Dr Reddys Labs gets 5 observations from USFDA for Bachupally facility

Hyderabad: Dr Reddy's Laboratories has received five observations from the United States Food & Drug Administration (USFDA), after a Pre-Approval Inspection (PAI) at the company's biologics manufacturing facility in Bachupally, Hyderabad. The inspection was conducted from September 4, 2025 to September 12, 2025. "We have been issued a Form 483 with five observations, which we will address within the stipulated timeline," the company stated in a BSE filing. Read also: Dr Reddy's Labs API Mirfield facility gets 7 USFDA observations Established in 1984, Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. The Company offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr Reddy's Labs major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe.