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Granules India Completes USFDA Inspection With Eleven Observations At Gagillapur


30 October 2026
Granules India Ltd.

Gagillapur finished-dose facility completed USFDA inspection Oct 19-30 with eleven observations, first since February 2025 warning letter. None involved data integrity or cross-contamination, no impact on manufacturing or distribution, response due in 15 business days. Context: warning-letter clearance still pending, extending key overhang.


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