Aurobindo Pharma arm Unit III facility gets USFDA OAI status
Hyderabad: Through a recent BSE filing, Aurobindo Pharma has informed that the United States Food and Drug Administration (US FDA) has determined the inspection classification status of Unit-III, a Formulation manufacturing facility, of Eugia Pharma Specialities Ltd., a wholly owned subsidiary of the Company, situated at Pashamylaram, Patancheru Mandal, Sangareddy District, Telangana as ‘Official Action Indicated (OAI)’
“The company remains committed to work closely with the US FDA and continues to enhance its
compliance on an ongoing basis,” the Company stated.
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 arm Telangana facility gets 9 USFDA observations
