Aurobindo Pharma arm New Jersey facility gets 10 USFDA observations
Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has closed a Pre-Approval Inspection (PAI) with ten observations at the new injectable facility of Eugia US Manufacturing LLC, a step-down wholly owned subsidiary of Aurobindo Pharma Ltd., situated at East Windsor, New Jersey, USA.
The inspection was conducted from December 11 to December 22, 2023.
"The observations are procedural in nature and will be responded to within the stipulated time. The plant is yet to start commercial operations," Aurobindo informed in a recent BSE filing.
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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.
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