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Inside information made public: Nanoform Granted European Commercial cGMP Manufacturing License
Prenumeration
Beskrivning
| Land | Finland |
|---|---|
| Lista | First North Finland |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
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Nanoform Finland Plc | Inside Information | November 11, 2025 at 08:00:00 EET
Helsinki, Finland – Nanoform Finland Plc (“Nanoform”), the medicine performance-enhancing company, today 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 (Active Pharmaceutical Ingredients).
This license authorizes 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, commented:
“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.”
Edward Hæggström, Chief Executive Officer, added:
“Securing this commercial manufacturing license is a major milestone for Nanoform. 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.”
The information in the company release is information that Nanoform is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out below, on November 11, 2025, 08.00 EEST / 07.00 CEST.
For further information, please contact:
Edward Hæggström, CEO
edward.haeggstrom@nanoform.com
+358 (0)50 317 5493
Henri von Haartman, IR
hvh@nanoform.com
+46 (0)7686 650 11
Christian Jones, CCO
Christian.jones@nanoform.com
+44 (0)7804 474 771
About Nanoform
Nanoform is the medicine performance-enhancing company that leverages best-in-class innovative nanoparticle engineering technologies, expert formulation, and scalable GMP API manufacturing to enable superior medicines for patients. The company focuses on reducing clinical attrition and on enhancing drug molecules’ performance through its nanoforming technologies and formulation services, from pre-clinical to commercial scale. Nanoform will help improve bioavailability and drug delivery profiles, drive differentiation, patient adherence and extend the lifecycle potential of products. 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: DNB Carnegie Investment Bank AB, +46 8 588 685 70, certifiedadviser@dnbcarnegie.se. For more information, please visit www.nanoform.com.
Nanoform forward-looking statements
This press release contains forward-looking statements, including, without limitation, statements regarding Nanoform’s strategy, business plans and focus. The words “may”, “will”, “could”, “would”, “should”, “expect”, “plan”, “anticipate”, “intend”, “believe”, “estimate”, “predict”, “project”, “potential”, “continue”, “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Nanoform’s business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other companies, and other risks described in the Report of the Board of Directors and Financial Statements for the year ended December 31, 2024 as well as our other past disclosures. Nanoform cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Nanoform disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Nanoform’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.