The approval follows an inspection conducted by the Swedish Medical Products Agency and marks an important milestone in the company’s continued development and long-term strategy within biological medicines.

“This is strategically very important for our manufacturing facility in Umeå,” says Sofia Mayans, Head of Manufacturing Site. “Receiving both GMP certification and manufacturing authorization for biological investigational medicinal products for human use is clear proof of the quality of our work and our technical expertise. The progress we are making in manufacturing, regulatory processes, and quality assurance lays a strong foundation for our continued development. I am extremely proud of the commitment and effort the team at the facility has invested to make this possible.”

The authorizations strengthen the manufacturing facility’s position and capabilities in the development and production of biological medicines and create improved conditions for the company’s future activities, it states.

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