Lupin receives two observations from USFDA for Ankleshwar facility

Lupin receives two observations from USFDA for Ankleshwar facility

By: IPP Bureau

Last updated : March 09, 2026 4:34 pm



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

First Published : March 09, 2026 12:00 am