Lupin's Pune-based biotech facility gets 5 observations from US FDA

Lupin said that the U.S. FDA has completed a pre-approval inspection of the company's biotech facility located in Pune, India.

The inspection was carried out from 25 September 2024 to 04 October 2024, and concluded with five observations.

The company is addressing the observations comprehensively and will respond to the U.S. FDA 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.

The scrip had advanced 0.65% to end at Rs 2197.60 on the BSE on Friday.

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