The U.S. Food and Drug Administration (FDA) has concluded its inspection of Lupin’s injectable facility in Nagpur. The inspection, conducted from September 8 to September 16, 2025, closed with six observations. Lupin has stated its commitment to address the observations within the stipulated timeframe and maintain compliance with CGMP quality standards across all facilities. The company considers this a disclosure under relevant SEBI regulations.
FDA Inspection Concluded
Lupin has announced the completion of an inspection by the U.S. Food and Drug Administration (FDA) at its Nagpur injectable facility. The inspection took place between September 8 and September 16, 2025.
Inspection Findings
The U.S. FDA inspection concluded with a total of six observations noted. Lupin has committed to addressing these observations in a timely manner and to upholding stringent quality standards.
Commitment to Quality
Lupin has reaffirmed its commitment to complying with CGMP quality standards across all its facilities. The company intends to respond to the U.S. FDA’s findings within the established timeframe.
Source: BSE
