Aurobindo Pharma subsidiary API facility gets one USFDA observation

Hyderabad: Through a recent BSE filing, Aurobindo Pharma has informed that the United States Food and Drug Administration (US FDA) has concluded the inspection with one observation at Unit-VII, an API manufacturing
facility, of Apitoria Pharma Private Limited, a wholly owned subsidiary of the Company, situated at
Parwada Mandal, Anakapally District, Andhra Pradesh.

The inspection was conducted from May 5 to 10, 2024.

“The observation is of procedural in nature and will be
responded to within the stipulated time,” the Company stated.

Read also: Aurobindo Pharma arm gets 7 USFDA observations for Alwar facility

Medical Dialogues team had earlier reported 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.

Read also: Aurobindo Pharma arm gets 3 USFDA observations for AP injectable facility

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 receives tax demand of over Rs 13 crore, including interest, penalty

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