USFDA concludes inspection at Aurobindo Pharma arm Unit I, III with zero observations

Published On 2023-11-18 07:00 GMT | Update On 2023-11-18 11:26 GMT

Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has closed the Pre-Approval Inspection (PAI) with zero observations at the Unit-I & III, Formulation manufacturing facility, of APL Healthcare Ltd., a wholly-owned subsidiary of the Company, situated at TSIIC Green Industrial Park, Pollepally Village, Jedcharla Mandal, Mahabubnagar District, Telangana, 509302.

The inspection was conducted from November 13 to 17, 2023.

"The inspection closed with zero observations and a classification of “No Action Indicated” (NAI)," the Company stated in a recent BSE filing. NAI means no objectionable conditions or practices were found during the inspection.

Aurobindo Pharma Limited, headquartered in Hyderabad, India, develops, manufactures, and distributes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, EU, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s product portfolio is spread over therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic. The Company is marketing these products globally in over 150 countries.

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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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USFDA concludes inspection at Aurobindo Pharma arm Unit I, III with zero observations

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