Industrial-scale production of Nystatin by biosynthesis processes

Brief history
Nystatin has been manufactured by Antibiotice since 1975. Between 1995 – 1997, the technology used to manufacture this API was upgraded to meet the requirements of the international market and to comply with the good manufacturing practice regulations and the specifications of international Pharmacopoeias. In 2006, the Nystatin manufacturing process was optimized, which resulted in a significant increase in productivity.

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

Nystatin Pharma Grade, powder

  • Particle size: 90% of the particles < 45µm;
  • Quality: according to EP / BP / 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 / BP / USP requirements.