Granules India has acquired a clear slate from the USFDA for its Virginia facility, marking a constructive flip after current regulatory challenges. The corporate introduced that its US arm, Granules Prescription drugs Inc., has obtained the Institution Inspection Report (EIR) from the USFDA, confirming the profitable closure of a June 2025 inspection.
The inspection, which was a Pre-Approval Inspection (PAI) for a first-to-file managed substance ANDA, had one remark. This has since been resolved, the Hyderabad-based drugmaker stated.
The clearance comes as a aid for Granules, which has been beneath regulatory scrutiny at a few of its Indian websites. In June, its Bonthapally API unit in Telangana acquired one Kind 483 remark. Furthermore, 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 high quality programs throughout its international community. In the meantime, the corporate appears to be like to develop its presence within the US generics market.
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