Ardena Pamplona celebrates 25 years of developing and manufacturing oral solid drugs for pharmaceutical and biotech companies around the world. What began in 2001 in Noáin (Navarre, Spain) as Idifarma is today is today Ardena’s CDMO site in Spain, specialized in highly potent compounds up to OEB5 and in spray drying to enhance the bioavailability of poorly soluble drugs. With a team of more than 110 professionals, the site focuses on niche oncology treatments and orphan drugs: difficult molecules, for patients who cannot wait.
This anniversary is a good opportunity to look back on the journey so far, at what we do in Pamplona today, and at why this site is a key part of Ardena as an integrated CDMO.
From Idifarma to Ardena Pamplona: 25 years of history
Idifarma was founded in 2001 with a clear idea: to offer outsourced pharmaceutical development with the quality and agility the industry demands. Its founders had experienced first-hand, within the pharmaceutical industry itself, how complex drug development is and how much companies need specialized partners.
The early years were not easy. At the time, few pharma companies in Spain outsourced development to a CDMO, the generics market was highly competitive, and the business required significant capital. The backing of regional investors and financial institutions, including a capital increase in 2006, was decisive in equipping the site with the facilities and equipment it needed.
It was during this period that the site made the decision that still defines it today: to focus on technically demanding segments, such as highly potent drugs for oncology, and on internationalization. During the pandemic, the company closed the year with 70% more new contracts, including projects with international pharmaceutical companies.
In September 2021, Ardena acquired Idifarma, adding 120 professionals and capabilities in high potency, spray drying and oral solid dosage forms. Since then, Ardena Pamplona has been part of an international group, today with five sites across Europe and the US.
| Year | Milestone |
| 2001 | Idifarma is founded in Noáin (Navarre) |
| 2004 | First GMP certification |
| 2006 | Capital increase; strategic focus on high potency and internationalization |
| 2007 | National recognition for the best track record of an innovative technology-based company |
| 2008 | Emprendedor XXI Award as the company with the highest growth potential in Navarre |
| 2021 | Ardena acquires Idifarma, which becomes Ardena Pamplona |
| 2022 | Investment in dry granulation and spray drying upgrades, including inhaled products |
| 2023 | Industrial PhD programs with the University of Navarra |
| 2026 | 25th anniversary, with more than 110 professionals |
Capabilities: high potency and enabling technologies at one site
What sets Ardena Pamplona apart is the combination of highly potent compound handling and spray drying at a single site. A highly potent, poorly soluble API can be solubilized, formulated and manufactured in Pamplona, with containment measures tailored to each compound.
Highly potent compounds up to OEB5. These molecules are active at microgram or nanogram doses, with occupational exposure limits below 1 µg/m³. The site was designed for them from the ground up:
- Negative pressure cascades in HPAPI zones, so that air always flows inward.
- 100% air renewal with HEPA filtration and no recirculation.
- Validated airlocks for personnel and materials.
- A rigid isolator for weighing operations, to be installed shortly.
Every project starts with a compound assessment: certified toxicologists calculate the OEL and assign the OEB band, which sets the containment requirements and cleaning limits before any laboratory work begins.
Bioavailability enhancement through spray drying. Many new molecules are poorly soluble in water. Pamplona develops amorphous solid dispersions by spray drying with organic solvents and turns them into tablets or capsules. In 2022, the site expanded this capability with ancillary equipment to manufacture inhaled drugs.
Process technologies for oral solids. Aqueous and organic wet granulation, dry granulation by roller compaction (added in 2022), direct compression and blending, functional or cosmetic coating (aqueous and organic), and hard capsule filling with powders or multiparticulates.
