Dr Reddy's Labs gets five USFDA observations for Bachupally unit

Dr Reddy?s Laboratories said the United States Food and Drug Administration (USFDA) completed a pre-approval inspection (PAI) at its biologics manufacturing facility in Bachupally, Hyderabad, on 12 September 2025.

The inspection was carried out from 4 to 12 September 2025. The company has received a Form 483 with five observations, which it said will be addressed within the stipulated timeline. The company added that this was pursuant to an earlier inspection and its disclosure made to the stock exchanges on 12 October 2023.

Hyderabad-based Dr. Reddy?s Laboratories is a global pharmaceutical company engaged in active pharmaceutical ingredients (APIs), generics, branded generics, biosimilars and over-the-counter (OTC) products.

On the financial front, the company?s consolidated net profit rose 1.8% to Rs 1,418.10 crore on an 11.4% increase in revenue from operations to Rs 8,545.20 crore in Q1 FY26 over Q1 FY25.

The scrip rose 1% to end at Rs 1,316.40 on the BSE on Friday, 12 September 2025.

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