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).
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.
- >> 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
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.