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SAURABH SAHU

13th Jul 2025 · SEBI-Registered Analyst

🔴 Glenmark Pharmaceuticals Faces US FDA Warning for Indore Facility

No Impact Expected on Revenues or Supply Chain **Mumbai, July 12, 2025:** Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) has received a **warning letter from the United States Food and Drug Administration (US FDA)** concerning its **Indore manufacturing facility**. The regulatory inspection was conducted earlier this year, between **February 3 and February 14, 2025**. This update follows Glenmark’s earlier disclosure on **May 9, 2025**, when the Indore plant was assigned **Official Action Indicated (OAI)** status by the US FDA. In its latest communication, Glenmark clarified that **no data integrity issues were cited by the regulator**. Furthermore, the company **does not expect any disruption in supplies or adverse impact on its current revenue streams** from this facility. Glenmark reaffirmed its commitment to resolving all concerns highlighted by the FDA at the earliest. The company also emphasized that it **upholds the highest standards of quality and compliance** and remains dedicated to meeting **CGMP (Current Good Manufacturing Practices)** across all its facilities. This development is a critical compliance update but not expected to materially affect Glenmark’s operational performance in the near term. 📄 **Source:** Exchange Filing | **Disclaimer:** For informational purposes only.

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