Lupin gets 2 USFDA observations for Aurangabad facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-09-06 05:51 GMT | Update On 2025-09-06 05:51 GMT
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Mumbai: Lupin has received two observations from the U.S. Food and Drug Administration (USFDA) at the closure of an inspection at the Company's Chhatrapati Sambhajinagar (Aurangabad) manufacturing facility.
The product-specific Pre-Approval Inspection (PAI) was held from September 01 to September 05, 2025.
"We will address the observations and respond to the U.S. FDA within the stipulated timeframe. We are committed to be compliant with CGMP quality standards across all our facilities," the company stated in a BSE filing.
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