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Ardena vs Lupin Limited

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CategoryArdenaLupin Limited
Listed sitebothcdmo
SummaryArdena 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 pharmaceutical manufacturer with robust quality systems aligned to US FDA, UK MHRA, and EU GMP standards; operates diversified manufacturing across generics, complex formulations, and specialty segments with advanced automation and digital quality infrastructure.
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
  • Quality Control Testing
  • Stability Testing & Storage
  • CMC Regulatory Submission Support
  • Technology Transfer
  • Formulation Development
  • Process Development
  • Inhalation & Nasal Dosage Manufacturing
  • Oral Solid Dosage Manufacturing
  • Sterile Fill-Finish & Aseptic Manufacturing
  • CMC Analytical Development
  • Combination Product Assembly & Final Packaging
Modalities
  • Small Molecule
  • Antibody-Drug Conjugate (ADC)
  • Biologics (Other)
  • Small Molecule
  • Biologics (Monoclonal Antibodies)
  • Biologics (Other)
IndicationsData not yet provided.
  • Gastroenterology
  • Metabolic
Locations
  • Ghent, Ghent, Belgium
  • Oss, Oss, Netherlands
  • Assen, Assen, Netherlands
  • Pamplona, Pamplona, Spain
  • Somerset, Somerset, New Jersey, United States
  • Headquarters, Mumbai, Maharashtra, India
  • Global presence, Multiple
  • Global presence, Multiple (100+ countries)
  • Global Operations, Multiple (100+ countries)
  • Global, Multiple (100+ countries)
CertificationsData not yet provided.
  • US FDA · Identifier: FDA-compliant manufacturing sites
  • EMA · Identifier: EU GMP-aligned operations
  • UK MHRA · Identifier: UK MHRA-aligned regulatory systems
  • FDA · Identifier: US FDA
  • EMA · Identifier: EU GMP
  • MHRA · Identifier: UK MHRA
  • US FDA · Identifier: US FDA
  • UK MHRA · Identifier: UK MHRA
  • EU GMP · Identifier: EU GMP
ReviewsReview summary appears after site-level review signal gate opens.Review summary appears after site-level review signal gate opens.