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Aurobindo Pharma arm Telangana facility concludes USFDA inspection with zero observations
Hyderabad: Aurobindo Pharma has recently announced that the United States Food and Drug Administration (USFDA) has closed the inspection with zero observations and a classification of No Action Indicated (NAI) at Unit I, a Formulation manufacturing facility, of Eugia Pharma Specialities Ltd., a wholly-owned subsidiary of the Company, situated at Koltur Village, Shameerpet, Medchal...
Hyderabad: Aurobindo Pharma has recently announced that the United States Food and Drug Administration (USFDA) has closed the inspection with zero observations and a classification of No Action Indicated (NAI) at Unit I, a Formulation manufacturing facility, of Eugia Pharma Specialities Ltd., a wholly-owned subsidiary of the Company, situated at Koltur Village, Shameerpet, Medchal District, Telangana.
No Action Indicated (NAI) means no objectionable conditions or practices were found during the inspection (or the objectionable conditions found do not justify further regulatory action),
The US FDA inspected the said facility from 17th July to 26thth July 2023.
Read also: Aurobindo Pharma gets 3 USFDA observations for Telangana facility
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.
Read also: Aurobindo Pharma gets USFDA EIR for Anakapalli facility
Ruchika Sharma joined Medical Dialogue as an Desk Editor 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