GMP API Manufacturing

GMP API Manufacturing
Product Description

Process development and manufacturing services represent a core part of our business. We utilise accumulated know-how and advanced technologies and provide everything that you desire from a high-quality API supplier. ChemCon is also experienced in manufacturing regulated substances and has the flexibility required to adjust the manufacturing schedule to accommodate urgent production needs. Besides the synthesis process itself, we offer complete supporting services: Continuous assessment of processes, analytical method development and validation, synthesis, identification and qualification of reference standards and impurities, stability studies that conform to ICH and EU-GMP guidelines, process validation, comprehensive regulatory support, safety/hazard assessment. ChemCon produces APIs for parenteral use under full microbiological control.

Read more Show less

ChemCon GmbH

  • DE
  • 2015
    On CPHI since
  • 1
    Certificates
  • 100 - 249
    Employees
Company types
CMO/CDMO
Manufacturer/Innovator
Primary activities
Analytical Services
API Producer
Chemical Development
Contract Manufacturer
Custom Manufacturing/Custom Synthesis
Excipients Manufacturer
Fine Chemicals Company
View company profile
Categories
more categories Show less

ChemCon GmbH

  • DE
  • 2015
    On CPHI since
  • 1
    Certificates
  • 100 - 249
    Employees
Company types
CMO/CDMO
Manufacturer/Innovator
Primary activities
Analytical Services
API Producer
Chemical Development
Contract Manufacturer
Custom Manufacturing/Custom Synthesis
Excipients Manufacturer
Fine Chemicals Company
View company profile

More Products from ChemCon GmbH (4)

  • Analytical Services

    Product Analytical Services

    ChemCon’s analytics team takes care of your inquiries if you are looking for ICH-compliant quality control, GMP validation, release analysis, impurity determination, reference standards or answers to other analytical queries. Close, outcome-oriented communication is the key to a successful partnership:...
  • Chemical Development

    Product Chemical Development

    Process development and manufacturing services represent a core part of ChemCon’s business. Multidisciplinary competences of experienced chemists include cGMP-compliant organic, inorganic, and polymer chemistry and the handling of highly potent and controlled substances. Production facilities are optimized...
  • Fine Chemicals Manufacturing

    Product Fine Chemicals Manufacturing

    ChemCon manufactures and markets valuable chemicals of high purity on demand, capitalizing on our experience in complex multi-step synthesis chemistry. It synthesizes organic and inorganic small molecules in the scale ranging from milligram to multi kilogram. Its core strengths in this field: Expert synthe...
  • GMP HPAPI and Controlled Substances Manufacturing

    Product GMP HPAPI and Controlled Substances Manufacturing

    Handling of cytotoxic and other highly active substances requires adequate facilities and enclosures as well as a lot of experience. ChemCon offers high-containment operations for the manufacturing of cytotoxic substances and highly potent active pharmaceutical ingredients (HPAPIs). Our services include...

ChemCon GmbH resources (1)