USFDA concludes inspection at Aurobindo Pharma Telangana facility with zero observations
Telangana: Aurobindo Pharma has announced that the United States Food and Drug Administration (USFDA) has concluded the Pre-Approval Inspection (PAI) with zero observations at the Company's Unit VII, a Formulation Manufacturing facility situated at Jedcherla Mandal, Mahaboob Nagar District, Telangana.
The facility was inspected from July 28 to August 4, 2023.
"The inspection closed with zero observations and a classification of No Action Indicated (NAI)," the Company stated in a BSE filing. NAI means no objectionable conditions or practices were found during the inspection.
Medical Dialogues team had earlier reported that the USFDA had issued Form 483 with 2 observations at the end of the inspection at the Company's wholly owned subsidiary, APL Health Care Limited’s Unit I & III, an Orals (Tablets, Capsules and Soft gel Capsules) and Derma Manufacturing facility located at Jadcherla, Mahabub Nagar District, Telangana.
Read also: Aurobindo Pharma arm gets 2 USFDA observations for Unit I, III in Telangana
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.
