INJECTABLES PLATFORM
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
Injectables Video
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.