Service offering: from the first gram to the patient
Ardena Pamplona supports programs from pre-formulation through clinical supply and small-scale commercial manufacturing. For clients looking for a CDMO partner in Spain, this means one team from development to manufacturing, with no technology transfers between sites.
| Service | What Ardena Pamplona offers |
| Formulation development | Pre-formulation, formulation design and scale-up using QbD and design of experiments (DoE) for tablets, capsules and granules |
| Bioavailability enhancement | Amorphous solid dispersions by spray drying, including highly potent molecules |
| Analytical development and services | Method development and validation, release testing and stability studies under GMP |
| Clinical GMP manufacturing | Phase I to III batches, including placebos matched to the active product |
| Small-scale commercial manufacturing | Production for niche therapies and orphan drugs, in the same facilities |
| Packaging and clinical supply | Primary and secondary packaging, double-blind designs and highly customized studies |
| Quality and release | In-house quality system with on-site QPs for batch certification |
This offering is part of Ardena’s clinical supply service, which brings together more than 20 years of experience, GDP-licensed distribution, just-in-time labeling and comparator sourcing.
Quality, talent and roots in Navarre
Quality and regulatory compliance. The site is GMP certified by the Spanish Agency of Medicines (AEMPS) and certified for HPAPI handling. Its quality system operates in line with EU GMP and FDA 21 CFR Part 210/211, with on-site QPs. Its analytical, QA and QP infrastructure supports IND, CTA and NDA/MAA submissions.
An experienced team with continuity. More than 110 professionals across science, operations, quality and project management. Some of the team have been at the site since the very beginning: Marta Agúndez, now Analytical Development Expert, joined in 2001 and helped implement the GMP systems and build the analytical area. The site is led by José Antonio Blanco, Business Unit Director, who brings more than 20 years of experience in the pharmaceutical industry.
Science in partnership with academia. Ardena Pamplona works closely with the University of Navarra. Several site professionals supervise master’s projects and doctoral theses, and the site hosts industrial PhDs. One of them is developing a forced degradation technology to speed up stability-indicating methods, presented at CAI 2026.
Roots in the Navarre ecosystem. Ardena Pamplona is part of the region’s healthcare industry and was one of the eight founding companies of the Navarre health cluster.
Pamplona’s role in Ardena as an integrated CDMO
Pamplona brings Ardena two complementary capabilities: handling of highly potent compounds up to OEB5 and spray drying at a single site. With the addition of Pamplona in 2021, Ardena extended its CDMO network into Spain and Southern Europe and gained GMP manufacturing capacity for oral solid dosage forms up to small commercial scale. By 2022 it was already the site with the largest manufacturing capacity in the group’s drug product division.
Ardena’s network enables clients to move from molecule to patient with a single partner:
| Site | Specialization |
| Ghent (Belgium) | Headquarters, drug product and CMC regulatory |
| Pamplona (Spain) | Oral solid dosage forms, HPAPI and spray drying |
| Somerset (USA) | Oral solid dosage forms, hot-melt extrusion (HME) and bioanalysis |
| Oss (Netherlands) | Drug substance, solid state research, bioanalysis and nanomedicine |
| Assen (Netherlands) | Bioanalytical CRO |
In practice, Pamplona connects with the rest of the network in several ways:
- Two technologies for solubility enhancement. Spray drying in Pamplona and HME in Somerset give Ardena two routes to amorphous solid dispersions, on both sides of the Atlantic.
- Continuity from API to drug product. An HPAPI synthesized and characterized in Oss can be formulated and manufactured in Pamplona within the same group.
- Clinical supply connected to bioanalysis. Sampling kits are designed in coordination with the group’s bioanalytical laboratories.
Looking ahead to the next 25 years
Industry trends play to Pamplona’s strengths: increasingly potent and targeted molecules, and more candidates with low solubility. Oncology, hormonal therapies and rare diseases will continue to need partners able to work with these compounds safely, in small batches and with regulatory rigor.
Twenty-five years after that entrepreneurial project in Noáin, Ardena Pamplona combines the experience of a team that knows every stage of development with the scale and network of an international group. Thank you to everyone who has made it possible, and to the clients who trust us with their most demanding molecules.
We know development™. Let’s talk about yours. Contact our team.