Aurobindo Pharma arm gets 7 USFDA observations for Alwar facility
Telangana: Aurobindo Pharma has informed in a recent BSE filing that the United States Food and Drug Administration (US FDA) has concluded an inspection with 7 observations at Unit-II, a Formulation manufacturing facility, of Eugia Pharma Specialities Ltd., a wholly-owned subsidiary of the Company, situated at Bhiwadi, Alwar, Rajasthan.
The inspection was held from April 25th to May 3 rd 2024.
"The observations are procedural in nature and will be responded to within the stipulated time," the Compay stated.
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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 arm gets 3 USFDA observations for AP injectable facility
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