- Business
- Bioton SA (BIO.WA) is a Poland-based biotechnology company that develops, manufactures, markets and sells recombinant human insulin and related pharmaceutical products; provides contract development and manufacturing organization (CDMO) services including process development, analytical testing, technology transfer and GMP-compliant production of recombinant proteins and peptides; and offers innovative gastroenterological foods for special medical purposes (FSMP) alongside diabetes care solutions such as insulin analogs, oral antidiabetics, medical devices and digital health platforms. Founded in 1989 and headquartered in Ożarów Mazowiecki near Warsaw, the company operates primarily in Poland with exports to 35 countries including China, Russia, Thailand and Egypt, positioning it as a leader in the Polish diabetes market and among the world's top eight producers of recombinant human insulin. In June 2025, Bioton signed a memorandum of understanding with The Heart to collaborate on R&D pipeline expansion in biotechnology production, diabetology and gut health innovations; in October 2024, it secured a production agreement with a global pharmaceutical company for recombinant human insulin; and it continues to invest in modernizing its Macierzysz manufacturing site while enhancing CDMO capabilities through scale-down model laboratories and QbD-compliant processes.