Lupin Limited has provided an update regarding the U.S. FDA inspection of its Pithampur Unit-2 manufacturing facility. The inspection, which took place from July 8 to July 17, 2025, has resulted in an inspection classification of “Official Action Indicated (OAI)”. The company is committed to resolving the compliance issues and maintaining CGMP standards at its manufacturing facilities.
Pithampur Unit-2 Inspection Result
Lupin Limited announced an update regarding the U.S. FDA inspection of its Pithampur Unit-2 manufacturing facility. The inspection concluded on July 17, 2025, following a period from July 8, 2025.
Official Action Indicated (OAI)
The U.S. FDA has classified the inspection as “Official Action Indicated (OAI)”. Lupin is committed to working with the U.S. FDA to satisfactorily resolve any compliance issues.
Commitment to Compliance
Lupin Limited reiterated its commitment to be compliant with CGMP standards across all of its manufacturing facilities. The company is taking steps to address the observations made during the inspection.
Source: BSE
