SMALL MOLECULES PLATFORM
Full-service Partner of Choice from Advanced Intermediates to Drug Products
- >> Diversified and multi-purpose services with extensive capabilities from small-scale to large-scale, spanning Development to Commercial Manufacturing.
- >> Multiple manufacturing locations across Europe & USA offering flexibility of supply.
- >> Backward integration for Key Starting Materials > securing the Supply Chain in terms of costs & quality.
- >> Full-service offering and Project Management from Advanced Intermediates and APIs to final Drug Products, including Packaging / Labeling and Clinical Trial drug kits management (logistics, track-trace & documentation).
Platform Description
CordenPharma’s Small Molecules Platform provides full-service capabilities including Advanced Intermediates, Active Pharmaceutical Ingredient (API) Development & Manufacturing and Drug Products (Formulation & Packaging).
Process Development
Whether you have a medicinal chemistry route or a fully-developed Small Molecules process seeking initial implementation, our experienced team of development chemists and engineers are prepared to assist in successfully scaling up your process in a phase-appropriate manner, with a keen grasp of your future regulatory requirements.
The team's aim is not just to produce a scalable route today, but to create a robust, comprehensive control strategy using the principles of Quality by Design (QbD). In this manner CordenPharma ensures the chemistry developed can be readily scalable as we advance your Small Molecule project from early clinical phase to commercial production.
Our Small Molecule API Development services include:
- >> Route Selection
- >> Process Development & Optimization (early to late-stage, small to large-scale)
- >> Analytical Development & Validation Services
- >> Synthesis & Purification of Analytical Reference Standards
- >> ICH Stability Studies
API Manufacturing
Our extensive network of facilities, utilizing multi-purpose equipment, enables us to deliver your project on time, within budget and to the highest quality standards, regardless of its clinical stage (from early-phase development through to commercial manufacture).
With over 200 years of combined manufacturing experience across our Small Molecule facilities, CordenPharma has extensive experience in a diverse array of chemical technologies.
Our multiple manufacturing locations across Europe and the US provide flexibility of supply and scale (reactors ranging from 25 L - 28,000 L).
Drug Product Manufacturing
Offered as an integrated supply solution for the Small Molecules Platform, CordenPharma offers a variety of Final Dosage Forms (Tablets, Capsules, Vials, Cartridges & Pre-filled Syringes). Our full-service offering includes Project Management, Packaging / Labeling and Serialization in globally approved facilities.
Platform Capabilities
- >> Small Molecule APIs
- >> API Development (QbD)
- >> Clinical Manufacturing of APIs & Advanced Intermediates
- >> Commercial Manufacturing of APIs & Advanced Intermediates
- >> Generic APIs
- >> Small Molecule Drug Products
- >> Solid Oral Drug Products (Tablets & Hard Capsules)
- >> Terminally Sterilized Injectable Drug Products (Barrel Syringes, Vials & Ampoules)
- >> Aseptic Filled Injectable Drug Products (Cartridges, Vials & PFS)
- >> Packaging, Labeling & Serialisation
Integrated Supply
CordenPharma’s ability to develop and manufacture Small Molecule 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.