| Listed site | both | cdmo |
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| Summary | Ardena is an integrated CDMO and bioanalytical CRO specializing in advanced drug product development, nanomedicine, and bioanalysis for complex molecules including poorly soluble compounds, highly potent APIs, and controlled substances. | Global CDMO with 16 production sites across four continents, offering integrated development and manufacturing from early-phase to commercial scale for drug substance and drug product. |
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| Services | - Formulation Development
- Process Development
- CMC Analytical Development
- Oral Solid Dosage Manufacturing
- Inhalation & Nasal Dosage Manufacturing
- Sterile Fill-Finish & Aseptic Manufacturing
- HPAPI Manufacturing (High-Potency)
- API Synthesis & Manufacturing
- Small Molecule Development & Manufacturing
- ADC (Antibody-Drug Conjugate) Manufacturing
- CMC Regulatory Submission Support
- Stability Testing & Storage
- Quality Control Testing
| - API Synthesis & Manufacturing
- Small Molecule Development & Manufacturing
- HPAPI Manufacturing (High-Potency)
- Controlled Substance Manufacturing
- Flow Chemistry & Continuous Manufacturing
- Oral Solid Dosage Manufacturing
- Vial Filling
- Sterile Fill-Finish & Aseptic Manufacturing
- Ophthalmic Manufacturing
- Inhalation & Nasal Dosage Manufacturing
- Cold-Chain Storage & Logistics
- Viral Vector Manufacturing
- Process Development
- CMC Analytical Development
- Quality Control Testing
- Technology Transfer
- Formulation Development
- CMC Regulatory Submission Support
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| Modalities | - Small Molecule
- Antibody-Drug Conjugate (ADC)
- Biologics (Other)
| - Gene Therapy
- Small Molecule
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| Indications | Data not yet provided. | Data not yet provided. |
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| Locations | - Ghent, Ghent, Belgium
- Oss, Oss, Netherlands
- Assen, Assen, Netherlands
- Pamplona, Pamplona, Spain
- Somerset, Somerset, New Jersey, United States
| - Headquarters, Zofingen, Aargau, Switzerland
- Drug Substances & R&D, Evionnaz, Valais, Switzerland
- Viral Vector Manufacturing, Schlieren, Zurich, Switzerland
- Drug Products, Hameln, Lower Saxony, Germany
- Drug Substances, Minden, North Rhine-Westphalia, Germany
- Drug Substances, St. Vulbas, Auvergne-Rhône-Alpes, France
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| Certifications | Data not yet provided. | - FDA · Identifier: U.S. Food and Drug Administration
- Swissmedic · Identifier: Swissmedic
- PMDA · Identifier: Japan's Pharmaceuticals and Medical Devices Agency
- AEMPS · Identifier: Spanish Agency of Medicines and Medical Devices
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| Reviews | Review summary appears after site-level review signal gate opens. | Review summary appears after site-level review signal gate opens. |
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