Aurobindo Pharma arm AP facility gets EIR from USFDA

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-09-18 06:00 GMT | Update On 2024-09-18 06:00 GMT

Hyderabad: Aurobindo Pharma has announced that the new injectable facility of Eugia Steriles Private Limited (a 100 percent subsidiary of Eugia Pharma Specialities Limited and a stepdown subsidiary of the Company), situated at Parawada Mandal, Anakapalli District, Andhra Pradesh has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA).

The USFDA had conducted a Pre-Approval Inspection (PAI) of the said injectable facility from March 28, 2024 to April 05, 2024.

"The Unit has now received the Establishment Inspection Report (EIR) and the inspection is closed," the Company stated in a BSE filing.

Medical Dialogues team had earlier reported that the inspection of the said facility had closed with 3 observations.

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 7 major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Aurobindo Pharma arm AP facility gets EIR from USFDA

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