma’s independence from external investors ensures solid ethics, unbiased decision-making and the ability to meet clients’ needs without delay. The unwavering commitment and strategic insight guarantee project success.

Furthermore, Dipharma applies the same principles of transparency by sharing its sustainability milestones and progress with clients. In 2024, Dipharma launched the “Development of a Sustainability Pathway” project, using a double materiality assessment. The project allows Dipharma to monitor all the launched initiatives for a responsible and ethical manufacturing.

It is this combination of steadfast dependability and enduring stability that has nurtured trust and loyalty among Dipharma’s clients over generations.

Scaling Up Processes to Support Clients at Every Phase

A key differentiating factor for Dipharma is its ability to support clients in every phase of their molecule’s journey, from pre-clinical studies to the supply of commercial volumes. This ability to walk side-by-side with clients throughout the project’s lifecycle makes Dipharma a true extension of their operational team.

Dipharma operates two state-of-the-art R&D hubs—one in Kalamazoo, U.S. and the other in Baranzate, Italy. Once the Route of Synthesis is defined, the Kalamazoo kilolab supplies GMP material for early clinical studies, with batch sizes ranging from approximately 300 grams to five kilograms. As projects progress, production transitions seamlessly through Dipharma’s pilot plants in Italy, accommodating batch sizes from five to nearly 100 kilograms and ultimately scaling up to commercial volumes of several tens of tons per year. Even as products mature and face challenges such as price pressure, Dipharma delivers cost-effective solutions by keeping GMP-critical steps in-house, while strategically outsourcing early synthesis stages.

“The addition of the Kalamazoo site was the crucial element our customers had been waiting for, completing our service offering and enhancing our ability to meet their needs,” adds Confetti.

Advanced Technologies for Smarter Processes, Faster Results

Dipharma excels in complex and hazardous reactions, including nitration and azides. With a background in explosives manufacturing, Dipharma brings unique expertise to safely manage these reactions, ensuring efficient and scalable processes.

Dipharma often receives processes designed for small-scale laboratories that require optimisation for commercial production. They rethink purification techniques, introduce innovative analytical methods and streamline syntheses to create efficient pathways for clients.

Analytical development plays a key role in modernising testing methods to secure faster and more reliable results, empowering clients to make informed decisions quickly and shortening development timelines.

Beyond process and analytical development, Dipharma supports clients with pre-formulation studies at its Baranzate R&D hub. Using specialised equipment to simulate oral dosage forms, Dipharma provides predictive insights into dissolution profiles and drug dosage availability, delivering critical data early to streamline collaboration during drug product development.

“Recognising the importance of speed to market for our clients, we are focused on meeting their timelines. This commitment fosters a culture of dedication, giving our clients confidence that their goals are always within reach,” states Confetti. “Whether facing regulatory hurdles or resource constraints, clients can trust that we will keep their project on track.”

Prepared for Any Challenge

Dipharma always has a Plan B, providing clients with extra confidence. If an issue arises with an external supplier, it promptly activates contingency measures to safeguard uninterrupted operations.

This was evident in a project with a customer developing a new chemical entity (NCE) under a tight clinical-phase timeline. While Dipharma handled drug substance production, another partner managed drug product manufacturing, making strict adherence to deadlines essential.

When the customer-recommended supplier failed to deliver consistent quality for a regulatory starting material, jeopardising the pilot batch timeline, Dipharma acted quickly. The team sourced a readily available precursor and expedited lab work to convert it into the required material. Leveraging the availability of appropriately sized reactors, Dipharma swiftly transitioned from lab to production, ensuring flexibility and resource optimisation. The rapid response delivered the material with minimal delay, keeping the project on track. This is the result of the strategic efforts that Dipharma has been carrying out for years to expand its network of trusted suppliers. This enhanced supply chain, combined with in-house capabilities, delivers proactive solutions and seamless project execution.

Dipharma’s success comes from treating each project as its own. From the spark of an idea to the moment a molecule makes its impact, Dipharma navigates challenges and provides steadfast support at every stage. This shared vision empowers clients to transform innovative concepts into life-changing solutions.