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Aurobindo Pharma arm Telangana injectable unit gets USFDA VAI classification
Telangana: Aurobindo Pharma has informed in a BSE filing that the injectable facility of Eugia SEZ Pvt. Ltd., a 100 per cent step-down subsidiary of Aurobindo Pharma Ltd., situated at Polepally Village, Jadcherla Mandal, Mahaboobnagar District, Telangana has received Establishment Inspection Report from the U.S. Food and Drug Administration (US FDA).
The US FDA has categorized the facility under "Voluntary Action Indicated" (VAI). VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
The USFDA had inspected the said facility from February 19 to February 29, 2024 and concluded an inspection with 7 observations.
Read also: USFDA issues 7 observations for Aurobindo Pharma arm Telangana injectable facility
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 25 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, supported by a strong R&D set-up.
Read also: Aurobindo Pharma unit partners with MSD to foray into contract manufacturing operations
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751