Ardena  is as a fully integrated Contract Development and Manufacturing Organization (CDMO), with a core focus on bringing molecules to the clinics.
Our comprehensive suite of services caters to every stage of pharmaceutical development, ensuring a smooth progression from initial idea to clinical application.

Within our offerings, Ardena  provides a range of essential services. From small-molecule API projects, including route scouting, development, and expedited manufacturing, to thorough assessment of solid state research utilizing high throughput screening methodology to identify solid forms suitable for development.
Additionally, our expertise extends to drug product development, navigating phase-appropriate processes under cGMP conditions, and facilitating clinical packaging and logistics. Furthermore, as experts in nanomedicine development, we offer scalable formulation, process, and analytical development, alongside GMP manufacturing, ensuring our partners meet their clinical schedules effectively.

Ardena is recognized for its expertise in CMC Regulatory affairs and bioanalysis. With a deep understanding of scientific writing, CMC documentation requirements, and regulatory processes, we expedite products towards global approval. Our bioanalytical solutions cater to diverse drug products and biomarkers, spanning small molecules to proteins, including antibodies, ADCs, oligonucleotides, and vaccines.

As your trusted CDMO partner, Ardena is ready to support you through the complexities of drug development, committed to realizing your clinical goals.

Type of Drugs Manufactured:

Small Molecule

CDMO Services offered:

Drug Substance Manufacturing (API);Drug Product Formulation (FDF);Aseptic Fill Finish;Research & Development;Clinical Trials materials and logistics;Packaging;Regulatory Services;Analytical Development

No. of Manufacturing Facilities:

3-5

High Potent Products capabilities:

OEB 3;OEB 4-5

Facilities Locations:

Europe;North America

Regulatory Approvals for facilities:

FDA (United States);EMA (Europe);GMP;PMDA (Japan);Health Canada;ANVISA (Brazil)

Manufacturing Technologies:

Solids;Sterile Vials