Dr Reddy's Labs gets USFDA EIR for Duvvada formulations manufacturing facilities

Hyderabad: Dr Reddy's Labs has informed in a BSE filing that the Company has received the Establishment Inspection Report (EIR) from the United States Food & Drug Administration (USFDA) for its formulations manufacturing facilities (FTO-7 & FTO-9) in Duvvada, Visakhapatnam.

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).

VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action or

The USFDA had conducted a routine GMP inspection from 8th May to 17th May, 2024 and concluded it with two observations.

Read also: Dr Reddy's Labs gets 2 USFDA observations for Duvvada facilities

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.

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