The inspection concluded with zero 483 observations by the US drug regulator.
The pharma major said that its injectable facility located at Nagpur has completed the United States Food and Drug Administration (USFDA) inspection with zero observations.
The inspection of the facility was carried out from 10 June 2024 to 13 June 2024 and the USFDA concluded with zero 483 observations.
Nilesh Gupta, managing director of Lupin said, We are pleased to have a successful outcome of the U.S. FDA inspection at our Nagpur injectable facility with zero observations. This reflects our dedication to uphold the highest quality and compliance standards across our facilities.
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 companys consolidated net profit tumbled 41.38% to Rs 359.43 crore on 3.64% decline in revenue from operations to Rs 4,895.11 crore in Q4 FY24 over Q4 FY23.
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