USFDA grants VAI classification to Dr Reddy's R&D centre

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.

Dr Reddy's Laboratories on Monday 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. Shares of the drugmaker on Monday ended 2.56 per cent up at Rs 6,309.95 apiece on the BSE.