Manufacturing
We work according to GMP and ISO standards from pre-clinical through clinical trial phases to scale up, validation and commercial manufacturing. Our Quality Control team is experienced and they make sure that the products are manufactured to the correct specifications within the Marketing Authorization (MA) or Clinical Trial Dossier (CTD). We have been successfully inspected by the FDA and our facility is regularly routinely inspected by the Swedish Medicines Agency.
About Magle Group
Magle AB (formed in 1995 as a pure development company) acquired Chemoswed AB (formed in 1944 as a manufacturing company) in 2016 before merging the companies in 2017 to form Magle Chemoswed. In 2019, Adroit Science AB was acquired to increase the development services segment. In 2021, PharmaCept GmbH was acquired as a first step to develop a sales and marketing organization for DSM products. In 2024 Magle Group welcomed Magle Biopolymers - a CDMO part of the group focusing on Dextran technology, and Magle BioPharma - a stem cell based CDMO.
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