Teltow / Leipzig, April 28, 2021 - The European Medicines Agency (EMA) has granted CO.DON AG approval for its new manufacturing facility in Leipzig. The Leipzig site is now formally approved for the manufacture, quality control and market release of Spherox for the EU. This means that the EMA has all the official requirements to produce the drug in Leipzig and bring it to the EU market.
The routine inspection by the state authority of Saxony, which will conclude the technology transfer and is expected for summer 2021, is still outstanding.
The start of Spherox production in Leipzig is planned for August / September 2021, with both locations initially producing in parallel for the EU market.
Tilmann Bur, CEO of CO.DON AG: “An important project of CO.DON AG has come to an end. What began in January 2018 with the signing of the contract for the machine delivery for the Leipzig location is now being routinely implemented. We are proud to be able to meet the increasing demand for our endogenous medicinal product and to continue to ensure the supply of cell therapy products of the highest quality for our users in Germany and Europe in the future.”
CO.DON AG develops, produces and sells endogenous cell therapies for the minimally invasive repair of cartilage defects. The drug offered is a cell therapy product for the minimally invasive treatment of cartilage damage in the knee joint using only the body's own cartilage cells. The method offered by CO.DON is currently used in over 200 clinics in Germany and has already been used in over 16.000 patients. In July 2017, CO.DON received EU-wide approval for this drug, and in March 2019 approval for Switzerland. At the Leipzig site, CO.DON built one of the largest plants for the production of human cells on an industrial scale for in-house and contract production. The shares of CO.DON AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227). Board of Directors of the company: Tilmann Bur, Dr. Achim Simons.
For more information, please visit www.codon.de.
Source: Press release CO.DON AG from 28.04.2021