USFDA concludes inspection at Aurobindo Pharma arm Unit I, III with zero observations
Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has closed the Pre-Approval Inspection (PAI) with zero observations at the Unit-I & III, Formulation manufacturing facility, of APL Healthcare Ltd., a wholly-owned subsidiary of the Company, situated at TSIIC Green Industrial Park, Pollepally Village, Jedcharla Mandal, Mahabubnagar District, Telangana, 509302.
The inspection was conducted from November 13 to 17, 2023.
"The inspection closed with zero observations and a classification of “No Action Indicated” (NAI)," the Company stated in a recent BSE filing. NAI means no objectionable conditions or practices were found during the inspection.
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Aurobindo Pharma Limited, headquartered in Hyderabad, India, develops, manufactures, and distributes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, EU, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s product portfolio is spread over therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic. The Company is marketing these products globally in over 150 countries.
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