Lupin Limited announced that the US Food and Drug Administration (US FDA) has completed its inspection of the company’s Pithampur Unit-3 manufacturing facility.
According to a regulatory filing dated July 17, 2025, the inspection was conducted between July 7 and July 17, 2025, and concluded with the issuance of a Form-483 containing three observations.
The company stated that it will address the observations and work with the US FDA to resolve them within the stipulated timeframe.
Lupin reaffirmed its commitment to maintaining Current Good Manufacturing Practices (CGMP) and ensuring compliance with quality standards at all its facilities.
This disclosure was made pursuant to Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.