Aurobindo Pharma Limited, one of India’s leading pharmaceutical companies, recently underwent a routine inspection by the United States Food and Drug Administration (US FDA) at its Unit-XII facility in Bachupally, Telangana. The inspection, which covered both oral solids and injectable manufacturing units, took place from August 25 to September 5, 2025.
Following the inspection, the US FDA issued a Form 483 with a total of eight observations. The company clarified that all the observations were procedural in nature, and there were no major compliance or quality issues identified. Aurobindo Pharma stated that it will respond to the US FDA within the stipulated timelines.
The company emphasized its commitment to maintaining the highest quality standards across all manufacturing facilities globally. Furthermore, it confirmed that there is no impact on its financials or operations due to this inspection.
About Aurobindo Pharma:
Founded in 1986, Aurobindo Pharma is a major player in the global pharmaceutical market, specializing in generic pharmaceuticals, active pharmaceutical ingredients (APIs), and biotechnology products. Its manufacturing facilities across India and overseas comply with international regulatory standards, including those set by the US FDA.
