Aurobindo Pharma arm Eugia Steriles gets 5 UFSDA observations

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-02-19 06:00 GMT   |   Update On 2025-02-19 06:00 GMT

Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded a pre-approval inspection (PAI) with 5 observations at Eugia Steriles PrivateLimited, a 100% subsidiary of Eugia Pharma Specialities Limited and a stepdown subsidiary of the Company, situated at Parawada Mandal, Anakapalli District, Andhra Pradesh.

The inspection was conducted from February 10, 2025 to February 18, 2025.
"The observations are procedural in nature and will be responded to within the stipulated time," the Company stated in a BSE filing.
Medical Dialogues team had earlier reported that the new injectable facility of Eugia Steriles Private Limited at Parawada Mandal had received the Establishment Inspection Report (EIR) from the USFDA

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 29 manufacturing and packaging facilities that are approved by 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 seven major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic.

Read also: Aurobindo Pharma to Begin European Supply from China Facility in April

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