IMG_0012.jpgPromulgated by the Health Authorities, cGMP (current Good Manufacturing Practice) regulations and guidelines govern the manufacturing, use and testing of drug products and their components, including Active Pharmaceutical Ingredients (APIs) intended for use in humans.
 
Few decisions in pharmaceutical operations are as critical as selecting the right cGMP Contract Manufacturer for an API. APIs manufactured to cGMP standards for commercial sale must meet requirements for identity, strength, quality and purity.

CordenPharma is linking together a legacy of expertise to provide reliable, effective cGMp contract manufacturing of APIs to support your small and large-scale projects through:
  • Big Pharma / Biotech calibre facilities with stringent quality systems and standards
  • Proven track record of success in API small and large-scale manufacturing, including the largest peptide API production capacity worldwide
  • Network of global cGMP manufacturing facilities with combined capabilities and successful track record of inspections by all relevant Health Authorities
  • Dedicated project managers supported by a project team to ensure consistent coordination, communication and alignment of progress throughout all project phases
We conduct commercial cGMP manufacturing of APIs and advanced intermediates for both clinical trial supplies and commercial products. Moreover, we are uniquely suited to provide the full spectrum of cGMP synthesis and chemical manufacturing services, from production of early stage clinical trial materials to product launch and commercialisation.

Our technical manufacturing capabilities span a wide range:
  • Reactors pools with high flexibility in size (100-18000L ), media compatibility (Hastelloy; glass-lined, steel) and temperature (-100°C to +200 °C)
  • Multiple product isolation technologies (centrifuge, filters) with wide material compatibility (Hastelloy; stainless steel)
  • Multiple drying options (agitated and static dryers)
  • Multiple powder handling and finishing capabilities including sieving, blending and milling
  • Handling of highly potent compounds down to exposure limits of 1ng/m3
CordenPharma's comprehensive repertoire of chemical reaction types at industrial scale includes almost all chemical transformations in use today such as:
  • Large-scale hydrogenations, including enantioselective hydrogenations up to 60 bar
  • Industrial-scale enzymatic reductions
  • Industrial-scale chemical peptide synthesis, both solid and solution phase

CordenPharma's full range of API Contract Manufacturing and Development Materials Includes:

  • Route Scouting & Process Development
    • Small Molecules
    • Peptides
    • Conjugates
    • Lipids
    • Carbohydrates
  • cGMP Large-scale synthetic Peptide API Production
    • Solid phase and solution phase synthesis
    • Peptidomimetics, lipopeptides
  • cGMP Small-molecule API Manufacturing
    • Pharmaceuticals
    • Fine chemicals
  • Highly Potent APIs (OEL 4)
  • Amino Acid Derivatives and Building Blocks for peptide synthesis
    • Natural and non-natural amino acids
    • Pseudoproline dipeptide building blocks
  • Derivitized Phospholipids and other Lipids
    • Hetero and homogeneous, conjugates
    • Helper lipids, sphingolipids, cationic lipids
  • Carbohydrates
  • Generic API Manufacturing
  • Sterile APIs
  • Standard Catalogue Products which are readily available:
  • Manufacturing and Development Support for Contracted Customers
    • Analytical method development and validation
    • Regulatory support activities including Pharmaceutical Writing

Could your pharmaceutical firm or biotech use our expertise?

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