Lupin's Madhya Pradesh facility receives EIR from USFDA

Drug maker, Lupin, received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its Mandideep Unit-2 facility in Madhya Pradesh. 

The US drug regulator issues an EIR to a company when an inspection is satisfactorily closed. Lupin received EIR after the last inspection of its Mandideep-based facility was conducted from August 7 to August 11, 2023. Shares of the drug firm ended 1.04 percent down at ₹1,128.40 apiece on the BSE.

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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.

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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.

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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. The medication will be produced at Lupin's Somerset facility in the US. 

As per the estimates, the net product sales for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution stood at $ 958.4 million 2022 and $ 604.3 million in the first half of 2023.