The U.S. Food and Drug Administration (U.S. FDA) has issued a warning letter to generic drugmaker Granules India’s finished dosages and pharmaceutical formulation intermediates manufacturing facility in Gagillapur, near Hyderabad.
While manufacturing and distribution of existing products continue unaffected from the facility, the warning letter may, however, temporarily impact the regulator’s review of pending product submissions, from the site, until the issue is resolved, the company said in a filing on Thursday.
The February 26 warning letter is related to the agency’s inspection of the facility from August 26 to September 6 and issue of six observations. Current good manufacturing practice (cGMP) and pre-approval inspection (PAI) processes were covered during the inspection at the Gagillapur facility that plays a vital role in the company’s global operations.
Subsequently, in December U.S. FDA had classified the inspection as Official Action Indicated which means it is recommending regulatory and administrative actions. The OAI classification came even as Granules paused manufacturing and dispatches in September to undertake a thorough risk assessment to ensure against product contamination or patient safety concerns. Subsequently it resumed operations.
The warning letter highlights four key areas previously outlined in the Form 483 observations. It has not indicated any further escalation, Granules said. Significant progress has been made to address all of the FDA observations across the four areas with most corrective actions completed and the rest on track as scheduled. Since September it has been is working with three independent consulting firms that are subject matter experts in quality, compliance, and regulatory practices to assess and validate the effectiveness of the company’s remediation efforts.
The company said it will respond to the warning letter within the stipulated timeframe and seek a meeting with the agency to demonstrate ongoing progress towards compliance. “We remain confident that this matter will be resolved satisfactorily within a reasonable timeframe,” it said.
Growth trajectory remains robust and diversified and not solely dependent on new product approvals from the Gagillapur site. Key drivers include new launches from the company’s GPI facility in the U.S.; growth from large-volume products in both the U.S. and Europe; capacity addition and commercialisation of the greenfield formulation facility at Genome Valley, near Hyderabad; value chain advancements in Europe; and expanding oncology pipeline from Unit V, Granules said.
Published – February 27, 2025 08:33 pm IST
