Drug Approval

Lupin receives two observations from USFDA for Ankleshwar facility

The company will address the observations and respond to the U.S. FDA within the stipulated timeframe

The U.S. FDA has concluded an inspection at Lupin Ltd's manufacturing facility at Ankleshwar, India.

The Inspection was conducted from March 02, 2026 to March 07, 2026 and closed with the issuance of a Form-483 with two observations.

The company will address the observations and respond to the U.S. FDA within the stipulated timeframe. The company is committed to be compliant with CGMP standards across all our facilities.

Lupin
USFDA

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