Dr. Reddy's

Dr. Reddy’s Laboratories, a key player in India’s pharmaceutical sector, has received a Form 483 with two observations from the U.S. Food and Drug Administration (USFDA) following an inspection of its active pharmaceutical ingredient (API) facility in Telangana. The six-day audit, conducted from May 19 to May 24, 2025, at the company’s Miryalaguda-based site (CTO-5), flagged specific procedural concerns under the U.S. regulatory framework. Dr.

Dr. Reddy's Laboratories has extended its partnership with Sanofi Healthcare to introduce Beyfortus, a novel drug aimed at preventing lower respiratory tract disease (LRTD) in newborns caused by the respiratory syncytial virus (RSV). The Hyderabad-based pharmaceutical company will have exclusive rights to promote and distribute the drug in India. Beyfortus, a monoclonal antibody-based prefilled injection, is already approved in various global markets and is expected to launch in India by the second quarter of FY25. This collaboration marks a significant step for Dr.