Dr Reddy's Labs receives EIR for Nalgonda-based API plant
New Delhi: Dr Reddy's Laboratories has announced that it has received an establishment inspection report (EIR) from the US health regulator for its Nalgonda-based active pharmaceutical ingredient (API) manufacturing unit.
"With regard to the audit of our API manufacturing plant 5 at Miryalaguda, Nalgonda district, Telangana, we would like to inform you that we have received the EIR from the USFDA, for the above-referred facility, indicating closure of the audit," the Hyderabad-based company said in a regulatory filing.
The inspection classification of this facility is determined as "voluntary action indicated" (VAI), it added.
USFDA issues an EIR to a company when an inspection is satisfactorily closed.
Dr Reddy's Laboratories Ltd. is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.
Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology.
Dr Reddy's operates in markets across the globe. Its major markets include – USA, India, Russia & CIS countries, and Europe.