Nanoform secures commercial cGMP license for API manufacturing

The new European authorization expands Nanoform’s ability to produce and supply nanoformed active pharmaceutical ingredients to global markets.

Nov. 13, 2025

GMP Good Manufacturing Practice concept. Cupped hands hold digital medical approval symbol.

Nanoform Finland, based in Helsinki, announced it has received a commercial cGMP manufacturing license from the Finnish Medicines Agency (FIMEA) for the production and quality control of nanoformed small molecule active pharmaceutical ingredients (APIs).

The license allows Nanoform to manufacture nanoformed APIs for the European market and for countries in the Middle East, North Africa, Asia and the Americas where mutual recognition with the European license applies. The company also received a cGMP clinical license for its second GMP suite dedicated to clinical trial production.

“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,” Johanna Kause, Nanoform’s chief quality officer, said in a statement.

“Securing this commercial manufacturing license … allows us to execute market launches of our NanoImproved medicines. Our first targeted European market launch is Nanoenzalutamide in 2028,” CEO Edward Hæggström said in the announcement.

_{This piece was created with the assistance of generative AI tools and was edited by our content team for clarity and accuracy.}