It has also received positive feedback from the Swedish Medical Products Agency regarding a previously conducted inspection.

As a result, Diamyd Medical expects to obtain manufacturing authorization and a GMP (Good Manufacturing Practice) certificate in the near future.

“This is a very important milestone for our production facility in Umeå,” says Sofia Mayans, Head of Manufacturing Site. “The progress we are now making in manufacturing, regulatory processes, and quality assurance lays a strong foundation for our continued development. I am extremely proud of the dedication and work that the team at the facility has put in to make this possible.”