Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded a pre-approval inspection (PAI) with 5 observations at Eugia Steriles PrivateLimited, a 100% subsidiary of Eugia Pharma Specialities Limited and a stepdown subsidiary of the
Company, situated at Parawada Mandal, Anakapalli District, Andhra Pradesh.The inspection was conducted from February 10, 2025 to
February 18, 2025.”The observations are procedural in nature and will be
responded to within the stipulated time,” the Company stated in a BSE filing.Medical Dialogues team had earlier reported that the new injectable facility of Eugia Steriles Private Limited at Parawada Mandal had received the Establishment Inspection Report (EIR) from the USFDARead also: Aurobindo Pharma arm gets marketing authorisation for Zefylti in EUAurobindo 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.Read also: Aurobindo Pharma to Begin European Supply from China Facility in April