Lupin's Pithampur facility completes USFDA inspection with 3 observations

Lupin announced that its Pithampur facility in Madhya Pradesh, which includes the unit-1 API and finished product manufacturing site, was inspected by the U.S. Food and Drug Administration (USFDA) from 16 September to 27 September 2024.

The inspection concluded with 3 observations on both the API and Finished Product sides.

The pharmaceutical major is addressing these observations comprehensively and will respond to the USFDA within the stipulated timeframe.

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 jumped 76.01% to Rs 801.31 crore during the quarter as compared with Rs 452.26 crore posted in Q1 FY24. Revenue from operations increased 16.28% YoY to Rs 5,514.34 crore during the quarter.

Shares of Lupin gained 1.56% to end at Rs 2,221.50 on Friday, 27 September 2024.

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