Lupin receives USFDA observations for two Pithampur manufacturing units
Written By : Ruchika Sharma
Written By : Dr. Kamal Kant Kohli
Published On 2025-07-18 06:27 GMT | Update On 2025-07-18 06:27 GMT
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Mumbai: Pharma major Lupin has received multiple observations from the U.S. Food and Drug Administration (USFDA) following inspections at two of its manufacturing facilities located in Pithampur, Madhya Pradesh.
According to a regulatory filing with the BSE, the USFDA conducted an inspection at Lupin’s Pithampur Unit-3 manufacturing facility from July 7 to July 17, 2025. The inspection concluded with the issuance of a Form-483 with three observations.
"We will address the observations and collaborate with the U.S. FDA to resolve them within the stipulated timeframe. We are committed to be compliant with CGMP quality standards across all our facilities," the company added.
In a seperate filing the company informed that the USFDA also inspected Lupin’s Pithampur Unit-2 manufacturing facility from July 08 to July 17, 2025. The inspection closed with Form-483 with four observations.
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