Aurobindo Pharma Telangana facility gets VAI classification from USFDA
New Delhi: Aurobindo Pharma has announced that the company has received Voluntary Action Indicated (VAI) from the US health regulator for its Telangana-based manufacturing plant.
As per the information available on the United States Food and Drug Administration (USFDA) website, the company's Unit - IX, an API intermediate facility situated at Sangareddy District, Telangana, has now been classified as Voluntary Action Indicated (VAI), the drug maker said in a regulatory filing.
The USFDA had inspected the site from November 10 to November 18, 2022.
As per the USFDA, a VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
Read also: Aurobindo Pharma arm gets 2 USFDA observations for Unit I, III in Telangana
Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 24 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic.
Read also: Aurobindo Pharma arm gets USFDA nod for Azacitidine for Injection to treat myelodysplastic syndrome
