Tue Dec 03 22:33:03 UTC 2024: ## Granules India Receives USFDA Warning After Hyderabad Plant Inspection
**Hyderabad, India –** Pharmaceutical company Granules India Ltd. saw its shares plummet 10.12% on Tuesday after the US Food and Drug Administration (USFDA) issued an “Official Action Indicated” (OAI) classification for its Hyderabad facility. This classification signifies that the plant is in violation of USFDA standards and is considered to be in an unacceptable state of compliance.
The OAI follows a USFDA inspection conducted between August 26 and September 6, which resulted in six observations. While Granules India has responded to these observations and is undertaking a comprehensive facility evaluation with external experts to address further issues, the OAI indicates significant concerns remain.
The company’s financial performance has already suffered, with a 19% year-on-year revenue drop to Rs 966 crore in the September quarter. Net profit also dipped 5% to Rs 97 crore. Granules India Chairman and Managing Director Krishna Prasad Chigurupati previously stated that financial recovery hinges on resolving the USFDA’s observations. The company maintains it is working with the USFDA to achieve full compliance.
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