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USFDA completes inspection at Aurobindo Pharma’s arm's API manufacturing facility in Telangana
Aug-30-2025

The United States Food and Drug Administration (USFDA) has inspected Unit-I, an API manufacturing facility, of Apitoria Pharma, a wholly owned subsidiary of Aurobindo Pharma, situated at Borpatla Village, Hatnoor Mandal, Sangareddy District, Telangana from August 21, 2025 to August 29, 2025.

At the end of the current inspection, a ‘Form 483’ was issued with 5 observations which are procedural in nature and no data integrity issues were reported. The company will respond to the US FDA within the stipulated timelines. The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe. 

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.


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