Lupin gets USFDA’s nod for Fluconazole Tablets

23 Oct 2023 Evaluate

Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Fluconazole Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg, to market a generic equivalent of Diflucan Tablets, 50 mg, 100 mg, 150 mg, and 200 mg, of Pfizer, Inc. This product will be manufactured at Lupin’s Pithampur facility in India. Fluconazole Tablets USP (RLD Diflucan) had estimated annual sales of $43 million in the U.S. (IQVIA MAT July 2023).  

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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