The drug maker on Friday announced that the US drug regulator has issued Form 483, with one observation after inspecting its Aurangabad manufacturing facility.
The United States Food and Drug Administration (USFDA) inspected Lupin's Aurangabad manufacturing facility from 6 March to 15 March 2024.
The pharmaceutical company stated, We are confident of addressing the concern raised by the U.S. FDA and will resolve the same at the earliest. We uphold quality and compliance with utmost importance and are committed to comply with Current Good Manufacturing Practice (CGMP) quality standards across all 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 pharmaceutical company reported consolidated net profit of Rs 613.12 crore in Q3 FY24, steeply higher than Rs 153.47 crore posted in Q3 FY23. Revenue from operations increased 19.67% YoY to Rs 5,079.88 crore in the quarter ended 31 December 2023.
Shares of Lupin shed 0.60% to settle at Rs 1,639.65 on Friday, 15 March 2024.
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