Granules India Limited, a prominent pharmaceutical manufacturer, has achieved a significant milestone as it received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its Unit V facility at Jawaharlal Nehru Pharma City (JNPC) in Andhra Pradesh.
Following an extensive inspection from April 8 to April 12, 2024, the facility was awarded a “No Action Indicated” (NAI) classification, showcasing its strict adherence to current Good Manufacturing Practices (cGMP) standards.
In the exchange filing, the company shared, “During the inspection, the FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit, which concluded with zero Form 483 observations, underscoring Granules India’s commitment to stringent quality control, regulatory compliance, and operational excellence.”
