Where We Are

From our headquarters in Milan, Italy - to research and commercial centers across Europe, and the U.S., Dompé operates as one global team, collaborating across borders to advance scientific innovation and deliver transformative therapies for patients worldwide

Focus on Production

The Plant

Our production hub in L’Aquila hosts two manufacturing units. The first is dedicated to the production of medicines in the primary care sector, while the second focuses on the production of biotechnological active ingredients for the treatment of rare diseases.

Production Plant

The heart of Dompé lies in its production hub in L’Aquila, which spans over 1,8 Mln square feet. It is here that our vision comes to life: transforming scientific and technological discoveries into therapeutic solutions.

 

The facility includes two distinct production units.

  • The pharmaceutical area is dedicated to the manufacturing, packaging, quality control, and release of solid and liquid oral pharmaceutical products.
  • The biotech area focuses on the production of biotechnological active ingredients. This is where cenegermin is produced—an active ingredient based on recombinant human nerve growth factor (rhNGF) used to treat neurotrophic keratitis, a rare degenerative eye disease.

 

The L’Aquila hub also houses warehouses, administrative offices, quality control laboratories, and other facilities such as research and development labs dedicated to identifying new therapies for rare diseases.

The L’Aquila Production Facility

Since 1993, over €200 million has been invested in the L’Aquila site. Today, the hub boasts numerous dedicated facilities designed to enable Dompé to conduct cutting‑edge research and produce and distribute high‑quality medicines to the market.

  • 1993: Inauguration of the L’Aquila production facility.
  • 1996: Launch of the biotech pilot plant for the development of experimental biotechnologies.
  • 2004: The biotech plant receives GMP certification.
  • 2012–2014: Construction of the industrial-scale Biotech production facility, including Upstream, Downstream, and Cell Bank biotechnology systems.
  • 2014–2018: Completion of the new Omega building, which houses three production lines.
  • 2019: Following a €30 million investment, Dompé completes new expansion projects. The newly built areas include a four-story building dedicated to coated granule production, a three-story packaging building, and a new warehouse.
  • 2025: Expansion of production capacity by approximately 600 square meters and installation of a new high-capacity liquid production line equipped with advanced control systems. With this addition, the site's total number of production lines rises to nine.
The two facilities are distinguished by their specific production processes:
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Biotech – Active Ingredients for Rare Diseases

Biotech production is characterized by tailored processes and cycles for each active ingredient, divided into two distinct phases: Upstream and Downstream.

  • In the Upstream phase, living microorganisms are used to synthesize molecules.
  • In the Downstream phase, these molecules are purified.

 

The microorganisms are cultivated in bioreactors that maintain optimal conditions of temperature, acidity, and oxygenation to support the biological processes that lead to the synthesis of active ingredients. At the end of this phase, teams of biotechnologists and specialized technicians recover the cells to extract and purify the desired product.

Primary & Specialty Care – Small Molecules

The production of small molecules for primary care involves several process cycles: weighing, granulation and/or preparation, followed by primary and secondary packaging. Quality, efficiency, and flexibility are continuously monitored. Our pharmaceutical unit is also equipped with serialization and aggregation systems to ensure full traceability of the manufactured batches.

Our Production Efficiency

Our facility is equipped with cutting-edge systems and technologies, but such efficient production is only possible thanks to the expertise, successful management, and teamwork of our people. We firmly believe that every professional role adds value to our company. That’s why we foster a mindset focused on solution-seeking.

For example, by promoting collaboration across departments, we are able to respond quickly to market changes and find effective solutions. We consider this a key competitive advantage.

 

At our facility, we have successfully adopted a production approach based on lean manufacturing and just-in-time procurement, meaning we order raw materials in alignment with production schedules.

Digital Tansformation: The Factory of the Future

At our production site in L’Aquila, research into how to make manufacturing even more efficient is ongoing. Beyond simple data acquisition, it is real-time analysis that enables us to implement targeted and precise improvement actions.

 

The benefits of digital technologies extend far beyond production processes: our research laboratories, maintenance operations, training program management, and supply chain processes all gain significant advantages from investments in digitalization.

Our current production processes are already highly efficient, but digital technologies will drive further improvements in performance and productivity.

 

Since 2012, all investments have complied with Industry 4.0 standards, allowing us to expand the digitalization of the facility. From the outset, critical utilities have been equipped with SCADA systems for supervision and control, which are now undergoing modernization to address obsolescence and integrate new technologies.

Types of Production

  • Small-molecule pharmaceutical products (Coated and uncoated granulated products, drops, sprays, syrups, mouthwashes)
  • Biotechnologically derived active ingredients (Recombinant human Nerve Growth Factor – rhNGF)

Production Lines

  • Sachets
  • Sticks
  • Liquids
  • Biotech APIs (Upstream and Downstream processes)

Pharmaceutical Facility Production Capacity

  • Over 1,500 tons of granulated products
  • 3 million liters of syrups and drops
  • More than 40 million packages per year
  • 700 million doses annually
  • 4 cartons per second

Certifications and Approvals

  • AIFA – Italian Medicines Agency, Italy
  • EMA – European Medicines Agency, Europe
  • FDA – Food and Drug Administration, USA
  • Roszdravnadzor – Federal Service for Surveillance in Healthcare, Russia
  • Ministry of Health (Clinical Trial Center), Italy
  • Fire Department – Fire Prevention Certificate (CPI)
  • Abruzzo Region – Unified Environmental Authorization (AUA)

CDMO Services

  • Contract manufacturing
  • Specialized structure for the development, manufacturing, quality control, and release of biotech products
  • Storage and development/validation of analytical methods

Our internal quality control system encompasses every stage of drug development and production—from sourcing raw materials through our suppliers, to processing, packaging the final product, and distribution. Before products are released to the market, quality checks are conducted in three specialized laboratories:

Chemical Laboratory

for chemical analysis

Microbiological Laboratory

for microbiological load testing

Packaging Materials Laboratory

to verify packaging compliance

Certificates of Excellence

UNI EN ISO 14001: 2015

Environmental Management System

UNI ISO 45001: 2018

Occupational Health and Safety Management System

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Manufacturing Biotech

Our Biotech facility is a center of excellence and the first site approved by the FDA for the production, packaging, quality control, release, and distribution of our drug cenegermin, based on recombinant human Nerve Growth Factor (rhNGF), for the treatment of neurotrophic keratitis.

Manufacturing Pharma

At our pharmaceutical production facility, we oversee the entire process—from research and sourcing to manufacturing and packaging—delivering high-quality essential medicines to our patients.