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Lupin's New Jersey-based facility gets Form-483 with three observations from US FDA

18-Apr-26   12:27 Hrs IST

The inspection was conducted from 13 April 2026 to 17 April 2026 and closed with the issuance of a Form-483 with three observations.

We will address the observations and respond to the U.S. FDA within the stipulated timeframe. We are committed to be compliant with CGMP standards across all our facilities,' Lupin stated.

Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

The pharmaceutical company reported a 37.46% surge in consolidated net profit to Rs 1,175.55 crore in Q3 FY26 as against Rs 855.16 crore posted in Q3 FY25. Total revenue from operations jumped 24.26% year-on-year to Rs 7,167.52 crore in the quarter ended 31 December 2025.

The scrip had shed 0.10% to end at Rs 2324.25 on the BSE on Friday.

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