USFDA inspection: Aurobindo Pharma receives 8 observations for Unit-XII

Telangana: Aurobindo Pharma has announced that the company has received eight observations from the United States Food and Drug Administration (US FDA) for its Unit-XII, which includes both oral solids and injectable manufacturing unit, situated at Bachupally, Medchal Malkajgiri District, 500090, Telangana. The facility was inspected from August 25 to September 05, 2025. "At the end of the current inspection, a ‘Form 483’ was issued with a total of 8 observations for both (oral solids & injectable)," the company stated in a BSE filing. All observations are procedural in nature. "We 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 added. Headquartered in Hyderabad, India, Aurobindo Pharma Ltd. is a leading global pharmaceutical company with operations spanning active pharmaceutical ingredients (APIs), generics, and biosimilars. CuraTeQ Biologics is its wholly owned subsidiary focused on biosimilars for oncology and other therapeutic areas, enhancing Aurobindo’s footprint in biologics markets in Europe and beyond. Read also: Aurobindo Pharma in lead to acquire Zentiva for US 5.5 billion: ET Report