Your Expert Partner for Clinical & Commercial Injectable Drug Product Supply

  • >> Extensive experience supplying high quality Injectable Drug Product manufacturing services from early-stage drug development to global commercial supply.
  • >> Substantial Drug Product regulatory and filing experience globally (EU, USA, Japan, Canada, Australia).
  • >> Full-service CDMO offering, Project Management & Integrated Supply from APIs to final Drug Products, including Packaging / Labeling, and Clinical Trial drug kit management (logistics, track-trace & documentation).

Injectables Platform Brochure

Platform Description

With over 25 years of extensive experience in Formulation Development and Drug Product manufacturing, CordenPharma supports its global customers with a full range of services for Injectable Drug Products including:

  • >> Pharmaceutical Formulation Development
  • >> Clinical Supply at any Scale and Stage of Drug Development
  • >> Sterile Liquid-fill & Lyophilized
  • >> Validation & CMC Dossier Registrations Globally
  • >> Commercial Injectable Drug Product Manufacture & Supply
  • >> Secondary Packaging,Labeling, Kit Assembly
  • >> Clinical Trial Material Management & Distribution, with a full Track & Trace of the drug at multiple Clinical Trial Sites

CordenPharma’s Injectable manufacturing covers both Terminal Sterilization and Aseptic Filling Technologies for Pre-filled Syringes (PFS), Vials, Ampoules and Lyophilized Vials, with a wide range of filling volumes. With multiple process and filling lines and an overall annual capacity of ~100 million units, the CordenPharma Injectable Platform offers the flexibility to support multiple programs and customers (> 110 markets) in parallel, at any scale and stage of drug development.

In addition to our experience in Sterile Injectable Development and Global Supply, CordenPharma is a worldwide recognized expert in Formulation Development & Fill - Finish of Sterile Emulsion Injectable Products.

Platform Capabilities

  • >> Sterile Drug Products
    • >> Pre-filled Syringes
    • >> Vials
    • >> Ampoules
    • >> Lyophilized Vials
  • >> Packaging & Labeling
  • >> Sterile Emulsion Technology
  • >> Small & Large Molecules, incl. Peptides & Biologics
  • >> Parenterals
  • >> Clinical Trial Services
    • >> Kit Preparation & Shipping
    • >> Management of Unused Medications
    • >> Fully Documented Track & Trace System

Integrated Supply

CordenPharma’s ability to develop and manufacture Small Molecule or Bio-organic APIs, Finished Dosage and Packaging in our network of facilities allows clients full access to integrated services. This results in a simplified supply chain, reduced risk and cost associated with technology transfers, and ultimately faster production and delivery timelines.