USFDA issues EIR for Dr Reddy's Labs Hyderabad facility
Hyderabad: 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 its API manufacturing facility (CTO-2) in Bollaram, 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).
In November, the US health regulator issued a Form 483 with seven observations to its active pharmaceutical ingredient manufacturing facility in Bollaram, Hyderabad.
Read also: USFDA Inspection: Dr Reddy's gets Form 483 with 7 observations for Bollaram facility
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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