Aurobindo Pharma arm Telangana facility concludes USFDA inspection with zero observations
Hyderabad: Aurobindo Pharma has recently announced that the United States Food and Drug Administration (USFDA) has closed the inspection with zero observations and a classification of No Action Indicated (NAI) at Unit I, a Formulation manufacturing facility, of Eugia Pharma Specialities Ltd., a wholly-owned subsidiary of the Company, situated at Koltur Village, Shameerpet, Medchal District, Telangana.
No Action Indicated (NAI) means no objectionable conditions or practices were found during the inspection (or the objectionable conditions found do not justify further regulatory action),
The US FDA inspected the said facility from 17th July to 26thth July 2023.
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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.
Read also: Aurobindo Pharma gets USFDA EIR for Anakapalli facility
