Aurobindo Pharma gets 1 USFDA observation for Sangareddy facility
Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (USFDA) has issued 1 observation after the inspection at Unit VI - B, a Formulation manufacturing facility of the Company, situated at Chitkul Village, Patancheru Mandal, Sangareddy District, Telangana.
The facility was inspected between September 22 to September 29, 2023.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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Medical Dialogues team had earlier reported that the Company had received Voluntary Action Indicated (VAI) from the US health regulator for its Telangana-based manufacturing plant.
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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 multiple therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.
