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Lupin receives EIR from USFDA for Mandideep plant

Nov 1, 2023

By: BlinkX Research Team

On October 31, the pharmaceutical company Lupin announced that the US health authorities had issued an Establishment Inspection Report (EIR) for its Mandideep Unit-2 manufacturing facility in Madhya Pradesh. When an inspection is satisfactorily concluded, the US Food and Drug Administration (USFDA) awards an EIR to a company.

In a regulatory filing, Lupin stated that the EIR was released following the facility's most recent inspection, which took place between August 7 and August 11, 2023. On the BSE, the drug company's shares closed 1.04 percent lower at ₹1128.40 a share.

The US FDA gave the pharmaceutical giant permission to sell generic versions of Fluconazole tablets and another medication meant to treat insomnia throughout the day this month. Tablets containing fluconazole are used to treat fungal infections. Fluconazole tablets in strengths of 50 mg, 100 mg, 150 mg, and 200 mg received the USFDA's approval for the abbreviated new drug application, Lupin reported in a regulatory filing.