GRANULES : GAGILLAPUR FACILITY GETS 11 USFDA OBSERVATIONS

• USFDA concluded cGMP inspection of finished dosage facility at Gagillapur, Hyderabad, held October 19 to October 30, 2026 • Form FDA 483 issued with eleven observations • First USFDA inspection of the facility since the Warning Letter of February 26, 2025 • None of the observations related to data integrity or cross-contamination • Observations relate to investigations, change control, process and equipment qualification, visual-inspection controls and documentation practices • No impact on manufacturing or distribution of products from the site; response to be filed within 15 business days

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