US FDA Issues Form 483 to Lupin's Ankleshwar Plant with Two Observations
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Lupin's Ankleshwar Facility Gets 2 US FDA Observations; Q3 Profit Up 37.5%
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CNBC TV18•07-03-2026, 23:17
Lupin's Ankleshwar Facility Gets 2 US FDA Observations; Q3 Profit Up 37.5%
•Lupin's Ankleshwar manufacturing facility received a Form 483 with two observations from the US FDA following an inspection from March 2-7, 2026.
•The drug firm committed to addressing the observations and responding to the US FDA within the stipulated timeframe, upholding its CGMP standards.
•A Form 483 lists inspection observations and is not a final FDA determination on GMP compliance; companies have 15 days to submit a response.
•Lupin reported a Q3 FY26 consolidated net profit of ₹1,175.6 crore, a 37.5% increase year-on-year, with consolidated revenue at ₹7,167.5 crore.
•Exceptional items included a ₹449.4 crore provision for antitrust litigations and ₹134.8 crore for Astellas settlement, alongside gains from divestments.
