Lupin's Madhya Pradesh facility receives EIR from USFDA

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₹1,128.40 apiece on the BSE. Also Read: Lupin Q2 Results: Board to meet on November 8 to discuss unaudited results This month, the pharma major received approval from the US FDA to market its generic Fluconazole tablets and another generic medicine used to treat daytime sleeplessness. Fluconazole tablets are used in the treatment of fungal infections.

The approval was granted by the USFDA for the abbreviated new drug application of Fluconazole tablets in strengths of 50 mg, 100 mg, 150 mg and 200 mg, Lupin said in a regulatory filing. Also Read: Lupin mulls internal restructuring options, looks to separate its API business: Report These medicines are a generic equivalents of Diflucan tablets, 50 mg, 100 mg, 150 mg, and 200 mg, of Pfizer Inc, it added. The mentioned generic medicine will be produced by Lupin at its Pithampur facility in India, the company said.

The Fluconazole Tablets had an estimated annual sales of $43 million in the US, Lupin said citing IQVIA MAT July 2023 data. Also Read: Q2 result preview: Strong US performance to lift the show for pharma companies In the beginning of the month, the company received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution (0.5 g/mL), the Mumbai-based drug maker said in a statement. The product is equivalent to the generic equivalent of Jazz Pharmaceuticals' Xywav Oral Solution, said Lupin in its stock exchange filing.