DMF for SAN HQ GMP accepted by the US FDA

Tromsø, Norway, 21^th September 2023 – ArcticZymes Technologies ASA (OSE:AZT) announces that Salt Active Nuclease High Quality GMP grade (SAN HQ GMP) has passed the DMF filing Type II with the US Food and Drug Administration (FDA) and has received the acknowledgement letter with the Master File number 29754 as a reference.

This means that ArcticZymes can provide its customers with a Letter of Authorization (LoA) for their product registrations with the US FDA upon request. AZT anticipates commercial launch of SAN HQ GMP in Q4 2023.

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About ArcticZymes Technologies ASA

ArcticZymes Technologies is a Norwegian life sciences company focused on the development, manufacturing and commercialization of novel recombinant enzymes for use in molecular research, In Vitro Diagnostics (IVD) and biomanufacturing.
The company is listed on the Oslo Stock Exchange since 2005 as ArcticZymes Technologies under the [AZT] ticker. Its headquarters are based in Tromsø, Norway, at the SIVA Innovation Centre.

ArcticZymes Technologies’ IP and capabilities are protected via a large portfolio of patents. For more information, please visit the website: www.arcticzymes.com