Aurobindo Pharma arm AP facility gets EIR from USFDA
Hyderabad: Aurobindo Pharma has announced that the new injectable facility of Eugia Steriles Private Limited (a 100 percent subsidiary of Eugia Pharma Specialities Limited and a stepdown subsidiary of the Company), situated at Parawada Mandal, Anakapalli District, Andhra Pradesh has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA).
The USFDA had conducted a Pre-Approval Inspection (PAI) of the said injectable facility from March 28, 2024 to April 05, 2024.
"The Unit has now received the Establishment Inspection Report (EIR) and the inspection is closed," the Company stated in a BSE filing.
Read also: Aurobindo Pharma step-down arm AP facility gets product approval from USFDA
Medical Dialogues team had earlier reported that the inspection of the said facility had closed with 3 observations.
Read also: Aurobindo Pharma arm gets 3 USFDA observations for AP 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 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 7 major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.
Read also: Aurobindo Pharma, Glenmark and 1 other recall products in US market over production issue: USFDA
