USFDA Grants VAI to Dr Reddy's R&D Center - Hyderabad
By Rediff Money Desk, NEWDELHI Feb 12, 2024 16:24
Dr Reddy's Laboratories' Hyderabad R&D center receives VAI classification from USFDA following inspection. The classification indicates no immediate regulatory action.
New Delhi, Feb 12 (PTI) 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.
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.
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