Aurobindo Pharma subsidiary API facility gets one USFDA observation
Hyderabad: Through a recent BSE filing, Aurobindo Pharma has informed that the United States Food and Drug Administration (US FDA) has concluded the inspection with one observation at Unit-VII, an API manufacturing facility, of Apitoria Pharma Private Limited, a wholly owned subsidiary of the Company, situated at Parwada Mandal, Anakapally District, Andhra Pradesh.
The inspection was conducted from May 5 to 10, 2024.
"The observation is of procedural in nature and will be responded to within the stipulated time," the Company stated.
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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.
