Nanoform Secures European Commercial CGMP Manufacturing License
Having secured a European Commercial CGMP Manufacturing License from FIMEA, Nanoform is now able to produce and control the quality of nanoformed APIs for Europe and other key markets.
Global expert in nanotechnology and drug particle engineering, Nanoform, has announced that it has been granted a commercial current good manufacturing practice (CGMP) Manufacturing License by FIMEA, the Finnish Medicines Agency (1). The license permits the company to manufacture and control the quality of nanoformed APIs for the European market and other territories — including the Middle East, North Africa, Asia, and the Americas, where recognition of the European license applies.
In addition, the company has obtained a CGMP Clinical License for its second GMP manufacturing suite to enable the production of nanoformed APIs specifically for clinical trial purposes, enabling the company to operate across pre-clinical to commercial scale manufacturing. The commercial license will support clients to reduce clinical attrition, drive differentiation, improve patient adherence, and extend product lifecycle potential.
"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," said Johanna Kause, Chief Quality Officer at Nanoform, in a company press release, emphasizing the impact the licenses will have on Nanoform’s ability to deliver advanced nanoforming technologies at scale (1).
"Securing this commercial manufacturing license is a major milestone for Nanoform,” added Edward Hæggström, Chief Executive Officer, Nanoform, in the press release (1). “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 (1)."
Nanoforming is a proprietary particle engineering technology that modifies drug molecules at the nanoscale to improve their physical properties for better drug delivery and therapeutic performance. By reducing particle size and increasing surface area, the technology enhances bioavailability and drug delivery profiles without reliance on polymers or complex formulations.
Founded in 2015, Nanoform has rapidly established itself as a leader in nanoparticle engineering for drug development. The announcement of the commercial cGMP manufacturing license will support Nanoform in its mission to accelerate the global delivery of next-generation therapies and reach its ambitious vision to double the number of lead compounds advancing to clinical trials.
Reference
Nanoform. Inside information made public: Nanoform Granted European Commercial cGMP Manufacturing License. Press Release, Nov. 11, 2025.