English
The US Food & Drug Administration has reconfirmed the performance of the quality system used throughout the production of the active substance Nystatin by SC Antibiotice SA - Iasi. The company is the world"s second largest producer of Nystatin, with a market share of 25%.
According to Antibiotice, the audit took place on January 23rd - 25th, five years after the issuance by the US Food & Drug Administration of the original clearance certificate for the production of this substance. The results of the audit can generate a competitive advantage for the Iasi-based company, which also has the Certificate of Suitability RO-CEP 2003-096-Rev 00) issued by EDQM.
Having such certification, the company has been able to export to over 30 countries, including Germany, USA, Austria, Belarus, Russia, India, Switzerland, Holland, Vietnam, China etc. Earlier this year, the company was also audited for Good Laboratory Practices by a British auditor.
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