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05/03/2026 12:16

Granules India Ltd US Packaging Facility Gets USFDA EIR with NAI Status

Granules India Limited said its US step-down subsidiary, Granules Consumer Health LLC, has received an Establishment Inspection Report (EIR) with No Action Indicated (NAI) status from the U.S. Food and Drug Administration.

The inspection was conducted at the company’s packaging facility in Manassas, Virginia, between December 1 and 3, 2025. This was the second inspection at the facility, following a March 2023 audit that also concluded with zero observations.

Granules Consumer Health serves as the company’s front-end division for over-the-counter (OTC) products in the US and handles packaging of both OTC and prescription medicines while also acting as a distribution hub for OTC products across the country.