Lupin's US facility receives single FDA inspection observation

Lupin Limited informed the National Stock Exchange of India and BSE Limited on October 11, 2025, about a pre-approval inspection conducted by the U.S. FDA at its manufacturing facility in Somerset, New Jersey. The inspection took place from September 29 to October 10, 2025.

The inspection concluded with one observation. Lupin stated it would address the observation and respond to the U.S. FDA within the stipulated timeframe, reaffirming its commitment to comply with CGMP standards across all its facilities.

This disclosure was made pursuant to Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015. The announcement was signed by Amit Kumar Gupta, company secretary & compliance officer.