Granules India in the red

Yesterday, post market hours, Granules India said that the US FDA, after inspection of its facility in Gagillapur, which had earlier been classified under “Official Action Indicated” said that the FDA has now issued warning letter though it not indicated any further escalation.

The company said that it was confident the matter would be resolved soon and assured that manufacturing and distribution of existing products from the Gagillapur facility will continue unaffected. However, the Warning Letter may temporarily impact the FDA review of pending product submissions from this site until the issue is resolved.

Following the FDA audit and six Form 483 observations, Granules has implemented a proactive and comprehensive remediation plan to strengthen compliance and reinforce product quality and safety at the Gagillapur site. As part of this initiative, the company voluntarily paused manufacturing and dispatches in September to conduct a thorough risk assessment, ensuring no product contamination or patient safety concerns. Operations resumed following this assurance.

Since September 2024, these independent consulting firms— that are subject matter experts in quality, compliance, and regulatory practices—have been engaged to assess and validate the effectiveness of its remediation efforts.

The market is not happy with this development; figuring among the top five losers on the BSE, the stock slipped down more than 8% to Rs.466.85, not too far from its lower price band of Rs.456.95.

Its 52-week low is at Rs.382.05 and high is at Rs.724.55.