Founded in 1945, PROCOS S.p.A. stands as one of the historical players in the pharmaceutical industry, known for its excellence in the development, scale-up, and manufacturing of smallmolecule APIs. As the company approached its 80th anniversary in 2025, PROCOS continues to strengthen its position as a trusted Contract Development and Manufacturing Organisation (CDMO), recognised for its deep technical expertise, operational reliability, and commitment to the highest quality standards. Throughout its history, PROCOS has constantly invested in technological advancement and capacity expansion to anticipate market needs and to better serve its global customer base. Over the past two decades, the company has diversified its portfolio, entering the Highly Potent API (HPAPI) segment while maintaining leadership in the synthesis of non-HP small molecules, a field that has defined its industrial identity since the early 2000s. Building upon this strong foundation, PROCOS has now completed Phase I of its new production facility, R11, a major milestone in the company’s ongoing Strategic Investment Plan.
Increased Capacity for Small Molecule Drug Substance GMP Manufacturing
R11 is a state-of-the-art, multipurpose manufacturing facility designed to meet the growing demand for complex small molecules and specialised intermediates. The four-floor building, covering approximately 4,000 m², hosts up to four production lines equipped with commercial-scale reactors ranging from 1,000 to 6,000 liters, along with centrifuges and advanced drying systems. This modern configuration enables PROCOS to flexibly manage a wide range of clinical and commercial manufacturing projects, from small to mid-size volumes, ensuring scalability and supply continuity across various product lifecycles. The investment in Phase I, exceeding €60 million, provides around 75 cubic meters of new cGMP manufacturing capacity, tailored to support clinical supply across phases I to III as well as commercial production. Every detail of the facility’s design emphasises modularity, containment, and operational efficiency, enabling PROCOS to adapt quickly to evolving customer requirements and stringent global regulatory standards. Construction, equipment installation, qualification activities, and Authorities inspections have been successfully completed, marking the transition from development to full operational readiness. Following regulatory approval, R11 is now fully authorised for production, an achievement that underscores the coordinated effort of PROCOS’s Engineering, Production, and Quality teams. Their work has ensured that every stage of the project met the most rigorous cGMP and environmental, health, and safety standards.
“Completing R11 and obtaining regulatory approval represents a defining moment in our strategic growth journey,” said Enrico Zodio, CEO of PROCOS. “This new facility embodies our commitment to continuous improvement, sustainable growth, and long-term collaboration with our partners. It reinforces our leadership in small-molecule manufacturing, including for high-value, niche, and rare-disease therapies.”
The completion of Phase I marks only the beginning of a broader vision. Phase II, already under planning, will further expand both scale and flexibility, adding up to fifteen additional reactors and increasing drying and filtration capacity. Once fully operational, R11’s two phases are expected to boost PROCOS’ total site capacity by approximately 25%, enabling production levels to exceed 350 metric tons of APIs per year. This increase will enhance production efficiency and strengthen supply chain resilience, allowing the company to accommodate a broader range of projects, from early-phase development to full-scale commercial manufacturing, while maintaining the agility and reliability that customers have long valued.
Sustainability Commitment
In keeping with PROCOS’ ESG and sustainability goals, R11 was designed with a strong focus on environmental responsibility, energy efficiency, and waste reduction. The facility integrates advanced HVAC systems, solvent recovery units, and modern process control technologies to minimise environmental impact and ensure safe, efficient operations. These features reflect PROCOS’ longterm vision of combining scientific innovation with sustainable industrial growth. Furthermore, R11’s design supports the implementation of Quality by Design (QbD) principles and digital monitoring tools, enabling data-driven process optimisation and continuous improvement. This approach reinforces the company’s high standards of consistency, safety, and product quality, ensuring that PROCOS remains aligned with the evolving expectations of both regulators and global partners.
Focusing on PROCOS’ long-term sustainability goals, the company is keeping in line with the new standards of Big Pharma on topics surrounding decarbonization. Recently, PROCOS committed to its plan to several global business partners on a decarbonization strategy, even being awarded Best Partner for People and Planet in November 2025. “It has been a great pleasure to attend Partnership Day and the DeCarbon Talk and accept this award as it represents the strong collaboration of PROCOS’s leadership and people, as we all work toward the company’s commitment to driving sustainability and innovation across the value chain,” said Sonia Rasi, Financial Director. This award, among other recognitions throughout the year, marks PROCOS’ dedication to its commitment
The completion and approval of R11 represent more than an infrastructural expansion, they stand as a symbol of the company’s resilience, ambition, and enduring commitment to excellence. Since its foundation in 1945 and its integration into the CBC Group in 2006, PROCOS has combined Italian industrial heritage with Japanese innovation and strategic vision. Over eight decades, the company has grown through investment, collaboration, and a strong dedication to scientific and technological progress. Today, with R11 ready for production, PROCOS reaffirms its role as a reliable, forward-looking CDMO partner, ready to meet the challenges of an increasingly complex pharmaceutical landscape and to continue building value through knowledge, quality, and innovation.
For more information about PROCOS and its capabilities, visit www.procos.it
