Granules India has received a clean slate from the USFDA for its Virginia facility, marking a positive turn after recent regulatory challenges. The company announced that its US arm, Granules Pharmaceuticals Inc., has obtained the Establishment Inspection Report (EIR) from the USFDA, confirming the successful closure of a June 2025 inspection.

The inspection, which was a Pre-Approval Inspection (PAI) for a first-to-file controlled substance ANDA, had one observation. This has since been resolved, the Hyderabad-based drugmaker said.

The clearance comes as a relief for Granules, which has been under regulatory scrutiny at some of its Indian sites. In June, its Bonthapally API unit in Telangana received one Form 483 observation. Moreover, its Gagillapur facility was issued a warning letter in February following an August 2024 inspection.

The Virginia facility’s compliance reinforces Granules’ efforts to strengthen quality systems across its global network. Meanwhile, the company looks to expand its presence in the US generics market.

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