Oasmia has a manufacturing authorisation from the Swedish Medical Products Agency (Sw. Läkemedelsverket) for both clinical trials and sales. Manufacturing authorisation requires the maintenance of cGMP (current Good Manufacturing Practice).
The production facility in Uppsala is dimensioned for manufacturing of all Oasmia’s products on a small scale. Chemical synthesis of XR-17 and manufacture of the oncology products Apealea, Paccal Vet, Doxophos, Doxophos Vet and Docecal can be carried out at the facility.
Under a five-year production agreement for global commercial production of Apealea that was entered into in November 2018, Apealea will be manufactured by Baxter BioPharma Solution’s production facility in Halle/Westfalen, Germany, which is one of the world’s most advanced facilities for contract manufacturing of cytotoxic drugs. The technology and processes have already been transferred to Baxter, and the completed validation results have been approved. The first batch of Apealea for commercial use was manufactured in spring 2019 and the first EU batch is produced in Q4 2019. Contract manufacturing is also used for XR-17 in order to match production at Baxter. The transfer of the technology and processes for XR-17 were therefore already secured several years ago as part of the strategic planning ahead of the manufacture of Apealea for the market. At Oasmia’s own production facility in Uppsala, focus is now shifting to Oasmia’s other products.