If the drug substance is fermented by microorganisms (e.g., bacteria, yeast, fungi or microalgae, etc.), should the identification of microorganisms be provided?

刊登日期:2019-11-12  |  點閱次數 : 304 次 

Yes, if the drug substance is primary or secondary metabolites (such as vitamins, amino acids, antibiotics, alkaloids, or polysaccharides, etc.) produced by fermentation of microorganisms (such as bacteria, yeast, fungi, or microalgae, etc.), the identification of microorganisms should be provided.



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