Lupin gets 1 USFDA observation for Somerset facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-10-12 09:15 GMT | Update On 2025-10-12 09:15 GMT
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Mumbai: Lupin has announced that the company has received one observation from the U.S. Food and Drug Administration (USFDA) after a Pre-Approval Inspection at its manufacturing facility located in Somerset, New Jersey, U.S.A.
The Inspection was conducted from September 29 to October 10, 2025.
"We will address the observation and respond to the U.S. FDA within the stipulated timeframe. We are committed to be compliant with CGMP standards across all our facilities," the company stated in a BSE filing.
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