USFDA issues EIR for Aurobindo Pharma arm AP facility

Hyderabad: Aurobindo Pharma has announced that the U.S. Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) for Unit IV of APL Healthcare Limited, a wholly-owned subsidiary of the Company, situated in Andhra Pradesh, classifying it as 'voluntary action indicated' (VAI).

VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

USFDA had inspected the said facility from September 13 to September 19, 2023 and issued a ‘Form 483’ with 1 observation at the end of the inspection.

Read also: USFDA issues 1 observation for Aurobindo Pharma arm AP facility

"The U.S. Food and Drug Administration (FDA) had conducted an inspection at the 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, from September 13 to September 19, 2023," Aurobindo stated in a recent BSE filing.

"The Unit has now received Establishment Inspection Report classifying the facility as "Voluntary Action Indicated" ("VAI")," the Company added.

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.