USFDA classifies Aurobindo Pharma arm Bhiwadi facility as OAI
Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has determined the inspection classification status of the Unit II, a Formulation manufacturing facility, of Eugia Pharma Specialities Ltd., a wholly owned subsidiary of the Company, situated at Bhiwadi, Alwar, Rajasthan as ‘Official Action Indicated (OAI).
The USFDA had inspected the facility from April 25th to May 3rd 2024 and issued 7 observations.
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"The United States Food and Drug Administration (US FDA) had conducted an inspection at UnitII, a Formulation manufacturing facility, of Eugia Pharma Specialities Ltd., a wholly owned subsidiary of the Company, situated at Bhiwadi, Alwar, Rajasthan, from April 25th to May 3rd 2024. Subsequently, the US FDA has determined the inspection classification status of this facility as ‘Official Action Indicated (OAI)," Aurobindo stated in a BSE filing.
OAI means regulatory and/or administrative actions are recommended.
"The company remains committed to work closely with the US FDA and continues to enhance its compliance on an ongoing basis," it further 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.
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