Granules India US FDA Issues EIR for Facility

Granules India announces that its facility has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA). The FDA conducted its first inspection from July 28, 2025, to August 01, 2025. The approval confirms the facility’s compliance with FDA quality standards and regulatory requirements. Granules Life Sciences Private Limited is engaged in the manufacturing of PFI & Finished Dosages.

EIR Received from US FDA

Granules India’s facility has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA). This follows the FDA’s inspection conducted from July 28, 2025 to August 01, 2025. The announcement was made on December 12, 2025.

Compliance and Manufacturing

The EIR confirms the facility’s compliance with FDA quality standards and regulatory requirements. Granules Life Sciences Private Limited is focused on the manufacturing of PFI (Pharmaceutical Formulation Intermediates) & Finished Dosages.

Source: BSE

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