Antibiotice is the leading worldwide manufacturer of  industrial-scale production of Nystatin by biosynthesis processes

Brief history

Nystatin has been manufactured by Antibiotice since 1970.

Between 1995 and 1997, the technology for obtaining this active substance was perfected, the biosynthetic activity being in line with the requirements of the international market, while respecting the rules of good manufacturing practice and the requirements of circulation international Pharmacopoeias.

In 2006, the manufacturing process of Nystatin was optimized, which led to a significant increase in the productivity of the substance.

Since 2017, Nystatin Atb has become a reference standard certified by United States Pharmacopeia.


  • GMP quality certificate
  • EDQM certification
  • FDA approval
  • USP  international reference standard


  • Nystatin contains a polymorphic form (polymorph A) as a result of a repeatable, stable and reproducible technological process. This provides advantages in the formation of finished forms containing Nystatin;
  • The stability of the product offers economic advantage in handling manufacturing, transport and storage conditions;
  • Nystatin is sold in over 70 countries around the world.

Nystatin Pharma Grade, powder

  • Particle size: 90% of the particles < 45 µm;
  • Quality: according to EP/USP requirements;
  • Available documentation: United States Drug Master File, European Drug Master File (EDMF) –EU-CTD format, CoS issued by(Certificate of Suitability) issued by EDQM (European Directorate for the Quality of Medicines & HealthCare).

Nystatin Pharma Grade, powder

  • Particle size: 90% of the particles < 10 µm and 100% of the particles < 15 µm;
  • Quality: according to EP/USP requirements.

Our company manufactures the following types of Nystatin for the domestic and international markets:

  • Nystatin Atb® 500000 IU – Film-coated tablets
  • Nystatin Atb® 100000 IU – Pessaries
  • Zifex® Pessaries Complex
  • Nidoflor Cream 15 gr