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BIOTON S.A.

Warszawa, POLANDS.A. (plc)Reg: 553095697938-69Since 25/04/2025

Budget

€10 — €0

EP Access

0

accredited persons

Staff

4

0.4 FTE

EU Grants

None

Mission & Goals

Bioton S.A. - European Biotech Company producing human insulin: API and finished forms in cartridges and vials. For more than 20years, we have been providing people with diabetes with efficacious and safe medicines. Bioton S.A. is an unquestionable leader on thePolish market, and in the world’s top eight commercial manufacturers of recombinant human insulin. Bioton S.A.continuously invests in the development of Polish biotechnology. We were the first company in Poland which, in cooperation with one of Polish scientific institutes, managed to commercialize the results ofthe Biotech Transfer. We apply the most current therapeutic and technological solutions to alleviate diabetes treatment for patients. We strive to build comprehensive solutions for the prevention and treatment of diabetes. Bioton S.A. offers CMO/CDMO and QC services. Our activities are based on QbD in line with cGMP standards. Bioton S.A. supplies also a range of innovative gastroenterological FSMP.

EU Legislative Interests

1) DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC 2) REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 3) REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 (Text with EEA relevance) 4) EU Biotech Act

Communication Activities

The LinkedIn account of Bioton may sometimes include content relevant to activities covered by the Register:https://www.linkedin.com/company/bioton/

Interests Represented

Promotes their own interests or the collective interests of their members

Member Of

Związek Firm Biotechnologicznych BioForum Pracodawcy Rzeczypospolitej Polskiej SEG Stowarzyszenie Emitentów Giełdowych

Commissioner Meetings

No recorded meetings with EU commissioners.