USFDA issues 1 observation for Aurobindo Pharma arm AP facility
Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has issued a ‘Form 483’ with 1 observation at the end of the inspection at Unit IV, a Formulation manufacturing facility, of APL Healthcare Limited, a wholly-owned subsidiary of the Company, situated at Menakuru Village, Naidupeta Mandal, Tirupati District, Andhra Pradesh.
The inspection was held from September 13 to September 19, 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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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.
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