Pharmaceutical manufacturer Granules India (NSE:GRANULES, BOM:532482), has received an establishment inspection report (EIR) from the US Food and Drug Administration (US FDA) for its Unit V facility at Jawaharlal Nehru Pharma City in Andhra Pradesh, India, according to a Friday filing to the stock exchanges.
The EIR follows an inspection conducted by the US FDA from April 8 to April 12 which classified the facility as a 'No Action Indicated' (NAI) indicating that no further regulatory action is required.
The regulator had conducted a comprehensive Pre-Approval Inspection (PAI) and current Good Manufacturing Practices (cGMP) audit, which concluded with zero Form 483 observations.
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