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 2024-02-13 09:30 GMT   |   Update On 2024-03-22 09:14 GMT

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...

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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.

Read also: Dr Reddy's Labs gets USFDA EIR for Bachupally facility

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.

Read also: Dr Reddy's Labs posts 11 percent increase in Q3 profit at Rs 1379 crore 

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