Granules Shares Plunge After US FDA Warning Letter

shares plummeted 8% following a US FDA warning letter issued after an inspection of its Gagillapur facility. The letter, received on February 26th and disclosed post-market on February 27th, highlighted four key concerns from initial observations. While the facility retains an "Official Action Indicated" (OAI) status, existing product manufacturing and distribution remain unaffected. However, pending product submissions from the site may face delayed FDA reviews until the issues are resolved. Granules stated it has made substantial progress addressing the FDA's concerns, with most corrective actions completed and ongoing monthly updates provided to the regulator. The company plans to respond to the warning letter within the stipulated timeframe and seek a meeting with the FDA to demonstrate compliance. Granules remains confident in a satisfactory resolution.