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
Advertisement

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.
Advertisement
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 

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News