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GRANULES
has received a positive regulatory update as its wholly owned subsidiary, Granules Life Sciences, secured a Voluntary Action Indicated (VAI) classification from the USFDA following an inspection of its Telangana (Shamirpet) manufacturing facility conducted between December 15–19, 2025.
The Establishment Inspection Report (EIR) confirms that while certain observations were noted, no regulatory or enforcement action has been recommended, indicating satisfactory compliance with global manufacturing standards.
This outcome not only closes the inspection successfully but also enhances the company’s operational flexibility by enabling multi-site manufacturing for approved products, thereby strengthening its finished dosage capabilities.
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