Granules India faces US FDA inspection challenges at Gagillapur facility
Pharmaceutical manufacturer Granules India Limited disclosed today that its Gagillapur facility in Hyderabad has been classified as “Official Action Indicated” (OAI) by the US Food and Drug Administration (FDA) following a September inspection.
The shares of Granules India Limited were trading at ₹530.55, down by ₹64.50 or 10.84 per cent on the NSE today at 3.10 pm.
The company received a Form 483 listing six observations during the initial FDA inspection. Granules India confirmed that it has comprehensively responded to all FDA observations. The company has additionally initiated a voluntary, detailed evaluation of the facility, working with external experts to address potential improvements.
Granules India remains optimistic about resolving the regulatory concerns, expressing confidence that the facility will receive FDA approval within a short timeframe. The company is actively collaborating with the US regulatory agency to address the identified issues.
