USFDA grants VAI status to Dr Reddy's R&D centre in Hyderabad

Dr Reddy's Laboratories: Hyderabad-based pharmaceutical giant Dr Reddy's Laboratories on Monday, February 12, 2024, said that the United States Food and Drug Administration (USFDA) granted its Research and Development (R&D) centre a Voluntary Action Indicated (VAI) classification following an inspection. This classification indicates that while objectionable conditions or practices were identified, the agency did not find cause for administrative or regulatory action.

The specific facility in question, the Integrated Product Development Organisation located in Bachupally, Hyderabad, underwent rigorous scrutiny during a Good Manufacturing Practice and pre-approval inspection conducted by the USFDA in December 2023. Subsequently, the regulatory body designated the inspection as VAI, signifying a favorable outcome for the R&D center.

This announcement comes on the heels of another positive development for Dr Reddy's, as the company recently said that the USFDA also granted VAI status to its largest formulations manufacturing plant, FTO-3, located in Bachupally. Following this determination, the inspection of FTO-3 was concluded and marked as closed.

The shares of Dr Reddy's Laboratories surged 2.56 per cent, closing at Rs 6,309.95 apiece on the Bombay Stock Exchange (BSE) on Monday.

(With PTI inputs.)