Dr. Reddy’s Laboratories has announced that the United States Food and Drug Administration (USFDA) has completed a Good Manufacturing Practice (GMP) and Pre-Approval Inspection (PAI) at its formulations manufacturing facility (FTO 11) in Srikakulam, Andhra Pradesh.

According to the company’s exchange filing, Dr. Reddy’s received the Establishment Inspection Report (EIR) on October 20, 2025, with the USFDA classifying the inspection outcome as ‘Voluntary Action Indicated (VAI)’. The inspection has now been officially closed.

Headquartered in Hyderabad, Dr. Reddy’s Laboratories is a leading pharmaceutical company dedicated to improving access to affordable and innovative medicines. Its diverse portfolio includes active pharmaceutical ingredients (APIs), generics, branded generics, biosimilars, and over-the-counter (OTC) products, with therapeutic focus areas spanning gastrointestinal, cardiovascular, diabetology, oncology, pain management, and dermatology. The company’s key markets include the USA, India, Russia and CIS countries, China, Brazil, and Europe.