Wed Dec 04 11:23:48 UTC 2024: ## Granules India Addresses US FDA Concerns Following Gagillapur Facility Classification

**Hyderabad, India –** Granules India has announced a comprehensive remediation plan to address concerns raised by the US Food and Drug Administration (US FDA) regarding its Gagillapur facility, which has been classified under “Official Action Initiated” (OAI). The OAI classification stems from six observations detailed in a Form 483 report, but the company emphasizes that it does not affect current product manufacturing, distribution, or sales. However, it may delay approvals for new products pending submission.

In response, Granules voluntarily halted manufacturing and dispatches in September to conduct a thorough risk assessment, confirming no product contamination or patient safety risks before resuming operations. The company’s remediation plan includes corrective and preventive actions (CAPAs), third-party oversight, rigorous product testing, and monthly updates to the US FDA. Granules reports over 80% of CAPAs are complete, with full implementation expected by March 2025. A meeting with the US FDA is planned to present progress and request a reinspection.

Despite the OAI, Granules highlighted its diversified growth strategy, citing new US product launches, growth in large-volume products, capacity expansion, European value chain advancements, and an expanding oncology pipeline as key drivers of continued success. The company remains committed to compliance and sustained performance.

**Other Pharmaceutical News:** Pharma funding experienced a significant 94.52% decline in November 2024. A new 3D printing technique shows promise in eliminating animal testing for drug development, and Gland Pharma secured US FDA approval for Latanoprost Ophthalmic Solution.

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