Nanoform granted European Commercial cGMP Manufacturing Licence for APIs

Published: 12-Nov-2025
Regulatory

The Finnish company is now authorised to manufacture nanoformed APIs for the European market and for countries in the Middle East and North Africa, Asia and the Americas, where mutual recognition applies to the European license

Nanoform Finland Plc has announced that it has received a Commercial cGMP Manufacturing License from the Finnish Medicines Agency (FIMEA) for the production and quality control of nanoformed small molecule APIs (Active Pharmaceutical Ingredients). 

This license authorises Nanoform to manufacture nanoformed APIs for the European market and for countries in the Middle East and North Africa, Asia and the Americas, where mutual recognition applies to the European license. 

Nanoform was also granted a cGMP Clinical License for its second GMP manufacturing suite for the production of Nanoformed API for clinical trial purposes. 

Johanna Kause, Chief Quality Officer, commented: "We are delighted to have received these important licenses."

"They mark a significant step forward in our mission to bring our ground-breaking proprietary particle engineering technology to the pharmaceutical industry.” 

Edward Hæggström, CEO, added: "Securing this commercial manufacturing license is a major milestone for Nanoform."

"It allows us to execute market launches of our NanoImproved medicines."

"Our first targeted European market launch is Nanoenzalutamide in 2028. We continue our path to provide Nanoformed medicines to patients."

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