The company’s 150mg fluconazole tablets are the first in China to pass the consistency evaluation.


Time:2019-05-21

Recently, the company received the “Supplementary Drug Application Approval” from the National Medical Products Administration for two specifications of fluconazole tablets (trade name “Yilikang”): 50mg and 150mg. Both specifications of this product have passed the evaluation of bioequivalence and therapeutic equivalence for generic drugs.
 
 
Recently, the company received the “Supplementary Drug Application Approval” from the National Medical Products Administration for two specifications of fluconazole tablets (trade name “Yilikang”): 50 mg and 150 mg. Both specifications of this product have passed the evaluation of bioequivalence and therapeutic equivalence for generic drugs. Notably, the 150-mg specification of fluconazole tablets produced by our company is the first domestically approved specification to undergo a bioequivalence study comparing it directly with the originator drug.
Fluconazole tablets are triazole antifungal agents with a broad antifungal spectrum, effective against fungal infections in humans. Their in vivo antibacterial activity is significantly higher than their in vitro activity, and they are widely used in clinical practice. Clinical studies have confirmed that fluconazole is effective in treating candidiasis, cryptococcosis, mucosal candidiasis, acute or recurrent vaginal candidiasis, and dermatophytosis, among other conditions. It has been included in both the National Essential Medicines List and the National Medical Insurance Catalogue due to its proven efficacy.
 

Keywords: