Aurobindo Pharma arm Telangana facility gets 10 USFDA observations
Telangana: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has issued ten observations at the closure of the inspection at the Unit-II, an API manufacturing facility, of Apitoria Pharma Private Limited, a wholly owned subsidiary of the Company, situated at Gaddapotharam Village IDA, Jinnaram Mandal, Sanga Reddy District, Telangana
The inspection was held from September 23 to 27, 2024.
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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