Aurobindo Pharma arm gets 3 USFDA observations for AP injectable facility
Hyderabad: In a recent BSE filing, Aurobindo Pharma has informed that the new injectable facility of Eugia Steriles Private Limited, a 100% subsidiary of Eugia Pharma
Specialities Limited and a stepdown subsidiary of the Company, situated at Parawada Mandal, Anakapalli
District, Andhra Pradesh, has recently started the commercial operations.
The United States Food and Drug Administration (US FDA) inspected the above-mentioned facility from
March 28, 2024 to April 05, 2024.
The inspection closed with 3 observations.
“The observations are
procedural in nature and will be responded to within the stipulated time,” the Company 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 announces successful Phase 1 clinical study outcome of their BP11 product
