GMP API manufacturing
We are a reliable partner in the GMP area and, with many years of experience, manufacture high-quality active ingredients for pharmaceutical applications - regardless of whether as an in-house development or as a one-to-one transfer of your manufacturing process: We use our long-standing experience in the field of chemical synthesis processes to scale up your process and for the manufacture of chemical products at the Gera site.
Our core competencies include the GMP-compliant manufacture of active pharmaceutical ingredients and excipients through chemical synthesis and physical shaping processes ("particle design") with the aim of fast and efficient production with high yields.
We can offer our customers a wide variety of chemical syntheses and shaping processes, from customized millilitre laboratory scale to 600-l production scale. To this end, we have several production laboratories ranging from laboratory up to 10-l scale as well as three technical plants with a reactor volume of up to 600 l.
Our range of services also includes controlled storage, packaging and GDP-compliant shipping of products. Our storage options range from 2 to 30 °C - if necessary for small quantities down to -20 °C and are subject to temperature controls. For national and international GDP-compliant shipping, we use the expertise of our qualified logistics service providers.
Our manufacture offering includes:
- manufacture of active pharmaceutical ingredients (APIs)
- manufacture of active ingredients for clinical trials
- manufacture and certification of reference substances
- manufacture of substances for in-vitro diagnostics
- optimization and scale-up of existing processes
- planning and qualification of equipment
- validation of the manufacture and cleaning processes
- complete GMP-compliant documentation
- assistance with regulatory matters
- storage and GDP-compliant shipping under various conditions
Contact Person: Dr Uwe Müller
