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(As on May 26, 2025, 10:14)

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USFDA issues two observations to Dr. Reddy’s API facility in Telangana

Dr. Reddy’s Laboratories Ltd announced that the United States Food and Drug Administration (USFDA) has completed a Good Manufacturing Practices (GMP) inspection at its Active Pharmaceutical Ingredient (API) manufacturing facility (CTO-5) located in Miryalaguda, Telangana.

The inspection was conducted from May 19 to May 24, 2025. Following the inspection, the USFDA issued a Form 483 with two observations. The company stated that it will address these observations within the stipulated timeline.

This disclosure has been made in accordance with regulatory requirements and is for public information and record.

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