Lupin receives US FDA approval for generic anti-fungal drug

Fluconazole Tablets USP had estimated annual sales of USD 43 million in the U.S. according to IQVIA MAT data in July 2023.

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26 Aug, 2025 12:21

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Pharma major Lupin Limited said that it has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Fluconazole tablets.

This product is an equivalent of Diflucan tablets by Pfizer. This medication prevents and treats fungal or yeast infections.

The product will be manufactured at Lupin’s Pithampur facility in India, the company informed exchanges. Fluconazole tablets USP had estimated annual sales of $43 million in the US according to IQVIA MAT data in July 2023.

The product will be available in 50 mg, 100 mg, 150 mg and 200 mg.

Shares of Lupin closed marginally down at Rs 1,168 on NSE on October 23.