Dr Reddy's Labs gets USFDA VAI classification for Hyderabad RnD centre

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-02-13T15:00:22+05:30 | Updated On 22 March 2024 2:44 PM IST

Dr Reddys Bollaram Unit gets 7 USFDA Observations

Hyderabad: Dr Reddy's Laboratories has said the US health regulator has granted Voluntary Action Indicated (VAI) classification to its Hyderabad-based R&D centre post inspection. A VAI classification means objectionable conditions or practices were found but the agency was not prepared to take or recommend any administrative or regulatory action.

The drug major said its R&D centre -- Integrated Product Development Organisation -- in Bachupally, Hyderabad, underwent a Good Manufacturing Practice and pre-approval inspection by the US Food and Drug Administration (USFDA) in December 2023.

The USFDA has now classified that inspection as VAI, it added.

Last week, the drug major said the USFDA has issued VAI status to FTO-3, its largest formulations manufacturing plant in Bachupally and concluded the inspection as closed.

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.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751