Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
The U.S. FDA has conducted an inspection at Lupin Ltd's manufacturing facility located at Goa, India. The Inspection was conducted from November 10 to November 21, 2025 and closed with the issuance of a Form-483 with seven observations.
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe.
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