On 25 June 2026, the drug maker informed the exchanges that the US Food and Drug Administration (USFDA) had completed a Pre-License Inspection (PLI) at its biologics manufacturing facility in Bachupally, Hyderabad. The inspection was conducted between 16 June 2026 and 25 June 2026.

Following the inspection, the USFDA issued a Form 483 with seven observations. Dr. Reddy's said it will respond to the observations within the stipulated timeline.

The company said the inspection is a continuation of earlier inspections and related disclosures made to the stock exchanges on 12 October 2023 and 13 September 2025.

Hyderabad-based Dr Reddy’s Laboratories is a global pharmaceutical company. It offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC.

The company reported a 86.14% decline in consolidated net profit to Rs 220.9 crore on 11.51% drop in revenue from operations to Rs 7,546.4 crore in Q4 FY26 over Q4 FY25.