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(03 Feb 2025, 13:46)

Lupin's Somerset -based facility completes US FDA inspection with zero Form 483 observations

Lupin has announced that the the United States Food and Drug Administration (US FDA) has concluded the pre-approval inspection of the company’s Edaravone Oral Suspension, located at its manufacturing facility in Somerset, New Jersey.


The inspection was carried out from 28 January 2025 to 01 February 2025, and has concluded with zero 483 observations.

Nilesh Gupta, managing director, Lupin, said: "The successful outcome of the U.S. FDA inspection at our Somerset facility is a testament to our commitment to uphold and maintain the highest standards of quality, compliance and safety across our facilities. We remain steadfast in our mission to improve the lives of our patients globally.”

Mumbai-based Lupin is an innovation-led transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The company's consolidated net profit jumped 74.1% to Rs 852.63 crore on 11.3% increase in sales to Rs 5,497.01 crore in Q2 FY25 over Q2 FY24.

The scrip fell 1.61% to currently trade at Rs 2022.05 on the BSE.


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