Granules India Secures USFDA Approval for Andhra Facility

12 Nov 2024 , 10:14 AM

Granules India Ltd received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Unit V facility in Andhra Pradesh.

The USFDA inspection, conducted at the Jawaharlal Nehru Pharma City facility from April 8 to April 12, concluded with a ‘No Action Indicated’ (NAI) classification, confirming the facility’s compliance with current Good Manufacturing Practices (cGMP). This designation means the facility meets USFDA standards, with no further regulatory actions required.

The inspection covered Active Pharmaceutical Ingredients (APIs) and Finished Dosages (FDs) for oncology and non-oncology segments, underscoring the plant’s adherence to high manufacturing standards. The USFDA also completed a Pre-Approval Inspection (PAI) and cGMP audit, which concluded with zero Form 483 observations.

Chairman & Managing Director Krishna Prasad Chigurupati noted that the inspection’s successful outcome reaffirms the company’s dedication to maintaining premium quality. Despite the positive inspection outcome, Granules India’s Q2 FY25 revenue dropped 19% YoY to ₹966.6 crore, attributed to a temporary production pause at its Gagillapur facility. The company’s net profit fell by 5% to ₹97.2 crore.