Our manufacturing operations are fully integrated with our sourcing, formulation development, process development, analytical testing, quality control, quality assurance teams. As part of our service we provide full cleaning method development, GMP batch manufacturing and GMP release testing with QP release, we offer a one-source solution for supplies for use from small to large scale.
Our Quality Control team are experienced in batch or lot release testing using a wide range of analytical technologies to provide responsive release analytics to ensure that your product is manufactured to the correct specification within the Marketing Authorisation (MA) or Clinical Trial Dossier (CTD).
We have been successfully inspected by FDA, our facility is routinely inspected by the Swedish Medicines Agency, the regulatory body within Sweden, which carries out inspections to ensure that manufacturing sites comply with GMP.
|4 multipurpose units operating in 2 shift|
|Reactor volumes from 200 to 10 000 L, glass lined and stainless steel|
|Production of batch sizes from 1 to 500 kg|
|Separate dryers in classified areas|
|Lab scale production of batch sizes from mg to kg scale|
|Contained production capabilities for highly potent material|
|USP purified water system|
|Temperature Range -100 ˚C to +175 ˚C|
|Pressure up to 30 bars|
Hans has been with the Magle Chemoswed organization since 1978 and has held numerous positions in both production and research and development. He is currently our Development Manufacturing Manager.