USFDA issues 7 observations for Aurobindo Pharma arm Telagana injectable facility
Telangana: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded an inspection with 7 observations at the injectable facility of Eugia SEZ Pvt. Ltd., a 100% step-down subsidiary of Aurobindo Pharma Ltd., situated at Polepally Village, Jadcherla Mandal, Mahaboobnagar District, Telangana.
"The observations are procedural in nature and will be responded to within the stipulated time," the Company stated.
In addition to this, the Company has informed that Eugia Pharma Specialities Limited has restarted production in its terminally sterilized product lines at its Unit-III, that was temporarily stopped to address some of the observations of USFDA in their recent inspection concluded on 2nd February 2024. The Company expects to start the production in the aseptic lines of the facility in the month of March 2024.
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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