ChemCon is a contract development and manufacturing partner for APIs and fine chemicals specialized in transferring R&D projects into fully cGMP-compliant manufacturing processes. Customers worldwide use our services to source APIs for clinical trials and/or commercial applications (i.e. orphan diseases), excipients, reference standards, and all kinds of other high-quality specialty chemicals. Our FDA-inspected facilities are optimized for the production of small to medium quantities. With multidisciplinary expertise we can meet your individual demands for small-molecule organic APIs, inorganic compounds including trace elements, polymers, and highly potent or controlled substances – all in full cGMP quality up to injection grade. Comprehensive in-house analytics, stability studies, documentation, and regulatory support complete our services. ChemCon looks back on an outstanding inspection history both by the FDA and European health authorities.
Contract API Manufacturing
Drug substance manufacturing in small to medium quantities (g to a few 100kg per year) on demand to your specifications; Close communication; High-quality technical and fully cGMP-compliant material.
Chemical Process Development (cGMP)
Customized, fully cGMP-compliant process development for inorganic, organic or polymeric substances, including highly potent or controlled substances; flexible development concept and weekly updates
Quality Control + Assurance, Regulatory
Full in-house quality control, quality assurance and regulatory support including stability programs, batch and release documentation, CoA, CoC, eCTD files.
Phone: +49 761 5597-0
Fax: +49 761 5597-449
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