Available EU CTD Dossiers

Available EU CTD Dossiers
Product Description

Darnytsia offers EU CTD dossiers across a wide range of therapeutic areas, including cardiology, neurology, pain management, critical care, and more. These dossiers are available for licensing and registration in international markets. Darnytsia provides comprehensive regulatory support and offers flexible licensing models to meet the needs of global partners. Atracurium/Arginine/Dexmedetomidine/Dexamethasone/Drotaverine/Furosemide/Fluconazole/Metronidazole/Moxifloxacin

PrJSC Pharmaceutical Firm Darnytsia

  • Country/Region:
    Ukraine
  • On CPHI since:
    2016
  • Certificates:
    2
  • Employees:
    1000 - 4999
Company types
CMO/CDMO
Distributor/Import Export
Generics/Biosimilars Manufacturer
Manufacturer/Innovator
Primary activities
Pharmaceutical Company (generic finished products)
Specifications
  • Details
    Atracurium/Arginine/Dexmedetomidine/Dexamethasone/Drotaverine/Furosemide/Fluconazole/Metronidazole/Moxifloxacin
  • Selling Points
    International Approvals/Standards; Atracurium/Arginine/Dexmedetomidine/Dexamethasone/Drotaverine/Furosemide/Fluconazole/Metronidazole/Moxifloxacin
  • Model
    Out-license
  • Supplied from
    Ukraine

PrJSC Pharmaceutical Firm Darnytsia

  • Country/Region:
    Ukraine
  • On CPHI since:
    2016
  • Certificates:
    2
  • Employees:
    1000 - 4999
Company types
CMO/CDMO
Distributor/Import Export
Generics/Biosimilars Manufacturer
Manufacturer/Innovator
Primary activities
Pharmaceutical Company (generic finished products)

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    Darnytsia offers EU GMP-compliant CMO services for small- and large-volume sterile injectables, including solutions for infusion and injection. We provide full-cycle support – from tech transfer to commercial-scale manufacturing and regulatory assistance. Our flexible production ensures high-quality, o...
  • FDF Pipeline 2025-2026

    Product FDF Pipeline 2025-2026

    Darnytsia is actively expending its portfolio with a focus on EU CTD dossier devepolment across key therapeutic areas, including cardiovascular, hospital-use sterile products. All dossier are prepared to EU standards and available for international licensing and registration.