Wed Dec 04 04:20:00 UTC 2024: ## Granules India Receives USFDA Warning After Hyderabad Plant Inspection
**Hyderabad, India** – Pharmaceutical company Granules India Ltd. saw its stock plummet 10.12% Tuesday after the US Food and Drug Administration (USFDA) issued an “Official Action Indicated” (OAI) classification for its Hyderabad facility. The OAI signifies that the plant is not in compliance with US regulatory standards.
The USFDA’s inspection, conducted between August 26 and September 6, resulted in six observations. While Granules India had previously disclosed these observations, the OAI classification represents a more serious setback.
The company stated it is actively addressing the FDA’s observations and has initiated a comprehensive internal review with the help of external experts to further improve the facility. Granules India reiterated its commitment to working with the USFDA to achieve full compliance.
The company’s financial performance has already been impacted. In the September quarter, revenue dropped 19% year-on-year to Rs 966 crore (approximately $117 million USD), and net profit fell 5% to Rs 97 crore (approximately $12 million USD). This follows Chairman and Managing Director Krishna Prasad Chigurupati’s November statement that financial normalcy depended on resolving the USFDA observations. The OAI classification suggests a prolonged period of uncertainty for the company.
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