Nanoform Finland, the medicine performance-enhancing company, has announced that it has received a Commercial cGMP Manufacturing License from FIMEA (Finnish Medicines Agency) for the production and quality control of nanoformed small molecule APIs.
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This license authorises Nanoform to manufacture nanoformed APIs for the European market and for countries in Middle East and North Africa, Asia and 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 trials purposes.
Johanna Kause, chief quality officer, said: “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.”