Nystatin for human use
A polyene macrolide antibiotic obtained by fermentation using our own highly potent bacterial strain of Streptomyces noursei.
Effective against fungi and yeasts, especially against Candida albicans. Candida causes fungal infections of the skin, mouth, vagina, and gastrointestinal tract.
No interactions with other drugs, no allergic side effects, or resistance have been observed since 1950, when Nystatin was discovered.
It has very low toxicity, does not cause local irritation, and adverse effects on the gastrointestinal tract are only occasional and mild. It is often used prophylactically in patients at risk of fungal infections, such as those with AIDS, cancer patients undergoing chemotherapy, taking immunosuppressive drugs, and patients with diabetes. The substance is widely used in medicinal products in the form of suspensions and topical preparations (creams, ointments, vaginal tablets, etc.).
An antimycotic from the polyenes group, developed in the USA back in 1950
Nystatin is an antifungal active substance from the polyene group, which was developed in the USA in 1950. Its use has now returned worldwide mainly because it has almost no side effects and shows minimal drug interactions with other medications. It is extremely effective against yeast fungi. The company is expanding its activities in developing a final dosage form containing nystatin.
Standard Production
Parameters | Limits |
|---|---|
Loss of mass | Not more than 5% |
Microbiological | Not less than 4400 IU/mg (dried substance) |
Particle size | The particle size distribution of nystatin is usually: |
Pharmacopoeial Quality
USP, Ph. Eur., BP
Regulatory Information / Certification
GMP, Certificate of Suitability (CEP), R1-CEP 2003-118-Rev 01, US DMF # 14056, EIR from FDA, USA, national registrations in many countries worldwide
Packaging and Transport
Standard: polyethylene bag in PET / Al / PE bag in fiber drums (50 or 100 Bou)
Non-standard: according to requirements
Shelf Life
3 years in the original packaging
Storage Conditions
Store at up to 25°C in a tightly closed container protected from light
Roztoky u Prahy
Production of injections for the hospital market
Production of Nystatin API for human and veterinary use, development of FDF
Research and development, QA/QC, supply and sales support
Czech quality for better health worldwide
The excellent reputation that VUAB Pharma a.s. has earned in the field of the pharmaceutical industry is based on its tradition, experience, and responsible approach to employees.
About us