Wed Dec 04 04:20:00 UTC 2024: ## Granules India Stock Plunges After US FDA Issues “Official Action Indicated” Classification

**MUMBAI, INDIA – September 24, 2024** – Shares of Granules India Ltd. experienced a significant drop on Tuesday, plummeting 10.20% to close at Rs 534. The sharp decline followed the company’s announcement that the US Food and Drug Administration (US FDA) had classified its inspection of the Gagillapur facility in Telangana as “Official Action Indicated” (OAI).

The FDA inspection, conducted earlier this month, resulted in six observations cited 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 crucial to Granules India’s global operations, manufacturing finished dosages (FDs) and pharmaceutical formulation intermediates (PFIs). The company, which operates in APIs, PFIs, and FDs segments, relies heavily on export markets, accounting for 94% of its sales.

Despite the significant drop, Granules India remains confident in resolving the FDA’s concerns. The company stated in a BSE filing that it is working closely with the US FDA and expects to secure approval for its Gagillapur facility in the near future. Promoters currently hold a 38.87% stake in the company. Despite today’s fall, the stock is still up 29.72% year-to-date.

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