Teltow / Leipzig, 28 April 2021 - The European Medicines Agency (EMA) has authorised the new manufacturing site in Leipzig for CO.DON AG. The Leipzig site is now formally approved for the manufacture, quality control and marketing of Spherox for the EU. This means that all the official requirements set by the EMA to produce the pharmaceutical product in Leipzig and its distribution within the EU market have been met.
The technology transfer process will be completed with a routine inspection by the state authority for Saxony, which we expect to take place in summer 2021.
Spherox production is planned to start in Leipzig in August/September 2021, whereby both sites will initially produce for the EU market in parallel.
Tilmann Bur, Executive Board member of CO.DON AG: “An important project for CO.DON AG has been brought to a close. A process that started in January 2018, when the contract was signed to supply the machinery for the Leipzig site, is now set to become part of routine operations. We are proud that we are now able to meet increasing demand for our autologous medical products and that we can maintain deliveries of the highest-quality cell therapy products for our users in Germany and Europe going forward.”
CO.DON AG develops, produces and distributes autologous cell therapies for the minimally invasive repair of cartilage defects. The product being marketed is a cell therapy product for the minimally invasive treatment of cartilage damage in the knee joint that uses only the patient's own cartilage cells ("autologous chondrocytes"). CO.DON's method is currently used in over 200 clinics in Germany and more than 16,000 patients have already been treated. In July 2017 CO.DON received EU-wide marketing authorisation for its product, with approval for Switzerland following in March 2019. At its site in Leipzig CO.DON has built one of the largest plants for the industrial-scale production and contract manufacturing of human cells. The shares in CO.DON AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227). Executive Board: Tilmann Bur, Dr Achim Simons
Further information is available from www.codon.de.
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