For over a century, Indena has stood as a beacon of research and development in the pharmaceutical landscape, evolving from its roots in botanical extracts to become a leading cGMP Contract Development and Manufacturing Organization (CDMO) for more than 35 years.
Today, Indena’s operational footprint spans multiple GMP-certified facilities which operate under stringent EU GMP guidelines with AIFA approval, buttressed by robust system certifications like ISO 14001 and ISO 45001. What truly sets Indena apart, is the profound integration of innovative R&D with GMP manufacturing within high-containment environments. This symbiotic approach facilitates an unbroken continuum from early development and clinical supply right through to full-scale commercial production.
Oncology & high-potency expertise
Indena’s deep-seated expertise is particularly evident in the realm of oncology, where it offers integrated capabilities in HPAPIs and ultra-potent compounds, supported by industry-leading containment solutions. Our advanced handling capabilities extend down to an Occupational Exposure Limit (OEL) of 1 ng/m3, ensuring the utmost safety and environmental protection for the most hazardous substances. We provide comprehensive manufacturing solutions that span the entire product lifecycle, from initial clinical stages to full-scale commercial production. This versatility is complemented by diverse sourcing strategies, encompassing complex chemical synthesis, precision fermentation, and biomass extraction, allowing for tailored approaches to meet specific project demands.
Advanced modalities
Beyond traditional APIs, Indena is at the forefront of advanced modalities. We possess unique capabilities in developing and manufacturing ADC Payload-Linkers, specifically handling highly potent payloads, irrespective of their molecular origin. This specialized proficiency is critical for the burgeoning field of targeted oncology therapies. Furthermore, Indena maintains a strategic focus on New Chemical Entities (NCEs) for rare diseases, prioritizing compounds characterized by high potency and molecular diversity to address significant unmet medical needs.
Large-scale processing technologies
Our facilities are equipped with sophisticated large-scale processing technologies essential for the production of complex molecules. Our Advanced Chromatography capabilities ensure the highest purity for challenging compounds, offering both conventional and HPAPI capacity with columns reaching up to 7,700 liters. Complementing this, our Spray Drying Excellence is demonstrated through five dedicated systems designed for APIs across a wide scale range, including potent compounds. These systems collectively contribute to a substantial total annual capacity of up to 93,000 kg, providing robust and reliable manufacturing solutions.
Indena’s experts wait for all industry stakeholders and potential partners at CPHI Japan, to discuss collaboration opportunities and learn more about the company’s comprehensive CDMO services.
Don’t miss the presentation Expectations for improvements to Japan’s pharmaceutical regulatory framework in relation to API exports, by Ms Eleonora Baioni, Area Manager at Indena S.p.A. on April 22nd, 2026, 1:30 p.m. – 3:00 p.m., East Hall 3, Tokyo Big Sight.
Visit Indena at CPHI Japan 2026: Italy Pavillon, Stand IP-9, 21st – 23th April – East Halls 1, 2 & 3, Tokyo Big Sight, Tokyo.
