Granules India provides update on the USFDA classification of its Gagillapur facility under "Official Action Initiated" (OAI), we provide the following updates.

According to the Granuels India, this classification does not impact the ongoing manufacturing, distribution, or sale of existing products from the site. However, it may impact review of pending submissions from Gagillapur for approval of new products, until the OAI status is resolved.

Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA. “As part of this effort, we voluntarily paused manufacturing and dispatches in September to conduct a thorough risk assessment, ensuring no product contamination or patient safety concerns. Operations and dispatches have since resumed following this assurance,” the company said.  

“Our voluntary remediation plan includes robust corrective and preventive actions (CAPAs), oversight by an independent third party, continued product testing for risk assessment, and regular monthly progress updates to the USFDA. To date, over 80% of CAPAs have been completed, with the remainder on track for closure by March 2025. We are now seeking a meeting with the USFDA to present our progress and request a potential reinspection,” the company stated.

Granules’ growth trajectory remains robust and diversified, underscoring that our strategy is not solely dependent on new product approvals from the Gagillapur site. Key drivers include new launches from our GPI facility in the US, growth from large-volume products in the US and Europe, capacity addition and commercialization of greenfield formulation facility at Genome Valley, value chain advancements in Europe, and our expanding oncology pipeline from Unit V. These initiatives ensure sustained performance as we work towards resolving the OAI status and reinforcing our commitment to compliance.