Dr Reddy's Labs gets 8 USFDA observations for Duwada facilities
Hyderabad: Drugmaker, Dr. Reddy's Laboratories has recently announced that the U. S. Food and Drug Administration (USFDA) has concluded an audit with 8 observations at its formulations manufacturing facilities (FTO 7 & FTO 9) at Duwada, Visakhapatnam.
"We have been issued a Form 483 with 8 (eight) observations, which we will address within the stipulated timeline," the company said in a BSE filing.
Medical Dialogues team had earlier reported that Dr. Reddy's Laboratories had received Form 483 with three observations from US health regulator after inspection at its manufacturing facility in Middleburg, New York.
Read also: Dr Reddy's Labs Gets USFDA 3 Observations For New York API Facility
Dr. Reddy's Laboratories Ltd. is an integrated pharmaceutical company headquartered in Hyderabad, Telangana, India. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management, and dermatology.
