Contact

Quality

Our Compliance Governance and Quality Management System fulfils regulatory requirements of the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) for Good Manufacturing Practice in the production of human and veterinary medicines.

We are a holder of the following certificates:

  • Manufacturing, distribution and export/import license for API issued by the State Institute for Drug Control of the Slovak Republic
  • Manufacturing License for human used medicinal products (Quality Control of non-sterile medicinal products) issued by the State Institute for Drug Control of the Slovak Republic
  • Certificates of compliance with the Good Manufacturing Practice for Phenoxymethylpenicillin Potassium and Polymyxin B Sulfate
  • Certificate of compliance with the European Pharmacopoeia (CEP) for Phenoxymethylpenicillin Potassium and Polymyxin B Sulfate
  • ISO 9001:2015 Quality Management System Certificate for research and development in the field of natural and technical sciences
  • GMP+ Feed Safety Certificate

We are under supervision and regularly inspected by:

  • the State Institute for Drug Control of the Slovak Republic for compliance with the Good Manufacturing Practice (GMP)
  • The U. S. Food and Drug Administration (FDA)

Certificates

For our in-house manufactured products, we are a holder of the following certificates and documents:

  • Phenoxymethylpenicillin Potassium – GMP, CEP, EDQM – ASMF, FDA – USDMF
  • Polymyxin B Sulfate – GMP, CEP, EDQM – ASMF, FDA – USDMF

For the contract manufactured active pharmaceutical ingredients, we hold the following certificates:

  • Gramicidin S Hydrochloride – GMP

Cooperate with a reliable partner
in biotechnology.

Contact information
Contact details

Menu

Informations

©2024 Biotika a.s.

Created by OWI