Comment from Xellia Pharmaceuticals ApS
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Summary: Xellia Pharmaceuticals, a global producer of fermentation-based antibiotics, supports the FDA's initiative to establish specific impurity guidelines for these products. They argue that current ICH guidelines are insufficient for complex fermentation profiles and propose specific, higher thresholds for different classes of antibiotics to align with European (EMA) standards.
Dear Sirs, Xellia Pharmaceuticals is a global producer of fermentation based antibiotics. Please find attached our comments to the draft FDA Guideline for Establishing Impurity Specifications for Antibiotics for your consideration.