Aurobindo Pharma arm gets USFDA EIR for Telangana unit
Telangana: Apitoria Pharma Private Limited, a wholly owned subsidiary of Aurobindo Pharma, has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (US FDA) for the Unit-V, an API manufacturing facility situated at Telangana.
The inspection was held from December 09 to December 17, 2024. In December, the company received 2 observations for Unit-V from the USFDA.
"The U.S. Food and Drug Administration (US FDA) had conducted an inspection at the Unit-V, an API manufacturing facility, of Apitoria Pharma Private Limited, a wholly owned subsidiary of the Company, situated at Pashamylaram Village, Patancheru Mandal, Sanga Reddy District, Telangana from December 09 to December 17, 2024. The Unit has now received Establishment Inspection Report classifying the facility as "Voluntary Action Indicated" ("VAI")," Aurobindo stated in a BSE filing.
Read also: USFDA inspection: Aurobindo Pharma arm Telangana facility gets 2 observations
VAI means 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 marketing authorisation for Zefylti in EU
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 29 manufacturing and packaging facilities that are approved by 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 seven major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic.
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