Overview

• The USFDA conducted a Good Manufacturing Practice inspection at the Monroe, North Carolina plant from June 9 to 17, 2025
• Inspectors issued a Form 483 listing five observations, all related to procedural compliance rather than data integrity
• Glenmark has pledged to collaborate with the regulator and submit its formal response within the stipulated deadline
• The absence of data integrity observations indicates no violations of the Food, Drug and Cosmetic Act were noted
• Glenmark’s stock dipped 0.34% to Rs 1,648.10 following the disclosure of the USFDA observations