Aurobindo Pharma arm New Jersey facility gets 10 USFDA observations

Published On 2023-12-25 06:52 GMT | Update On 2023-12-26 15:39 GMT

Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has closed a Pre-Approval Inspection (PAI) with ten observations at the new injectable facility of Eugia US Manufacturing LLC, a step-down wholly owned subsidiary of Aurobindo Pharma Ltd., situated at East Windsor, New Jersey, USA.

The inspection was conducted from December 11 to December 22, 2023.

"The observations are procedural in nature and will be responded to within the stipulated time. The plant is yet to start commercial operations," Aurobindo informed in a recent BSE filing.

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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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 New Jersey facility gets 10 USFDA observations

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