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FIMEA Renews Nanoform’s GMP License, Starts API Manufacture of Blockbuster Candidate

FIMEA fully reviewed Nanoform for compliance with its processes and adherence to GMP.

Nanoform Finland Plc, a nanoparticle medicine enabling company, announced that FIMEA (Finnish Medicines Agency) has completed another successful general good manufacturing practices (GMP) inspection of Nanoform.

During the inspection on March 28, 2023, FIMEA fully reviewed Nanoform for compliance with its processes and adherence to GMP for the manufacture of multiple clinical active pharmaceutical ingredients (APIs). Nanoform received no critical or major observations during this inspection, which the company said is a testimony to the importance Nanoform places on quality in everything it does and received by FIMEA a renewed licence May 8, 2023.

Meanwhile, following this renewed licence, Nanoform has now commenced GMP manufacture for nanoforming of a currently marketed blockbuster drug for a clinical trial planned in Q4 2023. Nanoform has also been audited by an independent European GMP auditor for this project and again received no critical or major observations.
 

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