Dr Reddy's Labs gets USFDA EIR for Bachupally facility
Hyderabad: Pharma major Dr Reddy's Labs has announced that the Company has received the Establishment Inspection Report (EIR) from the United States Food & Drug Administration (USFDA) for formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad.
The USFDA has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is "closed" under 21 CFR 20.64(d)(3).
Voluntary action indicated (VAI), means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action
Medical Dialogues team had earlier reported that the USFDA had completed an inspection with ten observations at the company's formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad.
Established in 1984, Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. The Company offer 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 major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe.
Read also: Dr Reddy's Labs posts 11 percent increase in Q3 profit at Rs 1379 crore
