"Procos is poised for transformative growth in 2025. Our R11 facility will significantly enhance our small-scale production capacity, enabling us to meet the growing demand for high-quality, specialized APIs in the US market."

David Short

SR. MANAGER, BUSINESS DEVELOPMENT - US & CANADA, PROCOS SPA

March 07, 2025

What does the 80-year anniversary signify for the company?

Procos will celebrate its 80th anniversary in 2025, marking a major milestone. This is particularly significant after our growth following the 2006 acquisition by CBC Group, which helped propel development and sustainability. To commemorate the anniversary, we will engage in various initiatives to connect with employees and partners. This 80-year achievement reflects our deep knowledge and history.

How will the new R11 manufacturing facility enhance production capacity and meet growing market demands?

We are launching the state-of-the-art R11 manufacturing facility to boost production capacity and drive innovation in response to growing global demand. With its building shell complete and equipment installation underway, the facility will feature 20 reactors across four multi-purpose production lines, offering capacities from 1,000 to 6,000 liters. This expansion will add 73 cubic meters of production capacity, targeting high-value, complex molecules, particularly in clinical development stages. Scheduled for full qualification by late 2025 or early 2026, the R11 facility will increase overall manufacturing capacity by 25%. For U.S. clients, it will provide flexible mid-scale production tailored to smaller volumes, and specialized therapeutics, ensuring a more robust, diversified, and geographically redundant supply chain.

What is recent example of a collaboration with a U.S. client and its impact on their growth?

Procos successfully collaborated with numerous US clients, often starting from early-stage development through various clinical phases. We helped clients develop robust manufacturing processes, scale their operations, and navigate critical phases of their product lifecycle. Many of these clients have experienced significant growth, some expanding their businesses or joining larger organizations, thanks to the comprehensive support we provided during their crucial development stages.

How does Procos differentiate itself from other API manufacturers?

Procos stands out through a customer-centric approach that emphasizes flexibility, innovation, and responsiveness to client needs. We specialize in custom synthesis, offering tailored solutions for emerging therapies that require highly specialized APIs. Our advanced R&D capabilities, combined with a strong manufacturing capacity and a collaborative approach, enable us to meet client demands efficiently and cost-effectively. This flexibility allows us to support clients in diversifying their supply chains while maintaining high-quality standards.

What strategies does the firm deploy to ensure supply chain reliability?

Procos ensures supply chain reliability through a comprehensive business continuity plan that proactively identifies potential risks and mitigates disruptions, enabling seamless operations and timely deliveries. We maintain long-term, trusted partnerships with key suppliers and continuously optimize our procurement and production processes. Our established global supplier network supports both generic API production and custom synthesis projects, enhancing flexibility and resilience.

How does Procos navigate regulatory challenges as an API manufacturer?

On the regulatory front, we adhere to the highest compliance standards in North America, Europe, and Japan by working closely with regulatory agencies to anticipate and adapt to evolving industry requirements. Our in-depth expertise in generic APIs allows us to navigate complex regulatory landscapes, ensuring full compliance while fostering productive collaborations with authorities. This dual focus on operational efficiency and regulatory excellence empowers Procos to deliver consistent, high-quality products to clients worldwide.
We continually invest in state-of-the-art facilities and ensure they meet or exceed regulatory expectations. This commitment to quality enhances our reputation as a trusted partner, especially in North America, where regulatory oversight is tightening. By prioritizing quality, we open opportunities for collaborations with leading pharmaceutical companies, positioning us to remain competitive in a rapidly changing regulatory environment.

What steps is Procos taking to minimize its environmental footprint?

Sustainability is a core component of Procos’ strategy. We are committed to reducing our environmental impact through investments in energy-efficient technologies, waste reduction, and sustainable sourcing practices. Our R&D team plays a vital role in optimizing manufacturing processes for maximum efficiency, which not only ensures high production standards but also contributes to a greener future. We are preparing our first sustainability report, scheduled for release in 2026, to detail our environmental initiatives and progress.

How does Procos adapt to the evolving needs of biotech firms?

Biotech firms are often at the forefront of cutting-edge medicine, requiring specialized manufacturing processes for complex molecules. Procos supports these companies by developing tailored processes to meet their unique needs. We work closely with smaller biotech firms, offering flexibility in adapting our services to their specific requirements. Our expertise enables us to assist in the development of critical components for advanced therapies, ensuring we meet the increasing demands of the specialized drug market.

What are the challenges of partnering with smaller biotech companies in today’s capital environment?

Smaller biotech firms often experience more fluid and rapidly changing dynamics compared to larger pharmaceutical companies, with their needs frequently shifting due to changes in the capital environment. Procos emphasizes flexibility and adaptability, adjusting timelines and being ready to scale production quickly as projects progress. Supporting these companies while managing the uncertainties in funding and timelines is key to fostering long-term, successful partnerships.

Can you discuss Procos’ growth strategy in the US and objectives for the upcoming year?

Procos is poised for transformative growth in 2025, driven in part by the commissioning of our R11 facility. This new facility will significantly enhance our small-scale production capacity, enabling us to meet the growing demand for high-quality, specialized APIs in the US market. We will continue to invest in cutting-edge technology and talent development to ensure we stay at the forefront of the API manufacturing industry and support our clients’ evolving needs.

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