Granules India Limited has informed the Exchange regarding a press release dated March 05, 2026, titled "Granules India s Packaging Facility in US gets FDA EIR with No Action Indicated Status".
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Granules India's US step-down subsidiary, Granules Consumer Health, LLC, has received an Establishment Inspection Report (EIR) with No Action Indicated (NAI) status from the US FDA for its packaging facility in Manassas, Virginia. The inspection took place from December 1 to 3, 2025, and resulted in zero observations. This was the facility's second FDA inspection, following a clean March 2023 audit. The Manassas facility serves as Granules' US front-end for OTC products, handling packaging of controlled substances and OTC products across three packaging lines, and also acts as a distribution hub for OTC products across the US.
A clean FDA inspection with NAI status is positive for shareholders as it confirms the facility meets US regulatory standards, removes compliance overhang, and supports uninterrupted US operations and future growth of the OTC segment. It reinforces investor confidence in Granules' regulatory and quality track record across its global manufacturing footprint.