Nanoform Finland Plc
May 9, 2023
15.00 Finnish time / 14.00 Swedish time
FIMEA renews Nanoform’s GMP license and Nanoform starts clinical API manufacturing of a blockbuster medicine candidate
Helsinki, Finland – Nanoform Finland Plc, an innovative nanoparticle medicine enabling company, are delighted to announce that FIMEA (Finnish Medicines Agency) has completed another successful general good manufacturing practices (GMP) inspection of Nanoform. During the inspection on March 28th, 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 is a testimony to the importance Nanoform places on quality in everything it does and received by FIMEA a renewed licence May 8th, 2023.
As previously communicated, 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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The Finnish Medicines Agency Fimea is the national competent authority for regulating pharmaceuticals. As a central administrative agency operating under the Ministry of Social Affairs and Health it promotes the health and safety of the population by regulating medicinal, medical devices, blood and tissue products, biobanks and by developing the pharmaceuticals sector. For more information, please visit https://www.fimea.fi/web/en
Nanoform is an innovative nanoparticle medicine enabling company. Nanoform works together with pharma and biotech partners globally to provide hope for patients in developing new and improved medicines utilizing Nanoform’s platform technologies. The company focuses on reducing clinical attrition and on enhancing drug molecules’ performance through its nanoforming technologies and formulation services. Nanoform’s capabilities include GMP manufacturing, and its services span the small to large molecule development space with a focus on solving key issues in drug solubility and bioavailability and on enabling novel drug delivery applications. Nanoform’s shares are listed on the Premier-segment of Nasdaq First North Growth Market in Helsinki (ticker: NANOFH) and Stockholm (ticker: NANOFS). Certified Adviser: Danske Bank A/S, Finland Branch, +358 40 744 1900. For more information, please visit http://www.nanoform.com
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