Wed Dec 04 14:44:27 UTC 2024: ## Granules India Stock Plunges After US FDA Issues “Official Action Indicated” Classification

**HYDERABAD, INDIA – September [Date of Publication]** – Shares of Granules India Ltd. experienced a significant downturn today, plummeting 10.20% to close at Rs 534 after the company announced that the US Food and Drug Administration (US FDA) had classified its recent inspection of its Gagillapur facility as “Official Action Indicated” (OAI).

The FDA inspection, conducted earlier this month, resulted in six observations detailed in a Form 483. While Granules India has responded to these observations and initiated a comprehensive facility evaluation with external experts, the OAI classification triggered heavy selling pressure. Trading volume surged to 7.45 lakh shares, far exceeding the two-week average of 81,000 shares.

The Gagillapur facility is a key manufacturing site for the company, producing finished dosages (FDs) and pharmaceutical formulation intermediates (PFIs). Its performance is crucial for Granules India’s global operations, which rely heavily on exports (approximately 94% of sales). The company operates across three segments: active pharmaceutical ingredients (APIs), PFIs, and FDs, with eight manufacturing facilities in total.

Despite the sharp drop, Granules India remains optimistic, stating in a BSE filing that it is confident of resolving the FDA’s concerns and regaining compliance “within a short time.” The company’s promoters currently hold a 38.87% stake. Despite today’s fall, the stock is still up 29.72% year-to-date.

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